What are the common side effects of Cefprozil. How should Cefprozil be administered to children. What precautions should parents take when giving Cefprozil to their child. When should parents seek immediate medical attention while their child is taking Cefprozil.

Understanding Cefprozil: An Antibiotic for Bacterial Infections

Cefprozil is an antibiotic medication used to treat various bacterial infections in both adults and children. As a member of the cephalosporin class of antibiotics, it works by stopping the growth of bacteria.

Primary Uses of Cefprozil

• Respiratory tract infections
• Skin and soft tissue infections
• Otitis media (middle ear infections)
• Pharyngitis (sore throat)
• Tonsillitis

Can Cefprozil treat all types of infections? No, Cefprozil is specifically designed to combat bacterial infections and is ineffective against viral infections such as the common cold or flu.

Common Side Effects and Precautions for Cefprozil

While Cefprozil is generally well-tolerated, it’s important for parents and patients to be aware of potential side effects. Some common side effects include:

• Nausea
• Vomiting
• Diarrhea
• Stomach pain
• Dizziness

In young children, diaper rash may also occur. Are these side effects typically severe? No, most side effects are mild and resolve on their own. However, if any of these effects persist or worsen, it’s crucial to inform your doctor or pharmacist promptly.

Serious Side Effects Requiring Immediate Attention

While rare, some serious side effects may occur. Parents should be vigilant and contact their child’s doctor immediately if they notice any of the following:

• Unusual tiredness or weakness
• Yellowing of the eyes or skin
• Severe stomach or abdominal pain
• Persistent nausea or vomiting
• Dark urine
• Signs of kidney problems (changes in urine output)
• Signs of new infection (fever, persistent sore throat)
• Easy bruising or bleeding
• Mental or mood changes (such as confusion)

Clostridium Difficile-Associated Diarrhea: A Rare but Serious Concern

Cefprozil, like other antibiotics, may rarely cause a severe intestinal condition known as Clostridium difficile-associated diarrhea. This condition can occur during treatment or even weeks to months after stopping the medication.

How can parents recognize C. difficile-associated diarrhea? Key symptoms include:

• Persistent diarrhea
• Abdominal or stomach pain/cramping
• Blood or mucus in the stool

It’s crucial to avoid using anti-diarrhea medications or opioids if these symptoms occur, as they may exacerbate the condition. Instead, contact your doctor immediately for proper evaluation and treatment.

Allergic Reactions and Hypersensitivity to Cefprozil

While severe allergic reactions to Cefprozil are rare, they can be life-threatening if they occur. Parents should seek immediate medical attention if their child exhibits any signs of a serious allergic reaction, including:

• Rash
• Itching or swelling (especially of the face, tongue, or throat)
• Severe dizziness
• Trouble breathing

Is it possible to predict who will have an allergic reaction to Cefprozil? While not always predictable, individuals with a history of allergies to penicillin or other cephalosporin antibiotics may be at higher risk and should inform their healthcare provider before starting treatment.

Special Considerations for Pediatric Use of Cefprozil

When prescribing Cefprozil for children, healthcare providers take into account several factors to ensure safe and effective treatment. Parents should be aware of the following considerations:

Dosage and Administration

The dosage of Cefprozil for children is typically based on their weight and the specific condition being treated. It’s crucial to follow the prescribed dosage carefully and complete the entire course of treatment, even if symptoms improve before the medication is finished.

Potential Drug Interactions

Cefprozil may interact with other medications or supplements. Parents should inform their child’s doctor about all current medications, including over-the-counter drugs and natural products.

Monitoring During Treatment

For children on long-term Cefprozil therapy, regular blood work may be necessary to monitor for potential side effects. Parents should discuss the frequency of these tests with their child’s healthcare provider.

Managing Side Effects in Children Taking Cefprozil

While side effects from Cefprozil are usually mild, they can be distressing for both children and parents. Here are some strategies to help manage common side effects:

Gastrointestinal Discomfort

• Administer the medication with food to reduce stomach upset
• Encourage small, frequent meals rather than large ones
• Ensure adequate hydration to prevent dehydration from diarrhea

Diaper Rash

• Change diapers frequently to keep the area dry
• Use a barrier cream to protect the skin
• Give the child diaper-free time to allow the skin to air out

How can parents differentiate between normal side effects and those requiring medical attention? While mild gastrointestinal symptoms are common, severe or persistent symptoms, especially when accompanied by fever or bloody stools, warrant immediate medical evaluation.

Long-Term Considerations and Potential Complications

While Cefprozil is generally safe for short-term use, prolonged or repeated courses may lead to additional concerns:

Oral Thrush and Vaginal Yeast Infections

Extended use of antibiotics like Cefprozil can disrupt the body’s natural balance of microorganisms, potentially leading to overgrowth of fungi. Parents should be alert for signs such as:

• White patches in the mouth (oral thrush)
• Changes in vaginal discharge
• Itching or burning in the vaginal area

Antibiotic Resistance

Improper use of antibiotics can contribute to the development of antibiotic-resistant bacteria. To minimize this risk, it’s crucial to:

• Only use antibiotics when prescribed by a healthcare professional
• Complete the entire course of treatment as directed
• Never share antibiotics or use leftover medication from previous illnesses

Does completing the full course of antibiotics guarantee prevention of resistance? While it doesn’t guarantee prevention, completing the prescribed course significantly reduces the risk of antibiotic resistance and ensures the most effective treatment of the current infection.

Reporting Side Effects and Seeking Medical Advice

Effective communication with healthcare providers is essential for ensuring the safe use of Cefprozil. Parents should be aware of the appropriate channels for reporting side effects and seeking medical advice:

In the United States

• Contact your child’s doctor for medical advice about side effects
• Report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

In Canada

• Call your doctor for medical advice about side effects
• Report side effects to Health Canada at 1-866-234-2345

Is it necessary to report all side effects, even mild ones? While severe side effects should always be reported, documenting milder side effects can help healthcare providers adjust treatment plans and contribute to overall drug safety monitoring.

Special Populations and Cefprozil Use

Certain groups may require additional precautions or monitoring when taking Cefprozil:

Pregnant and Breastfeeding Individuals

If a child or adolescent taking Cefprozil is pregnant or breastfeeding, it’s crucial to discuss the potential risks and benefits with their healthcare provider. While Cefprozil is generally considered safe during pregnancy and breastfeeding, individual circumstances may affect this assessment.

Individuals with Phenylketonuria (PKU)

Some Cefprozil products contain phenylalanine, which can be problematic for individuals with PKU. Parents of children with this condition should consult with their doctor about suitable alternatives or precautions.

Patients with Diabetes

Cefprozil may affect certain urine glucose tests. Parents of diabetic children should discuss appropriate testing methods with their healthcare provider to ensure accurate monitoring of blood sugar levels during treatment.

Are there any absolute contraindications for Cefprozil use? While rare, individuals with a known severe allergy to cephalosporin antibiotics should not take Cefprozil. Always provide a complete medical history to your healthcare provider to ensure safe and appropriate prescribing.

Enhancing Treatment Efficacy and Safety

To maximize the benefits of Cefprozil treatment while minimizing risks, parents can take several proactive steps:

Medication Adherence

• Administer doses at regular intervals as prescribed
• Use a medication tracker or set reminders to ensure no doses are missed
• Complete the entire course of treatment, even if symptoms improve

Lifestyle Considerations

• Encourage a balanced diet to support the immune system
• Ensure adequate rest and hydration during treatment
• Practice good hygiene to prevent the spread of infection

Open Communication

• Keep all healthcare providers informed about your child’s medication regimen
• Report any new symptoms or concerns promptly
• Ask questions if you’re unsure about any aspect of the treatment

How can parents best prepare for a medical appointment regarding Cefprozil treatment? Come prepared with a list of all current medications, a detailed description of symptoms and their timeline, and any questions or concerns about the treatment. This information will help healthcare providers make informed decisions and provide the best care for your child.

By understanding the uses, benefits, and potential risks of Cefprozil, parents can play an active role in their child’s treatment and recovery. Always consult with healthcare professionals for personalized advice and guidance throughout the course of antibiotic therapy.

Cefprozil Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Nausea, vomiting, diarrhea, stomach pain, or dizziness may occur. Diaper rash may occur in young children. If any of these effects persist or worsen, notify 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 any of these unlikely but serious side effects occur: unusual tiredness/weakness.

Tell your doctor right away if any of these rare but very serious side effects occur: yellowing of the eyes/skin, severe stomach/abdominal pain, persistent nausea/vomiting, dark urine, signs of kidney problems (such as change in the amount of urine), signs of new infection (e.g., fever, persistent sore throat), easy bruising/bleeding, mental/mood changes (such as confusion).

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a resistant bacteria. This condition may occur while receiving therapy or even weeks to months after treatment has stopped. Do not use anti-diarrhea or opioid medications if you have the following symptoms because these products may make them worse. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

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

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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.

Cefprozil: Pediatric Medication | Memorial Sloan Kettering Cancer Center

This information from Lexicomp^® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.

Brand Names: Canada

APO-Cefprozil; Auro-Cefprozil; Cefzil [DSC]; SANDOZ Cefprozil [DSC]; TARO-Cefprozil

What is this drug used for?

• It is used to treat bacterial infections.

What do I need to tell the doctor BEFORE my child takes this drug?

• If your child is allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had.

This drug may interact with other drugs or health problems.

Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe to give this drug with all of your child’s other drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.

What are some things I need to know or do while my child takes this drug?

• Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
• Have blood work checked if your child is on this drug for a long time. Talk with your child’s doctor.
• If your child has high blood sugar (diabetes) and you test your child’s urine glucose, talk with your child’s doctor to find out which tests are best to use.
• This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
• Do not give to your child longer than you have been told. A second infection may happen.
• If your child has phenylketonuria (PKU), talk with your child’s doctor. Some products have phenylalanine.

If your child is pregnant or breast-feeding a baby:

• Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.

What are some side effects that I need to call my child’s doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Seizures.
• Diarrhea is common with antibiotics. Rarely, a severe form called C diff–associated diarrhea (CDAD) may happen. Sometimes, this has led to a deadly bowel problem. CDAD may happen during or a few months after taking antibiotics. Call your child’s doctor right away if your child has stomach pain, cramps, or very loose, watery, or bloody stools. Check with your child’s doctor before treating diarrhea.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:

These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.

You may report side effects to your national health agency.

How is this drug best given?

Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.

All products:

• Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
• Give this drug with or without food. Give with food if it causes an upset stomach.

Liquid (suspension):

• Shake well before use.
• Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.

What do I do if my child misses a dose?

• Give a missed dose as soon as you think about it.
• If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
• Do not give 2 doses at the same time or extra doses.

How do I store and/or throw out this drug?

Tablets:

• Store at room temperature in a dry place. Do not store in a bathroom.

Liquid (suspension):

• Store in a refrigerator. Throw away any part not used after 2 weeks.
• Do not freeze.

All products:

• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

General drug facts

• If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
• Do not share your child’s drug with others and do not give anyone else’s drug to your child.
• Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

This generalized information is a limited summary of diagnosis, treatment, and/or medication information. It is not meant to be comprehensive and should be used as a tool to help the user understand and/or assess potential diagnostic and treatment options. It does NOT include all information about conditions, treatments, medications, side effects, or risks that may apply to a specific patient. It is not intended to be medical advice or a substitute for the medical advice, diagnosis, or treatment of a health care provider based on the health care provider’s examination and assessment of a patient’s specific and unique circumstances. Patients must speak with a health care provider for complete information about their health, medical questions, and treatment options, including any risks or benefits regarding use of medications. This information does not endorse any treatments or medications as safe, effective, or approved for treating a specific patient. UpToDate, Inc. and its affiliates disclaim any warranty or liability relating to this information or the use thereof. The use of this information is governed by the Terms of Use, available at https://www.wolterskluwer.com/en/solutions/lexicomp/about/eula.

Last Reviewed Date

2021-05-10

Copyright

© 2021 UpToDate, Inc. and its affiliates and/or licensors. All rights reserved.

Cefprozil oral suspension

What is this medicine?

CEFPROZIL (sef PROE zil) 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): Cefzil

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

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

• bleeding problems
• bowel disease, like colitis
• kidney disease
• phenylketonuria
• an unusual or allergic reaction to cefprozil, other cephalosporins, penicillins, other antibiotics, medicines, foods, dyes or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Shake well before using. Use a specially marked spoon or dropper to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Bottles of suspension may contain more liquid than you need to take. Follow your doctors instructions about how much to take and for how many days to take it. Do not take more medicine than directed. But, finish all the medicine that is prescribed even if you think you are better. Do not skip doses or stop your medicine early.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 6 months for selected conditions, precautions do apply.

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?

This medicine may interact with the following medications:

• birth control pills
• certain medicines for infection like amikacin, gentamicin, tobramycin
• diuretics
• probenecid

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 begin to improve.

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 have diabetes, you may get a false-positive result for sugar in your urine. Check with your doctor or health care provider.

This product may contain aspartame, which is a source of phenylalanine. If you have phenylketonuria (PKU), you may need to contact your health care provider for advice.

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 or infection
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• seizures
• unusual bleeding or bruising
• unusually weak or tired
• yellowing of the eyes, skin

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

• diarrhea
• genital or anal irritation
• headache
• nausea, vomiting
• stomach pain
• trouble sleeping

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.

After this medicine is mixed by your pharmacist, store it in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. Throw away unused medicine after 14 days.

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.

RAN-Cefprozil – Uses, Side Effects, Interactions

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

Cefprozil is an antibiotic that belongs to the family of medications known as cephalosporins. It is used to treat certain types of infections caused by bacteria. It is most commonly used to treat infections of the throat, ear, sinus, skin, and bladder. It works by weakening the cell walls of the bacteria causing the infection, thereby killing the bacteria.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. 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?

Tablets

250 mg
Each oval, white-to-off-white, film-coated tablet, debossed with “RB 41” on one side and plain on the other side, contains cefprozil 250 mg.  Nonmedicinal ingredients: hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc, and titanium dioxide.

500 mg
Each oval, white-to-off-white, film-coated tablet, debossed with “RB 42” on one side and plain on the other side, contains cefprozil 500 mg. Nonmedicinal ingredients: hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc, and titanium dioxide.

Powder for suspension

Each bottle contains yellowish-pink granular powder forming yellowish-pink suspension on constitution with water. The resulting suspension has a characteristic fruity flavour. Each bottle contains cefprozil monohydrate equivalent to 125 mg or 250 mg of cefprozil per 5 mL of constituted solution. Nonmedicinal ingredients: aspartame, citric acid anhydrous, colloidal silicon dioxide, FD&C Red No. 40 Aluminium Lake, FD&C Yellow No. 6 Aluminium Lake, flavour fruit gum 912, flavour cherry 594 SD, glycine, polysorbate 80, simethicone emulsion, sodium benzoate, sodium chloride, microcrystalline cellulose, carboxymethylcellulose sodium, carboxymethyl cellulose sodium, and sucrose.

How should I use this medication?

Adults: The recommended dose for adults and adolescents 13 years and older is 250 mg to 500 mg every 12 to 24 hours. The exact dose depends on the condition being treated.

Children: The recommended children’s dose is 7.5 mg to 15 mg per kilogram of body weight every 12 hours, or up to 20 mg per kilogram every 24 hours. The exact dose depends on the condition being treated.

Cefprozil can be taken with or without food.

Finish all of this medication, even you start to feel better. This will reduce the chance of the infection returning.

Many things can affect the dose of a 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. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store liquid forms of this medication in the refrigerator, out of reach and sight of children. Any medication remaining after 14 days should be safely discarded.

Tablets should be stored at room temperature, and kept out of reach and sight 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 take cefprozil if you:

• are allergic to cefprozil or to any of the ingredients of the medication
• are allergic to cephalosporin antibiotics

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.

• mild diarrhea
• dizziness
• headache
• nausea
• sore mouth or tongue
• stomach cramps (mild)
• vaginal itching or discharge
• vomiting

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

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

• abdominal tenderness
• decrease in amount of urine
• fever
• hearing loss
• joint pain
• severe abdominal or stomach cramps and pain
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• skin rash, itching, redness, or swelling
• unusual bleeding or bruising
• unusual tiredness or weakness

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

• diarrhea (watery and severe, which may also be bloody)
• seizures
• signs of a serious allergic reaction (i.e., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• symptoms of a severe skin rash (such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort)

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.

Allergy: Before starting treatment with cefprozil, inform your doctor about any adverse reactions you have had to medications, especially cefprozil, cephalosporins, and penicillins. Some people allergic to penicillin may also be allergic to cephalosporins such as cefprozil. If you have an allergic reaction, contact a doctor.

Antibiotic-associated colitis: Like other antibiotics, this medication may cause a potentially dangerous condition called antibiotic-associated colitis (or pseudomembranous colitis). Symptoms include severe, watery diarrhea that may be bloody. If you notice these symptoms, stop taking cefprozil and contact your doctor as soon as possible.

Bacterial resistance: Misuse of an antibiotic such as cefprozil may lead to the growth of resistant bacteria that will not be killed by the antibiotic. If this happens, the antibiotic may not work for you in the future. Although you may begin to feel better when you first starting taking cefprozil, you need to take all of the medication exactly as prescribed by your doctor to finish ridding your body of the infection and to prevent resistant bacteria from taking hold. Do not take cefprozil or other antibiotics to treat a viral infection such as the common cold; antibiotics do not kill viruses, and using them to treat viral infections can lead to the growth of resistant bacteria.

Kidney function: Kidney disease and decreased kidney function may cause this medication to build up in the body, causing side effects. People with kidney disease or reduced kidney function should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Overgrowth of organisms: Prolonged or repeated use of cefprozil may result in an overgrowth of bacteria or fungi and organisms that are not killed by the medication. This can cause problems such as yeast infections.

Pregnancy: It is not known if cefprozil is safe for use by pregnant women. 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: This medication passes into breast milk. If you are a breast-feeding mother and are taking cefprozil, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: It is not known if cefprozil is safe for children under 6 months of age.

What other drugs could interact with this medication?

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

• aminoglycoside antibiotics (e.g., gentamicin, tobramycin)
• BCG vaccine
• cholera vaccine
• sodium picosulfate
• typhoid vaccine
• warfarin

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/RAN-Cefprozil

Cefprozil Side Effects, Adverse Reactions | Healthgrades

The adverse reactions to cefprozil are similar to those observed with other orally administered cephalosporins. Cefprozil was usually well tolerated in controlled clinical trials. Approximately 2% of patients discontinued cefprozil therapy due to adverse events.

The most common adverse effects observed in patients treated with cefprozil are:

Diarrhea (2.9%), nausea (3.5%), vomiting (1%), and abdominal pain (1%).

