البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
MINOCYCLINE HYDROCHLORIDE (UNII: 0020414E5U) (MINOCYCLINE - UNII:FYY3R43WGO)
Par Pharmaceutical, Inc.
MINOCYCLINE HYDROCHLORIDE
MINOCYCLINE 50 mg
ORAL
PRESCRIPTION DRUG
Minocycline hydrochloride tablets are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: Minocycline is indicated for treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: Minocycline hydrochloride tablets are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections: In acute intestinal amebiasis , minocycline may be a useful adjunct to amebicides. In severe acne , minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate the meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the tre
Minocycline hydrochloride tablets are supplied as aqueous film coated tablets containing minocycline hydrochloride equivalent to 50 mg, 75 mg and 100 mg minocycline. The 50 mg tablets are white, unscored, modified capsule shaped, coated tablet debossed with “Par” on one side and “511” on the other. Each tablet contains minocycline hydrochloride equivalent to 50 mg minocycline, supplied as follows: NDC49884-096-01 Bottle of 100 The 75 mg tablets are white, unscored, modified capsule shaped, coated tablet debossed with “Par” on one side and “512” on the other. Each tablet contains minocycline hydrochloride equivalent to 75 mg minocycline, supplied as follows: NDC49884-097-01 Bottle of 100 The 100 mg tablets are white, unscored, modified capsule shaped, coated tablet debossed with “Par” on one side and “513” on the other. Each tablet contains minocycline hydrochloride equivalent to 100 mg minocycline, supplied as follows: NDC49884-098-03 Bottle of 50 Store at 20 to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature] Protect from light, moisture, and excessive heat. Dispense in a tight, light-¬resistant container as defined in the USP. Text Here
Abbreviated New Drug Application
DYNACIN- MINOCYCLINE HYDROCHLORIDE TABLET PAR PHARMACEUTICAL, INC. ---------- To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride tablets and other antibacterial drugs, minocycline hydrochloride tablets 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 tablets for oral administration contain minocycline HCl equivalent to 50 mg, 75 mg or 100 mg of minocycline. In addition, 50 mg, 75 mg and 100 mg tablets contain the following inactive ingredients: Microcrystalline Cellulose NF, Lactose Anhydrous NF, Povidone USP, Colloidal Silicon Dioxide NF, Magnesium Stearate NF, and Sodium Starch Glycolate NF. The 50 mg, 75 mg and 100 mg tablets also contain Opadry White which contains: Titanium Dioxide USP, Hypromellose Type 2910 USP, Polyethylene Glycol 400 NF, and Polysorbate 80 NF. CLINICAL PHARMACOLOGY Following a single dose of one 100 mg tablet of minocycline hydrochloride administered to 28 normal fasting adult volunteers, maximum serum concentrations were attained in 1 to 3 hours (average 1.71 hours) and ranged from 491.71 to 1292.70 ng/mL (average 758.29 ng/mL). The serum half-life in the normal volunteers ranged from 11.38 to 24.31 hours (average 17.03 hours). When minocycline hydrochloride tablets were given concomitantly with a meal, which included dairy products, the extent of absorption of minocycline hydrochloride tablets was slightly decreased (6%). The peak plasma concentrations were slightly decreased (12%) and delayed by 1.09 hours when administered with food, compared to dosing under fasting conditions. Minocycline HCl may be administered with or without food. In previous studies with ot اقرأ الوثيقة كاملة