How is Rocephin administered. What are the common side effects of Rocephin. When should you seek medical attention while using Rocephin. How does Rocephin interact with other medications. What precautions should be taken when using Rocephin.

Understanding Rocephin: A Powerful Antibiotic

Rocephin, also known by its generic name ceftriaxone, is a potent antibiotic belonging to the cephalosporin class. This injectable medication is widely used to treat various bacterial infections and prevent surgical site infections. Its broad-spectrum activity makes it an invaluable tool in modern medicine, but it’s crucial to understand its proper use, potential side effects, and important precautions.

What is Rocephin Used For?

Rocephin is prescribed for a range of bacterial infections, including:

• Lower respiratory tract infections
• Urinary tract infections
• Skin and soft tissue infections
• Bone and joint infections
• Meningitis
• Sexually transmitted infections, such as gonorrhea
• Intra-abdominal infections
• Surgical prophylaxis

Its effectiveness against both gram-positive and gram-negative bacteria makes it a versatile choice for healthcare providers.

Administration and Dosage Guidelines

Proper administration of Rocephin is crucial for its effectiveness and safety. How is Rocephin typically administered. Rocephin is usually given as an intramuscular injection or intravenous infusion. The exact method, dosage, and duration of treatment depend on the type and severity of the infection, as well as the patient’s age, weight, and overall health status.

Key Points for Administration:

1. Rocephin should be administered exactly as prescribed by a healthcare professional.
2. It may be mixed with a diluent before use, following strict guidelines for preparation.
3. The medication should not be mixed with calcium-containing solutions or other incompatible substances.
4. Patients receiving home injections must be properly trained in sterile technique and proper disposal of medical waste.
5. The full course of antibiotics should be completed, even if symptoms improve before the end of treatment.

Potential Side Effects and Adverse Reactions

While Rocephin is generally well-tolerated, it can cause side effects in some patients. What are the most common side effects of Rocephin. The most frequently reported side effects include:

• Injection site reactions (swelling, redness, or pain)
• Gastrointestinal disturbances (nausea, diarrhea, or abdominal pain)
• Headache
• Dizziness
• Rash or itching

These side effects are usually mild and transient. However, more serious adverse reactions can occur, albeit rarely.

Serious Side Effects Requiring Immediate Medical Attention

When should you seek immediate medical attention while using Rocephin. Patients should contact their healthcare provider immediately if they experience:

• Severe allergic reactions (anaphylaxis)
• Severe diarrhea or bloody stools
• Unusual bleeding or bruising
• Yellowing of the skin or eyes (jaundice)
• Signs of kidney problems (changes in urination)
• Neurological symptoms (seizures, confusion, or uncontrollable movements)

Prompt medical attention in these cases can prevent potentially life-threatening complications.

Drug Interactions and Precautions

Understanding potential drug interactions is crucial for patient safety. How does Rocephin interact with other medications. Rocephin can interact with various substances, including:

• Calcium-containing products
• Oral anticoagulants
• Oral contraceptives
• Probenecid

These interactions can affect the efficacy of Rocephin or increase the risk of side effects. Patients should inform their healthcare provider about all medications, supplements, and herbal products they are taking.

Special Precautions for Specific Patient Groups

What precautions should be taken when using Rocephin in special populations. Certain groups require additional monitoring or dosage adjustments:

• Pregnant and breastfeeding women
• Elderly patients
• Patients with renal or hepatic impairment
• Individuals with a history of gastrointestinal diseases
• Patients with known allergies to cephalosporins or penicillins

Healthcare providers should carefully assess the risk-benefit ratio in these populations before prescribing Rocephin.

Monitoring and Follow-up During Treatment

Regular monitoring is essential to ensure the effectiveness of Rocephin treatment and to detect any potential complications early. What types of monitoring are typically required during Rocephin therapy. Healthcare providers may recommend:

• Blood tests to check liver and kidney function
• Prothrombin time monitoring in patients on anticoagulant therapy
• Periodic assessment of bacterial susceptibility in long-term treatments
• Monitoring for signs of superinfection

Patients should attend all scheduled follow-up appointments and report any new or worsening symptoms promptly.

Proper Storage and Handling of Rocephin

Correct storage and handling of Rocephin are crucial for maintaining its efficacy and safety. How should Rocephin be stored and handled. Key points include:

• Store unopened vials at room temperature, protected from light
• Once reconstituted, use within specified time limits based on storage conditions
• Do not use if the solution is cloudy or contains particles
• Follow proper disposal procedures for used vials and needles

Healthcare facilities and patients administering Rocephin at home should adhere to these guidelines strictly to ensure the medication’s integrity.

Alternatives and Comparative Efficacy

While Rocephin is highly effective for many bacterial infections, it’s not always the first-line treatment. What are some alternatives to Rocephin, and how do they compare in efficacy. Alternative antibiotics may include:

• Other cephalosporins (e.g., cefotaxime, cefepime)
• Fluoroquinolones (e.g., ciprofloxacin, levofloxacin)
• Carbapenems (e.g., meropenem, imipenem)
• Penicillin derivatives (e.g., piperacillin-tazobactam)

The choice of antibiotic depends on factors such as the specific pathogen, local resistance patterns, patient allergies, and the site of infection. In some cases, combination therapy may be necessary for optimal treatment outcomes.

Comparative Studies and Clinical Guidelines

Numerous clinical studies have compared Rocephin to other antibiotics for various indications. For example, in the treatment of community-acquired pneumonia, Rocephin has shown comparable efficacy to respiratory fluoroquinolones. In managing complicated urinary tract infections, it has demonstrated non-inferiority to newer cephalosporins like ceftazidime-avibactam.

Clinical guidelines often recommend Rocephin as a first-line or alternative treatment for many infections, particularly in settings where broad-spectrum coverage is needed or when oral antibiotics are not suitable. Its once-daily dosing regimen also offers an advantage in terms of patient compliance and resource utilization in healthcare settings.

Future Developments and Research

As antibiotic resistance continues to be a global health concern, ongoing research is crucial to maintain the effectiveness of antibiotics like Rocephin. What future developments can we expect in the field of antibiotic therapy. Current areas of research include:

• Development of new beta-lactamase inhibitors to combat resistance mechanisms
• Investigation of novel drug delivery systems for improved tissue penetration
• Exploration of combination therapies to enhance efficacy and reduce resistance development
• Studies on optimal dosing strategies to maximize therapeutic effect while minimizing side effects

Additionally, there is growing interest in the potential role of Rocephin in treating certain viral infections, such as Lyme disease, when co-infections with bacteria are present. These emerging areas of research may expand the utility of Rocephin in the future.

Antibiotic Stewardship and Rocephin

The responsible use of Rocephin is a key component of antibiotic stewardship programs worldwide. How can healthcare providers and patients contribute to antibiotic stewardship when using Rocephin. Important strategies include:

• Reserving Rocephin for infections where it is truly needed
• Using the most narrow-spectrum antibiotic effective for the diagnosed infection
• Adhering to recommended treatment durations
• Educating patients about the importance of completing the full course of antibiotics
• Implementing robust infection control measures to prevent the spread of resistant organisms

By following these principles, the medical community can help preserve the effectiveness of Rocephin and other critical antibiotics for future generations.

Patient Education and Empowerment

Effective patient education is crucial for the safe and successful use of Rocephin. How can patients be empowered to take an active role in their treatment with Rocephin. Key aspects of patient education should include:

• Understanding the importance of completing the full course of antibiotics
• Recognizing and reporting potential side effects
• Proper technique for self-administration, if applicable
• Awareness of potential drug interactions and dietary restrictions
• The role of follow-up appointments and monitoring tests

Healthcare providers should take the time to discuss these points with patients, providing written materials and demonstrating proper administration techniques when necessary. Patient engagement can significantly improve treatment outcomes and reduce the risk of complications.

Cultural Considerations and Health Literacy

When educating patients about Rocephin, it’s essential to consider cultural factors and health literacy levels. Materials should be available in multiple languages and at appropriate reading levels. Visual aids, such as diagrams or videos, can be particularly helpful for demonstrating proper injection techniques or explaining complex concepts.

Additionally, healthcare providers should be sensitive to cultural beliefs or practices that may affect a patient’s willingness to use injectable medications or adhere to certain treatment regimens. Open communication and a respectful approach can help address concerns and ensure optimal patient care.

Economic Considerations and Access to Rocephin

While Rocephin is a highly effective antibiotic, economic factors can impact its availability and use in different healthcare settings. How do economic considerations affect access to Rocephin globally. Several factors come into play:

• Cost of the medication and associated administration supplies
• Availability of generic versions and their quality
• Healthcare system infrastructure for administering injectable medications
• Insurance coverage and reimbursement policies
• National and institutional formulary decisions

In some regions, the cost of Rocephin may limit its use to more severe infections or as a second-line therapy. Efforts to improve global access to essential antibiotics like Rocephin are ongoing, involving collaborations between pharmaceutical companies, governments, and international health organizations.

Cost-Effectiveness Analysis

Numerous studies have examined the cost-effectiveness of Rocephin compared to other antibiotics or treatment strategies. In many cases, the higher upfront cost of Rocephin may be offset by factors such as:

• Reduced length of hospital stay
• Lower risk of treatment failure and subsequent complications
• Decreased need for additional medications or interventions
• Improved patient outcomes and quality of life

These analyses help inform policy decisions and treatment guidelines, ensuring that healthcare resources are used efficiently while providing optimal patient care.

Rocephin Injection: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Swelling, redness, or pain at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, unusual tiredness, symptoms of gallbladder disease (such as stomach/abdominal pain, nausea, vomiting), signs of kidney problems (such as change in the amount of urine), pink/bloody/dark urine, painful/frequent urination, back/side pain, yellowing eyes/skin, uncontrollable movements, mental/mood changes (such as confusion), seizures.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn’t stop, abdominal or stomach pain/cramping, blood/mucus in your stool.

Do not use anti-diarrhea or opioid medications if you have any of these symptoms because these products may make them worse.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

If ceftriaxone is mixed with a numbing medication (such as lidocaine) before injection into a muscle, it may rarely cause a serious blood problem (methemoglobinemia). Get medical help right away if you have any very serious side effects, including: pale/gray/blue skin, fast heartbeat, shortness of breath.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US –

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Rocephin (Ceftriaxone (Injection)) – Side Effects, Interactions, Uses, Dosage, Warnings

Use Rocephin (Ceftriaxone (Injection)) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Ceftriaxone is injected into a muscle or as an infusion into a vein (IV). A healthcare provider will give you this injection when ceftriaxone is used to prevent infection from surgery. You may be shown how to use the injection at home to treat an infection.

Read and carefully follow any Instructions for Use provided with your medicine. You may need to mix ceftriaxone with a liquid (diluent) before using it. When using injections by yourself, be sure you understand how to properly mix and store the medicine.

Prepare an injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Do not mix ceftriaxone in the same injection with other antibiotics, or with any diluent that contains calcium, including a TPN (total parenteral nutrition) solution.

If you use other injectable medications, be sure to flush your intravenous catheter between injections of each medication.

Drink plenty of liquids to keep your kidneys working properly while using ceftriaxone.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Ceftriaxone will not treat a viral infection such as the flu or a common cold.

Ceftriaxone can affect the results of certain medical tests. Tell any doctor who treats you that you are using ceftriaxone.

After mixing ceftriaxone with a diluent, you must use the medicine within a certain number of hours or days. This will depend on the diluent and how you store the mixture (at room temperature, in a refrigerator, or frozen). Carefully follow all mixing and storage instructions provided with your medicine. Ask your pharmacist if you have questions.

If your medicine was provided in a frozen form, thaw it in a refrigerator or at room temperature. Do not warm in a microwave or boiling water. Use the medicine as soon as possible after thawing it. Do not refreeze.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Rocephin – Uses, Side Effects, Interactions

How does this medication work? What will it do for me?

Ceftriaxone belongs to the family of antibiotics known as cephalosporins. It is used to prevent or treat certain infections caused by bacteria. It is given by injection only into a muscle or vein.

Ceftriaxone is often used to treat infections of the lung, urinary tract, skin, abdomen, bone, joint, and lining of the brain (meningitis), depending on the bacteria causing them. It can also be used to treat gonorrhea (a sexually transmitted infection).

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Rocephin is no longer being manufactured for sale in Canada. For brands that may still be available, search under ceftriaxone. This article is being kept available for reference purposes only. If you are using this medication, speak with your doctor or pharmacist for information about your treatment options.

