HYDROXYCHLOROQUINE SULFATE tablet film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

AvKARE, Inc.

INN (Διεθνής Όνομα):

HYDROXYCHLOROQUINE SULFATE

Σύνθεση:

HYDROXYCHLOROQUINE SULFATE 200 mg

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

HYDROXYCHLOROQUINE SULFATE - HYDROXYCHLOROQUINE SULFATE TABLET, FILM
COATED
AVKARE, INC.
----------
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-term therapy in children.
WAR