Cefdinir 250mg/5ml Suspension 60ml

Manufacturer AUROBINDO PHARMA Active Ingredient Cefdinir Suspension(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 medicine used to treat various bacterial infections, such as ear infections, strep throat, pneumonia, and skin infections. It works by stopping the growth of bacteria.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. If you experience stomach upset, taking it with food may help. Continue using the medication even if your symptoms improve.

Important considerations:

Do not take antacids containing aluminum or magnesium within 2 hours of taking this medication.
Avoid taking iron products 2 hours before or 2 hours after taking this medication.
Before using the liquid form, shake the bottle well and measure the dose carefully using the provided measuring device. If one is not included, ask your pharmacist for a suitable device.

You can give this medication to infants along with iron-fortified formula.

Storing and Disposing of Your Medication

To maintain the medication's effectiveness:

Store the liquid suspension at room temperature and discard any unused portion after 10 days.
Keep the medication in a dry place, away from bathrooms.
Store all medications in a safe location, out of reach of children and pets.

Missing 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.
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Lifestyle & Tips

  • Take the medicine exactly as prescribed by your doctor, even if you start feeling better. Do not skip doses or stop taking it early, as this can lead to the infection coming back or bacteria becoming resistant.
  • Shake the oral suspension well before each use.
  • Measure the liquid medicine carefully using the provided measuring spoon or oral syringe, not a household spoon.
  • Cefdinir suspension can be taken with or without food.
  • Store the suspension at room temperature and discard any unused portion after 10 days.
  • If you are taking antacids containing aluminum or magnesium, or iron supplements, take cefdinir at least 2 hours before or 2 hours after antacids, and at least 3 hours before or 3 hours after iron supplements. Taking them too close together can reduce how much cefdinir your body absorbs.
  • Be aware that cefdinir, especially when taken with iron-fortified infant formula or iron supplements, can cause reddish-brown stools. This is a harmless effect due to the formation of a non-absorbable complex.

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 (up to 600 mg/day) in 1 or 2 divided doses for infants 6 months to 12 years of age
Child: 14 mg/kg/day (up to 600 mg/day) in 1 or 2 divided doses
Adolescent: Same as adult dosing (300 mg every 12 hours or 600 mg once daily) if weight/age appropriate
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl > 30 mL/min)
Moderate: No adjustment needed (CrCl > 30 mL/min)
Severe: 300 mg once daily (CrCl < 30 mL/min)
Dialysis: 300 mg every other day. A supplemental dose of 300 mg should be given at the completion of each hemodialysis session.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Cefdinir is a third-generation cephalosporin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs). This binding prevents the cross-linking of peptidoglycan, leading to the disruption of the bacterial cell wall and subsequent cell lysis.
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Pharmacokinetics

Absorption:

Bioavailability: 21% (suspension) to 25% (capsule) in adults; higher in children
Tmax: 2-4 hours
FoodEffect: Food decreases Cmax and AUC by approximately 16% and 10% respectively, but this is not considered clinically significant for the suspension. Can be taken with or without food.

Distribution:

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

Elimination:

HalfLife: 1.7-1.8 hours
Clearance: Not readily available as a specific rate, but primarily renal
ExcretionRoute: Renal (glomerular filtration)
Unchanged: 18% (in urine)
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Pharmacodynamics

OnsetOfAction: Rapid, within hours of first dose
PeakEffect: Within 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 Help Right Away

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 immediate medical attention:

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
Urination problems, such as:
+ Inability to pass urine
+ Changes in urine output
Dark urine or yellowing of the skin or eyes
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. 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.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they persist, contact your doctor:

* Diarrhea

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 diarrhea (watery or bloody stools), especially if accompanied by fever or abdominal cramps, which may be a sign of Clostridioides difficile-associated diarrhea (CDAD).
  • New signs of infection (e.g., fever, sore throat, rash) which could indicate a superinfection.
  • Signs of an allergic reaction: rash, itching, hives, swelling of the face/lips/tongue/throat, difficulty breathing.
  • Unusual bruising or bleeding.
  • Yellowing of the skin or eyes (jaundice).
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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, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
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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.

