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Primaquine

Generic Name: Primaquine phosphate
Dosage Form: tablet, film coated

DESCRIPTION

Primaquine phosphate is 8-[(4-Amino-1-methylbutyl) amino]-6-methoxyquinoline phos-phate, 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: C15H21N3O•2H3PO4 Molecular Weight: 455.34

Inactive Ingredients: Hypromellose, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Triacetin, Pregelatinized Starch, FD&C Yellow#6/Sunset Yellow FCF Aluminum Lake, Talc, Titanium Dioxide.

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 granulo-cytopenia, such as rheumatoid arthritis and lupus erythematosus. The drug is also contra-indicated 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.

Warnings

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 glucose-6-phosphate dehydrogenase (G-6-PD) deficiency and in individuals with a family or personal history of favism. Areas of high prevalence of G-6-PD 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 glucose-6-phosphate dehydrogenase) while receiving Primaquine and related drugs.

Usage in Pregnancy

Safe usage of this preparation in pregnancy has not been established. Therefore, use of it during pregnancy should be avoided except when in the judgment of the physician the benefit outweighs the possible hazard.

PRECAUTIONS

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. It is also advisable to make routine blood examinations (particularly blood cell counts and hemoglobin determinations) during therapy.

If Primaquine phosphate is prescribed for (1) an individual who has shown a previous idiosyncrasy to Primaquine phosphate (as manifested by hemolytic anemia, methemoglobinemia, or leukopenia), (2) an individual with a family or personal history of favism, or (3) an individual with erythrocytic glucose-6-phosphate dehydrogenase (G-6-PD) deficiency or nicotinamide adenine dinucleotide (NADH) methemoglobin reductase deficiency, the person should be observed closely for tolerance. The drug should be discontinued immediately if marked darkening of the urine or sudden decrease in hemoglobin concentration or leukocyte count occurs.

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 InteractionsADVERSE REACTIONS, and OVERDOSAGE).

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 glucose-6-phosphate dehydrogenase (G-6-PD) deficient individuals, and methemoglobinemia in nicotinamide adenine dinucleotide (NADH) methemoglobin reductase deficient individuals.

Cardiac: Cardiac arrhythmia and QT interval prolongation (see PRECAUTIONS, OVERDOSAGE).

OVERDOSAGE

Symptoms of overdosage of Primaquine phosphate include abdominal cramps, vomiting, burning epigastric distress, central nervous system and cardiovascular disturbances, cyanosis, including cardiac arrhythmia and QT interval prolongation, methemoglobinemia, moderate leukocytosis or leukopenia, and anemia. The most striking symptoms are granulocytopenia and acute hemolytic anemia in sensitive persons. Acute hemolysis occurs, but patients recover completely if the dosage is discontinued.

DOSAGE & 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 Tablets USP are supplied as Orange colored, round, biconvex, film-coated tablets of 26.3 mg (= 15 mg base), debossed with a "059" on one side and plain on the other side.

Available in bottles of 100 (NDC 52682-059-01) and bottles of 500 (NDC 52682-059-03)

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 eliminate 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.

Revised June 2016

Manufactured By:

Ingenus Pharmaceuticals NJ, LLC

140 New Dutch Lane

Fairfield, NJ 07004

PRINCIPAL DISPLAY PANEL - 26.3 mg Tablet Bottle Label

NDC 52682-059-01    100 tablets

NDC 52682-059-03    500 tablets

Primaquine PHOSPHATE 
Primaquine phosphate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:52682-059
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
LACTOSE MONOHYDRATE  
CELLULOSE, MICROCRYSTALLINE  
STARCH, PREGELATINIZED CORN  
TALC  
MAGNESIUM STEARATE  
HYPROMELLOSE 2910 (15 MPA.S)  
FD&C YELLOW NO. 6  
TITANIUM DIOXIDE  
TRIACETIN  
Product Characteristics
Color orange Score no score
Shape ROUND (biconvex) Size 7mm
Flavor Imprint Code 059
Contains         
Packaging
# Item Code Package Description
1 NDC:52682-059-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
2 NDC:52682-059-03 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206043 06/23/2016
Labeler - Ingenus Pharmaceuticals NJ, LLC (964680206)
Registrant - Ingenus Pharmaceuticals NJ, LLC (964680206)
Establishment
Name Address ID/FEI Operations
Ingenus Pharmaceuticals NJ, LLC 964680206 manufacture(52682-059), analysis(52682-059), label(52682-059), pack(52682-059)
Revised: 06/2016
 
Ingenus Pharmaceuticals NJ, LLC
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