CEPHALEXIN capsule CEPHALEXIN powder, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

CEPHALEXIN

Composition:

CEPHALEXIN ANHYDROUS 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes. 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. 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 . Cephalexin is indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis. 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 . To reduce the development of drug-resistant bacteria and maintain the effectiveness of cep

Product summary:

Cephalexin Capsules USP 250 mg: Swedish orange body and gray cap imprinted “TEVA” on the cap and “3145” on the body, in bottles of 100 (NDC 0093-3145-01) and 500 (NDC 0093-3145-05). 500 mg: Swedish orange body and Swedish orange cap imprinted “TEVA” on the cap and “3147” on the body, in bottles of 100 (NDC 0093-3147-01) and 500 (NDC 0093-3147-05). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Cephalexin for Oral Suspension* USP (a cherry mixed fruit flavored formula) 125 mg/5 mL: bottles of 100 mL (NDC 0093-4175-73) and 200 mL (NDC 0093-4175-74). 250 mg/5 mL: bottles of 100 mL (NDC 0093-4177-73) and 200 mL (NDC 0093-4177-74). Directions for mixing are included on the label. Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Shake well before using. Keep tightly closed. * After mixing, store in refrigerator. May be kept for 14 days without significant loss of potency.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEPHALEXIN- CEPHALEXIN CAPSULE
CEPHALEXIN- CEPHALEXIN POWDER, FOR SUSPENSION
TEVA PHARMACEUTICALS USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEPHALEXIN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CEPHALEXIN.
CEPHALEXIN CAPSULES, AND CEPHALEXIN FOR ORAL SUSPENSION, FOR ORAL USE
INITIAL U.S. APPROVAL: 1971
INDICATIONS AND USAGE
Cephalexin 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, and
cephalexin for oral suspension and other antibacterial drugs,
cephalexin capsules, and cephalexin for oral suspension
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: 250 mg and 500 mg (3)
For oral suspension: 125 mg/5 mL and 250 mg/5 mL
CONTRAINDICATIONS
Patients with known hypersensitivity to cephalexin or other members of
the cephalosporin class of antibacterial drugs. (4)
WARNINGS AND PRECAUTIONS
Ser