What are the common side effects of cefdinir. How can you manage diarrhea caused by cefdinir. What serious side effects should you watch out for when taking cefdinir. How does cefdinir interact with other medications. What precautions should seniors take when using cefdinir.

Common Side Effects of Cefdinir

Cefdinir, a third-generation cephalosporin antibiotic, is widely used to treat various bacterial infections. While generally well-tolerated, it can cause several common side effects that patients should be aware of:

• Diarrhea
• Nausea
• Vomiting
• Headache
• Abdominal pain
• Vaginal yeast infections

These side effects are typically mild and often resolve on their own as the body adjusts to the medication. However, if they persist or worsen, it’s important to consult a healthcare provider.

Managing Diarrhea

Diarrhea is one of the most common side effects of cefdinir. To manage this symptom:

• Stay hydrated by drinking plenty of fluids
• Consume probiotic-rich foods or supplements
• Avoid caffeine and high-fat foods
• Consider over-the-counter anti-diarrheal medications (after consulting with a healthcare provider)

Is diarrhea from cefdinir always harmless? While mild diarrhea is common, severe or persistent diarrhea could indicate a more serious condition like C. difficile infection and should be evaluated by a healthcare professional.

Yeast Infections: A Common Concern

Cefdinir, like other antibiotics, can disrupt the natural balance of microorganisms in the body, potentially leading to yeast overgrowth. This is particularly common in vaginal yeast infections in women. Symptoms may include:

• Itching and burning in the vaginal area
• Thick, white, cottage cheese-like discharge
• Redness and swelling of the vulva

How can you prevent yeast infections while taking cefdinir? Consider taking a probiotic supplement or consuming probiotic-rich foods like yogurt. If you develop symptoms of a yeast infection, consult your healthcare provider for appropriate treatment.

Serious Side Effects to Watch For

While less common, cefdinir can cause serious side effects that require immediate medical attention. These include:

• Severe allergic reactions (anaphylaxis)
• Stevens-Johnson syndrome
• Clostridium difficile (C. diff) infections
• Severe skin reactions
• Unusual bleeding or bruising
• Seizures

Can cefdinir cause long-term side effects? Most side effects of cefdinir are short-term and resolve after discontinuing the medication. However, in rare cases, serious conditions like C. diff infections can have longer-lasting impacts and require additional treatment.

Understanding Cefdinir-Related Rashes

Skin reactions, including rashes, can occur in some individuals taking cefdinir. These can range from mild to severe and may include:

• Hives
• Itching
• Redness
• Peeling or blistering skin

When should you be concerned about a rash while taking cefdinir? Mild rashes may not be cause for immediate concern, but any severe rash, especially if accompanied by fever, blistering, or peeling skin, should be reported to a healthcare provider immediately as it could indicate a serious allergic reaction.

C. Difficile Infection: A Serious Complication

Clostridium difficile (C. diff) infection is a potentially serious complication associated with antibiotic use, including cefdinir. Symptoms include:

• Severe, persistent diarrhea
• Abdominal pain and cramping
• Fever
• Blood or pus in the stool

Why is C. diff infection a concern with cefdinir use? Antibiotics can disrupt the normal balance of bacteria in the gut, allowing C. diff to overgrow and cause infection. This condition can be severe and may require specific treatment.

Special Considerations for Seniors

Older adults may be more susceptible to certain side effects of cefdinir and may require special monitoring. Considerations for seniors include:

• Increased risk of diarrhea and dehydration
• Greater susceptibility to C. diff infections
• Potential for drug interactions with other medications commonly used by older adults
• Possible need for dose adjustments in those with impaired kidney function

How can seniors minimize the risk of side effects from cefdinir? Seniors should ensure their healthcare provider is aware of all medications they’re taking, stay well-hydrated, and report any unusual symptoms promptly.

Duration of Side Effects

The duration of cefdinir side effects can vary depending on the individual and the specific side effect. Generally:

• Common side effects like diarrhea and nausea often improve within a few days of starting the medication
• Yeast infections may persist until treated specifically
• Most side effects resolve shortly after completing the course of antibiotics

How long should you wait before contacting your doctor about persistent side effects? If side effects are severe or persist for more than a few days, it’s advisable to consult your healthcare provider.

Important Warnings and Precautions

Before taking cefdinir, it’s crucial to be aware of certain warnings and precautions:

• Allergies: Inform your doctor if you have any allergies, especially to cephalosporins or penicillins
• Kidney function: Dose adjustments may be necessary for those with impaired kidney function
• Pregnancy and breastfeeding: Discuss the risks and benefits with your healthcare provider
• Phenylketonuria: The suspension form of cefdinir contains phenylalanine

Why is it important to complete the full course of cefdinir? Completing the prescribed course helps ensure the infection is fully treated and reduces the risk of antibiotic resistance.

