OMNICEF- cefdinir capsule
OMNICEF- cefdinir powder, for suspension
To reduce the development of drug-resistant bacteria and maintain the effectiveness of OMNICEF and other antibacterial drugs, OMNICEF should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
OMNICEF (cefdinir) capsules and OMNICEF (cefdinir) for oral suspension contain the active ingredient cefdinir, an extended-spectrum, semisynthetic cephalosporin, for oral administration. Chemically, 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 is a white to slightly brownish-yellow solid. It is slightly soluble in dilute hydrochloric acid and sparingly soluble in 0.1 M pH 7.0 phosphate buffer. The empirical formula is C14 H13 N5 O5 S2 and the molecular weight is 395.42. Cefdinir has the structural formula shown below:
OMNICEF Capsules contain 300 mg cefdinir and the following inactive ingredients: carboxymethylcellulose calcium, NF; polyoxyl 40 stearate, NF; and magnesium stearate, NF. The capsule shells contain FD&C Blue #1; FD&C Red #40; D&C Red #28; titanium dioxide, NF; gelatin, NF; silicon dioxide, NF; and sodium lauryl sulfate, NF.
OMNICEF for Oral Suspension, after reconstitution, contains 125 mg cefdinir per 5 mL or 250 mg cefdinir per 5 mL and the following inactive ingredients: sucrose, NF; citric acid, USP; sodium citrate, USP; sodium benzoate, NF; xanthan gum, NF; guar gum, NF; artificial strawberry and cream flavors; silicon dioxide, NF; and magnesium stearate, NF.
Maximal plasma cefdinir concentrations occur 2 to 4 hours postdose following capsule or suspension administration. Plasma cefdinir concentrations increase with dose, but the increases are less than dose-proportional from 300 mg (7 mg/kg) to 600 mg (14 mg/kg). Following administration of suspension to healthy adults, cefdinir bioavailability is 120% relative to capsules. Estimated bioavailability of cefdinir capsules is 21% following administration of a 300 mg capsule dose, and 16% following administration of a 600 mg capsule dose. Estimated absolute bioavailability of cefdinir suspension is 25%. Cefdinir oral suspension of 250 mg/5 mL strength was shown to be bioequivalent to the 125 mg/5 mL strength in healthy adults under fasting conditions.
The Cmax and AUC of cefdinir from the capsules are reduced by 16% and 10%, respectively, when given with a high-fat meal. In adults given the 250 mg/5 mL oral suspension with a high-fat meal, the Cmax and AUC of cefdinir are reduced by 44% and 33%, respectively. The magnitude of these reductions is not likely to be clinically significant because the safety and efficacy studies of oral suspension in pediatric patients were conducted without regard to food intake. Therefore, cefdinir may be taken without regard to food.
Cefdinir plasma concentrations and pharmacokinetic parameter values following administration of single 300- and 600-mg oral doses of cefdinir to adult subjects are presented in the following table:
|Dose||Cmax (µg/mL)||tmax (hr)||AUC (µg•hr/mL)|
Cefdinir plasma concentrations and pharmacokinetic parameter values following administration of single 7- and 14-mg/kg oral doses of cefdinir to pediatric subjects (age 6 months-12 years) are presented in the following table:
|Dose||Cmax (µg/mL)||tmax (hr)||AUC (µg•hr/mL)|
Cefdinir does not accumulate in plasma following once- or twice-daily administration to subjects with normal renal function.
The mean volume of distribution (Vdarea ) of cefdinir in adult subjects is 0.35 L/kg (± 0.29); in pediatric subjects (age 6 months-12 years), cefdinir Vdarea is 0.67 L/kg (± 0.38). Cefdinir is 60% to 70% bound to plasma proteins in both adult and pediatric subjects; binding is independent of concentration.
In adult subjects, median (range) maximal blister fluid cefdinir concentrations of 0.65 (0.33-1.1) and 1.1 (0.49-1.9) µg/mL were observed 4 to 5 hours following administration of 300- and 600-mg doses, respectively. Mean (± SD) blister Cmax and AUC (0-∞) values were 48% (± 13) and 91% (± 18) of corresponding plasma values.
In adult patients undergoing elective tonsillectomy, respective median tonsil tissue cefdinir concentrations 4 hours after administration of single 300- and 600-mg doses were 0.25 (0.22-0.46) and 0.36 (0.22-0.80)µg/g. Mean tonsil tissue concentrations were 24% (± 8) of corresponding plasma concentrations.
In adult patients undergoing elective maxillary and ethmoid sinus surgery, respective median sinus tissue cefdinir concentrations 4 hours after administration of single 300- and 600-mg doses were< 0.12 (< 0.12-0.46) and 0.21 (< 0.12-2.0) µg/g. Mean sinus tissue concentrations were 16% (± 20) of corresponding plasma concentrations.
In adult patients undergoing diagnostic bronchoscopy, respective median bronchial mucosa cefdinir concentrations 4 hours after administration of single 300- and 600-mg doses were 0.78 (< 0.06-1.33) and 1.14 (< 0.06-1.92) µg/mL, and were 31% (± 18) of corresponding plasma concentrations. Respective median epithelial lining fluid concentrations were 0.29 (< 0.3-4.73) and 0.49 (< 0.3-0.59)µg/mL, and were 35% (± 83) of corresponding plasma concentrations.
In 14 pediatric patients with acute bacterial otitis media, respective median middle ear fluid cefdinir concentrations 3 hours after administration of single 7- and 14-mg/kg doses were 0.21 (< 0.09-0.94) and 0.72 (0.14-1.42) µg/mL. Mean middle ear fluid concentrations were 15% (± 15) of corresponding plasma concentrations.
Data on cefdinir penetration into human cerebrospinal fluid are not available.
Cefdinir is not appreciably metabolized. Activity is primarily due to parent drug. Cefdinir is eliminated principally via renal excretion with a mean plasma elimination half-life (t½ ) of 1.7 (± 0.6) hours. In healthy subjects with normal renal function, renal clearance is 2.0 (± 1.0) mL/min/kg, and apparent oral clearance is 11.6 (± 6.0) and 15.5 (± 5.4) mL/min/kg following doses of 300- and 600-mg, respectively. Mean percent of dose recovered unchanged in the urine following 300- and 600-mg doses is 18.4% (± 6.4) and 11.6% (± 4.6), respectively. Cefdinir clearance is reduced in patients with renal dysfunction (see Special Populations — Patients with Renal Insufficiency).
Because renal excretion is the predominant pathway of elimination, dosage should be adjusted in patients with markedly compromised renal function or who are undergoing hemodialysis (see DOSAGE AND ADMINISTRATION).
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