Medicinal Products

DROPERIDOL AGUETTANT 1.25 mg / 1 mL

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

IV injectable solution
Box of 10 ampoules of 1 mL
All forms

Indication

In the adult

· Prevention of postoperative nausea and vomiting in adults with a moderate to severe risk of PONV, ie with at least two risk factors with a simplified APFEL score.

· Treatment of postoperative nausea and vomiting.

· Prevention of nausea and vomiting induced by morphine administered in self-controlled analgesia, postoperatively.

In the child

· Prevention of postoperative nausea and vomiting in children over 2 years of age with moderate to severe risk of PONV, second-line and multimodal management.

· Treatment of postoperative nausea and vomiting.

Dosage DROPERIDOL AGUETTANT 1.25 mg / 1 mL Solution for injection IV Box of 10 ampoules of 1 mL

· Prevention and treatment of postoperative nausea and vomiting:

o of the adult

- Prevention: at a dosage of 0.625 mg to 1.25 mg intravenously, 30 minutes before the end of the surgical procedure.

- Treatment: at the dosage of 0.625 mg to 1.25 mg intravenously, according to the titration technique. Low doses are generally effective. If necessary, the dose may reach 2.5 mg.

o the child

- Prevention: at the dosage of 0.020 to 0.050 mg / kg intravenously, 30 minutes before the end of the surgical procedure.

- Treatment: at the dosage of 0.020 to 0.050 mg / kg intravenously, according to the titration technique. Low doses are generally effective.

· Prevention of nausea and vomiting induced by the opioids administered in self-controlled analgesia, post-operatively, in adults.

During self-controlled postoperative analgesia, each 1 mg bolus of morphine is coupled to a bolus of 0.05 to 0.1 mg droperidol IV, up to a maximum daily dose of 5 mg.

Optionally, postoperative self-controlled analgesia may also be preceded by a single bolus of IV droperidol. The recommended single bolus dose is 0.625 to 1.25 mg or even 2.5 mg.

Against indications

This medicine MUST NEVER BE USED in the following cases:

· Known hypersensitivity to droperidol or any of the components of the product,

· Comatose states,

· Known hypokalemia,

· Hypomagnesemia,

· Bradycardia less than 55 beats per minute,

· Knowledge of ongoing treatment with a drug that causes bradycardia, slowing of intracardiac conduction, prolongation of the QT interval (see Warnings and Precautions and Interactions with Other Drugs and Other Forms sections) interactions ),

Congenital long QT syndrome,

· Severe depressive syndrome,

· Pheochromocytoma (severe hypertension and tachycardia have been observed),

· Breastfeeding

· In association with :

o sultopride,

o Dopaminergic agonists (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramiprexole, quinagolide, ropinirole) apart from the patient with Parkinson's disease (see section 4.5 Interactions with other medicinal products and other forms of interaction ) .

This medicine is NOT RECOMMENDED in the following cases:

· In association with :

o drugs giving torsades de pointes:

class Ia antiarrhythmic agents (quinidine, hydroquinidine, disopyramide, etc.),

o class III antiarrhythmic agents (amiodarone, sotalol, dofetilide, ibutilide ...),

o certain anti-infectives (halofantrine, pentamidine, sparfloxacin and moxifloxacin),

o certain neuroleptics (thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, tiapride, amisulpride, pimozide, haloperidol, etc.),

o in case of acute alcoholism,

o in association with:

§ the alcohol,

§ Levodopa,

§ Dopaminergic agonists (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramiprexole, quinagolide, ropinirole) in Parkinson's disease. (see section Interactions with other drugs and other forms of interaction )

Droperidol Aguettant Adverse Effects

Neuropsychic disorders

· Early dyskinesias (spinal torticollis, oculogyric crises, trismus ...).

· Extrapyramidal syndrome:

o akinetic with or without hypertonia, and partially giving in to antiparkinsonian anticholinergics,

o hyperkineto-hypertonic, excito-motor,

o akathisie.

· Late dyskinesias, occurring during prolonged cures. Antiparkinsonian anti-cholinergic drugs have no action or can cause aggravation.

· Sedation or drowsiness, more marked at the beginning of treatment.

· Indifference, anxious reactions, variation of the mood state.

· Neuroleptic malignant syndrome (see section Warnings and precautions for use ).

Cardiovascular disorders

· Mild to moderate hypotension and occasionally tachycardia (reflex) have been observed with droperidol (see Warnings and Precautions section ).

· Cases of QT prolongation, ventricular arrhythmias, especially torsades de pointes, and sudden death have been reported rarely with parenteral droperidol. These side effects occur mainly in patients treated with high doses of droperidol or in patients with predisposing factors for ventricular arrhythmias (see Warnings and Precautions and Interactions with other medicinal products and other forms of ventricular arrhythmias ). interactions ).

Endocrine and metabolic disorders

· Impotence, frigidity.

· Hyperprolactinemia: amenorrhea, galactorrhea, gynecomastia.

· Thermal dysregulation.

· Weight gain.

· Hyperglycemia, impaired glucose tolerance.

Hematological disorders:

· Moderate and usually transient decreases in the blood count have occasionally been reported.

· Cases of agranulocytosis and thrombocytopenia have only rarely been reported, and usually when combined with other drugs.

Neuro-vegetative disorders

· Orthostatic hypotension.

Other

· Rash, rash, or anaphylaxis have been reported in rare cases.

· Exceptionally inappropriate secretion of antidiuretic hormone and angioedema, especially of the tongue.

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