HYDROXYCHLOROQUINE SULFATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROXYCHLOROQUINE SULFATE (UNII: 8Q2869CNVH) (HYDROXYCHLOROQUINE - UNII:4QWG6N8QKH)

Available from:

Prasco Laboratories

INN (International Name):

HYDROXYCHLOROQUINE SULFATE

Composition:

HYDROXYCHLOROQUINE SULFATE 200 mg

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. - Hydroxychloroquine sulfate tablets do not prevent relapses

Product summary:

Hydroxychloroquine sulfate tablets are white, to off-white, film coated tablets imprinted "PLAQUENIL" on one face in black ink. Each tablet contains 200 mg hydroxychloroquine sulfate (equivalent to 155 mg base).                            Bottles of 100 tablets with child resistant closure (NDC 66993-057-02) and                            Bottles of 500 tablets with child resistant closure (NDC 66993-057-04). 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/NF. Keep out of the reach of children. Store at room temperature [20° to 25°C (68° to 77°F), allows excursions between 15° and 30°C (59° and 86°F)]. Distributed by: Prasco Laboratories Mason, OH 45040 USA Revised 01/2018 ©2015 Prasco Laboratories All rights reserved.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

HYDROXYCHLOROQUINE SULFATE - HYDROXYCHLOROQUINE SULFATE TABLET
PRASCO LABORATORIES
----------
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 .
Hydroxychloroquine sulfate tablets contain 200 mg hydroxychloroquine
sulfate,
equivalent to 155 mg base, and are for oral administration.
_Inactive Ingredients_: Dibasic calcium phosphate USP, hypromellose
USP, magnesium
stearate NF, polyethylene glycol 400 NF, polysorbate 80 NF, corn
starch, titanium
dioxide USP, carnauba wax NF, shellac NF, black iron oxide NF.
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.
Pharmacokinetic
parameters were not