Cefdinir 125mg/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 used to treat various bacterial infections, such as ear infections, strep throat, sinus infections, and certain skin infections. It works by killing the bacteria that cause these infections.
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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.

To ensure accurate dosing, shake the liquid medication well before use and measure it carefully using the measuring device provided. If you don't have a measuring device, ask your pharmacist for one.

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

Storing and Disposing of Your Medication

To maintain the effectiveness of your medication:

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

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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Take the medication 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 antibiotic resistance and recurrence of infection.
  • Shake the suspension well before each use.
  • Use an accurate measuring spoon or oral syringe provided with the medication, not a household spoon.
  • Cefdinir can be taken 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.
  • 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: 300 mg every 12 hours or 600 mg every 24 hours 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 every 24 hours for 10 days
Acute maxillary sinusitis: 300 mg every 12 hours for 10 days OR 600 mg every 24 hours for 10 days
Pharyngitis/Tonsillitis: 300 mg every 12 hours for 5-10 days OR 600 mg every 24 hours 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
Infant: 6 months to 12 years: 14 mg/kg/day (maximum 600 mg/day) in 1 or 2 divided doses. For 125mg/5ml suspension, this translates to 5ml per 125mg.
Child: 6 months to 12 years: 14 mg/kg/day (maximum 600 mg/day) in 1 or 2 divided doses. For 125mg/5ml suspension, this translates to 5ml per 125mg.
Adolescent: 13 years and older: Adult dosing (300 mg every 12 hours or 600 mg every 24 hours)
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl > 50 mL/min)
Moderate: CrCl 30-49 mL/min: No adjustment needed
Severe: CrCl < 30 mL/min: 300 mg once daily
Dialysis: Hemodialysis: 300 mg once daily at the end of each hemodialysis session. Cefdinir is removed by hemodialysis.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Cefdinir is a bactericidal antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs). This binding interferes with the transpeptidation step of peptidoglycan synthesis, leading to cell lysis and bacterial 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: 60-70%
CnssPenetration: Limited

Elimination:

HalfLife: 1.7-1.8 hours
Clearance: Not available
ExcretionRoute: Renal (primarily unchanged)
Unchanged: Approximately 90% of absorbed dose
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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 for q12h or q24h dosing)

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 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
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. 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 only minor ones. If you are bothered by any of the following side effects or if they do not go away, 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:

  • Seek immediate medical attention if you experience signs of a severe allergic reaction: rash, hives, itching, swelling (especially of the face, lips, tongue, or throat), severe dizziness, or trouble breathing.
  • Contact your doctor if you develop severe, watery, or bloody diarrhea, even several weeks after stopping the medication. This could be a sign of a serious intestinal infection (Clostridioides difficile-associated diarrhea).
  • Report any new or worsening symptoms, or if your infection does not improve.
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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 affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.

To ensure safe use, tell your doctor and pharmacist about:

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

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.

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 testing method, as some products may affect the accuracy of these 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 in conjunction with an iron product, your stools may appear reddish in color, which is a normal and harmless side 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:

Call 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention. Treatment is supportive; hemodialysis may be useful in removing cefdinir from the body.

Drug Interactions

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Moderate Interactions

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

Monitoring

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Baseline Monitoring

Culture and Sensitivity

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

Timing: Prior to initiating therapy

Renal Function (CrCl, BUN, Creatinine)

Rationale: To assess baseline kidney function, especially in elderly patients or those with pre-existing renal impairment, as dose adjustment may be necessary.

Timing: Prior to initiating therapy, if renal impairment is suspected or known

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Routine Monitoring

Clinical Response to Therapy

Frequency: Daily

Target: Resolution of signs and symptoms of infection (e.g., fever, pain, inflammation)

Action Threshold: Lack of improvement or worsening symptoms after 2-3 days may indicate treatment failure, resistant organism, or alternative diagnosis.

Renal Function (CrCl, BUN, Creatinine)

Frequency: Periodically, as clinically indicated

Target: Within patient's baseline or normal limits

Action Threshold: Significant decline in renal function may necessitate dose adjustment.

Stool consistency/frequency

Frequency: Daily

Target: Normal bowel habits

Action Threshold: Development of severe, persistent diarrhea may indicate Clostridioides difficile-associated diarrhea (CDAD).

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Symptom Monitoring

  • Signs of allergic reaction (rash, itching, hives, swelling of face/lips/tongue, difficulty breathing)
  • Severe or persistent diarrhea (especially if bloody or watery)
  • Abdominal pain or cramping
  • Nausea, vomiting
  • Headache
  • Vaginal itching or discharge (signs of yeast infection)
  • Oral thrush (white patches in mouth)
  • Unusual bruising or bleeding (rare, but possible blood dyscrasias)

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. It is generally considered safe for use during pregnancy when clearly needed.

Trimester-Specific Risks:

First Trimester: Low risk; no evidence of increased risk of birth defects.
Second Trimester: Low risk.
Third Trimester: Low risk.
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Lactation

Cefdinir is excreted in human milk in very low concentrations. The amount ingested by a breastfed infant is considered negligible. It is generally considered compatible with breastfeeding (Lactation Risk L2).

Infant Risk: Low risk of adverse effects. Monitor infant for diarrhea, candidiasis (thrush, diaper rash), or allergic reaction (rash).
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Pediatric Use

Cefdinir suspension is commonly used in pediatric patients aged 6 months to 12 years. Dosing is weight-based (14 mg/kg/day). Safety and efficacy in infants younger than 6 months have not been established.

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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 significant renal impairment.

Clinical Information

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Clinical Pearls

  • Cefdinir is a third-generation cephalosporin effective against a broad range of gram-positive and gram-negative bacteria, including common respiratory pathogens.
  • It is a convenient option due to its once- or twice-daily dosing.
  • Counsel patients on the potential for reddish-brown stools when taking cefdinir with iron-containing products, which is due to a non-absorbable complex and is harmless.
  • Always complete the full course of antibiotics to prevent resistance and ensure eradication of the infection.
  • Consider alternative antibiotics if the patient has a history of severe allergic reaction (e.g., anaphylaxis) to penicillins, due to potential cross-reactivity (though rare with third-generation cephalosporins).
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Alternative Therapies

  • Amoxicillin
  • Amoxicillin/clavulanate
  • Azithromycin
  • Clarithromycin
  • Cefuroxime
  • Cefpodoxime
  • Levofloxacin (for adults, specific indications)
  • Doxycycline (for adults, specific indications)
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Cost & Coverage

Average Cost: Varies widely, typically $20-$100+ per 60ml bottle of 125mg/5ml 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 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 details about the overdose, including the medication taken, the amount, and the time it occurred.