Generic
Flupentixol Dihydrochloride
2 brands available in the market
At a glance
Flupentixol Dihydrochloride is used for short-term symptomatic treatment of mild to moderate depression and schizophrenia.
Description
Introduction: Flupentixol Dihydrochloride is a low-dose neuroleptic of the thioxanthene group. In low doses (up to 3 mg/day), flupentixol has an anxiolytic, antidepressive and mood stabilizing effect and certain activating properties. It is indicated in schizophrenia and other psychoses, particularly with apathy and withdrawal, but not mania or psychomotor hyperactivity.
How it works: Flupentixol Dihydrochloride acts mainly through a blockage of central monoamine receptors, especially in the dopaminergic system. At low doses, it exhibits anxiolytic, antidepressive and mood-stabilizing effects with some activating properties.
Important Information: Patients often respond to flupentixol within two or three days. If no effect has been observed within one week at maximum dosage, the drug should be withdrawn.
Indications
- Short-term symptomatic treatment of mild to moderate depression: with or without anxiety, or where treatment with other antidepressants has failed.
- Schizophrenia and other psychoses: particularly with apathy and withdrawal, but not mania or psychomotor hyperactivity.
Therapeutic class
SSRIs & related anti-depressant drugs
Pharmacological class
Thioxanthene group neuroleptic
Pharmacology
Flupentixol Dihydrochloride is a low-dose neuroleptic of the thioxanthene group. In low doses (up to 3 mg/day), flupentixol has an anxiolytic, antidepressive and mood stabilizing effect and certain activating properties. It acts mainly through a blockage of central monoamine receptors, especially in the dopaminergic system.
Patients often respond to flupentixol within two or three days. If no effect has been observed within one week at maximum dosage, the drug should be withdrawn.
Mechanism of action
Flupentixol Dihydrochloride blocks dopamine receptors in the CNS to alleviate psychosis and depression. It also affects serotonin and noradrenaline levels, which helps improve mood.
Dosage
Adult (Depression):
- Standard initial dosage: 1 mg as a single morning dose.
- After one week, the dose may be increased to 2 mg if there is inadequate clinical response.
- Daily dosage of more than 2 mg should be in divided doses up to a maximum of 3 mg.
- Due to activating properties, give the last dose no later than evening.
Adult (Psychosis):
- Standard initial dosage: 3 to 9 mg twice daily, adjusted according to response.
- Maximum 18 mg daily.
Elderly:
- Standard initial dosage: 0.5 mg as a single morning dose.
- After one week, if response is inadequate, dosage may be increased to 1 mg once a day.
- Maximum 2 mg a day in divided doses (1 mg at breakfast time and 1 mg at about evening).
Children: Not recommended in children.
* Use as directed by the registered physician
Administration
Oral tablet. Can be taken with or without food. Swallow whole, do not chew or crush.
Missed dose
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and follow your regular schedule.
Side effects
Main Side Effects (Extrapyramidal symptoms):
- Parkinsonian symptoms (including tremor): May occur more commonly in adults or the elderly.
- Dystonia: Abnormal face and body movements - occur more commonly in children or young adults.
- Akathisia (restlessness): Characteristically occurs after large initial doses.
- Tardive dyskinesia: Rhythmic, involuntary movements of tongue, face, and jaw - usually develops on long-term therapy or with high dosage.
Other Side Effects:
- Drowsiness
- Apathy
- Agitation, excitement and insomnia
- Dizziness
- Headache
- Confusion
- Gastro-intestinal disturbances
- Nasal congestion
- Antimuscarinic symptoms (dry mouth, constipation, difficulty with micturition, and blurred vision)
- Cardiovascular symptoms (hypotension, tachycardia, and arrhythmias)
- ECG changes
- Endocrine effects (menstrual disturbances, galactorrhoea, gynaecomastia, impotence, and weight gain)
- Blood dyscrasias
- Photosensitisation
- Jaundice
Precautions & warnings
Precautions:
- Use with caution in patients with Parkinson's disease, severe arteriosclerosis, senile confusional state, or severe hepatic, renal, cardiovascular, cerebrovascular or respiratory disease.
- Avoid during pregnancy and lactation (especially first and last trimesters).
- Caution in epilepsy or conditions predisposing to epilepsy.
- Caution in severe respiratory disease.
- Caution in patients with a history of jaundice or blood dyscrasias.
- Elderly are particularly susceptible to postural hypotension and to hyper or hypothermia - use with caution.
- As photosensitisation may occur with higher dosages, patients should avoid direct sunlight.
Contraindications
Contraindications:
- Excitable and overactive patients
- Comatose states
- Pre-existing CNS depression
- Bone marrow suppression
- Phaeochromocytoma
- Severe alcohol, barbiturate and opiate intoxications
- Severe depression requiring ECT and/or hospitalization
- Pregnancy (avoid unless essential)
Drug interactions
Drug Interactions:
- Dosage adjustments may be necessary when given with drugs that produce postural hypotension.
- Phenothiazines reduce the antihypertensive action of guanethidine and other adrenergic neuron blockers.
- May potentiate the adverse effects of other antimuscarinics.
- Concomitant administration of metoclopramide may increase the risk of neuroleptic-induced extrapyramidal effects.
- Antiarrhythmics which prolong the QT interval may increase the likelihood of ventricular arrhythmias.
Food interactions
Food Interactions:
- Avoid alcohol as it may increase drowsiness and dizziness.
Use in pregnancy
Use in Pregnancy: As there is no unequivocal evidence as to the safety of flupentixol in human pregnancy, use during pregnancy, especially the first and last trimesters, should be avoided.
Pregnancy Category: C — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Flupentixol is excreted in small amounts in breast milk. It is recommended that mothers receiving flupentixol should not breast feed.
Pediatric use
Pediatric Use: Not recommended in children.
Geriatric use
Geriatric Use: Elderly are particularly susceptible to postural hypotension and to hyper or hypothermia. Serious consideration should be given before prescribing. Initial dose: 0.5 mg in the morning, may be increased to 1 mg if needed.
Renal / hepatic impairment
Renal & Hepatic Impairment:
- Use with caution in hepatic impairment.
- Use with caution in renal impairment.
Overdose effects
Overdose:
- Extrapyramidal symptoms may occur.
- Gastric lavage should be carried out as soon as possible and activated charcoal may be administered.
- Measures aimed at supporting the respiratory and cardiovascular systems should be instituted.
- Epinephrine (adrenaline) must not be used.
- Convulsions may be treated with diazepam and extrapyramidal symptoms with biperiden.
Storage conditions
Storage:
- Do not store above 30°C.
- Keep away from light and wet place.
- Keep out of reach of children.
Chemical structure
Flupentixol Dihydrochloride Tablet