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:

Malaria   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 not recommended for malaria prophylaxis in geographic areas where chloroquine resistance occurs. - Hy

Product summary:

Hydroxychloroquine Sulfate Tablets, USP contain 200 mg of hydroxychloroquine sulfate, equivalent to 155 mg base, are white to off-white, capsule-shaped, biconvex, film-coated tablets debossed with "ZC38" on one side and plain on other side, and are supplied as follows: NDC 68382-096-01 in bottles of 100 tablets NDC 68382-096-05 in bottles of 500 tablets NDC 68382-096-77 in unit-dose blister cartons of 100 (10 x 10) unit dose 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/NF. Keep out of the reach of children. Do not crush or divide hydroxychloroquine sulfate film-coated tablets (see DOSAGE AND ADMINISTRATION ).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROXYCHLOROQUINE SULFATE- HYDROXYCHLOROQUINE SULFATE TABLET, FILM
COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
HYDROXYCHLOROQUINE SULFATE TABLETS, USP
DESCRIPTION
Hydroxychloroquine sulfate 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 433.95, and
molecular formula is
C
H ClN O.H SO
Each hydroxychloroquine sulfate tablet intended for oral
administration contains 200 mg of
hydroxychloroquine sulfate equivalent to 155 mg base. In addition,
each tablet contains the following
inactive ingredients: dibasic calcium phosphate dihydrate, magnesium
stearate, pregelatinized starch,
polyethylene glycol, polyvinyl alcohol, starch, talc 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
18
26
3
2
4.
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 infu