CEPHALEXIN suspension

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Hikma Pharmaceuticals USA Inc.

INN (mednarodno ime):

CEPHALEXIN

Sestava:

CEPHALEXIN 125 mg in 5 mL

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Cephalexin for Oral Suspension is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes . Cephalexin for Oral Suspension 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 for Oral Suspension 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 for Oral Suspension is indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis . Cephalexin for Oral Suspension is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli , Proteus mirabilis , and Klebsiella

Povzetek izdelek:

Cephalexin for oral suspension, USP, is supplied as follows: The 125 mg per 5 mL oral suspension is available as follows: • 100-mL Bottles NDC 0143-9769-01 • 200-mL Bottles NDC 0143-9769-24 The 250 mg per 5 mL oral suspension is available as follows: • 100-mL Bottles NDC 0143-9770-01 • 200-mL Bottles NDC 0143-9770-24 Directions for mixing are included on the label. 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]. Shake well before using. Keep tightly closed. *After mixing, store in refrigerator. May be kept for 14 days without significant loss of potency.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

CEPHALEXIN- CEPHALEXIN SUSPENSION
HIKMA PHARMACEUTICALS USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEPHALEXIN FOR ORAL SUSPENSION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CEPHALEXIN FOR ORAL
SUSPENSION.
CEPHALEXIN FOR ORAL SUSPENSION, USP
DYE FREE
INITIAL U.S. APPROVAL: 1971
INDICATIONS AND USAGE
Cephalexin for Oral Suspension is a cephalosporin antibacterial drug
indicated for the treatment of the following infections
caused by susceptible isolates of designated bacteria: (1)
• Respiratory tract infection (1.1) (1)
• Otitis media (1.2) (1)
• Skin and skin structure infections (1.3) (1)
• Bone infections (1.4) (1)
• Genitourinary tract infections (1.5) (1)
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) (1)
DOSAGE AND ADMINISTRATION
Adults and patients at least 15 years of age (2)
The usual dose is 250 mg every 6 hours, but a dose of 500 mg every 12
hours may be administered (2.1). (2)
Pediatric patients (over 1 year of age) (2)
• Otitis media: 75 to 100 mg/kg in equally divided doses every 6
hours (2.2)
(2)
• All other indications: 25 to 50 mg/kg given in equally divided
doses (2.2)
(2)
• In severe infections: 50 to 100 mg/kg may be administered in
equally
divided doses (2.2) (2)
• Duration of therapy ranges from 7 to 14 days depending on the
infection type and severity. (2) (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) (2)
DOSAGE FORMS AND STRENGTHS
For oral suspension: 125mg/5mL and 250mg/5mL (3) (3)
CONTRAINDICATIONS
Patients with known hypersensitivity to cephalexin or other members of
the cephalosporin class of antibacterial drugs. (4)
(4)
WARNINGS AND PRECAUTIONS
_• _Serious hypersensi