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

PRINCIPAL DISPLAY PANEL -- 26.3 mg Tablet Bottle Label
(click image for full-size original)
PRIMAQUINE PHOSPHATE
primaquine phosphate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0024-1596
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRIMAQUINE PHOSPHATE (PRIMAQUINE) PRIMAQUINE 15 mg
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
FERRIC OXIDE RED
TALC
TITANIUM DIOXIDE
HYPROMELLOSE 2910 (15000 MPA.S)
STARCH, CORN
Product Characteristics
Color PINK Score no score
Shape ROUND (convex, discoid) Size 8mm
Flavor Imprint Code W;P97
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0024-1596-01 100 TABLET, FILM COATED in 1 BOTTLE None
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 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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