Elevations of AST (SGOT) (2%), ALT (SGPT) (2%), alkaline phosphatase (0.2%), and bilirubin values (<0.1%). As with some penicillins and some other cephalosporin antibiotics, cholestatic jaundice has been reported rarely.

Rash (0.9%), urticaria (0.1%). Such reactions have been reported more frequently in children than in adults. Signs and symptoms usually occur a few days after initiation of therapy and subside within a few days after cessation of therapy.

Dizziness (1%). Hyperactivity, headache, nervousness, insomnia, confusion, and somnolence have been reported rarely (<1%). All were reversible.

Decreased leukocyte count (0.2%), eosinophilia (2.3%).

Elevated BUN (0.1%), serum creatinine (0.1%).

Diaper rash and superinfection (1.5%), genital pruritus and vaginitis (1.6%).

The following adverse events, regardless of established causal relationship to cefprozil, have been rarely reported during postmarketing surveillance: anaphylaxis, angioedema, colitis (including pseudomembranous colitis), erythema multiforme, fever, serum-sickness like reactions, Stevens-Johnson syndrome, and thrombocytopenia.

cephalosporin class paragraph

In addition to the adverse reactions listed above which have been observed in patients treated with cefprozil, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics:

Aplastic anemia, hemolytic anemia, hemorrhage, renal dysfunction, toxic epidermal necrolysis, toxic nephropathy, prolonged prothrombin time, positive Coombs’ test, elevated LDH, pancytopenia, neutropenia, agranulocytosis.

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment, when the dosage was not reduced. (See DOSAGE AND ADMINISTRATION and OVERDOSAGE .) If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

Cefprozil oral suspension

Brand Name: Cefzil

What is this medicine?

CEFPROZIL (sef PROE zil) 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.

How should I use this medicine?

Take this medicine by mouth. Follow the directions on the prescription label. Shake well before using. Use a specially marked spoon or dropper to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Bottles of suspension may contain more liquid than you need to take. Follow your doctors instructions about how much to take and for how many days to take it. Do not take more medicine than directed. But, finish all the medicine that is prescribed even if you think you are better. Do not skip doses or stop your medicine early.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 6 months for selected conditions, precautions do apply.

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 or infection
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• seizures
• unusual bleeding or bruising
• unusually weak or tired
• yellowing of the eyes, skin

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

• diarrhea
• genital or anal irritation
• headache
• nausea, vomiting
• stomach pain
• trouble sleeping

What may interact with this medicine?

This medicine may interact with the following medications:

• birth control pills
• certain medicines for infection like amikacin, gentamicin, tobramycin
• diuretics
• probenecid

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.

Where should I keep my medicine?

Keep out of the reach of children.

After this medicine is mixed by your pharmacist, store it in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. Throw away unused medicine after 14 days.

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

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

• bleeding problems
• bowel disease, like colitis
• kidney disease
• phenylketonuria
• an unusual or allergic reaction to cefprozil, other cephalosporins, penicillins, other antibiotics, medicines, foods, dyes or preservatives
• pregnant or trying to get pregnant
• breast-feeding

What should I watch for while using this medicine?

Tell your doctor or health care professional if your symptoms do not begin to improve.

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 have diabetes, you may get a false-positive result for sugar in your urine. Check with your doctor or health care professional.

This product may contain aspartame, which is a source of phenylalanine. If you have phenylketonuria (PKU), you may need to contact your health care provider for advice.

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. Copyright© 2020 Elsevier

Efficacy and tolerability of cefprozil versus amoxicillin/clavulanate for the treatment of adults with severe sinusitis

Cefprozil is a beta-lactamase-stable oral cephalosporin with an antimicrobial spectrum that includes gram-positive and gram-negative pathogens commonly associated with acute bacterial sinusitis, one of the most common upper respiratory tract infections among adults. We conducted a multicenter, open-label study to compare the efficacy and safety of cefprozil and amoxicillin/clavulanate in the treatment of adults with severe acute bacterial sinusitis diagnosed by clinical and radiographic criteria. A total of 278 patients entered the study, 140 (59 males, 81 females) in the cefprozil group and 138 (69 males, 69 females) in the amoxicillin/clavulanate group. Patients were randomized to 10 days of treatment with either cefprozil 500 mg BID or amoxicillin/clavulanate 500 mg/125 mg TID. Clinical severity was assessed at study entry, and patients were stratified based on symptom grade. Efficacy was evaluated using a 10-point questionnaire administered during, at the end of, and 2 weeks after completing therapy. At the end of treatment, 84.5% (71/84) of patients with severe sinusitis treated with cefprozil had a satisfactory clinical response, which was not significantly different from the 89.9% (80/89) of patients in the amoxicillin/clavulanate group who had a satisfactory clinical response. Two weeks after completing treatment, 80.8% (63/78) of cefprozil-treated patients and 81.0% (64/79) of amoxicillin/clavulanate-treated patients with severe sinusitis had a satisfactory response. Relapse was more common among amoxicillin/clavulanate patients (6/70; 8.6%) than among cefprozil patients (2/65; 3.1%), but the difference was not statistically significant. Significantly more amoxicillin/clavulanate-treated patients experienced adverse events compared with cefprozil-treated patients (P < 0.001), including diarrhea (P < 0.001), nausea (P < 0.042), and rash (P < 0.035). Three times as many amoxicillin/clavulanate patients discontinued treatment because of adverse events. Cefprozil demonstrated comparable clinical efficacy to amoxicillin/clavulanate in the treatment of adults with severe sinusitis; however, cefprozil was associated with a significantly lower incidence of diarrhea, nausea, and rash.

Memorial Sloan Kettering Cancer Center

This document, provided by Lexicomp ^® , contains all the information you need to know about the drug, including the indications, route of administration, side effects and when you should contact your healthcare provider.

Trade names: Canada

APO-Cefprozil; Auro-Cefprozil; Cefzil [DSC]; SANDOZ Cefprozil [DSC]; TARO-Cefprozil

What is this drug used for?

• It is used to treat various types of bacterial infections.

What do I need to tell my doctor BEFORE taking this drug?

• If you are allergic to this drug, any of its ingredients, other drugs, foods or substances. Tell your doctor about your allergy and how it manifested itself.

Combination of this drug with certain medications and medical conditions may be adverse.

Tell your doctor and pharmacist about all the medicines you take (both prescription and over-the-counter, natural products and vitamins) and your health problems.You need to make sure that this drug is safe for your medical conditions and in combination with other drugs you are already taking. Do not start or stop taking any medication or change the dosage without your doctor’s approval.

What do I need to know or do while taking this drug?

• Tell all healthcare providers that you are taking this drug.These are doctors, nurses, pharmacists and dentists.
• With long-term use of the drug, a blood test must be performed. Talk to a medical professional.
• If you have high blood sugar (diabetes) and are performing urine glucose tests, consult your doctor about the best tests to use.
• This drug may interfere with some laboratory tests. Tell all healthcare providers and laboratory staff that you are taking this drug.
• Do not use for longer than the prescribed time. A secondary infection is possible.
• Consult your doctor if you have PKU. Some foods contain phenylalanine.
• If you are 65 years of age or older, use this drug with caution. You may have more side effects.
• Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. The benefits and risks for you and your child will need to be discussed.

What side effects should I report to my doctor immediately?

WARNING. In rare cases, some people with this drug can have serious and sometimes deadly side effects. Call your healthcare professional or get medical attention right away if you have any of the following signs or symptoms, which may be associated with serious side effects:

• Signs of an allergic reaction such as rash, hives, itching, reddened and swollen skin with blistering or scaling, possibly associated with fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue, or throat.
• Convulsions.
• Diarrhea is common with antibiotics. In rare cases, severe diarrhea caused by the bacteria Clostridium difficile (C. diff.) [CDAD] can occur. This sometimes leads to gut problems that end in death. CDAD can occur during or several months after taking antibiotics. If you have pain, abdominal cramps, or very loose, watery or bloody stools, see your doctor right away. Check with your doctor before treating diarrhea.

What are some other side effects of this drug?

Any medicine can have side effects. However, many people have little or no side effects. Call your doctor or get medical help if these or any other side effects bother you or do not go away:

• Nausea.
• Diarrhea.

This list of potential side effects is not exhaustive.If you have any questions about side effects, please contact your doctor. Talk to your doctor about side effects.

You can report side effects to the National Health Office.

You can report side effects to the FDA at 1-800-332-1088. You can also report side effects at https://www.fda.gov/medwatch.

What is the best way to take this drug?

Use this drug as directed by your healthcare practitioner.Read all the information provided to you. Follow all instructions strictly.

All forms of issue:

• Continue taking this drug as directed by your doctor or other healthcare professional, even if you feel well.
• Take with or without food. Take with food if the medicine causes nausea.

Liquid (suspension):

• Shake well before use.
• Care should be taken to measure the doses of the liquid preparation. Use the dispenser that comes with the medicine. If a dispenser is not included in the package, ask your pharmacist for a dosing product for this drug.

What should I do if a dose of a drug is missed?

• Take the missed dose as soon as you can.
• If it is time for your next dose, do not take the missed dose and then return to your normal drug schedule.
• Do not take 2 doses at the same time or an additional dose.

How do I store and / or discard this drug?

Tablets:

• Store at room temperature in a dry place. Do not store in the bathroom.

Liquid (suspension):

• Store in refrigerator. Throw away any unused portion after 2 weeks.
• Do not freeze.

All forms of production:

• Store all medicines in a safe place.Keep all medicines out of the reach of children and pets.
• Dispose of unused or expired drugs. Do not empty into toilet or drain unless directed to do so. If you have any questions about the disposal of your medicinal products, consult your pharmacist. Your area may have drug recycling programs.

