Generic Drug Therapeutic Class: Neurology-Psychiatry
active ingredients: Droperidol
laboratory: Prostrakan Limited
IM Injectable Solution
Box of 10 ampoules of 2 ml
States of agitation during acute and chronic psychoses and in states of aggression, in adults.
Dosage DROLEPTAN 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 (because of greater sensitivity to sedation and orthostatic hypotension), in patients with a history of adverse effects to neuroleptics or in patients in poor general condition, doses should be decreased by half, then if necessary adapted to the response and clinical effectiveness.
- Similarly, a reduction in the dose 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.
This medicine MUST NEVER BE USED in case of:
- Known hypersensitivity to droperidol or to any of the components of the product.
- comatose states.
- Hypokalemia known.
- Bradycardia less than 55 beats per minute.
- Knowledge of ongoing treatment with a drug that may lead to bradycardia, slowing of intracardiac conduction, prolongation of cardiac repolarization, prolongation of the QT interval (see warnings and interactions).
- 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:
. dopaminergic agonists (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramipexole, quinagolide, ropinirole) except for the patient with Parkinson's disease.
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,
. dopaminergic agonists (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramipexole, quinagolide, ropinirole) in Parkinson's disease.
- 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
LOW DOSES :
- Early dyskinesias (spasmodic torticollis, oculogyric crises, trismus ...).
- Extrapyramidal syndrome:
. akinetic with or without hypertonia, and partially yielding to antiparkinsonian anticholinergics,
. hyperkineto-hypertonic, excito-motor,
- 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 warnings: pallor, hyperthermia, vegetative disorders such as sweating and arterial instability, impaired consciousness, coma, CPK elevation).
- QT interval prolongation, ventricular arrhythmias, particularly torsade de pointes, and sudden death cases have been reported during parenteral administration of droperidol. The occurrence of these adverse effects may be higher in patients treated with high doses of droperidol or in patients with predisposing factors (see warnings and interactions).
- Mild to moderate hypotension and occasionally tachycardia (reflex) have been observed with droperidol (see warnings).
ENDOCRINE AND METABOLIC DISORDERS:
- Impotence, frigidity.
- Hyperprolactinemia: amenorrhea, galactorrhea, gynecomastia.
- Thermal dysregulation.
- Weight gain.
- Hyperglycemia, impaired glucose tolerance.
- 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.
AT HIGHER DOSES :
- skin rash, rash, or anaphylactic reaction have been reported in rare cases.
- exceptionally inappropriate secretion of antidiuretic hormone and angioedema, especially of the tongue.