CEPHALEXIN powder, for suspension

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

MedVantx, Inc.

INN (Alþjóðlegt nafn):

CEPHALEXIN

Samsetning:

CEPHALEXIN ANHYDROUS 250 mg in 5 mL

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Cephalexin 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 Escherichia coli, Pr

Vörulýsing:

Cephalexin capsules USP— 250 mg: Swedish orange body and gray cap imprinted “TEVA” on the cap and “3145” on the body, in bottles of 100, 500, and unit-dose boxes of 100 (10 x 10). 500 mg: Swedish orange body and Swedish orange cap imprinted “TEVA” on the cap and “3147” on the body, in bottles of 100, 500, and unit-dose boxes of 100 (10 x 10). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Cephalexin for oral suspension* USP (a cherry mixed fruit flavored formula)— 125 mg/5 mL: bottles of 100 mL and 200 mL. 250 mg/5 mL: bottles of 100 mL and 200 mL. Directions for mixing are included on the label. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Shake well before using. Keep tightly closed. * After mixing, store in refrigerator. May be kept for 14 days without significant loss of potency. Cephalexin tablets USP— 250 mg: bottles of 100. Tablet identification number and color: white, capsule-shaped tablet, debossed “2238” on one side with a score between the “2” and the “3” and “TEVA” on the reverse side. 500 mg: bottles of 100. Tablet identification number and color: white, capsule-shaped tablet, debossed “2240” on one side with a score between the “2” and the “4” and “TEVA” on the reverse side. Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

CEPHALEXIN- CEPHALEXIN POWDER, FOR SUSPENSION
MEDVANTX, INC.
----------
CEPHALEXIN CAPSULES USP, 250 MG AND 500 MG / CEPHALEXIN FOR ORAL
SUSPENSION USP, 125 MG/5 ML AND 250 MG/5 ML / CEPHALEXIN TABLETS USP,
250 MG
AND 500 MG
3145
3147
4175
4177
2238
2240
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cephalexin
capsules, cephalexin for oral suspension, cephalexin tablets, and
other antibacterial drugs, cephalexin
capsules, cephalexin for oral suspension, and cephalexin tablets
should be used only to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Cephalexin, 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 following structural formula:
C
H N O S•H O M.W. 365.41
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 (720
μmol) or 500 mg (1,439
μmol) of cephalexin.
INACTIVE INGREDIENTS: CAPSULES: magnesium stearate, silicon dioxide,
and sodium starch glycolate.
_Capsule Shell and Print Constituents: _black iron oxide, D&C Yellow
#10 Aluminum Lake, FD&C Blue
#1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum