Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
CEPHALEXIN (UNII: OBN7UDS42Y) (CEPHALEXIN ANHYDROUS - UNII:5SFF1W6677)
Aidarex Pharmaceuticals LLC
CEPHALEXIN
CEPHALEXIN ANHYDROUS 250 mg in 5 mL
ORAL
PRESCRIPTION DRUG
Cephalexin is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: Respiratory tract infections caused by S. pneumoniae and S. 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 S. pneumoniae, H. influenzae , staphylococci, streptococci, and M. catarrhalis . Skin and skin structure infections caused by staphylococci and/or streptococci. Bone infections caused by staphylococci and/or P. mirabilis . Genitourinary tract infections, including acute prostatitis, caused by E. coli, P. mirabilis, and K. pneumoniae. Note – Culture and susceptibility tests should be initiated prior to and
Cephalexin for Oral Suspension, USP, is available in: The 250 mg per 5 mL oral suspension* is available as follows: 100-mL Bottles NDC 33261-485-01 ———————————————————————————————————— * After mixing, store in a refrigerator. May be kept for 14 days without significant loss of potency. Shake well before using. Keep tightly closed. Prior to mixing, store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
CEPHALEXIN- CEPHALEXIN FOR SUSPENSION AIDAREX PHARMACEUTICALS LLC ---------- CEPHALEXIN FOR ORAL SUSPENSION USP RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin for oral suspension 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. Cephalexin for Oral Suspension, USP, is a pink colored powder forming pink colored suspension on constitution. After mixing, each 5 mL of cephalexin for oral suspension, will contain cephalexin USP equivalent to 125 mg (360 µmol) or 250 mg (720 µmol) of anhydrous cephalexin. The suspension also contains the following inactive ingredients: colloidal silicon dioxide, FD&C Red No. 40, sodium benzoate, strawberry flavor, sucrose, xanthan gum. CLINICAL PHARMACOLOGY _Human Pharmacology _– Cephalexin is acid stable and may be given without regard t Διαβάστε το πλήρες έγγραφο