CEPHALEXIN capsule

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Preferred Pharmaceuticals, Inc.

INN (International namn):

CEPHALEXIN

Sammansättning:

CEPHALEXIN ANHYDROUS 500 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Cephalexin capsules are indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes. 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. 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 . Cephalexin capsules are indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis. Cephalexin capsules are 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-resist

Produktsammanfattning:

Cephalexin capsules, USP are available in: 500 mg Capsule Dark green opaque/light green opaque size “0” hard gelatin capsule filled with off white granular powder and imprinted with “A 43” on dark green opaque cap and “500 mg” on light green opaque body with black ink Bottle of 6 – 68788-9404-5 Bottle of 12 – 68788-9404-1 Bottle of 20 – 68788-9404-2 Bottle of 21 – 68788-9404-7 Bottle of 28 – 68788-9404-8 Bottle of 30 – 68788-9404-3 Bottle of 40 – 68788-9404-4 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].  Dispense in a tight, light-resistant container.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

CEPHALEXIN- CEPHALEXIN CAPSULE
PREFERRED PHARMACEUTICALS, INC.
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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:
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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)
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)
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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
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ADVERSE REACTIONS
The most common adverse reactions associated with cephalexin include
diarrhea, nausea, vomiting, dyspepsia and
abdominal pain. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AUROBINDO PHARMA USA,
INC. AT 1-866-850-2876 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH .
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)
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
infecti