Cefdinir Capsules

DESCRIPTION

Cefdinir capsules contain 300 mg cefdinir and the following inactive ingredients: carboxymethylcellulose calcium, colloidal silicon dioxide and magnesium stearate. The empty hard gelatin capsule shells contain FD&C Blue #1, D&C Red #28, titanium dioxide, gelatin and sodium lauryl sulphate. The capsules are printed with edible ink containing black iron oxide and shellac.

CLINICAL PHARMACOLOGY

Pharmacokinetics and Drug Metabolism

Absorption

Oral Bioavailability

Effect of Food

Cefdinir Capsules

300 mg	1.6(0.55)	2.9(0.89)	7.05(2.17)
600 mg	2.87(1.01)	3(0.66)	11.1(3.87)

Cefdinir Suspension

7 mg/kg	2.3(0.65)	2.2(0.6)	8.31(2.5)
14 mg/kg	3.86(0.62)	1.8(0.4)	13.4(2.64)

Multiple Dosing

Distribution

Skin Blister

Tonsil Tissue

Sinus Tissue

Lung Tissue

Middle Ear Fluid

CSF

Metabolism and Excretion

Special Populations

Patients with Renal Insufficiency

Hemodialysis

Hepatic Disease

Geriatric Patients

Gender and Race

Microbiology

Aerobic Gram-Positive Microorganisms

Aerobic Gram-Negative Microorganisms

Aerobic Gram-Positive Microorganisms

Aerobic Gram-Negative Microorganisms

Susceptibility Tests

Dilution Techniques

≤1	Susceptible (S)
2	Intermediate (I)
≥4	Resistant (R)

≤1	Susceptible (S)

Escherichia coli ATCC 25922	0.12-0.5
Haemophilus influenzae ATCC 49766c	0.12-0.5
Staphylococcus aureus ATCC 29213	0.12-0.5

Diffusion Techniques

≥20	Susceptible (S)
17-19	Intermediate (I)
≤16	Resistant (R)

≥20	Susceptible (S)

Escherichia coli ATCC 25922	24-28
Haemophilus influenzae ATCC 49766g	24-31
Staphylococcus aureus ATCC 25923	25-32

INDICATIONS AND USAGE

Adults and Adolescents

Pediatric Patients

CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

General

Information for Patients

Drug Interactions

Antacids (Aluminum- or magnesium-containing)

Concomitant administration of 300 mg cefdinir capsules with 30 mL Maalox® TC suspension reduces the rate (Cmax) and extent (AUC) of absorption by approximately 40%. Time to reach Cmax is also prolonged by 1 hour. There are no significant effects on cefdinir pharmacokinetics if the antacid is administered 2 hours before or 2 hours after cefdinir. If antacids are required during cefdinir therapy, cefdinir should be taken at least 2 hours before or after the antacid.

Probenecid

Iron Supplements and Foods Fortified With Iron

Drug/Laboratory Test Interactions

Carcinogenesis, Mutagenesis, Impairment of Fertility

Pregnancy

Teratogenic effects

Labor and Delivery

Nursing Mothers

Pediatric Use

Geriatric Use

ADVERSE REACTIONS

Clinical Trials – Cefdinir Capsules (Adult and Adolescent Patients)

Incidence ≥1%	Diarrhea	15%
Vaginal moniliasis	4% of Women
Nausea	3%
Headache	2%
Abdominal pain	1%
Vaginitis	1% of Women
Incidence <1% but >0.1%	Rash	0.9%
Dyspepsia	0.7%
Flatulence	0.7%
Vomiting	0.7%
Abnormal stools	0.3%
Anorexia	0.3%
Constipation	0.3%
Dizziness	0.3%
Dry mouth	0.3%
Asthenia	0.2%
Insomnia	0.2%
Leukorrhea	0.2% of Women
Moniliasis	0.2%
Pruritus	0.2%
Somnolence	0.2%

Incidence ≥1%	↑Urine leukocytes	2%
↑Urine protein	2%
↑Gamma-glutamyltransferasea	1%
↓Lymphocytes, ↑Lymphocytes	1%, 0.2%
↑Microhematuria	1%
Incidence <1% but >0.1%	↑Glucosea	0.9%
↑Urine glucose	0.9%
↑White blood cells, ↓White blood cells	0.9%, 0.7%
↑Alanine aminotransferase (ALT)	0.7%
↑Eosinophils	0.7%
↑Urine specific gravity, ↓Urine specific gravitya	0.6%, 0.2%
↓Bicarbonatea	0.6%
↑Phosphorus, ↓Phosphorusa	0.6%, 0.3%
↑Aspartate aminotransferase (AST)	0.4%
↑Alkaline phosphatase	0.3%
↑Blood urea nitrogen (BUN)	0.3%
↓Hemoglobin	0.3%
↑Polymorphonuclear neutrophils (PMNs), ↓PMNs	0.3%, 0.2%
↑Bilirubin	0.2%
↑Lactate dehydrogenasea	0.2%
↑Platelets	0.2%
↑Potassiuma	0.2%
↑Urine pHa	0.2%

Clinical Trials - Cefdinir for Oral Suspension (Pediatric Patients)

