fluphenazine (Rx)

Brand and Other Names:Modecate, Modecate Concentrate, more...Moditen, Prolixin, RhoFluphenazine
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 1mg
  • 2.5mg
  • 5mg
  • 10mg

elixir

  • 2.5mg/5mL

oral concentrate

  • 5mg/mL

injectable solution

  • 2.5mg/mL (fluphenazine hydrochloride)
  • 25mg/mL (fluphenazine decanoate)

Psychotic Disorders

Fluphenazine hydrochloride

  • 2.5-10 mg/day PO divided q6-8hr initially; maintenance: 1-5 mg PO/IM divided q6-8hr; not to exceed 40 mg/day

Fluphenazine decanoate

  • 16.25-25 mg (25 mg/mL) IM/SC q2weeks; after achieving steady state, effects of a single injection may last 4-6 weeks; use caution titrating dosages; if doses >50 mg needed; use increments of 12.5 mg; not to exceed 100 mg

Dosing considerations

  • Conversion from oral hydrochloride salt to decanoate dosage form: 12.5 mg of decanoate every 3 weeks is approximately equivalent to 10 mg/day of oral hydrochloride and 12.5 mg/day IM/SC

Dosing Modifications

Renal impairment: Use with caution; monitor

Hepatic impairment: Use with caution; monitor

Safety and efficacy not established

1-2.5 mg/day PO; dosage titrated according to response

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Interactions

Interaction Checker

and fluphenazine

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequency Not Defined

            Confusion

            Decreased gag reflex

            Extrapyramidal symptoms

            • Akathisia
            • Dystonia
            • Dyskinesia
            • Muscle stiffness
            • Neuroleptic malignant syndrome (NMS; infrequent but serious)
            • Parkinsonism
            • Tardive dyskinesia

            Common

            • Anticholinergic effects
            • Sedation
            • Weight gain
            • Erectile dysfunction
            • Oligomenorrhea or amenorrhea

            Less common

            • Orthostatic hypotension (after IM injection), tachycardia
            • Agitation, anxiety, cerebral edema, depression, dizziness, euphoria, headache, poikilothermia, restlessness, weakness
            • Anorexia, constipation, dyspepsia, ileus
            • Lens opacities (with prolonged use)

            Uncommon

            • ECG changes
            • Photosensitivity
            • Pruritus
            • Diarrhea
            • Blood dyscrasia
            • Galactorrhea
            • Ejaculatory disorder

            Rare

            • Seizure
            • Priapism
            • Cholestatic jaundice
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            Warnings

            Black Box Warnings

            Patients with dementia-related psychosis who are treated with antipsychotic drugs are at increased risk for death, as shown in short-term controlled trials; deaths in these trials appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature

            This drug is not approved for treatment of patients with dementia-related psychosis

            Contraindications

            Documented hypersensitivity

            Coma, severe hypotension, severe central nervous system (CNS) depression, concurrent use of large amounts of CNS depressants, subcortical brain damage, poorly controlled seizure disorder

            Blood dyscrasias, severe cardiovascular disease, coma, patients receiving large doses of hypnotics, children <12 years (decanoate dosage form only)

            Cautions

            Use caution in glaucoma, prostatic hypertrophy, stenosing peptic ulcer disease (PUD), history of NMS, Parkinson disease, hypocalcemia, renal or hepatic impairment, history of severe reaction to insulin or electroconvulsive therapy (ECT), history of seizures, asthma, respiratory tract infections, cardiovascular disease

            May affect cardiac conduction, which may result in life-threatening arrhythmias

            Mild leukocytosis, leukopenia, and eosinophilia occasionally occur

            Antipsychotic use has been associated with aspiration and esophageal dysmotility; risk increases with age; use caution in patients at risk for aspiration pneumonia

            May be associated with neuroleptic malignant syndrome; monitor for fever, mental status changes, muscle rigidity, and /or autonomic instability

            Dermatologic reactions are common

            May cause pigmentary retinopathy, and lenticular and corneal deposits, especially in prolonged therapy

            May impair core body temperature regulation; caution with strenuous exercise, dehydration, heat exposure, and concomitant medication possessing anticholinergic effects

            CNS depression may impair physical or mental abilities; use caution operationg heavy machinery

            Watch for urinary retention, blurred vision, dry mouth, and constipation as result of anticholinergic effects

            Risk of extrapyramidal symptoms (EPS), NMS, hypotension; hypotension may be particularly severe in patients with pheochromocytoma or mitral insufficiency

            May need anticholinergic antiparkinsonian agent to counter EPS; in case of severe hypotension, use norepinephrine or phenylepinephrine, and do not use epinephrine or dopamine

            Use caution in patients with urinary retention, paralytic ileus, decreased gastrointestinal motility, BPH, visual problems or xerostomia

            Depresses hypothalamic thermoregulatory mechanism; exposure to extreme temperatures may cause hypo- or hyperthermia

            May increase risk of falls, resulting from orthostatic hypotension, somnolence, and motor sensory instability; complete fall risk assessment patients on medications or with diseases that may increase fall risk

            Use associated with increased prolactin levels; clinical significance in patients with breast cancer or other prolactin-dependent tumors unknown

            US Food and Drug Administration (FDA) warning regarding off-label use for dementia in elderly

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Drug enters breast milk; not recommended

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Phenothiazine; antagonizes dopaminergic D1 and D2 receptors; depresses release of hypothalamic and hypophyseal hormones

            Absorption

            Bioavailability: Rapidly absorbed

            Onset: Hydrochloride salt, 1 hr; decanoate, 24-72 hr

            Duration: Hydrochloride salt, 6-8 hr; decanoate, 4 weeks

            Peak plasma time: Hydrochloride salt, 2 hr; decanoate, 8-10 hr

            Peak effect: Decanoate, 48-96 hr

            Elimination

            Half-life: Hydrochloride salt, 14-16 hr; decanoate, 14 days

            Excretion: Urine, feces

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.