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:

Amneal Pharmaceuticals of New York LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Chloroquine phosphate tablets are 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 are 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 s

Product summary:

Chloroquine Phosphate Tablets USP, 250 mg , equivalent to 150 mg of chloroquine base are supplied as white to off-white, round tablets, single scored on one side and debossed with “0115” over “2790” on the other side. They are available as follows: Bottles of 50:              NDC 0115-2790-06 Bottles of 500:            NDC 0115-2790-02 Dispense in tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLOROQUINE PHOSPHATE- CHLOROQUINE PHOSPHATE TABLET
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
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CHLOROQUINE PHOSPHATE TABLETS, USP
(250 MG)
RX ONLY
DESCRIPTION
Chloroquine phosphate tablet, USP, is a 4-aminoquinoline compound for
oral
administration. It is a white, crystalline powder, freely soluble in
water, practically
insoluble in alcohol (ethanol 96%), in chloroform and in ether.
Chloroquine phosphate tablet 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_: Anhydrous citric acid, hydrogenated vegetable
oil, lactose
monohydrate, magnesium stearate, corn starch, pregelatinized starch
and starch.
FDA approved dissolution test specifications differ from USP.
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. Slightly more than
half of the urinary
drug products can be accounted for as unchanged chloroquine.
CARDIAC ELECTROPHYSIOLOGY
QTc interv