Drug Interactions with Cefdinir

Cefdinir can interact with various medications and substances. Some notable interactions include:

• Antacids containing aluminum or magnesium
• Iron supplements
• Probenecid
• Oral contraceptives

How can you minimize the risk of drug interactions with cefdinir? Always inform your healthcare provider about all medications, supplements, and herbal products you’re taking. In some cases, adjusting the timing of doses or using alternative medications may be necessary.

Strategies to Minimize Side Effects

While some side effects of cefdinir may be unavoidable, there are strategies to minimize their impact:

• Take cefdinir with food to reduce stomach upset
• Stay well-hydrated to help prevent diarrhea and other gastrointestinal issues
• Use probiotics to maintain a healthy gut flora
• Follow dosing instructions carefully
• Complete the full course of antibiotics as prescribed

Can lifestyle changes help reduce the side effects of cefdinir? Yes, maintaining a healthy diet, staying hydrated, and getting adequate rest can help your body better tolerate the medication and potentially reduce side effects.

When to Seek Medical Attention

While most side effects of cefdinir are mild, certain symptoms warrant immediate medical attention:

• Signs of an allergic reaction (rash, itching, swelling, severe dizziness, difficulty breathing)
• Severe or persistent diarrhea, especially if bloody
• Unusual bleeding or bruising
• Yellowing of the skin or eyes
• Seizures

Understanding the potential side effects of cefdinir and knowing how to manage them can help ensure a safer and more comfortable treatment experience. Always consult with your healthcare provider if you have concerns about side effects or if your symptoms persist or worsen while taking this medication.

Cefdinir Interactions Checker – Drugs.com

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There are 45 drugs known to interact with
cefdinir, along with
7 disease interactions, and 1 alcohol/food interaction.

Of the total drug interactions,
3 are major, and 42 are moderate.

Does cefdinir interact with my other drugs?

Enter other medications to view a detailed report.

• View all 45 medications that may interact with cefdinir
• View cefdinir alcohol/food interactions (1)
• View cefdinir disease interactions (7)

Most frequently checked interactions

View interaction reports for cefdinir and the medicines listed below.

• Major
• Moderate
• Minor
• Unknown

• Aspirin Low Strength (aspirin)
• Augmentin (amoxicillin / clavulanate)
• Benadryl (diphenhydramine)
• Claritin (loratadine)
• CoQ10 (ubiquinone)
• Cymbalta (duloxetine)
• Eliquis (apixaban)
• Fish Oil (omega-3 polyunsaturated fatty acids)
• Flexeril (cyclobenzaprine)
• Flonase (fluticasone nasal)
• Lyrica (pregabalin)
• Metoprolol Succinate ER (metoprolol)
• Metoprolol Tartrate (metoprolol)
• MiraLAX (polyethylene glycol 3350)
• Mucinex (guaifenesin)
• Norco (acetaminophen / hydrocodone)
• ProAir HFA (albuterol)
• Probiotic Formula (bifidobacterium infantis / lactobacillus acidophilus)
• Protonix (pantoprazole)
• Singulair (montelukast)
• Symbicort (budesonide / formoterol)
• Synthroid (levothyroxine)
• Tylenol (acetaminophen)
• Vitamin B12 (cyanocobalamin)
• Vitamin C (ascorbic acid)
• Vitamin D2 (ergocalciferol)
• Vitamin D3 (cholecalciferol)
• Xanax (alprazolam)
• Zofran (ondansetron)
• Zyrtec (cetirizine)

Cefdinir alcohol/food interactions

There is 1 alcohol/food interaction with cefdinir.

Cefdinir disease interactions

There are 7 disease interactions with cefdinir which include:

• colitis
• renal dysfunction
• diabetes
• nitroprusside tests
• dialysis
• liver disease
• seizure disorders

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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.

Major	Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate	Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor	Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown	No interaction information available.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Cefdinir side effects and how to avoid them

Diarrhea, yeast infection, and headache are common cefdinir side effects, but this antibiotic can also cause a rash and C.Diff

Common cefdinir side effects | Diarrhea | Yeast infection | Serious side effects | Rash | C.Diff | Side effects in seniors | How long do side effects last? | Warnings | Interactions | How to avoid side effects

Cefdinir (brand name: Omnicef) is a third-generation cephalosporin antibiotic used to treat certain bacterial infections such as bronchitis, sinusitis, pharyngitis (sore throat), and urinary tract infections (UTIs). It works by killing harmful bacteria throughout the body. It comes in both capsule and oral suspension form and is usually taken for up to 10 days, depending on the type of infection being treated.

Common side effects include diarrhea, vomiting, and headache. Serious adverse reactions are less common and include severe allergic reactions, Steven-Johnson’s syndrome, and Clostridium difficile (C. difficile) infections. Drug interactions are also possible when taking cefdinir. Be sure to tell your healthcare provider if you have any medical conditions or are taking any medications before taking cefdinir.

