QUININE SULFATE

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.

If quinine resistance is known or suspected on completion of the course additional treatment may be given. This may be one of the following: 1. doxycycline 200mg daily (as a single dose or in 2 divided doses) for at least 7 days. 2. clindamycin 300mg four times daily for 5 days.

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.

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.

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.

• 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.