Haldol Decanoate 50 AmpulSend the page " " to a friend, relative, colleague or yourself. We do not record any personal information haldol depot 100mg above. Use haloperidol with caution in the geriatric patient. The elderly are more prone to orthostatic hypotension and have greater sensitivity to anticholinergic effects. In addition, the elderly, test enanthate 250 prices elderly females, may be more likely to haldol depot 100mg extrapyramidal side effects, including tardive dyskinesia. Elderly patients may require lower initial doses of haloperidol, followed by careful titration. Antipsychotics such as haloperidol are not FDA approved for the treatment of dementia-related psychosis in geriatric patients and there is a boxed warning to this effect in the drug labels.
Haldol Decanoate - Summary of Product Characteristics (SmPC) - (eMC)
Send the page " " to a friend, relative, colleague or yourself. We do not record any personal information entered above. Use haloperidol with caution in the geriatric patient. The elderly are more prone to orthostatic hypotension and have greater sensitivity to anticholinergic effects.
In addition, the elderly, particularly elderly females, may be more likely to develop extrapyramidal side effects, including tardive dyskinesia. Elderly patients may require lower initial doses of haloperidol, followed by careful titration. Antipsychotics such as haloperidol are not FDA approved for the treatment of dementia-related psychosis in geriatric patients and there is a boxed warning to this effect in the drug labels.
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials modal duration of 10 weeks , largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1. Over the course of a typical week controlled trial, the rate of death in drug-treated patients was about 4.
Although the causes of death were varied, most of the deaths appeared to be either cardiovascular e. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality.
The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic s of the patients is not clear.
According to the Beers Criteria, antipsychotics are considered potentially inappropriate medications PIMs in elderly patients, and use should be avoided except for treating schizophrenia or bipolar disorder, and for short-term use as antiemetics during chemotherapy. In addition, avoidance of haloperidol is recommended in geriatric patients with the following disease states or symptoms due to the potential for exacerbation of the condition or increased risk of adverse effects: Parkinson's disease symptom exacerbation , delirium possible new-onset or worsening delirium , and dementia adverse CNS effects.
There is an increased risk of stroke and greater rate of cognitive decline and mortality in persons with dementia receiving antipsychotics, and the Beers expert panel recommends avoiding antipsychotics to treat delirium- or dementia-related behavioral problems unless non-pharmacological options have failed or are not possible and the patient is a substantial threat to self or others.
The Panel recommends avoiding antipsychotics in elderly patients with a history of falls or fractures, unless safer alternatives are not available, since antipsychotics can cause ataxia, impaired psychomotor function, syncope, and additional falls; if an antipsychotic must be used, consider reducing use of other CNS-active medications that increase the risk of falls and fractures and implement other strategies to reduce fall risk.
Because antipsychotics can cause or exacerbate hyponatremia and SIADH and the elderly are at increased risk of developing these conditions, sodium levels should be closely monitored when starting or changing dosages of antipsychotics in older adults.
An antipsychotic should generally be used only for the conditions listed in the guidelines e. There is an increased risk of morbidity and mortality in elderly patients treated with antipsychotics for dementia-related psychosis. Therefore, identify and address all possible causes of behavioral or psychological symptoms of dementia BPSD before considering an antipsychotic.
To initiate antipsychotic therapy, behavioral symptoms must be a danger to self or others and are either 1 due to mania or psychosis or 2 the plan of care includes documentation of attempted behavioral interventions except in an emergency.
For acute conditions persisting beyond 7 days, pertinent non-pharmacologic interventions must be attempted, unless clinically contraindicated, and documented. Treatment of non-acute, chronic, or prolonged BPSD must meet all of the OBRA criteria for BPSD treatment, and include monitoring that ensures the behavioral symptoms are not due to a treatable or correctable medical condition, are not due to correctable environmental or treatable psychological stressors alone, and provides clearly documented evidence of persistence.
The LTCF must evaluate the appropriateness of the antipsychotic during or within 2 weeks of admission for a newly admitted resident on an antipsychotic. In all cases, the lowest possible dose and shortest duration should be prescribed. Monitoring of antipsychotics should include evaluation of ongoing effectiveness, rationale for use, and potential adverse effects e.
Antipsychotics are subject to periodic review for effectiveness, necessity, and the potential for gradual dose reduction GDR or discontinuation.
Refer to the OBRA guidelines for complete information. High-potency oral and parenteral conventional antipsychotic structurally related to droperidol Oral formulation and immediate-release intramuscular injection FDA-approved for treating schizophrenia and Tourette's Disorder; immediate-release IM formulation is effective for acute agitation in hospitalized settings An intramuscular depot injection is available for schizophrenic patients requiring prolonged antipsychotic therapy As with all antipsychotics, there is an increased risk of death in elderly patients treated for dementia-related psychosis; IV administration is not FDA-approved and is associated with an increased risk of QT prolongation and torsade de pointes TdP.
For severe, chronic, or refractory target symptoms, initiate with 3 to 5 mg PO given 2 to 3 times per day. Optimal response in geriatric patients is usually obtained with more gradual dosage adjustments and at lower dosages than what is required for younger adults.
Adjust the dose based on response and tolerability. After the initial therapeutic response is achieved, slowly reduce to the lowest effective maintenance dose.
