HYDROXYCHLOROQUINE SULFATE - hydroxychloroquine sulfate tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Aphena Pharma Solutions - Tennessee, LLC

INN (Kansainvälinen yleisnimi):

HYDROXYCHLOROQUINE SULFATE

Koostumus:

HYDROXYCHLOROQUINE SULFATE 200 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Hydroxychloroquine sulfate tablets, USP are indicated for the suppressive treatment and treatment of acute attacks of malaria due to Plasmodium vivax , P. malariae , P. ovale , and susceptible strains of P. falciparum . Hydroxychloroquine sulfate tablets, USP are 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.

Tuoteyhteenveto:

Hydroxychloroquine sulfate tablets, USP are white, to off-white, capsule-shaped tablets, debossed "HCQS" on one side and plain on the reverse side and are available in bottles of 100 and 180. Each tablet contains 200 mg hydroxychloroquine sulfate, USP (equivalent to 155 mg base). NDC 42291-318-90 bottles of 90 NDC 42291-318-01 bottles of 100 NDC 42291-318-18 bottles of 180 NDC 42291-318-50 bottles of 500 Dispense in a tight, light-resistant container as defined in the USP/NF. Store at 20° - 25° C (68° - 77° F) excursions permitted to 15° - 30° C (59° - 86° F) [See USP Controlled Room Temperature]. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 11/13 AV Rev. 09/14 (P)

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

HYDROXYCHLOROQUINE SULFATE - HYDROXYCHLOROQUINE SULFATE TABLET, FILM
COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
HYDROXYCHLOROQUINE SULFATE TABLETS, USP 200 MG*
RX ONLY
*(Each tablet contains 200 mg of hydroxychloroquine sulfate, USP
equivalent to 155 mg of base)
WARNING
PHYSICIANS SHOULD COMPLETELY FAMILIARIZE THEMSELVES WITH THE
COMPLETE CONTENTS OF THIS LEAFLET BEFORE PRESCRIBING
HYDROXYCHLOROQUINE SULFATE TABLETS, USP.
DESCRIPTION
Hydroxychloroquine sulfate, USP 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, USP has the following structural
formula:
Molecular Formula: C
H ClN O.H SO
Molecular Weight of 433.95
Each tablet, for oral administration, contains 200 mg
hydroxychloroquine sulfate, USP (equivalent to
155 mg base). In addition, each tablet contains the following Inactive
Ingredients: colloidal silicon
dioxide, dibasic calcium phosphate, hypromellose, macrogol/PEG 3350,
magnesium stearate,
polysorbate 80, pregelatinized starch, talc and titanium dioxide.
CLINICAL PHARMACOLOGY
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 AND USAGE
Hydroxychloroquine sulfate tablets, USP are indicated for the
suppressive treatment and treatment of
acute attacks of malaria due to _Plasmodium vivax_, _P. malariae_, _P.
ovale_, and susceptible strains of _P._
_falciparum_. Hydroxychloroquine sulfate tablets, USP are also
indicated for the treatment of discoid and
systemic lupus erythematosus, and rheumatoid arthritis.
18
26
3
2
4
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-t