Medicinal Products

DROLEPTAN 1.25 mg / 2.5 mL

Generic drug of the therapeutic class: Gastro-Entero-Hepatology
active ingredients: Droperidol
laboratory: Prostrakan Limited

IV injectable solution
Box of 10 ampoules of 2.5 ml
All forms

Indication

· Prevention and treatment of postoperative nausea and vomiting (PONV) in adults, and second-line treatment in children (aged 2 to 11) and adolescents (aged 12 to 18).

· Prevention of morphine-induced nausea and vomiting in self-controlled postoperative analgesia in adults (PCA).

Dosage DROLEPTAN 1.25 mg / 2.5 mL Solution for injection IV Box of 10 ampoules of 2.5 ml

Intravenous way. Slowly inject the solution (hypotonic solution).

Some precautions should be taken when administering droperidol (see sections Contraindications and Warnings and Precautions for Use ).

Prevention and treatment of postoperative nausea and vomiting (PONV).

Adults: 0.625 mg to 1.25 mg (1.25 to 2.5 ml).

Elderly patients (over 65 years old): 0.625 mg (1.25 ml).

Renal / hepatic impairment: 0.625 mg (1.25 ml).

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

Children (under 2 years of age): Not recommended.

In the prevention of PONV, droperidol, because of its anti-emetic properties, is indicated in patients with a moderate to severe risk of PONV. The risk should be assessed using validated standard scales or scores, such as the simplified Apfel score.

It is recommended to administer droperidol 30 minutes before the planned end of surgery. If necessary, the administration can be repeated every 6 hours.

In adults, the prevention of early vomiting and late nausea is improved by doses ranging from 0.75 mg to 1.25 mg maximum.

In adults and children, higher doses are associated with an increased risk of sedation and drowsiness.

Prevention of nausea and vomiting induced by the opioids administered in self-controlled analgesia, postoperatively (PCA).

Adults: 15 to 50 micrograms per mg of morphine, without exceeding a maximum daily dose of 5 mg droperidol.

Elderly (over 65 years) and renal and hepatic insufficiency: no data available.

Children (aged 2 to 11) and adolescents (aged 12 to 18): Droperidol is not indicated in the PCA.

In patients who may be at risk for ventricular arrhythmias, pulse oximetry should be performed during administration and for 30 minutes following a single intravenous injection.

For instructions on how to dilute the product before administration, see the section Instructions for Use, Handling, and Disposal .

See also sections Contraindications, Warnings and precautions for use and Pharmacodynamic properties .

Against indications

Droperidol should never be used in the following cases:

Hypersensitivity to droperidol or to any of the excipients of the product;

· Hypersensitivity to butyrophenones;

· Known or suspected prolongation of the QT interval (QTc> 450 ms for women and> 440 ms for men). This includes patients with congenital long QT syndrome, patients with a family history of congenital QT prolongation, and patients treated concomitantly with drugs known to cause torsades de pointes by prolongation of the QT interval. QT interval (see section Interactions with other medicinal products and other forms of interaction );

· Hypokalemia or hypomagnesemia;

· Bradycardia (heart rate <55 beats per minute);

· Concomitant therapy known to induce bradycardia;

Pheochromocytoma;

· Comatose states;

· Parkinson disease ;

· Severe depression

Droleptan side effects

The most commonly reported adverse events in the clinic are drowsiness and sedation. Hypotension, cardiac arrhythmias, neuroleptic malignant syndrome (NMS) and associated symptoms have also been described, but at a lower frequency, as well as abnormal movements such as dyskinesia and anxiety or agitation.

Class of organ systems

Frequent

≥ 1/100 to <1/10

Rare

≥ 1/1000 to <1/10 0

Rare

≥ 1/10 000 to <1/1000

Very rare

<1/10 000

Not known (can not be estimated from the available data)

Blood and lymphatic system disorders

Dyscrasias.

Immune system disorders

Anaphylactic reaction. Angioneurotic edema. hypersensitivity

Metabolism and nutrition disorders

Inappropriate secretion of antidiuretic hormone.

Psychiatric disorders

Anxiety. Agitation / akathisia.

Confusional states. Restlessness.

Dysphoria.

Hallucinations.

Nervous system disorders

Drowsiness.

Dystonia. Oculogyrie.

Extrapyramidal disorders. Convulsions. tremors

Epileptic seizures. Parkinson disease. Psychomotor hyperactivity. Coma

Heart conditions

Tachycardia. Dizzying sensations

Cardiac arrhythmias, including ventricular arrhythmias.

Cardiac arrest. Torsades de pointes. Lengthening the QT interval at the ECG.

Vascular disorders

Hypotension.

Syncope.

Respiratory, thoracic and mediastinal disorders

Bronchospasm. Laryngospasm.

Skin and subcutaneous tissue disorders

Transient rashes.

General disorders and administration site conditions

Neuroleptic malignant syndrome (NMS).

Sudden death

Some of the possible symptoms of NMS have sometimes been reported, including changes in body temperature, rigidity and fever. A change in mental state, with confusion or agitation and impaired consciousness, has been observed. Autonomic instability may manifest as tachycardia, fluctuation of blood pressure, excessive sweating / salivation, and tremors. In extreme cases, NMS may result in coma or kidney and / or hepatobiliary problems.

Prolonged exposure in psychiatric indications has been associated with isolated cases of amenorrhea, galactorrhea, gynecomastia, hyperprolactinemia and oligomenorrhea.

Cases of venous thromboembolism including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic medications; the frequency is unknown.

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