How should I use this medication?

To treat bacterial infections, the recommended dose and dosing schedule of ceftriaxone varies according to the specific infection being treated, the response to therapy, and other medications or treatments being used. The dose administered is also based on age, body size, and kidney and liver function. For moderate to severe infections in adults, the dose ranges from 1 g to 2 g daily given once every 24 hours or divided into 2 equal doses and given every 12 hours.

For uncomplicated gonorrhea in adults, one dose of 250 mg is injected into a muscle.

For children 12 years of age and under, the dose is based on body weight and is given every 12 hours. The maximum daily dose for adults and children is 4 g. The duration of treatment depends on the type of infection and usually ranges from 4 to 14 days. Some infections require only one dose while others require treatment for several weeks.

Ceftriaxone is injected into a vein or into a muscle by a health care professional under the supervision of your doctor.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.

Store this medication (as unmixed vials) at room temperature, protect it from light, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not use this medication if you:

• are allergic to ceftriaxone or any ingredients of this medication
• are allergic to other cephalosporins (e.g., cephalexin) or penicillins (e.g., penicillin, amoxicillin)
  • the risk of developing a reaction to ceftriaxone given a history of cephalosporin or penicillin allergy is relatively low, but check with your health care provider before starting treatment

Do not give this medication to a newborn or premature infant who has high amounts of bilirubin in their blood.

Do not give this medication to a newborn who is receiving (or expected to receive) calcium-containing intravenous solutions (calcium-containing solutions should not be given within 5 days of ceftriaxone in infants up to 10 weeks of age).

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• dizziness
• headache
• mild diarrhea

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• chills
• fever
• pain, redness, and swelling at site of injection
• rash

Stop taking the medication and seek immediate medical attention if any of the following occur:

• severe, persistent diarrhea
• symptoms of a severe allergic reaction, e.g.:
  • difficulty breathing
  • hives
  • swelling of the mouth, throat, or tongue

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergic reactions: Ceftriaxone can cause severe allergic reactions. If you develop symptoms of a severe allergic reaction (hives; difficulty breathing; swelling of the mouth, tongue, or throat), get immediate medical attention.

Anemia: Although rare, certain drugs can cause a blood condition called hemolytic anemia, where people have low red blood cells due to premature destruction of this type of blood cell. If you have a history of cephalosporin-related hemolytic anemia, you should talk to your doctor before starting treatment.

Blood tests: Depending on various factors, including how long you will be receiving treatment, your doctor may order blood tests while you are taking ceftriaxone.

Calcium-containing solutions: The interaction with calcium-containing solutions has only been reported for newborns. For all other people, ceftriaxone can be administered before or after calcium-containing solutions provided that the infusion lines are flushed well in between the solutions. In newborns, calcium-containing solutions should not be given within 5 days for infants up to 10 weeks of age.

Gallbladder disease: If you have gallbladder disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney problems: Ceftriaxone may cause kidney stones. If you have high calcium levels in your urine or a history of kidney stones, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Low vitamin K: People with impaired vitamin K synthesis or low vitamin K stores (e.g., chronic liver disease and malnutrition) may require monitoring of blood clotting during treatment, as ceftriaxone may decrease clotting ability.

Overgrowth of organisms: Treatment with this antibiotic may allow normal fungus or types of bacteria not killed by the antibiotic to overgrow, causing unwanted infections.

Stomach and bowel disorders: If you have stomach and bowel problems (especially colitis), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: Ceftriaxone passes into breast milk in small amounts. If you are a breast-feeding mother and are taking ceftriaxone, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: Newborn and premature infants (up to the age of 10 weeks) should not receive calcium-containing solutions within 5 days of receiving ceftriaxone.

What other drugs could interact with this medication?

There may be an interaction between ceftriaxone and any of the following:

• anticoagulant medications (e.g., warfarin)
• solutions injected into a vein that contain calcium
• typhoid vaccine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2021. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Rocephin

Rocephin 250mg Powder for Solution for Injection – Patient Information Leaflet (PIL)

Rocephin 2 g Powder for solution for injection or infusion

Rocephin 1 g Powder for solution for injection or infusion

Rocephin 250 mg Powder for solution for injection

Ceftriaxone (as ceftriaxone sodium)

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Rocephin is and what it is used for

2. What you need to know before you are given Rocephin

3. How Rocephin is given

4. Possible side effects

5. How to store Rocephin

6. Contents of the pack and other information

Rocephin is an antibiotic given to adults and children (including newborn babies). It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

Rocephin is used to treat infections of

• the brain (meningitis).
• the lungs.
• the middle ear.
• the abdomen and abdominal wall (peritonitis).
• the urinary tract and kidneys.
• bones and joints.
• the skin or soft tissues.
• the blood.
• the heart.

It can be given:

• to treat specific sexually transmitted infections (gonorrhoea and syphilis).
• to treat patients with low white blood cell counts (neutropenia) who have fever due to bacterial infection.
• to treat infections of the chest in adults with chronic bronchitis.
• to treat Lyme disease (caused by tick bites) in adults and children including newborn babies from 15 days of age.
• to prevent infections during surgery.

• You are allergic to ceftriaxone or any of the other ingredients of this medicine (listed in section 6).
• You have had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, carbapenems or monobactams). The signs include sudden swelling of the throat or face which might make it difficult to breath or swallow, sudden swelling of the hands, feet and ankles, and a severe rash that develops quickly.
• You are allergic to lidocaine and you are to be given Rocephin as an injection into a muscle.

• The baby is premature.
• The baby is newborn (up to 28 days of age) and has certain blood problems or jaundice (yellowing of the skin or the whites of the eyes) or is to be given a product that contains calcium into their vein.

Talk to your doctor or pharmacist or nurse before you are given Rocephin if:

• You have recently received or are about to receive products that contain calcium.
• You have recently had diarrhoea after having an antibiotic medicine. You have ever had problems with your gut, in particular colitis (inflammation of the bowel).
• You have liver or kidney problems (see section 4).
• You have gall stones or kidney stones
• You have other illnesses, such as haemolytic anaemia (a reduction in your red blood cells that may make your skin pale yellow and cause weakness or breathlessness).
• You are on a low sodium diet.
• You experience or have previously experienced a combination of any of the following symptoms: rash, red skin, blistering of the lips eyes and mouth, skin peeling, high fever, flu-like symptoms, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (signs of severe skin reactions, see also section 4 “Possible side effects”).

If you are given Rocephin for a long time, you may need to have regular blood tests. Rocephin can affect the results of urine tests for sugar and a blood test known as the Coombs test. If you are having tests:

• Tell the person taking the sample that you have been given Rocephin.

If you are diabetic or need to have your blood glucose level monitored you should not use certain blood glucose monitoring systems which may estimate blood glucose incorrectly while you are receiving ceftriaxone. If you use such systems check the instructions for use and tell your doctor, pharmacist or nurse. Alternative testing methods should be used if necessary.

Talk to your doctor or pharmacist or nurse before your child is administered Rocephin if:

• He/She has recently been given or is to be given a product that contains calcium into their vein.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• A type of antibiotic called an aminoglycoside.
• An antibiotic called chloramphenicol (used to treat infections, particularly of the eyes).

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

The doctor will consider the benefit of treating you with Rocephin against the risk to your baby.

Rocephin can cause dizziness. If you feel dizzy, do not drive or use any tools or machines. Talk to your doctor if you experience these symptoms.

Rocephin 2 g powder for solution for injection or infusion contains 169.1 mg sodium (main component of cooking/table salt) in each 2 g bottle. This is equivalent to 8.5% of the recommended maximum daily dietary intake of sodium for an adult.

Rocephin 1 g powder for solution for injection or infusion contains 85.4 mg sodium (main component of cooking/table salt) per 1g vial, equivalent to 4.3% of the recommended maximum daily dietary intake of sodium for an adult.

Rocephin 250 mg powder for solution for injection contains less than 1 mmol sodium (23 mg) per 250 mg vial, i.e. is essentially “sodium free”.

Rocephin is usually given by a doctor or nurse. It can be given as

• a drip (intravenous infusion) or as an injection directly into a vein or
• into a muscle.

Rocephin is made up by the doctor, pharmacist or nurse and will not be mixed with or given to you at the same time as calcium-containing injections.

Your doctor will decide the correct dose of Rocephin for you. The dose will depend on the severity and type of infection; whether you are on any other antibiotics; your weight and age; how well your kidneys and liver are working. The number of days or weeks that you are given Rocephin depends on what sort of infection you have.

Adults, older people and children aged 12 years and over with a body weight greater than or equal to 50 kilograms (kg):

• 1 to 2 g once a day depending on the severity and type of infection. If you have a severe infection, your doctor will give you a higher dose (up to 4 g once a day). If your daily dose is higher than 2 g, you may receive it as a single dose once a day or as two separate doses.

Newborn babies, infants and children aged 15 days to 12 years with a body weight of less than 50 kg:

• 50-80 mg Rocephin for each kg of the child’s body weight once a day depending on the severity and type of infection. If you have a severe infection, your doctor will give you a higher dose up to 100 mg for each kg of body weight to a maximum of 4 g once a day. If your daily dose is higher than 2 g, you may receive it as a single dose once a day or as two separate doses.
• Children with a body weight of 50 kg or more should be given the usual adult dose.

Newborn babies (0-14 days)

• 20 – 50 mg Rocephin for each kg of the child’s body weight once a day depending on the severity and type of infection.
• The maximum daily dose is not to be more than 50 mg for each kg of the baby’s weight.

You may be given a different dose to the usual dose. Your doctor will decide how much Rocephin you will need and will check you closely depending on the severity of the liver and kidney disease.

If you accidentally receive more than your prescribed dose, contact your doctor or nearest hospital straight away.

If you miss an injection, you should have it as soon as possible. However, if it is almost time for your next injection, skip the missed injection. Do not take a double dose (two injections at the same time) to make up for a missed dose.

Do not stop taking Rocephin unless your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may happen with this medicine:

Treatment with ceftriaxone, particularly in elderly patients with serious kidney or nervous system problems may rarely cause decreased consciousness, abnormal movements, agitation and convulsions.

Severe allergic reactions (not known, frequency cannot be estimated from the available data)

If you have a severe allergic reaction, tell a doctor straight away.

The signs may include:

• Sudden swelling of the face, throat, lips or mouth. This can make it difficult to breathe or swallow.
• Sudden swelling of the hands, feet and ankles.

Severe skin reactions (not known, frequency cannot be estimated from the available data)

If you get a severe skin reaction, tell a doctor straight away.

The signs may include:

• A severe rash that develops quickly, with blisters or peeling of the skin and possibly blisters in the mouth (Stevens-Johnson syndrome and toxic epidermal necrolysis which are also known as SJS and TEN).
• A combination of any of the following symptoms: widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome).
• Jarisch-Herxheimer reaction which causes fever, chills, headache, muscle pain, and skin rash that is usually self-limiting. This occurs shortly after starting Rocephin treatment for infections with spirochete such as Lyme disease.

Other possible side effects:

Common (may affect up to 1 in 10 people)

• Abnormalities with your white blood cells (such as a decrease of leucocytes and an increase of eosinophils) and platelets (decrease of thrombocytes).
• Loose stools or diarrhoea.
• Changes in the results of blood tests for liver functions.
• Rash.

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (for example, thrush).
• A decrease in the number of white blood cells (granulocytopenia).
• Reduction in number of red blood cells (anaemia).
• Problems with the way your blood clots. The signs may include bruising easily and pain and swelling of your joints.
• Headache.
• Dizziness.
• Feeling sick or being sick.
• Pruritis (itching).
• Pain or a burning feeling along the vein where Rocephin has been given. Pain where the injection was given.
• A high temperature (fever).
• Abnormal kidney function test (blood creatinine increased).

Rare (may affect up to 1 in 1,000 people)

• Inflammation of the large bowel (colon). The signs include diarrhoea, usually with blood and mucus, stomach pain and fever.
• Difficulty in breathing (bronchospasm).
• A lumpy rash (hives) that may cover a lot of your body, feeling itchy and swelling.
• Blood or sugar in your urine.
• Oedema (fluid build-up).
• Shivering.

