CEPHALEXIN powder, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

OrchidPharma Inc

INN (International Name):

CEPHALEXIN

Composition:

CEPHALEXIN ANHYDROUS 125 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 p

Product summary:

Cephalexin for Oral Suspension, USP, is supplied as follows: The 125 mg/5 mL oral suspension is available as follows 100 - mL Bottles NDC 42043-142-38 200 - mL Bottles NDC 42043-142-58 The 250 mg/5 mL oral suspension is available as follows 100 - mL Bottles NDC 42043-143-38 200 - mL Bottles NDC 42043-143-58 Direction for mixing are included on the label. Store 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 a refrigerator. May be kept for 14 days without significant loss of potency.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEPHALEXIN- CEPHALEXIN POWDER, FOR SUSPENSION
ORCHIDPHARMA INC
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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
SUSPENSIONCEPHALEXIN FOR ORAL
SUSPENSION 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)
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 for Oral Suspension
and other antibacterial drugs, Cephalexin for Oral Suspension 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
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
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 hypersensitivity (anaphylactic) reactions: Prior to use,
inquire regarding history of