Haloperidol decanoate prescribing information

Decanoic acid acts as a non-competitive AMPA receptor antagonist at therapeutically relevant concentrations, in a voltage- and subunit-dependent manner, and this is sufficient to explain its antiseizure effects. [12] This direct inhibition of excitatory neurotransmission by decanoic acid in the brain contributes to the anticonvulsant effect of the MCT ketogenic diet . [12] Decanoic acid and the AMPAr antagonist drug perampanel act at separate sites on the AMPA receptor, and so it is possible that they have a cooperative effect at the AMPA receptor, suggesting that perampanel and the ketogenic diet could be synergistic. [12]

Haloperidol is a typical butyrophenone type antipsychotic that exhibits high affinity dopamine D 2 receptor antagonism and slow receptor dissociation kinetics. [42] It has effects similar to the phenothiazines . [17] The drug binds preferentially to D 2 and α 1 receptors at low dose (ED 50 = and  mg/kg, respectively), and 5-HT 2 receptors at a higher dose (ED 50 =  mg/kg). Given that antagonism of D 2 receptors is more beneficial on the positive symptoms of schizophrenia and antagonism of 5-HT 2 receptors on the negative symptoms, this characteristic underlies haloperidol's greater effect on delusions, hallucinations and other manifestations of psychosis. [43] Haloperidol's negligible affinity for histamine H 1 receptors and muscarinic M 1 acetylcholine receptors yields an antipsychotic with a lower incidence of sedation, weight gain, and orthostatic hypotension though having higher rates of treatment emergent extrapyramidal symptoms .

Haloperidol decanoate is a depot preparation of haloperidol, a commonly used butyrophenone derivative with antipsychotic activity. Haloperidol decanoate has no intrinsic activity: its pharmacodynamic actions are those of haloperidol--primarily that of central antidopamine activity. The monthly administered depot formulation has several clinical and practical advantages over oral haloperidol: better compliance and more predictable absorption; more controlled plasma concentrations; fewer extrapyramidal side effects; less frequent reminders of condition; and reduced medical workload. In open and controlled studies, haloperidol decanoate has produced adequate maintenance or improvement of the condition of patients with psychoses (mainly schizophrenia) when an abrupt change from orally administered haloperidol or other antipsychotic drugs has been instituted. Limited comparative studies indicate that the depot and oral forms of haloperidol are equally effective, and that haloperidol decanoate is at least as effective as depot forms of fluphenazine, pipothiazine, flupenthixol and perphenazine in controlling the symptoms of psychosis. Extrapyramidal side effects and the need for concomitant anti-Parkinsonian drugs may be a problem, but may be less frequent than with oral haloperidol or other depot antipsychotics. Thus, haloperidol decanoate offers a useful alternative in the treatment of psychoses to orally administered haloperidol or to other depot antipsychotic drugs.

Very common (10% or more): Extrapyramidal disorder (up to 34%), hyperkinesia (up to 13%), headache (up to 12%)
Common (1% to 10%): Tardive dyskinesia, dystonia, dyskinesia, akathisia, bradykinesia, hypertonia, somnolence, masked facies, tremor, dizziness, parkinsonism/parkinsonian effects
Uncommon (% to 1%): Convulsion, akinesia, cogwheel rigidity, sedation, involuntary muscle contractions, gait disturbance, persistent tardive dyskinesia
Rare (% to %): Motor dysfunction, neuroleptic malignant syndrome, nystagmus
Frequency not reported: Drowsiness, epileptic/grand mal seizure, vertigo, lethargy
Postmarketing reports: Opisthotonos [ Ref ]

In order to evaluate the efficacy and tolerance to Haloperidol Decanoate, 26 patients with different psychotic disorders were included in a six month's clinical study. The dose administered monthly was equivalent to twenty times the oral daily doses of neuroleptics generally used by these patients. In 92% of the cases an improvement higher than a 70% of the clinical symptoms was achieved, if comparing the baseline with final data. In no patient results inferior to those observed with oral neuroleptics were detected. Adverse reactions like parkinsonism or dyskinesia were present in some patients. However their intensity was mild to moderate, over a short period of time only.

Haloperidol decanoate prescribing information

haloperidol decanoate prescribing information

Very common (10% or more): Extrapyramidal disorder (up to 34%), hyperkinesia (up to 13%), headache (up to 12%)
Common (1% to 10%): Tardive dyskinesia, dystonia, dyskinesia, akathisia, bradykinesia, hypertonia, somnolence, masked facies, tremor, dizziness, parkinsonism/parkinsonian effects
Uncommon (% to 1%): Convulsion, akinesia, cogwheel rigidity, sedation, involuntary muscle contractions, gait disturbance, persistent tardive dyskinesia
Rare (% to %): Motor dysfunction, neuroleptic malignant syndrome, nystagmus
Frequency not reported: Drowsiness, epileptic/grand mal seizure, vertigo, lethargy
Postmarketing reports: Opisthotonos [ Ref ]

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