Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
RIFABUTIN (UNII: 1W306TDA6S) (RIFABUTIN - UNII:1W306TDA6S)
Department of State Health Services, Pharmacy Branch
RIFABUTIN
RIFABUTIN 150 mg
ORAL
PRESCRIPTION DRUG
MYCOBUTIN Capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection. MYCOBUTIN Capsules are contraindicated in patients who have had clinically significant hypersensitivity to rifabutin or to any other rifamycins.
MYCOBUTIN (rifabutin) Capsules, USP, are supplied as hard-gelatin capsules having an opaque red-brown cap and body, imprinted with MYCOBUTIN/PHARMACIA & UPJOHN in white ink, each containing 150 mg of rifabutin, USP. MYCOBUTIN is available as follows: NDC 0013-5301-17 Bottles of 100 capsules Keep tightly closed and dispense in a tight container as defined in the USP. Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature].
New Drug Application
MYCOBUTIN- RIFABUTIN CAPSULE DEPARTMENT OF STATE HEALTH SERVICES, PHARMACY BRANCH ---------- MYCOBUTIN (RIFABUTIN) CAPSULES, USP DESCRIPTION MYCOBUTIN Capsules for oral administration contain 150 mg of the rifamycin antimycobacterial agent rifabutin, USP, per capsule, along with the inactive ingredients microcrystalline cellulose, magnesium stearate, red iron oxide, silica gel, sodium lauryl sulfate, titanium dioxide, and edible white ink. The chemical name for rifabutin is 1',4-didehydro-1-deoxy-1,4-dihydro-5'-(2-methylpropyl)-1- oxorifamycin XIV (Chemical Abstracts Service, 9th Collective Index) or (9 _S_,12 _E_,14 _S_,15 _R_, 16 _S_,17 _R_,18 _R_,19 _R_,20 _S_,21 _S_,22 _E_, 24 _Z_)-6,16,18,20-tetrahydroxy-1'-isobutyl-14-methoxy-7,9,15,17,19,21,25- heptamethyl-spiro [9,4-(epoxypentadeca[1,11,13]trienimino)-2 _H_-furo[2',3':7,8]naphth[1,2-d] imidazole- 2,4'-piperidine]-5,10,26-(3 _H_,9 _H_)-trione-16-acetate. Rifabutin has a molecular formula of C H N O , a molecular weight of 847.02 and the following structure: Rifabutin is a red-violet powder soluble in chloroform and methanol, sparingly soluble in ethanol, and very slightly soluble in water (0.19 mg/mL). Its log P value (the base 10 logarithm of the partition coefficient between n-octanol and water) is 3.2 (n-octanol/water). CLINICAL PHARMACOLOGY PHARMACOKINETICS Absorption Following a single oral dose of 300 mg to nine healthy adult volunteers, rifabutin was readily absorbed from the gastrointestinal tract with mean (±SD) peak plasma levels (C ) of 375 (±267) ng/mL (range: 141 to 1033 ng/mL) attained in 3.3 (±0.9) hours (T range: 2 to 4 hours). Absolute bioavailability ® 46 62 4 11 max max assessed in five HIV-positive patients, who received both oral and intravenous doses, averaged 20%. Total recovery of radioactivity in the urine indicates that at least 53% of the orally administered rifabutin dose is absorbed from the gastrointestinal tract. The bioavailability of rifabutin from the capsule dosage form, relative to an oral solution, was 85% in 12 hea Pročitajte cijeli dokument