fluphenazine (Rx) - Modecate, Modecate Concentrate, more..Moditen, Prolixin, RhoFluphenazine

 
 
 

Adult Dosing & Uses

Dosing Forms & Strengths

tablets

  • 1mg
  • 2.5mg
  • 5mg
  • 10mg

elixir

  • 2.5mg/5mL

oral concentrate

  • 5mg/mL

injectable solution

  • 2.5mg/mL
  • 25mg/mL

Psychotic Disorders

Initial 2.5-10 mg/day PO divided q6-8hr

Maintenance: 1-5 mg PO/IM divided q6-8hr

Not to exceed 40 mg/day

Decanoate: 12.5-75 mg (25 mg/mL) IM/SC q2-4week

Daily PO dose x1.2 = decanoate dose q2week (10 mg PO approximately equals 12.5 mg decanoate)

Geriatric Dosing

1-2.5 mg PO qDay; titrate dose to response

Renal Impairment

Use caution; monitor

Hepatic Impairment

Use caution; monitor

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Pediatric Dosing & Uses

<12 years old: not indicated

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Drug Interactions

Interaction Checker

fluphenazine and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequency Not Defined

            Confusion

            Decreased gag reflex

            EPS

            • Akathesia (60%; maybe less with decanoate form)
            • Dystonia
            • Dyskinesia
            • Muscle stiffness
            • NMS (infrequent but serious)
            • Parkinsonism
            • Tardive dyskinesia

            Common

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

            Less Common

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

            Uncommon

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

            Rare

            • Seizure
            • Priapism
            • Cholestatic jaundice
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            Contraindications & Cautions

            Black Box Warnings

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

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

            Contraindications

            Documented hypersensitivity

            Coma, severe hypotension, severe CNS depression, concurrency with large amounts of CNS depressants, subcortical brain damage, poorly controlled seizure disorder, blood dyscrasias, severe cardiovascular disease

            Narrow-angle glaucoma

            Lactation

            Cautions

            Glaucoma, prostatic hypertrophy, stenosing PUD, history of NMS, Parkinson's disease, hypocalcemia, renal/hepatic impairment, patients who have exhibited a severe reaction to insulin or ECT, history of seizures, asthma, respiratory tract infections, cardiovascular disease

            Mild leukocytosis, leukopenia, and eosinophilia occasionally occur

            Dermatological reactions are common

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

            Risk of EPS, NMS, hypotension

            Hypotension may be particularly severe in patients with pheochromocytoma or mitral insufficiency

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

            In case of severe hypotension, use norepinephrine or phenylepinephrine, do NOT use epinephrine or dopamine

            May need anticholinergic antiparkinsonian agent to counter EPS

            FDA Warning regarding off-label use for dementia in elderly

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            View Category Definitions

            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: enters breast milk; not recommended

            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; dopaminergic D1 and D2 receptor antagonist; depresses release of hypothalamic and hypophyseal hormones

            Pharmacokinetics

            Half-Life: 14-16 hr (hydrochloride); 7-14 d (decanoate)

            Onset: 1 hr; 24-72 hr (decanoate)

            Duration: 6-8 hr; 2 wk (decanoate)

            Peak effect: 48-96 hr (decanoate)

            Peak Plasma Time: 2 hr (hydrochloride); 8-10 hr (decanoate)

            Bioavailability: rapidly absorbed

            Excretion: urine, feces

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            Pricing & Images

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