HYDROXYCHLOROQUINE SULFATE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Adı):

HYDROXYCHLOROQUINE SULFATE

Kompozisyon:

HYDROXYCHLOROQUINE SULFATE 200 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 do not prevent relapses

Ürün özeti:

Hydroxychloroquine sulfate tablets are white, to off-white, film coated tablets imprinted "PLAQUENIL" on one face in black ink. Each tablet contains 200 mg hydroxychloroquine sulfate (equivalent to 155 mg base).                            Bottles of 100 tablets with child resistant closure (NDC 66993-057-02) and                            Bottles of 500 tablets with child resistant closure (NDC 66993-057-04). 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/NF. Keep out of the reach of children. Store at room temperature [20° to 25°C (68° to 77°F), allows excursions between 15° and 30°C (59° and 86°F)]. Distributed by: Prasco Laboratories Mason, OH 45040 USA Revised 01/2018 ©2015 Prasco Laboratories All rights reserved.

Yetkilendirme durumu:

New Drug Application Authorized Generic

Ürün özellikleri

HYDROXYCHLOROQUINE SULFATE- HYDROXYCHLOROQUINE SULFATE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
HYDROXYCHLOROQUINE SULFATE TABLETS, USP
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 contain 200 mg hydroxychloroquine
sulfate, equivalent to 155 mg
base, and are for oral administration.
_Inactive Ingredients_: Dibasic calcium phosphate USP, hypromellose
USP, magnesium stearate NF,
polyethylene glycol 400 NF, polysorbate 80 NF, corn starch, titanium
dioxide USP, carnauba wax NF,
shellac NF, black iron oxide NF.
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