HYDROXYCHLOROQUINE SULFATE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Havix Group Inc d-b-a Aavis Pharmaceuticals

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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

Ürün özeti:

Each tablet contains 200 mg of hydroxychloroquine sulfate, USP equivalent to 155 mg base. Hydroxychloroquine Sulfate Tablets USP, 200 mg are supplied as White to off-white, film coated tablets imprinted "A19" on one side in black ink and free from physical defects. They are available as:             Bottles of 100 tablets with child-resistant closure: NDC 71337-019-01             Bottles of 500 tablets with continuous thread closure: NDC 71337-019-05 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)] [see USP Controlled Room Temperature]. Manufactured by: VKT Pharma Private Limited Srikakulam, India-532 409 ML No.: 02/SKL/AP/2015/F/R Distributed by: Aavis Pharmaceuticals, Hoschton, GA 30548 Code. xxxxx/xx Rev. xx/xxxx

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

HYDROXYCHLOROQUINE SULFATE- HYDROXYCHLOROQUINE SULFATE TABLET
HAVIX GROUP INC D-B-A AAVIS PHARMACEUTICALS
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HYDROXYCHLOROQUINE SULFATE TABLETS
DESCRIPTION
Hydroxychloroquine sulfate, USP is a white or practically white,
crystalline powder, freely soluble in
water; practically insoluble in ethanol (96%), 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 SO4.
Hydroxychloroquine sulfate tablets, USP 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, shellac NF, black
iron oxide NF, talc and propylene glycol.
CLINICAL PHARMACOLOGY
PHARMACOKINETICS: Following a single 200 mg oral dose of
hydroxychloroquine sulfate to healthy
male, 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. Pharmacokinet