CEPHALEXIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Carlsbad Technology, Inc.

INN (International Name):

Cephalexin

Composition:

Cephalexin Anhydrous 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

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