XOMOLIX Solution for injection Ref.[2772] Active ingredients: Droperidol

Posology

Prevention and treatment of post-operative nausea and vomiting (PONV)

Adults: 0.625 mg to 1.25 mg (0.25 to 0.5 ml).

Elderly: 0.625 mg (0.25 ml).

Renal/hepatic impairment: 0.625 mg (0.25 ml).

Paediatric population:

Children (2 to 11 years) and adolescents (12 to 18 years): 20 to 50 microgram/kg (up to a maximum of 1.25 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 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.

Continuous pulse oximetry should be performed in patients with identified or suspected risk of ventricular arrhythmia and should continue for 30 minutes following single i.v. administration.

Method of administration

For intravenous use.

For instructions on dilution of the medicinal product before administration, see section 6.6.

See also sections 4.3, 4.4 and 5.1.

Symptoms

The manifestations of droperidol overdose are an extension of its pharmacologic actions.

Symptoms of accidental overdose are psychic indifference with a transition to sleep, sometimes in association with lowered blood pressure.

At higher doses or in sensitive patients, extrapyramidal disorders may occur (salivation, abnormal movements, sometimes muscle rigidity). Convulsions may occur at toxic doses.

Cases of QT-interval prolongation, ventricular arrhythmias and sudden death have been reported rarely.

Treatment

No specific antidote is known. However, when extrapyramidal reactions occur, an anticholinergic should be administered.

Patients with droperidol overdose should be closely monitored for signs of QT interval prolongation.

Factors which predispose to torsades de pointes, e.g. electrolyte disturbances (especially hypokalaemia or hypomagnesaemia) and bradycardia should be taken into consideration.

Pronounced hypotension should be treated by boosting circulation volume and taking other appropriate measures. Clear airways and adequate oxygenation should be maintained; an oropharyngeal airway or endotracheal tube might be indicated.

If required, the patient should be observed carefully for 24 hours or longer; body warmth and adequate fluid intake should be maintained.

Unopened:

3 years.

After first opening:

For immediate use.

Following dilution:

Compatibility of droperidol with morphine sulphate in 0.9% sodium chloride (14 days at room temperature) has been demonstrated in plastic syringes. From a microbiological point of view, the diluted product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

Store in the original package in order to protect from light.

For storage conditions after dilution, and first opening of the medicinal product, see section 6.3.

Type I amber glass ampoules containing 1 ml solution for injection, in packs of 10 ampoules.

For single use only. Any unused solution should be discarded.

The solution should be inspected visually prior to use. Only clear and colourless solutions free from visible particles should be used.

For use in PCA: Draw droperidol and morphine into a syringe and make up the volume with 0.9% sodium chloride for injection.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.