QUINATE

What it is

QUINATE contains quinine sulfate dihydrate 300 mg per tablet. The tablets are white, round, biconvex film coated tablets. The product contains lactose as an excipient with known effect.

Approved indications

— Treatment of malaria due to strains of *P. falciparum* resistant to chloroquine and the related 4-aminoquinolines.

Dosing overview

Adults: quinine sulfate dihydrate 600 mg (or 450 mg for adults under 50 kg) orally after a meal, 8 hourly for 7 to 14 days, in combination with Pyrimethamine 75 mg and sulfadoxine 1500 mg as a single dose on the second day of treatment. Children: quinine sulfate dihydrate 10 mg per kg body weight (up to 600 mg) orally, 8 hourly for 7 to 10 days, in combination with appropriate single dose of Pyrimethamine and sulfadoxine.

Key safety warnings

Administration of QUINATE may give rise to cinchonism, which is generally more severe in overdose but may also occur in normal therapeutic doses. Patients should be warned not to exceed the prescribed dose because of the possibility of serious, irreversible side effects in overdose. Symptoms of cinchonism include tinnitus, impaired hearing, nausea, and disturbed vision. QUINATE has dose-dependent QT-prolonging effects. Caution is recommended in patients with conditions which predispose to QT-prolongation and in patients with atrioventricular block. QUINATE should be used with caution in patients with heart block, other cardiac conduction defects or other serious heart disease. Quinine-induced thrombocytopenia is an immune-mediated disorder. Severe cases of thrombocytopenia that are fatal or life-threatening have been reported, including cases of haemolytic uraemic syndrome and thrombotic thrombocytopenic purpura. Thrombocytopenia usually resolves within a week upon discontinuation of QUINATE. If QUINATE is not stopped, a patient is at risk for fatal haemorrhage. Serious hypersensitivity reactions reported with quinine sulfate include anaphylactic shock, anaphylactoid reactions, serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis, angioedema, bronchospasm and pruritus. QUINATE stimulates release of insulin from the pancreas, and patients, especially pregnant women, may experience clinically significant hypoglycaemia.

Contraindications

QUINATE is contraindicated in patients hypersensitive to quinine, mefloquine or quinidine or any of the excipients, and in patients with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency. Since thrombocytopenia, which may be fatal, and haemolytic uraemic syndrome with acute renal failure may follow the administration of quinine in highly sensitive patients, a history of this occurrence associated with previous quinine ingestion contraindicates its further use. QUINATE is contraindicated in myasthenia gravis as quinine may cause severe respiratory distress and dysphagia in these patients. QUINATE is contraindicated in tinnitus, optic neuritis or in patients with a history of blackwater fever. QUINATE is contraindicated in haemolysis or haemoglobinuria, and in prolongation of QT interval.

PBS listing

QUINATE 300 mg tablets are listed on the PBS with one item under a streamlined restriction. The ex-manufacturer price is A$8.20.

Regulatory history

QUINATE (ARTG 50707) was first listed on the Australian Register of Therapeutic Goods on 22 November 1994 as a reformulation. The product information was most recently revised on 12 June 2024.