General information on medicinal products

• If your health does not improve or even worsens, see your doctor.
• You should not give your medicine to anyone or take someone else’s medicine.
• Some medicines may have different patient information sheets. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other healthcare professional.
• Some medicines may have different patient information sheets. Check with your pharmacist. If you have questions about this drug, talk with your doctor, nurse, pharmacist, or other healthcare professional.
• If you think an overdose has occurred, call a Poison Control Center immediately or seek medical attention. Be prepared to tell or show which drug you took, how much and when it happened.

Use of information by the consumer and limitation of liability

This information should not be used to make decisions about taking this or any other drug. Only the attending physician has the necessary knowledge and experience to make decisions about which drugs are appropriate for a particular patient.This information does not guarantee that the drug is safe, effective, or approved for the treatment of any disease or specific patient. Here are only brief general information about this drug. It does NOT contain all available information on the possible use of the drug with instructions for use, warnings, precautions, information about interactions, side effects and risks that may be associated with this drug. This information should not be construed as a guide to treatment and does not replace the information provided to you by your healthcare professional.For complete information on the possible risks and benefits of taking this drug, consult your doctor. Use of this information is governed by the Lexicomp End User License Agreement available at https://www.wolterskluwer.com/en/solutions/lexicomp/about/eula.

Copyright

© UpToDate, Inc. and its affiliates and / or licensors, 2021. All rights reserved.

Cefprozil: Pediatric Medication | Memorial Sloan Kettering Cancer Center

This document, provided by Lexicomp ^® , contains all the information you need to know about the drug, including the indications, route of administration, side effects and when you should contact your healthcare provider.

Trade names: Canada

APO-Cefprozil; Auro-Cefprozil; Cefzil [DSC]; SANDOZ Cefprozil [DSC]; TARO-Cefprozil

What is this drug used for?

• It is used to treat various types of bacterial infections.

What do I need to tell my doctor BEFORE my child takes this drug?

• If your child is allergic to this drug, any of its ingredients, other drugs, foods, or substances.Tell your doctor about the allergy and how your child has it.

Combination of this drug with certain medications and medical conditions may be adverse.

Talk to your doctor or pharmacist about all medications your child is taking (prescription and over-the-counter, natural products, and vitamins) and any health concerns. You need to make sure it is safe to take this drug if your child is ill and in combination with other drugs that he or she is already taking.You should not start, stop, or change the dosage of any drug your child is taking without talking to your doctor.

What do I need to know or do while my child is taking this drug?

• Tell all health care providers for your child that your child is taking this drug. These are your child’s doctors, nurses, pharmacists and dentists.
• If a child has been taking this drug for a long time, a blood test should be done.Talk to your child’s doctor.
• If your child has high blood sugar (diabetes) and you are having urine glucose tests, talk with your child’s healthcare provider about which tests are best.
• This drug may interfere with some laboratory tests. Tell all healthcare professionals and laboratory staff providing your child’s healthcare that your child is taking this drug.
• Do not give to your child for longer than prescribed. A secondary infection is possible.
• If your child has PKU, talk to your doctor. Some foods contain phenylalanine.

If your daughter is pregnant or breastfeeding:

• Consult a doctor if your daughter is pregnant, pregnant, or breastfeeding. The benefits and risks for your daughter and her child will need to be discussed.

What side effects should I report to my child’s healthcare provider right away?

WARNING / CAUTION: Although rare, this drug can cause very serious and sometimes deadly side effects in some people. Call your child’s doctor right away or get medical attention if your child has any of the following signs or symptoms that could be associated with a very bad side effect:

• Signs of an allergic reaction such as rash, hives, itching, reddened and swollen skin with blistering or scaling, possibly associated with fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue, or throat.
• Convulsions.
• Diarrhea is common with antibiotics. In rare cases, severe diarrhea caused by the bacteria Clostridium difficile (C. diff.) [CDAD] can occur. This sometimes leads to gut problems that end in death. CDAD can occur during or several months after taking antibiotics. If your child has pain, abdominal cramps, or very loose, watery or bloody stools, see your doctor right away.Check with your child’s doctor before treating diarrhea.

What are some other side effects of this drug?

Any drug can have side effects. However, many people have little or no side effects. Call your child’s doctor or get medical help if any of these or other side effects bothers your child or does not go away:

• Nausea.
• Diarrhea.

This list of potential side effects is not exhaustive. If you have any questions about side effects, talk to your child’s doctor. Talk to your child’s doctor about side effects.

You can report side effects to the National Health Office.

What is the best way to give this drug?

Give this drug to your child as directed by the doctor.Read all the information provided to you. Follow all instructions strictly.

All forms of issue:

• Continue giving this drug as directed by your child’s doctor or other healthcare professional, even if your child is well.
• Give this drug with or without food. If the drug causes stomach upset, give it with food.

Liquid (suspension):

• Shake well before use.
• Care should be taken to measure the doses of the liquid preparation. Use the dispenser that comes with the medicine. If a dispenser is not included in the package, ask your pharmacist for a dosing product for this drug.

What if my child misses a dose of a drug?

• Give the missed dose as soon as possible.
• If it is time for your child to take the next dose, do not take the missed dose and then return to your child’s normal dosage schedule.
• Do not give a double dose at the same time or additional doses.

How do I store and / or discard this drug?

Tablets:

• Store at room temperature in a dry place. Do not store in the bathroom.

Liquid (suspension):

• Store in refrigerator. Throw away any unused portion after 2 weeks.
• Do not freeze.

All forms of production:

• Store all medicines in a safe place.Keep all medicines out of the reach of children and pets.
• Dispose of unused or expired drugs. Do not empty into toilet or drain unless directed to do so. If you have any questions about the disposal of your medicinal products, consult your pharmacist. Your area may have drug recycling programs.

General information on medicinal products

• If your child’s symptoms or health problems do not improve, or if they get worse, see your child’s doctor.
• Do not share your child’s medicine with others or give anyone else’s medicine to your child.
• Some medicines may have different patient information sheets. If you have questions about this drug, talk with your child’s doctor, nurse, pharmacist, or other healthcare professional.
• If you think an overdose has occurred, call a Poison Control Center immediately or seek medical attention.Be prepared to tell or show which drug you took, how much and when it happened.

Use of information by the consumer and limitation of liability

This information should not be used to make decisions about taking this or any other drug. Only the attending physician has the necessary knowledge and experience to make decisions about which drugs are appropriate for a particular patient. This information does not guarantee that the drug is safe, effective, or approved for the treatment of any disease or specific patient.Here are only brief general information about this drug. It does NOT contain all available information on the possible use of the drug with instructions for use, warnings, precautions, information about interactions, side effects and risks that may be associated with this drug. This information should not be construed as a guide to treatment and does not replace the information provided to you by your healthcare professional. For complete information on the possible risks and benefits of taking this drug, consult your doctor.Use of this information is governed by the Lexicomp End User License Agreement available at https://www.wolterskluwer.com/en/solutions/lexicomp/about/eula.

Copyright

© UpToDate, Inc. and its affiliates and / or licensors, 2021. All rights reserved.

90,000 What are the most common side effects of Cefprozil?

Cefprozil is a prescription antibiotic for the treatment of various bacterial infections.Although the drug is considered to be well tolerated, side effects are possible. Generally, the most common side effects of cefprozil include diarrhea, stomach cramps, nausea, or vomiting. These common side effects are usually mild and dissipate after the body adjusts to the drug. Other, more serious side effects of cefprozil are rare but possible.

Cefprozil is marketed under the brand name Cefzil® and is part of the drug class cephalosporin antibiotics.Some people may be allergic to cephalosporin medications. Side effects of Cefprozil, which may indicate an allergic reaction, include hives, itching, rashes, difficulty breathing, or shortness of breath. These side effects, along with any other anxiety or concern, should be reported to your healthcare professional immediately. Common side effects of nausea and indigestion can be reduced by taking cefprozil with food, although it can be safely taken without.

General conditions for which cefprozil may be prescribed include strep throat, ear infection, and bronchitis.There are also other types of infections and other illnesses that a doctor can treat with cefprozil. The drug is available as a tablet or a liquid suspension for oral administration and can be administered once or twice a day, usually for ten days. Doses can be 250 or 500 mg in tablet form. Like all antibiotics, cefprozil’s effectiveness depends on how you take the medication as prescribed and how you finish it all.

There are some known drug interactions that can occur with cefprozil, so it is important to report all use of the medication to the prescribing physician.In addition to telling their doctor about other prescription drugs, patients should also tell their doctor about the vitamins or supplements they may be taking. If the prescribing physician is not familiar with the patient’s past or current medical history, they should also be informed if the patient has diabetes, kidney or liver disease, is pregnant, or may be pregnant or breastfeeding.

Except for the rare but serious side effects of cefprozil, the risk of taking the medication as prescribed is generally minimal and far outweighs the risk of not treating the bacterial infection.Although a wide variety of bacteria respond to cefprozil, some strains may be resistant. If symptoms of an infection treated with cefprozil do not improve, worsen, or go away and then reappear, see your doctor. Questions or concerns about side effects and the use of cefprozil should be discussed with your doctor or pharmacist.

