CHLOROQUINE PHOSPHATE tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Chartwell RX, 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 is widespread in P. falciparum , and is reported in P. vivax (see WARNINGS). - Concomitant therapy with an 8-aminoquinoline drug is necessary for treat

Product summary:

Chloroquine Phosphate Tablets, USP contains 500 mg chloroquine phosphate USP, equivalent to 300 mg of chloroquine base Bottle of 25 (NDC 62135-717-26) White, round, biconvex film-coated tablets, with debossing of ‘CP 500’ on one side and plain surface on the other side. Dispense in tight, light-resistant container as defined in the USP/NF. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°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, COATED
CHARTWELL RX, LLC
----------
CHLOROQUINE PHOSPHATE TABLETS, USP
DESCRIPTION
Chloroquine Phosphate Tablet, USP, is a 4-aminoquinoline compound for
oral
administration. It is a white, odorless, bitter tasting, crystalline
substance, freely soluble
in water.
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 500 mg of chloroquine phosphate USP, equivalent
to 300 mg
chloroquine base.
_Inactive Ingredients:_
microcrystalline cellulose, dibasic calcium phosphate, pregelatinzed
starch, sodium
starch glycolate, colloidal silicon dioxide, magnesium stearate,
polyethylene glycol,
titanium dioxide, hydroxy propyl methyl cellulose and polysorbate 80.
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 interval prolongation was studied in a randomi