Not known (Frequency cannot be estimated from the available data)

• A secondary infection that may not respond to the antibiotic previously prescribed
• Form of anaemia where red blood cells are destroyed (haemolytic anaemia).
• Severe decrease in white blood cells (agranulocytosis).
• Convulsions.
• Vertigo (spinning sensation).
• Inflammation of the pancreas (pancreatitis). The signs include severe pain in the stomach which spreads to your back.
• Inflammation of the mucus lining of the mouth (stomatitis).
• Inflammation of the tongue (glossitis). The signs include swelling, redness and soreness of the tongue.
• Problems with your gallbladder, which may cause pain, feeling sick and being sick.
• A neurological condition that may occur in neonates with severe jaundice (kernicterus).
• Kidney problems caused by deposits of calcium ceftriaxone. There may be pain when passing water (urine) or low output of urine.
• A false positive result in a Coombs’ test (a test for some blood problems).
• A false positive result for galactosaemia (an abnormal build up of the sugar galactose).
• Rocephin may interfere with some types of blood glucose tests – please check with your doctor.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the vial or bottle label after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C, keep vial or bottle in the outer carton in order to protect from light.

Chemical and physical in-use stability of the reconstituted product has been demonstrated for at least 6 hours at or below 25°C or 24 hours at 2-8°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than the times stated above for the chemical and physical in-use stability.

Do not throw away any medicines via wastewater. Ask your pharmacist to throw away medicines you no longer use. These measures will help protect the environment.

Rocephin 2 g powder for solution for injection or infusion

The active substance is ceftriaxone.

Each bottle contains 2 g (grams) ceftriaxone as ceftriaxone sodium.

The displacement volume of 2 g of Rocephin is 1.37 ml in water for injections. When adding 40 ml of water for injections, the final concentration of the reconstituted solution is 48.34 mg/ml.

Rocephin 1 g powder for solution for injection or infusion

The active substance is ceftriaxone.

Each vial contains 1 g (grams) ceftriaxone as ceftriaxone sodium.

The displacement volume of 1 g of Rocephin is 0.71 ml in water for injections and 1% lidocaine hydrochloride solution. When adding 10 ml of water for injections, the final concentration of the reconstituted solution is 93.37 mg/ml. When adding 3.5 ml of 1% lidocaine hydrochloride solution, the final concentration of the reconstituted solution is 237. 53 mg/ml.

Rocephin 250 mg powder for solution for injection

The active substance is ceftriaxone.

Each vial contains 250 mg (milligrams) ceftriaxone as ceftriaxone sodium.

Rocephin should not be mixed in the same syringe with any drug.

The displacement volume of 250 mg of Rocephin is 0.18 ml in water for injections and 1% lidocaine hydrochloride solution. When adding 2.5 ml of water for injections, the final concentration of the reconstituted solution is 93.28 mg/ml. When adding 2 ml of 1% lidocaine hydrochloride solution, the final concentration of the reconstituted solution is 114.68 mg/ml.

The infusion line should be flushed after each administration.

Rocephin 2 g powder for solution for injection or infusion

Rocephin 1 g powder for solution for injection or infusion

Rocephin consists of a powder for solution for injection or infusion

Rocephin 250 mg powder for solution for injection

Rocephin consists of a powder for solution for injection.

The powder is white to yellowish-orange.

Rocephin is available in packs of 1 vial or bottle.

Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

This medicinal product is authorised in the Member States of the EEA under the following names:

Rocephin 2 g Powder for Solution for Injection or Infusion

United Kingdom: Rocephin

Rocephin 1 g Powder for Solution for Injection or Infusion

Ireland, United Kingdom: Rocephin

Rocephin 250 mg Powder for Solution for Injection

United Kingdom: Rocephin

This leaflet was last revised in January 2021

uk-pil-rocephin-clean-210121-2g-1g-250mg-vial

Rocephin 1g Powder for Solution for Injection or Infusion – Summary of Product Characteristics (SmPC)

This information is intended for use by health professionals

Rocephin 2 g Powder for solution for injection or infusion.

Rocephin 1 g Powder for solution for injection or infusion.

Rocephin 250 mg Powder for solution for injection.

Rocephin 2 g powder for solution for injection or infusion.

Each bottle contains 2 g ceftriaxone as ceftriaxone sodium.

Rocephin 1 g powder for solution for injection or infusion

Each vial contains 1 g ceftriaxone as ceftriaxone sodium.

Rocephin 250 mg powder for solution for injection

Each vial contains 250 mg ceftriaxone as ceftriaxone sodium.

2 g powder for solution for injection or infusion

1 g powder for solution for injection or infusion

Powder for solution for injection or infusion.

250 mg powder for solution for injection

Powder for solution for injection.

White to yellowish-orange crystalline powder.

Rocephin is indicated for the treatment of the following infections in adults and children including term neonates (from birth):

Bacterial Meningitis

Community acquired pneumonia

Hospital acquired pneumonia

Acute otitis media

Intra-abdominal infections

Complicated urinary tract infections (including pyelonephritis)

Infections of bones and joints

Complicated skin and soft tissue infections

Gonorrhoea

Syphilis

Bacterial endocarditis

Rocephin may be used:

For treatment of acute exacerbations of chronic obstructive pulmonary disease in adults

For treatment of disseminated Lyme borreliosis (early (stage II) and late (stage III)) in adults and children including neonates from 15 days of age

For Pre-operative prophylaxis of surgical site infections

In the management of neutropenic patients with fever that is suspected to be due to a bacterial infection

In the treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above

Rocephin should be co-administered with other antibacterial agents whenever the possible range of causative bacteria would not fall within its spectrum (see section 4. 4).

Consideration should be given to official guidelines on the appropriate use of antibacterial agents.

Posology

The dose depends on the severity, susceptibility, site and type of infection and on the age and hepato-renal function of the patient.

The doses recommended in the tables below are the generally recommended doses in these indications. In particularly severe cases, doses at the higher end of the recommended range should be considered.

Adults and children over 12 years of age (≥ 50 kg)

* In documented bacteraemia, the higher end of the recommended dose range should be considered.

** Twice daily (12 hourly) administration may be considered where doses greater than 2 g daily are administered.

Indications for adults and children over 12 years of age (≥ 50 kg) that require specific dosage schedules:

Acute otitis media

A single intramuscular dose of Rocephin 1-2 g can be given.

Limited data suggest that in cases where the patient is severely ill or previous therapy has failed, Rocephin may be effective when given as an intramuscular dose of 1-2 g daily for 3 days.

Pre-operative prophylaxis of surgical site infections

2 g as a single pre-operative dose.

Gonorrhoea

500 mg as a single intramuscular dose.

Syphilis

The generally recommended doses are 500 mg-1 g once daily increased to 2 g once daily for neurosyphilis for 10-14 days. The dose recommendations in syphilis, including neurosyphilis, are based on limited data. National or local guidance should be taken into consideration.

Disseminated Lyme borreliosis (early [Stage II] and late [Stage III])

2 g once daily for 14-21 days. The recommended treatment durations vary and national or local guidelines should be taken into consideration.

Paediatric population

Neonates, infants and children 15 days to 12 years of age (< 50 kg)

For children with bodyweight of 50 kg or more, the usual adult dosage should be given.

* In documented bacteraemia, the higher end of the recommended dose range should be considered.

** Twice daily (12 hourly) administration may be considered where doses greater than 2 g daily are administered.

Indications for neonates, infants and children 15 days to 12 years (< 50 kg) that require specific dosage schedules:

Acute otitis media

For initial treatment of acute otitis media, a single intramuscular dose of Rocephin 50 mg/kg can be given. Limited data suggest that in cases where the child is severely ill or initial therapy has failed, Rocephin may be effective when given as an intramuscular dose of 50 mg/kg daily for 3 days.

Pre-operative prophylaxis of surgical site infections 50-80 mg/kg as a single pre-operative dose.

Syphilis

The generally recommended doses are 75-100 mg/kg (max 4 g) once daily for 10-14 days. The dose recommendations in syphilis, including neurosyphilis, are based on very limited data. National or local guidance should be taken into consideration.

Disseminated Lyme borreliosis (early [Stage II] and late [Stage III])

50–80 mg/kg once daily for 14-21 days. The recommended treatment durations vary and national or local guidelines should be taken into consideration.

Neonates 0-14 days

Rocephin is contraindicated in premature neonates up to a postmenstrual age of 41 weeks (gestational age + chronological age).

* In documented bacteraemia, the higher end of the recommended dose range should be considered.

A maximum daily dose of 50 mg/kg should not be exceeded.

Indications for neonates 0-14 days that require specific dosage schedules:

Acute otitis media

For initial treatment of acute otitis media, a single intramuscular dose of Rocephin 50 mg/kg can be given.

Pre-operative prophylaxis of surgical site infections 20-50 mg/kg as a single pre-operative dose.

Syphilis

The generally recommended dose is 50 mg/kg once daily for 10-14 days. The dose recommendations in syphilis, including neurosyphilis, are based on very limited data. National or local guidance should be taken into consideration.

Duration of therapy

The duration of therapy varies according to the course of the disease. As with antibiotic therapy in general, administration of ceftriaxone should be continued for 48 – 72 hours after the patient has become afebrile or evidence of bacterial eradication has been achieved.

Older people

The dosages recommended for adults require no modification in older people provided that renal and hepatic function is satisfactory.

Patients with hepatic impairment

Available data do not indicate the need for dose adjustment in mild or moderate liver function impairment provided renal function is not impaired.

There are no study data in patients with severe hepatic impairment (see section 5.2).

Patients with renal impairment

In patients with impaired renal function, there is no need to reduce the dosage of ceftriaxone provided hepatic function is not impaired. Only in cases of preterminal renal failure (creatinine clearance < 10 ml/min) should the ceftriaxone dosage not exceed 2 g daily.

In patients undergoing dialysis no additional supplementary dosing is required following the dialysis. Ceftriaxone is not removed by peritoneal- or haemodialysis. Close clinical monitoring for safety and efficacy is advised.

Patients with severe hepatic and renal impairment

In patients with both severe renal and hepatic dysfunction, close clinical monitoring for safety and efficacy is advised.

Method of administration

Intramuscular administration

Rocephin can be administered by deep intramuscular injection. Intramuscular injections should be injected well within the bulk of a relatively large muscle and not more than 1 g should be injected at one site.

As the solvent used is lidocaine, the resulting solution should never be administered intravenously (see section 4.3). The information in the Summary of Product Characteristics of lidocaine should be considered.

Intravenous administration

Rocephin can be administered by intravenous infusion over at least 30 minutes (preferred route) or by slow intravenous injection over 5 minutes. Intravenous intermittent injection should be given over 5 minutes preferably in larger veins. Intravenous doses of 50 mg/kg or more in infants and children up to 12 years of age should be given by infusion. In neonates, intravenous doses should be given over 60 minutes to reduce the potential risk of bilirubin encephalopathy (see section 4. 3 and 4.4). Intramuscular administration should be considered when the intravenous route is not possible or less appropriate for the patient. For doses greater than 2 g intravenous administration should be used.

Ceftriaxone is contraindicated in neonates (≤ 28 days) if they require (or are expected to require) treatment with calcium-containing intravenous solutions, including continuous calcium-containing infusions such as parenteral nutrition, because of the risk of precipitation of ceftriaxone-calcium (see section 4.3).

Diluents containing calcium, (e.g. Ringer’s solution or Hartmann’s solution), should not be used to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for intravenous administration because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calcium-containing solutions in the same intravenous administration line. Therefore, ceftriaxone and calcium-containing solutions must not be mixed or administered simultaneously (see sections 4. 3, 4.4 and 6.2).

For pre-operative prophylaxis of surgical site infections, ceftriaxone should be administered 30-90 minutes prior to surgery.

For instructions on reconstitution of the medicinal product before administration, see section 6.6.

Hypersensitivity to ceftriaxone, to any other cephalosporin or to any of the excipients listed in section 6.1.

History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems).

Ceftriaxone is contraindicated in:

Premature neonates up to a postmenstrual age of 41 weeks (gestational age + chronological age)*

Full-term neonates (up to 28 days of age):

– with hyperbilirubinaemia, jaundice, or who are hypoalbuminaemic or acidotic because these are conditions in which bilirubin binding is likely to be impaired*

– if they require (or are expected to require) intravenous calcium treatment, or calcium-containing infusions due to the risk of precipitation of a ceftriaxone-calcium salt (see sections 4. 4, 4.8 and 6.2).

* In vitro studies have shown that ceftriaxone can displace bilirubin from its serum albumin binding sites leading to a possible risk of bilirubin encephalopathy in these patients.

