PRIMAQUINE PHOSPHATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Primaquine Phosphate (UNII: H0982HF78B) (primaquine - UNII:MVR3634GX1)

Available from:

Bayshore Pharmaceuticals, LLC

INN (International Name):

Primaquine Phosphate

Composition:

primaquine 15 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Primaquine phosphate is indicated for the radical cure (prevention of relapse) of vivax malaria. Severe glucose-6-phosphate dehydrogenase (G6PD) deficiency (see WARNINGS). Pregnant women (see WARNINGS, Usage in Pregnancy). 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.

Product summary:

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) Store at controlled room temperature: 25°C (77°F); excursions are permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP/NF.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PRIMAQUINE PHOSPHATE- PRIMAQUINE PHOSPHATE TABLET
BAYSHORE PHARMACEUTICALS, LLC
----------
PRIMAQUINE
PHOSPHATE
TABLETS, USP
WARNING
PHYSICIANS SHOULD COMPLETELY FAMILIARIZE THEMSELVES WITH THE
COMPLETE CONTENTS OF THIS LEAFLET BEFORE PRESCRIBING PRIMAQUINE
PHOSPHATE.
DESCRIPTION
Primaquine phosphate is
8-[(4-Amino-1-methylbutyl)amino]-6-methoxyquinoline
phosphate, 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.
_Inactive Ingredients: _Microcrystalline Cellulose, Pregelatinized
Starch, Lactose
Monohydrate, Magnesium Stearate, Purified water, Hypromellose, Opadry
Purple,
Titanium Dioxide, Macrgol/PEG, FD&C Red #40 and FD&C Blue #2.
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
Severe glucose-6-phosphate dehydrogenase (G6PD) deficiency (see
WARNINGS).
Pregnant women (see WARNINGS, Usage in Pregnancy).
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 ha