HYDROXYCHLOROQUINE SULFATE- 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:

Major Pharmaceuticals

INN (International Name):

HYDROXYCHLOROQUINE SULFATE

Composition:

HYDROXYCHLOROQUINE SULFATE 200 mg

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 h

Product summary:

Hydroxychloroquine sulfate tablets, USP for oral administration are available as: 200 mg: Round, off white tablets, scored and debossed GG 260 on one side and plain on the reverse side, film coated white and supplied as: 50 Tablets in unit dose blisters per box, NDC 0904-6508-06 (5 cards of 10 tablets each) 100 Tablets in unit dose blisters per box, NDC 0904-6508-61 (10 cards of 10 tablets each) Each tablet contains 200 mg hydroxychloroquine sulfate (equivalent to 155 mg base). Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Dispense in a tight, light-resistant container. Each tablet contains 200 mg hydroxychloroquine sulfate (equivalent to 155 mg base). Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Dispense in a tight, light-resistant container as defined in the USP/NF. Keep out of the reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROXYCHLOROQUINE SULFATE- HYDROXYCHLOROQUINE SULFATE TABLET, FILM
COATED
MAJOR PHARMACEUTICALS
----------
HYDROXYCHLOROQUINE SULFATE TABLETS, USP
DESCRIPTION
Hydroxychloroquine sulfate 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).
Hydroxychloroquine sulfate has the following structural formula:
Each tablet for oral administration contains 200 mg hydroxychloroquine
sulfate (equivalent to 155 mg
hydroxychloroquine). Inactive ingredients: Dibasic calcium phosphate,
hydroxypropyl cellulose,
hydroxypropyl methylcellulose, magnesium stearate, polyethylene
glycol, povidone, sodium
bicarbonate, and titanium dioxide.
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 and 310 mg
indicating linear kinetics.
Following chronic oral administration of hydroxychloroquine,
significant levels of three