Rx Item-Primaquine 26.3Mg Tab 100 By Aventis Pharma

PRIMAQUINE PHOSPHATE- primaquine phosphate tablet, film coated
sanofi-aventis U.S. LLC

DESCRIPTION

Primaquine phosphate is 8-[(4-Amino-1-methylbutyl)amino]-6-methoxyquinoline phosphate, a synthetic compound with potent antimalarial activity. Each tablet contains 26.3 mg of primaquine phosphate (equivalent to 15 mg of primaquine base). The dosage is customarily expressed in terms of the base.

Inactive Ingredients: Carnauba Wax, Hydroxypropyl Methylcellulose, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol 400, Polysorbate 80, Pregelatinized Starch, Red Ferric Oxide, Talc, Titanium Dioxide.

CLINICAL PHARMACOLOGY



Primaquine phosphate is an 8-amino-quinoline compound which eliminates tissue (exoerythrocytic) infection. Thereby, it prevents the development of the blood (erythrocytic) forms of the parasite which are responsible for relapses in vivax malaria. Primaquine phosphate is also active against gametocytes of Plasmodium falciparum.

Primaquine Phosphate Indications and Usage

Primaquine phosphate is indicated for the radical cure (prevention of relapse) of vivax malaria.

CONTRAINDICATIONS

Severe glucose-6-phosphate dehydrogenase (G6PD) deficiency (see WARNINGS).

Pregnant women (see WARNINGS, Usage in Pregnancy).

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.

WARNINGS

Hemolytic anemia and G6PD deficiency
Due to the risk of hemolytic anemia in patients with G6PD deficiency, G6PD testing has to be performed before using primaquine. Due to the limitations of G6PD tests, physicians need to be aware of residual risk of hemolysis and adequate medical support and follow-up to manage hemolytic risk should be available.

Primaquine should not be prescribed for patients with severe G6PD deficiency (see CONTRAINDICATIONS).

In case of mild to moderate G6PD deficiency, a decision to prescribe primaquine must be based on an assessment of the risks and benefits of using primaquine. If primaquine administration is considered, baseline hematocrit and hemoglobin must be checked before treatment and close hematological monitoring (e.g. at day 3 and 8) is required. Adequate medical support to manage hemolytic risk should be available.

RX ITEM-Primaquine 26.3Mg Tab 100 By Ave
NDC 00024-1596-01 UPC/GTIN No.3-00241-59601-1 Mfg.Part W, P97 tablet , pink , round round Black inkW within a squareNo.00024-1596-01

Primaquine 26.3Mg Tab 100 By Aventis Pha
BRAND: PRIMAQUINE NDC: 00024-1596-01,24159601 UPC: 3-00241-59601-1,300241596011 Aventis Pharmaceuticals

PRIMAQUINE PHOSPHATE ORAL
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