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:

Bayshore Pharmaceuticals 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 treatment of the hypnozoite liver stage forms of P.vivax and P.ovale (see DOSAGE AND ADMINISTRATION). Use of chloroquine phosphate tablets for indications other than acute malaria is contraindicated in the presence of retinal or visual field changes of any etiology. Use of chloroquine phosphate tablets is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds.

Product summary:

Tablets containing 250 mg chloroquine phosphate USP, equivalent to 150 mg of chloroquine base are white to off-white, round, film-coated tablets, debossed with “RF” and “27” on one side and break line on the other side. NDC Number Size 76385-142-05                            bottles of 50 Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Protect from light and moisture. You may report side effects to FDA at 1-800-FDA-1088 .

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLOROQUINE PHOSPHATE- CHLOROQUINE PHOSPHATE TABLET, FILM COATED
BAYSHORE PHARMACEUTICALS LLC
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CHLOROQUINE PHOSPHATE TABLETS, USP
DESCRIPTION
Chloroquine phosphate tablet, 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 tablet, USP 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:
C
H
CIN
.2H
PO
Molecular Weight: 515.86
Each tablet contains 250 mg of chloroquine phosphate USP, equivalent
to 150 mg
chloroquine 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.
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