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Fluphenazine Hcl

Fluphenazine hcl Prescription
Generic Name: fluphenazine (oral/injection) (floo FEN a zeen)
Brand Name: Permitil, Prolixin, Prolixin Decanoate, Prolixin Enanthate
Physician reviewed fluphenazine patient information - includes fluphenazine description, dosage and directions.
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Fluphenazine Hcl Drug Information:

Fluphenazine is a phenothiazine (FEEN-oh-THYE-a-zeen) antipsychotic medicine that is used to treat psychotic disorders such as schizophrenia. Fluphenazine may also be used for purposes not listed in this medication guide. You should not use fluphenazine if you have liver disease, brain damage, severe depression, a blood cell disorder, or if you are also using large amounts of Alcohol or medicines that make you sleepy. Fluphenazine is not approved for use in older adults with dementia-related psychosis. Learn more

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Fluphenazine Hcl Side Effects

In Summary

Commonly reported side effects of fluphenazine include: depression. Other side effects include: dystonic reaction, cataract, corneal deposits, corneal opacity, pigment deposits on lens, retinitis pigmentosa, akathisia, blurred vision, drowsiness, extrapyramidal reaction, involuntary choreoathetoid movements, lethargy, nasal congestion, protrusion of the tongue, vermiform tongue movement, dysphagia, dysphasia, muscle spasm, tremor, sucking movements of the mouth, and pallor. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to fluphenazine: oral elixir, oral solution concentrate, oral tablets, parenteral injection

Warning

    Increased Mortality in Geriatric Patients with Dementia-related Psychosis
  • Geriatric patients with dementia-related psychosis treated with antipsychotic agents are at an increased risk of death.

  • Analyses of 17 placebo-controlled trials in geriatric patients mainly receiving atypical antipsychotic agents revealed an approximate 1.6- to 1.7-fold increase in mortality compared with that in patients receiving placebo.

  • Most fatalities appeared to result from cardiovascular-related events (e.g., heart failure, sudden death) or infections (mostly pneumonia).

  • Observational studies suggest that conventional or first-generation antipsychotic agents also may increase mortality in such patients.

  • Antipsychotic agents, including fluphenazine, are not approved for the treatment of dementia-related psychosis.

Side effects include:

Extrapyramidal reactions (e.g., pseudo-parkinsonism, dystonia, dyskinesia, akathisia, oculogyric crises, opisthotonos, hyperreflexia), drowsiness, lethargy, weight gain.

For Healthcare Professionals

Applies to fluphenazine: injectable solution, oral concentrate, oral elixir, oral tablet

General

The most commonly reported side effects include extrapyramidal symptoms (e.g., pseudoparkinsonism, dystonia, dyskinesia).

Hematologic

Rare (0.01% to 0.1%): Blood dyscrasias

Frequency not reported: Transient leukopenia/leukopenia, thrombocytopenia, leukocytosis, agranulocytosis/fatal agranulocytosis, cellular depression, eosinophilia, pancytopenia, aplastic/hemolytic anemia, thrombocytopenic or nonthrombocytopenic purpura

Metabolic

Rare (0.01% to 0.1%): Increased serum cholesterol

Frequency not reported: Hyponatremia, loss of appetite, weight changes, blood glucose level alterations and loss of diabetic control

Hepatic

Rare (0.01% to 0.1%): Jaundice

Frequency not reported: Cholestatic jaundice, hepatitis, increased cephalin flocculation and transient liver function test abnormalities (in the absence of jaundice)

Musculoskeletal

Very rare (less than 0.01%): Systemic lupus erythematosus

Frequency not reported: Muscular rigidity, altered creatine phosphokinase, acute, distressing muscle spasms in the face, neck, eyes, tongue, and back

Acute, distressing muscle spasms usually occurred within 24 hours of injection, and required immediate administration of an anticholinergic agent.

Immunologic

Very rare (less than 0.01%): Antinuclear antibodies

Nervous system

Parkinsonism/parkinsonian-like states tended to occur 2 to 5 days after each injection, with a decreased frequency in subsequent injections. This side effect may be reduced by using smaller, more frequent doses or adding an anti-parkinsonism agent temporarily.

Frequency not reported: Opisthotonos, parkinsonism, pseudoparkinsonism/parkinsonian-like states, dyskinesia, tardive dyskinesia, drowsiness, lethargy, headache, dystonia, acute dystonia/acute dystonic reactions, epileptiform attacks, altered consciousness, stupor, coma, neuroleptic malignant syndrome, autonomic instability, hyperreflexia, akinesia, electroencephalographic tracing alterations, alterations in cerebrospinal fluid proteins, cerebral edema, impairment in judgement and mental skills

Cardiovascular

Frequency not reported: Mild hypotension/hypotension, hypertension, arrhythmias, ventricular tachycardia/fibrillation, venous thromboembolism, deep vein thrombosis, edema, peripheral edema, labile blood pressure, tachycardia, ECG changes, fatal cardiac arrest, QT and T-wave changes

ECG changes (including QT and T-wave changes) were dose-related side effects that usually occurred at moderate to high doses. These changes may preclude serious arrhythmias.

Genitourinary

Frequency not reported: Galactorrhea, abnormal lactation, oligomenorrhea, amenorrhea, menstrual irregularities, impotence, priapism, inhibition of ejaculation (men), increased libido (women), impaired sexual function, bladder paralysis, polyuria, urinary hesitance and/or incontinency

Dermatologic

Frequency not reported: Abnormal skin pigmentation, skin rashes, diaphoresis/perspiration, itching, erythema multiforme, contact sensitivity, urticaria, seborrhea, photosensitivity, eczema, exfoliative dermatitis, angioneurotic edema

Abnormal skin pigmentation occurred in patients receiving high doses for long durations of time.

Gastrointestinal

Frequency not reported: Tongue protrusion, dry mouth, constipation, vomiting, nausea, gastric irritation, salivation, fecal impaction, paralytic ileus, difficulty swallowing, aspiration of gastric contents, hypertrophic papillae of the tongue

Ocular

Lens opacities occurred in patients receiving high doses for long durations of time.

Frequency not reported: Oculogyric crises, blurred vision, lens opacities, glaucoma, mydriasis, corneal opacity, pigmentation of the eyes, pigmentary retinopathy, defective color vision, night blindness, deposition of particulate matter in the lens and cornea

Other

Sudden, unexplained/unexpected death occurred in hospitalized patients with psychosis.

Frequency not reported: Neonatal drug withdrawal syndrome

Postmarketing reports: Sudden, unexplained/unexpected deaths, body temperature dysregulation, hypothermia, hyperthermia

Psychiatric

Frequency not reported: Agitation, restlessness, excitement, insomnia, bizarre dreams, increased aggressiveness, reactivation/aggravation of psychotic processes, catatonic and confusional states

Respiratory

Frequency not reported: Nasal congestion, pulmonary embolism, laryngeal dystonia, asthma, throat tightness, difficulty breathing, active fulminating pneumonia or pneumonitis

Endocrine

Frequency not reported: Hyperprolactinemia, gynecomastia, false positive pregnancy test, syndrome of inappropriate antidiuretic hormone secretion

Hypersensitivity

Frequency not reported: Anaphylactic and hypersensitivity reactions

Renal

Frequency not reported: Acute renal failure

Local

Frequency not reported: Local tissue reactions

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Fluphenazine Hcl (www.drugs.com/mtm/fluphenazine.html).