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  • Fludecate
    / Unipharm

    Active Ingredient
    Fluphenazine (decanoate) 25 mg/ml

    Status in Israel

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft


    5 X 1 ml X 25 mg/ml

    partial basket chart 893 6052

    Related information


    See prescribing information for full details.


    Maintenance treatment of psychotic disorders, especially schizophrenia.


    Ateriosclerosis, parkinsonism, renal failure, cardiac defects. Not to be used in child under 12 years. Known hypersensitivity. Phenothiazines are contraindicated in patients with suspected or established subcortical brain damage, with or without hypothalamic damage. Patients receiving large doses of CNS depressants (barbiturates, alcohol, narcotics, analgesics, or antihistamines). Comatose or severely depressed states, and in the presence of blood dyscrasias or liver damage.


    Special Precautions

    Patients hypersensitive to one phenothiazine may also be hypersensitive to other phenothiazines. Tardive dyskinesia may develop. Patients who require chronic treatment, the smallest dose and the shortest duration of treatment to produce a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically. Neuroleptic malignant syndrome (NMS). If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. The patient should be closely monitored, since recurrences of NMS have been reported. Pregnancy and lactation, cholestatic jaundice, dermatoses, or other allergic reactions to phenothiazine derivatives. Periodic examinations for blood cell count, liver function tests and urine tests for bilirubin and bile should be considered. Ophthalmological examinations may be required at periodic intervals. History of epilepsy, possible liver damage, abnormal thyroid function, glaucoma or prostatic hypertrophy, patients exposed to extreme heat, organophosphorus insecticides, and in patients receiving atropine or related drugs. When discontinuing extended therapy, a gradual reduction in dosage over several weeks is recommended. Pschotic patients should be monitored carefully for possible hypotensive phenomena. Intramuscular injections should be administered slowly and deeply into the upper, outer quadrant of the buttock. Ability to perform potentially-hazardous tasks may be impaired.

    Side Effects

    Extrapyramidal symptoms including pseudoparkinsonism, dystonia, akathisia, oculogyric crises, opisthotonus and hyperreflexia. These extrapyramidal symptoms are usually reversible. Drowsiness or lethargy, dry mouth or salivation, nausea, vomiting, diarrhea, anorexia, constipation, fecal impaction, urinary retention, frequency or incontinence, bladder paralysis, polyuria, nasal congestion, pallor, myosis, mydriasis, blurred vision, glaucoma, perspiration, hypertension, hypotension and change in pulse rate, postural hypotension, tachycardia, ECG changes, skin disorders, hematological, liver damage, weight change, peripheral edema, abnormal lactation, gynecomastia, menstrual irregularities, false results on pregnancy tests, pigmentation of the skin.
    See prescribing information for full details.

    Drug interactions

    Alcohol, CNS depressants, opiate analgesics, antihypertensives, anticholergenics, levodopa, metoclopramide, reserpine, anticonvulsants, clinidine, adrenaline, amphetamine, β-blockers, lithium, hypoglycemics, cardioactive or neuroleptic agents, disulfiram.

    Rafa Laboratories Ltd.