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:

TWi Pharmaceuticals, Inc.

INN (International Name):

CEPHALEXIN

Composition:

CEPHALEXIN ANHYDROUS 125 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Cephalexin for oral suspension, USP is a white to off-white powder with strawberry flavor. After reconstitution a pink colored suspension is formed with strawberry flavor and is available in: The 125 mg per 5 mL oral suspension is available as follows: 100-mL Bottles NDC 24979-154-14 200-mL Bottles NDC 24979-154-38 The 250 mg per 5 mL oral suspension is available as follows: 100-mL Bottles NDC 24979-155-14 200-mL Bottles NDC 24979-155-38 Directions 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
TWI PHARMACEUTICALS, INC.
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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 FOR ORAL SUSPENSION USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1971
INDICATIONS AND USAGE
Cephalexin for oral suspension, 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 for oral suspension,
USP and other antibacterial drugs, Cephalexin for oral suspension, 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)
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DOSAGE FORMS AND STRENGTHS
For oral suspension: 125 mg/5 mL and 250 mg/5 mL (3)
CONTRAINDICATIONS
Patients with known hypersensitivity to cephalexin or other members of
the cephalosporin class of antibacterial drugs. (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions associated with cephalexin include
diarrhea, nausea, vomiting, dyspepsia and
abdominal pain. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TWI PHARMACEUTICALS,
INC. AT 1-844-518-2989 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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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