CEPHALEXIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

ADVANCED RX PHARMACY OF TENNESSEE, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

1 INDICATIONS AND USAGE 1.1 Respiratory Tract Infections Cephalexin capsules USP are indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes. 1.2 Otitis Media 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. 1.3 Skin and Skin Structure Infections 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. 1.4 Bone Infections Cephalexin capsules USP are indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis. 1.5 Genitourinary Tract Infections 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. 1.6 Usage 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. 8.1 Pregnancy 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. 8.2 Lactation 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. 8.4 Pediatric Use 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)] 8.5 Geriatric Use 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)]. 8.6 Renal Impairment 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, Bottles of: Bottles of 28: NDC 80425-0005-01 Bottles of 40: NDC 80425-0005-02 Bottles of 6: NDC 80425-0005-03 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEPHALEXIN- CEPHALEXIN CAPSULE
ADVANCED RX PHARMACY OF TENNESSEE, LLC
----------
CEPHALEXIN 500MG CAPSULES
1. INDICATIONS AND USAGE SECTION
1 INDICATIONS AND USAGE
1.1 Respiratory Tract Infections
Cephalexin capsules USP are indicated for the treatment of respiratory
tract infections
caused by susceptible isolates of Streptococcus pneumoniae and
Streptococcus
pyogenes.
1.2 Otitis Media
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.
1.3 Skin and Skin Structure Infections
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.
1.4 Bone Infections
Cephalexin capsules USP are indicated for the treatment of bone
infections caused by
susceptible isolates of Staphylococcus aureus and Proteus mirabilis.
1.5 Genitourinary Tract Infections
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.
1.6 Usage
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.
2. DOSAGE AND ADMINISTRATION SECTION
2 DOSAGE AND ADMINISTRATION
2.1 Adults and Pediatric Patients at Least 15 Years of Age
The usual dose of oral cephalexin capsules USP is 250 mg e