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HALOPERIDOL DECANOATE LA is a brand name for Haloperidol, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
Adverse reactions following the administration of haloperidol decanoate 50 (intramuscular) or haloperidol decanoate 100 (intramuscular) are those of haloperidol. Since vast experience has accumulated with haloperidol, the adverse reactions are reported for that compound as well as for haloperidol decanoate (intramuscular).
As with all injectable medications, local tissue reactions have been reported with haloperidol decanoate (intramuscular). Cardiovascular Effects Tachycardia, hypotension, and hypertension have been reported. QT prolongation and/or ventricular arrhythmias have also been reported, in addition to ECG pattern changes compatible with the polymorphous configuration of torsade de pointes, and may occur more frequently with high doses and in predisposed patients (see WARNINGS and PRECAUTIONS).
Central Nervous System Effects Extrapyramidal Symptoms (EPS):
EPS during the administration of haloperidol have been reported frequently, often during the first few days of treatment. EPS can be categorized generally as Parkinson-like symptoms, akathisia, or dystonia (including opisthotonos and oculogyric crisis).
While all can occur at relatively low doses, they occur more frequently and with greater severity at higher doses. The symptoms may be controlled with dose reductions or administration of antiparkinson drugs such as benztropine mesylate USP or trihexyphenidyl hydrochloride USP.
It should be noted that persistent EPS have been reported; the drug may have to be discontinued in such cases.
Withdrawal Emergent Neurological Signs:
Generally, patients receiving short-term therapy experience no problems with abrupt discontinuation of antipsychotic drugs. However, some patients on maintenance treatment experience transient dyskinetic signs after abrupt withdrawal.
In certain of these cases the dyskinetic movements are indistinguishable from the syndrome described below under Tardive Dyskinesia except for duration. Although the long-acting properties of haloperidol decanoate (intramuscular) provide gradual withdrawal, it is not known whether gradual withdrawal of antipsychotic drugs will reduce the rate of occurrence of withdrawal emergent neurological signs.
Tardive Dyskinesia:
As with all antipsychotic agents, haloperidol has been associated with persistent dyskinesias. Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may appear in some patients on long-term therapy with haloperidol decanoate (intramuscular) or may occur after drug therapy has been discontinued.
The risk appears to be greater in elderly patients on high-dose therapy, especially females. The symptoms are persistent, and in some patients, appear irreversible. g. protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Sometimes these may be accompanied by involuntary movements of extremities and the trunk. Haloperidol Decanoate LA Injection Page 12 of 31 There is no known effective treatment for tardive dyskinesia; antiparkinson agents usually do not alleviate the symptoms of this syndrome.
It is suggested that all antipsychotic agents be discontinued if these symptoms appear. Should it be necessary to reinstitute treatment, or increase the dosage of the agent, or switch to a different antipsychotic agent, the syndrome may be masked.
It has been reported that fine vermicular movements of the tongue may be an early sign of tardive dyskinesia and if the medication is stopped at that time the full syndrome may not develop.
Tardive Dystonia:
Tardive dystonia, not associated with the above syndrome, has also been reported. Tardive dystonia is characterized by delayed onset of choreic or dystonic movements, is often persistent, and has the potential of becoming irreversible.
Other CNS Effects:
Toxic confusional states, insomnia, restlessness, anxiety, euphoria, agitation, drowsiness, depression, lethargy, stupor, headache, confusion, vertigo, grand mal seizures, exacerbation of psychotic symptoms including hallucinations, and catatonic-like behavioural states which may be responsive to drug withdrawal and/or treatment with anticholinergic drugs.
Body as a Whole Neuroleptic malignant syndrome (NMS), hyperpyrexia and heat stroke have been reported with haloperidol. ) Hematologic Effects Reports have appeared citing the occurrence of mild and usually transient leukopenia and leukocytosis, minimal decreases in red blood cell counts, anemia, or a tendency toward lymphomonocytosis.
Agranulocytosis has rarely been reported to have occurred with the use of haloperidol, and then only in association with other medication. Liver Effects Impairment of liver function and/or jaundice or hepatitis have been reported rarely.
One case of photosensitization is known and isolated cases of idiosyncratic cutaneous involvement have been observed. Dermatologic Reactions Maculopapular and acneiform skin reactions and isolated cases of photosensitivity and loss of hair.
Endocrine Disorders Lactation, breast engorgement, mastalgia, menstrual irregularities, gynecomastia, impotence, increased libido, hyperglycemia, hypoglycemia and hyponatremia. Gastrointestinal Effects Heartburn, weight loss, weight gain, anorexia, constipation, diarrhea, hypersalivation, dyspepsia, Haloperidol Decanoate LA Injection Page 13 of 31 nausea and vomiting.
Patients should be advised of the risk of severe constipation during haloperidol decanoate treatment, and that they should tell their doctor if constipation occurs or worsens, as they may need laxatives. Autonomic Reactions Dry mouth, blurred vision, urinary retention, diaphoresis, priapism and incontinence.
Respiratory Effects Laryngospasm, bronchospasm and increased depth of respiration. Special Senses Cataracts, retinopathy and visual disturbances. Post-marketing Events Hyperammonemia […]