Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
PRIMAQUINE PHOSPHATE (UNII: H0982HF78B) (PRIMAQUINE - UNII:MVR3634GX1)
Alvogen, Inc.
PRIMAQUINE PHOSPHATE
PRIMAQUINE 26.3 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
PRIMAQUINE PHOSPHATE - PRIMAQUINE PHOSPHATE TABLET, FILM COATED ALVOGEN, INC. ---------- BOXED 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. Molecular Formula C H N O·2H PO Molecular Wt 455.34 Inactive Ingredients: Colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, talc, titanium dioxide, FD&C Yellow #5 aluminum lake, FD&C Yellow #6 aluminum lake, FD&C Blue #2 aluminum lake and FD&C Red #40 aluminum Lake. 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 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 15 21 3 3 4 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 receiv Baca dokumen lengkap