Cefdinir (Cefdinir) capsules, USP contain the active ingredient Cefdinir (Cefdinir) monohydrate, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, Cefdinir (Cefdinir) is [6R-[6α, 7β (Z)]]-7-[[(2-amino-4-thiazolyl)-(hydroxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Cefdinir (Cefdinir) monohydrate is a white to slightly brownish-yellow solid. It is slightly soluble in dilute hydrochloric acid and sparingly soluble in 0.1M pH 7 phosphate buffer. The empirical formula is CHNOS.HO and the molecular weight is 413.47. Cefdinir (Cefdinir) monohydrate has the structural formula shown below:

Cefdinir (Cefdinir) Capsules, USP contain Cefdinir (Cefdinir) USP equivalent to anhydrous Cefdinir (Cefdinir) 300 mg and the following inactive ingredients: carboxymethylcellulose calcium, NF; croscarmellose sodium NF; polyoxyl 40 stearate, NF; colloidal silicon dioxide NF and magnesium stearate NF. The capsule shells contain FD&C Blue #1, FD&C Green #3, FD&C Red #40, D&C Red #28, D&C Red #33, titanium dioxide and gelatin. Ink constituents are: shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide and black iron oxide.

As with other cephalosporins, bactericidal activity of Cefdinir (Cefdinir) results from inhibition of cell wall synthesis. Cefdinir (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) .

Cefdinir (Cefdinir) has been shown to be active against most strains of the following microorganisms, both and in clinical infections as described in .

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefdinir (Cefdinir) and other antibacterial drugs, Cefdinir (Cefdinir) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Cefdinir (Cefdinir) capsules are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.

Cefdinir (Cefdinir) is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.

Prescribing Cefdinir (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.

As with other broad-spectrum antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate alternative therapy should be administered.

Cefdinir (Cefdinir) , as with other broad-spectrum antimicrobials (antibiotics), should be prescribed with caution in individuals with a history of colitis.

In patients with transient or persistent renal insufficiency (creatinine clearance
Patients should be counseled that antibacterial drugs including Cefdinir (Cefdinir) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Cefdinir (Cefdinir) is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. 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 (Cefdinir) or other antibacterial drugs in the future.

Antacids containing magnesium or aluminum interfere with the absorption of Cefdinir (Cefdinir) . If this type of antacid is required during Cefdinir (Cefdinir) therapy, Cefdinir (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 (Cefdinir) . If iron supplements are required during Cefdinir (Cefdinir) therapy, Cefdinir (Cefdinir) should be taken at least 2 hours before or after the supplement.

Iron-fortified infant formula does not significantly interfere with the absorption of Cefdinir (Cefdinir) .

In clinical trials, 5093 adult and adolescent patients (3841 U.S. and 1252 non-U.S.) were treated with the recommended dose of Cefdinir (Cefdinir) capsules (600 mg/day). Most adverse events were mild and self-limiting. No deaths or permanent disabilities were attributed to Cefdinir (Cefdinir) . One hundred forty-seven of 5093 (3%) patients discontinued medication due to adverse events thought by the investigators to be possibly, probably, or definitely associated with Cefdinir (Cefdinir) therapy. The discontinuations were primarily for gastrointestinal disturbances, usually diarrhea or nausea. Nineteen of 5093 (0.4%) patients were discontinued due to rash thought related to Cefdinir (Cefdinir) administration.

In the U.S., the following adverse events were thought by investigators to be possibly, probably, or definitely related to Cefdinir (Cefdinir) capsules in multiple-dose clinical trials (N = 3841 Cefdinir (Cefdinir) -treated patients):

The following laboratory value changes of possible clinical significance, irrespective of relationship to therapy with Cefdinir (Cefdinir) , were seen during clinical trials conducted in the U.S.:

The following adverse events and altered laboratory tests have been reported for cephalosporin-class antibiotics in general:

Allergic reactions, anaphylaxis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, renal dysfunction, toxic nephropathy, hepatic dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhage, false-positive test for urinary glucose, neutropenia, pancytopenia, and agranulocytosis. Pseudomembranous colitis symptoms may begin during or after antibiotic treatment (see ).

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced (see and ). If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

Information on Cefdinir (Cefdinir) overdosage in humans is not available. In acute rodent toxicity studies, a single oral 5600-mg/kg dose produced no adverse effects. Toxic signs and symptoms following overdosage with other β-lactam antibiotics have included nausea, vomiting, epigastric distress, diarrhea, and convulsions. Hemodialysis removes Cefdinir (Cefdinir) from the body. This may be useful in the event of a serious toxic reaction from overdosage, particularly if renal function is compromised.

(see for Indicated Pathogens)

The recommended dosage and duration of treatment for infections in adults and adolescents are described in the following chart; the total daily dose for all infections is 600 mg. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in pneumonia or skin infections; therefore, Cefdinir (Cefdinir) Capsules should be administered twice daily in these infections. Cefdinir (Cefdinir) Capsules may be taken without regard to meals.

Cefdinir (Cefdinir) Capsules USP, 300 mg: Purple Opaque Cap / Teal Opaque body, size “0” hard gelatin capsules imprinted  “C” on cap & “300” on body with black ink, filled with off-white to yellow granular powder.

They are supplied as follows:

Bottles of 30                         NDC 16714-205-01

Bottles of 60                        NDC 16714-205-02

Bottles of 500                      NDC 16714-205-05

Carton of 30 (3 unit-of-use, 5-day, 10-capsule blister cards) NDC 16714-205-04

In a controlled, double-blind study in adults and adolescents conducted in the U.S., Cefdinir (Cefdinir) BID was compared with cefaclor 500 mg TID. Using strict evaluability and microbiologic/clinical response criteria 6 to 14 days posttherapy, the following clinical cure rates, presumptive microbiologic eradication rates, and statistical outcomes were obtained:

In a second controlled, investigator-blind study in adults and adolescents conducted primarily in Europe, Cefdinir (Cefdinir) BID was compared with amoxicillin/clavulanate 500/125 mg TID. Using strict evaluability and clinical response criteria 6 to 14 days posttherapy, the following clinical cure rates, presumptive microbiologic eradication rates, and statistical outcomes were obtained:

In four controlled studies conducted in the United States, Cefdinir (Cefdinir) was compared with 10 days of penicillin in adult, adolescent, and pediatric patients. Two studies (one in adults and adolescents, the other in pediatric patients) compared 10 days of Cefdinir (Cefdinir) QD or BID to penicillin 250 mg or 10 mg/kg QID. Using strict evaluability and microbiologic/clinical response criteria 5 to 10 days posttherapy, the following clinical cure rates, microbiologic eradication rates, and statistical outcomes were obtained:

Two studies (one in adults and adolescents, the other in pediatric patients) compared 5 days of Cefdinir (Cefdinir) BID to 10 days of penicillin 250 mg or 10 mg/kg QID. Using strict evaluability and microbiologic/clinical response criteria 4 to 10 days posttherapy, the following clinical cure rates, microbiologic eradication rates, and statistical outcomes were obtained:

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Manufactured for: Northstar Rx LLC

Memphis, TN 38141

Toll free number: 1 800 206 7821

Manufactured by: Hospira Healthcare India Pvt. Ltd.,

At Irungattukottai - 602 105, India

On behalf of: Orchid Healthcare

(A Division of Orchid Chemicals & Pharmaceuticals Ltd.)

At Irungattukottai - 602 105, India

Revised: 07/10                                                                                           

948026030

NDC 16714-205-02

NDC 16714-205-04