KEFLEX- cephalexin capsule

Keflex by

Drug Labeling and Warnings

Keflex by is a Prescription medication manufactured, distributed, or labeled by Advanced Rx Pharmacy of Tennessee, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Dosage and Administration Section

2 DOSAGE & ADMINISTRATION

2.1 Adults and Pediatric Patients at Least 15 Years of Age

The usual dose of oral Cephalexin capsule, USP is 250 mg every 6 hours, but a dose of 500 mg every 12 hours may be administered. Treatment is administered for 7 to 14 days.

For more severe infections larger doses of oral Cephalexin capsules, USP may be needed, up to 4 grams daily in two to four equally divided doses.

2.2 Pediatric Patients (over 1 year of age)

The recommended total daily dose of oral Cephalexin capsules, USP for pediatric patients is 25 to 50 mg/kg given in equally divided doses for 7 to 14 days. In the treatment of β-hemolytic streptococcal infections, duration of at least 10 days is recommended. In severe infections, a total daily dose of 50 to 100 mg/kg may be administered in equally divided doses.

For the treatment of otitis media, the recommended daily dose is 75 to 100 mg/kg given in equally divided doses.

2.3 Dosage Adjustments in Adult and Pediatric Patients at Least 15 Years of Age with Renal Impairment

Administer the following dosing regimens for Cephalexin capsules, USP to patients with renal impairment [see Warnings and Precautions (5.4) and Use in Specific Populations (8.6 )].

Table 1. Recommended Dose Regimen for Patients with Renal Impairment

Renal function Dose regimen recommendation
Creatinine clearance >60mL/min. No dose adjustment
Creatinine clearance 30 to 59 mL / min
No dose adjustment; maximum daily dose should not exceed 1 g
Creatinine clearance 15 to 29 mL / min
250 mg, every 8 hours or every 12 hours
Creatinine clearance 5 to 14 mL / min not yet on dialysis*
250 mg, every 24 hours
Creatinine clearance 1 to 4 mL / min not yet on dialysis*
250 mg, every 48 hours or every 60 hours

*There is insufficient information to make dose adjustment recommendations in patients on hemodialysis.

Indications and Usage Section

1 INDICATIONS & USAGE

1.1 Respiratory Tract Infections

Cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes.

1.2 Otitis Media

Cephalexin is 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 is 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 is indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis.

1.5 Genitourinary Tract Infections

Cephalexin is 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 and other antibacterial drugs, Cephalexin 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.

Description Section

11 DESCRIPTION

Cephalexin capsules, USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Cephalexin has the molecular formula C 16 H 17 N3O4SH2O and the molecular weight is 365.41.

Cephalexin has the following structural formula:

[cephalexin-str]

Each capsule contains cephalexin monohydrate equivalent to 250 mg, 333 mg, 500 mg, or 750 mg of cephalexin. The 250 mg, 333 mg, 500 mg and 750 mg capsules contain anhydrous lactose, colloidal silicon dioxide, magnesium stearate, FD & C Blue No. 1, D & C Yellow No. 10, gelatin, sodium lauryl sulphate, titanium dioxide. In addition, the 250 mg capsule contains FD & C Red No. 40; 333 mg and 750 mg Capsules contains FD & C Yellow No. 6. The imprinting ink contains; shellac, propylene glycol, strong ammonia solution and potassium hydroxide. Also black Iron oxide is used in 250mg, 333mg and 500mg and titanium dioxide is used in 750mg.

Principal Display Panel

INGREDIENTS AND APPEARANCE

KEFLEX 
cephalexin capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 80425-0121(NDC:67877-219)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CEPHALEXIN (UNII: OBN7UDS42Y) (CEPHALEXIN ANHYDROUS - UNII:5SFF1W6677)	CEPHALEXIN ANHYDROUS	500 mg

Product Characteristics
Color	green	Score	no score
Shape	CAPSULE	Size	22mm
Flavor		Imprint Code	219
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80425-0121-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	01/19/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090836	01/19/2011

Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)

Establishment
Name	Address	ID/FEI	Business Operations
Advanced Rx Pharmacy of Tennessee, LLC		117023142	repack(80425-0121)