Hydroxychloroquine Sulfate Tablets USP 200 mg

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

hydroxychloroquine sulfate

Saadav alates:

Alphapharm Pty Ltd

INN (Rahvusvaheline Nimetus):

Hydroxychloroquine sulfate

Klass:

Medicine Listed (Export Only)

Volitamisolek:

Listed (Export Only)

Toote omadused

HYDROXYCHLOROQUINE SULFATE- HYDROXYCHLOROQUINE SULFATE TABLET, FILM
COATED
MYLAN PHARMACEUTICALS INC.
----------
DESCRIPTION
Hydroxychloroquine sulfate, USP 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:
C H CLN • H SO
The molecular weight of hydroxychloroquine sulfate is 433.96, 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: anhydrous lactose, croscarmellose sodium,
glyceryl triacetate, hypromellose,
magnesium stearate, microcrystalline cellulose, polydextrose,
polyethylene glycol, povidone, sodium
lauryl sulfate 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 ng/mL)
following the 155 mg
infusion and 6 months following the 310 mg infusion. Pharmacokinetic
par