HYDROXYCHLOROQUINE SULFATE tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

HYDROXYCHLOROQUINE SULFATE (UNII: 8Q2869CNVH) (HYDROXYCHLOROQUINE - UNII:4QWG6N8QKH)

Tilgjengelig fra:

NuCare Pharmaceuticals,Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 re

Produkt oppsummering:

Hydroxychloroquine Sulfate Tablets, USP contain 200 mg of hydroxychloroquine sulfate, equivalent to 155 mg base, are white to off-white, capsule-shaped, biconvex, film-coated tablets debossed with "ZC38" on one side and plain on other side, and are supplied as follows: NDC 68071-4648-1 BOTTLES OF 100 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP/NF. Keep out of the reach of children. Do not crush or divide hydroxychloroquine sulfate film-coated tablets (see DOSAGE AND ADMINISTRATION ).

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

HYDROXYCHLOROQUINE SULFATE- HYDROXYCHLOROQUINE SULFATE TABLET, FILM
COATED
NUCARE PHARMACEUTICALS,INC.
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HYDROXYCHLOROQUINE SULFATE TABLETS, USP
DESCRIPTION
Hydroxychloroquine sulfate is an odorless, white or practically white
crystalline powder,
freely soluble in water; practically insoluble in alcohol, in
chloroform, and in ether.
Chemically the drug 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
Each hydroxychloroquine sulfate tablet intended for oral
administration contains 200 mg
of hydroxychloroquine sulfate equivalent to 155 mg base. In addition,
each tablet
contains the following inactive ingredients: dibasic calcium phosphate
dihydrate,
magnesium stearate, pregelatinized starch, polyethylene glycol,
polyvinyl alcohol, starch,
talc and titanium dioxide.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
Following a single 200 mg oral dose of hydroxychloroquine sulfate to
healthy males, the
mean peak blood concentration of hydroxychloroquine was 129.6 ng/mL,
reached in
18
26
3
2
4.
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 paramet