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:

RedPharm Drug, Inc.

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 relap

Product summary:

Hydroxychloroquine sulfate tablets, USP for oral administration are available as: 200 mg: Round, Off White, Standard Cup Tablet Core, Debossed GG 260 on One Side and Plain on the Reverse Side, Film Coated White NDC 0781-5994-01 bottles of 100 NDC 0781-5994-05 bottles of 500 Each tablet contains 200 mg hydroxychloroquine sulfate, USP (equivalent to 155 mg base). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not crush or divide hydroxychloroquine sulfate film-coated tablets, USP (see DOSAGE AND ADMINISTRATION). Dispense in a tight, light-resistant container. KEEP OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROXYCHLOROQUINE SULFATE- HYDROXYCHLOROQUINE SULFATE TABLET, FILM
COATED
REDPHARM DRUG, INC.
----------
HYDROXYCHLOROQUINE 200MGTABLETS
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). Hydroxychloroquine sulfate has the
following
structural formula:
Each tablet for oral administration contains 200 mg hydroxychloroquine
sulfate, USP
(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
me