OTHER LANGUAGES

Cefprozil / Cefprozil in Russian – Item

Cefzil (cefprozil): use, dosage, side effects, interactions, warning

• Generic name: cefprozil
• Brand name: Cefzil

Product description

Cefzil Tablets
(cefprozil) 250 mg and 500 mg

Cefzil for oral suspension
(cefprozil) 125 mg / 5 ml and 250 mg / 5 ml

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefzil (cefprozil) and other antibacterial drugs, cefzil (cefprozil) should only be used to treat or prevent infections that have been proven or strongly suspected to be caused by bacteria.

DESCRIPTION

CEFZIL (cefprozil) is a semi-synthetic broad-spectrum cephalosporin antibiotic.

Cefprozil is a mixture of cis and trans isomers (> 90% cis). Chemical name of monohydrate (6 p , 7 p ) -7 – [( p ) -2-amino-2- ( p Monohydrate -hydroxyphenyl) acetamido] -8-oxo-3-propenyl-5 -thia-1-azabicyclo [4.2.0] oct-2-ene-2-carboxylic acid, the structural formula of which is as follows:

Cefprozil is a white to yellowish powder with the molecular formula of monohydrate C ₁₈ HOUR ₁₉ N ₃ OR ₅ S & bull; H _{is two} O and a molecular weight of 407.45.

Cefzil (cefprozil) tablets and cefzil (cefprozil) for oral suspension are intended for oral administration.

CEFZIL tablets contain cefprozil equivalent to 250 mg or 500 mg of cefprozil anhydrous. In addition, each tablet contains the following inactive ingredients: cellulose, hypromellose, magnesium stearate, methylcellulose, simethicone, sodium starch glycolate, polyethylene glycol, polysorbate 80, sorbic acid and titanium dioxide. The 250 mg tablets also contain FD&C Yellow No.6.

Cefzil for oral suspension contains cefprozil equivalent to 125 mg or 250 mg of anhydrous cefprozil per 5 ml of suspension. In addition, the oral suspension contains the following inactive ingredients: aspartame, cellulose, citric acid, colloidal silicon dioxide, FD&C Red No. 3, flavors (natural and artificial), glycine, polysorbate 80, simethicone, sodium benzoate, sodium carboxymethyl cellulose, sodium. chloride and sucrose.

Indications

INDICATIONS

CEFZIL (cefprozil) is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of these microorganisms, under the conditions listed below:

Upper respiratory tract

Pharyngitis / Streptogenes .

NOTE. Generally, for the treatment and prevention of streptococcal infections, including the prevention of rheumatic fever, the drug of choice is intramuscularly administered penicillin. Cefprozil is usually effective in eradicating Streptococcus pyogenes from the nasopharynx; however, there are currently no significant data on the effectiveness of cefprozil for the subsequent prevention of rheumatic fever.

Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae (including strains producing β-lactamases), and Moraxella (Branhamella) catarrhalis (including strains producing β-lactamases).(See CLINICAL STUDIES .)

NOTE: In the treatment of otitis media caused by microorganisms that produce β-lactamase, cefprozil showed a slightly lower rate of bacteriological eradication than those observed with a product containing a specific β-lactamase inhibitor. When considering the use of cefprozil, the lower overall eradication rates must be balanced with the susceptibility characteristics of common microbes in the geographic area and the increased toxicity potential of products containing β-lactamase inhibitors.

Acute sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including strains producing β-lactamases), and Moraxella (Branhamella) catarrhalis (including strains producing β-lactamases).

Lower respiratory tract

Secondary bacterial infection of acute bronchitis and acute bacterial exacerbation of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including strains producing β-lactamase), and Moraxella (including Branharalis producing β-lactamases).

Skin and skin structure

Uncomplicated infections of the skin and skin structures caused by Staphylococcus aureus (including strains producing penicillinase) and Streptococcus pyogenes . Abscesses usually require surgical drainage.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefzil (cefprozil) and other antibacterial drugs, cefzil (cefprozil) should only be used to treat or prevent infections that have been shown or strongly suspected to be caused by susceptible bacteria.When culture and susceptibility information is available, these should be considered when choosing or modifying antibiotic therapy. In the absence of such data, local epidemiology and susceptibility patterns can guide empirical treatment choices.

Dosage

DOSAGE AND ADMINISTRATION

CEFZIL (cefprozil) is administered orally.

Renal failure

Cefprozil can be prescribed to patients with impaired renal function. The following dosage schedule should be used.

Hepatic impairment

No dosage adjustment is required in patients with impaired liver function.

HOW SUPPLIED

CEFZIL (cefprozil) tablets

Each light orange film-coated tablet labeled 7720 on one side and 250 on the other contains the equivalent of 250 mg of anhydrous cefprozil.

Bottles of 100 tablets … NDC 0087-7720-60

Each white film-coated tablet, on which says “7721” on one side and “500” on the other, contains the equivalent of 500 mg of anhydrous cefprozil.

Bottles of 50 tablets …………………….. NDC 0087-7721-50
Bottles of 100 tablets … ……………….. NDC 0087-7721-60

can you get high from mucinex?

Store at Controlled Room Temperature, 59 ° -86 ° F (15 ° -30 ° C).

Cefzil (cefprozil) for oral suspension

Each 5 ml of prepared suspension contains the equivalent of 125 mg of anhydrous cefprozil.

50 ml bottle…………………….. NDC 0087-7718-40
75 ml bottle …………. …………. NDC 0087-7718-62
Bottle 100 ml …………………… NDC 0087-7718-64

Each 5 ml of the prepared suspension contains the equivalent of 250 mg of anhydrous cefprozil.

50 ml bottle …………………….. NDC 0087-7719-40
75 ml bottle ……. ………………. NDC 0087-7719-62
Bottle 100 ml…………………… NDC 0087-7719-64

All powder preparations for oral suspension contain cefprozil in a mixture flavored with chewing gum.

Recommendations for reconstitution of oral suspension

Prepare suspension during dosing; for ease of preparation, add water in two portions and shake well after each aliquot.

Total amount of water required for reconstitution

After mixing, keep refrigerated and discard unused portion after 14 days.Store at 59–77 ° F (15–25 ° C) prior to cooking. US Patent No. 4,520,022.

Bristol-Myers Squibb Company, Princeton, NJ 08543. USA. March 2007 revision Date FDA revised: September 14, 2007

Adverse effects

SIDE EFFECTS

Adverse reactions to cefprozil are similar to those seen with other oral cephalosporins. In controlled clinical trials, cefprozil was generally well tolerated. Approximately 2% of patients discontinued cefprozil therapy due to side effects.

The most common side effects observed in patients taking cefprozil are:

Gastrointestinal tract: Diarrhea (2.9%), nausea (3.5%), vomiting (1%) and abdominal pain (1%).

Hepatobiliary system: increased AST (SGOT) (2%), ALT (SGPT) (2%), alkaline phosphatase (0.2%) and bilirubin values ​​(

Hypersensitivity: Rash (0.9%) , urticaria (0.1%). These reactions were reported more often in children than in adults.Signs and symptoms usually appear a few days after starting therapy and disappear within a few days after stopping therapy.

CNS: Dizziness (1%), hyperactivity, headache, nervousness, insomnia, confusion and drowsiness were reported rarely (

Hematopoiesis: Decreased leukocytes (0.2%), eosinophilia (2.3%

Renal: Elevated urea nitrogen (0.1%), serum creatinine (0.1%).

Other: Diaper rash and superinfection (1.5%), genital itching and vaginitis (1.6%).

The following side effects, regardless of the established causal relationship with cefzil (cefprozil), have rarely been reported during post-marketing surveillance: anaphylaxis, angioedema, colitis (including pseudomembranous colitis), erythema multiforme, fever, serum-like reactions, Stevens syndrome Johnson. and thrombocytopenia.

Cephalosporin class paragraph

In addition to the adverse reactions listed above that were observed in patients treated with cefprozil, the following adverse reactions and altered laboratory tests for antibiotics of the cephalosporin class were reported:

Aplastic anemia, hemolytic anemia, renal hemorrhage, impaired function , toxic epidermal necrolysis, toxic nephropathy, prolonged prothrombin time, positive Coombs test, increased LDH, pancytopenia, neutropenia, agranulocytosis.

Certain cephalosporins can cause seizures, especially in patients with renal impairment, when the dosage has not been reduced. (See DOSAGE AND ADMINISTRATION and OVERDOSE .) If seizures occur associated with drug therapy, the drug should be discontinued. If clinically indicated, anticonvulsant therapy may be prescribed.

Drug interactions

DRUG INTERACTIONS

Nephrotoxicity has been reported with concomitant use of aminoglycoside antibiotics and cephalosporin antibiotics.Simultaneous administration of probenecid doubled the AUC of cefprozil.

The bioavailability of the capsule preparation of cefprozil did not change when administered 5 minutes after taking the antacid.

Drug / laboratory test interactions

Cephalosporin antibiotics can cause false positive glucose in urine on copper recovery tests (Benedict’s or Fehling’s solution or Clinitest tablets) but not on enzyme-based glucosuria tests (such as Clinistix) …When testing blood glucose levels for ferricyanide, a false negative reaction may occur. The presence of cefprozil in the blood does not affect the determination of creatinine in plasma or urine by the alkaline picrate method.

linseed oil thins the blood

Warnings

WARNINGS

BEFORE STARTING THERAPY WITH CEFZIL (cefprozil), IT SHOULD BE CAREFULLY DETERMINED WHETHER THE PATIENT HAS BEEN PREVIOUS REACTION OF HYPERSENSITIVES TO CEFZIL, OTHER MEDICINES.IF THIS PRODUCT IS PROVIDED TO PENICILLIN SENSITIVE PATIENTS, THIS SHOULD BE CAREFUL, BECAUSE THE MUTUAL SENSITIVITY AMONG β-LACTAM ANTIBIOTICS MUST BE DOCUMENTATED 10%. IF AN ALLERGIC REACTION OCCURS TO CEFZIL (cefprozil), stop taking the drug. SEVERE ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINA AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVESTENA, ANTIDYSTHYSTENA

Clostridium difficile associated diarrhea (CDAD) has been reported with almost all antibacterial agents, including CEFZIL (cefprozil), and its severity can range from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, resulting in overgrowth This is hard .

