CEPHALEXIN capsule

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Denton Pharma, Inc. DBA Northwind Pharmaceuticals

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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

產品總結:

Cephalexin capsules USP, are supplied as follows: Bottles of 20 NDC 70934-082-20 Bottles of 30 NDC 70934-082-30 Dose Pack of 30 NDC 70934-082-94 Cephalexin capsules USP should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

授权状态:

Abbreviated New Drug Application

产品特点

CEPHALEXIN- CEPHALEXIN CAPSULE
DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEPHALEXIN CAPSULES
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CEPHALEXIN CAPSULES USP
CEPHALEXIN CAPSULES USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1971
INDICATIONS AND USAGE
Cephalexin capsules USP 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 USP and other antibacterial drugs, cephalexin capsules USP
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)
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