CEPHALEXIN for suspension

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Lupin Pharmaceuticals, Inc.

INN (Διεθνής Όνομα):

CEPHALEXIN

Σύνθεση:

CEPHALEXIN ANHYDROUS 125 mg in 5 mL

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 pneumon

Περίληψη προϊόντος:

Cephalexin for Oral Suspension USP is a pink colored powder forming pink colored suspension on constitution. Cephalexin for Oral Suspension USP is available in: The 125 mg per 5 mL oral suspension* is available as follows: 100-mL Bottles                       NDC 68180-440-01 200-mL Bottles                       NDC 68180-440-02 The 250 mg per 5 mL oral suspension* is available as follows: 100-mL Bottles                       NDC 68180-441-01 200-mL Bottles                       NDC 68180-441-02 Directions for mixing are included on the label. Prior to mixing, 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 refrigerator. May be kept for 14 days without significant loss of potency.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

CEPHALEXIN - CEPHALEXIN FOR SUSPENSION
LUPIN PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
CEPHALEXIN FOR ORAL SUSPENSION, USP
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
INITIAL U.S. APPROVAL: 1971
INDICATIONS AND USAGE
Cephalexin 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 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)
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: 125 mg/5mL and 250 mg/5mL (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