RELATED: Learn more about cefdinir |Get cefdinir discounts

Common side effects of cefdinir

The most common side effects of cefdinir include:

• Diarrhea 
• Yeast infection (candidiasis) 
• Nausea and/or vomiting
• Headache
• Abdominal pain
• Inflammation of the vagina (vaginitis)
• Rash 
• Indigestion/Flatulence

Some clinically significant laboratory changes that might be seen include:

• Increased white blood cells in urine 
• Increased levels of protein in the urine (proteinuria)
• Microscopic amounts of blood in the urine (microhematuria) 
• Increased blood sugar (glucose)
• High levels of eosinophils (eosinophilia), which are a special type of white blood cells
• Elevated liver enzymes i. e. alanine aminotransferase (ALT) or aspartate aminotransferase (AST)

Diarrhea

In the same adult clinical trial mentioned above, 15% of adults and adolescents experienced diarrhea. 

The pediatric clinical trial showed 8% of children being treated with cefdinir experienced diarrhea and 0.8% experienced abdominal pain. The rates of diarrhea were highest in patients younger than 2 years old (17%).

If diarrhea is severe during treatment with cefdinir, consult your healthcare provider to rule out a C. difficile infection.

Yeast infection

Cefdinir destroys harmful bacteria in the body, but can also destroy the good bacteria. This may result in oral thrush and vaginal yeast infections during treatment with cefdinir. 

A clinical trial of 5,093 adults and adolescents taking 600 mg of cefdinir per day found that 4% of women experienced a vaginal yeast infection during treatment. In the same group, there was a 0.2% occurrence of yeast infections unrelated to the vagina.

Another trial of 2,289 pediatric patients showed vaginal yeast infections in 0.3% of girls being treated with cefdinir and fungal skin infections in 0.9% of all children.

RELATED: How to prevent yeast infections from antibiotics

Serious side effects of cefdinir

Serious side effects while taking cefdinir are rare but possible. These side effects include:

• Severe allergic reaction (anaphylaxis)
• Stevens-Johnson syndrome: flu-like symptoms accompanied by painful rash and blisters
• Toxic epidermal necrolysis: a rare condition causing skin peeling and blistering
• Exfoliative dermatitis: redness and peeling of large areas of skin
• C. difficile infection causing severe diarrhea and colitis
• Low neutrophils (neutropenia)
• Low platelet count (thrombocytopenia)
• Hemolytic anemia
• Aplastic anemia
• A severe immune reaction (serum sickness)
• Renal toxicity
• Liver toxicity

Cefdinir rash

Several side effects of cefdinir may be accompanied by a rash, including an allergic reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis, and exfoliative dermatitis.

Clinical trials reported rash at an incidence of 0.9% in adults and adolescents being treated with cefdinir. Rash occurred in 3% of children taking this medication, although the majority of these occurrences were in children younger than 2 years old.

Seek emergency medical attention right away if rash-like symptoms are accompanied by wheezing, tightness in the chest or throat, or trouble breathing. This could be a sign of a potentially dangerous allergic reaction.

Clostridium difficile-associated diarrhea

Treatment with Cefdinir can destroy some of the bacteria in the gut. This allows other organisms such as C. difficile to grow out of control. C. difficile produces toxins that may cause swelling/inflammation in the lining of the large intestine. This inflammation is called pseudomembranous colitis. This can cause diarrhea ranging in severity from mild diarrhea to fatal colitis. Symptoms include:

• Frequent watery diarrhea that is sometimes bloody
• Pain and tenderness in the stomach
• Cramping
• Nausea
• Fever
• Loss of appetite

RELATED: Antibiotics that cause C. Difficile

Cefdinir side effects in elderly

People with multiple comorbidities may have an increased risk of side effects when treated with antibiotics, and older adults have more underlying health conditions than younger patients. However, clinical trials found cefdinir to be a safe drug for older patients, with a lower adverse reaction rate compared to young adults.

How long do cefdinir side effects last?

Most cefdinir side effects will subside during or shortly after treatment, although some may require medical attention. Yeast infections, oral thrush, and C. difficile are some examples of side effects that may need to be treated with other medications.

Severe allergic reactions require immediate medical attention. Signs of a severe allergic reaction include:

• Rash or hives
• Swollen or blistered areas of skin
• Red, peeling skin
• Wheezing
• Chest tightness
• Swelling of the mouth, face, lips, throat, or tongue
• Difficulty breathing

Cefdinir contraindications and warnings

Cefdinir may not be appropriate for everyone. Discuss any medical conditions with your healthcare provider before starting treatment, especially if you have ever had:

• Kidney disease or a history of dialysis
• Allergies to other antibiotics, especially cephalosporins and penicillins
• Colitis
• Diabetes (oral suspension contains sucralose)
• Seizure disorders

Kidney disease

Use caution in patients with a creatinine clearance of <30mL/min. Dosage should be reduced in these patients with kidney problems. There is evidence that cephalosporin antibiotics may cause seizures in patients with renal impairment whose dosage was not reduced.

