CEPHALEXIN capsule
País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
Ficha técnica
(SPC)
29-06-2022
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Ingredientes activos:
CEPHALEXIN (UNII: OBN7UDS42Y) (CEPHALEXIN ANHYDROUS - UNII:5SFF1W6677)
Disponible desde:
Ascend Laboratories, LLC
Designación común internacional (DCI):
CEPHALEXIN
Composición:
CEPHALEXIN ANHYDROUS 500 mg
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 cephalexin
Resumen del producto:
Cephalexin capsules, USP, are supplied as follows: The 250 mg capsules are a white to off white powder filled into size 2 capsules (dark green cap and dark green body) that are imprinted with “220” on the both cap and body in edible black ink. They are available as follows: Bottles of 20 NDC-67877-220-20 Bottles of 100 NDC-67877-220-01 Bottles of 500 NDC-67877-220-05 Bottles of 1000 NDC-67877-220-10 30 Capsules (3 x 10 Unit-Dose) NDC 67877-220-84 50 Capsules (5 x 10 Unit-Dose) NDC-67877-220-74 100 Capsules (10 x 10 Unit-Dose) NDC-67877-220-38 The 500 mg capsules are a white to off white powder filled into size 0 capsules (light green cap and light green body) that are imprinted with “219” on the both cap and body in edible black ink. They are available as follows: Bottles of 20 NDC-67877-219-20 Bottles of 100 NDC-67877-219-01 Bottles of 500 NDC-67877-219-05 Bottles of 1000 NDC-67877-219-10 30 Capsules (3 x 10 Unit-Dose) NDC 67877-219-84 50 Capsules (5 x 10 Unit-Dose) NDC-67877-219-74 100 Capsules (10 x 10 Unit-Dose) NDC-67877-219-38 The 333 mg capsules are a white to off white powder filled into size 1 capsules (light green cap and light green body) that are imprinted “CEP” on cap and “333” on body in edible black ink. They are available as follows: Bottles of 20 NDC-67877-254-20 Bottles of 100 NDC-67877-254-01 Bottle of 500 NDC-67877-254-05 Bottle of 1000 NDC-67877-254-10 100 Capsules (10 X 10 Unit-Dose) NDC-67877-254-38 The 750 mg capsules are a white to off white powder filled into size '00 Elongated' capsules (dark green cap and dark green body) that are imprinted “CEP” on cap and “750” on body in edible white ink. They are available as follows: Bottles of 20 NDC-67877-255-20 Bottles of 50 NDC-67877-255-23 Bottles of 100 NDC-67877-255-01 Bottle of 500 NDC-67877-255-05 Bottle of 1000 NDC-67877-255-10 Store at 20°C to 25°C (68°F to77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].
Estado de Autorización:
Abbreviated New Drug Application
Ficha técnica
CEPHALEXIN - CEPHALEXIN CAPSULE
ASCEND LABORATORIES, LLC
----------
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 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 and
other antibacterial drugs, Cephalexin 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 to14 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, 333 mg, 500 mg and 750 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 if signs or symptoms of
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