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:

AvPAK

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 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 an 8-aminoquinoline compound is necessary (see CLINICAL PHARMACOLOGY – Microbiology ). Prior to prescribing hydroxychloroquine sulfate tablets for the treatment or prophylaxis of malaria, consult the Centers for Disease Control and Prevention (CDC) Malaria website   ( http://www.cdc.gov/malaria ).   Lupus Erythematosus Hydroxychloroquine Sulfate Tablets are indicated for the treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus in adults. Rheumatoid Arthritis Hydroxychloroquine Sulfate Tablets are indicated for the treatment of acute and chronic rheumatoid arthritis in adults. Use of hydroxychloroquine sulfate tablets is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds.

Product summary:

Hydroxychloroquine Sulfate Tablets, USP are white to off-white film-coated capsule shaped tablets debossed with “AC 384” on one side and plain on the other side. Each tablet contains 200 mg hydroxychloroquine sulfate (equivalent to 155 mg base). NDC 50268-412-15 (10 tablets per card, 5 cards per carton) For Institutional Use Only. Dispensed in Unit Dose Package. Do not crush or divide hydroxychloroquine sulfate film-coated tablets, USP (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), excursions permitted between 15° and 30°C (59° and 86°F) [See USP Controlled Room Temperature]. Manufactured for: AvKARE Pulaski, TN 38478 Mfg. Rev. 05/18 AV 05/20 (P) AvPAK

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROXYCHLOROQUINE SULFATE- HYDROXYCHLOROQUINE SULFATE TABLET
AVPAK
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HYDROXYCHLOROQUINE SULFATE TABLETS, USP
RX ONLY
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, USP contain 200 mg
hydroxychloroquine sulfate,
equivalent to 155 mg base, and are for oral administration.
Inactive Ingredients: corn starch, crospovidone, hydroxypropyl
methylcellulose, lactose
monohydrate, magnesium stearate, polyethylene glycol, polyvinyl
alcohol, talc and
titanium dioxide.
CLINICAL PHARMACOLOGY:
Pharmacokinetics: Following a single 200 mg oral dose of
hydroxychloroquine sulfate
tablets 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 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 was 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
18
26
3
2
4
ng/mL) following the 155 mg infusion and 6 months following the 310 mg
infusion.
Pharmacokinetic parameters were not significantly di