CEPHALEXIN- 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:

1.1 Respiratory Tract Infections Cephalexin capsules 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 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 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 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 are indicated for the treatment of genitourinary tract infections, includi

Product summary:

Cephalexin capsules USP, are supplied as follows: 250 mg Capsules Bottles of 100 NDC 42043-140-01 Bottles of 500 NDC 42043-140-05 500 mg Capsules Bottles of 100 NDC 42043-141-01 Bottles of 500 NDC 42043-141-05 Cephalexin capsules 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 for Northwind Pharmaceuticals, LLC Indianapolis, IN 46256 Please review the manufacturer's complete drug information available from the FDA at www.fda.gov Permanent Link: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=80f6f146-a91c-4452-bc83-2e47c5671d91

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEPHALEXIN- CEPHALEXIN CAPSULE
REMEDYREPACK INC.
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CEPHALEXIN 500MG
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
CEPHALEXIN CAPSULES safely
and effectively. See full prescribing information for CEPHALEXIN
CAPSULES
CEPHALEXIN capsules, for oral use
Initial U.S. Approval: 1971
INDICATIONS AND USAGE
Cephalexin capsules are a cephalosporin antibacterial drug indicated
for the treatment of the following
infections caused by susceptible isolates of designated bacteria: (1)
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 other antibacterial drugs, cephalexin capsules should be
used only to treat infections that
are proven or strongly suspected to be caused by bacteria. (1.6) (1)
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)
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. Discontinue the
drug