Country: United States
Language: English
Source: NLM (National Library of Medicine)
CHLOROQUINE PHOSPHATE (UNII: 6E17K3343P) (CHLOROQUINE - UNII:886U3H6UFF)
Amneal Pharmaceuticals of New York LLC
ORAL
PRESCRIPTION DRUG
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 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 are contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds.
Chloroquine Phosphate Tablets USP, 500 mg , equivalent to 300 mg of chloroquine base are supplied as white to off-white, round tablets, debossed with "7010" on one side and plain on the other side. They are available as follows: Bottles of 25: NDC 0115-7010-09 Bottles of 100: NDC 0115-7010-01 Bottles of 500: NDC 0115-7010-02 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]
Abbreviated New Drug Application
CHLOROQUINE PHOSPHATE- CHLOROQUINE PHOSPHATE TABLET AMNEAL PHARMACEUTICALS OF NEW YORK LLC ---------- CHLOROQUINE PHOSPHATE TABLETS, USP (500 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 500 mg of chloroquine phosphate USP, equivalent to 300 mg chloroquine base. _Inactive Ingredients_: Anhydrous citric acid, hydrogenated vegetable oil, lactose monohydrate, magnesium stearate, corn starch, pregelatinized starch and starch. 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 randomized, placebo-controlle Read the complete document