CEPHALEXIN capsule

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

Cephalexin (UNII: OBN7UDS42Y) (Cephalexin Anhydrous - UNII:5SFF1W6677)

可用日期:

Carlsbad Technology, Inc.

INN（国际名称）:

Cephalexin

组成:

Cephalexin Anhydrous 250 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Cephalexin Capsule, USP is 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 mirabilis Genitourinary tract infections, including acute prostatitis, caused by Escheric

產品總結:

Cephalexin Capsules, USP are available in: Cephalexin Capsule, USP 250 mg (deep green cap and white body hard gelatin capsule imprinted with “” on both capsule cap and capsule body) contains cephalexin monohydrate equivalent to 250 mg anhydrous cephalexin.       Bottle of 100 NDC 61442-161-01       Bottle of 500 NDC 61442-161-05 Cephalexin Capsule, USP 500 mg (green cap and pale green body hard gelatin capsule imprinted with “” on both capsule cap and capsule body) contains cephalexin monohydrate equivalent to 500 mg anhydrous cephalexin.       Bottle of 100 NDC 61442-162-01       Bottle of 500 NDC 61442-162-05 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

授权状态:

Abbreviated New Drug Application

产品特点

CEPHALEXIN- CEPHALEXIN CAPSULE
CARLSBAD TECHNOLOGY, INC.
----------
CEPHALEXIN CAPSULES, USP
RX ONLY
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 or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Cephalexin Capsule, USP is a semisynthetic cephalosporin antibiotic
intended for oral administration. It
is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic
acid monohydrate. Cephalexin
has the molecular formula C
H N O S•H O and the molecular weight is 365.41.
Cephalexin has the following structural formula:
The nucleus of cephalexin is related to that of other cephalosporin
antibiotics. The compound is a
zwitterion; i.e., the molecule contains both a basic and an acidic
group. The isoelectric point of
cephalexin in water is approximately 4.5 to 5.
The crystalline form of cephalexin which is available is a
monohydrate. It is a white crystalline solid
having a bitter taste. Solubility in water is low at room temperature;
1 or 2 mg/mL may be dissolved
readily, but higher concentrations are obtained with increasing
difficulty.
The cephalosporins differ from penicillins in the structure of the
bicyclic ring system.
Cephalexin has a _D_-phenylglycyl group as substituent at the 7-amino
position and an unsubstituted
methyl group at the 3-position.
Each 250-mg capsule contains cephalexin monohydrate equivalent to 250
mg of cephalexin and each
500-mg capsule contains cephalexin monohydrate equivalent to 500 mg of
cephalexin. The inactive
ingredients: magnesium stearate, sodium starch glycolate, lactose
monohydrate, talc, colloidal silicone
dioxide.
The capsule shells contain gelatin, titanium dioxide, FD&C Blue No. 1,
FD&C Yellow No. 5. The
imprinting ink components on 250 mg and 500 mg capsules: shellac,
dehydrated alcohol, isopropyl
alcohol, butyl alcohol, propylene glycol, purified water, strong
ammonia solution, potassiu