Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
PRIMAQUINE PHOSPHATE (UNII: H0982HF78B) (PRIMAQUINE - UNII:MVR3634GX1)
Golden State Medical Supply, Inc.
ORAL
PRESCRIPTION DRUG
Primaquine phosphate is indicated for the radical cure (prevention of relapse) of vivax malaria. 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.
Primaquine Phosphate USP Tablets are solid oral formulation round tablet debossed "BY4" available in 26.3 mg and 100 count. Available in bottles of 14 (NDC 60429-035-14), 28 (NDC 60429-035-28), and 100 (NDC 60429-035-01). Store at controlled room temperature: 25°C (77°F); excursions are permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP/NF.
Abbreviated New Drug Application
PRIMAQUINE PHOSPHATE- PRIMAQUINE PHOSPHATE TABLET GOLDEN STATE MEDICAL SUPPLY, INC. ---------- PRIMAQUINE PHOSPHATE TABLETS, USP WARNING PHYSICIANS SHOULD COMPLETELY FAMILIARIZE THEMSELVES WITH THE COMPLETE CONTENTS OF THIS LEAFLET BEFORE PRESCRIBING PRIMAQUINE PHOSPHATE. 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:_Microcrystalline Cellulose, Pregelatinized Starch, Lactose Monohydrate, Magnesium Stearate, Purified water, Hypromellose, Opadry Purple, Titanium Dioxide, Macrgol/PEG, FD&C Red #40 and FD&C Blue #2. CLINICAL PHARMACOLOGY Primaquine phosphate is an 8-aminoquinoline 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._ 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 Прочетете целия документ