Colitis

Use caution in patients with a history of colitis. Clostridium difficile-associated diarrhea may be more severe in these patients if it occurs. 

Diabetes

Cefdinir can increase blood sugar on its own. The liquid form of cefdinir also contains sugar, which may alter blood glucose levels. Diabetic patients should avoid using cefdinir suspension to ensure that blood sugar levels aren’t altered during treatment. Careful glucose monitoring is required when Cefdinir must be used.

Withdrawal

Cefdinir does not cause dependency or withdrawal symptoms. However, like all antibiotics, if a patient does not finish the full course of antibiotics, an infection may persist or recur.

Overdose

Overdose on any medication is possible, including cefdinir. Signs of overdose include:

• Nausea
• Vomiting
• Stomach pain
• Diarrhea
• Seizures

If an overdose is suspected, seek emergency medical attention or call the Poison Control Center immediately. 

Children

Cefdinir is FDA-approved to treat certain bacterial infections in children as young as 2 months. It may treat bacterial ear infections (otitis media), sinusitis, pharyngitis, tonsillitis, pneumonia, and bacterial skin infections.

Pregnancy

According to the FDA, cefdinir is a pregnancy category B medication. There is no human data available to measure risk, but animal data shows no known risks or complications of taking cefdinir while pregnant. If you’re pregnant, be sure to talk to your healthcare provider about the risks before taking this medication.

Breastfeeding

Cefdinir may be taken while breastfeeding. There is no human data available to determine the risk to the infant, however, no risk is expected based on data from other cephalosporin antibiotics. It is not yet known if cefdinir affects breast milk production.

Cefdinir interactions

There are several drugs and supplements that may interact with cefdinir, according to the FDA. Be sure to tell your healthcare provider what medications, vitamins, and supplements you’re taking before beginning treatment.

• Antacids, magnesium, and iron supplements: Some antacids or supplements containing iron or magnesium may interfere with cefdinir absorption. Take 2 hours before or after Cefdinir. Patients taking iron may also experience a reddish stool discoloration (not related to bleeding). The reddish color is due to the formation of a complex between cefdinir and iron in the gut.
• Probenecid: Taking probenecid, a uric acid reducer that treats gout, may increase levels of cefdinir in the body.
• Hormonal contraceptives: Cefdinir may decrease the efficacy of hormonal birth control; use another form of birth control while taking cefdinir.
• Tetracyclines: Taking tetracyclines with cefdinir may alter the way cefdinir works inside the body.

How to avoid cefdinir side effects

Cefdinir may cause side effects, but there are ways to reduce the risk for these undesired effects. Some ways to avoid side effects while taking cefdinir include:

• Take cefdinir as directed. Follow the medical advice of your healthcare provider and instructions given by your pharmacist. Be sure to shake your liquid cefdinir before use and measure using an appropriate dosing syringe.
• Take cefdinir with or without food. You don’t have to take cefdinir with food, however, taking it with food may decrease stomach discomfort.
• Don’t skip doses. If you forget a dose of cefdinir, take the missed dose as soon as possible. If it’s almost time for your next dose, skip the missed dose. Never double up on doses, as this may cause unwanted side effects.
• Avoid antacids, magnesium, and iron supplements for at least two hours before and after taking cefdinir. Some antacids and supplements interfere with the absorption of cefdinir. Avoid taking antacids or supplements containing magnesium or iron within two hours of taking cefdinir to prevent these interactions.
• Tell your provider about all medical conditions. Cefdinir may not be the best medication for patients with certain medical conditions. Avoid taking cefdinir if you’ve had an allergic reaction to cephalosporin antibiotics in the past.
• Tell your provider what other medications you are taking. Drug interactions while taking cefdinir are possible. Tell your healthcare provider of any prescription drugs, over-the-counter medications, supplements, and herbal products before beginning treatment.
• Don’t stop taking cefdinir before you’ve finished treatment unless directed to do so by a healthcare professional. It’s important to finish your entire treatment, even if your symptoms improve. Discontinuing the medication early may cause repeat infection or antibiotic resistance.
• Store cefdinir properly. Keep this medication at room temperature away from moisture and heat and out of reach of children. Discard your unused cefdinir after treatment.

Resources

• Omnicef drug information, Federal Drug Administration (FDA)
• Cefdinir adverse reactions, Epocrates
• Cefdinir contraindications, Epocrates
• Cefdinir drug label info, DailyMed

Rinicef ​​300mg/ Rinicef ​​300mg

Trade name: Rinicef

International Nonproprietary Name: Cefdinir/Cefdinir

Presentation: capsules 300 mg.

