KEFLEX Capsule (2021)

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Pragma Pharmaceuticals, LLC

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1. Indications and Usage

1.1 Respiratory Tract Infections KEFLEX is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes . 1.2...

2. Dosage and Administration

2.1 Adults and Pediatric Patients at Least 15 Years of Age The usual dose of oral KEFLEX is 250 mg every 6 hours, but a dose of 500 mg every 12 hours may be administered. Treatment is administered ...

3. Dosage Forms and Strengths

250 mg capsules: a white to light yellow powder filled into an opaque white and opaque dark green capsule that is imprinted with KEFLEX 250 mg in edible black ink on the white body. 500 mg capsule...

4. Contraindications

KEFLEX is contraindicated in patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs.

5. Warnings and Precautions

5.1 Hypersensitivity Reactions Allergic reactions in the form of rash, urticaria, angioedema, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, or toxic epidermal necrolysis have been rep...

6. Adverse Reactions

The following serious events are described in greater detail in the Warning and Precautions section: Hypersensitivity reactions [see Warning and Precautions (5.1)] Clostridium difficile -associate...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials o...

7. Drug Interactions

7.1 Metformin Administration of KEFLEX with metformin results in increased plasma metformin concentrations and decreased renal clearance of metformin. Careful patient monitoring and dose adjustment...

8.1. Pregnancy

Risk Summary Available data from published epidemiologic studies and pharmacovigilance case reports over several decades with cephalosporin use, including KEFLEX use in pregnant women have not esta...

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 <l% of the maternal weight adjust...

8.4. Pediatric Use

The safety and effectiveness of KEFLEX in pediatric patients was established in clinical trials for the dosages described in the dosage and administration section [see Dosage and Administration (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 sub...

8.6. Renal Impairment

KEFLEX 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 obs...

10. Overdosage

Symptoms of oral overdose may include nausea, vomiting, epigastric distress, diarrhea, and hematuria. In the event of an overdose, institute general supportive measures. Forced diuresis, peritoneal...

11. Description

KEFLEX (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 mon...

12.1. Mechanism of Action

Cephalexin is a cephalosporin antibacterial drug [see Microbiology (12.4)] .

12.3. Pharmacokinetics

Absorption Cephalexin is acid stable and may be given without regard to meals. Following doses of 250 mg, 500 mg, and 1 g, average peak serum levels of approximately 9, 18, and 32 mcg/mL, respectiv...

12.4. Microbiology

Mechanism of Action Cephalexin is a bactericidal agent that acts by the inhibition of bacterial cell-wall synthesis. Resistance Methicillin-resistant staphylococci and most isolates of enterococci ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Lifetime studies in animals have not been performed to evaluate the carcinogenic potential of cephalexin. Tests to determine the mutagenic potential of cephalexin have not been performed. In male a...

16.1. How Supplied

KEFLEX (cephalexin) Capsules, USP, is supplied as follows: 250 mg Capsules, bottles of 100 – NDC 58463-011-01 500 mg Capsules, bottles of 100 – NDC 58463-012-01 750 mg Capsules, bottles of 50 – NDC...

16.2. Storage and Handling

KEFLEX should be stored at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

17. Patient Counseling Information

Allergic Reactions Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. Ask the patient about any previ...