Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
MINOCYCLINE HYDROCHLORIDE (UNII: 0020414E5U) (MINOCYCLINE - UNII:FYY3R43WGO)
Carilion Materials Management
MINOCYCLINE HYDROCHLORIDE
MINOCYCLINE 100 mg
ORAL
PRESCRIPTION DRUG
Minocycline hydrochloride capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: - Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. - Respiratory tract infections caused by Mycoplasma pneumoniae. Respiratory tract infections caused by Mycoplasma pneumoniae. - Lymphogranuloma venereum caused by Chlamydia trachomatis. Lymphogranuloma venereum caused by Chlamydia trachomatis. - Psittacosis (Ornithosis) due to Chlamydia psittaci. Psittacosis (Ornithosis) due to Chlamydia psittaci. - Trachoma caused by , although the
NDC:68151-2299-5 in a PACKAGE of 1 CAPSULES
Abbreviated New Drug Application
MINOCYCLINE HYDROCHLORIDE- MINOCYCLINE HYDROCHLORIDE CAPSULE CARILION MATERIALS MANAGEMENT ---------- MINOCYCLINE HYDROCHLORIDE CAPSULES USP REVISED: JUNE 2009 RX ONLY 190791 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. 493.95 Each minocycline hydrochloride capsule, for oral administration, contains the equivalent of 50 mg, 75 mg, or 100 mg of minocycline. In addition each capsule contains the following inactive ingredients: magnesium stearate and starch (corn). The 50 mg, 75 mg, and 100 mg capsule shells contain: D&C Red No. 28, D&C Yellow No. 10, gelatin, silicon dioxide, sodium lauryl sulfate and titanium dioxide. The 100 mg capsule shell also contains black iron oxide. CLINICAL PHARMACOLOGY Following a single dose of two 100 mg capsules of minocycline HCl 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 μg/mL (average 3.5 μg/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 meal which included dairy products, the extent of absorption of minocycline hydrochloride capsules was not noticeably influenced. The peak plasma concentrations were slightly decreased (11.2%) and delayed by one hour when administered with food, compared to dosing under fasting conditions. In previous studies with other minocycline dosage forms, the minocycline serum half-life ranged from 11 t Aqra d-dokument sħiħ