Description: hard gelatin capsules, black opaque cap and gray opaque base.

Composition:

1 capsule contains:

active substance : cefdinir – 300.00 mg;

Pharmacotherapeutic group

Antibacterial agents for systemic use. Third generation cephalosporins. ATX code: J01DD15

Pharmacological properties.

Pharmacodynamics

The active substance cefdinir is a semi-synthetic broad-spectrum cephalosporin antibiotic of the third generation for oral administration. Like other antibiotics of the cephalosporin group, cefdinir has a bactericidal effect against susceptible microorganisms due to the inhibition of the synthesis of peptidoglycan of the bacterial cell wall by disrupting the final stage of transamination necessary for the formation of cross-links. Cefdinir is resistant to many, but not all, beta-lactamases produced by Gram-positive and Gram-negative bacteria. Due to this, many microorganisms resistant to penicillins and some cephalosporins are sensitive to cefdinir. The spectrum of action of cefdinir includes:

Aerobic Gram-positive microorganisms

Staphylococcus aureus (including beta-lactamase producing strains)

Staphylococcus pneumoniae
(only strains sensitive to penicillin)

Staphylococcus pyogenes

Aerobic gram-negative microorganisms

Haemophilus influenzae (including beta-lactamase producing strains)

Haemophilus parainfluenzae
(including beta-lactamase producing strains)

Moraxella catarrhalis (including beta-lactamase producing strains)

The following data was obtained in vitro , but their clinical significance is unknown.

Minimum inhibitory concentration (MIC) of cefdinir in in vitro
is 1 μg / ml or less in relation to (≥ 90%) strains of the following microorganisms; however, the safety and efficacy of cefdinir in the treatment of infections caused by the following microorganisms has not been demonstrated in clinical studies.

Aerobic gram-positive microorganisms

Staphylococcus epidermidis

Streptococcus agalactiae

Streptococcus viridans group

Aerobic gram-negative microorganisms

Citrobacter diversus

Escherichia coli

Klebsiela pneumoniae

Proteus mirabilis

Cefdinir is inactive against strains Pseudomonas, Enterobacter, Enterococcus and methicillin-resistant strains of staphylococci.

Method of administration and dosage

Recommended dosages and duration of treatment for infections in adults and adolescents are described in the table below. The total daily dose for the treatment of all infections is 600 mg. Dosing the drug once a day for 10 days is as effective as taking it twice a day. Once-daily dosing has not been studied for the treatment of pneumonia and skin infections, so Rinicef ​​should be taken twice daily in these cases. The capsules can be taken with or without food.

For the treatment of children (6 months – 12 years), cefdinir is used in the form of a suspension.

Adults and adolescents (ages 13 and over)

Elderly patients: does not require a change in dosing regimen, unless there is a significant impairment of renal function (CC < 30 ml / min). If CC < 30 ml / min, the drug should be taken at a dose of 300 mg once a day.

Patients with renal insufficiency

For patients with CC < 30 ml/min, cefdinir should be given at a dose of 300 mg once daily.

Hemodialysis patients

Hemodialysis promotes the elimination of cefdinir from the body. For patients on permanent hemodialysis, the recommended starting dose is 300 mg or 7 mg/kg every other day. At the end of each hemodialysis session, 300 mg (or 7 mg/kg) of cefdinir is given. Subsequent doses (300 mg or 7 mg/kg) are then given every other day.

If you miss the next dose of the drug, you should take it as soon as you remember. If this missed dose occurs at the time of the next dose, skip the missed dose and follow the previous dosing regimen, do not double the dose.

Side effect

Cefdinir is well tolerated, the identified adverse reactions were mild in nature and resolved spontaneously after discontinuation. Most withdrawals were associated with gastrointestinal disturbances, mainly manifested by diarrhea or nausea. In rare cases, the withdrawal of the drug was due to the development of a rash while taking cefdinir.

Adverse reactions are classified according to the frequency of occurrence: very often (? 1/10), often (from ? 1/100 to < 1/10), infrequently (from ? 1/1,000 to < 1/100), rarely (? 1/10,000, <1/1000), very rarely (< 1/10,000), and the frequency is unknown (the frequency cannot be established according to the available data).

Very common: diarrhea, rash, nausea.

Often: skin candidiasis, abdominal pain, leukopenia, candidal vaginitis, vaginitis, stool changes, dyspepsia, hyperkinesis, macolopapular rash, nausea, increased AST.

Adverse reactions specific to cephalosporins

Allergic reactions, anaphylaxis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, renal dysfunction, toxic nephropathy, liver dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhagic disorders, false positive urine glucose test, neutropenia, pancytopenia and agranulocytosis. Pseudomembranous colitis can develop both during and after the end of the antibiotic prescription.

