QUININE SULPHATE

1.

For the treatment of chloroquine-resistant malaria:

Adults including the elderly: 600 mg of quinine salt 8-hourly for 7 days. Children: 10 mg of quinine salt per kg bodyweight 8-hourly for 7 days. 2.

For the treatment and prevention of nocturnal leg cramps:

Adults (including elderly): The recommended dose is 200mg at bedtime. The maximum dose is 300mg. A reduction in frequency of leg cramps may take up to 4 weeks to become apparent. Patients should be monitored closely during the early stages of treatment for adverse effects.

After an initial trial of 4 weeks, treatment should be stopped if there is no benefit. Treatment should be interrupted at approximately three monthly intervals to reassess the benefit of treatment. Route of administration: oral

MedDRA system organ class Adverse Reaction Blood and lymphatic system disorders Thrombocytopenia, intravascular coagulation, hypoprothrombinaemia, haemoglobinuria, oliguria, haemolytic-uremic syndrome, pancytopenia, haemolysis, agranulocytosis, thrombocytopenic purpura Immune system disorders Generalised hypersensitivity reactions including angioneurotic oedema and fever Metabolism and nutrition disorders Hypoglycaemia Psychiatric disorders Agitation, confusion Nervous system disorders Headache, vertigo Eye disorders Blurred vision, defective colour perception, visual field constriction Ear and labyrinth disorders Tinnitus, impaired hearing Cardiac disorders Atrioventricular conduction disturbances, hypotension, prolongation of the QT interval, widening of the QRS complex and T wave flattening Respiratory, thoracic and mediastinal disorders Bronchospasm Gastrointestinal disorders Nausea, vomiting, diarrhoea, abdominal pain Skin and subcutaneous tissue disorders Flushing, rash, urticaria, eczematous dermatitis, oedema, erythema, lichen planus, pruritis, photosensitivity Musculoskeletal and connective tissue disorders Muscle weakness, aggravation of myasthenia gravis Renal and urinary disorders Renal insufficiency, acute renal failure

8), should be carefully considered relative to the potential benefits. These risks are likely to be of particular concern in the elderly. Quinine should only be considered when cramps are very painful or frequent, when other treatable causes of cramp have been ruled out, and when non-pharmacological measures have not worked.

6). Quinine may cause unpredictable serious and life-threatening thrombocytopenia, which is thought to be an idiosyncratic hypersensitivity reaction. Quinine should not be prescribed or administered to patients who have previously experienced any adverse reaction to quinine, including that in tonic water or other beverages.

Patients should be instructed to stop treatment and consult a physician if signs of thrombocytopenia such as unexplained bruising or bleeding occur. Quinine should be used with caution in patients with atrial fibrillation or other serious heart disease.

It may cause hypoprothrombinaemia. Patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency may develop acute haemolytic anaemia. Administration of quinine 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. Treatment for night cramps should be stopped if symptoms of cinchonism emerge. 9). Hypersensitivity to quinine may also occur with symptoms of cinchonism together with urticaria, flushing, pruritis, rash, fever, angioedema, dyspnoea and asthma.

Quinine is contra-indicated in patients with:

Hypersensitivity to quinine or to any of the excipient in the tablet Haemoglobinuria during malaria Tinnitus Myasthenia gravis Optic neuritis.