Primaquine phosphate

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# Black Box Warning

# Overview
Primaquine phosphate is an antimalarial aminoquinoline that is FDA approved for the treatment of vivax malaria. There is a Black Box Warning for this drug as shown here.  Common adverse reactions include abdominal pain, nausea.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)

### Vivax Malaria
- 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.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Primaquine phosphate in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Primaquine phosphate in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Primaquine phosphate FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Primaquine phosphate in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Primaquine phosphate in pediatric patients.

# Contraindications
- 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.

# 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.

# Adverse Reactions

## Clinical Trials Experience

### Gastrointestinal
- Nausea
- Vomiting
- Epigastric distress
- Abdominal cramps.

### Hematologic
- Leukopenia
- Hemolytic anemia in glucose-6-phosphate dehydrogenase (G-6-PD) deficient individuals
- Methemoglobinemia in nicotinamide adenine dinucleotide (NADH) methemoglobin reductase deficient individuals.

## Postmarketing Experience
There is limited information regarding Primaquine phosphate Postmarketing Experience in the drug label.

# Drug Interactions
There is limited information regarding Primaquine phosphate Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA):
- 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.
Pregnancy Category (AUS): D
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Primaquine phosphate in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Primaquine phosphate during labor and delivery.

### Nursing Mothers
There is no FDA guidance on the use of Primaquine phosphate in women who are nursing.

### Pediatric Use
There is no FDA guidance on the use of Primaquine phosphate in pediatric settings.

### Geriatic 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.

### Gender
There is no FDA guidance on the use of Primaquine phosphate with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Primaquine phosphate with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Primaquine phosphate in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Primaquine phosphate in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Primaquine phosphate in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Primaquine phosphate in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Oral

### Monitoring
- 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.

# IV Compatibility
There is limited information regarding the compatibility of Primaquine phosphate and IV administrations.

# Overdosage
- Symptoms of overdosage of primaquine phosphate are similar to those seen after overdosage of pamaquine.
- They include:
- Abdominal cramps
- Vomiting
- Burning epigastric distress
- Central nervous system disturbances
- Cardiovascular disturbances
- Cyanosis
- Methemoglobinemia
- Moderate leukocytosis or leukopenia,
- 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.

# Pharmacology

## Mechanism of Action
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.

## Structure
Primaquine phosphate is 8--6-methoxyquinoline phosphate, a synthetic compound with potent antimalarial activity.

## Pharmacodynamics
There is limited information regarding Primaquine phosphate Pharmacodynamics in the drug label.

## Pharmacokinetics
There is limited information regarding Primaquine phosphate Pharmacokinetics in the drug label.

## Nonclinical Toxicology
There is limited information regarding Primaquine phosphate Nonclinical Toxicology in the drug label.

# Clinical Studies
Malariologists agree that malaria produced by Plasmodium vivax is the most difficult form to treat. This is ascribed to the ability of the parasite to develop extremely resistant tissue forms which are not eradicated by ordinary antimalarial compounds.
Thus, 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. However, prior to the discovery of primaquine phosphate, no antimalarial drug was available that could be relied on to eliminate tissue (exoerythrocytic) infection and to prevent relapses. The various investigations made with primaquine in experimentally induced vivax malaria in human volunteers and in persons with naturally occurring infections have demonstrated that the drug is a valuable adjunct to conventional therapy in this refractory form of the disease.

# How Supplied
- Primaquine Phosphate USP Tablets are solid oral formulation round tablet debossed "BY4" available in 26.3 mg and 100 count.
- Available in bottles of 100. (NDC 76385-102-02)

## Storage
- Store at 25 C (77 F)
- Excursions permitted to 15 C  30 C (59 F  86 F)

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Primaquine phosphate Patient Counseling Information in the drug label.

# Precautions with Alcohol
Alcohol-Primaquine phosphate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- PRIMAQUINE PHOSPHATE

# Look-Alike Drug Names
There is limited information regarding Primaquine phosphate Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price