The use of some cephalosporins was accompanied by the development of seizures, especially in patients with impaired renal function, who were not dose recalculated. If convulsions develop during therapy, the antibiotic should be discontinued. If clinically necessary, anticonvulsant therapy may be prescribed.

According to the results of post-registration experience of use, the following adverse reactions were identified: shock, anaphylaxis (in rare cases with a fatal outcome), edema of the subglottic space and face, feeling of suffocation, serum-like syndrome, conjunctivitis, stomatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme, erythema nodosum, acute hepatitis, cholestatic syndrome, lightning nasal hepatitis, liver failure, jaundice, amylase elevation, acute enterocolitis, hemorrhagic diarrhea, hemorrhagic colitis, melena, pseudomembranous colitis, pancytopenia, granulocytopenia, leukopenia, thrombocytopenia, idiopathic thrombocytopenic purpura, hemolytic anemia, acute respiratory failure, asthma attack, drug-induced pneumonia, eosinophilic pneumonia, idiopathic interstitial pneumonia, fever, acute renal failure, nephropathy, bleeding tendency, bleeding disorder, generalized thrombohemorrhagic syndrome, upper gastrointestinal bleeding, peptic ulcer, intestinal obstruction, unconsciousness, allergic vasculitis, possible cefdinir-diclofenac interaction, heart failure, chest pain, myocardial infarction, rhabdomyolysis, involuntary movements, hypertension.

In the event of the listed adverse reactions, as well as a reaction not indicated in the instructions for use, you should consult a doctor.

Contraindications

Rinicef ​​is contraindicated in patients with a history of allergy to the cephalosporin class of antibiotics and hypersensitivity to excipients in the composition of the drug.

Overdose

Data on cefdinir overdose in humans are not available.

In acute toxicity studies in rodents, a single oral dose of cefdinir at a dose of 5600 mg/kg did not lead to the development of adverse reactions. The following signs and symptoms of overdose have been observed with other beta-lactam antibiotics: nausea, vomiting, stomach discomfort, diarrhea, and convulsions.

During hemodialysis, cefdinir is removed from the body, which can be useful in case of serious toxic reactions caused by overdose, especially if the patient has impaired renal function.

Precautions

Before starting therapy with Rinicef, it is necessary to exclude the presence of a history of hypersensitivity reactions to penicillins, cephalosporins or other drugs.

In case of suspicion or confirmation of the development of Clostridium difficile -associated diarrhea, antibiotic therapy should be discontinued if it does not work on Clostridium difficile . Based on the clinical condition, the patient may be indicated for fluid replacement, administration of electrolyte and amino acid solutions, antibiotic therapy. Clostridium difficile

Rinicef, like other broad-spectrum antimicrobials (antibiotics), should be used with caution in patients with a history of colitis.

In patients with transient or persistent renal insufficiency (CC <30 ml/min), the daily dose of Rinicef ​​should be reduced, since administration at the recommended doses can lead to a significant increase in plasma concentrations and the half-life of cefdinir.

The administration of cephalosporins can sometimes lead to a positive Coombs test result.

Use during pregnancy and lactation.

Pregnancy and childbirth

Experimental reproduction studies have shown the absence of any teratogenic effect.

Data on the results of the use of cefdinir in pregnant women are not available. Cefdinir should only be used during pregnancy if there is a justified clinical need.

Data on the effect of the appointment of cefdinir on childbirth are not available.

Lactation

When prescribing cefdinir at a dose of 600 mg, it is not detected in breast milk in nursing mothers. Cefdinir is prescribed during lactation only after a careful assessment of the benefit / risk ratio for mother and child.

Influence on the ability to drive vehicles and work with mechanisms.

Rincef does not affect the ability to drive vehicles and work with mechanisms.

Interaction with other drugs

Co-administration of cefdinir and an antacid results in a decrease in the rate (C _max ) and extent (AUC) of cefdinir absorption by approximately 40%. If antacids are required during treatment with Rinicef, Rinicef ​​should be taken at least 2 hours before or 2 hours after taking the antacid.

As with other beta-lactam antibiotics, probenicide interferes with renal excretion of cefdinir when administered concomitantly, resulting in an approximately two-fold increase in AUC, a 54% increase in maximum cefdinir plasma concentration, and a prolongation of the half-life t _1/2 by 50%.

The simultaneous administration of cefdinir with iron-containing drugs containing 60 mg of elemental iron (as FeSO ₄ ), or vitamin drugs containing 10 mg of iron, reduces the absorption of cefdinir by 80% and 31%, respectively. If a patient requires iron medications during cefdinir therapy, Rinicef ​​should be taken at least 2 hours before or after taking iron medications.

There have been reports of reddish-colored stools in patients taking cefdinir. In many cases, iron-fortified foods were taken concomitantly by these patients. The reddish coloration may be due to the formation in the gastrointestinal tract of a non-absorbable complex of cefdinir or its degradation products and iron.

