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:

Proficient Rx LP

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 because it is not active against the hypnozoite forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with

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 12 tablets with child resistant closure (NDC 71205-448-12).          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 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 Rev. 09/19 ©2015 All rights reserved.

Authorization status:

New Drug Application

Summary of Product characteristics

PLAQUENIL- HYDROXYCHLOROQUINE SULFATE TABLET
PROFICIENT RX LP
----------
PLAQUENIL®
HYDROXYCHLOROQUINE SULFATE TABLETS, USP
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
s