PRIMAQUINE PHOSPHATE- 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:

PD-Rx Pharmaceuticals, Inc.

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. 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. 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
PD-RX PHARMACEUTICALS, INC.
----------
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
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 sign