Label: PRIMAQUINE PHOSPHATE- primaquine phosphate tablet, film coated
- NDC Code(s): 0024-1596-01
- Packager: sanofi-aventis U.S. LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated August 18, 2016
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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.Close
- 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.Close
- INDICATIONS AND USAGE
Primaquine phosphate is indicated for the radical cure (prevention of relapse) of vivax malaria.Close
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.Close
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.
When the G6PD status is unknown and G6PD testing is not available, a decision to prescribe primaquine must be based on an assessment of the risks and benefits of using primaquine. Risk factors for G6PD deficiency or favism must be assessed. 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.
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 G6PD deficiency and in individuals with a family or personal history of favism. Areas of high prevalence of G6PD 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 G6PD) while receiving primaquine and related drugs.
Usage in Pregnancy
Safe usage of this preparation in pregnancy has not been established. Primaquine is contraindicated in pregnant women. Even if a pregnant woman is G6PD normal, the fetus may not be (see CONTRAINDICATIONS).
It is not known whether primaquine is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from primaquine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Since anemia, methemoglobinemia, and leukopenia have been observed following administration of large doses of primaquine, the adult dosage of 1 tablet (= 15 mg base) daily for fourteen days should not be exceeded. In G6PD normal patients it is also advisable to perform routine blood examinations (particularly blood cell counts and hemoglobin determinations) during therapy.
If primaquine phosphate is prescribed for an individual who has shown a previous idiosyncratic reaction to primaquine phosphate as manifested by hemolytic anemia, methemoglobinemia, or leukopenia; an individual with a family or personal history of hemolytic anemia or nicotinamide adenine dinucleotide (NADH) methemoglobin reductase deficiency, the person should be observed closely. In all patients, the drug should be discontinued immediately if marked darkening of the urine or sudden decrease in hemoglobin concentration or leukocyte count occurs.
Potential Prolongation of QT Interval
Due to potential for QT interval prolongation, monitor ECG when using primaquine in patients with cardiac disease, long QT syndrome, a history of ventricular arrhythmias, uncorrected hypokalemia and/or hypomagnesemia, or bradycardia (<50 bpm), and during concomitant administration with QT interval prolonging agents (see PRECAUTIONS, Drug Interactions, ADVERSE REACTIONS, and OVERDOSAGE).
Clinical studies of primaquine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
- ADVERSE REACTIONS
Gastrointestinal: Nausea, vomiting, epigastric distress, and abdominal cramps.
Hematologic: Leukopenia, hemolytic anemia in G6PD deficient individuals, and methemoglobinemia in nicotinamide adenine dinucleotide (NADH) methemoglobin reductase deficient individuals.
Nervous System: Dizziness.
Skin and Soft Tissue: Rash, pruritus.Close
Symptoms of overdosage of primaquine phosphate include abdominal cramps, vomiting, burning epigastric distress, central nervous system and cardiovascular disturbances, including cardiac arrhythmia and QT interval prolongation, cyanosis, methemoglobinemia, moderate leukocytosis or leukopenia, and anemia. The most striking symptoms are granulocytopenia and acute hemolytic anemia in G6PD deficient patients. Acute hemolysis occurs, but patients recover completely if the dosage is discontinued.Close
- DOSAGE AND ADMINISTRATION
Primaquine phosphate is recommended only for the radical cure of vivax malaria, the prevention of relapse in vivax malaria, or following the termination of chloroquine phosphate suppressive therapy in an area where vivax malaria is endemic. Patients suffering from an attack of vivax malaria or having parasitized red blood cells should receive a course of chloroquine phosphate, which quickly destroys the erythrocytic parasites and terminates the paroxysm. Primaquine phosphate should be administered concurrently in order to eradicate the exoerythrocytic parasites in a dosage of 1 tablet (equivalent to 15 mg base) daily for 14 days.Close
- HOW SUPPLIED
Primaquine phosphate is supplied as pink, convex, discoid, film-coated tablets of 26.3 mg (= 15 mg base), printed with a "W" and "P97" on one side.
Available in bottles of 100. (NDC 0024-1596-01)
Store at 25° C (77° F); excursions permitted to 15° C – 30° C (59° F – 86° F) [see USP Controlled Room Temperature]
Dispense in tight, light-resistant container as defined in the USP/NF.
- CLINICAL STUDIES
Persons with acute attacks of vivax malaria, provoked by the release of erythrocytic forms of the parasite, respond readily to therapy, particularly to chloroquine phosphate. Primaquine eliminates tissue (exoerythrocytic) infection and prevents relapses in experimentally induced vivax malaria in human volunteers and in persons with naturally occurring infections and is a valuable adjunct to conventional therapy in vivax malaria.Close
- SPL UNCLASSIFIED SECTION
Revised July 2016
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY
©2016 sanofi-aventis U.S. LLCClose
- PRINCIPAL DISPLAY PANEL - 26.3 mg Tablet Bottle Label
P-425 NDC 0024-1596-01 100 tablets
Primaquine phosphate Tablets, USP
26.3 mg (=15 mg base)
Usual Dosage: See package insert.
Dispense in tight, light-resistant container as
defined in the USP/NF. Store at 25° C (77° F);
excursions permitted to 15° C - 30° C (59° F - 86° F)
[see USP Controlled Room Temperature].
- INGREDIENTS AND APPEARANCE
primaquine phosphate tablet, film coated
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0024-1596 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Primaquine Phosphate (UNII: H0982HF78B) (primaquine - UNII:MVR3634GX1) primaquine 15 mg Inactive Ingredients Ingredient Name Strength Carnauba Wax (UNII: R12CBM0EIZ) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) Magnesium Stearate (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Polyethylene Glycol 400 (UNII: B697894SGQ) Polysorbate 80 (UNII: 6OZP39ZG8H) Ferric Oxide Red (UNII: 1K09F3G675) Talc (UNII: 7SEV7J4R1U) Titanium Dioxide (UNII: 15FIX9V2JP) Hypromellose 2910 (15000 MPA.S) (UNII: 288VBX44JC) Starch, Corn (UNII: O8232NY3SJ) Product Characteristics Color PINK Score no score Shape ROUND (convex, discoid) Size 11mm Flavor Imprint Code W;P97 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0024-1596-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 04/15/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA008316 04/15/2011 Labeler - sanofi-aventis U.S. LLC (824676584) Establishment Name Address ID/FEI Business Operations Valeant Pharmaceuticals International 245141858 MANUFACTURE(0024-1596) , PACK(0024-1596) , ANALYSIS(0024-1596) , LABEL(0024-1596)