Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
HYDROXYCHLOROQUINE SULFATE (UNII: 8Q2869CNVH) (HYDROXYCHLOROQUINE - UNII:4QWG6N8QKH)
Sun Pharmaceutical Industries, Inc.
ORAL
PRESCRIPTION DRUG
Malaria Hydroxychloroquine sulfate tablets are indicated for the treatment of uncomplicated malaria due to P. falclparum, P. malariae, P. ovale, and P. vlvax. Hydroxychloroquine sulfate tablets are indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. Limitations of Use in Malaria Prior to prescribing hydroxychloroquine sulfate tablets for the treatment or prophylaxis of malaria, consult the Centers for Disease Control and Prevention (CDC) Malaria website (http://www.cdc.gov/malaria). Lupus Erythematosus Hydroxychloroquine sulfate tablets are indicated for the treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus in adults. Rheumatoid Arthritis Hydroxychloroquine sulfate tablets are indicated for the treatment of acute and chronic rheumatoid arthritis in adults. Use of hydroxychloroquine sulfate tablets is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds.
Hydroxychloroquine sulfate tablets, USP are white to off white, capsule-shaped, film coated debossed with "HCQS" on one side and plain on the reverse side and are available in bottles of 10, 100, 500 and 1000. Each tablet contains 200 mg hydroxychloroquine sulfate, USP (equivalent to 155 mg base). NDC 63304-296-03 Bottles of 10 NDC 63304-296-01 Bottles of 100 NDC 63304-296-05 Bottles of 500 NDC 63304-296-10 Bottles of 1000 Dispense in a tight, light-resistant container as defined in the USP/NF. Store at 20° - 25°C (68° - 77°F) excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
HYDROXYCHLOROQUINE SULFATE- HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED SUN PHARMACEUTICAL INDUSTRIES, INC. ---------- HYDROXYCHLOROQUINE SULFATE TABLETS, USP RX ONLY *(Each tablet contains 200 mg of hydroxychloroquine sulfate, USP equivalent to 155 mg of base) DESCRIPTION Hydroxychloroquine sulfate USP is a white or practically white, crystalline powder, freely soluble in water; practically insoluble in alcohol, in chloroform, and in ether. The chemical name for hydroxychloroqulne suttate, USP Is 2-[[4-[(7-Chloro-4-qulnolyl) amlno]pentyl] ethylamlno)ethanol Sulfate (1 :1 ). Its structural formula is: The molecular weight of hydroxychloroquine sulfate, USP is 433.95, and molecular formula is C,.H,.CIN,O.H,SO,. Hydroxychloroquine sulfate tablets, USP contain 200 mg hydroxychloroquine sulfate, USP equivalent to 155 mg base, and are for oral administration. _Inactive Ingredients_: Colloidal silicon dioxide, dibasic calcium phosphate, hypromellose, macrogol/PEG 3350, magnesium stearate, polysorbate 80, pregelatinized starch, talc, and titanium dioxide. CLINICAL PHARMACOLOGY PHARMACOKINETICS: Following a single 200 mg oral dose of hydroxychloroquine sulfate tablets to healthy males, the mean peak blood concentration of hydroxychloroquine was 129.6 ng/mL, reached In 3.26 hours with a half-life of 537 hours (22.4 days). In the same study, the plasma peak concentration was 50.3 ng/mL reached in 3.74 hours with a half-life of 2963 hours (123.5 days). Urine hydroxychloroquine levels were still detectable after 3 months with approximately 10% of the dose excreted as the parent drug. Results following a single dose of a 200 mg tablet versus i.v. infusion (155 mg), demonstrated a half-life of about 40 days and a large volume of distribution. Peak blood concentrations of metabolites were observed at the same time as peak levels of hydroxychloroquine. The mean fraction of the dose absorbed was 0.74. After administration of single 155 mg and 310 mg intravenous doses, peak blood concentrations ranged from 1161 ng/mL to 2436 ng Lugege kogu dokumenti