DIMERCAPROL Solution for injection Ref.[9520] Active ingredients: Dimercaprol

Dimercaprol Injection should be used with care in patients with hypertension or impaired renal function. It should be discontinued or continued with extreme caution if acute renal insufficiency develops during therapy. Dimercaprol Injection may not be effective in cases of concomitant renal failure, e.g. in arsine poisoning and some cases of arsenic poisoning. Any abnormal reaction (e.g. pyrexia) occurring after the initial injection of dimercaprol should be assessed before continuing treatment. The use of Dimercaprol Injection does not eliminate the need for the general treatment of poisoning due to the particular heavy metal.

A reaction apparently peculiar to children is fever which may persist during therapy (see section 4.8). It occurs in approximately 30% of children.

A transient reduction of the percentage of polymorphonuclear leukocytes may also be observed (see section 4.8).

Dimercaprol has been reported to induce hemolysis (which may be severe) in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Therefore, high-risk individuals should be screened for G6PD deficiency, and susceptible patients should be monitored for hemolysis during therapy with dimercaprol.

Dimecaprol Injection contains Arachis oil (peanut oil)

Dimercaprol Injection should not be given to patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to Soya, patients with Soya allergy should also avoid Dimercaprol Injection.

Dimercaprol Injection contains benzyl benzoate

May increase the risk of jaundice in newborn babies.

Iron supplements must not be taken during dimercaprol therapy as iron forms toxic complexes with it.

Dimercaprol Injection has been used in Wilson’s disease with successful full-term pregnancies, but since there is no other experience of its use in pregnancy or lactation, it should be prescribed with caution during these periods.

No adverse effects known.

Side effects are relatively frequent, but at the therapeutic dosage employed, are seldom severe enough to warrant cessation of treatment and are almost invariably reversible. There is some evidence to indicate that 30-60 mg of ephedrine sulphate by mouth, given half an hour before each injection of dimercaprol, will reduce these reactions. Also, a minimum interval of four hours between doses appears to reduce side effects.

Dimercaprol may cause the following side effects, particularly at the higher dosage levels:

Blood and lymphatic system disorders: Haemolysis, transient reductions in leukocyte count have also been reported (see section 4.4).

Psychiatric disorders: Anxiety, restlessness

Nervous system disorders: Headache, tingling of the hands and other extremities, tremor. High doses have produced hypertensive encephalopathy with convulsions and coma.

Eye disorders: Burning sensation of the eyes, lacrimation, conjunctivitis, blepharospasm

Cardiac disorders: Elevation of blood pressure accompanied by tachycardia

Respiratory, thoracic and mediastinal disorders: Rhinorrhoea, a feeling of constriction in the chest and throat

Gastrointestinal disorders: Nausea and possibly vomiting, salivation, abdominal pain, burning sensation of the lips, mouth and throat

Hepatobiliary disorders: Hepatotoxicity/liver injury

Skin and subcutaneous tissue disorders: Sweating of the forehead and hands

Musculoskeletal and connective tissue disorders: Muscle pain and spasm, pain in jaw

Renal and urinary disorders: Renal impairment

Reproductive system and breast disorders: Burning sensation in the penis

General disorders and administration site conditions: Local pain may occur at the site of injection and gluteal abscess has occasionally been encountered. Pyrexia.

Investigations: Activated partial thromboplastin time prolonged, blood zinc decreased

Paediatric population

A side effect apparently peculiar to children is a fever which develops after the second or third injection, and persists until treatment with dimercaprol is terminated.

Reporting of suspected adverse reactions

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard).

Not applicable.