Primaquine Phosphate (Page 2 of 2)
Drug Interactions
Caution is advised if primaquine is used concomitantly with other drugs that prolong the QT interval (see PRECAUTIONS, ADVERSE REACTIONS, and OVERDOSAGE).
Geriatric Use
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.
Cardiac: Cardiac arrhythmia and QT interval prolongation (see PRECAUTIONS, OVERDOSAGE).
Nervous System: Dizziness.
Skin and Soft Tissue: Rash, pruritus.
OVERDOSAGE
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.
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.
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.
REFERENCES
1. Shubber EK, Jacobson-Kram D, Williams JR. Comparison of the Ames assay and the induction of sister chromatid exchanges: results with ten pharmaceuticals and five selected agents. Cell Biol Toxicol. 1986;2:379–99.
2. Chatterjee T, Muhkopadhyay A, Khan KA, Giri AK. Comparative mutagenic and genotoxic effects of three antimalarial drugs, chloroquine, primaquine and amodiaquine. Mutagenesis. 1998;13:619–24.
3. Marss TC. Bright JE, Morris BC. Methemoglobinogenic potential of primaquine and its mutagenicity in the Ames test. Toxicol Lett. 1987;36:281–7.
4. Ono T, Norimatsu M, Yoshimura H. Mutagenic evaluation of primaquine, pentaquine and pamaquine in the Salmonella/mammalian microsome assay. Mutat Res. 1994;325:7–10.
5. Giovanella F, Ferreira GK, de Prá1 SDT, et al. Effects of primaquine and chloroquine on oxidative stress parameters in rats. An Acad Bras Cienc (Annals of the Brazilian Academy of Sciences). 2015;87:1487–1496.
6. Trutter JA, Reno FE, Durloo RS. Teratogenicity studies with a candidate antileishmanial drug. The Toxicologist. 1983;3:65.
7. Beveridge E, Caldwell IC, Latter VS, Neal RA, Udall V, Waldron MM. The activity against Trypanosoma cruzi and cutaneous leishmaniasis, and toxicity, of moxipraquine (349C59). Trans R Soc Trop Med Hyg. 1980;74:43–51.
Revised July 2017
Manufactured for:
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY
©2017 sanofi-aventis U.S. LLC
PRINCIPAL DISPLAY PANEL — 26.3 mg Tablet Bottle Label
P-425 NDC 0024-1596-01
Rx only
Primaquine phosphate
Tablets, USP
26.3 mg (=15 mg base)
Store at 25° C (77° F); excursions
permitted to 15° C — 30° C
(59° F — 86° F) [see USP Controlled
Room Temperature].
NSN 6505-01-348-2465
100 tablets SANOFI
PRIMAQUINE PHOSPHATE primaquine phosphate tablet, film coated | ||||||||||||||||||||||||||
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Labeler — Sanofi-Aventis U.S. LLC (824676584) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Bayer Healthcare LLC | 072827066 | ANALYSIS (0024-1596), LABEL (0024-1596), MANUFACTURE (0024-1596), PACK (0024-1596) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Curia New York, Inc. | 124193793 | ANALYSIS (0024-1596), API MANUFACTURE (0024-1596) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Bausch Health Companies Inc. | 245141858 | ANALYSIS (0024-1596), LABEL (0024-1596), MANUFACTURE (0024-1596), PACK (0024-1596) |
Revised: 11/2021 Sanofi-Aventis U.S. LLC
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