MALARIVON

5-30ml Adults: 30ml PROPHYLAXIS OR SUPPRESSION OF MALARIA, NON-IMMUNE A single weekly dose, as shown in Table 1, beginning two weeks before and continuing four weeks after exposure to infection PROPHYLAXIS OR SUPPRESSION OF MALARIA, PARTIALLY-IMMUNE Half the dose in table 1 every two weeks will afford a high degree of protection.

TREATMENT OF MALARIA, NON-IMMUNE Give twice the dose in Table 1, then give the same dose as in table 1 six hours later and then once a day for two days. TREATMENT OF MALARIA, PARTIALLY IMMUNE Give twice the dose in table 1 once only No distinction is made between the dose for adults and the elderly.

01%; Not known (frequency cannot be estimated from available data) Cardiac disorders - Uncommon: cardiomyopathy has been reported during long term therapy at high doses, which may result in cardiac failure and in some cases a fatal outcome.

- Rare: cardiac arrhythmias, including QT prolongation, torsade de pointes, ventricular tachycardia and ventricular fibrillation have been reported with therapeutic doses of chloroquine as well as with overdose. The risk is greater if chloroquine is administered at high doses.

Fatal cases have been reported. - Not known - hypotension. Nervous system disorders - Very common: headache - Common: convulsions have been reported rarely (these may result from cerebral malaria). - Uncommon: neuropathy - Rare: polyneuropathy - Not known: acute extrapyramidal disorders (such as dystonia, dyskinesia, tongue protrusion, torticollis).

Psychiatric disorders - Very common: insomnia - Common: depression - Rare: psychiatric disorders such as anxiety, agitation, confusion, hallucinations, delirium - Not known: suicidal behaviour, psychosis, aggression, delusion, paranoia, mania, attention deficit, sleep disorders.

Eye disorders - Common: transient blurred vision - Rare: reversible corneal opacity, cases of retinopathy as well as cases of irreversible retinal damage have been reported during long term, high dose therapy. - Not known: maculopathy and macular degeneration have been reported and may be irreversible, macular defects of colour vision, optic atrophy, scotomas, field defects, blindness and pigmented deposits, difficult in focusing, diplopia.

Gastro-intestinal disorders - Very common: gastrointestinal disturbances such as nausea, vomiting, diarrhoea. - Not known: abdominal cramps Blood and lymphatic system disorders - Rare: bone marrow depression, including aplastic anaemia, agranulocytosis, pancytopenia, thrombocytopenia, neutropenia Hepatobiliary disorders - Rare: changes in liver function, including hepatitis and abnormal liver function tests - Immune system disorders - Common: allergic and anaphylactic reactions, including angioedema Ear and labyrinth disorders - Uncommon: ototoxicity such as tinnitus, hypoacusis, nerve deafness.

When used as malaria prophylaxis official guidelines and local information on prevalence of resistance to anti-malarial drugs should be taken into consideration. Irreversible retinal damage and corneal changes may develop during long term therapy and after the drug has been discontinued.

6g/kg (cumulative dose 100g) Patients should be advised to stop taking the drug immediately and seek the advise of their doctor if any disturbances of vision occur. Bone marrow suppression may occur rarely so full blood counts should be carried out during extended treatment.

Caution is required if drugs known to induce blood disorders are used concurrently. Use with caution in patients with impaired hepatic function, particularly cirrhosis. Use with caution in patients with porphyria as the disease may be precipitated.

This may be especially apparent in patients with a high alcohol intake. Use with caution in patients with a renal impairment. Use with caution in patients with a history of epilepsy, convulsions and other neurological disorders. Use with caution in patients with psoriasis as chloroquine may precipitate a severe attack.

Use with caution in patients with severe gastro-intestinal disease. Use with caution in patients with glucose-6-phosphate dehydrogenase deficiency, as there may be risk of haemolysis. 5). Chloroquine has been shown to cause severe hypoglycaemia including loss of consciousness that could be life threatening in patients treated with and without antidiabetic medications.

Patients treated with chloroquine should be warned about the risk of hypoglycaemia and the associated clinical signs and symptoms. Patients presenting with clinical symptoms suggestive of hypoglycaemia during treatment with chloroquine should have their blood glucose level checked and treatment reviewed as necessary.

A small number of cases of diffuse parenchymal lung disease have been identified in patients taking chloroquine. A response after therapy with steroids has been observed in some of these cases. Cases of drug rash with eosinophilia and systemic symptoms (DRESS) syndrome have been identified in patients taking chloroquine.

1 Concomitent use with amiodarone. 5)