CHLOROQUINE PHOSPHATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rising Pharmaceuticals, Inc.

INN (International Name):

CHLOROQUINE PHOSPHATE

Composition:

CHLOROQUINE PHOSPHATE 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Chloroquine phosphate is indicated for the: - Treatment of uncomplicated malaria due to susceptible strains of P. falciparum, P.malariae, P. ovale, and P.vivax . - Prophylaxis of malaria in geographic areas where resistance to chloroquine is not present. - Treatment of extraintestinal amebiasis. Chloroquine phosphate tablets do not prevent relapses in patients with vivax or ovale malaria because it is not effective against exoerythrocytic forms of the parasites. Limitations of Use in Malaria: - Do not use chloroquine phosphate tablets for the treatment of complicated malaria (high-grade parasitemia and/or complications e.g., cerebral malaria or acute renal failure). - Do not use chloroquine phosphate tablets for malaria prophylaxis in areas where chloroquine resistance occurs, Resistance to chloroquine phosphate tablets is widespread in P. falciparum , and is reported in P.vivax (see WARNINGS). - Concomitant therapy with an 8-aminoquinoline drug is necessary for treatment of the hypnozoite liver stage form

Product summary:

Tablets containing 250 mg chloroquine phosphate USP, equivalent to 150 mg of chloroquine base Bottle of 50 (NDC 64980-177-50) Bottle of 100 (NDC 64980-177-01) Bottle of 500 (NDC 64980-177-05) Bottle of 1000 (NDC 64980-177-10) Chloroquine phosphate tablets are white to off-white colour round, bi-convex tablets, debossed with 'CN 250' on one side and score line on the other side. Dispense in tight, light-resistant container as defined in the USP/NF. Store at 20-25°C (68-77° F) [See USP Controlled Room Temperature]. Protect from light and moisture.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLOROQUINE PHOSPHATE - CHLOROQUINE PHOSPHATE TABLET
RISING PHARMACEUTICALS, INC.
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CHLOROQUINE PHOSPHATE TABLET, USP
DESCRIPTION
Chloroquine phosphate tablets 250 mg, chloroquine phosphate, USP, is a
4-aminoquinoline compound
for oral administration. It is a white, odorless, bitter tasting,
crystalline substance, freely soluble in
water.
Chloroquine phosphate is an antimalarial and amebicidal drug.
Chemically, it is 7-chloro-4-[[4- (diethylamino)-1-methylbutyl]amino]
quinoline phosphate (1:2) and has
the following structural formula:
Each tablet contains 250 mg of chloroquine phosphate USP, equivalent
to 150 mg chloroquine base.
_Inactive Ingredients:_ Colloidal silicon dioxide, dibasic calcium
phosphate, magnesium stearate,
microcrystalline cellulose, pregelatinized starch and sodium starch
glycolate.
CLINICAL PHARMACOLOGY
Chloroquine is rapidly and almost completely absorbed from the
gastrointestinal tract, and only asmall
proportion of the administered dose is found in the stools.
Approximately 55% of the drug inthe 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 considerableamounts. 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,
incontrast, contain only 10 to 30 times
the amount present in plasma.
Chloroquine undergoes appreciable degradation in the body. The main
metabolite
isdesethylchloroquine, which accounts for one fourth of the total
material appearing in the
urine;bisdesethylchloroquine, a carboxylic acid derivative, and other
metabolic products as
yetuncharacterized are found in small amounts. Slightly more than half
of the urinary drug productscan
be accounted for as unchanged chloroquine.
MICROBIOLOGY
Mechanism of Action: Chloroquine, a 4-aminoquinoline, is an
anti-protozoal agent. The precise
mechanism by which chloroquine exhib