Contraindications to lidocaine must be excluded before intramuscular injection of ceftriaxone when lidocaine solution is used as a solvent (see section 4.4). See information in the Summary of Product Characteristics of lidocaine, especially contraindications.

Ceftriaxone solutions containing lidocaine should never be administered intravenously.

Hypersensitivity reactions

As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported (see section 4.8). In case of severe hypersensitivity reactions, treatment with ceftriaxone must be discontinued immediately and adequate emergency measures must be initiated. Before beginning treatment, it should be established whether the patient has a history of severe hypersensitivity reactions to ceftriaxone, to other cephalosporins or to any other type of beta-lactam agent. Caution should be used if ceftriaxone is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents.

Severe cutaneous adverse reactions (Stevens Johnson syndrome or Lyell’s syndrome/toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS)) which can be life-threatening or fatal have been reported in association of ceftriaxone treatment; however, the frequency of these events is not known (see section 4.8).

Interaction with calcium containing products

Cases of fatal reactions with calcium-ceftriaxone precipitates in lungs and kidneys in premature and full-term neonates aged less than 1 month have been described. At least one of them had received ceftriaxone and calcium at different times and through different intravenous lines. In the available scientific data, there are no reports of confirmed intravascular precipitations in patients, other than neonates, treated with ceftriaxone and calcium-containing solutions or any other calcium-containing products. In vitro studies demonstrated that neonates have an increased risk of precipitation of ceftriaxone-calcium compared to other age groups.

In patients of any age ceftriaxone must not be mixed or administered simultaneously with any calcium-containing intravenous solutions, even via different infusion lines or at different infusion sites. However, in patients older than 28 days of age ceftriaxone and calcium-containing solutions may be administered sequentially one after another if infusion lines at different sites are used or if the infusion lines are replaced or thoroughly flushed between infusions with physiological salt-solution to avoid precipitation. In patients requiring continuous infusion with calcium-containing total parenteral nutrition (TPN) solutions, healthcare professionals may wish to consider the use of alternative antibacterial treatments which do not carry a similar risk of precipitation. If the use of ceftriaxone is considered necessary in patients requiring continuous nutrition, TPN solutions and ceftriaxone can be administered simultaneously, albeit via different infusion lines at different sites. Alternatively, infusion of TPN solution could be stopped for the period of ceftriaxone infusion and the infusion lines flushed between solutions (see sections 4.3, 4.8, 5.2 and 6.2).

Paediatric population

Safety and effectiveness of Rocephin in neonates, infants and children have been established for the dosages described under Posology and Method of Administration (see section 4.2). Studies have shown that ceftriaxone, like some other cephalosporins, can displace bilirubin from serum albumin.

Rocephin is contraindicated in premature and full-term neonates at risk of developing bilirubin encephalopathy (see section 4.3).

Immune mediated haemolytic anaemia

An immune mediated haemolytic anaemia has been observed in patients receiving cephalosporin class antibacterials including Rocephin (see section 4.8). Severe cases of haemolytic anaemia, including fatalities, have been reported during Rocephin treatment in both adults and children.

If a patient develops anaemia while on ceftriaxone, the diagnosis of a cephalosporin–associated anaemia should be considered and ceftriaxone discontinued until the aetiology is determined.

Long term treatment

During prolonged treatment complete blood count should be performed at regular intervals.

Colitis/Overgrowth of non-susceptible microorganisms

Antibacterial agent-associated colitis and pseudo-membranous colitis have been reported with nearly all antibacterial agents, including ceftriaxone, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of ceftriaxone (see section 4.8). Discontinuation of therapy with ceftriaxone and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given.

Superinfections with non-susceptible micro-organisms may occur as with other antibacterial agents.

Severe renal and hepatic insufficiency

In severe renal and hepatic insufficiency, close clinical monitoring for safety and efficacy is advised (see section 4.2).

Interference with serological testing

Interference with Coombs tests may occur, as Rocephin may lead to false-positive test results. Rocephin can also lead to false-positive test results for galactosaemia (see section 4.8).

Non-enzymatic methods for the glucose determination in urine may give false-positive results. Urine glucose determination during therapy with Rocephin should be done enzymatically (see section 4.8).

The presence of ceftriaxone may falsely lower estimated blood glucose values obtained with some blood glucose monitoring systems. Please refer to instructions for use for each system. Alternative testing methods should be used if necessary.

Sodium

Rocephin 2 g powder for solution for injection or infusion contains 169.1 mg sodium per 2 g bottle, equivalent to 8.5% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Rocephin 1 g powder for solution for injection or infusion contains 85.4 mg sodium per 1g vial, equivalent to 4.3% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Rocephin 250 mg powder for solution for injection contains less than 1 mmol sodium (23 mg) per 250 mg vial, i.e. is essentially “sodium free”.

Antibacterial spectrum

Ceftriaxone has a limited spectrum of antibacterial activity and may not be suitable for use as a single agent for the treatment of some types of infections unless the pathogen has already been confirmed (see section 4.2). In polymicrobial infections, where suspected pathogens include organisms resistant to ceftriaxone, administration of an additional antibiotic should be considered.

Use of lidocaine

In case a lidocaine solution is used as a solvent, ceftriaxone solutions must only be used for intramuscular injection. Contraindications to lidocaine, warnings and other relevant information as detailed in the Summary of Product Characteristics of lidocaine must be considered before use (see section 4.3). The lidocaine solution should never be administered intravenously.

Biliary lithiasis

When shadows are observed on sonograms, consideration should be given to the possibility of precipitates of calcium ceftriaxone. Shadows, which have been mistaken for gallstones, have been detected on sonograms of the gallbladder and have been observed more frequently at ceftriaxone doses of 1 g per day and above. Caution should be particularly considered in the paediatric population. Such precipitates disappear after discontinuation of ceftriaxone therapy. Rarely precipitates of calcium ceftriaxone have been associated with symptoms. In symptomatic cases, conservative nonsurgical management is recommended and discontinuation of ceftriaxone treatment should be considered by the physician based on specific benefit risk assessment (see section 4.8).

Biliary stasis

Cases of pancreatitis, possibly of biliary obstruction aetiology, have been reported in patients treated with Rocephin (see section 4.8). Most patients presented with risk factors for biliary stasis and biliary sludge e.g. preceding major therapy, severe illness and total parenteral nutrition. A trigger or cofactor of Rocephin-related biliary precipitation cannot be ruled out.

Renal lithiasis

Cases of renal lithiasis have been reported, which is reversible upon discontinuation of ceftriaxone (see section 4.8). In symptomatic cases, sonography should be performed. Use in patients with history of renal lithiasis or with hypercalciuria should be considered by the physician based on specific benefit risk assessment.

Jarisch-Herxheimer reaction (JHR)

Some patients with spirochete infections may experience a Jarisch-Herxheimer reaction (JHR) shortly after ceftriaxone treatment is started. JHR is usually a self – limiting condition or can be managed by symptomatic treatment. The antibiotic treatment should not be discontinued if such reaction occurs.

Encephalopathy

Encephalopathy has been reported with the use of ceftriaxone (see section 4.8), particularly in elderly patients with severe renal impairment (see section 4.2) or central nervous system disorders. If ceftriaxone-associated encephalopathy is suspected (e.g. decreased level of consciousness, altered mental state, myoclonus, convulsions), discontinuation of ceftriaxone should be considered.

Calcium-containing diluents, such as Ringer’s solution or Hartmann’s solution, should not be used to reconstitute Rocephin vials or to further dilute a reconstituted vial for intravenous administration because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calcium-containing solutions in the same intravenous administration line. Ceftriaxone must not be administered simultaneously with calcium-containing intravenous solutions, including continuous calcium-containing infusions such as parenteral nutrition via a Y-site. However, in patients other than neonates, ceftriaxone and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid. In vitro studies using adult and neonatal plasma from umbilical cord blood demonstrated that neonates have an increased risk of precipitation of ceftriaxone-calcium (see sections 4.2, 4.3, 4.4, 4.8 and 6.2).

Concomitant use with oral anticoagulants may increase the anti-vitamin K effect and the risk of bleeding. It is recommended that the International Normalised Ratio (INR) is monitored frequently and the posology of the anti-vitamin K drug adjusted accordingly, both during and after treatment with ceftriaxone (see section 4.8).

There is conflicting evidence regarding a potential increase in renal toxicity of aminoglycosides when used with cephalosporins. The recommended monitoring of aminoglycoside levels (and renal function) in clinical practice should be closely adhered to in such cases.

In an in-vitro study antagonistic effects have been observed with the combination of chloramphenicol and ceftriaxone. The clinical relevance of this finding is unknown.

There have been no reports of an interaction between ceftriaxone and oral calcium-containing products or interaction between intramuscular ceftriaxone and calcium-containing products (intravenous or oral).

In patients treated with ceftriaxone, the Coombs’ test may lead to false-positive test results.

Ceftriaxone, like other antibiotics, may result in false-positive tests for galactosaemia.

Likewise, non-enzymatic methods for glucose determination in urine may yield false-positive results. For this reason, glucose level determination in urine during therapy with ceftriaxone should be carried out enzymatically.

No impairment of renal function has been observed after concurrent administration of large doses of ceftriaxone and potent diuretics (e.g. furosemide).

Simultaneous administration of probenecid does not reduce the elimination of ceftriaxone.

Pregnancy

Ceftriaxone crosses the placental barrier. There are limited amounts of data from the use of ceftriaxone in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to embryonal/foetal, perinatal and postnatal development (see section 5.3). Ceftriaxone should only be administered during pregnancy and in particular in the first trimester of pregnancy if the benefit outweighs the risk.

Breastfeeding

Ceftriaxone is excreted into human milk in low concentrations but at therapeutic doses of ceftriaxone no effects on the breastfed infants are anticipated. However, a risk of diarrhoea and fungal infection of the mucous membranes cannot be excluded. The possibility of sensitisation should be taken into account. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ceftriaxone therapy, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility

Reproductive studies have shown no evidence of adverse effects on male or female fertility.

During treatment with ceftriaxone, undesirable effects may occur (e.g. dizziness), which may influence the ability to drive and use machines (see section 4.8). Patients should be cautious when driving or operating machinery.

The most frequently reported adverse reactions for ceftriaxone are eosinophilia, leucopenia, thrombocytopenia, diarrhoea, rash, and hepatic enzymes increased.

Data to determine the frequency of ceftriaxone ADRs was derived from clinical trials.

The following convention has been used for the classification of frequency:

Very common (≥ 1/10)

Common (≥ 1/100 – < 1/10)

Uncommon (≥ 1/1000 – < 1/100)

Rare (≥ 1/10000 – < 1/1000)

Not known (cannot be estimated from the available data)

^a Based on post-marketing reports. Since these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorised as not known.

^b See section 4.4

Description of selected adverse reactions

Infections and infestations

Reports of diarrhoea following the use of ceftriaxone may be associated with Clostridium difficile. Appropriate fluid and electrolyte management should be instituted (see section 4.4).

Ceftriaxone-calcium salt precipitation

Rarely, severe, and in some cases, fatal, adverse reactions have been reported in pre-term and full-term neonates (aged < 28 days) who had been treated with intravenous ceftriaxone and calcium. Precipitations of ceftriaxone-calcium salt have been observed in lung and kidneys post-mortem. The high risk of precipitation in neonates is a result of their low blood volume and the longer half-life of ceftriaxone compared with adults (see sections 4.3, 4.4, and 5.2).

Cases of ceftriaxone precipitation in the urinary tract have been reported, mostly in children treated with high doses (e.g. ≥ 80 mg/kg/day or total doses exceeding 10 grams) and who have other risk factors (e.g. dehydration, confinement to bed). This event may be asymptomatic or symptomatic, and may lead to ureteric obstruction and postrenal acute renal failure, but is usually reversible upon discontinuation of ceftriaxone (see section 4.4).

Precipitation of ceftriaxone calcium salt in the gallbladder has been observed, primarily in patients treated with doses higher than the recommended standard dose. In children, prospective studies have shown a variable incidence of precipitation with intravenous application – above 30 % in some studies. The incidence appears to be lower with slow infusion (20 – 30 minutes). This effect is usually asymptomatic, but the precipitations have been accompanied by clinical symptoms such as pain, nausea and vomiting in rare cases. Symptomatic treatment is recommended in these cases. Precipitation is usually reversible upon discontinuation of ceftriaxone (see section 4.4).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

In overdose, the symptoms of nausea, vomiting and diarrhoea can occur. Ceftriaxone concentrations cannot be reduced by haemodialysis or peritoneal dialysis. There is no specific antidote. Treatment of overdose should be symptomatic.

