QUININE SULFATE

Posology For treatment of uncomplicated (falciparum) malaria:

Adult (including elderly) and children aged 12 years and over: 600mg of Quinine Sulfate every eight hours for 7 days. The dose may depend upon the size of the patient, severity of infection, and evidence of renal or liver disease (when the intervals should be increased), due to a prolonged half-life of the drug.

Quinine should usually be combined (simultaneously or sequentially) with a second anti-malarial agent such as doxycycline (adults) or clindamycin (pregnant women and children). For further guidance please refer to the ‘UK malaria treatment guidelines 2016’.

Children aged 11 years and under:

Equivalent of 10mg/kg Quinine Sulfate every eight hours for 7 days 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.

Method of Administration For oral administration.

Cinchonism is more common in overdose, but may occur even after normal doses of quinine. In its mild form symptoms include tinnitus, impaired hearing, rashes, headache, nausea and disturbed vision. 9). Visual disorders may include blurred vision, defective colour perception, visual field constriction and total blindness.

MedDRA system organ class Adverse Reaction Blood and lymphatic system disorders Thrombocytopenia, intravascular coagulation, hypoprothrombinaemia, haemoglobinuria, oliguria, haemolytic-uraemic syndrome, pancytopenia, haemolysis, agranulocytosis, thrombocytopenic purpura Immune system disorders Generalised hypersensitivity reactions including angioneuro oedema, fever, asthma, photosensitivity, hot and flushed ski pruritis, thrombocytopenic purpura and urticaria.

Reports h been received of eczematous dermatitis, oedema, erythema a lichen planus. Metabolism and nutrition disorders Hypoglycaemia Psychiatric disorders Agitation, confusion Nervous system disorders Headache, vertigo, excitement, loss of consciousness, coma and death 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 comp and T wave flattening Respiratory, thoracic and mediastinal disorders Bronchospasm, dyspnoea Gastrointestinal disorders Nausea, vomiting, diarrhoea, abdominal pain after long term administration of quinine 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 Reproductive system and breast disorders toxic doses of quinine may induce abortion, but it is unwise to withhold the drug if less toxic antimalarials are no available Reporting of side effects Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Cinchonism • 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 • Hypersensitivity to quinine may also occur with symptoms of cinchonism together with urticaria, flushing, pruritus, rash, fever, angioedema, dyspnoea and asthma.

Cardiac disorders • Quinine should be used with caution in patients with atrial fibrillation or other serious heart disease. It may cause hypoprothrombinaemia. Glucose-6-Phosphate Dehydrogenase (G-6-PD) Deficiency • The administration of quinine to a patient who has previously been suffering from a chronic and inadequately controlled malarial infection may precipitate an attack of blackwater fever.

However, in some cases deficiency of glucose- 6-phosphate dehydrogenase may have been involved. Glucose-6-phosphate dehydrogenase deficient patients with malaria or taking quinine to treat leg cramps may be at increased risk of haemolysis during quinine therapy.

Quinine may aggravate the symptoms of myasthenia gravis. • Quinine can affect the results of certain urine tests for alkaloids and steroids. It may also interfere with tests for plasma catecholamines as well as slowing the erythrocyte sedimentation rate.

6). • Treatment with quinine should be monitored in case signs of resistance develop. 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 nonpharmacological 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. • Excessive amounts of beverages containing quinine should not be consumed while taking quinine, as this may increase the risk of adverse reactions and toxicity.

• Reduce the dosage (or increase intervals between doses) in renal or hepatic disease. Lactose and sucrose warning • Patients with rare hereditary problems of galactose intolerance, fructose intolerance or sucrose-isomaltase insufficiency, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

• Known hypersensitivity to quinine or any of the excipients in the tablet • Haemoglobinuria • Optic neuritis • Tinnitus • Myasthenia gravis, quinine may cause severe respiratory distress and dysphagia in these patients.