HYDROXYCHLOROQUINESULFATE tablet, film coated

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Lupin Pharmaceuticals, Inc.

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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

Bidhaa muhtasari:

Hydroxychloroquine sulfate tablets, USP are white colored, oval shaped film coated tablets, debossed with "LU" on one side and "H17" on other side.  Each tablet contains 200 mg hydroxychloroquine sulfate (equivalent to 155 mg base).  Bottles of 100 tablets (NDC 68180-120-01) Bottles of 500 tablets (NDC 68180-120-02)   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 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]   Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States   Manufactured by: Lupin Limited Aurangabad - 431210 India July 2018                                                                                                                        ID#: 255860  

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

HYDROXYCHLOROQUINESULFATE- HYDROXYCHLOROQUINESULFATE TABLET, FILM
COATED
LUPIN PHARMACEUTICALS, INC.
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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, USP contain 200 mg
hydroxychloroquine sulfate, equivalent to 155
mg base, and are for oral administration.
_Inactive Ingredients: _colloidal silicon dioxide, crospovidone,
hypromellose, lactose monohydrate,
magnesium aluminometasilicate, magnesium stearate, polyethylene
glycol, povidone, 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
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
parameters were not signif