CEPHALEXIN capsule

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

MedVantx, Inc.

INN (Isem Internazzjonali):

CEPHALEXIN

Kompożizzjoni:

CEPHALEXIN ANHYDROUS 500 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Cephalexin capsules, USP is indicated for the treatment of the following infections when caused by susceptibile 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 estabilishing 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 Escher

Sommarju tal-prodott:

Cephalexin capsules, USP are available in: The 250 mg capsules are white opaque body imprinted with “KLX” in black ink and green opaque cap imprinted with “140” in black ink.  They are available as follows: Bottles of 100                           NDC 42043-140-01 Bottles of 500                           NDC 42043-140-05 The 500 mg capsules are light green opaque body imprinted with “KLX” in black ink and green opaque cap imprinted with “141” in black ink.  They are available as follows: Bottles of 100                           NDC 42043-141-01 Bottles of 500                           NDC 42043-141-05 Store at 25° C (77° F); excursions permitted to 15-30° C (59-86° F) [see USP Controlled Room Temperature].

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

CEPHALEXIN- CEPHALEXIN CAPSULE
MEDVANTX, INC.
----------
CEPHALEXIN CAPSULES, USP
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 capsules, 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 capsule contains cephalexin monohydrate equivalent to 250 mg or
500 mg of cephalexin. The
capsules also contain the following inactive ingredients:
Croscarmellose Sodium, D & C Yellow No.
10, F D & C Blue No.1, F D & C Yellow No. 6, Gelatin, Magnesium
Stearate, Microcrystalline
Cellulose, Titanium Dioxide. Ink constituents are: Black Iron Oxide,
Butyl Alcohol, Dehydrated
Alcohol, Isopropyl Alcohol, Potassium Hydroxide, Propylene Glycol,
Shellac and Strong Ammonia
Solution.
CLINICAL PHARMACOLOGY
HUMAN PHARMACOLOGY
Cephalexin is acid stable and may be given without regard to meals. It
is rapid