Cefdinir 300mg Capsules

Manufacturer AUROBINDO Active Ingredient Cefdinir Capsules(SEF di ner) Pronunciation SEF di ner
It is used to treat bacterial infections.
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Drug Class
Antibiotic
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Pharmacologic Class
Third-generation cephalosporin
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Pregnancy Category
Category B
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FDA Approved
Dec 1997
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Cefdinir is an antibiotic used to treat various bacterial infections, such as pneumonia, bronchitis, sinus infections, sore throats, and skin infections. It works by stopping the growth of bacteria. It is important to take the full course of medication as prescribed, even if you start feeling better, to prevent the infection from returning.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food, but if it causes stomach upset, take it with food.

It's essential to continue taking this medication as directed, even if your symptoms improve. However, there are some important precautions to keep in mind:

Do not take antacids containing aluminum or magnesium within 2 hours of taking this medication.
Avoid taking iron products within 2 hours before or 2 hours after taking this medication.

Storing and Disposing of Your Medication

To maintain the quality and safety of your medication:

Store it at room temperature in a dry place, away from the bathroom.
Keep all medications in a safe and secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist for guidance on the best way to dispose of medications, and consider participating in local drug take-back programs.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
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Lifestyle & Tips

  • Take with or without food.
  • Separate administration of cefdinir from antacids containing magnesium or aluminum, or iron supplements (including iron-fortified foods) by at least 2 hours before or 3 hours after cefdinir.
  • Do not take antidiarrheal medications without consulting your doctor if you develop severe or persistent diarrhea, as this could be a sign of a more serious infection (Clostridioides difficile-associated diarrhea).

Dosing & Administration

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Adult Dosing

Standard Dose: 300 mg every 12 hours or 600 mg once daily
Dose Range: 300 - 600 mg

Condition-Specific Dosing:

Community-acquired pneumonia: 300 mg every 12 hours for 10 days
Acute exacerbation of chronic bronchitis: 300 mg every 12 hours for 5-10 days or 600 mg once daily for 10 days
Acute maxillary sinusitis: 300 mg every 12 hours for 10 days or 600 mg once daily for 10 days
Pharyngitis/Tonsillitis: 300 mg every 12 hours for 5-10 days or 600 mg once daily for 10 days
Uncomplicated skin and skin structure infections: 300 mg every 12 hours for 10 days
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Pediatric Dosing

Neonatal: Not established (safety and efficacy not established in infants less than 6 months of age)
Infant: 14 mg/kg/day (maximum 600 mg/day) in 1 or 2 divided doses for 6 months to 12 years of age
Child: 14 mg/kg/day (maximum 600 mg/day) in 1 or 2 divided doses
Adolescent: Same as adult dosing (300 mg every 12 hours or 600 mg once daily)
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl > 50 mL/min)
Moderate: 300 mg once daily (CrCl 30-49 mL/min)
Severe: 300 mg once daily (CrCl < 30 mL/min)
Dialysis: 300 mg every other day. At the conclusion of each hemodialysis session, 300 mg should be administered. Subsequent doses are 300 mg every other day.

Hepatic Impairment:

Mild: No adjustment
Moderate: No adjustment
Severe: No adjustment

Pharmacology

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Mechanism of Action

Cefdinir is a third-generation cephalosporin antibiotic that exerts its bactericidal action by inhibiting bacterial cell wall synthesis. It binds to penicillin-binding proteins (PBPs) located inside the bacterial cell wall, thereby inhibiting the transpeptidation step of peptidoglycan synthesis. This leads to the disruption of cell wall integrity and ultimately bacterial cell lysis and death.
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Pharmacokinetics

Absorption:

Bioavailability: 21% (600 mg dose) to 25% (300 mg dose)
Tmax: 2-4 hours
FoodEffect: Food decreases Cmax and AUC by 16% and 10% respectively, but this is not considered clinically significant. Cefdinir can be administered without regard to food.

Distribution:

Vd: 0.35 L/kg
ProteinBinding: 60-70%
CnssPenetration: Limited

Elimination:

HalfLife: 1.7-1.8 hours
Clearance: Not available
ExcretionRoute: Renal (primarily unchanged)
Unchanged: Approximately 18% of an oral dose
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Pharmacodynamics

OnsetOfAction: Rapid
PeakEffect: 2-4 hours (Tmax)
DurationOfAction: Dependent on dosing frequency (e.g., 12 or 24 hours)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Inability to urinate or changes in urine output
Dark urine or yellowing of the skin or eyes (jaundice)
Seizures
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak

Important: Antibiotic-Associated Diarrhea

Diarrhea is a common side effect of antibiotics. However, in rare cases, a severe form of diarrhea called Clostridioides difficile-associated diarrhea (CDAD) may occur. This condition can lead to a life-threatening bowel problem. If you experience any of the following symptoms, contact your doctor immediately:

Stomach pain
Cramps
Very loose, watery, or bloody stools

Before treating diarrhea, consult your doctor for advice.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

* Diarrhea

Note: This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe or persistent diarrhea (especially if bloody or watery)
  • Rash, hives, or itching
  • Difficulty breathing or swallowing
  • Swelling of the face, throat, or tongue
  • Severe abdominal pain or cramps
  • Unusual bruising or bleeding
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine or pale stools
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate certain health problems.

