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Basic Drug Info
Drug Name:Primaquine Phosphate
Manufacturer:Sanofi-Synthelabo Inc.
Other Info:Manufactured forSanofi-Synthelabo Inc.New York, NY 10016by Bayer CorporationMyerstown, PA 17067Made In USARevised November 2007Copyright, Sanofi-Synthelabo Inc., 2007PSW-11E



Clinical Trials:


Indications and Usage
Primaquine phosphate is indicated for the radical cure (prevention of relapse) of vivax malaria.
Recurrent disease -- The return of signs and symptoms of cancer after a period of improvement.

Vivax Malaria -- Malaria caused by PLASMODIUM VIVAX. This form of malaria is less severe than MALARIA, FALCIPARUM, but there is a higher probability for relapses to occur. Febrile paroxysms often occur every other day.

Contraindications

Primaquine phosphate is contraindicated in acutely ill patients suffering from systemic disease manifested by tendency to granulocytopenia, such as rheumatoid arthritis and lupus erythematosus.

The drug is also contraindicated in patients receiving concurrently other potentially hemolytic drugs or depressants of myeloid elements of the bone marrow.Because quinacrine hydrochloride appears to potentiate the toxicity of antimalarial compounds which are structurally related to primaquine, the use of quinacrine in patients receiving primaquine is contraindicated.

Similarly, Primaquine should not be administered to patients who have received quinacrine recently, as toxicity is increased.
Systemic disease -- Disease that affects the whole body.

Agranulocytosis -- A decrease in the number of GRANULOCYTES; (BASOPHILS; EOSINOPHILS; and NEUTROPHILS).

Rheumatoid Arthritis -- A chronic systemic disease, primarily of the joints, marked by inflammatory changes in the synovial membranes and articular structures, widespread fibrinoid degeneration of the collagen fibers in mesenchymal tissues, and by atrophy and rarefaction of bony structures. Etiology is unknown, but autoimmune mechanisms have been implicated.

Lupus Erythematosus -- A chronic inflammatory connective tissue disease marked by skin rashes, joint pain and swelling, inflammation of the kidneys, inflammation of the fibrous tissue surrounding the heart (i.e., the pericardium), as well as other problems. Not all affected individuals display all of these problems. Also called systemic lupus erythematosus.

Warnings

Discontinue the use of Primaquine phosphate promptly if signs suggestive of hemolytic anemia occur (darkening of the urine, marked fall of hemoglobin or erythrocytic count).Hemolytic reactions (moderate to severe) may occur in individuals with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency and in individuals with a family or personal history of favism.

Areas of high prevalence of G-6-PD deficiency are Africa, Southern Europe, Mediterranean region, Middle East, South-East Asia, and Oceania.

People from these regions have a greater tendency to develop hemolytic anemia (due to a congenital deficiency of erythrocytic glucose-6-phosphate dehydrogenase) while receiving Primaquine and related drugs.
Branded Drugs
The following US Branded drugs contain Primaquine Phosphate


ARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATE -- SANOFI AVENTIS US LLC

PRIMAQUINE -- SANOFI AVENTIS US LLC


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