quinine

quinine bisulphate

Each tablet contains 300mg of quinine bisulphate

Quinine Bisulphate 300mg Tablets are plain white, film-coated tablets for oral administration.

The treatment of Chloroquine-resistant malaria

For the protection of pregnant women, nursing mothers, infants and young children in areas where P. falciparum is resistant to Chloroquine.

Treatment and prevention of nocturnal leg cramps in adults and the elderly, when cramps cause regular disruption of sleep

Acute Malaria

Adults :

600mg three times daily for 7 to 10 days

For the treatment and prevention of nocturnal leg cramps:

Adults including the elderly:

300mg at bedtime

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

4 – 6 years: 300 – 600mg daily

7 – 11 years: 900mg daily in divided doses

- Use in patients hypersensitive to quinine or any of the excipients in the tablet.

- Use in patients with Haemoglobinuria

- Optic neuritis

- Tinnitus

- Myasthenia gravis

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. Such symptoms include tinnitus, impaired hearing, headache, nausea, and disturbed vision.

Before use for nocturnal leg cramps, the risks, which include significant adverse effects and interactions, should be carefully considered relative to the potential benefits. These risks are likely to be of particular concern in the elderly. Quinne should only be considered when cramps are very painful and frequent, when other treatable causes of cramps have been ruled out, and when non-pharmacological measures have not worked. Quinne should not be used for this indication during pregnancy.

Quinine may cause unpredictable serious and life-threatening thrombocytopenia, which is thought to be an idiosyncratic hypersensitivity reaction. Quinne 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.

Effects of other drugs on quinine:

Quinine is metabolised via hepatic oxidative cytochrome P450, predominantly by CYP3A4. There is the potential for increased quinine toxicity with concurrent use of potent CYP3A4 inhibitors, which include azole antifungal drugs and HIV protease inhibitors.

Sub optimal quinine serum levels may result from concomitant use of CYP3A4 inducers, which include Rifampicin, barbiturates, carbamazepine and phenytoin.

Care should be taken when quinine is used in combination with other CYP3A4 substrates, especially those causing prolongation of the QT interval.

Effects of quinine on other drugs.

The plasma concentration of flecanide, digoxin and mefloquine may be increased.

Quinine can decrease plasma concentrations of ciclosprin.

Other drug interactions

There is an increased risk of ventricular arrhythmias with other drugs, which prolong the QT interval, including amiodarone, moxifloxacin, pimozide, thioridazine and halofantrine.

Concurrent use with oral hypoglcaemics may increase the risk of hypoglycaemia.

Quinine may cause hypoprothrombinarmia and enhance the effects of anticoagulants.

Quinine enhances the neuromuscular effects of Suxamethonium.

Concomitant use of quinidine may increase the possibility of cinchonism.

Chloroquine and quinine appear to be antagonistic when given together for P falciparum malaria.

Kent Pharmaceuticals Ltd

(POM)

29 March 2012