Pharmacotherapeutic group: Antibacterials for systemic use, Third-generation cephalosporins, ATC code: J01DD04.

Mode of action

Ceftriaxone inhibits bacterial cell wall synthesis following attachment to penicillin binding proteins (PBPs). This results in the interruption of cell wall (peptidoglycan) biosynthesis, which leads to bacterial cell lysis and death.

Resistance

Bacterial resistance to ceftriaxone may be due to one or more of the following mechanisms:

• hydrolysis by beta-lactamases, including extended-spectrum beta-lactamases (ESBLs), carbapenemases and Amp C enzymes that may be induced or stably derepressed in certain aerobic Gram-negative bacterial species.

• reduced affinity of penicillin-binding proteins for ceftriaxone.

• outer membrane impermeability in Gram-negative organisms.

• bacterial efflux pumps.

Susceptibility testing breakpoints

Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:

a. Susceptibility inferred from cefoxitin susceptibility.

b. Susceptibility inferred from penicillin susceptibility.

c. Isolates with a ceftriaxone MIC above the susceptible breakpoint are rare and, if found, should be re-tested and, if confirmed, should be sent to a reference laboratory.

d. Breakpoints apply to a daily intravenous dose of 1 g x 1 and a high dose of at least 2 g x 1.

Clinical efficacy against specific pathogens

The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of ceftriaxone in at least some types of infections is questionable.

£ All methicillin-resistant staphylococci are resistant to ceftriaxone.

⁺ Resistance rates >50% in at least one region

^% ESBL producing strains are always resistant

Absorption

Intramuscular administration

Following intramuscular injection, mean peak plasma ceftriaxone levels are approximately half those observed after intravenous administration of an equivalent dose. The maximum plasma concentration after a single intramuscular dose of 1 g is about 81 mg/l and is reached in 2 – 3 hours after administration.

The area under the plasma concentration-time curve after intramuscular administration is equivalent to that after intravenous administration of an equivalent dose.

Intravenous administration

After intravenous bolus administration of ceftriaxone 500 mg and 1 g, mean peak plasma ceftriaxone levels are approximately 120 and 200 mg/l respectively. After intravenous infusion of ceftriaxone 500 mg, 1 g and 2 g, the plasma ceftriaxone levels are approximately 80, 150 and 250 mg/l respectively.

Distribution

The volume of distribution of ceftriaxone is 7 – 12 l. Concentrations well above the minimal inhibitory concentrations of most relevant pathogens are detectable in tissue including lung, heart, biliary tract/liver, tonsil, middle ear and nasal mucosa, bone, and in cerebrospinal, pleural, prostatic and synovial fluids. An 8 – 15 % increase in mean peak plasma concentration (C_max) is seen on repeated administration; steady state is reached in most cases within 48 – 72 hours depending on the route of administration.

Penetration into particular tissues

Ceftriaxone penetrates the meninges. Penetration is greatest when the meninges are inflamed. Mean peak ceftriaxone concentrations in CSF in patients with bacterial meningitis are reported to be up to 25 % of plasma levels compared to 2 % of plasma levels in patients with uninflamed meninges. Peak ceftriaxone concentrations in CSF are reached approximately 4-6 hours after intravenous injection. Ceftriaxone crosses the placental barrier and is excreted in the breast milk at low concentrations (see section 4.6).

Protein binding

Ceftriaxone is reversibly bound to albumin. Plasma protein binding is about 95 % at plasma concentrations below 100 mg/l. Binding is saturable and the bound portion decreases with rising concentration (up to 85 % at a plasma concentration of 300 mg/l).

Biotransformation

Ceftriaxone is not metabolised systemically; but is converted to inactive metabolites by the gut flora.

Elimination

Plasma clearance of total ceftriaxone (bound and unbound) is 10 – 22 ml/min. Renal clearance is 5 – 12 ml/min. 50 – 60 % of ceftriaxone is excreted unchanged in the urine, primarily by glomerular filtration, while 40 – 50 % is excreted unchanged in the bile. The elimination half-life of total ceftriaxone in adults is about 8 hours.

Patients with renal or hepatic impairment

In patients with renal or hepatic dysfunction, the pharmacokinetics of ceftriaxone are only minimally altered with the half-life slightly increased (less than two fold), even in patients with severely impaired renal function.

The relatively modest increase in half-life in renal impairment is explained by a compensatory increase in non-renal clearance, resulting from a decrease in protein binding and corresponding increase in non-renal clearance of total ceftriaxone.

In patients with hepatic impairment, the elimination half-life of ceftriaxone is not increased, due to a compensatory increase in renal clearance. This is also due to an increase in plasma free fraction of ceftriaxone contributing to the observed paradoxical increase in total drug clearance, with an increase in volume of distribution paralleling that of total clearance.

Older people

In older people aged over 75 years the average elimination half-life is usually two to three times that of young adults.

Paediatric population

The half-life of ceftriaxone is prolonged in neonates. From birth to 14 days of age, the levels of free ceftriaxone may be further increased by factors such as reduced glomerular filtration and altered protein binding. During childhood, the half-life is lower than in neonates or adults.

The plasma clearance and volume of distribution of total ceftriaxone are greater in neonates, infants and children than in adults.

Linearity/non-linearity

The pharmacokinetics of ceftriaxone are non-linear and all basic pharmacokinetic parameters, except the elimination half-life, are dose dependent if based on total drug concentrations, increasing less than proportionally with dose. Non-linearity is due to saturation of plasma protein binding and is therefore observed for total plasma ceftriaxone but not for free (unbound) ceftriaxone.

Pharmacokinetic/pharmacodynamic relationship

As with other beta-lactams, the pharmacokinetic-pharmacodynamic index demonstrating the best correlation with in vivo efficacy is the percentage of the dosing interval that the unbound concentration remains above the minimum inhibitory concentration (MIC) of ceftriaxone for individual target species (i.e. %T > MIC).

There is evidence from animal studies that high doses of ceftriaxone calcium salt led to formation of concrements and precipitates in the gallbladder of dogs and monkeys, which proved to be reversible. Animal studies produced no evidence of toxicity to reproduction and genotoxicity. Carcinogenicity studies on ceftriaxone were not conducted.

Based on literature reports, ceftriaxone is not compatible with amsacrine, vancomycin, fluconazole and aminoglycosides.

Solutions containing ceftriaxone should not be mixed with or added to other agents except those mentioned in section 6.6. In particular diluents containing calcium, (e.g. Ringer’s solution, Hartmann’s solution) should not be used to reconstitute ceftriaxone vials or bottles or to further dilute a reconstituted vial or bottle for intravenous administration because a precipitate can form. Ceftriaxone must not be mixed or administered simultaneously with calcium containing solutions including total parenteral nutrition (see section 4.2, 4.3, 4.4 and 4.8).

If treatment with a combination of another antibiotic with Rocephin is intended, administration should not occur in the same syringe or in the same infusion solution.

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Unopened vials or bottles: 3 years

Chemical and physical in-use stability of the reconstituted product has been demonstrated for at least 6 hours at or below 25°C or 24 hours at 2-8°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than the times stated above for the chemical and physical in-use stability.

Do not store above 30°C, keep vial or bottle in the outer carton in order to protect from light.

For storage conditions of the reconstituted medicinal product, see section 6.3.

Rocephin 2 g powder for solution for injection or infusion

Type II Ph. Eur 50 ml glass bottle with fluorobutyl rubber stopper and aluminium cap, containing a sterile powder, equivalent to 2 g ceftriaxone.

Rocephin 1 g powder for solution for injection or infusion

Type 1 Ph. Eur 15 ml glass vial with fluorobutyl rubber stopper and aluminium cap, containing a sterile powder, equivalent to 1 g ceftriaxone.

Rocephin 250 mg powder for solution for injection

Type 1 Ph. Eur 15 ml glass vial with fluorobutyl rubber stopper and aluminium cap, containing a sterile powder, equivalent to 250 mg ceftriaxone.

Pack size of 1 vial or bottle.

Concentrations for the intravenous injection: 100 mg/ml,

Concentrations for the intravenous infusion: 50 mg/ml

(Please refer to section 4.2 for further information).

Preparation of solutions for injection and infusion

The use of freshly prepared solutions is recommended. For storage conditions of the reconstituted medicinal product, see section 6.3.

Rocephin should not be mixed in the same syringe with any drug other than 1% Lidocaine Hydrochloride solution (for intramuscular injection only).

The infusion line should be flushed after each administration.

Rocephin 2 g powder for solution for injection or infusion

For IV infusion 2 g Rocephin is dissolved in 40 ml of one of the following calcium-free infusion fluids: sodium chloride 0.9%, sodium chloride 0.45% + dextrose 2.5%, dextrose 5%, dextrose 10%, dextran 6% in dextrose 5%, hydroxyethly-starch 6 – 10%, water for injections. The infusion should be administered over at least 30 minutes. See also the information in section 6.2.

The displacement volume of 2 g of Rocephin is 1.37 ml in water for injections. When adding 40 ml of water for injections, the final concentration of the reconstituted solution is 48.34 mg/ml.

In neonates, intravenous doses should be given over 60 minutes to reduce the potential risk of bilirubin encephalopathy.

Rocephin 1 g powder for solution for injection or infusion

For IV injection 1 g Rocephin is dissolved in 10 ml of water for injections. The injection should be administered over 5 minutes, directly into the vein or via the tubing of an intravenous infusion.

For IM injection 1 g Rocephin is dissolved in 3.5 ml of 1% Lidocaine Hydrochloride solution. The solution should be administered by deep intramuscular injection. Dosages greater than 1 g should be divided and injected at more than one site.

The displacement volume of 1 g of Rocephin is 0.71 ml in water for injections and 1% lidocaine hydrochloride solution. When adding 10 ml of water for injections, the final concentration of the reconstituted solution is 93.37 mg/ml. When adding 3.5 ml of 1% lidocaine hydrochloride solution, the final concentration of the reconstituted solution is 237.53 mg/ml.

Rocephin 250 mg powder for solution for injection

For IV injection 250 mg Rocephin is dissolved in 2.5 ml of water for injections. The injection should be administered over 5 minutes, directly into the vein or via the tubing of an intravenous infusion.

For IM injection 250 mg Rocephin is dissolved in 2 ml of 1% lidocaine hydrochloride solution. The solution should be administered by deep intramuscular injection. Dosages greater than 1 g should be divided and injected at more than one site.

The displacement volume of 250 mg of Rocephin is 0.18 ml in water for injections and 1% lidocaine hydrochloride solution. When adding 2.5 ml of water for injections, the final concentration of the reconstituted solution is 93.28 mg/ml. When adding 2 ml of 1% lidocaine hydrochloride solution, the final concentration of the reconstituted solution is 114.68 mg/ml.

Any unused product or waste material should be disposed of in accordance with local requirements.

Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom.

Rocephin 2 g Powder for solution for injection or infusion PL00031/0172

Rocephin 1 g Powder for solution for injection or infusion PL 00031/0171

Rocephin 250 mg Powder for solution for injection PL 00031/0169

Ceftriaxone injection

What is this medicine?

CEFTRIAXONE (sef try AX one) is a cephalosporin antibiotic. It is used to treat certain kinds of bacterial infections. It will not work for colds, flu, or other viral infections.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Ceftrisol Plus, Rocephin

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• any chronic illness
• bowel disease, like colitis
• both kidney and liver disease
• high bilirubin level in newborn patients
• an unusual or allergic reaction to ceftriaxone, other cephalosporin or penicillin antibiotics, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This medicine is injected into a muscle or infused it into a vein. It is usually given in a medical office or clinic. If you are to give this medicine you will be taught how to inject it. Follow instructions carefully. Use your doses at regular intervals. Do not take your medicine more often than directed. Do not skip doses or stop your medicine early even if you feel better. Do not stop taking except on your doctor’s advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

This medicine may also interact with the following medications:

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or health care provider if your symptoms do not improve or if they get worse.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your health care provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

Do not treat diarrhea with over the counter products. Contact your doctor if you have diarrhea that lasts more than 2 days or if it is severe and watery.

If you are being treated for a sexually transmitted disease, avoid sexual contact until you have finished your treatment. Having sex can infect your sexual partner.

