Psychotropic Medication Audit Criteria and Guidelines Fluphenazine decanoate (Prolixin®, decanoate) and Haloperidol decanoate (Haldol®, decanoate) PEFC Approved: July 2021 Indications Label: ● Patients with schizophrenia who require prolonged parenteral antipsychotic therapy Off label: • Schizoaffective disorder Black Box Warning ● Increased mortality in elderly patients with dementia-related psychosis Contraindications ● Severe central nervous system depression or comatose states from any cause ● Hypersensitivity to the drug or derivatives ● Haloperidol decanoate Parkinson’s disease Dementia with Lewy bodies ● Fluphenazine decanoate Suspected or established subcortical brain damage Receiving large doses of hypnotics Blood dyscrasias Hepatic disease Warnings and Precautions ● Severe cardiovascular disorders ● Concomitant use with other CNS depressants ● Diagnosis of a seizure disorder or history of seizures ● Haloperidol only 1 Texas Health and Human Services ● hhs.texas.gov Antipsychotics-decanoates Must not be administered intravenously. QTc prolonging conditions (electrolyte imbalances, drugs known to prolong QTc, underlying cardiac abnormalities, hypothyroidism, familial long QT-syndrome) Leukopenia/neutropenia Thyrotoxicosis Myasthenia gravis Bipolar disorder ● Fluphenazine only History of cholestatic jaundice, dermatoses, or other allergic reactions to phenothiazine derivatives Reduced amounts of anesthetics or CNS depressants may be necessary Effects of atropine may be potentiated Use caution in patients exposed to extreme heat or phosphorus insecticides Pheochromocytoma Adverse Reactions Side Effects Which Require Medical Attention ● Extrapyramidal side effects ● Tardive dyskinesia ● Rashes ● Early symptoms of agranulocytosis (fever, sore throat, weakness) ● Galactorrhea/gynecomastia ● Amenorrhea ● Fluctuating vital signs ● Orthostatic hypotension ● Altered consciousness/lethargy ● Decreased sensation of thirst ● Signs and symptoms of neuroleptic malignant syndrome (NMS) Drug Interactions of Major Significance See: Indiana Univ Drug Interaction Table See: Lexicomp, Micromedex for more information Special Populations ● Pediatrics/Adolescents Safety and efficacy have not been established in children younger than 18 years. 2 Texas Health and Human Services ● hhs.texas.gov Antipsychotics-decanoates ● Geriatric Lower doses recommended in geriatric patients ● Renal No dosage adjustments provided in manufacturer labeling ● Hepatic Haloperidol concentrations may increase in hepatically impaired patients Fluphenazine is contraindicated in patients with hepatic impairment ● Pregnancy and Breastfeeding Review product-specific labeling. Consider risks/benefits in reviewing medication-specific labeling Patient Monitoring Parameters Baseline Tests: ● Pregnancy test (females) ● Waist circumference and BMI (weight in lbs x 703)/height2 in inches ● FPG or HbgA1c ● Fasting lipid profile within 30 days of initiation if not done within last year ● EPS evaluation (exam for rigidity, tremor, akathisia) ● TD assessment ● CMP ● CBC Ongoing Tests: ● Pregnancy test (females) as clinically indicated ● BMI and waist circumference monthly for 6 months then quarterly when dose is stable ● FPG or HbgA1c repeat 3-4 months after starting then at least annually ● Fasting lipid panel 3-4 months after initiating a new antipsychotic and at least annually if lipid levels are in normal range; repeat every 6 months if LDL is > 130 mg/dL ● EPS evaluation weekly after initiation & dose increases, continue 2 weeks after last increase ● TD assessment every 3 months and as clinically indicated ● CMP, CBC as clinically indicated ● Inquiry for symptomatic prolactin elevation yearly (quarterly during 1st year for antipsychotics associated with increased prolactin) ● Prolactin level yearly if symptoms of prolactin elevation (e.g. gynecomastia, amenorrhea) ● Vision questionnaire and ocular evaluation yearly, ocular eval. every 2 years if ≤ 40 years old 3 Texas Health and Human Services ● hhs.texas.gov Antipsychotics-decanoates ● Determine if metabolic syndrome criteria (3 of the 5 criteria) are met 3-4 months after initiating a new antipsychotic medication and at least annually thereafter Dosing ● See HHSC Psychiatric Drug Formulary for dosage guidelines. ● Exceptions to maximum dosage must be justified as per medication rule. 4 Texas Health and Human Services ● hhs.texas.gov .