HYDROXYCHLOROQUINE SULFATE- hydroxychloroquine sulfate tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

West-ward Pharmaceutical Corp

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Hydroxychloroquine Sulfate Tablets are indicated for the suppressive treatment and treatments of acute attacks of malaria due to Plasmodium vivax , P. malariae , P. ovale , and susceptible strains of P. falciparum . It is also indicated for the treatment of discoid and systemic lupus erythematosus, and rheumatoid arthritis. Use of this drug is contraindicated (1) in the presence of retinal or visual field changes attributable to any 4-aminoquinoline compound, (2) in patients with known hypersensitivity to 4-aminoquinoline compounds, and (3) for long-term therapy in children.

Povzetek izdelek:

Hydroxychloroquine Sulfate Tablets are White, Round Tablets; Embossed "WW28". Each tablet contains 200 mg hydroxychloroquine sulfate (equivalent to 155 mg base).     Bottles of 100 tablets  Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Manufactured by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 Revised September 2009

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

HYDROXYCHLOROQUINE SULFATE- HYDROXYCHLOROQUINE SULFATE TABLET, FILM
COATED
WEST-WARD PHARMACEUTICAL CORP
----------
HYDROXYCHLOROQUINE SULFATE TABLETS, USP
RX ONLY
REV. 09/09
WARNING
PHYSICIANS SHOULD COMPLETELY FAMILIARIZE THEMSELVES WITH THE
COMPLETE CONTENTS OF THIS LEAFLET BEFORE PRESCRIBING
HYDROXYCHLOROQUINE.
DESCRIPTION
Hydroxychloroquine sulfate is a colorless crystalline solid, soluble
in water to at least 20 percent;
chemically the drug is
2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino] ethanol sulfate
(1:1).
Hydroxychloroquine Sulfate Tablets contain 200 mg hydroxychloroquine
sulfate, equivalent to 155 mg
base, and are for oral administration.
_Inactive Ingredients:_ Colloidal Silicon Dioxide, Corn Starch,
Croscarmellose Sodium, Lactose
Anhydrous, Lactose Monohydrate, Magnesium Stearate, Pregelatinized
Starch 1500, and Sodium Lauryl
Sulfate.
_Film Coating_: Hypromellose, Polyethylene Glycol, Polysorbate 80,
Titanium Dioxide.
ACTIONS
The drug possesses antimalarial actions and also exerts a beneficial
effect in lupus erythematosus
(chronic discoid or systemic) and acute or chronic rheumatoid
arthritis. The precise mechanism of
action is not known.
INDICATIONS
Hydroxychloroquine Sulfate Tablets are indicated for the suppressive
treatment and treatments of acute
attacks of malaria due to _Plasmodium vivax_, _P. malariae_, _P.
ovale_, and susceptible strains of _P._
_falciparum_. It is also indicated for the treatment of discoid and
systemic lupus erythematosus, and
rheumatoid arthritis.
CONTRAINDICATIONS
Use of this drug is contraindicated (1) in the presence of retinal or
visual field changes attributable to
any 4-aminoquinoline compound, (2) in patients with known
hypersensitivity to 4-aminoquinoline
compounds, and (3) for long-term therapy in children.
WARNINGS, GENERAL
Hydroxychloroquine Sulfate Tablets are not effective against
chloroquine-resistant strains of _P._
_falciparum_.
Children are especially sensitive to the 4-aminoquinoline compounds. A
number of fatalities have been
reported followi