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:

DOH CENTRAL PHARMACY

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Malaria Hydroxychloroquine sulfate tablets are indicated for the treatment of uncomplicated malaria due to P. falclparum, P. malariae, P. ovale, and P. vlvax. Hydroxychloroquine sulfate tablets are indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. Limitations of Use in Malaria 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, capsule-shaped, film coated debossed with "HCQS" on one side and plain on the reverse side and are available in bottles of 10, 100, 500 and 1000.  Each tablet contains 200 mg hydroxychloroquine sulfate, USP (equivalent to 155 mg base). They are supplied by DOH CENTRAL PHARMACY as follows: Store at 20° - 25°C (68° - 77°F) excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROXYCHLOROQUINE SULFATE - HYDROXYCHLOROQUINE SULFATE TABLET, FILM
COATED
DOH CENTRAL PHARMACY
----------
HYDROXYCHLOROQUINE SULFATE TABLETS, USP
RX ONLY
*(Each tablet contains 200 mg of hydroxychloroquine sulfate, USP
equivalent to 155 mg of base)
DESCRIPTION
Hydroxychloroquine sulfate USP is a white or practically white,
crystalline powder, freely soluble in
water; practically insoluble in alcohol, in chloroform, and in ether.
The chemical name for
hydroxychloroqulne suttate, USP Is 2-[[4-[(7-Chloro-4-qulnolyl)
amlno]pentyl] ethylamlno)ethanol
Sulfate (1 :1 ).
Its structural formula is:
The molecular weight of hydroxychloroquine sulfate, USP is 433.95, and
molecular formula is
C,.H,.CIN,O.H,SO,. Hydroxychloroquine sulfate tablets, USP contain 200
mg hydroxychloroquine
sulfate, USP equivalent to 155 mg base, and are for oral
administration.
_Inactive Ingredients_: Colloidal silicon dioxide, dibasic calcium
phosphate, hypromellose,
macrogol/PEG 3350, magnesium stearate, polysorbate 80, pregelatinized
starch, talc, and titanium
dioxide.
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