During treatment with cefdinir, false-positive results for urinary ketones may occur with nitroprusside, but not with nitroferricyanide. False-positive results may also be noted when determining glucose in the urine using Benedict’s solution or Fehling’s reagent (it is recommended to determine glycosuria only by the enzyme method). The use of cephalosporins can sometimes lead to a positive Coombs test result.

Storage conditions and shelf life

At a temperature not higher than 25°C.

Keep out of the reach of children!

Shelf life 3 years. Do not use after the expiry date stated on the packaging.

Holiday conditions

By prescription.

Packaging

10 capsules in a blister pack made of PVC film and flexible packaging based on aluminum foil.

1 or 2 blister packs, together with the leaflet, are placed in a cardboard pack.

Manufacturer information

Foreign production and trade unitary enterprise “Reb-Pharma”, 223216, Republic of Belarus, Minsk region, Chervensky district, settlement. Smilovichi, st. Sadovaya, 1, tel./fax: (+375) 17 240 26 35, e-mail: [email protected], http://www.rebpharma.by.

Rodinir 300 mg №10 caps

Trade name

Rodinir

International non-proprietary name

Cefdinir

Dosage form

Capsules s 300 mg

Composition

One capsule contains

active substance – cefdinir (form A) 300 mg,

excipients: carmellose calcium 50 mg, polyoxyl 40 stearate 5. 4 mg, colloidal anhydrous silicon dioxide 1.0 mg, magnesium stearate 3.6 mg,

composition of the capsule, in percent: iron (III) oxide black (E172), titanium dioxide (E171), gelatin.

Description

Hard gelatin capsules, size #1, gray body, black cap.

The contents of the capsules are an almost white to white powder.

Pharmacotherapeutic group

Antimicrobials for systemic use. Other beta-lactam antibacterials. Third generation cephalosporins. Cefdinir

ATC code J01DD15

Pharmacological properties

Pharmacokinetics

Absorption: Peak plasma concentrations of cefdinir are reached 2-4 hours after ingestion. Bioavailability at a single dose of 300 mg is 21%, at a dose of 600 mg – 16%. The maximum concentration (Cmax) and AUC are reduced by 16% and 10%, respectively, when eating fatty foods.

Distribution: The mean volume of distribution of cefdinir in adults is 0.35 L/kg and in children (6 months to 12 years of age) 0. 67 L/kg. The drug is distributed into the fluid of the skin bladder, fluid of the middle ear, tonsils, sinus sinuses, bronchial mucosa, lung tissue at a concentration of 15-48% of the plasma level. Cefdinir is 60-70% bound to plasma proteins, the binding does not depend on the concentration of the drug.

Metabolism and elimination: cefdinir is not significantly metabolized, being excreted primarily by the kidneys. The mean plasma half-life is 1.7-1.8 hours. Renal clearance – 2.0 ml / min / kg. Clearance after oral doses of 300 mg and 600 mg is 11.6 ml/min/kg and 15.5 ml/min/kg, respectively; 18.4% and 11.6%, respectively, are excreted unchanged in the urine.

Pharmacodynamics

Cefdinir is a semi-synthetic β-lactam antibiotic that exhibits a bactericidal effect by inhibiting the synthesis of the bacterial cell wall. The drug acts on many microorganisms that produce β-lactamases and are resistant to penicillins and other cephalosporins, but can be hydrolyzed by certain broad-spectrum plasmid-mediated β-lactamases.

Cefdinir is active against most strains of the following microorganisms, both in vitro and in clinical practice:

– aerobic gram-positive microorganisms: Staphylococcus aureus (including β-lactamase producing strains), Streptococcus pneumoniae (penicillin-susceptible strains only), Streptococcus pyogenes;

– aerobic Gram-negative microorganisms: Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Moraxella catarrhalis (including β-lactamase producing strains).

Cefdinir is inactive against Pseudomonas aeruginosa, Enterobacter spp., Enterococcus spp. and methicillin-resistant Staphylococcus spp.

Indications for use

Infectious and inflammatory diseases from mild to moderate severity caused by susceptible microorganisms:

– ENT infections: acute sinusitis, acute otitis media, pharyngitis, tonsillitis

– lower respiratory tract infections: exacerbation of chronic bronchitis , community-acquired pneumonia

Uncomplicated skin and soft tissue infections.

Method of administration and doses

Rodinir capsules are taken orally 1-2 times a day, regardless of food intake.

Doses are determined by the nature and severity of the infection and the susceptibility of the suspected pathogen.

For adults and children over 13 years of age, the following dosing regimen is recommended for treatment:

– pharyngitis, tonsillitis, exacerbation of chronic bronchitis: 300 mg every 12 hours for 5-10 days or 600 mg once a day for 10 days;

– acute sinusitis: 300 mg every 12 hours or 600 mg once a day for 10 days;

– community-acquired pneumonia, uncomplicated skin and soft tissue infections: 300 mg every 12 hours for 10 days.

