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:

Aphena Pharma Solutions - Tennessee, LLC

Administration route:

ORAL

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: 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.

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 0378-0373-01 bottles of 100 tablets NDC 0378-0373-05 bottles of 500 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). Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 6/2018 HXCQ:R11

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROXYCHLOROQUINE SULFATE- HYDROXYCHLOROQUINE SULFATE TABLET, FILM
COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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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:
C H CLN • H SO
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 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. Pharm