Adult: For the management of manifestations of psychotic disorders: As fluphenazine hydrochloride: Usual initial dose: 1.25 mg via inj as a single dose. Alternatively, initial dose range of 2.5-10 mg daily given in divided doses at 6- to 8-hour intervals may be needed depending on the severity and duration of symptoms. Once symptoms are controlled, may transfer to oral maintenance therapy. Dosage must be adjusted according to patient response and tolerance; use the lowest possible effective dose.
Adult: For the management of manifestations of psychotic disorders: As fluphenazine hydrochloride: Usual initial dose: 2.5-10 mg daily given in divided doses at 6- to 8-hour intervals depending on severity and duration of symptoms. Usual maintenance dose: 1-5 mg daily, may be given as single daily dose. Dosage must be adjusted according to patient response and tolerance; use the lowest possible effective dose. Elderly: As fluphenazine hydrochloride: Initially, 1-2.5 mg daily, adjusted according to patient response and tolerance.
Parenteral Psychoses, Schizophrenia
Adult: For the maintenance treatment in patient with chronic cases, requiring prolonged parenteral treatment: As fluphenazine decanoate: Usual initial dose: 12.5-25 mg via IM or SC inj, subsequent doses and dosage interval are determined based on patient response. Usual maintenance dose: 12.5-100 mg at intervals of 2 weeks to 5 or 6 weeks. If doses >50 mg are necessary, increase dose cautiously in 12.5 mg increments. Max: 100 mg/dose. Dosage must be adjusted according to patient response and tolerance; use the lowest possible effective dose. Elderly: As fluphenazine decanoate: Initially, 6.25 mg via IM inj, may be adjusted according to patient response and tolerance. Reduced maintenance dose may be necessary.
May be taken with or without food.
Oral liquid concentrate: Dilute in at least 60 mL of milk, tomato or fruit juice, and uncaffeinated soft drinks immediately prior to administration. Do not mix with beverages containing tannics (e.g. tea), caffeine (e.g. coffee, cola), or pectinates (e.g. apple juice).
Comatose or severely depressed states; subcortical brain damage, phaeochromocytoma, marked cerebral atherosclerosis, blood dyscrasias, severe CNS depression; patient receiving large doses of hypnotics. Hepatic impairment. As fluphenazine decanoate: Children.
Patient with paralytic ileus, decreased gastrointestinal motility, xerostomia, urinary retention, benign prostatic hyperplasia, or visual problems; risk factors for blood dyscrasia (e.g. history of drug-induced leucopenia/neutropenia, pre-existing low WBC); risk factors for aspiration pneumonia (e.g. Alzheimer’s disease); CV disease (e.g. mitral insufficiency), cerebrovascular disease, hypovolaemia or other conditions prone to hypotensive reactions; thyrotoxicosis, severe respiratory disease, Parkinson’s disease, Lewy body dementia, diabetes, personal or family history of narrow-angle glaucoma, hypothyroidism, myasthenia gravis; history of seizures or conditions predisposing to epilepsy (e.g. brain damage, alcohol withdrawal). Patients subjected to strenuous exercise or dehydration; exposed to extreme heat or phosphorus insecticides; receiving large doses of phenothiazines who are undergoing surgery. Not indicated for the management of behavioural complications in patients with mental retardation. Avoid abrupt withdrawal. Renal impairment. Elderly (particularly with dementia-related psychosis). Pregnancy and lactation.
Significant: Extrapyramidal symptoms including tardive dyskinesia, akathisia, acute dystonic reactions, pseudoparkinsonism, hyperreflexia, oculogyric crises, opisthotonos; liver damage (prolonged use), reactivation or aggravation of psychosis, silent pneumonia, venous thromboembolism; anticholinergic effects (e.g. constipation, xerostomia, blurred vision, urinary retention), ocular effects with prolonged use (e.g. pigmentary retinopathy, lenticular and corneal deposit), CNS depression, oesophageal dysmotility or aspiration, hyperprolactinaemia, orthostatic hypotension, impaired core body temperature regulation, falls, grand mal convulsions, withdrawal symptoms. Cardiac disorders: Tachycardia, QT interval prolongation. Eye disorders: Glaucoma. Gastrointestinal disorders: Vomiting, nausea, salivation, faecal impaction, paralytic ileus. General disorders and administration site conditions: Lethargy, peripheral oedema. Investigations: Transient LFT abnormalities, blood pressure fluctuations, weight change. Rarely, increased serum cholesterol. Metabolism and nutrition disorders: Hyponatraemia, loss of appetite. Nervous system disorders: Drowsiness, headache, agitation. Psychiatric disorders: Insomnia. Renal and urinary disorders: Urinary retention, polyuria. Reproductive system and breast disorders: Gynaecomastia, menstrual irregularities, erectile dysfunction. Respiratory, thoracic and mediastinal disorders: Nasal congestion. Skin and subcutaneous tissue disorders: Rash, erythema, urticaria, seborrhoea, photosensitivity, eczema, exfoliative dermatitis. Vascular disorders: Hypertension. Potentially Fatal: Neuroleptic malignant syndrome (NMS), arrhythmias, blood dyscrasias (e.g. leucopenia, neutropenia, agranulocytosis).
