Cefdinir 125mg/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 medication used to treat various bacterial infections, such as ear infections, sinus infections, throat infections, and certain types of pneumonia and skin infections. It works by stopping the growth of bacteria.
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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 to help minimize discomfort.

It's essential to continue taking this medication as directed, even if your symptoms improve. However, there are some important interactions to be aware of:

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 the dose carefully using the measuring device provided with the medication. If no device is included, ask your pharmacist for a suitable measuring device. If you're giving this medication to an infant, you can mix it with infant formula that contains iron.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety 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 bathrooms.
Store all medications in a secure 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 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 the missed one.
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Lifestyle & Tips

  • Take the medication exactly as prescribed by your doctor, even if you start to feel better. Do not skip doses or stop taking it early, as this can lead to antibiotic resistance.
  • Shake the oral suspension well before each use.
  • Measure the liquid medicine carefully using the provided dosing syringe or spoon, not a household spoon.
  • Avoid taking antacids containing magnesium or aluminum, or iron supplements, within 2 hours before or after taking cefdinir, as they can reduce its absorption. If you must take them, separate the doses.
  • This medication is for bacterial infections only; it will not work for viral infections like the common cold or flu.
  • Stay hydrated and maintain good hygiene to prevent the spread of infection.

Dosing & Administration

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Adult Dosing

Standard Dose: 300 mg every 12 hours or 600 mg every 24 hours
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 (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 (up to 600 mg/day) in 1 or 2 divided doses for 5-10 days (e.g., 7 mg/kg every 12 hours or 14 mg/kg every 24 hours). For otitis media and sinusitis, 7 mg/kg every 12 hours or 14 mg/kg every 24 hours for 10 days. For pharyngitis/tonsillitis and skin infections, 7 mg/kg every 12 hours for 5-10 days or 14 mg/kg every 24 hours for 10 days.
Adolescent: Same as 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: 300 mg every 24 hours (CrCl 30-49 mL/min)
Severe: 300 mg every 48 hours (CrCl < 30 mL/min)
Dialysis: 300 mg every 48 hours. 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% (capsule) to 25% (suspension) for 300 mg dose; 16% (capsule) for 600 mg dose
Tmax: 2-4 hours
FoodEffect: Food does not significantly affect the extent of absorption, but Tmax may be delayed by 1 hour.

Distribution:

Vd: 0.35 L/kg (adults)
ProteinBinding: 67%
CnssPenetration: Limited (achieves low concentrations in CSF, generally not recommended for meningitis)

Elimination:

HalfLife: 1.7-1.8 hours
Clearance: Not available (primarily renal excretion)
ExcretionRoute: Renal (glomerular filtration)
Unchanged: Approximately 60-65% of an oral dose is recovered unchanged in the urine.
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Pharmacodynamics

OnsetOfAction: Rapid (within hours of first dose)
PeakEffect: Within 2-4 hours (Tmax)
DurationOfAction: Dependent on dosing interval (e.g., 12 or 24 hours), maintains concentrations above MIC for susceptible organisms.

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 a life-threatening bowel problem. If you experience any of the following symptoms, contact your doctor right away:

Stomach pain
Cramps
Very loose, watery, or bloody stools

Before treating diarrhea, consult with your doctor.

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 with 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 watery or bloody)
  • New or worsening rash, hives, or itching
  • Swelling of the face, lips, tongue, or throat
  • Difficulty breathing or swallowing
  • Severe stomach pain or cramps
  • Unusual tiredness or weakness
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine or pale stools
  • Signs of a new infection (e.g., fever, sore throat, vaginal itching or discharge)
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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.
All medications you are currently taking, including prescription and over-the-counter (OTC) medications, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as these may affect the safety and efficacy of this medication.

To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication in conjunction with your other medications and health conditions.
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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 supplement, 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 (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
  • Iron supplements (including iron-fortified foods)
  • Probenecid

Monitoring

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Baseline Monitoring

Allergy history (especially to cephalosporins or penicillins)

Rationale: To prevent hypersensitivity reactions

Timing: Prior to initiation of therapy

Renal function (serum creatinine, CrCl)

Rationale: To guide dose adjustment in patients with renal impairment

Timing: Prior to initiation of therapy, especially in elderly or those with known renal issues

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Routine Monitoring

Clinical response to therapy (e.g., resolution of fever, reduction in symptoms)

Frequency: Daily during treatment

Target: Improvement of infection symptoms

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

Signs and symptoms of adverse reactions (e.g., diarrhea, rash, nausea)

Frequency: Daily during treatment

Target: Absence of severe adverse effects

Action Threshold: Development of severe diarrhea (especially C. difficile-associated diarrhea), severe rash, or other concerning symptoms requires evaluation and potential discontinuation

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Symptom Monitoring

  • Diarrhea (especially severe or persistent)
  • Abdominal pain/cramping
  • Nausea/vomiting
  • Skin rash or itching
  • Headache
  • Vaginitis
  • Signs of superinfection (e.g., oral thrush, vaginal yeast infection)
  • Signs of allergic reaction (e.g., hives, swelling, difficulty breathing)

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. However, 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 increased risk of congenital anomalies observed in animal studies.
Second Trimester: No specific risks identified beyond general pregnancy considerations.
Third Trimester: No specific risks identified beyond general pregnancy considerations.
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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 caution is advised.

Infant Risk: Low risk. Potential for alteration of bowel flora, diarrhea, or sensitization in the infant. Monitor for signs of diarrhea or rash 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. Renal function should be monitored in children with impaired renal function.

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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 renal impairment.

Clinical Information

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Clinical Pearls

  • Cefdinir is a convenient once or twice daily dosing option for many common infections.
  • Advise patients to separate cefdinir administration from antacids and iron supplements by at least 2 hours to avoid reduced absorption.
  • Patients taking iron supplements may experience reddish-orange stools due to the formation of a non-absorbable iron-cefdinir complex, which is harmless but can be alarming.
  • While generally well-tolerated, diarrhea is a common side effect; counsel patients on signs of C. difficile-associated diarrhea.
  • Not effective against MRSA or Pseudomonas aeruginosa.
  • Consider alternative antibiotics for severe infections where CNS penetration is critical (e.g., meningitis).
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Alternative Therapies

  • Other oral third-generation cephalosporins (e.g., Cefixime, Ceftibuten)
  • Other oral cephalosporins (e.g., Cefuroxime, Cefpodoxime)
  • Macrolides (e.g., Azithromycin, Clarithromycin) for respiratory tract infections
  • Penicillins (e.g., Amoxicillin, Amoxicillin/Clavulanate) for susceptible infections
  • Tetracyclines (e.g., Doxycycline) for certain infections
  • Fluoroquinolones (e.g., Levofloxacin, Moxifloxacin) for specific indications
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Cost & Coverage

Average Cost: Varies widely, typically $50-$200 per 100ml 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 your 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 medication taken, the amount, and the time it happened.