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:

NCS HealthCare of KY, Inc dba Vangard Labs

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Malaria Hydroxychloroquine sulfate is indicated for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax. Hydroxychloroquine sulfate is indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. Limitations of Use in Malaria - Hydroxychloroquine sulfate is not recommended for the treatment of complicated malaria. - Hydroxychloroquine sulfate is not effective against chloroquine or hydroxychloroquine-resistant strains of Plasmodium species (see CLINICAL PHARMACOLOGY - Microbiology). Hydroxychloroquine sulfate is 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 is not recommended for malaria prophylaxis in geographic areas where chloroquine resistance occurs. - Hydroxychloroquine sulfate does not prevent relapses of P. vivax or P. ovale because it is not active against the

Product summary:

Hydroxychloroquine Sulfate Tablets, USP are white to off-white, film-coated, oval, biconvex unscored tablets, debossed with “698 200 ”on one side and “WATSON ” on the other side supplied in blistercards of 30 (NDC 0615-8325-39). Each tablet contains 200 mg hydroxychloroquine sulfate (equivalent to 155 mg base). Do not crush or divide hydroxychloroquine sulfate film-coated tablets (see DOSAGE AND ADMINISTRATION). Dispense in a tight, light-resistant container as defined in the USP. Keep out of the reach of children.  Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured in India By: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Rev. A 3/2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROXYCHLOROQUINE SULFATE- HYDROXYCHLOROQUINE SULFATE TABLET, FILM
COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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HYDROXYCHLOROQUINE SULFATE TABLETS, USP
RX ONLY
DESCRIPTION
Hydroxychloroquine Sulfate, USP is a colorless crystalline solid,
soluble in water to at least 20
percent; chemically the drug is
(±)-2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino] ethanol
sulfate (1:1) (salt). It has the following structural formula:
C
H ClN O•H SO
Molecular Weight: 433.95
Hydroxychloroquine Sulfate Tablets, USP contain 200 mg
hydroxychloroquine sulfate, equivalent to
155 mg base, and are for oral administration.
_Inactive Ingredients:_ colloidal silicon dioxide, dextrates,
hypromellose, magnesium stearate,
maltodextrin, microcrystalline cellulose, polydextrose, polyethylene
glycol, sodium starch glycolate,
starch (corn), titanium dioxide, and triacetin.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS: Following a single 200 mg oral dose of
hydroxychloroquine sulfate 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 not significantly different over the therapeutic dose
range of 155 mg