Rotate the site of injection to avoid irritation or sterile abscess formation with repeat administration. Intramuscular Depot injection (fluphenazine decanoate or . PACKAGE LEAFLET: INFORMATION FOR THE USER. Modecate® 25mg/ml Injection fluphenazine decanoate. Is this leaflet hard to see or read? Phone . ADMINISTRATION). Fluphenazine decanoate is not indicated for the management of severely agitated psychotic patients or psychoneurotic.
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Send the page ” ” to a friend, relative, colleague or yourself. We do not record any personal information entered above. Antipsychotics, including fluphenazine, are not FDA-approved for the treatment of dementia-related psychosis in geriatric patients.
In Aprilthe FDA mandated that all manufacturers of atypical antipsychotics e. Death typically occurred due to heart failure, sudden death, or infections primarily pneumonia. In Junethis warning was expanded to include all conventional antipsychotics following an FDA review of data which included 2 population-based, retrospective cohort studies evaluating the risk of death in elderly patients with dementia receiving conventional antipsychotics.
One of the studies found that those receiving atypical antipsychotics had an increase in mortality compared to the placebo group, and that those receiving conventional antipsychotics had a marginally higher risk of death compared to the atypical antipsychotic group.
Modecate Injection 25mg/ml – Summary of Product Characteristics (SmPC) – (eMC)
The causes of death were not available. Investigators from a separate study reported that the risk of death all cause mortality in the conventional antipsychotic group was comparable to and possibly greater than the risk of death in the atypical antipsychotic group. Deaths due to cancer and cardiac disease carried the highest relative risk. Additionally, elderly patients may be more susceptible to the actions and adverse effects of phenothiazines, including tardive dyskinesia, dystonias, orthostatic hypotension, and anticholinergic effects.
Elderly patients taking psychotropic drugs may be at increased risk for falling and consequent hip fractures.
Initiate treatment with lower doses followed by careful dosage titration and close monitoring. 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 fluphenazine 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 exacerbationdelirium possible new-onset or worsening deliriumand 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 decanoaye psychological stressors alone, and provides clearly documented evidence of persistence.
The LTCF must evaluate the appropriateness of the antipsychotic during or decanaote 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 packags antipsychotics should include evaluation of ongoing effectiveness, rationale for use, and potential adverse effects e. Antipsychotics are subject to periodic review for effectiveness, fkuphenazine, and the potential for gradual dose reduction GDR or discontinuation. Refer to the OBRA guidelines for complete information. Piperazine phenothiazine antipsychotic; 2 mg orally equivalent to mg of oral chlorpromazine, the prototype antipsychotic; depot IM injections i.
Adjust to lowest effective and tolerated dose. Initially, 1 mg to 2. May increase gradually as needed and tolerated.
The usual initial dose According to the manufacturer, a single injection may be effective for up to 3 fuphenazine 4 weeks, and can be as long as 6 weeks in a few patients on maintenance therapy.
For doses greater than 50 mg, increase cautiously in increments of It may be advisable that patients with no history of taking phenothiazines be treated initially with a shorter-acting form of fluphenazine before administering the decanoate to determine response to fluphenazine and to establish an appropriate dosage.
Those with known hypersensitivity to phenothiazines or who are predisposed to undue reactions should have therapy initiated with oral or immediate-release parenteral fluphenazine hydrochloride before receiving fluphenazine decanoate. When the pharmacologic effects and an appropriate fluphenazne are apparent, an equivalent dose of fluphenazine decanoate may be administered. There is no exact formula for conversion from oral therapy to the decanoate; flupjenazine, results from 1 study indicated that 20 mg fluphenazine hydrochloride orally daily was equivalent to 25 mg of fluphenazine decanoate every 3 weeks.
This represents an approximate conversion ratio of Oral medication should be discontinued after the first injection has been given. Prior to the third dose, determine if the patient may be able to have the dose reduced, to compensate for accumulation toward steady state. The dose may be reduced by either giving a lower dose at the same interval or the same dose at longer intervals.
Failure to reduce the dose as steady state is approached can result in avoidable adverse effects, particularly akathisia. Do not increase the dose to prolong the dosing interval. Fluphenazine decanoate is not indicated for acute symptom management.
It is a long-acting flupyenazine antipsychotic intended for use in the management of patients requiring prolonged parenteral antipsychotic therapy. The fluphenazind starting dose is 1.
Depending on the severity and duration of symptoms, the total initial daily dosage may range from 2. In general, the parenteral dose has been found to be approximately one-third to one-half the oral dose.
