CEPHALEXIN capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

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Produktets egenskaber Produktets egenskaber (SPC)
14-08-2019

Aktiv bestanddel:

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

Tilgængelig fra:

Direct_Rx

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

1.1 Respiratory Tract Infections Cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes. 1.2 Otitis Media 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. 1.3 Skin and Skin Structure Infections 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. 1.4 Bone Infections Cephalexin is indicated for the treatment of bone infections caused by susceptible isolates of Staphylococcus aureus and Proteus mirabilis. 1.5 Genitourinary Tract Infections Cephalexin is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherich

Produkt oversigt:

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 Bottles of 100 Bottles of 500 Bottles of 1000 30 Capsules (3 x 10 Unit-Dose) 50 Capsules (5 x 10 Unit-Dose) 100 Capsules (10 x 10 Unit-Dose) 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 Bottles of 100 Bottles of 500 Bottles of 1000 30 Capsules (3 x 10 Unit-Dose) 50 Capsules (5 x 10 Unit-Dose) 100 Capsules (10 x 10 Unit-Dose) 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 Bottles of 100 Bottle of 500 Bottle of 1000 100 Capsules (10 X 10 Unit-Dose) 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 Bottles of 50 Bottles of 100 Bottle of 500 Bottle of 1000 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].

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

                                CEPHALEXIN- CEPHALEXIN CAPSULE
DIRECT_RX
----------
CEPHALEXIN
1.1 Respiratory Tract Infections
Cephalexin is indicated for the treatment of respiratory tract
infections caused by susceptible isolates
of Streptococcus pneumoniae and Streptococcus pyogenes.
1.2 Otitis Media
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.
1.3 Skin and Skin Structure Infections
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.
1.4 Bone Infections
Cephalexin is indicated for the treatment of bone infections caused by
susceptible isolates of
Staphylococcus aureus and Proteus mirabilis.
1.5 Genitourinary Tract Infections
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.
1.6 Usage
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 susceptible bacteria. When culture and
susceptibility information is available,
this information should be considered in selecting or modifying
antibacterial therapy. In the absence of
such data, local epidemiology and susceptibility patterns may
contribute to the empiric selection of
therapy.
2.1 Adults and Pediatric Patients at Least 15 Years of Age
The usual dose of oral Cephalexin capsule, USP is 250 mg every 6
hours, but a dose of 500 mg every
12 hours may be administered. Treatment is administered for 7 to 14
days.
For more severe infections larger doses of oral Cephalexin capsules,
USP may be needed, up to 4
grams daily in two to four equally divided doses.
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