Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
CEPHALEXIN (UNII: OBN7UDS42Y) (CEPHALEXIN ANHYDROUS - UNII:5SFF1W6677)
Rebel Distributors Corp
CEPHALEXIN
CEPHALEXIN ANHYDROUS 500 mg
ORAL
PRESCRIPTION DRUG
Cephalexin capsules, USP are 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 capsules, USP are generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin capsules, USP in the subsequent prevention of rheumatic fever are not available at present.) Otitis media due to Streptococcus pneumoniae , Haemophilus influenzae , Staphylococcus aureus, treptococcus pyogenes , and Moraxella catarrhalis Skin and skin structure infections caused by Staphylococcus aureus and/or Streptococcus yogenes Bone infections caused by Staphylococcus aureus and/or Proteus mirabilis Genitourinary tract infections, including acute
Cephalexin capsules, USP, are available in: The 500 mg cephalexin capsules, USP are a white to off white powder filled into size 0 capsules (opaque dark green cap and opaque light green body) that are imprinted with “294” in edible black ink on cap and body. They are available as follows: Bottle of 6’s......................NDC 42254-080-06 Bottle of 12’s....................NDC 42254-080-12 Bottle of 14’s....................NDC 42254-080-14 Bottle of 20’s....................NDC 42254-080-20 Bottle of 21’s....................NDC 42254-080-21 Bottle of 28’s....………... NDC 42254-080-28 Bottle of 30’s....................NDC 42254-080-30 Bottle of 40's.....................NDC 42254-080-40 Store at 25°C (77°F); excursions permitted to 15‑30°C (59‑86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.
Abbreviated New Drug Application
CEPHALEXIN- CEPHALEXIN CAPSULE REBEL DISTRIBUTORS CORP ---------- CEPHALEXIN CAPSULES, USP TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE EFFECTIVENESS OF CEPHALEXIN CAPSULES, USP AND OTHER ANTIBACTERIAL DRUGS, CEPHALEXIN CAPSULE, USP SHOULD BE USED ONLY TO TREAT OR PREVENT INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE CAUSED BY BACTERIA. DESCRIPTION Cephalexin Capsules, USP is a semisynthetic cephalosporin antibiotic intended for oral administration. It is 7-(D-a-Amino-a-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, USP 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. Each capsule contains cephalexin monohydrate equivalent to 250 mg (720 µmol) or 500 mg (1439 µmol) of cephalexin. The capsules also contain the following inactive ingredients magnesium stearate, capsule shell contains D & C Yellow No. 10, FD & C Yellow No. 6, FD & C green 3, sodium lauryl sulfate, gelatin, titanium dioxide. In addition, the 500 mg capsule also contains FD & C Blue No. 1. Imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, purified water. CLIN Perskaitykite visą dokumentą