For children from 6 to 12 years old, the drug is prescribed in the following doses:

– acute otitis media, pharyngitis, tonsillitis: 7 mg / kg every 12 hours for 5-10 days or 14 mg / kg once a day for 10 days;

– acute sinusitis: 7 mg/kg every 12 hours or 14 mg/kg once a day for 10 days;

Uncomplicated skin and soft tissue infections: 7 mg/kg every 12 hours for 10 days.

For children, it is preferable to administer the drug in the form of a suspension.

Dosage in renal insufficiency (creatinine clearance less than 30 ml/min):

Adults: 300 mg once a day.

Children 6 to 12 years: 7 mg/kg once daily (up to 300 mg/day).

For hemodialysis, the recommended starting dose is 300 mg (or 7 mg/kg for children 6 months to 12 years of age) every 48 hours. At the end of each hemodialysis session, 300 mg (or 7 mg/kg for children 6 to 12 years of age) should be taken. Subsequent doses of 300 mg (or 7 mg/kg for children 6 to 12 years of age) are taken every 48 hours.

Adverse reactions

The following classification is used to describe the frequency of adverse reactions: very common (≥1/10), common (≥1/100 and <1/10), infrequent (≥1/1000 and <1/100), rare (≥1/10000 and <1/1000) and very rare (<1/10000 ), including isolated cases.

Often (more than 1%)

– nausea, abdominal pain, diarrhea

– headache

Sometimes

– nausea, diarrhea

– headache

– urticaria, erythema multiforme exudative (including Steven-Johnson syndrome), angioedema, pruritus, toxic epidermal necrolysis (Lyell’s syndrome), anaphylactic shock

– anaphylaxis, bronchospasm, dyspnea, skin rash hemolytic anemia and internal bleeding, positive direct Coombs test

– impaired renal function, toxic nephropathy, acute renal failure, interstitial nephritis, glucosuria, ketonuria

– superinfection

Rarely

– dyspepsia, gastritis, vomiting, abdominal pain, increased activity of AST, ALT and LDH

– dizziness

Very rarely

– convulsions

Contraindications 900 07

– hypersensitivity to the components of the drug or to other antibiotics of the cephalosporin class.

– individual intolerance to antibiotics of the cephalosporin group

– nonspecific ulcerative colitis

– children under 6 years of age (in children under 6 years of age, it is recommended to use the drug in the form of a suspension).

Drug interactions

The action of Rodinir is significantly reduced when used simultaneously with magnesium- or aluminum-containing antacids, as well as with iron-containing drugs. Rodinir should be taken 2 hours before or 2 hours after taking antacids or iron supplements.

As with other β-lactam antibiotics, probenecid inhibits the renal excretion of cefdinir, resulting in an increase in peak plasma concentrations of cefdinir.

Precautions

Patients should be carefully evaluated for hypersensitivity to cefpodoxime, other cephalosporins, penicillins or other medicinal products before initiating therapy with Rodinir.

Special care should be taken when prescribing the drug to patients with hypersensitivity to penicillin antibiotics, due to the development of an allergic cross reaction between beta-lactam antibiotics.

If an allergic reaction occurs, stop taking the drug. Serious hypersensitivity reactions to the drug may require epinephrine therapy and other emergency measures, including oxygenation, intravenous fluids, antihistamines, and ventilatory therapy as clinically indicated.

With prolonged use of the drug, a violation of the normal intestinal microflora is possible, which can lead to excessive reproduction of Clostridium difficile and the development of pseudomembranous colitis. With the appearance of mild forms of antibiotic-associated diarrhea, as a rule, it is enough to stop taking the drug. In severe forms, corrective treatment is recommended (eg, oral vancomycin 250 mg 4 times a day).

The possibility of developing pseudomembranous colitis should be considered when taking any broad-spectrum antibacterial agent.

A false-positive direct Coombs test has been reported during treatment with cephalosporin antibiotics; in this regard, it should be noted that a positive Coombs test result may be due to the use of this drug.

As with other cephalosporins, an increase in prothrombin time has been observed in some patients. Therefore, caution should be exercised in patients receiving anticoagulant therapy.

As with other broad-spectrum antibiotics, long-term treatment may cause the emergence and overgrowth of resistant organisms. If a fungal or bacterial superinfection develops during treatment, an appropriate alternative treatment is prescribed.

Cephalosporins in rare cases can reduce prothrombin activity, which leads to an increase in prothrombin time.

Pediatric use

In children under 6 years of age, it is recommended to use Rodinir in the form of a suspension.

Pregnancy and lactation

Use of the drug during pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus. If necessary, the use of the drug Rodinir during lactation, breastfeeding should be temporarily discontinued.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.