HYDROXYCHLOROQUINE SULFATE tablet, film coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

NCS HealthCare of KY, LLC dba Vangard Labs

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Hydroxychloroquine sulfate is indicated for the treatment of uncomplicated malaria due to P. falciparum , P. malariae , P. ovale , and P. vivax . Hydroxychloroquine sulfate is indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. Limitations of Use in Malaria - Hydroxychloroquine sulfate is not recommended for the treatment of complicated malaria. Hydroxychloroquine sulfate is not recommended for the treatment of complicated malaria. - Hydroxychloroquine sulfate is not effective against chloroquine or hydroxychloroquine-resistant strains of Plasmodium species (see CLINICAL PHARMACOLOGY - Microbiology ). Hydroxychloroquine sulfate 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. Hydroxychloroquine sulfate is not effective against chloroquine or hydroxychloroquine-resistant strains of Plasmodium species (see CLINICAL PHARMACOLOGY - Mi

Toote kokkuvõte:

Hydroxychloroquine Sulfate Tablets USP, 200 mg (equivalent to 155 mg of base), are white, unscored, film-coated, capsule-shaped tablets debossed “TV” and “2401” on one side and plain on the other side in blisterpacks of 30 (NDC 0615-8374-39). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not crush or divide hydroxychloroquine sulfate film-coated tablets (see DOSAGE AND ADMINISTRATION ). Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep out of the reach of children. Distributed By: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054 Rev. F 4/2020

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

HYDROXYCHLOROQUINE SULFATE- HYDROXYCHLOROQUINE SULFATE TABLET, FILM
COATED
NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS
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HYDROXYCHLOROQUINE SULFATE TABLETS, USP
RX ONLY
DESCRIPTION
Hydroxychloroquine Sulfate, USP is a white to almost 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 O•H SO Molecular Weight: 433.95C
H
ClN O•H SO Molecular Weight:
433.95
Hydroxychloroquine Sulfate Tablets, USP contain 200 mg
hydroxychloroquine sulfate,
equivalent to 155 mg base, and are for oral administration.
_Inactive Ingredients:_ Dicalcium Phosphate Dihydrate, Hypromellose,
Magnesium
Stearate, Polydextrose, Polyethylene Glycol, Starch 1500 Partically
Pregelatinized Maize
Starch, Titanium Dioxide, Triacetin.
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 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
18
26
3
2
4
18
26
3
2
4
the 155 mg infusion and 6 months following the 310 mg infusion.
Pharmacokinetic