CEPHALEXIN- cephalexin capsule
Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
Valmisteyhteenveto
(SPC)
14-02-2019
Lähetä pyyntö.
Aktiivinen ainesosa:
CEPHALEXIN (UNII: OBN7UDS42Y) (CEPHALEXIN ANHYDROUS - UNII:5SFF1W6677)
Saatavilla:
REMEDYREPACK INC.
Antoreitti:
ORAL
Prescription tyyppi:
PRESCRIPTION DRUG
Käyttöaiheet:
Cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcuspyogenes. Cephalexin is indicated for the treatment of otitis media caused by susceptible isolates of Streptococcuspneumoniae, Haemophilus infl uenz ae, Staphylococcus aureus, Streptococcuspyogenes, and Mo raxella 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 treat ment of bone infections caused by susceptible isolates of Staphylococcusaureus and Proteus mi rabilis. Cephalexin is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escheric hia c oli, Proteus mirabilis, and Klebsiella pneumonia e. To reduce the development of drug-resistant bacteria and maintain the effectiveness of c
Tuoteyhteenveto:
Cephalexin capsules, USP, are supplied as follows: The 250 mg capsules are a white to off white powder filled into size 2 capsules (dark green cap and dark green body) that are imprinted with “220” on the both cap and body in edible black ink. They are available as follows: Bottles of 20 NDC-67877-220-20 Bottles of 100 NDC-67877-220-01 Bottles of 500 NDC-67877-220-05 Bottles of 1000 NDC-67877-220-10 30 Capsules (3 x 10 Unit-Dose) NDC67877-220-84 50 Capsules (5 x 10 Unit-Dose) NDC-67877-220-74 100 Capsules (10 x 10 Unit-Dose) NDC-67877-220-38 The 500 mg capsules are a white to off white powder filled into size 0 capsules (light green cap and light green body) that are imprinted with “219” on the both cap and body in edible black ink. They are available as follows: Bottles of 20 NDC-67877-219-20 Bottles of 100 NDC-67877-219-01 Bottles of 500 NDC-67877-219-05 Bottles of 1000 NDC-67877-219-10 30 Capsules (3 x 10 Unit-Dose) NDC67877-219-84 50 Capsules (5 x 10 Unit-Dose) NDC-67877-219-74 100 Capsules (10 x 10 Unit-Dose) NDC-67877-219-38 The 333 mg capsules are a white to off white powder filled into size 1 capsules (light green cap and light green body) that are imprinted “CEP” on cap and “333” on body in edible black ink. They are available as follows: Bottles of 20 NDC-67877-254-20 Bottles of 100 NDC-67877-254-01 Bottle of 500 NDC-67877-254-05 Bottle of 1000 NDC-67877-254-10 100 Capsules (10 X 10 Unit-Dose) NDC-67877-254-38 The 750 mg capsules are a white to off white powder filled into size '00 Elongated' capsules (dark green cap and dark green body) that are imprinted “CEP” on cap and “750” on body in edible white ink. They are available as follows: Bottles of 20 NDC-67877-255-20 Bottles of 50 NDC-67877-255-23 Bottles of 100 NDC-67877-255-01 Bottle of 500 NDC-67877-255-05 Bottle of 1000 NDC-67877-255-10 Store at 20°C to 25°C (68°F to77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].
Valtuutuksen tilan:
Abbreviated New Drug Application
Valmisteyhteenveto
CEPHALEXIN- CEPHALEXIN CAPSULE
REMEDYREPACK INC.
----------
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 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 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
T he usual dose is 250 mg every 6 hours, but a dose of 5 00 mg every
12 hours may be
administered ( 2. 1)
Pediatric patients (over 1 year of
age)
Otitis media: 75 to 100 m g/kg in equally divided d oses every 6 hours
( 2. 2 )
age)
All other indicati ons: 25 to 50 m g/kg given in equally divided d
oses ( 2. 2)
In severe infections: 50 to 100 m g/kg m ay be a d ministered in e
qually divided
doses ( 2. 2)
Duration of therapy ranges from 7 to14 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
Capsules: 250 m g, 333mg, 500 mg and 750 mg ( 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 hypersensitivity to beta-
lactam antibacterial drugs. Discontinue
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