CEPHALEXIN USP- cephalexin suspension

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Jazeera Pharmaceutical

Designació comuna internacional (DCI):

CEPHALEXIN ANHYDROUS

Composición:

CEPHALEXIN ANHYDROUS 125 mg in 5 mL

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Cephalexin for Oral Suspension 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 for Oral Suspension USP is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of Cephalexin for Oral Suspension USP 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 mirabili

Resumen del producto:

Cephalexin For Oral Suspension USP, is available in: The 125 mg per 5 mL oral suspension is available as follows:        100-mL Bottles                    200-mL Bottles             The 250 mg per 5 mL oral suspension is available as follows:        100-mL Bottles                    200-mL Bottles             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); excursions permitted to 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature].

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

CEPHALEXIN USP- CEPHALEXIN SUSPENSION
JAZEERA PHARMACEUTICAL
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CEPHALEXIN FOR ORAL SUSPENSION USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Cephalexin for
Oral Suspension USP and other antibacterial drugs, Cephalexin for Oral
Suspension, USP 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 µcmol) or 250 mg (720 µcmol) of
cephalexin. The suspensions also contain
citric acid, guarana flavour, sodium saccharin, sucrose, xanthan gum.
The 125-mg suspension contains
FD&C Red No.40, and the 250-mg suspension contains FD&C Yellow No. 6.
CLINICAL PHARMACOLOGY
HUMAN PHARMACOLOGY:
Cephalexin for Oral Suspension USP is acid stable and may be given
without regard to meals. It is
rapidly absorbed after oral administration.