This hard produces toxins A and B that contribute to the development of CDAD. Hypertoxin-producing strains It is hard cause increased morbidity and mortality because these infections may be refractory to antimicrobial therapy and may require colectomy.CDAD should be considered in all patients with diarrhea following antibiotic use. Careful history taking is necessary, as CDAD has been reported to occur for more than two months after taking antibacterial drugs.

photo tags of skin in mouth

If CDAD is suspected or confirmed, continued antibiotic use is not directed against This severe may require discontinuation of production. Appropriate fluid and electrolyte control, protein supplementation, antibiotic treatment. This is difficult , and surgery should be ordered as clinically indicated.

PRECAUTIONS

PRECAUTIONS

General

Prescribing cefzil (cefprozil) in the absence of a proven or highly suspected bacterial infection or prophylactic indication is unlikely to benefit the patient and increase the risk of developing drug-resistant bacteria.

In patients with known or suspected renal impairment (see DOSAGE AND ADMINISTRATION ), close clinical observation and appropriate laboratory studies should be performed prior to and during therapy. In these patients, the total daily dose of cefzil (cefprozil) should be reduced, since high and / or prolonged plasma antibiotic concentrations may be observed in these patients at normal doses. Cephalosporins, including cefzil (cefprozil), should be used with caution in patients concurrently receiving potent diuretics, as these agents are thought to adversely affect renal function.

Prolonged use of CEFZIL (cefprozil) may lead to overgrowth of non-susceptible organisms. Close monitoring of the patient is important. If superinfection occurs during therapy, appropriate measures should be taken.

Cefprozil should be prescribed with caution to people with a history of gastrointestinal diseases, in particular colitis.

Positive direct Coombs tests have been reported during treatment with cephalosporin antibiotics.

Carcinogenesis, mutagenesis and impaired fertility

Long-term in vivo No studies have been performed to evaluate the carcinogenic potential of cefprozil.

Cefprozil was not mutagenic in any of Ames’s studies. Salmonella or E.coli WP2 urvA reversal tests or HGPRT direct gene mutation assay in Chinese hamster ovary cells, and it did not cause chromosomal abnormalities in Chinese hamster ovary cells or unplanned DNA synthesis in rat hepatocytes 000 in vitro.Chromosomal aberrations were not observed in bone marrow cells of rats given orally more than 30 times the highest recommended human dose on a mg / m 2 basis. ^two .

No impairment of fertility was observed in male or female rats given oral doses of cefprozil that were 18.5 times the maximum recommended human dose on a mg / m basis ^two .

Pregnancy

Teratogenic Effects: Pregnancy Category B

Reproduction studies were performed in rabbits, mice and rats using oral doses of cefprozil 0.8, 8.5 and 18.5 times the maximum daily human dose (1000 mg) on ​​a mg / m3 basis. ^two , and did not reveal any harm to the fetus. However, there have been no adequate and well-controlled studies in pregnant women. Since animal reproduction studies do not always predict human response, this drug should only be used during pregnancy if absolutely necessary.

Operation and Delivery

Cefprozil has not been studied for use during labor and delivery. Treatment should be given only when clearly needed.

Nursing mothers

Small amounts of cefprozil (

Pediatric use

(See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION ) 12 years The use of CEFZIL for the treatment of otitis media is supported by evidence from adequate and well-controlled studies of cefprozil in pediatric patients.(See CLINICAL STUDIES. )

The safety and efficacy of cefprozil in the treatment of pharyngitis / tonsillitis or uncomplicated infections of the skin and dermal structures have been established in age groups from 2 to 12 years. The use of CEFZIL (cefprozil) for the treatment of these infections is supported by evidence from adequate and well-controlled studies of cefprozil in pediatric patients.

The safety and efficacy of cefprozil in the treatment of acute sinusitis have been established in the age groups from 6 months to 12 years.The use of CEFZIL (cefprozil) in these age groups is supported by evidence from adequate and well-controlled studies of cefprozil in adults.

Safety and efficacy in pediatric patients under 6 months of age have not been established for the treatment of otitis media or acute sinusitis, or for the treatment of pharyngitis / tonsillitis or uncomplicated infections of the skin and skin structures under 2 years of age. However, the accumulation of other cephalosporin antibiotics in newborns has been reported (as a result of the long half-life of the drug in this age group).

Geriatric use

Of the more than 4500 adults who received cefzil (cefprozil) in clinical trials, 14% were 65 years of age or older and 5% were 75 years of age or older. When geriatric patients received the usual recommended adult doses, their clinical efficacy and safety were comparable to those in non-geriatric adult patients. Other reported clinical experience found no difference in response between older and younger patients, but a higher sensitivity of some older people to the effects of CEFZIL cannot be ruled out (see section 4.4). CLINICAL PHARMACOLOGY ).

It is known that cefzil (cefprozil) is largely excreted by the kidneys, and the risk of toxic reactions to this drug may be higher in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, caution should be exercised in dose selection and it may be helpful to monitor renal function. See DOSAGE AND ADMINISTRATION for dosage recommendations for patients with impaired renal function.

Overdose and contraindications

OVERDOSE

Single oral doses of 5000 mg / kg cefprozil did not cause mortality or signs of toxicity in adult rats, weaned or newborn rats, or adult mice. A single oral dose of 3000 mg / kg caused diarrhea and loss of appetite in Javanese macaques, but did not lead to death.

Cefprozil is excreted mainly by the kidneys. In the event of a serious overdose, especially in patients with impaired renal function, hemodialysis will help remove cefprozil from the body.

CONTRAINDICATIONS

Cefzil (cefprozil) is contraindicated in patients with known allergy to antibiotics of the cephalosporin class.

Clinical Pharmacology

CLINICAL PHARMACOLOGY

Pharmacokinetic data were obtained for the capsule formulation; however, bioequivalence has been demonstrated for oral solutions, capsules, tablets, and suspensions under fasting conditions.

Approximately 95% of the dose was absorbed after oral administration of cefprozil on an empty stomach.The median plasma half-life in normal subjects was 1.3 hours, while the steady state volume of distribution was estimated as 0.23 L / kg. Total body clearance and renal clearance were approximately 3 ml / min / kg and 2.3 ml / min / kg, respectively.

Mean peak plasma concentrations after administration of 250 mg, 500 mg or 1 g doses of cefprozil on an empty stomach were approximately 6.1, 10.5 and 18.3 μg / ml, respectively, and were obtained within 1.5 hours after administration dose.Excretion in the urine was approximately 60% of the administered dose. (See Table.)

approx.

During the first 4 hours after administration of the drug, the mean urinary concentrations after doses of 250 mg, 500 mg and 1 g were approximately 700 μg / ml, 1000 μg / ml and 2900 μg / ml, respectively.

Administration of cefzil (cefprozil) tablets or suspensions with food did not affect the degree of absorption (AUC) or peak plasma concentration of cefprozil (Cmax).However, there was an increase in the time to reach the maximum plasma concentration of cefprozil (Tmax) by 0.25–0.75 hours.

The bioavailability of the capsule preparation of cefprozil did not change when administered 5 minutes after taking the antacid.

Plasma protein binding is approximately 36% and does not depend on the concentration in the range from 2 μg / ml to 20 μg / ml.

There was no evidence of plasma cefprozil accumulation in individuals with normal renal function after taking multiple oral doses up to 1000 mg every 8 hours for 10 days.

In patients with reduced renal function, the plasma half-life may increase to 5.2 hours, depending on the degree of renal impairment. In patients with complete absence of renal function, the plasma half-life of cefprozil reaches 5.9 hours. The half-life is shortened during hemodialysis. Excretion routes in patients with severe renal impairment have not been determined. (See PRECAUTIONS and DOSAGE AND ADMINISTRATION .)

In patients with impaired liver function, the half-life is increased to about 2 hours. The magnitude of the change does not require dose adjustment for patients with impaired liver function.

Healthy geriatric volunteers (> 65 years) who received a single 1 g dose of cefprozil had 35-60% higher AUC values ​​and 40% lower renal clearance values ​​compared to healthy adult volunteers aged 20 up to 40 years old. The average AUC in young and older women was approximately 15-20% higher than in younger and older men.The magnitude of these age-related and gender-related changes in the pharmacokinetics of cefprozil is insufficient for dosage adjustment.

There are no adequate data on the level of cefprozil in the cerebrospinal fluid.

Comparable pharmacokinetic parameters of cefprozil are observed between pediatric patients (6 months to 12 years) and adults after oral administration of selected selected doses. Maximum concentrations are reached within 1-2 hours after dosing. The plasma half-life is approximately 1.5 hours.In general, the observed plasma concentrations of cefprozil in pediatric patients at doses of 7.5, 15 and 30 mg / kg are similar to those observed at the same time in normal adult subjects at doses of 250, 500 and 1000 mg, respectively. … Comparative plasma concentrations of cefprozil in pediatric patients and adult subjects at the equivalent dose level are presented in the table below.

T / 2 (h)

Microbiology

Cefprozil has in vitro activity against a wide range of gram-positive and gram-negative bacteria. The bactericidal effect of cefprozil is due to inhibition of cell wall synthesis. Cefprozil has been shown to be active against most strains of the following microorganisms: in vitro and in clinical infections, as described in the INDICATIONS AND USAGE section.

Follow-up in vitro data available; however, their clinical significance is unknown. Cefprozil exhibits in vitro minimum inhibitory concentrations (MIC) 8 μg / ml or less against most (> 90%) strains of the following microorganisms; however, the safety and efficacy of cefprozil in the treatment of clinical infections caused by these organisms have not been established in adequate and well-controlled clinical trials.

Susceptibility Tests

Dilution Methods: Quantitative methods are used to determine the minimum inhibitory concentrations (MICs) of antimicrobial drugs. These MICs make it possible to assess the sensitivity of bacteria to antimicrobial compounds. MIC should be determined using a standard procedure. Standardized procedures are based on the dilution method. ^1.2 (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of cefprozil powder.MIC values ​​should be interpreted according to the following criteria:

The Susceptible report indicates that the pathogen is likely to be suppressed if the antimicrobial compound in the blood reaches commonly achievable concentrations.An “Intermediate” report indicates that the result should be considered equivocal and, if the organism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in areas of the body where the drug is physiologically concentrated, or in situations where high dosages of the drug can be used. This category also provides a buffer zone that prevents small, uncontrollable technical factors that cause serious discrepancies in interpretation.The Resistant report indicates that the pathogen is unlikely to be suppressed if the antimicrobial compound in the blood reaches commonly achievable concentrations; another therapy should be chosen.

Routine susceptibility testing procedures require the use of laboratory control microorganisms to control the technical aspects of laboratory procedures. A standard cefprozil powder should provide the following MIC values:

Pneumococcus 1

Technical Distribution: Quantitative methods requiring zone diameter measurements also provide reproducible estimates of bacterial susceptibility to antimicrobial compounds.One such standardized procedure ³ requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 30 mcg of cefprozil to test the susceptibility of microorganisms to cefprozil.

Laboratory reports containing the results of a standard single disc susceptibility test with 30 μg cefprozil should be interpreted according to the following criteria:

Interpretation should be as above for results using dilution methods.The interpretation includes the correlation of the diameter obtained in the disc test with the MIC for cefprozil.

As with standard dilution methods, diffusion methods require the use of laboratory control microorganisms, which are used to control the technical aspects of laboratory procedures. For the diffusion method, the 30 μg cefprozil disc should provide the following zone diameters in these laboratory test quality control strains.

Clinical studies

Study first

In a controlled clinical study with an average significant numbers of β-lactamase-producing organisms were found, cefprozil was compared with an oral antimicrobial agent that contained a specific β-lactamase inhibitor.In this study, using very stringent evaluation criteria as well as microbiological and clinical response criteria for an observation period of 10 to 16 days after therapy, the following putative bacterial eradication / clinical cure results (i.e. clinical success) and safety results were obtained:

Acute otitis media study in the United States Cefprozil versus a control containing a β-lactamase inhibitor

4)
(n = 15514)

Safety

The frequency of adverse events, primarily diarrhea and rash *, was clinically and statistically significantly higher in the control group by compared with the cefprozil group.

* Most of them concerned the diaper area of ​​young children.

Study II

In a controlled clinical study acute otitis media Cefprozil was compared in Europe with an oral antimicrobial agent containing a specific β-lactamase inhibitor.As expected in the European population, this study population had a lower frequency of β-lactamase producing organisms than is usually observed in US studies. In this study, using very stringent evaluation criteria as well as microbiological and clinical response criteria for a follow-up period of 10 to 16 days after therapy, the following expected bacterial eradication / clinical cure results (i.e. Clinical Success) were obtained:

European study of acute otitis media Cefprozil in comparison with a control drug containing a β-lactamase inhibitor

the cefprozil group was comparable to the incidence of adverse events in the control group (agent containing a specific β-lactamase inhibitor).

RECOMMENDATIONS

1. National Committee for Clinical Laboratory Standards. Antimicrobial Susceptibility Test Methods for Bacteria That Grow Under Aerobic Conditions – Third Edition. NCCLS Approved Standard Document M7-A3, Vol. 13, No. 25, NCCLS, Villanova, PA December 1993

white round tablets, ip 203

2. National Committee for Clinical Laboratory Standards. Antimicrobial Susceptibility Testing Methods for Anaerobic Bacteria – Third Edition. NCCLS Approved Standard Document M11-A3, Vol. 13, No. 26, NCCLS, Villanova, PA, December 1993

3. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Susceptibility Tests – Fifth Edition. NCCLS Approved Standard Document M2-A5, Vol. 13, No. 24, NCCLS, Villanova, PA, December 1993.

Medication Guide

PATIENT INFORMATION

Phenylketonuria: cefzil (cefprozil) for oral suspension contains 28 mg phenylalanine per 5 ml (1 teaspoon) suspension for dosage forms 125 mg / 5 ml and 250 mg / 5 ml.

Patients should be advised to use antibacterial drugs, including cefzil (cefprozil), only to treat bacterial infections. They do not cure viral infections (such as the common cold). When CEFZIL (cefprozil) is prescribed to treat a bacterial infection, patients should be informed that although there is usually an improvement in well-being at the beginning of the course of treatment, the medication should be taken exactly as directed.Missing doses or incomplete treatment can (1) reduce the effectiveness of immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treated with cefzil (cefprozil) or other antibacterial drugs in the future. …

Diarrhea is a common problem caused by antibiotics and usually ends when the antibiotic is stopped. Sometimes, after starting antibiotic treatment, patients may develop watery and bloody stools (with or without stomach cramps and fever) even two or more months after the last dose of the antibiotic.In this case, patients should contact their doctor as soon as possible.

Procef (Cefprozil) – instructions for use, dosage, composition, analogs, side effects / Pillintrip

Special warnings and precautions

WARNINGS

before therapy with (Cefprozil), (cefprozil) WILL BE INITIATED, ADDED , ON PATIENT AT A REACTION TO SEKMENDALNYE Procef (cefprozil), (cefprozil) ,, CEPHALOSPORINE, penicillin or other medicinal products to manage, IF PENITSILLINDY products must be ADMINISTRATIROVANNY, suggestions that responsibility KREYZEMPA necessary in β – LACTAM-ANTIBIOTIKA BIS AND 10% patients allergic to penicillin MAY BE REPRESENTED IN HISTORY.IF ANALLER GOVERNMENT is on Procef (cefprozil), (cefprozil) CALL US, APPLY MEDICAL. LIABILITY EFFECTS FROM SUSPENSION MAY REQUIRE TREATMENT WITH ADRENALINE AND OTHER EMERGENCY MEASURES INCLUDING OXYGEN, CONTINUOUS LIQUIDS, INSUFFICIENT ANTIHISTAMINICS, CORTICVISTEROIDS, BUT CORTICVISTEROIDS.

Clostridium difficile Associated diarrhea (CADD) has been reported with almost all antibacterial agents, including Procef (Cefprozil) (cefprozil), and can range from mild diarrhea to fatal colitis.Treatment with antibacterial agents alters the normal intestinal flora and results in overgrowth of C. difficile .

C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin-producing strains C. difficile cause increased morbidity and mortality because these infections may be refractory to antimicrobial therapy and may require colectomy. CDAD should be considered in all patients who have diarrhea after antibiotic use.A careful medical history is required as CDAD has been reported to occur two months after antibiotic administration.

If CDAD is suspected or confirmed, continued antibiotic use that is not directed against C. difficile may be discontinued. Adequate fluid and electrolyte management, protein supplementation, antibiotic treatment C. difficile , and surgical evaluation should be clinically initiated.

PRECAUTIONS

General

Prescription Procef (Cefprozil) (cefprozil) in the absence of a proven or highly suspected bacterial infection or prophylactic indication is unlikely to benefit the patient and increase the risk of developing drug-resistant bacteria.

In patients with known or suspected renal impairment (see DOSAGE AND ADMINISTRATION ) close clinical observation and appropriate laboratory tests should be performed before and during therapy. The total daily dose of Procef (Cefprozil) (cefprozil) should be reduced in these patients, as these individuals may have high and / or prolonged plasma antibiotic concentrations compared to usual doses. Cephalosporins, including Procef (Cefprozil) (cefprozil), should be used with caution in patients receiving strong diuretics as they are suspected of affecting renal function.

Cefprozil (cefprozil) may cause overgrown, unresponsive organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.

Cefprozil should be used with caution in people with a history of gastrointestinal diseases, especially colitis.

Positive direct tests on the cob have been reported with cephalosporin antibiotics.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Long Term in vivo – No studies have been performed to evaluate the carcinogenic potential of cefprozil.

Cefprozil was not in the Ames Salmonella – or E. coli WP2 urvA reversal assays are still detectable as mutagens in the HGPRT direct gene mutation assays in Chinese hamster ovary cells and do not cause chromosomal abnormalities in ovary cells or extra-hamster DNA synthesis rat hepatocytes in vitro Chromosomal aberrations were found in bone marrow cells in rats that were oral, with more than 30 times the recommended human dose depending on mg / m. ₂ were not complied with.

Fertility was impaired in male or female rats receiving oral doses of cefprozil 18.5 times higher than the highest recommended human dose depending on mg / m ₂ not observed.