Although a pediatric dose for children and adolescents weighing more than 40 kg is not specified, FDA-approved labeling recommends 0. Higher doses may be required in some cases to achieve prompt control.
Patients who remain severely disturbed or inadequately controlled may require dosage adjustment. After a therapeutic response is achieved, the dosage should be slowly reduced to the lowest effective maintenance dose. If clinically warranted, the dose may be increased by 0. The usual dose range is 0. Patients should be stabilized on an immediate-release antipsychotic before considering a conversion to haloperidol decanoate for treating schizophrenic patients who require prolonged parenteral therapy.
In order to reduce the possibility of an unexpected adverse reaction to haloperidol decanoate, it is recommended that patients be treated with and tolerate short-acting haloperidol. The initial recommended IM depot dose is 10 to 15 times the previous antipsychotic dose in oral haloperidol equivalents, with subsequent adjustments based on response and tolerability.
The initial suggested IM depot dose is 20 times the previous antipsychotic dose in oral haloperidol equivalents, with downward titration on subsequent monthly doses. For all patients, the initial injection should not exceed mg regardless of the previous antipsychotic dose requirements. If conversion requires an initial dose of more than mg, the dose should be divided into 2 injections consisting of an initial injection not to exceed mg followed by the balance in 3 to 7 days.
The usual monthly maintenance range is 10 to 15 times the previous daily oral dose; however, the maintenance dosage should be titrated upward or downward based upon response and tolerability to reach the optimal regimen for each patient. With careful monitoring, haloperidol decanoate can be supplemented with oral haloperidol during dosage adjustments or symptom exacerbation. The initial and usual monthly IM maintenance dose range in geriatric patients is 10 to 15 times the previous antipsychotic dose in oral haloperidol equivalents, with titration upward or downward based on response and tolerability.
The initial injection should not exceed mg regardless of the previous antipsychotic dose requirements. Patients should be assessed periodically to determine the need for continued therapy; short-term treatment may be sufficient in some patients.
Increase based on response. For severe, chronic or refractory target symptoms, 3 to 5 mg PO given 2 to 3 times per day. After therapeutic response is achieved, dosage should be slowly reduced according to patient tolerance and response. The daily dosage may be given in 2 or 3 divided doses. Max for those weighing 40 kg and less: Although a pediatric dose for adolescents weighing more than 40 kg is not specified, FDA-approved labeling recommends 0.
FDA approved labeling states the usual dose range is 0. Repeat doses should be based on clinical response and safety considerations. Geriatric patients may require a lower dose; optimal response is usually obtained with more gradual dosage adjustments and at lower dosage levels.
Use the lowest effective dose and convert to oral therapy as soon as clinically indicated. When switching from IM to oral administration, the parenteral dose administered in the preceding 24 hours may be used initially as the total daily PO dosage. Thereafter, closely monitor the patient for signs and symptoms of efficacy and adverse effects and adjust the dose accordingly.
Depending on the clinical status of the patient, the first oral dose should be given within 12 to 24 hours following the last intramuscular dose. The intravenous route is not FDA approved and is generally not recommended except when no other alternatives are available.
Intravenous administration appears to be associated with a higher risk of QT prolongation and torsade de pointes TdP than other forms of administration. A dose in the range of 1 to 5 mg IV has been suggested, with the dose being repeated at 30 to 60 minute intervals, if needed. A maximum IV dose has not been established. The lowest effective dose should be used in conjunction with conversion to oral therapy as soon as possible. In one small study of children 10 years and older, haloperidol was initiated at 0.
Thereafter, the dose was adjusted as clinically indicated. The mean daily dose was 1. In a separate study enrolling children 2. Haloperidol was associated with significant improvement in withdrawal and stereotypy in children 4. Data from clinical trials assessing dyskinesias in young children 2 to 8 years of age receiving long-term treatment e. The majority of cases have been withdrawal dyskinesias which were reversible. Due to the risk of extrapyramidal effects, haloperidol is generally reserved for children who have not responded to or are intolerant to therapy with an atypical antipsychotic.
The following have been recommended in the literature for adults. Single doses of 0. Repeat doses should be based on clinical response. Single doses of 5 to 10 mg PO or IM. Repeat doses are based on clinical response. Single doses of 10 mg or more PO or IM. The IV route has been used in critically ill patients; the best quality consensus reviews available recommend intermittent dosing; well controlled clinical trials are lacking.
The usual initial dose is 2 mg to 10 mg IV. Many experts begin with a loading regimen of 2 mg IV, followed by repeat doses every 15 to 20 minutes while agitation persists. Thereafter once delirium is controlled, may repeat a dose every 4 to 6 hours, as needed, for a few days. Dosage reductions can be attempted, with tapering doses over several days.
A typical taper regimen for the first day is one-half of the previous hour total dose, given in divided doses. ECG monitoring is recommended during IV administration. The risk increases with higher dosages e. Limited data available, particularly in young children.
A loading dose of 0. Treatment of delirium often consisted of psychosocial, environmental, and, if warranted, pharmaceutical intervention. In general, IV haloperidol was reserved for patients with psychomotor agitation that was acutely threatening to their health.
Pharmaceutical intervention lasted from a few hours to days and, in most cases, was stopped or tapered off during hospitalization or subsequently in an outpatient setting.
Discontinue pharmacotherapy as soon as the acute phase of delirium has resolved. Haloperidol has less potential for producing hypotension as compared to chlorpromazine.