Calcium may bind to this medicine and cause lung or kidney problems. Avoid calcium products while taking this medicine and for 48 hours after taking the last dose of this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• fever, chills
• irregular heartbeat
• pain when passing urine
• redness, blistering, peeling, or loosening of the skin, including inside the mouth
• seizures
• stomach pain, cramps
• unusual bleeding, bruising
• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• dizzy, drowsy
• headache
• nausea, vomiting
• pain, swelling, irritation where injected
• stomach upset
• sweating

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature below 25 degrees C (77 degrees F). Protect from light. Throw away any unused vials after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

uses, dosage and side effects

Ceftriaxone injection is an antibiotic treatment that can be used to relieve symptoms of many illnesses. It is usually given once a day by injection or infusion (drip) into a vein (intravenously or IV). The injection can also be given into a muscle such as the upper buttock or thigh (intramuscularly or IM).

Here’s everything you need to know about ceftriaxone, including side effects and who shouldn’t be given the antibiotic.

What is ceftriaxone?

Ceftriaxone is an antibiotic given by injection (usually in hospital) to treat serious bacterial infections such as pneumonia, septicaemia (blood poisoning), meningitis, bone and joint infections, abdominal infections, skin and soft tissue infections, urinary tract or kidney infections and Lyme disease.

Ceftriaxone injection is also used to treat STIs such as syphilis, gonorrhoea and pelvic inflammatory disease.

In addition, ceftriaxone can be given to help prevent infection if you’re having surgery. You might also be given it if you have a low white blood cell count (neutropenia) and your doctor suspects you have a bacterial infection.

If you have been in close contact with someone diagnosed with meningococcal meningitis or Haemophilus influenzae type b disease you might be given this antibiotic to help stop you developing these infections.

How does ceftriaxone work?

Ceftriaxone is a type of antibiotic called a cephalosporin, only given by injection. It works by interfering with the formation of bacterial cell walls. Ceftriaxone impairs the bonds that hold the bacterial cell wall together, which allows holes to appear in the cell walls. This kills off the bacteria causing the infection.

To make sure the bacteria causing an infection are susceptible to ceftriaxone your doctor may take a swab from the infected area, or a urine, sputum or blood sample.

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Who shouldn’t be given ceftriaxone?

While it is suitable for adults, children and pregnant women, ceftriaxone is not suitable for:

🔹 People who have ever had an allergic reaction to penicillin or cephalosporin-type antibiotics. Make sure your doctor knows if you’ve ever had an allergic reaction to an antibiotic.

🔹 Premature babies.

🔹 Full-term newborn babies less than four weeks old with jaundice, low levels of albumin in their blood, high levels of bilirubin in their blood or who need intravenous calcium treatment or calcium containing drips.

🔹 People with kidney or liver problems may need a lower ceftriaxone dose or extra monitoring. Also tell your doctor if you have ever had kidney stones or gallstones.

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Ceftriaxone when pregnant

Ceftriaxone is not known to be harmful if used during pregnancy, but it will only be prescribed if your doctor thinks it is essential to treat your infection. Make sure your doctor knows if you are pregnant or breastfeeding.

Ceftriaxone passes into breast milk in small amounts that are unlikely to be harmful to a nursing baby.

Ceftriaxone side effects

Medicines and their possible side effects can affect people in different ways. The following are some of the side effects that may be associated with ceftriaxone. Just because a side effect is stated here doesn’t mean that all people treated with this antibiotic will experience that or any side effect.

Common side effects

• Diarrhoea.
• Rash. Tell your doctor if you get a rash.

Uncommon side effects

• Feeling or being sick.
• Overgrowth of the yeast Candida, which may cause infections such as thrush.
• Headache.
• Dizziness.
• Itching.

Other possible side effects

• Inflammation of the bowel (colitis). Tell your doctor if you get diarrhoea that is severe, persistent or contains blood or mucus.
• Problems with your gall bladder or kidneys.
• Problems with your blood cells. Tell your doctor if you experience unexplained bruising, sore throat, fever or infections.

Read the leaflet that comes with the medicine or talk to your doctor or pharmacist if you want any more information about the possible side effects of ceftriaxone. If you think you have experienced a side effect, did you know you can report it using the yellow card website?

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Ceftriaxone and other medicines

Before you have ceftriaxone injections, tell your doctor or pharmacist if you’re already taking any medicines, including those bought without a prescription and herbal medicines. Similarly, always check with your doctor or pharmacist before taking any new medicines while you’re having treatment with ceftriaxone. Some key points are:

Painkillers and ceftriaxone

If you need to take a painkiller while you’re having ceftriaxone injections it’s fine to take paracetamol. It’s also usually fine to take ibuprofen but check with your pharmacist if you have any kidney problems.

Contraception and ceftriaxone

Ceftriaxone doesn’t affect hormonal contraceptives such as the pill. However, if you experience vomiting or diarrhoea while having treatment with this antibiotic, this can potentially make your pill less effective at preventing pregnancy. If this happens to you, follow the instructions for vomiting and diarrhoea described in the leaflet provided with your pills.

Anticoagulants and ceftriaxone

Ceftriaxone may rarely increase the anti-blood-clotting effects of warfarin. If you’re taking warfarin your doctor may want to check your blood clotting time (INR) after you start and finish treatment with ceftriaxone.

Vaccines and ceftriaxone

The oral typhoid vaccine (Vivotif) should not be taken until at least three days after you have finished a course of this antibiotic, because the antibiotic could make this vaccine less effective.

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Last updated 21.03.2020

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instructions for use, analogs, composition, indications

Hypersensitivity reactions

As with other beta-lactam antibiotics, severe hypersensitivity reactions, including fatal ones, have been reported. With the development of a severe hypersensitivity reaction, therapy with Rocefin should be discontinued immediately and appropriate urgent medical measures should be taken. Before starting therapy with Rocefin, it is necessary to establish whether the patient has experienced hypersensitivity reactions to ceftriaxone, cephalosporins, or severe hypersensitivity reactions to other beta-lactam antibiotics (penicillins, monobactams and carbapenems).Care must be taken when using ceftriaxone in patients with a history of mild hypersensitivity reactions to other beta-lactam antibiotics (penicillins, monobactams and carbapenems).

Cases of skin hypersensitivity reactions (Stevens-Johnson syndrome or Lyell’s syndrome / toxic epidermal necrolysis) have been reported. The frequency of these reactions is unknown.

Interaction with calcium-containing drugs

Cases of fatal reactions as a result of the deposition of ceftriaxone-calcium precipitates in the lungs and kidneys of newborns have been described.

For all groups of patients, except for newborns, sequential administration of the drug Rocefin and calcium-containing solutions is possible with thorough rinsing of the infusion systems between infusions with saline.

In order to prevent the formation of precipitates, if it is necessary to prescribe calcium-containing solutions for parenteral nutrition, the possibility of prescribing an alternative antibiotic should be considered. In cases where the administration of ceftriaxone to patients receiving parenteral nutrition is necessary, the drug Rocefin and calcium-containing solutions for parenteral nutrition are administered simultaneously using different venous approaches.In addition, for the period of ceftriaxone infusion, the administration of calcium-containing solutions for parenteral nutrition may be suspended.

Application in children

The safety and efficacy of Rocefin in neonates, infants and young children have been determined for the dosages described in the “Dosage and Administration” section. Studies have shown that, like other cephalosporins, ceftriaxone can displace bilirubin from its association with serum albumin.Rocefin should not be used in newborns, especially premature infants, who are at risk of developing bilirubin encephalopathy.

Hemolytic anemia

As with other cephalosporins, autoimmune hemolytic anemia may develop during treatment with Rocefin. Cases of severe hemolytic anemia in adults and children, including fatal ones, have been reported. If anemia develops in a patient being treated with ceftriaxone, the diagnosis of cephalosporin-associated anemia cannot be ruled out and treatment should be canceled until the cause is clarified.

Long-term treatment

With long-term treatment, it is necessary to regularly monitor the peripheral blood picture, indicators of the functional state of the liver and kidneys.

Colitis / Superinfection

As with most other antibacterial drugs, cases of diarrhea caused by Clostridium difficile (C. difficile) have been reported during treatment with ceftriaxone, ranging from mild diarrhea to fatal colitis.

Treatment with antibacterial drugs suppresses the normal microflora of the colon and provokes the growth of C. difficile. In turn, C. difficile forms toxins A and B, which are factors in the pathogenesis of C. difficile diarrhea. C. difficile strains that overproduce toxins are infectious agents with a high risk of complications and mortality due to their possible resistance to antimicrobial therapy, while treatment may require colectomy. It is important to be aware of the possibility of C.difficile in all patients with diarrhea following antibiotic therapy. Careful history taking is necessary, because C. difficile diarrhea has been reported more than 2 months after antibiotic therapy.

If you suspect or confirm diarrhea caused by C. difficile, you may need to cancel the current antibiotic therapy not directed to C. difficile. In accordance with clinical indications, appropriate treatment should be prescribed with the introduction of fluids and electrolytes, proteins, antibiotic therapy for C.difficile, surgical treatment. Do not use drugs that inhibit intestinal motility.

As with other antibacterial drugs, superinfections can develop.

With a combination of severe renal and hepatic impairment, the efficacy and safety of the drug should be carefully monitored.

Serological tests

When treating with ceftriaxone, false-positive results of Coombs’s test, galactosemia test, in the determination of glucose in urine may be noted (glucosuria is recommended to be determined only by the enzymatic method).

Sodium content

1 g of the drug Rocefin contains 3.6 mmol of sodium. This should be taken into account in patients on a sodium controlled diet.

Spectrum of action of ceftriaxone

Ceftriaxone has a limited spectrum of action and Rocefin monotherapy may be ineffective against some types of bacteria, unless the pathogenic agent has been identified.In case of polymicrobial infection with the presence of ceftriaxone-resistant strains, Rocefin should be administered concurrently with other antibiotics.

As with the use of other cephalosporins, anaphylactic reactions, including fatal ones, have been reported, even in cases where the patient did not have a history of allergic reactions.

As with other cephalosporins, autoimmune hemolytic anemia may develop during treatment with Rocefin.Cases of severe hemolytic anemia in adults and children, including fatal ones, have been reported.

If anemia develops in a patient being treated with ceftriaxone, the diagnosis of cephalosporin-associated anemia cannot be ruled out and treatment should be canceled until the cause is clarified.

Lidocaine

Ceftriaxone solutions containing lidocaine should be administered intramuscularly only. Contraindications to the use of lidocaine are given in the instructions for medical use of lidocaine.The lidocaine solution cannot be administered intravenously.

Formation of precipitates of calcium salts of ceftriaxone in the gallbladder After using ceftriaxone, usually in doses exceeding the standard recommended (1 g per day or more), ultrasound examination of the gallbladder revealed precipitates of calcium salt of ceftriaxone, the formation of which is most likely in pediatric patients. The precipitates rarely give any symptoms and disappear after completion or discontinuation of therapy with Rocefin.If these phenomena are accompanied by clinical symptoms, conservative non-surgical treatment is recommended, and the decision to discontinue the drug is left to the discretion of the attending physician and should be based on an individual assessment of the benefits and risks.

Pancreatitis

In patients receiving the drug Rocefin, rare cases of pancreatitis have been described, which developed, possibly due to obstruction of the biliary tract. Most of these patients already had risk factors for biliary congestion, such as previous therapy, severe illness, and all-parenteral nutrition.At the same time, it is impossible to exclude a starting role in the development of pancreatitis of precipitates formed under the influence of the drug Rocefin in the biliary tract.

Formation of precipitates of calcium salts of ceftriaxone in the kidneys

Reported cases of formation of precipitates in the kidneys, which were reversible and disappeared after discontinuation of drug therapy. When clinical symptoms appear, an ultrasound examination is recommended. Prescribing the drug to patients with a history of renal lesions or hypercalciuria requires an assessment of the benefits and risks.

Pregnancy and lactation

Rocefin crosses the placental barrier. The safety of use during pregnancy has not been established. Pregnant women should be prescribed the drug only on strict indications, provided that the intended benefit to the mother outweighs the potential risk to the fetus.

Rocefin passes into breast milk. The effect of ceftriaxone on a breastfed child is unlikely when it is used by the mother in therapeutic doses, however, the risk of diarrhea, fungal infections of the mucous membranes and hypersensitivity reactions in the child cannot be excluded.It is necessary to discontinue breastfeeding or to discontinue / abstain from ceftriaxone therapy, taking into account the benefits of breastfeeding for the baby and the benefits of therapy for the mother.

