CEPHALEXIN capsule

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Blenheim Pharmacal, Inc.

Designació comuna internacional (DCI):

CEPHALEXIN

Composición:

CEPHALEXIN ANHYDROUS 500 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Cephalexin capsules are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Respiratory tract infections caused by Streptococcus pneumoniae and Streptococcus pyogenes (Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.) Otitis media due to Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pyogenes, and Moraxella catarrhalis Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus pyogenes Bone infections caused by Staphylococcus aureus and/or Proteus mir

Resumen del producto:

Cephalexin capsules, USP are available in: The 500 mg capsules are a white to off white powder filled into size 0 capsules (white opaque cap and white opaque body) that are imprinted with 802 on the cap in black. They are available as follows: Bottles of 10 NDC 10544-868-10 Bottles of 14 NDC 10544-868-14 Bottles of 20 NDC 10544-868-20 Bottles of 21 NDC 10544-868-21 Bottles of 28 NDC 10544-868-28 Bottles of 30 NDC 10544-868-30 Bottles of 40 NDC 10544-868-40 Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. REFERENCES Literature revised May 2011 Manufactured by:  Manufacturer for:  Marketed/ Packaged by: Belcher Pharmaceuticals, LLC. Virtus Pharmaceuticals, LLC Blenheim Pharmacal, Inc. Largo, Florida 33773 Tampa, FL 33619 North Blenheim, NY 12131 May 2011 L02I-AA R-1105    

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

CEPHALEXIN- CEPHALEXIN CAPSULE
BLENHEIM PHARMACAL, INC.
----------
CEPHALEXIN CAPSULES, USP
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 or
prevent infections that are proven
or strongly suspected to be caused by bacteria.
CLINICAL PHARMACOLOGY
HUMAN PHARMACOLOGY
Cephalexin is acid stable and may be given without regard to meals. It
is rapidly absorbed after oral
administration. Following doses of 250 mg, 500 mg, and 1 g, average
peak serum levels of
approximately 9, 18, and 32 µg/mL respectively were obtained at 1
hour. Measurable levels were
present 6 hours after administration. Cephalexin is excreted in the
urine by glomerular filtration and
tubular secretion. Studies showed that over 90% of the drug was
excreted unchanged in the urine within
8 hours. During this period, peak urine concentrations following the
250 mg, 500 mg, and 1g doses
were approximately 1000, 2200, and 5000 µg/mL respectively.
MICROBIOLOGY
_In vitro_ tests demonstrate that the cephalosporins are bactericidal
because of their inhibition of cell-wall
synthesis. Cephalexin has been shown to be active against most strains
of the following microorganisms
both _in vitro_ and in clinical infections as described in the
INDICATIONS AND USAGE section.
Aerobes, Gram-positive:
_ Staphylococcus aureus _(including penicillinase-producing strains)
_ Streptococcus pneumoniae_ (penicillin-susceptible strains)
_ Streptococcus pyogenes_
Aerobes, Gram-negative:
_ Escherichia coli_
_ Haemophilus influenzae_
_ Klebsiella pneumoniae_
_ Moraxella (Branhamella) catarrhalis_
_ Proteus mirabilis_
_Note:_ Methicillin-resistant staphylococci and most strains of
enterococci ( _Enterococcus faecalis_
[formerly _Streptococcus faecalis_]) are resistant to cephalosporins,
including cephalexin. It is not active
against most strains of _Enterobacter_ spp., _Morganella morganii_,
and _Proteus vulgaris_. It has no activity
against _Pseudomonas_ spp. or