Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
HYDROXYCHLOROQUINE SULFATE (UNII: 8Q2869CNVH) (HYDROXYCHLOROQUINE - UNII:4QWG6N8QKH)
Mylan Pharmaceuticals Inc.
ENTERAL
PRESCRIPTION DRUG
Hydroxychloroquine sulfate tablets are indicated for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax. 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). Hydroxychloroquine sulfate tablets are indicated for the treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus in adults. Hydroxychloroquine sulfate tablets are indicated for the treatment of acute and chronic rheumatoid arthritis in adults. Use of hydroxychloroquine sulfate tablets are contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds.
Hydroxychloroquine Sulfate Tablets, USP are available containing 200 mg of hydroxychloroquine sulfate, USP, equivalent to 155 mg of base. The 200 mg tablets are white, film-coated, round, unscored tablets debossed with M on one side of the tablet and 373 on the other side. They are available as follows: NDC 0378-0373-99 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child resistant closure. Keep out of the reach of children. Do not crush or divide hydroxychloroquine sulfate film-coated tablets (see DOSAGE AND ADMINISTRATION). Manufactured by and for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 2/2017 ALM:HXCQ:R9
Abbreviated New Drug Application
HYDROXYCHLOROQUINE SULFATE- HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED MYLAN PHARMACEUTICALS INC. ---------- DESCRIPTION Hydroxychloroquine sulfate, USP is a white or practically white, crystalline powder, freely soluble in water; practically insoluble in alcohol, chloroform, and in ether. The chemical name for hydroxychloroquine sulfate is 2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino] ethanol sulfate (1:1). Its structural formula is: The molecular weight of hydroxychloroquine sulfate is 433.96, and molecular formula is C H ClN 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: anhydrous lactose, croscarmellose sodium, glyceryl triacetate, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium lauryl sulfate 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/mL (mean 1918 ng/mL) following the 155 mg infusion and 6 months following the 310 mg infusion. Pharmacokinetic parameters were Prečítajte si celý dokument