DROPERIDOL

Posology For intravenous use. To inject slowly the solution (hypotonic solution). 5 ml). 25 mg). Children (below the age of 2 years): not recommended. Administration of droperidol is recommended 30 minutes before the anticipated end of surgery.

Repeat doses may be given every 6 hours as required. The dosage should be adapted to each individual case. The factors to be considered here include age, body weight, use of other medicinal products, type of anaesthesia and surgical procedure.

Prevention of nausea and vomiting induced by morphine and derivatives during post- operative patient controlled analgesia (PCA) Adults: 15 to 50 micrograms droperidol per mg of morphine, up to a maximum daily dose of 5 mg droperidol.

Elderly (over 65 years), renal and hepatic impairment: no data in PCA available. Paediatric population Children (2 to 11 years) and adolescents (12 to 18 years): not indicated in PCA. v. administration. 6. 1.

The most frequently reported events during clinical experience are incidents of drowsiness and sedation. In addition, less frequent reports of hypotension, cardiac arrhythmias, neuroleptic malignant syndrome (NMS) and symptoms associated with NMS, plus movement disorders, such as dyskinesias, plus incidents of anxiety or agitation have occurred.

e. changes in body temperature, stiffness and fever. An alteration in mental status with confusion or agitation and altered consciousness, have been seen. Autonomic instability may manifest as tachycardia, fluctuating blood pressure, excessive sweating/salivation and tremor.

In extreme cases NMS may lead to coma, or renal and/or hepato-biliary problems. Isolated cases of amenorrhoea, galactorrhoea, gynaecomastia, hyperprolactinaemia, and oligomenorrhoea have been associated with prolonged exposure in psychiatric indications.

Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic medicinal products - frequency unknown. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Central Nervous System Droperidol may enhance CNS depression produced by other CNS-depressant drugs. Any patient subjected to anaesthesia and receiving potent CNS depressant medicinal products or showing symptoms of CNS depression should be monitored closely.

5). Use with caution in patients with epilepsy (or a history of epilepsy) and conditions predisposing to epilepsy or convulsions. Cardiovascular Mild to moderate hypotension and occasionally (reflex) tachycardia have been observed following the administration of droperidol.

This reaction usually subsides spontaneously. However, should hypotension persist, the possibility of hypovolaemia should be considered and appropriate fluid replacement administered. Patients with, or suspected of having, the following risk factors for cardiac arrhythmia should be carefully evaluated prior to administration of droperidol: - a history of significant cardiac disease including serious ventricular arrhythmia, second or third degree atrio-ventricular block, sinus node dysfunction, congestive heart failure, ischemic heart disease and left ventricular hypertrophy; - family history of sudden death; - renal failure (particularly when on chronic dialysis); - significant chronic obstructive pulmonary disease and respiratory failure; - risk factors for electrolyte disturbances, as seen in patients taking laxatives, glucocorticoids, potassium-wasting diuretics, in association with the administration of insulin in acute settings, or in patients with prolonged vomiting and/or diarrhoea.

Patients at risk for cardiac arrhythmia should have serum electrolytes and creatinine levels assessed and the presence of QT prolongation excluded prior to administration of droperidol. v. administration. g. potassium-wasting diuretics, laxatives and glucocorticoids.

Substances inhibiting the activity of cytochrome P450 iso-enzymes (CYP) CYP1A2, CYP3A4 or both could decrease the rate at which droperidol is metabolised and prolong its pharmacological action. 5). Patients who have, or are suspected of having, a history of alcohol abuse or recent high intakes, should be thoroughly assessed before droperidol is administered.

1. • Hypersensitivity to butyrophenones; • Known or suspected prolonged QT interval (QTc of > 450 msec in females and > 440 msec in males). 5); • Hypokalaemia or hypomagnesaemia; • Bradycardia (< 55 heartbeats per minute); • Known concomitant treatment leading to bradycardia; • Phaeochromocytoma; • Comatose states; • Parkinson's Disease; • Severe depression.