Patient Counseling Information
This drug may cause drowsiness and impair your mental and physical abilities, if affected, do not drive or operate machinery.
Monitor mental status; vital signs and CBC as clinically indicated; weight, height, BMI, waist circumference at baseline, every visit for the 1st 6 months then quarterly; electrolytes, renal and liver function annually then as clinically indicated; fasting plasma glucose level or HbA1c at baseline then annually; lipid panel at baseline then as clinically indicated; ECG prior to treatment in patient at risk for CV disease. Monitor for anticholinergic and extrapyramidal symptoms; visual changes; signs of hypotension (IM). Perform ocular examination annually (in patients >40 years) or every 2 years (in younger patients).
Symptoms: Severe extrapyramidal symptoms, hypotension, and difficulty breathing. Management: Symptomatic and supportive treatment. For severe hypotension, institute procedures to manage circulatory shock, including administration of IV fluids and vasoconstrictors (e.g. norepinephrine).
May increase risk of QT interval prolongation with class IA (e.g. quinidine, disopyramide, procainamide) and class III (e.g. amiodarone, sotalol) antiarrhythmics; certain tetracyclic antidepressants (e.g. maprotiline), other antipsychotics (e.g. phenothiazines, pimozide), lithium, quinine, pentamidine, sparfloxacin, terfenadine. May potentiate CNS depressant effects of opioids, antihistamines, barbiturates, sedatives, hypnotics, or analgesics. Antagonise the effects of sympathomimetic agents (e.g. epinephrine) and adrenergic-blocking agents (e.g. guanethidine, clonidine). May impair the effects of anti-parkinsonian agents (e.g. levodopa) and anticonvulsant agents. May decrease the metabolism of TCAs. May increase the effect of anticoagulants. May enhance the adverse effects of anticholinergic agents. May enhance the absorption of corticosteroids, digoxin, neuromuscular blocking agents. May increase the risk of hypotension with ACE inhibitors, angiotensin II antagonists, thiazide diuretics, MAOIs, and β-blockers. May increase the risk of extrapyramidal effects with methyldopa.
May potentiate CNS depressant effect of alcohol.
As fluphenazine decanoate: May interfere with the results of positron emission tomography (PET) studies using labelled glucose.
Description: Fluphenazine, a piperazine phenothiazine 1st generation antipsychotic, non-selectively blocks the postsynaptic mesolimbic dopamine D2 receptors in the brain. It has limited activity on histaminergic, muscarinic, and α receptors. Onset: Within 1 hour (as hydrochloride); 24-72 hours (as decanoate). Duration: 6-8 hours (as hydrochloride); approx 4-6 weeks (as decanoate). Pharmacokinetics: Absorption: Rapidly absorbed from the gastrointestinal tract and IM inj sites (as hydrochloride). Slowly absorbed from IM or SC inj sites (as decanoate). Bioavailability: 35%. Time to peak plasma concentration: Oral: 0.5 hours (as hydrochloride); IM: 1.5-2 hours (as hydrochloride); 8-10 hours (as decanoate). Metabolism: Metabolised in the liver by CYP2D6 isoenzyme. Excretion: Via urine and faeces. Elimination half-life: 14.7-15.3 hours (as hydrochloride); 6.8-9.6 days (as decanoate).
Store between 20-25°C. Protect from light. Do not freeze.
N05AB02 - fluphenazine ; Belongs to the class of phenothiazine antipsychotics with piperazine structure.
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