Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
CEPHALEXIN ANHYDROUS (UNII: 5SFF1W6677) (CEPHALEXIN ANHYDROUS - UNII:5SFF1W6677)
Jazeera Pharmaceutical
CEPHALEXIN ANHYDROUS
CEPHALEXIN ANHYDROUS 125 mg in 5 mL
ORAL
PRESCRIPTION DRUG
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
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].
Abbreviated New Drug Application
CEPHALEXIN USP- CEPHALEXIN SUSPENSION JAZEERA PHARMACEUTICAL ---------- 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. Pročitajte cijeli dokument