CEPHALEXIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CEPHALEXIN (UNII: OBN7UDS42Y) (CEPHALEXIN ANHYDROUS - UNII:5SFF1W6677)

Available from:

REMEDYREPACK INC.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cephalexin capsules USP are indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes . Cephalexin capsules USP are indicated for the treatment of otitis media caused by susceptible isolates of Streptococcus pneumoniae , Haemophilus influenzae , Staphylococcus aureus , Streptococcus pyogenes , and Moraxella catarrhalis . Cephalexin capsules USP are indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and Streptococcus pyogenes . Cephalexin capsules USP are indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis . Cephalexin capsules USP are indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli , Proteus mirabilis , and Klebsiella pneumoniae . To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules USP and other antibacterial drugs, cephalexin capsules USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information 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. Cephalexin capsules are contraindicated in patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs. Risk Summary Available data from published epidemiologic studies and pharmacovigilance case reports over several decades with cephalosporin use, including cephalexin use in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data) . Animal reproduction studies with mice and rats using oral doses of cephalexin that are 0.6- and 1.2-times the maximum recommended human dose (MRHD) based on body surface area during organogenesis revealed no evidence of harm to the fetus (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data: While available studies cannot definitively establish the absence of risk, published data from epidemiologic studies and postmarketing case reports over several decades have not identified a consistent association with cephalosporin use, including cephalexin, during pregnancy, and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Available studies have methodologic limitations, including small sample size, retrospective data collection, and inconsistent comparator groups. Animal Data: In animal reproduction studies, pregnant mice and rats administered oral cephalexin doses of 250 or 500 mg/kg/day (approximately 0.6 and 1.2 times the MRHD) based on body surface area, respectively during the period of organogenesis showed no adverse effects on embryofetal development. In a pre-and post-natal developmental toxicity study, pregnant rats that received oral doses of 250 or 500 mg/kg/day of cephalexin from Day 15 of pregnancy to litter Day 21 showed no adverse effects on parturition, litter size, or growth of offspring. Risk Summary Data from a published clinical lactation study reports that cephalexin is present in human milk. The Relative Infant Dose (RID) is considered to be <1% of the maternal weight adjusted dose. There are no data on the effects of cephalexin on the breastfed child or on milk production. The development of health benefits of breastfeeding should be considered along with the mother's clinical need for cephalexin and any potential adverse effects on the breastfed child from cephalexin or from the underlying maternal condition. The safety and effectiveness of cephalexin capsules in pediatric patients was established in clinical trials for the dosages described in the dosage and administration section [see DOSAGE AND ADMINISTRATION ( 2.2)] Of the 701 subjects in 3 published clinical studies of cephalexin, 433 (62%) were 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. This drug is substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection [see WARNINGS AND PRECAUTIONS ( 5.4)]. Cephalexin capsules should be administered with careful monitoring in the presence of renal impairment (creatinine clearance < 30 mL/min, with or without dialysis). Under such conditions, careful clinical observation and laboratory studies renal function monitoring should be conducted because safe dosage may be lower than that usually recommended [see DOSAGE AND ADMINISTRATION ( 2.3)]. Monitor patients longer for toxicity and drug interactions due to delayed clearance.

Product summary:

Cephalexin capsules USP, are supplied as follows: 500 mg Capsules, Green, Capsule shape, Imprint: 500;LUPIN NDC: 70518-3857-00 NDC: 70518-3857-01 NDC: 70518-3857-02 NDC: 70518-3857-03 PACKAGING: 42 in 1 BOTTLE PLASTIC PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 10 in 1 BOTTLE PLASTIC PACKAGING: 40 in 1 BOTTLE PLASTIC Cephalexin capsules USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEPHALEXIN- CEPHALEXIN CAPSULE
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEPHALEXIN CAPSULES
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CEPHALEXIN CAPSULES USP
CEPHALEXIN CAPSULES USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1971
INDICATIONS AND USAGE
Cephalexin capsules USP is a cephalosporin antibacterial drug
indicated for the treatment of the following
infections caused by susceptible isolates of designated bacteria:
Respiratory tract infection ( 1.1)
Otitis media ( 1.2)
Skin and skin structure infections ( 1.3)
Bone infections ( 1.4)
Genitourinary tract infections ( 1.5)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cephalexin
capsules USP and other antibacterial drugs, cephalexin capsules USP
should be used only to treat
infections that are proven or strongly suspected to be caused by
bacteria. ( 1.6)
DOSAGE AND ADMINISTRATION
Adults and
patients at least
15 years of age
The usual dose is 250 mg every 6 hours, but a dose of 500 mg every 12
hours may be
administered ( 2.1)
Pediatric patients
(over 1 year of
age)
• Otitis media: 75 to 100 mg/kg in equally divided doses every 6
hours ( 2.2)
• All other indications: 25 to 50 mg/kg given in equally divided
doses ( 2.2)
• In severe infections: 50 to 100 mg/kg may be administered in
equally divided doses ( 2.2)
Duration of therapy ranges from 7 to 14 days depending on the
infection type and severity. ( 2)
Dosage adjustment is required in patients with severe and end stage
renal disease (ESRD) defined as
creatinine clearance below 30 mL/min. ( 2.3)
DOSAGE FORMS AND STRENGTHS
Capsules: 500 mg ( 3)
CONTRAINDICATIONS
Patients with known hypersensitivity to cephalexin or other members of
the cephalosporin class of
antibacterial drugs. ( 4)
WARNINGS AND PRECAUTIONS
Serious hypersensitivity (anaphylactic) reactions: Prior to use,
inquire regarding history of
hypersensitivity to beta-lactam antibacterial drugs. Discont