Convert to oral therapy as soon as oral administration is possible or acute symptoms have subsided. Initially, 1 to 2. Gradual titration of no more than 1 to 2. As daily dosages increase, administer in 2 to 3 divided doses as needed in order to control symptoms or side effects.
Antipsychotics are not FDA-approved for this indication and the labeling of all antipsychotics contains a boxed warning noting an increased risk of death in geriatric patients being treated for behavioral problems associated with dementia.
In addition, the facility must attempt a gradual dose reduction GDR in 2 separate quarters, at least 1 month apart, within the decanoafe year of admission to the facility or after the facility has initiated fluphwnazine antipsychotic, unless clinically contraindicated. After the packagr year, a GDR must be attempted annually unless clinically contraindicated. The GDR may be considered clinically contraindicated if the target symptoms returned or worsened after the most recent GDR attempt within the facility and the physician has documented justification for why attempting additional dose reductions at that time would likely impair the resident’s function or increase distressed behavior.
Fluphenazine decanoate and fluphenazine enanthate are depot injection formulations that are contraindicated in patients with hepatic impairment.
In general, phenothiazines are contraindicated in patients with liver damage. Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed. Administer using a calibrated measuring device.
Dilute fluphenazine just prior to administration with — mL of water, saline, milk, 7-Up, carbonated orange beverage, or the following juices: Do not mix with beverages containing caffeine coffee, colatannics teaor pectinates apple juice or with other liquid medications.
Avoid spilling the solution on the skin and clothing. Administer fluphenazine using a calibrated measuring device. Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. Slight yellow to amber color does not alter potency. However, markedly discolored solutions should be discarded.
Intramuscular IM injection fluphenazine hydrochloride only: Fluphenazine HCl is administered via IM injection only, do not administer intravenously or subcutaneously. However, if irritation occurs, subsequent IM doses may be diluted with 0. Inject slowly and deeply into the upper, outer quadrant of the gluteal muscle using a dry syringe and needle. Keep patient in a recumbent position for at least 30 minutes following injection to minimize hypotensive effects.
Rotate the site of injection to avoid irritation or sterile abscess formation with repeat administration. Intramuscular Depot injection fluphenazine decanoate or fluphenazine enanthate: Fluphenazine decanoate or enanthate injections are administered via IM or subcutaneous injection only, do not administer intravenously.
Fluphenazine depot injections must be drawn up using a dry syringe and needle of at least gauge. Inject slowly and deeply into the upper outer quadrant of the gluteal muscle.
Modecate Injection 25mg/ml
Keep patient in a recumbent position for at least 30 minutes following the initial injection to minimize hypotensive effects. Once dose-stabilized on depot formulation, this precaution may be modified for ambulatory patients as clinically appropriate for the individual. Subcutaneous injection fluphenazine decanoate or fluphenazine enanthate: Fluphenazine depot injection solutions must be drawn up using a dry syringe and a needle of at least gauge. Inject subcutaneously taking care not to inject intradermally.
Fluphenazine is contraindicated for use pacoage patients with known hypersensitivity to fluphenazine or other phenothiazine hypersensitivity. The fluphenazine decanoate depot in oil injections are formulated with sesame oil and benzyl alcohol, and should be avoided in patients with benzyl alcohol hypersensitivity or sesame oil hypersensitivity.
Fluphenazine hydrochloride injection solution is for intramuscular administration only and contains several parabens as preservatives, and should be avoided in patients with paraben hypersensitivity. Some oral preparations of fluphenazine have contained tartrazine dye. Patients with tartrazine dye hypersensitivity should avoid these products.
Fluphenazine is contraindicated in patients with hematological disease. Hematologic effects including leukopenia, neutropenia, and agranulocytosis have been associated with antipsychotic decanozte. A history of drug-induced leukopenia or neutropenia or pre-existing low white blood cell WBC count may increase the likelihood of developing hematologic effects during treatment with an antipsychotic medication.
Discontinuation of the antipsychotic should be considered oackage a clinically significant decline in WBC occurs in the absence of an identifiable cause. Patients with clinically significant neutropenia should be closely monitored for fever and infection, and appropriate medical intervention should be instituted if necessary. Patients with bone marrow suppression secondary to phenothiazine use should not be re-exposed to phenothiazine treatment.
Parenteral fluphenazine is available in different salts formulations, each with specific precautions regarding route of administration and inactive ingredients. Fluphenazine decanoate depot injection in oil formulations may be administered by subcutaneous or intramuscular injection only; intravenous administration should be avoided as injection by this route may result in serious adverse effects.