Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
METRONIDAZOLE (UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E)
NuCare Pharmaceuticals, Inc.
METRONIDAZOLE
METRONIDAZOLE 500 mg
ORAL
PRESCRIPTION DRUG
Symptomatic Trichomoniasis. Metronidazole tablets USP are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets USP are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat a
Metronidazole Tablets, USP: 500 mg - White to off white, oblong shaped, biconvex, uncoated tablet, debossed with “HP65” on one side and plain on other side. NDC Number Size 66267-148-04 Bottle of 4 66267-148-14 Bottle of 14 66267-148-21 Bottle of 21 66267-148-28 Bottle of 28 66267-148-30 Bottle of 30 66267-148-40 Bottle of 40 Storage and Stability: Store at 20°-25°C (68°-77°F) [see USP controlled room temperature]. Preserve in well closed light resistant container. Call your doctor for medical advice about side effects. You may report side effects to Heritage Pharmaceuticals Inc. at 1.866.901.DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Abbreviated New Drug Application
METRONIDAZOLE- METRONIDAZOLE TABLET NUCARE PHARMACEUTICALS, INC. ---------- METRONIDAZOLE - METRONIDAZOLE TABLET Metronidazole Tablets USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets USP and other antibacterial drugs, metronidazole tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. WARNING Metronidazole has been shown to be carcinogenic in mice and rats (see PRECAUTIONS). Unnecessary use of the drug should be avoided. Its use should be reserved for the conditions described in the INDICATIONS AND USAGE section below. DESCRIPTION Metronidazole tablets USP, 250 mg or 500 mg is an oral formulation of the synthetic nitroimidazole antimicrobial, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula: Metronidazole tablets USP, contain 250 mg or 500 mg of metronidazole. Inactive ingredients include hydroxypropyl cellulose, crospovidone, microcrystalline cellulose, colloidal silicon dioxide and hydrogenated vegetable oil. CLINICAL PHARMACOLOGY ABS ORPTION Disposition of metronidazole in the body is similar for both oral and intravenous dosage forms. Following oral administration, metronidazole is well absorbed, with peak plasma concentrations occurring between one and two hours after administration. Plasma concentrations of metronidazole are proportional to the administered dose. Oral administration of 250 mg, 500 mg, or 2,000 mg produced peak plasma concentrations of 6 mcg/mL, 12 mcg/mL, and 40 mcg/mL, respectively. Studies reveal no significant bioavailability differences between males and females; however, because of weight differences, the resulting plasma levels in males are generally lower. DIS TRIBUTION Metronidazole is the major component appearing in the plasma, with lesser quantities of metabolites also being present. Less than 20% of the circulating metronidazole is bound to plasma proteins. Metronidazole appears in cerebrospinal fluid, saliva Les hele dokumentet