CHLOROQUINE PHOSPHATE tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHLOROQUINE PHOSPHATE (UNII: 6E17K3343P) (CHLOROQUINE - UNII:886U3H6UFF)

Available from:

Bryant Ranch Prepack

INN (International Name):

CHLOROQUINE PHOSPHATE

Composition:

CHLOROQUINE PHOSPHATE 250 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLOROQUINE PHOSPHATE - CHLOROQUINE PHOSPHATE TABLET, FILM COATED
BRYANT RANCH PREPACK
----------
RX ONLY
For Malaria and Extraintestinal Amebiasis
DESCRIPTION
Chloroquine phosphate, USP is a 4-aminoquinoline compound for oral
administration. It is a white
crystalline powder; odorless; has a bitter taste, and is discolored
slowly on exposure to light. It is
freely soluble in water, practically insoluble in alcohol, in
chloroform and in ether.
Chloroquine phosphate, USP is an antimalarial and amebicidal drug.
Each tablet, for oral administration, contains 250 mg of chloroquine
phosphate, USP (equivalent to 150
mg base).
Inactive ingredients: colloidal silicon dioxide, corn starch,
hypromellose, magnesium stearate,
microcrystalline cellulose, polyethylene glycol 400, polyethylene
glycol 3350, polysorbate 80,
povidone, sodium starch glycolate, talc, and titanium dioxide.
Chemically, it is 7-chloro-4-[[4-(diethylamino)-1-methylbutyl]amino]
quinoline phosphate (1:2) and has
the following molecular structure:
C
H ClN .2H PO Molecular Weight: 515.86
CLINICAL PHARMACOLOGY
Chloroquine is rapidly and almost completely absorbed from the
gastrointestinal tract, and only a small
proportion of the administered dose is found in the stools.
Approximately 55% of the drug in the plasma
is bound to nondiffusible plasma constituents. Excretion of
chloroquine is quite slow, but is increased
by acidification of the urine. Chloroquine is deposited in the tissues
in considerable amounts. In
animals, from 200 to 700 times the plasma concentration may be found
in the liver, spleen, kidney, and
lung; leukocytes also concentrate the drug. The brain and spinal cord,
in contrast, contain only 10 to 30
times the amount present in plasma.
Chloroquine undergoes appreciable degradation in the body. The main
metabolite is
desethylchloroquine, which accounts for one fourth of the total
material appearing in the urine;
bisdesethylchloroquine, a carboxylic acid derivative, and other
metabolic products as yet
uncharacterized are found in small amounts