Cefdinir

What is Cefdinir?

• Cefdinir (Omnicef) is an extended-spectrum, semisynthetic cephalosporin, for oral administration used to treat certain infections caused by bacteria such as bronchitis (infection of the airway tubes leading to the lungs); pneumonia; and infections of the skin, ears, sinuses, throat, and tonsils.

Cefdinir

Cefdinir

What are the uses of this medicine?

• Cefdinir (Omnicef) capsules are used for the treatment of patients with mild to moderate infections listed below:

In Adults and Adolescents:

• Community-Acquired Pneumonia
• Acute Exacerbations of Chronic Bronchitis
• Acute Maxillary Sinusitis
• Pharyngitis/Tonsillitis
• Uncomplicated Skin and Skin Structure Infections

In Pediatric Patients:

• Acute Bacterial Otitis Media
• Pharyngitis/Tonsillitis
• Uncomplicated Skin and Skin Structure Infections

How does this medicine work?

• As with other cephalosporins, bactericidal activity of cefdinir results from inhibition of cell wall synthesis.
• Cefdinir is stable in the presence of some, but not all, β-lactamase enzymes.
• As a result, many organisms resistant to penicillins and some cephalosporins are susceptible to cefdinir.

Cefdinir has been shown to be active against most strains of the following microorganisms: Gram-Positive Bacteria:

• Staphylococcus aureus (methicillin-susceptible strains only)
• Streptococcus pneumoniae (penicillin-susceptible strains only)
• Streptococcus pyogenes

Gram-Negative Bacteria:

• Haemophilus influenzae
• Haemophilus parainfluenzae
• Moraxella catarrhalis

The following in vitro data are available, but their clinical significance is unknown.

• However, the safety and effectiveness of cefdinir in treating clinical infections due to these microorganisms have not been established.

Gram-Positive Bacteria:

• Staphylococcus epidermidis (methicillin-susceptible strains only)
• Streptococcus agalactiae
• Viridans group streptococci

Gram-Negative Bacteria:

• Citrobacter koseri
• Escherichia coli
• Klebsiella pneumoniae
• Proteus mirabilis

Who Should Not Use this medicine ?

This medicine cannot be used:

• with known allergy to the cephalosporin class of antibiotics.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• probenecid ( Probalan)
• Antacids (Aluminum- or Magnesium-Containing)
• Iron Supplements and Foods Fortified With Iron

Is this medicine FDA approved?

• It was patented in 1979 and approved for medical use in 1991.
• It is available as a generic medication.
• In 2020, it was the 228th most commonly prescribed medication in the United States, with more than 2 million prescriptions.

How should this medicine be used?

Recommended dosage:

• The recommended dosage and duration of treatment for infections in adults and adolescents (Age 13 Years and Older) are as fallows:

Community-Acquired Pneumonia:

• 300 mg q12h for 10 days.

Acute Exacerbations of Chronic Bronchitis:

• 300 mg q12h for 5 to 10 days /600 mg q24h for 10 days.

Acute Maxillary Sinusitis:

• 300 mg q12h for 10 days/ 600 mg q24h for 10 days.

Pharyngitis/Tonsillitis:

• 300 mg q12h for 5 to 10 days/ 600 mg q24h for 10 days.

Uncomplicated Skin and Skin Structure Infections:

• 300 mg q12h for 10 days.

• For adult patients with creatinine clearance < 30 mL/min, the dose of cefdinir should be 300 mg given once daily.
• For pediatric patients with a creatinine clearance of < 30 mL/min/1.73 m2, the dose of cefdinir should be 7 mg/kg (up to 300 mg) given once daily.

Administration:

• Cefdinir comes as a capsule and suspension (liquid) to take by mouth. It is usually taken with or without food every 12 or 24 hours for 5 to 10 days, depending on the condition being treated. Take cefdinir at around the same times every day.
• Shake the suspension well before each use to mix the medication evenly.
• You should begin to feel better during the first few days of treatment with cefdinir.
• If your symptoms do not improve or get worse, call your doctor.
• Continue to take cefdinir even if you feel better.
• If you stop taking cefdinir too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As as a capsule and suspension (liquid)

This medicine is available in fallowing brand namesː

• Omnicef

What side effects can this medication cause?

The most common side effects of this medicine include:

• Vaginal moniliasis
• Nausea
• Headache
• Abdominal pain
• Vaginitis
• Rash
• Dyspepsia
• Flatulence
• Vomiting
• Abnormal stools
• Anorexia
• Constipation
• Dizziness
• Dry mouth
• Asthenia
• Insomnia
• Leukorrhea
• Moniliasis
• Pruritus
• Somnolence

What special precautions should I follow?

• Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefdinir, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
• If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
• Prescribing cefdinir in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
• Cefdinir, as with other broad-spectrum antimicrobials (antibiotics), should be prescribed with caution in individuals with a history of colitis.
• Patients should be counseled that antibacterial drugs including cefdinir should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).
• Skipping doses or not completing the full course of therapy may

(1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by cefdinir or other antibacterial drugs in the future.

• Antacids containing magnesium or aluminum interfere with the absorption of cefdinir. If this type of antacid is required during cefdinir therapy, cefdinir should be taken at least 2 hours before or after the antacid.
• Iron supplements, including multivitamins that contain iron, interfere with the absorption of cefdinir. If iron supplements are required during cefdinir therapy, cefdinir should be taken at least 2 hours before or after the supplement.
• Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. If this occurs, patients should contact their physician as soon as possible.
• If you have diabetes, you should know that cefdinir suspension solution contains sucrose (sugar).
• Following administration of single 600 mg doses, cefdinir was not detected in human breast milk.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• nausea, vomiting, epigastric distress, diarrhea, and convulsions

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Hemodialysis removes cefdinir from the body.
• This may be useful in the event of a serious toxic reaction from overdosage, particularly if renal function is compromised.

Can this medicine be used in pregnancy?

• Pregnancy Category B.
• There are, however, no adequate and well-controlled studies in pregnant women.
• Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Can this medicine be used in children?

• Safety and efficacy in neonates and infants less than 6 months of age have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• CEFDINIR

Inactive ingredients:

• CARBOXYMETHYLCELLULOSE CALCIUM
• FD&C BLUE NO. 2
• GELATIN, UNSPECIFIED
• MAGNESIUM STEARATE
• POLYOXYL 40 STEARATE
• SILICON DIOXIDE
• TITANIUM DIOXIDE
• SHELLAC
• PROPYLENE GLYCOL
• FERROSOFERRIC OXIDE
• AMMONIA
• POTASSIUM HYDROXIDE

Who manufactures and distributes this medicine?

Manufactured by:

• Sandoz GmbH for
• Sandoz Inc., Princeton, NJ

What should I know about storage and disposal of this medication?

• Store at 20°-25°C (68°-77°F).

• Dailymed label info on Cefdinir
• FDA Cefdinir

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