Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
MINOCYCLINE HYDROCHLORIDE (UNII: 0020414E5U) (MINOCYCLINE - UNII:FYY3R43WGO)
Cardinal Health
MINOCYCLINE HYDROCHLORIDE
MINOCYCLINE 50 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
MINOCYCLINE HYDROCHLORIDE- MINOCYCLINE HYDROCHLORIDE CAPSULE CARDINAL HEALTH ---------- MINOCYCLINE HYDROCHLORIDE CAPSULES, USP 3165 7300 3167 RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules and other antibacterial drugs, minocycline hydrochloride capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Minocycline hydrochloride, is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)- 1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is: C H N O •HCl M.W. 493.94 Minocycline hydrochloride capsules, USP for oral administration contain minocycline hydrochloride equivalent to 50 mg, 75 mg, or 100 mg of minocycline. INACTIVE INGREDIENTS _Drug Product:_ corn starch and magnesium stearate. _Capsule Shell:_ gelatin and titanium dioxide. In addition, the 100 mg capsule shells contain, D&C Red #28, FD&C Blue #1, FD&C Red #40, and red iron oxide; the 75 mg capsule shells contain black iron oxide; and the 50 mg capsule shells contain D&C Red #33, FD&C Red #3, and FD&C Yellow #6. _Printing Ink: _black iron oxide and shellac. In addition, the 50 mg and 100 mg ink contains D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, propylene glycol, and strong ammonia solution and the 75 mg ink contains antifoam DC 1510, industrial methylated spirit 74 OP BP, and soya lecithin. CLINICAL PHARMACOLOGY Following a single dose of two minocycline hydrochloride capsules, 100 mg administered to 18 normal fasting adult volunteers, maximum serum concentrations were attained in 1 to 4 hours (average 2.1 hours) and ranged from 2.1 to 5.1 mcg/mL (average 3.5 mcg/mL). The serum half-life in the normal volunteers ranged from 11.1 to 22.1 hours (average 15.5 hours). When minocycline hydrochloride capsules were given concomitantly with a high-fat meal, which included dairy products, the e Đọc toàn bộ tài liệu