PRIMAQUINE PHOSPHATE 15 mg/1
PRIMAQUINE PHOSPHATE · TABLET, FILM COATED · Ingenus Pharmaceuticals, LLC
PRIMAQUINE PHOSPHATE is a tablet, film coated containing primaquine phosphate at 15 mg/1, taken oral. Manufactured by Ingenus Pharmaceuticals, LLC.
Key Facts
- Brand Name
- PRIMAQUINE PHOSPHATE
- Generic Name
- PRIMAQUINE PHOSPHATE
- NDC Code (Product)
50742-191- Manufacturer
- Ingenus Pharmaceuticals, LLC
- Strength
- 15 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA206043
- Marketing Start
- 01/23/2018
Recall History
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Primaquine phosphate is indicated for the radical cure (prevention of relapse) of vivax malaria.
Dosage & Administration
DOSAGE AND ADMINISTRATION Primaquine phosphate tablets are 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 tablets should be administered concurrently to eradicate the exoerythrocytic parasites in adults at a dosage of 1 tablet (equivalent to 15 mg base) daily for 14 days. Primaquine phosphate tablets can be taken with or without food. Administration of primaquine phosphate tablets with food may reduce the incidence of gastrointestinal symptoms.
Warnings
WARNINGS Hemolytic Anemia 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. Due to the risk of hemolytic anemia in patients with G6PD deficiency, G6PD testing must be performed before using primaquine. Before initiating treatment, obtain baseline hemoglobin and hematocrit. In case of severe anemia, postpone the G6PD test and decision on treatment with primaquine until recovery. 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. This is of particular importance in individuals with a personal or family history of hemolytic anemia. Patients with G6PD Deficiency Primaquine is contraindicated in patients with severe G6PD deficiency (see CONTRAINDIC…
Contraindications
CONTRAINDICATIONS Known hypersensitivity reactions to primaquine phosphate, other 8-aminoquinolones, or to any component in primaquine. Severe glucose-6-phosphate dehydrogenase (G6PD) deficiency (see WARNINGS, Hemolytic Anemia ). Pregnant women (see WARNINGS, Pregnancy ). Breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if G6PD status is unknown (see WARNINGS, Nursing Mothers ). 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.
Drug Interactions
Drug Interactions Pharmacodynamics Interactions Quinacrine Concurrent use of quinacrine (mepacrine) and primaquine are contraindicated. Increased toxicity was seen when quinacrine was used with pamaquine, another 8-aminoquinoline (see CONTRAINDICATIONS ). Hemolytic Agents and Methemoglobinemia-Inducing Drugs The concurrent administration of hemolytic agents or methemoglobinemia-inducing drugs and primaquine should be avoided (see PRECAUTIONS ). If the concurrent administration cannot be avoided, close blood monitoring is required. QT Interval Prolonging Drugs The pharmacodynamic interaction potential to prolong the QT interval of the electrocardiogram between primaquine and other drugs that effect cardiac conduction is unknown. If primaquine is used concomitantly with other drugs that prolong the QT interval, close and frequent electrocardiogram monitoring is advised (see PRECAUTIONS , ADVERSE REACTIONS , and OVERDOSAGE ). Effects of Other Drugs on the Pharmacokinetics of Primaquine Potent CYP2D6 Inhibitors Published clinical and non-clinical reports indicate reduced CYP2D6 activity may decrease the formation of active metabolites of primaquine, which may reduce antimalarial effica…
Adverse Reactions
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, please call Ingenus Pharmaceuticals, LLC at 1-877-748-1970 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Gastrointestinal: Nausea, vomiting, epigastric distress, abdominal cramps. Hematologic: Leukopenia, hemolytic anemia, decreased hemoglobin, methemoglobinemia. Hemolytic anemia occurs commonly in patients with G6PD deficiency and may be severe or fatal in patients with severe G6PD deficiency (see WARNINGS ). Methemoglobin levels are usually <10%, but methemoglobinemia may be severe in nicotinamide adenine dinucleotide (NADH) methemoglobin reductase deficient individuals or in patients with other risk factors (see PRECAUTIONS ). Leukopenia was observed in patients with rheumatoid arthritis or lupus erythematosus (see PRECAUTIONS ). Cardiac: Cardiac arrhythmia and QT interval prolongation (see PRECAUTIONS , OVERDOSAGE ). Nervous System: Dizziness. Skin and Soft Tissue: Rash, pruritus.
Frequently Asked Questions
What is PRIMAQUINE PHOSPHATE used for?
PRIMAQUINE PHOSPHATE contains PRIMAQUINE PHOSPHATE. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is PRIMAQUINE PHOSPHATE a controlled substance?
PRIMAQUINE PHOSPHATE is not classified as a controlled substance by the DEA.
What is the generic name for PRIMAQUINE PHOSPHATE?
The generic name for PRIMAQUINE PHOSPHATE is PRIMAQUINE PHOSPHATE. There are 3 other brand versions of PRIMAQUINE PHOSPHATE.
What is the NDC code for PRIMAQUINE PHOSPHATE 15 mg/1?
The NDC (National Drug Code) for PRIMAQUINE PHOSPHATE 15 mg/1 is 50742-191, listed by Ingenus Pharmaceuticals, LLC.