Pregnancy

Teratogenic Effects: Pregnancy Category B

Reproduction studies were performed in rabbits, mice and rats with oral doses of cefprozil 0.8, 8.5 and 18.5 times the maximum daily human dose (1000 mg) per mg / m ₂ is carried out and does not harm the fetus.However, there are no adequate and well-controlled studies in pregnant women. Since animal reproduction studies do not always predict human response, this drug should only be used during pregnancy if clearly needed.

Operation and Delivery

Cefprozil has not been studied for use during childbirth. Treatment should only be given if clearly needed.

Nursing mothers

Small amounts of cefprozil (<0.3% of the dose) have been found in breast milk after a single dose of 1 g was given to women who were breastfeeding.Average values ​​over 24 hours ranged from 0.25 to 3.3 μg / ml. Caution should be exercised when administering Procef (Cefprozil) (cefprozil) to a nursing woman, as the effect of cefprozil on infants is unknown.

Pediatric use

(See INDICATIONS AND ADMINISTRATION and DOSAGE AND ADMINISTRATION .)

The safety and efficacy of cefprozil in the treatment of otitis media was determined in age groups from 6 months to 12 years.The use of Procef (Cefprozil) (cefprozil) for the treatment of otitis media is supported by evidence from adequate and well-controlled studies of cefprozil in pediatric patients. (See CLINICAL STUDIES. )

The safety and efficacy of cefprozil in the treatment of pharyngitis / tonsillitis or uncomplicated infections of the skin and skin structure was determined in age groups from 2 to 12 years. The use of Procef (Cefprozil) (cefprozil) for the treatment of these infections is supported by evidence from adequate and well-controlled studies of cefprozil in pediatric patients.

The safety and efficacy of cefprozil in the treatment of acute sinusitis was determined in the age groups from 6 months to 12 years. The use of Procef (Cefprozil) (cefprozil) in these age groups is supported by evidence from adequate and well-controlled studies of cefprozil in adults.

Safety and efficacy in pediatric patients under 6 months of age have not been demonstrated for the treatment of otitis media or acute sinusitis or under 2 years of age for the treatment of pharyngitis / tonsillitis or uncomplicated infections of the skin and skin structure.However, the accumulation of other cephalosporin antibiotics in newborns has been reported (as a result of the long half-life of drugs in this age group).

Geriatric use

Of the more than 4500 adults who received Procef (Cefprozil) (cefprozil) in clinical trials, 14% were 65 years of age or older, while 5% were 75 years of age or older. When geriatric patients received the usual recommended doses for adults, their clinical efficacy and safety were comparable to the clinical efficacy and safety in non-geriatric adult patients.Other reported clinical experiences have not found differences in responses between older and younger patients, but greater sensitivity of some older people to the effects of Procef (Cefprozil) cannot be ruled out (see CLINICAL PHARMACOLOGY ).

Procef (cefprozil) (cefprozil) is known to be excreted primarily through the kidney, and the risk of toxic reactions to this drug may be higher in patients with renal insufficiency. Since older patients are more likely to have decreased renal function, caution should be exercised in dose selection and this may be helpful in monitoring renal function.Please refer to DOSAGE AND ADMINISTRATION for dosage recommendations for patients with renal impairment.

instructions for use, dosage, composition, analogs, side effects / Pillintrip

Special warnings and precautions

WARNINGS

BEFORE STARTING THERAPY WITH Cefpro (cefprozil), THIS SHOULD BE CAREFULLY EXAMINED TO DETERMINE WHETHER THE PATIENT HAS PREVIOUSLY HAS PRELIMINARY REACTIONS OF HYPERSENSITIVITY OF CEFPROZIL.WHEN PRESENTING THIS PREPARATION TO PATIENTS SENSITIVE TO PENICILLIN, CARE SHOULD BE EXERCISED BECAUSE THE CROSS SENSITIVITY AMONG β-LACTAM ANTIBIOTICS IS CLEARLY 10% DOCUMENTATIVE OF PENICILLIN. IF AN ALLERGIC REACTION OCCURS TO Cefpro (cefprozil), STOP THE MEDICINE. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT epinephrine and other emergency measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines and Management airways, as is clinically indicated

Clostridium difficile -associated diarrhea (CDAD) has been registered with almost all antibacterial agents, including Cefpro (cefprozil), and can range in severity from mild diarrhea to fatal colitis.Antibacterial treatment alters the normal flora of the colon, resulting in an overgrowth of C. difficile .

C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin-producing strains C. difficile cause increased morbidity and mortality, as these infections may be refractory to antimicrobial therapy and may require colectomy. CDAD should be considered in all patients who develop diarrhea after antibiotic use.A thorough medical history is required, as CDAD has been reported to occur within two months of the administration of antibacterial drugs.

If suspected or confirmed, continued use of antibiotics not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment C. difficile , and surgical examination should be performed as clinically indicated.

PRECAUTIONS

General

Prescribing Cefpro (cefprozil) in the absence of a proven or highly suspected bacterial infection or prophylactic indication is unlikely to benefit the patient and increase the risk of developing drug-resistant bacteria.

In patients with known or suspected renal impairment (see DOSAGE AND ADMINISTRATION ), close clinical observation and appropriate laboratory tests should be carried out before and during therapy.The total daily dose of Cefpro (cefprozil) should be reduced in these patients, since such individuals may experience high and / or prolonged plasma antibiotic concentrations compared to usual doses. Cephalosporins, including Cefpro (cefprozil), should be used with caution in patients receiving concomitant treatment with potent diuretics, as it is suspected that these drugs adversely affect renal function.

Prolonged use of Cefpro (cefprozil) may lead to overgrowth of refractory organisms.Careful observation of the patient is necessary. If superinfection occurs during therapy, appropriate measures should be taken.

Cefprozil should be prescribed with caution to persons with a history of gastrointestinal diseases, especially colitis.

Positive direct Coombs’ tests have been reported during treatment with cephalosporin antibiotics.

Carcinogenesis, Mutagenesis and Impairment of Fertility

Long Term In vivo No studies have been conducted to evaluate the carcinogenic potential of cefprozil.

Cefprozil was not mutagenic in any of the Ames Salmonella or Escherichia coli WP2 urvA reversal assay or HGPRT direct mutation assay in Chinese hamster ovary cells did not cause chromosomal abnormalities in ovarian cells or hepatocyte hepatocytes rats artificial Chromosomal aberrations were not observed in bone marrow cells of rats given orally more than 30 times the recommended human dose, based on mg / m ² .

No fertility impairment was observed in either male or female rats receiving oral doses of cefprozil 18.5 times the highest recommended human dose in mg / m ² .

Pregnancy

Teratogenic Effects: Pregnancy Category B

Reproductive studies were performed in rabbits, mice and rats using oral doses of cefprozil 0.8, 8.5 and 18.5 times the maximum daily human dose (1000 mg) in converted to mg / m ² , and did not reveal any harm to the fetus.However, there have been no adequate and well-controlled studies in pregnant women. Since animal reproduction studies do not always predict human response, this drug should only be used during pregnancy when clearly needed.

Labor and Delivery

Cefprozil has not been studied for use during labor and delivery. Treatment should be given only when clearly needed.

Breastfeeding Mothers

Small amounts of cefprozil (<0.3% of the dose) have been found in human milk after a single 1 gram dose of breastfeeding women.Average levels over 24 hours ranged from 0.25 to 3.3 Mkg / ml. Caution should be exercised when administering Cefpro (cefprozil) to a nursing woman, since the effect of cefprozil on infants is unknown.

Pediatric use

(See INDICATIONS FOR USE and DOSAGE AND ADMINISTRATION .)

The safety and efficacy of cefprozil in the treatment of otitis media have been established in age groups from 6 months to 12 years.The use of Cefpro (cefprozil) for the treatment of otitis media is supported by evidence from adequate and well-controlled studies of cefprozil in pediatric patients. (See CLINICAL STUDIES . )

The safety and efficacy of cefprozil in the treatment of pharyngitis / tonsillitis or uncomplicated infections of the skin and dermal structures have been established in age groups 2 to 12 years. The use of Cefpro (cefprozil) for the treatment of these infections is supported by evidence from adequate and well-controlled studies of cefprozil in pediatric patients.

The safety and efficacy of cefprozil in the treatment of acute sinusitis have been established in the age groups from 6 months to 12 years. The use of cefprozil in these age groups is supported by data from adequate and well-controlled studies of cefprozil in adults.

Safety and efficacy in pediatric patients under 6 months of age have not been established for the treatment of otitis media or acute sinusitis, or for the treatment of pharyngitis / tonsillitis or uncomplicated infections of the skin and dermal structures under 2 years of age.However, the accumulation of other cephalosporin antibiotics in newborns has been reported (as a result of the long half-life of the drug in this age group).

Geriatric Uses

Of the more than 4500 adults who received Cefpro (cefprozil) in clinical trials, 14% were over 65 years of age and 5% were over 75 years of age. When geriatric patients received the usual recommended adult doses, their clinical efficacy and safety were comparable to the clinical efficacy and safety in non-geriatric adult patients.Other reported clinical experience has not found differences in responses between elderly and young patients, but the greater sensitivity of some elderly people to the effects of Cefpro cannot be ruled out (see CLINICAL PHARMACOLOGY ).

It is known that Cefpro (cefprozil) is largely excreted by the kidneys, and the risk of toxic reactions to this drug may be higher in patients with impaired renal function. Since elderly patients are more likely to have decreased renal function, caution should be exercised in dose selection and it may be helpful to monitor renal function.See DOSAGE AND METHOD OF APPLICATION dosage recommendations for patients with impaired renal function.