International generic name
Drug form and composition
Solution for injection. One ampoule of 1 ml contains 5 mg Haloperidol.
Psychomotor excitation in acute psychosis of different genesis (reactive psychosis,
schizoaffective psychosis) acute neurosis with anxiety and tenseness; vomiting,
resistant to other medicines.
Dosage and administration
In acute psychosis - 2-5 mg intramuscularly. The same dose may be repeated in
1-hour or in 4-8-hours, in order to control clinical manifestations. Maximal daily
dose in severe cases is 100 mg. In prompt treatment of the acute psychosis Haloperidol
can be applied slowly intravenously (5 mg per minute) in dose 20-50 mg. If necessary
the same dose can be repeated in 30 minutes. Alternatively the dose can be diluted
in 30-50 ml saline and applied as an intravenous infusion within 30 minutes. Duration
of the treatment and dosage should be individualized, depending on the disease,
its severity, and patient toleration.
Parkinson’s disease; hypersensitivity to the preparation; epilepsy; hyperthyroidism;
glaucoma; coronary artery disease; severe hepatal and renal diseases; pregnancy
Special warnings and precautions
It long-term treatment hepatic and renal function, blood count and blood coagulation
indices should be monitored. The preparation should be combined with care with analgesic
and hypnotic medicines, as it considerably increases their effects. During the treatment
with Haloperidol alcohol consumption should be avoided.
Haloperidol potentiates the effect of the medicines influencing CNS; diminishes
the convulsion threshold and indirectly reduces effectiveness of the anti-epileptic
medicines; potentiates effects of atihypertensive medicines, lithium preparations,
and alcohol; reduces the effect of anticoagulant drugs. Cholinolytic agents reduce
extrapyramidal symptoms caused by Haloperidol.
Following symptoms may develop: dyskinesia; rigidity; somnolence; depression;
ataxia; convulsions; mouth drying; constipation; and rash. In long-term treatment
hyperprolactinemia and body weight increasing were described. Occasionally conduction
disturbances and tachycardia may appear.
Haloperidol, being a butyrophenone derivative, is a neuroleptic. Butyrpherones
possess a powerful dopaminolytic and more weak adrenolytic action. Haloperidol possesses
prominent antipsychotic and anxiolytic effects. It blocks mainly post- and presynaptic
D2-dopamine receptors in CNS. Its effect appears rapidly. For this reason the preparation
is considered an appropriate medicine for prompt treatment of the psychomotor excitation
in different psychotic conditions. Haloperidol is a powerful antiemetic.
10 or 100 ampoules of 1 ml (5 mg).