CEPHALEXIN- cephalexin capsule

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Preferred Pharmaceuticals, Inc.

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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

Rezumat produs:

Cephalexin capsules USP, are supplied as follows: The 250 mg capsules are white opaque body imprinted with “KLX” in black ink and green opaque cap imprinted with “140” in black ink. They are available as follows: Bottle of 20 – 68788-9951-2 Bottle of 21 – 68788-9951-7 Bottle of 28 – 68788-9951-8 Bottle of 30 – 68788-9951-3 Bottle of 40 – 68788-9951-4 Bottle of 60 – 68788-9951-6 The 500 mg capsules are light green opaque body imprinted with “KLX” in black ink and green opaque cap imprinted with “141” in black ink. They are available as follows: Bottle of 12 – 68788-9950-1 Bottle of 20 – 68788-9950-2 Bottle of 21 – 68788-9950-7 Bottle of 28 – 68788-9950-8 Bottle of 30 – 68788-9950-3 Bottle of 40 – 68788-9950-4 Bottle of 60 – 68788-9950-6 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

CEPHALEXIN- CEPHALEXIN CAPSULE
PREFERRED PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEPHALEXIN CAPSULES SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CEPHALEXIN CAPSULES
CEPHALEXIN CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1971
INDICATIONS AND USAGE
Cephalexin capsules are a cephalosporin antibacterial drug indicated
for the treatment of the following infections caused by
susceptible isolates of designated bacteria: (1)
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To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cephalexin capsules and other
antibacterial drugs, cephalexin capsules 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)
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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
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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 PROPHARMA AT
866-562-4590 OR FDA AT 1-800-FDA-
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)
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)
Dos