CHLOROQUINE- 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:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

CHLOROQUINE PHOSPHATE

Composition:

CHLOROQUINE PHOSPHATE 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Chloroquine Phosphate Tablets are indicated for suppressive treatment and for acute attacks of malaria due to P. vivax, P. malariae, P. ovale, and susceptible strains of P. falciparum. The drug is also indicated for the treatment of extraintestinal amebiasis. Chloroquine Phosphate Tablets do not prevent relapses in patients with vivax or malariae malaria because it is not effective against exoerythrocytic forms of the parasite, nor will it prevent vivax or malariae infection when administered as a prophylactic. It is highly effective as a suppressive agent in patients with vivax or malariae malaria, in terminating acute attacks, and significantly lengthening the interval between treatment and relapse. In patients with falciparum malaria it abolishes the acute attack and effects complete cure of the infection, unless due to a resistant strain of P. falciparum. Use of this drug is contraindicated in the presence of retinal or visual field changes either attributable to 4-aminoquinoline compounds or to any oth

Product summary:

Chloroquine Phosphate Tablets USP 500 mg: Pink Color, Round Tablets Debossed "WW 125". Bottles of 10 and 40 tablets. Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLOROQUINE- CHLOROQUINE PHOSPHATE TABLET, COATED
PD-RX PHARMACEUTICALS, INC.
----------
CHLOROQUINE PHOSPHATE
TABLETS, USP
500 MG
Rev. 05/10
RX ONLY
FOR MALARIA AND EXTRAINTESTINAL AMEBIASIS
DESCRIPTION
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 Tablets are an antimalarial and amebicidal drug.
Each tablet, for oral administration, contains 250 mg chloroquine
phosphate (equivalent to 150 mg base)
or 500 mg chloroquine phosphate (equivalent to 300 mg base).
Inactive ingredients 250 mg: Calcium Stearate, Colloidal Silicon
Dioxide, Dibasic Calcium Phosphate,
Microcrystalline Cellulose, and Talc.
Inactive ingredients 500 mg: Colloidal Silicon Dioxide, Corn Starch,
Lactose Monohydrate, Magnesium
Stearate, Microcrystalline Cellulose, Polyvinylpyrrolidone, Sodium
Starch Glycolate, and Titanium
Dioxide. Film Coating and Polishing Solution contains: D&C Red #27
Aluminum Lake, D&C Yellow
#10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, Hypromellose,
Polyethylene Glycol, Polysorbate
80 and Titanium Dioxide.
Chemically, it is 7-chloro-4-[[4-(diethylamino)-1-methylbutyl]amino]
quinoline phosphate (1:2) and has
the following structural formula:
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
met