Chloroquine

Indications

INDICATIONS AND USAGE 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.

Dosage and administration (summary)

DOSAGE & ADMINISTRATION The dosage of chloroquine phosphate is often expressed in terms of equivalent chloroquine base. Each 500 mg tablet of Chloroquine phosphate contains the equivalent of 300 mg chloroquine base. In infants and children the dosage is preferably calculated by body weight. Prophylaxis against chloroquine-sensitive Plasmodium species Adult Dose: The dosage for prophylaxis is 500 mg (= 300 mg base) administered once per week on exactly the same day of each week. Pediatric Dose: The dosage for prophylaxis is 5 mg calculated as base, per kg of body weight, administered once per week on exactly the same day of each week.

Contraindications

CONTRAINDICATIONS 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.

Warnings and precautions

WARNINGS Chloroquine-Resistant Malaria Chloroquine phosphate tablets are not effective against chloroquine-or hydroxychloroquine-resistant strains of Plasmodium species (see CLINICAL PHARMACOLOGY , Microbiology ). Chloroquine resistance is widespread in P. falciparum and is reported in P. vivax . Before using chloroquine for prophylaxis, it should be ascertained whether chloroquine is appropriate for use in the region to be visited by the traveler.

Storage and supply

HOW SUPPLIED 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.

Source: Chloroquine Phosphate (Chloroquine Phosphate) — US FDA prescribing information, 2025-12-10, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.