Incidence ≥ 1%	Diarrhea	8%
Rash	3%
Vomiting	1%
Incidence <1% but >0.1%	Cutaneous moniliasis	0.9%
Abdominal pain	0.8%
Leukopeniab	0.3%
Vaginal moniliasis	0.3% of girls
Vaginitis	0.3% of girls
Abnormal stools	0.2%
Dyspepsia	0.2%
Hyperkinesia	0.2%
Increased ASTb	0.2%
Maculopapular rash	0.2%
Nausea	0.2%

Incidence ≥1%	↑Lymphocytes, ↓Lymphocytes	2%, 0.8%
↑Alkaline phosphatase	1%
↓Bicarbonatea	1%
↑Eosinophils	1%
↑Lactate dehydrogenase	1%
↑Platelets	1%
↑PMNs, ↓PMNs	1%, 1%
↑Urine protein	1%
Incidence <1% but >0.1%	↑Phosphorus, ↓Phosphorus	0.9%, 0.4%
↑Urine pH	0.8%
↓White blood cells, ↑White blood cells	0.7%, 0.3%
↓Calciuma	0.5%
↓Hemoglobin	0.5%
↑Urine leukocytes	0.5%
↑Monocytes	0.4%
↑AST	0.3%
↑Potassiuma	0.3%
↑Urine specific gravity, ↓Urine specific gravity	0.3%, 0.1%
↓Hematocrita	0.2%

Postmarketing Experience

Cephalosporin Class Adverse Events

OVERDOSAGE

DOSAGE AND ADMINISTRATION

Community-Acquired Pneumonia	300 mg q12h	10 days
Acute Exacerbations of Chronic Bronchitis	300 mg q12h or600 mg q24h	5 to 10 days 10 days
Acute Maxillary Sinusitis	300 mg q12h or600 mg q24h	10 days10 days
Pharyngitis/Tonsillitis	300 mg q12h or600 mg q24h	5 to 10 days 10 days
Uncomplicated Skin and Skin Structure Infections	300 mg q12h	10 days

Patients With Renal Insufficiency

Patients on Hemodialysis

HOW SUPPLIED

Bottles of 14	NDC 54868-5767-3
Bottles of 20	NDC 54868-5767-0
Bottles of 30	NDC 54868-5767-1
Bottles of 60	NDC 54868-5767-2

CLINICAL STUDIES

Community-Acquired Bacterial Pneumonia

Clinical Cure Rates	150/187 (80%)	147/186 (79%)	Cefdinir equivalent to control
Eradication Rates
Overall	177/195 (91%)	184/200 (92%)	Cefdinir equivalent to control
S. pneumoniae	31/31 (100%)	35/35 (100%)
H. influenzae	55/65 (85%)	60/72 (83%)
M. catarrhalis	10/10 (100%)	11/11 (100%)
H. parainfluenzae	81/89 (91%)	78/82 (95%)

Clinical Cure Rates	83/104 (80%)	86/97(89%)	Cefdinir not equivalent to control
Eradication Rates
Overall	85/96 (89%)	84/90 (93%)	Cefdinir equivalent to control
S. pneumoniae	42/44 (95%)	43/44 (98%)
H. influenzae	26/35 (74%)	21/26 (81%)
M. catarrhalis	6/6 (100%)	8/8 (100%)
H. parainfluenzae	11/11 (100%)	12/12 (100%)

Streptococcal Pharyngitis/Tonsillitis

Adults/Adolescents	Eradication of S. pyogenes	192/210 (91%)	199/217 (92%)	181/217 (83%)	Cefdinir superior to control
Clinical Cure Rates	199/210 (95%)	209/217 (96%)	193/217 (89%)	Cefdinir superior to control
Pediatric Patients	Eradication of S. pyogenes	215/228 (94%)	214/227 (94%)	159/227 (70%)	Cefdinir superior to control
Clinical Cure Rates	222/228 (97%)	218/227 (96%)	196/227 (86%)	Cefdinir superior to control

Adults/Adolescents	Eradication of S. pyogenes	193/218 (89%)	176/214 (82%)	Cefdinir equivalent to control
Clinical Cure Rates	194/218 (89%)	181/214 (85%)	Cefdinir equivalent to control
Pediatric Patients	Eradication of S. pyogenes	176/196 (90%)	135/193 (70%)	Cefdinir superior to control
Clinical Cure Rates	179/196 (91%)	173/193 (90%)	Cefdinir equivalent to control

REFERENCES

Manufactured for:Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810

Revised: 12/2008

National Committee for Clinical Laboratory Standards, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically, 4th ed. Approved Standard, NCCLS Document M7-A4, Vol 17(2) NCCLS, Villanova, PA, Jan 1997.
National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Disk Susceptibility Tests, 6th ed. Approved Standard, NCCLS Document M2-A6, Vol 17(1). NCCLS, Villanova, PA, Jan 1997.
Cockcroft DW, Gault MH. Prediction of creatinine clearance from secum creatinine, Nephron 1976;16:31-41.
Schwartz GJ, Haycock GB, Edelmann CM, Spitzer A. A simple estimate of glomerular filtration rate in children derived from body length and plasma creatinine. Pediatrics 1976;58:259-63.
Schwartz GJ, Feld LG, Langford DJ. A simple estimate of glomerular filtration rate in full-term infants during the first year of life. J Pediatrics 1984;104:849-54.

SPL UNCLASSIFIED SECTION

Relabeling and Repackaging by:Physicians Total Care, Inc.Tulsa, OK 74146

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