Features of influence on the ability to drive a vehicle or potentially dangerous machinery

During therapy with Rocefin, caution should be exercised due to the possibility of dizziness and other undesirable reactions that may affect the ability to drive vehicles and mechanisms.

Rocefin – instructions for use

Standard dosing regimen

Intravenous, intramuscular.

Adults and children over 12 years of age ≥50 kg: 1-2 g once a day (every 24 hours). In severe cases or with infections, the causative agents of which have only moderate sensitivity to ceftriaxone, the daily dose can be increased to 4 g. The duration of treatment depends on the course of the disease.As always with antibiotic therapy, the administration of Rocefin ^® should be continued to patients for at least 48-72 hours after the temperature has returned to normal and the eradication of the pathogen is confirmed.

The course of treatment is usually 4-14 days; for complicated infections, a longer administration may be required.

The course of treatment for infections caused by Streptococcus pyogenes should not be

less than 10 days.

Introduction

The general rule should be to use solutions immediately after preparation.The prepared solutions retain their physical and chemical stability for 6 hours at room temperature (or for 24 hours at 2-8 ° C). Depending on the concentration and duration of storage, the color of the solutions can vary from pale yellow to amber. The color of the solution does not affect the effectiveness or tolerability of the drug.

For intramuscular injection of 250 mg or 500 mg of Rocefin ^® is dissolved in 2 ml, a1 g – in 3.5 ml of 1% lidocaine solution and injected deep into a sufficiently large muscle (buttock). It is recommended to inject no more than 1 g into the same muscle. A solution containing lidocaine should not be administered intravenously.

For intravenous injection dissolve 250 mg or 500 mg of Rocefin ^® in 5 ml, and 1 g in 10 ml of sterile water for injection; injected intravenously slowly over 5 minutes, preferably into a large vein.

Intravenous infusion of should last at least 30 minutes.To prepare the solution, dilute 2 g of Rocefin ^® in 40 ml of one of the following infusion solutions that do not contain calcium ions: 0.9% sodium chloride solution, 0.45% sodium chloride solution + 2.5% dextrose solution, 5% dextrose solution, 10% solution dextrose, 6% dextran solution in 5% dextrose solution, 6-10% hydroxyethyl starch solution, water for injection. Solutions of Rocefin® should not be mixed or added to solutions containing other antimicrobial drugs or other solvents, except for those listed above, due to possible incompatibility.

Do not use solvents containing calcium, such as Ringer’s solution or Hartman’s solution, for the preparation of solutions of the drug Rocefin ^® for intravenous administration and their subsequent dilution, due to the possible formation of precipitates. The formation of precipitates of calcium salts of ceftriaxone can also occur when mixing Rocefin ^® and calcium-containing solutions using a single venous access. Do not use Rocefin ^® simultaneously with calcium-containing solutions for intravenous administration, including with long-term infusions of calcium-containing solutions, for example, during parenteral nutrition using the Y-connector.For all groups of patients, except for newborns, sequential administration of the drug Rocefin ^® and calcium-containing solutions is possible with thorough rinsing of the infusion systems between infusions with a compatible fluid (see the section “Interaction with other medicinal products”).

There have been no reports of interactions between ceftriaxone and oral calcium-containing drugs, or interactions between intramuscular ceftriaxone and calcium-containing drugs (for intravenous or oral administration).

Dosing in special cases

Patients with impaired liver function

In patients with impaired liver function, it is necessary to reduce the dose in the absence of impaired renal function.

Patients with nocturnal dysfunction

In patients with impaired renal function, there is no need to reduce the dose, provided that there are no impaired liver function. The daily dose of Rocefin ^® should not exceed 2 g only in cases of renal failure with creatinine clearance less than 10 ml / min.Ceftriaxone is not excreted during hemodialysis or peritoneal dialysis, therefore, the administration of an additional dose of Rocefin ^® to the patient after the end of dialysis is not required.

In case of combination of severe renal and hepatic insufficiency , the efficacy and safety of the drug should be carefully monitored.

Elderly and senile patients

Usual doses for adults without age adjustment in the absence of severe renal and hepatic impairment.

Children

Newborns, infants and children under 12 years old

When prescribing the drug Rocefin ^® once a day, it is recommended to adhere to the following dosage regimens:

– newborns (up to 14 days): 20-50 mg / kg body weight once a day; the daily dose should not exceed 50 mg / kg of body weight;

– newborns, infants and young children (from 15 days to 12 years): 20-80 mg / kg body weight once a day;

– Doses for adults are prescribed for children weighing over 50 kg.

For premature infants up to 41 weeks of age inclusive (total gestational and chronological age), the use of peftriaxone is contraindicated. Rocefin ^® is contraindicated in neonates (≤28 days) who are already prescribed or are expected to receive intravenous treatment with calcium-containing solutions, including long-term calcium-containing infusions, for example, with parenteral nutrition due to the risk of precipitation of calcium salts of ceftriaxone (see section “Contraindications”) ,

For infants and children under 12 years of age, intravenous doses of 50 mg / kg or higher should be administered by drip for at least 30 minutes.In neonates, intravenous administration should be given for 60 minutes to reduce the potential risk of developing bilirubin encephalopathy.

Meningitis

With bacterial meningitis in infants and young children , treatment begins with a dose of 100 mg / kg (but not more than 4 g) 1 time per day. After identification of the pathogen and determination of its sensitivity, the dose can be reduced accordingly. The best results in meningococcal meningitis were achieved with a treatment duration of 4 days, with meningitis caused by Haemophilus influenzae – 6 days, Streptococcus pneumoniae – 7 days.

Lyme disease

50 mg / kg (the highest daily dose – 2 g) for adults and children once a day for 14 days.

Gonorrhea (caused by penicillinase-forming and penicillinase-forming strains)

Single intramuscular injection of 250 mg of Rocefin ^® for adults and children over 12 years of age ≥50 kg.

Acute otitis media

In the treatment of acute otitis media in children, we recommend a single intramuscular injection at a dose of 50 mg / kg (but not more than 1 g).

Adults are recommended a single intramuscular injection in a dose of 1-2 g. According to limited data, in severe cases or with ineffectiveness of previous therapy. Rocefin ^® can be effective when administered intramuscularly at a dose of 1-2 g per day for 3 days.

Prevention of postoperative infections

Depending on the degree of infectious risk, 1-2 g of Rocefin ^® are administered once 30-90 minutes before the start of the operation.In operations on the colon and rectum, the simultaneous (but separate, see section “Dosage and Administration”) administration of the drug Rocefin ^® and one of the 5-nitroimidazoles, for example, ornidazole, has proven itself well.

Rocephin – Medical Guide PRO7

Ceftibuten. Antibiotic (cephalosporin, 3rd generation) Cedex Ceftriaxone. Antibiotic (cephalosporin, 3rd generation) Azaran Bio-traxon Ificef Lendacin Lifaxon Loraxon Megion Medaxone Novosef Oframax Roceferin Rocephin Stericef… [Page 776]

Cephobac – see Ciprofloxacin Ceftor – see Cefaclor Ceftriaxone, antibiotic, cephalosporin. Betasporina Ificef Lendacin Longacef Novosef Oframax Rocefin Torocef Cefaxone Ceftriaxone sodium salt … [Page 782]

Ceftriaxone sodium (Rocefin, R) – 20 mg / kg IV every 12 hours … [Page 864]

Ceftriaxone (Rocefin) IV, IM 50-75 mg in 1 or 2 injections (daily dose for adults 2 g) 80-100 mg in 1 or 2 injections (daily dose for adults 4 g) Large doses approved for the treatment of penicillin-resistant pneumococcal meningitis… [Page 878]

Ceftriaxone (longacef, of. Max, rocephin, cefaxone) 2-3 24 … [Page 247]

Azaran, Biotraxon, Ificef, Lendacin, Lifaxon, Loraxon, Megion, Medaxon, Novosef, Oframax, Protekh, Roceferin, Rocefin, Stericsef, Tercef, Torocef, Triaxon, Troxon, Cefaxon, Cefatrin, Cefogram, Cefson, Ceftriabol, Ceftriaxone, Ceftriaxon-AKOS-Keftriaxone Sodium. .. [Page 764]

Treatment. For the treatment of streptococcal pneumonia, penicillin or its semisynthetic derivatives is used at the rate of 100-200 mg / kg per day intramuscularly in two doses.Other antibiotics can also be used (amoxiclav, lendacin, amoxicillin, unazine, wilprafen, rocefin, cefobid, duracef). With empyema, thoracocentesis is performed. [Page 544]

Etiotropic therapy. Penicillin every 4-6 hours intravenously in high doses or erythromycin, with meningitis ceftriaxone (rocephin) or cefotaxime, chloramphenicol intravenously for a week. [Page 397]

In case of intolerance to penicillin, macrolides are prescribed – erythromycin, wilprafen, rulide or metacyclin. Perhaps the appointment of sulfonamides or cephalosporins (cefobid, unazine, lendacin, rocephin, duracef, etc.)). It is advisable to prescribe ascorbic acid, rutin, B vitamins, niacin. [Page 549]

There are short-acting and prolonged-acting antibiotics. So, to maintain the bactericidal concentration in the plasma, penicillin should be injected every 4 hours, and rocephin (3rd generation cephalosporin) – once a day. [Page 379]

In case of allergy to penicillin, aminoglycosides are combined with cephalosporins (ceftriaxone or rocefin) – 25-50 mg / (kg day) intramuscularly or intravenously 1 time per day (Korshunova R.A. et al., 2000). For allergies to penicillin and cephalosporins, vancomycin is prescribed at 15 mg / (kg day) intravenously 2-4 times a day for 4-6 weeks. [Page 433]

Features frequency of admission from 4 to 1 times a day. Recently, there has been a tendency to administer drugs once a day (rocephin). [Page 563]

Treatment. Etiotropic therapy of antibiotic-induced intestinal clostridiosis with dificile is the administration of metronidazole, parenteral aminoglycosides (gentamicin, sizomycin, amikacin, brulamycin, etc.)), as well as cephalosporins (cephobid, rocephin, unazine, lendacin, etc.). [Page 494]

The most widely used antibiotics lately are cefobid, cefamezin, lendacin, unazine, amoxiclav, rocephin, amoxicillin, amikacin, duracef. Intravenous antibiotics are especially effective. [Page 564]

On the background of antibacterial (rocephin, amikacin), anti-mediator (gordox), infusion and transfusion (30.10 blood transfusion of 300 ml of erythrocyte suspension) therapy, healing of postoperative wounds by primary intention.[Page 479]

Roferon 2A – see Interferon a-2a Roferon-A – see Interferon a-2a Roceferin – see Ceftriaxone Rocefin – see Ceftriaxone Ruwax – see Rudivax anti-measles vaccine – see Ruby vaccine … [Page 886]

Ceftriaxone (Ificef, Lifaxon, Longacef, Novotsef, Lendacin, Oframax, Rocefin) Powder for injection solution 250 500 1000 and 2000 mg – i / v, i / m 1-2 g 1- 2 … [Page 767]

Rifodex – see Rifampicin Roaccutane – see Isotretinoin Robitussin – seePseudoephedrine Rosevin – see Vinblastine Roxicam – see Piroxicam Ronal – see Aspirin Rondex – see Dextran Ronian – see Nifedipine Roscillin – see Ampicillin Roferon A – see Interferon and Rocephin – see Ceftriaxone … [ ]

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Prices for Medaxone and analogues: Ceftriaxone-AKOS, Ceftriaxone, Rocefin in pharmacies in Moscow and the Moscow region. Availability, order. Pharmacies on the map. Reviews.