To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
* Existing health problems or conditions

Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere to the prescribed duration of treatment, as using this drug for an extended period may increase the risk of a second infection.

This medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug. If you have diabetes and regularly test your urine glucose levels, consult with your doctor to determine the most suitable tests to use, as some products may affect the accuracy of these tests.

Additionally, if you have diabetes, discuss your treatment with your doctor, as some formulations of this medication may contain sugar. When taking this drug concurrently with an iron product, your stools may appear reddish in color, but this is a normal and harmless effect.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Epigastric distress
  • Diarrhea
  • Convulsions (rarely)

What to Do:

In case of overdose, contact a poison control center immediately (Call 1-800-222-1222). Hemodialysis may be useful in removing cefdinir from the body.

Drug Interactions

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Moderate Interactions

  • Antacids containing magnesium or aluminum (e.g., Maalox, Mylanta)
  • Iron supplements (e.g., ferrous sulfate, multivitamins with iron)
  • Probenecid

Monitoring

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Baseline Monitoring

Renal function (CrCl)

Rationale: To determine appropriate dosing, especially in elderly patients or those with known renal impairment.

Timing: Prior to initiation of therapy if renal impairment is suspected or known.

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Routine Monitoring

Signs and symptoms of superinfection (e.g., oral thrush, vaginal yeast infection, severe diarrhea)

Frequency: Throughout therapy and for several weeks post-therapy

Target: Absence of new infections

Action Threshold: If new infection develops, discontinue cefdinir and initiate appropriate therapy.

Resolution of infection symptoms

Frequency: Daily

Target: Improvement or resolution of fever, pain, inflammation

Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure or resistant organism.

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Symptom Monitoring

  • Diarrhea (especially severe or persistent, which could indicate Clostridioides difficile-associated diarrhea)
  • Rash or itching (signs of allergic reaction)
  • Nausea/vomiting
  • Abdominal pain
  • Headache

Special Patient Groups

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Pregnancy

Cefdinir is classified as Pregnancy Category B. Animal reproduction studies have shown no evidence of harm to the fetus. While there are no adequate and well-controlled studies in pregnant women, it is generally considered safe for use during pregnancy when clearly needed.

Trimester-Specific Risks:

First Trimester: Low risk, no evidence of teratogenicity in animal studies.
Second Trimester: Low risk.
Third Trimester: Low risk.
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Lactation

Cefdinir is excreted in human breast milk in very low concentrations. The amount ingested by a breastfed infant is generally considered to be clinically insignificant. It is generally considered compatible with breastfeeding, but monitor the infant for potential changes in bowel flora (e.g., diarrhea, candidiasis) or allergic reactions.

Infant Risk: Low risk (L2)
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Pediatric Use

Safety and efficacy have not been established in infants younger than 6 months of age. Dosing for children 6 months to 12 years is weight-based. Adolescents typically follow adult dosing guidelines.

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Geriatric Use

No overall differences in safety or effectiveness were observed between elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. Dose adjustment is necessary for elderly patients with renal impairment.

Clinical Information

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Clinical Pearls

  • Cefdinir is a commonly prescribed oral third-generation cephalosporin with good activity against common respiratory pathogens, including penicillin-resistant Streptococcus pneumoniae.
  • It is well-tolerated and can be taken with or without food, offering dosing flexibility.
  • Patients should be advised to separate cefdinir from iron supplements and antacids to avoid significant reduction in absorption.
  • A common side effect is reddish stools in infants taking iron-fortified formula, due to the formation of a non-absorbable complex between cefdinir and iron.
  • It is a good option for patients who cannot tolerate penicillin or have a non-severe penicillin allergy.
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Alternative Therapies

  • Amoxicillin
  • Amoxicillin/clavulanate (Augmentin)
  • Azithromycin (Zithromax)
  • Clarithromycin (Biaxin)
  • Cefuroxime (Ceftin)
  • Cefpodoxime (Vantin)
  • Levofloxacin (Levaquin) - for specific indications
  • Doxycycline
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Cost & Coverage

Average Cost: Varies widely, typically $15-$50 per 30 capsules (300mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.