CEPHALEXIN powder, for suspension

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Preferred Pharmaceuticals, Inc.

Designación común internacional (DCI):

CEPHALEXIN

Composición:

CEPHALEXIN ANHYDROUS 125 mg in 5 mL

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

Cephalexin Capsules USP (a cherry mixed fruit flavored formula)— 125mg/5ml 100mL - 68788-9538-1 200mL - 68788-9538-2 250 mg/5 mL: bottles of 100 mL and 200 mL. 100mL - 68788-9539-1 200mL - 68788-9539-2 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.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

CEPHALEXIN- CEPHALEXIN POWDER, FOR SUSPENSION
PREFERRED PHARMACEUTICALS, INC.
----------
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:
•
•
•
•
•
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)
•
•
•
•
•
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
•
•
•
•
ADVERSE REACTIONS
The most common adverse reactions associated with cephalexin include
diarrhea, nausea, vomiting,
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
infection type and severity. (2)
Dosage