Bratislav

9030

307 Lyublino

New

8 9030
9

Pyatkinskaya

309 9030

Riga Roman

Rostokino Rumyantsevo

Ryazan prospectus Savelovskaya

Salaryevo Sviblovo

9030

91

Filatovskaya

9 911

Starokachalovskaya

Starokachalovskaya

9030 Filyovsky Park

Tsvetino

Tsvetino

Any Station of Subway
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	South 908 9012 South 90,000 Different generations of cephalosporin drugs – Health Cephalosporins are one of the most widely prescribed drug classes in the world.Most likely, you have met these antibiotics, even if you do not know their name. For example, among other things, keflex Contents Cephalosporins are one of the most widely prescribed drug classes in the world. Most likely, you have met these antibiotics, even if you do not know their name. For example, among other things, keflex (cephalexin) is used to treat skin infections. Rocephin (ceftriaxone) is also used to treat pneumonia. What are cephalosporins? Cephalosporins were first detected in sewage off the coast of Sardinia in 1945. By 1964, the first cephalosporin was prescribed. Cephalosporins are structurally similar to other antibiotics. Like penicillins, cephalosporins have a beta-lactam ring attached to the dihydothiazole ring. From this diidothiazole ring hang down various side chains, the composition of which gives different cephalosporins with different pharmacology and antimicrobial activity. Cephalosporins have three different mechanisms of action: Binding to specific penicillin-binding proteins. Suppression of cell wall synthesis. Activation of autolytic (self-destructive) enzymes of the bacterial cell wall. Cephalosporins are divided into five generations. However, different cephalosporins of the same generation are sometimes not chemically related and have different spectra of activity (for example, cefamycins). The generalization taught by many health professionals is that with successive generations of cephalosporins, coverage of gram-positive decreases and coverage of gram-negative increases. 1 to 3% of all people are allergic to cephalosporins. In reality, however, this number is likely higher because people who are allergic to penicillin often do not prescribe cephalosporins. First generation cephalosporins First generation cephalosporins are oral and intravenous. They are active against Viridans streptococci, group A hemolytic streptococci, Staphylococcus aureus, Escherichia coli, Klebsiella and Proteus bacteria. Like all other cephalosporins, first-generation cephalosporins have no effect on enterococci. Examples of first generation cephalosporins include the following: Cephalexin (Keflex) Cefradine Cefadroxil Cefazolin (intravenous and intramuscular) In general, first generation cephalosporins can be used to combat other soft tissue infections, and other soft tissue infections and other skin infections respiratory and urinary tract infections. First-generation intravenous cephalosporins can be used as prophylaxis after clean surgical procedures. The prevalence of MRSA has reduced the effectiveness of first-generation cephalosporins as a preventive and therapeutic agent. Second-generation cephalosporins In general, second-generation cephalosporins are more active against gram-negative organisms, making them more useful in many clinical situations. For example, second generation cephalosporins are active against Proteus and Klebsiella strains. Second-generation cephalosporins also fight H.influenza is the cause of pneumonia, sepsis and meningitis. However, first-generation cephalosporins are generally still better at treating gram-positive infections. Examples of second-generation cephalosporins include the following: Cefoxitin Cefotetan Cefuroxime (tablet and injection) Cefprozil Second-generation cephalosporins treat the following: Sinusitis Medium anaerobic infections, including peritonitis and diverticulitis Prophylaxis after colorectal surgery Second-generation cephalosporins are not active against Pseudomonas aeruginosa. Third-generation cephalosporins The main advantage of third- and fourth-generation antibiotics is a significantly expanded coverage against gram-negative bacteria. In addition, the third-generation cephalosporin ceftazidime is active against Pseudomonas aeruginosa, a bacteria that can cause skin infections in people with normal immune systems (for example, after exposure to an insufficiently chlorinated hot bath or pool), as well as pneumonia, blood infections, and so on in humans. with a weakened immune system.P. aeruginosa is most common in patients who have been hospitalized for one week or longer.) Infections can be very complex and life-threatening. There are several third generation cephalosporins. Discussing all of them is beyond the scope of this article. Instead, let’s focus on ceftriaxone (rocephin), which has many uses, including: Lower respiratory infections Skin and soft tissue infections Uncomplicated gonorrhea Urinary tract infections Otitis media pelvic organs Surgical prophylaxis Bacterial sepsis (blood poisoning) Meningitis Bone infections Joint infections Intra-abdominal infections Fourth-generation cephalosporin Cefepime is the only fourth-generation cephalosporin available (FDA-approved).Like the third-generation cephalosporin ceftazidime, cefepime is active against Pseudomonas aeruginosa. In addition, cefepime is more active against Enterobacter and Citrobacterr bacteria. Finally, cefepime has a gram-positive effect comparable to ceftriaxone. Some of the clinical uses of cefepime are: Moderate to severe pneumonia Severe urinary tract infection Skin and soft tissue infections Complicated intra-abdominal infections Fifth-generation cephalosporin In 2010, the FDA approved ceftaroline (Teflaro), the only fifth-generation or advanced cephalosporin.Like cefepime, ceftaroline is a powerful antibiotic that should be used for serious infections. In particular, it is active against multidrug-resistant infections such as MRSA (methicillin-resistant S. aureus ) and VRSA (vancomycin-resistant S. aureus) . This drug is also used for injection and is indicated for treating community-acquired pneumonia and serious skin and soft tissue infections. Fortunately, ceftaroline is safe and does not induce resistance. A word from Verywell As you now understand, cephalosporins are an amazingly diverse class of antibiotics with a wide coverage. However, as with most antibiotics, antibiotic resistance is a concern for many clinicians, epidemiologists, health officials, and patients. Bacterial resistance is partly due to over-prescription; however, we as patients can also help combat the development of resistance.For example, you may not always have to expect or require your doctor to prescribe antibiotics for you to treat an infection that may well be viral. (Antibiotics are not effective against viruses.) Also, when prescribing antibiotics, it is imperative that you complete the entire course, even if you “feel better.” Doctors of the Russian Federation 1 coated tablet contains ciprofloxacin hydrochloride monohydrate 250 or 500 mg, in a cold-pressed blister or blister 10 pcs.respectively; in a box of 1 or 10 blisters. 100 ml solution for infusion contains ciprofloxacin lactate 200 mg; in bottles of 100 ml, in a box 1 bottle. 1 ml of eye drops – ciprofloxacin hydrochloride 3 mg; in vials of 10 ml, in a box 1 bottle. Pharmacological action – bactericidal, antibacterial, antibacterial broad spectrum. Blocks bacterial DNA gyrase and disrupts the synthesis of bacterial DNA, leading to the death of the bacterial cell. Rapidly absorbed from the gastrointestinal tract, oral bioavailability of about 70%. After a single dose of 250 and 500 mg, the average peak serum concentrations are 1.5 and 2.5 μg / l, respectively, and are many times higher than the MIC 90 for most microorganisms. After i.v. administration of 200 mg, the serum concentration is 3.8 μg / ml. It is evenly distributed and reaches therapeutic concentrations in most tissues and fluids. The level of protein binding is low (19-40%).It is excreted unchanged in the urine, as well as in bile and feces. Infections: respiratory, urinary tract, gynecological, bones and joints, ENT organs, gastrointestinal, abdominal; prostatitis, gonorrhea, sepsis, peritonitis. Hypersensitivity, children’s age (up to 12 years). Contraindicated, stop breastfeeding. Digits are well tolerated. From the digestive tract: diarrhea, nausea, vomiting. From the side of the central nervous system: headache, anxiety. Allergic reactions: hypersensitivity (rash, Quincke’s edema). Other: arthralgias. The effect is reduced by antacids containing magnesium or aluminum hydroxide. Enhances the effect of theophylline. ENT organs infections: inside – 250-500 mg 2 times / day; i / v, drip – 200 mg 2 times / day. Urinary tract infections: inside – 250-500 mg 2 times / day; IV, drip – 200-400 mg 2 times / day. Particularly severe infections (sepsis, osteomyelitis, peritonitis): IV, drip – 400 mg 2 times / day, then inside – 500-750 mg / day. For gonorrhea (uncomplicated): inside – 500 mg once. Lower respiratory tract infections, exacerbation of chronic bronchitis, pneumonia: inside – 500 mg 2 times / day. Eye drops. For diseases of mild to moderate severity: 1-2 drops in the lower conjunctival sac of the affected eye every 4 hours. In severe disease: , 2 drops / h until improvement is achieved, the course is 5–7 days. Treatment is continued for an additional 3 days after the disappearance of the clinical symptoms of infection. Prescribe with caution to patients with CNS pathology (severe cerebral atherosclerosis, epilepsy). To prevent crystalluria, drink plenty of water. Patients with renal insufficiency require dose adjustment. With the introduction of eye drops and other ophthalmic preparations, the interval between their administration should be at least 5 minutes. At a temperature not exceeding 25 ° C. 3 years. Do not use after the expiry date stated on the package. Rocefin is … What is Rocefin? Rocephin Active ingredient ›› Ceftriaxone * (Ceftriaxone *) Latin name Rocephin ATC: ›› J01Daxonologic group: Cepht2000 10) ›› A39 Meningococcal infection ›› A41 Other septicemia ›› A54 Gonococcal infection ›› G00 Bacterial meningitis, not elsewhere classified JOST Jstr00 upper respiratory tract infections ›› J18 Pneumonia without specifying the causative agent ›› K65 Peritonitis ›› K81 Cholecystitis ›› L00-L08 Infections of the skin and subcutaneous tissue arthropathy M60.0 Infectious myositis ›› M65.0 Tendon sheath abscess ›› M65.1 Other infectious tendosynovitis ›› M71.0 Bursa abscess ›› M71.1 Other infectious bursitis › M86 Osteomyelitis ›› N15 Other tubulointerstitial kidney diseases ›› N39.0 Urinary tract infection with no known localization ›› N49 Inflammatory diseases of the male genital organs, not elsewhere classified N73 Other inflammatory diseases of the female pelvic organs N74.3 Gonococcal female pelvic inflammatory disease (A54.2 +) ›› T79.3 Post-traumatic wound infection, not elsewhere classified ›› Z100 * CLASS XXII Surgical practice Composition and form of production 1 ampoule with powder for preparation of an injection solution contains ceftriaxone (in the form of disodium hydrate) 0.25, 0.5, 1 or 2 g, complete with or without a solvent, in a box of 1, 5, or 143 pcs. Solvents: for intramuscular administration – 1% lidocaine solution in ampoules of 2, 3.5, 5 ml, for intravenous administration – 1 ampoule with 10 ml of distilled water for injection. Pharmacological action Pharmacological action – antibacterial, bactericidal. Inhibits the synthesis of peptidoglycan of the cell membrane of most gram-positive and gram-negative microorganisms. Pharmacokinetics Well and quickly absorbed after intramuscular administration and penetrates into tissues and biofluids, including spinal cord (in particular, with inflammation of the meninges). T 1/2 – 8 hours. Within 24 hours after taking a therapeutic dose – the concentration in the body is higher than the minimum inhibitory concentration for most infectious agents.From 30 to 60% is excreted in the active form by the kidneys, the rest – by the liver (with bile). Pharmacodynamics Has a bactericidal effect on many gram-negative and gram-positive bacteria. Highly susceptible species are: Proteus mirabilis, Haemophilus influenzae, Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Salmonella spp., Shigella spp., Klebsiella spp., Klebsiella pneumoniae, Enterobacter, Indole-positive Proteus, virptocine-positive.Moderately sensitive strains are: Serratia marcescens, Pseudomonas aeruginosa, Staphylococcus aureus, Listeria monocytogenes, Bacteroides fragilis, Clostridium spp., Chlamydia trachomatis. Weakly susceptible strains are: Pseudomonas spp. (except P. aeruginosa), Streptococcus faecalis, Mycoplasma hominis and pathogenic fungi. It is resistant to the action of most beta-lactamases and therefore acts on strains with acquired tolerance to other cephalosporins. Clinical Pharmacology After the symptoms of infection have disappeared, the patient is treated for at least three more days.In patients with impaired renal function (with normal liver function), the dose may not be reduced. Indications Infections of the urinary, respiratory and biliary tract, gastrointestinal tract, bones and joints, skin and soft tissues, ENT organs, reproductive system; peritonitis, sepsis, meningitis, gonorrhea. Contraindications Hypersensitivity (including to other beta-lactamines), hepatic renal failure. Application during pregnancy and lactation Not recommended during lactation (you must stop breastfeeding).Contraindicated in the first trimester of pregnancy. Side effects Headache, dyspepsia, diarrhea, nausea, vomiting, stomatitis, glossitis, cholestasis, eosinophilia, leukopenia, thrombocytopenia, granulocytopenia, hemolytic anemia, increased activity of hepatic transaminases, hypercreaticulencemia, phytococulencemia, oligobacillus at the injection site, mycoses, pseudomembranous colitis, allergic reactions (exanthema, dermatitis, pruritus, urticaria). Interaction Pharmaceutical incompatible with other antibiotics. Method of administration and doses V / m, deep into the gluteus muscle or IV – 1-2 g once a day, if necessary – up to 4 g per day for 2 injections. Newborns (up to 2 weeks) – 20-50 mg / kg per day, children under 12 years old – 20-80 mg / kg. Leave a Reply Cancel reply Your email address will not be published. Required fields are marked * Comment * Name * Email * Website