CEPHALEXIN capsule CEPHALEXIN powder, for suspension

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

RPK Pharmaceuticals, Inc.

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

Product: 53002-2181 NDC: 53002-2181-1 500 CAPSULE in a BOTTLE NDC: 53002-2181-2 500 CAPSULE in a BOTTLE NDC: 53002-2181-3 500 CAPSULE in a BOTTLE NDC: 53002-2181-4 500 CAPSULE in a BOTTLE NDC: 53002-2181-5 500 CAPSULE in a BOTTLE NDC: 53002-2181-6 500 CAPSULE in a BOTTLE NDC: 53002-2181-9 500 CAPSULE in a BOTTLE Product: 53002-2540 NDC: 53002-2540-1 100 mL in a BOTTLE NDC: 53002-2540-2 200 mL in a BOTTLE

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

CEPHALEXIN- CEPHALEXIN CAPSULE
CEPHALEXIN- CEPHALEXIN POWDER, FOR SUSPENSION
RPK PHARMACEUTICALS, 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
Serious