HYDROXYCHLOROQUINE SULFATE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROXYCHLOROQUINE SULFATE (UNII: 8Q2869CNVH) (HYDROXYCHLOROQUINE - UNII:4QWG6N8QKH)

Available from:

Mylan Institutional Inc.

INN (International Name):

HYDROXYCHLOROQUINE SULFATE

Composition:

HYDROXYCHLOROQUINE SULFATE 200 mg

Administration route:

ENTERAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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: - Hydroxychloroquine sulfate tablets are not recommended for the treatment of complicated malaria. - Hydroxychloroquine sulfate tablets are not effective against chloroquine or hydroxychloroquine-resistant strains of Plasmodium species (see CLINICAL PHARMACOLOGY: Microbiology). Hydroxychloroquine sulfate tablets are not recommended for the treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified. - Hydroxychloroquine sulfate tablets are

Product summary:

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 42292-011-06 – Unit dose blister packages of 50 (5 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Do not crush or divide hydroxychloroquine sulfate film-coated tablets (see DOSAGE AND ADMINISTRATION). Manufactured by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12272 R1 8/17

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROXYCHLOROQUINE SULFATE- HYDROXYCHLOROQUINE SULFATE TABLET, FILM
COATED
MYLAN INSTITUTIONAL 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 n