Medicinal Products

DROLEPTAN 2.5 mg / 1 mL

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

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

Indication

- In adults:
. Prevention of postoperative nausea and vomiting in adults with a moderate to severe risk of PONV, that is to say having 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 children:
. 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 DROLEPTAN 2.5 mg / 1 mL Solution for injection IV Box of 10 ampoules of 1 mL

PREVENTION AND TREATMENT OF NAUSEA AND POST-OPERATIVE VOMITING:
- of the adult:
. Prevention : 0.625 mg to 1.25 mg intravenously, 30 minutes before the end of the surgical procedure.
. Treatment : 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.
- the child:
. Prevention : at a 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 MORPHINICS ADMINISTERED IN AUTOCONTROLATED ANALGESIA, POST-OPERATIVE, IN ADULT:
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, post-operative self-controlled analgesia may also be preceded by a single bolus of droperidol IV. The recommended single bolus dose is 0.625 to 1.25 mg or even 2.5 mg.

Against indications

CONTRAINDICATED:
This medicine MUST NEVER BE USED in the following cases:
- Known hypersensitivity to droperidol or to any of the components of the product.
- comatose states.
- Hypokalemia known.
- Hypomagnesemia.
- Bradycardia less than 55 beats per minute.
- Knowledge of ongoing treatment with a drug resulting in bradycardia, slowing of intracardiac conduction, prolongation of the QT interval (see warnings and precautions for use and interactions). Congenital long QT syndrome. - Severe depressive syndrome.
- Pheochromocytoma (severe hypertension and tachycardia have been observed).
- Breast-feeding: there is a passage of neuroleptic butyrophenones in breast milk; therefore, breastfeeding is contraindicated during the course of treatment.
- In association with:
. sultopride,
. dopaminergic agonists (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramipexole, quinagolide, ropinirole) except for the patient with Parkinson's disease.
(see interactions section).
NOT RECOMMENDED :
This medicine is NOT RECOMMENDED in the following cases:
- In association with:
drugs giving torsades de pointes:
. anti-arrhythmic class la (quinidine, hydroquinidine, disopyramide ...),
. class III antiarrhythmics (amiodarone, sotalol, dofetilide, ibutilide ...),
. some anti-infectives (halofantrine, pentamidine, sparfloxacin and moxifloxacin),
. certain neuroleptics (thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, tiapride, amisulpride, pimozide, haloperidol, etc.),
- in case of acute alcoholism,
- in association with:
. the alcohol,
. levodopa,
. dopaminergic agonists (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramipexole, quinagolide, ropinirole) in Parkinson's disease.
(see interactions section).
- Pregnancy: the maintenance of a good maternal psychic balance is desirable throughout the pregnancy to avoid any decompensation. If medication is necessary to ensure this balance, it should be instituted or continued in an effective dose throughout the pregnancy. Clinical data, although limited, do not support an increase in malformation risk. Injectable neuroleptics used in emergency situations can cause maternal hypotension. Given these data, it is best to avoid using droperidol during pregnancy, regardless of the term.

Droleptan side effects

NEUROPSYCHIC DISORDERS:
- Early dyskinesias (spasmodic torticollis, oculogyric crises, trismus ...).
- Extrapyramidal syndrome:
. akinetic with or without hypertonia, and partially yielding to antiparkinsonian anticholinergics,
. hyperkineto-hypertonic, excito-motor,
. akathisia.
- 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 thymic state.
- Neuroleptic malignant syndrome (see section on warnings and precautions for use: pallor, hyperthermia, vegetative disorders such as sweating and arterial instability, impaired consciousness, coma, elevation of CPK).
CARDIOVASCULAR DISORDERS:
- Mild to moderate hypotension and occasionally tachycardia (reflex) have been observed with droperidol (see section cautionary statements and precautions for use).
- Cases of QT interval prolongation, ventricular arrhythmias, particularly torsades de pointes, and cases of sudden death have been rarely reported during parenteral administration of droperidol. These adverse effects occur mainly in patients treated with high doses of droperidol or in patients with predisposing factors of ventricular arrhythmias (see caution and use precautions and 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 been reported rarely, and usually when combined with other drugs.
NEUROVEGETATIVE DISORDERS:
Orthostatic hypotension.
OTHER:
- skin rash, rash, or anaphylactic reaction have been reported in rare cases.
- exceptionally inappropriate secretion of antidiuretic hormone and angioedema, especially of the tongue.

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