PLAQUENIL- 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:

RedPharm Drug, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

PLAQUENIL 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 60 tablets with child resistant closure (NDC 59212-562-60).         Bottles of 100 tablets with child resistant closure (NDC 59212-562-10). Do not crush or divide PLAQUENIL 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)]. Mfd. for: Concordia Pharmaceuticals Distributed by: Amdipharm Limited 17 Northwood House Dublin 9, Ireland Rev. 09/19 ©2015 All rights reserved.

Authorization status:

New Drug Application

Summary of Product characteristics

PLAQUENIL- HYDROXYCHLOROQUINE SULFATE TABLET
REDPHARM DRUG, INC.
----------
PLAQUENIL 200MG TAB
DESCRIPTION
PLAQUENIL
(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
.
PLAQUENIL (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 PLAQUENIL to
healthy male
volunteers, 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 was 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
hydroxycholoquine. 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 3as10 mg infusion. Pharmacokinetic parameters were not
significantly different over