CEPHALEXIN suspension

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

Cephalexin (UNII: OBN7UDS42Y) (Cephalexin - UNII:OBN7UDS42Y)

متاح من:

Carlsbad Technology, Inc.

INN (الاسم الدولي):

Cephalexin

تركيب:

Cephalexin 125 mg in 5 mL

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Cephalexin for oral suspension 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

ملخص المنتج:

Cephalexin For Oral Suspension, USP, is a white to off-white powder with strawberry flavor. After reconstitution a pink colored suspension is formed with strawberry flavor and is available in: The 125 mg per 5 mL oral suspension is available as follows: The 250 mg per 5 mL oral suspension is available as follows: After mixing, store in a refrigerator. May be kept for 14 days without significant loss of potency. Shake well before using. Keep tightly closed. Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature].

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

CEPHALEXIN- CEPHALEXIN SUSPENSION
CARLSBAD TECHNOLOGY, INC.
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CEPHALEXIN FOR ORAL SUSPENSION USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cephalexin and
other antibacterial drugs, cephalexin for oral suspension 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 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.
After mixing, each 5 mL of cephalexin for oral suspension, USP, will
contain cephalexin monohydrate
equivalent to 125 mg (360 μmol) or 250 mg (720 μmol) of cephalexin.
The suspensions also contain the
following inactive ingredients: strawberry powder, methylcellulose,
sodium lauryl sulfate, sucrose and
FD&C Red No. 40.
Cephalexin for oral suspension, USP is a white to off-white powder
with strawberry flavor. After
reconstitution a pink colored suspension is formed with strawberry
flavor.
CLINICAL PHARMACOLOGY
HUMAN PHARMACOLOGY
Cephalexin is acid stable and may be given without