Be aware that this medication may interfere with certain laboratory tests. Therefore, 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 for glucose, consult with your doctor to determine the most suitable tests to use, as this medication may affect the accuracy of some tests. Additionally, if you have diabetes, discuss your condition 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 are 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 (rare)

What to Do:

In case of overdose, contact a poison control center immediately or seek emergency medical attention. Hemodialysis may be useful in removing cefdinir from the body. Call 1-800-222-1222 for poison control.

Drug Interactions

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Moderate Interactions

  • Antacids (aluminum- or magnesium-containing)
  • Iron supplements (including iron-fortified foods/infant formula)
  • Probenecid

Monitoring

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Baseline Monitoring

Culture and Susceptibility

Rationale: To identify the causative pathogen and confirm its susceptibility to cefdinir, guiding appropriate therapy.

Timing: Prior to initiation of therapy

Renal Function (CrCl)

Rationale: To determine if dose adjustment is necessary, especially in elderly patients or those with pre-existing renal impairment.

Timing: Prior to initiation of therapy in patients with suspected renal impairment

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Routine Monitoring

Clinical Response

Frequency: Daily

Target: Resolution of signs and symptoms of infection

Action Threshold: Lack of improvement or worsening symptoms after 2-3 days may indicate treatment failure or resistant organism; consider re-evaluation.

Signs of Superinfection (e.g., C. difficile-associated diarrhea, fungal infections)

Frequency: Daily throughout therapy and for several weeks post-therapy

Target: Absence of new infections

Action Threshold: Development of severe diarrhea, fever, abdominal pain, or oral/vaginal candidiasis; discontinue cefdinir and initiate appropriate therapy.

Renal Function (CrCl)

Frequency: Periodically, as clinically indicated

Target: Stable renal function

Action Threshold: Significant decline in renal function; adjust dose accordingly.

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Symptom Monitoring

  • Resolution of fever
  • Decrease in pain or inflammation at infection site
  • Improvement in respiratory symptoms (e.g., cough, shortness of breath)
  • Absence of new or worsening diarrhea
  • Absence of rash or allergic reactions

Special Patient Groups

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Pregnancy

Cefdinir is classified as Pregnancy Category B. Animal reproduction studies have not demonstrated a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed.

Trimester-Specific Risks:

First Trimester: No evidence of increased risk of major birth defects based on animal studies.
Second Trimester: No evidence of increased risk.
Third Trimester: No evidence of increased risk.
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Lactation

Cefdinir is excreted in human 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 adverse effects like diarrhea, candidiasis (thrush, diaper rash), or allergic reaction.

Infant Risk: Low risk of adverse effects to the infant.
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Pediatric Use

Safety and efficacy have been established in pediatric patients 6 months through 12 years of age. Dosing is weight-based. Not recommended for infants younger than 6 months due to lack of established safety and efficacy.

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Geriatric Use

No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dose adjustment is necessary for elderly patients with significant renal impairment (CrCl < 30 mL/min).

Clinical Information

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Clinical Pearls

  • Cefdinir is a commonly prescribed oral antibiotic for various community-acquired infections, particularly in pediatric patients.
  • A notable interaction is with iron supplements or iron-fortified foods/formula, which can lead to reddish-brown discoloration of stools. This is a harmless, non-absorbable complex and not a sign of gastrointestinal bleeding.
  • Ensure proper spacing between cefdinir and antacids or iron supplements to maximize absorption.
  • The suspension must be shaken well before each use and discarded after 10 days.
  • It is a good option for patients who may have difficulty tolerating penicillin-class antibiotics (though cross-reactivity with cephalosporins can occur, especially with first-generation agents).
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Alternative Therapies

  • Amoxicillin/clavulanate (Augmentin)
  • Azithromycin (Zithromax)
  • Clarithromycin (Biaxin)
  • Other oral cephalosporins (e.g., cefuroxime, cephalexin)
  • Doxycycline (for certain indications, not pediatric)
  • Levofloxacin (for certain indications, not pediatric)
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Cost & Coverage

Average Cost: Not available (highly variable by pharmacy and insurance) per 60ml suspension
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to 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 details about the overdose, including the medication taken, the amount, and the time it occurred.