Chloroquine Phosphate

Generic Name: chloroquine phosphate

Over-the-Counter (OTC)

Brand Names:

Chloroquine Phosphate

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.

Overview

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.

Uses

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).

Dosage

DOSAGE AND ADMINISTRATION The dosage of chloroquine phosphate is often expressed in terms of equivalent chloroquine base. Each 500 mg tablet of chloroquine phosphate tablet 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. The pediatric dose should never exceed the adult dose regardless of weight.

Side Effects

ADVERSE REACTIONS The following adverse reactions have been identified during post-approval use of chloroquine or other 4-aminoqunoline compounds. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Ocular disorders: Maculopathy and macular degeneration have been reported and may be irreversible. Irreversible retinopathy with retinal pigmentation changes (bull’s eye appearance) and visual field defects (paracentral scotomas) in patients receiving long-term or high-dosage 4- aminoquinoline therapy have been reported (see WARNINGS ).

Interactions

Drug Interactions Antacids and kaolin: Antacids and kaolin can reduce absorption of chloroquine; an interval of at least 4 hours between intake of these agents and chloroquine should be observed. Cimetidine: Cimetidine can inhibit the metabolism of chloroquine, increasing its plasma level. Concomitant use of cimetidine should be avoided. Insulin and other antidiabetic drugs: As chloroquine may enhance the effects of a hypoglycemic treatment, a decrease in doses of insulin or other antidiabetic drugs may be required. Arrhythmogenic drugs: There may be an increased risk of inducing ventricular arrhythmias if chloroquine is used concomitantly with other arrhythmogenic drugs, such as amiodarone or moxifloxacin.

Warnings

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. Information regarding the geographic areas where resistance to chloroquine occurs, is available at the Centers for Disease Control and Prevention (www.cdc.gov\malaria). 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 are contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds.

Pregnancy

Pregnancy See WARNINGS , Usage in Pregnancy .

Storage

HOW SUPPLIED 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 42291-047-25 Dispense in tight, light-resistant container as defined in the USP.

Frequently Asked Questions

What is Chloroquine Phosphate used for?

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).

What are the side effects of Chloroquine Phosphate?

ADVERSE REACTIONS The following adverse reactions have been identified during post-approval use of chloroquine or other 4-aminoqunoline compounds. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Ocular disorders: Maculopathy and macular degeneration have been reported and may be irreversible. Irreversible retinopathy with retinal pigmentation changes (bull’s eye appearance) and visual field defects (paracentral scotomas) in patients receiving long-term or high-dosage 4- aminoquinoline therapy have been reported (see WARNINGS ).

Can I take Chloroquine Phosphate during pregnancy?

Pregnancy See WARNINGS , Usage in Pregnancy .

What are the important warnings for Chloroquine Phosphate?

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. Information regarding the geographic areas where resistance to chloroquine occurs, is available at the Centers for Disease Control and Prevention (www.cdc.gov\malaria). 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 are contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.