CHLOROQUINE PHOSPHATE - 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:

Ranbaxy Pharmaceuticals Inc.

INN (International Name):

CHLOROQUINE PHOSPHATE

Composition:

CHLOROQUINE PHOSPHATE 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Chloroquine phosphate tablets are indicated for the 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 does 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

Product summary:

Chloroquine phosphate tablets, USP 250 mg 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 63304-460-03 Bottles of 10 NDC 63304-460-50 Bottles of 50 NDC 63304-460-10 Bottles of 1000 Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Store at 20 - 25° C (68 - 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
RANBAXY PHARMACEUTICALS INC.
----------
RX ONLY
For Malaria and Extraintestinal Amebiasis
DESCRIPTION
Chloroquine phosphate, 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, USP is an antimalarial and amebicidal drug.
Each tablet, for oral administration, contains 250 mg of chloroquine
phosphate, USP (equivalent to 150
mg 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.
Chemically, it is 7-chloro-4-[[4-(diethylamino)-1-methylbutyl]amino]
quinoline phosphate (1:2) and has
the following molecular structure:
C
H ClN .2H PO Molecular Weight: 515.86
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