Cefdinir 250mg/5ml Suspension 100ml

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 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

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 it causes stomach upset, take it with food to help minimize discomfort. 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 within 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 no device is included, ask your pharmacist for a suitable measuring tool.

You can give this medication with infant formula that contains iron.

Storing and Disposing of Your Medication

To maintain the medication's effectiveness and safety:

Store the liquid suspension at room temperature.
Discard any unused portion after 10 days.
Keep the medication in a dry place, away from bathrooms.
* Store all medications in a secure 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

  • Shake the oral suspension well before each use.
  • Measure the liquid medicine carefully using the provided measuring spoon or cup, not a household spoon.
  • Take with or without food.
  • If you are taking antacids containing aluminum or magnesium, or iron supplements, take cefdinir at least 2 hours before or 2 hours after these products.
  • Finish the entire course of medication, even if symptoms improve, to prevent antibiotic resistance and recurrence of infection.
  • Store the suspension at room temperature or as directed by the pharmacist; do not freeze.

Dosing & Administration

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Adult Dosing

Standard Dose: 600 mg/day (e.g., 300 mg every 12 hours or 600 mg once daily) for 5-10 days depending on infection type and severity.
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: Not established (safety and efficacy not established in infants less than 6 months of age)
Child: 14 mg/kg/day (maximum 600 mg/day) in 1 or 2 divided doses. For 250mg/5ml suspension: 7 mg/kg every 12 hours or 14 mg/kg every 24 hours for 5-10 days depending on infection.
Adolescent: Same as adult dosing (typically for patients 13 years and older)
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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. 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. It 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 the cell wall, resulting in bacterial cell lysis and death.
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Pharmacokinetics

Absorption:

Bioavailability: 21-25% (capsule), 25-30% (suspension)
Tmax: 2-4 hours
FoodEffect: Minimal effect on absorption; can be taken with or without food.

Distribution:

Vd: 0.35 L/kg
ProteinBinding: 67%
CnssPenetration: Limited (does not readily penetrate the cerebrospinal fluid)

Elimination:

HalfLife: 1.7-1.8 hours
Clearance: Not available (primarily renal excretion)
ExcretionRoute: Renal (glomerular filtration)
Unchanged: 60-65% excreted unchanged 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

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

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 life-threatening bowel problems. 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 may cause side effects. Many people experience no side effects or only 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 potential 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, which could indicate Clostridioides difficile-associated diarrhea)
  • New or worsening rash, hives, or itching
  • Difficulty breathing or swallowing (signs of allergic reaction)
  • Swelling of the face, throat, or tongue
  • Unusual bruising or bleeding
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine or pale stools
  • Severe abdominal pain
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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.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate existing 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
Natural products and vitamins you are using
* Any existing health problems or conditions

It is crucial to verify that it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage 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 results.

Additionally, if you have diabetes, discuss your treatment with your doctor, as some formulations of this medication may contain sugar.

When taking this drug in conjunction 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, especially in patients with renal impairment)

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, especially in patients with significant renal impairment. Call 1-800-222-1222 for poison control.

Drug Interactions

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Moderate Interactions

  • Antacids containing aluminum or magnesium (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 pre-existing renal impairment.

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

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Routine Monitoring

Signs and symptoms of infection resolution

Frequency: Daily during therapy

Target: Improvement in fever, pain, inflammation, etc.

Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure or resistant organism, requiring re-evaluation.

Adverse effects (e.g., diarrhea, rash)

Frequency: Daily during therapy

Target: Absence or mild, tolerable side effects

Action Threshold: Severe diarrhea (especially if bloody), persistent rash, or other severe adverse effects warrant discontinuation and medical evaluation (e.g., C. difficile infection).

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Symptom Monitoring

  • Diarrhea (especially severe or bloody)
  • Rash or hives
  • Nausea
  • Vomiting
  • Abdominal pain
  • Headache
  • Vaginitis
  • Reddish-brown stools (if taking iron supplements)

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. There are no adequate and well-controlled studies in pregnant women, but based on animal data and clinical experience with other cephalosporins, the risk is considered low. Use during pregnancy only if clearly needed.

Trimester-Specific Risks:

First Trimester: Low risk based on animal studies; no evidence of increased risk of congenital anomalies.
Second Trimester: Low risk; no specific concerns identified.
Third Trimester: Low risk; no specific concerns identified.
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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 changes in bowel flora (e.g., diarrhea, candidiasis) or allergic reactions.

Infant Risk: Low risk (L2 - Safer). Potential for minor gastrointestinal disturbances (e.g., diarrhea) or sensitization in the infant.
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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 (14 mg/kg/day). Close monitoring for adverse effects is important.

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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 suspension should be shaken well before each use.
  • Patients should be advised that reddish-brown stools may occur when cefdinir is taken with iron-containing products or infant formulas fortified with iron, due to the formation of a non-absorbable iron-cefdinir complex. This is harmless.
  • Ensure patients complete the full course of therapy to prevent resistance and relapse.
  • Counsel patients on the importance of separating cefdinir administration from antacids or iron supplements by at least 2 hours.
  • Cefdinir is not effective against viral infections (e.g., common cold, flu).
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Alternative Therapies

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

Average Cost: Not available (varies widely by pharmacy, location, and insurance) per 100ml bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (often preferred 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 medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.