Medicinal Products

DROPERIDOL AGUETTANT 5 mg / 2 mL

Droleptan Generic Drug
Therapeutic Class: Neurology-Psychiatry
active ingredients: Droperidol
laboratory: Aguettant

IM Injectable Solution
Box of 10 ampoules of 2 ml
All forms

Indication

States of agitation during acute and chronic psychoses and in states of aggression, in adults.

Dosage DROPERIDOL AGUETTANT 5 mg / 2 mL Solution for injection IM Box of 10 ampoules of 2 ml

The dosage is 5 mg (2 ml) intramuscularly.

In the absence of clinical efficacy observed within 15 to 30 minutes, it is possible to make a new injection of 5 mg (2 ml).

When the clinical situation warrants, IM injections of 5 mg (2 ml) can be performed with a minimum interval of 4 to 6 hours between injections.

In elderly patients (due to greater sensitivity to sedation and orthostatic hypotension), in patients with a history of neuroleptic adverse effects or in patients with poor general health, doses should be decreased in half, then if necessary adapted to the response and clinical effectiveness.

Similarly, a dose reduction should be considered in adolescents.

It is best to administer the treatment under strict clinical supervision.

The dosage should be individualized taking into account the age of the patient, the severity of the symptoms and the response to previous antipsychotic treatments.

Against indications

This medicine MUST NEVER BE USED in case of:

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

· Comatose states,

· Known hypokalemia,

· Bradycardia less than 55 beats per minute,

· Knowledge of ongoing treatment with a drug that may cause bradycardia, slow intracardiac conduction, prolongation of cardiac repolarization, prolongation of the QT interval (see Warnings and Precautions sections) and interactions with other drugs and other forms of interactions ),

· 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 Medications giving torsades de pointes:

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

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

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

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

· In case of acute alcoholism,

· in association with:

o alcohol,

o levodopa,

o dopaminergic agonists (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramiprexole, quinagolide, ropinirole) in parkinsonian patients

(see section Interactions with other medicines and other forms of interaction ).

Droperidol Aguettant Adverse Effects

LOW DOSES

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:

· QT prolongation, ventricular arrhythmias, particularly torsade de pointes, and cases of sudden death have been reported with parenteral droperidol. The occurrence of these adverse effects may be higher in patients treated with high doses of droperidol or in patients with pre-disposing factors (see Warnings and Precautions and Interactions with other medicinal products and other items). forms of interactions ).

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

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.

AT HIGHER DOSES:

Neuro-vegetative disorders:

· Orthostatic hypotension.

Other:

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

· Exceptionally inappropriate secretion of anti-diuretic hormone and angioedema, especially of the tongue.

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