Chemical formula: C₂₃H₂₅F₃N₂OS Molecular mass: 434.52 g/mol PubChem compound: 5281881
As the safety of this drug during pregnancy has not been established, use during pregnancy, especially the first and last trimesters, should be avoided, unless the expected benefit to the patient outweighs the potential risk to the foetus.
Neonates exposed to antipsychotics (including flupentixol) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully.
Animal studies have shown reproductive toxicity.
Flupentixol is excreted into the breast milk. If the use of flupentixol is considered essential, nursing mothers should be advised to stop breast-feeding.
In humans, adverse events such as hyperprolactinaemia, galactorrhoea, amenorrhoea, libido decreased, erectile dysfunction and ejaculation failure have been reported. These events may have a negative impact on female and/or male sexual function and fertility.
If clinical significant hyperprolactinaemia, galactorrhoea, amenorrhoea or sexual dysfunctions occur, a dose reduction (if possible) or discontinuation should be considered. The effects are reversible on discontinuation.
In preclinical fertility studies in rats, flupentixol slightly affected the pregnancy rate of female rats.
Alertness may be impaired, especially at the start of treatment, or following the consumption of alcohol; patients should be warned of this risk and advised not to drive or operate machinery until their susceptibility is known. Patients should not drive if they have blurred vision.
Cases of suicidal ideation and suicidal behaviours have been reported during flupentixol therapy or early after treatment discontinuation.
The majority of undesirable effects are dose dependent. The frequency and severity are most pronounced in the early phase of treatment and decline during continued treatment.
Extrapyramidal reactions may occur, especially in the early phase of treatment. In most cases these side effects can be satisfactorily controlled by reduction of dosage and/or use of antiparkinsonian drugs. The routine prophylactic use of antiparkinsonian drugs is not recommended. Antiparkinsonian drugs do not alleviate tardive dyskinesia and may aggravate them. Reduction in dosage or, if possible, discontinuation of flupentixol therapy is recommended. In persistent akathisia a benzodiazepine or propranolol may be useful.
Frequencies are taken from the literature and spontaneous reporting. Frequencies are defined as: very common (≤1/10), common (≤1/100 to <1/10), uncommon (≤1/1,000 to <1/100), rare (≤1/10,000 to <1/1,000), very rare (<1/10,000), or not known (can not be estimated from the available data).
Rare: Thrombocytopenia, neutropenia, leukopenia, agranulocytosis
Rare: Hypersensitivity, anaphylactic reaction.
Rare: Hyperprolactinaemia.
Common: Increased appetite, weight increased.
Uncommon: Decreased appetite.
Rare: Hyperglycaemia, glucose tolerance abnormal.
Common: Insomnia, depression, nervousness, agitation, libido decreased.
Uncommon: Confusional state.
Not known: Suicidal ideation, suicidal Behaviour
Very common: Somnolence, akathisia, hyperkinesia, hypokinesia.
Common: Tremor, dystonia, dizziness, headache, disturbance in attention.
Uncommon to Rare: Tardive dyskinesia, dyskinesia, parkinsonism, speech disorder, convulsion.
Very Rare: Neuroleptic malignant syndrome.
Common: Accommodation disorder, vision abnormal.
Uncommon: Oculogyration.
Common: Tachycardia, palpitations.
Rare: Electrocardiogram QT prolonged.
Uncommon: Hypotension, hot flush.
Not known: Venous thromboemoblism
Common: Dyspnoea.
Very common: Dry mouth.
Common: Salivary hypersecretion, constipation, vomiting, dyspepsia, diarrhoea.
Uncommon: Abdominal pain, nausea, flatulence.
Uncommon: Liver function test abnormal.
Very rare: Jaundice
Common: Hyperhidrosis, pruritus.
Uncommon: Rash, photosensitivity reaction, dermatitis.
Common: Myalgia.
Uncommon: Muscle rigidity.
Common: Micturition disorder, urinary retention.
Not known: Drug withdrawal syndrome neonatal
Uncommon: Ejaculation failure, erectile dysfunction.
Rare: Gynaecomastia, galactorrhoea, amenorrhoea.
Common: Asthenia, fatigue.
Uncommon: Injection site reaction1.
1 For injectable flupentixol presentations.
As with other drugs belonging to the therapeutic class of antipsychotics, rare cases of QT prolongation, ventricular arrhythmias – ventricular fibrillation, ventricular tachycardia, Torsade de Pointes and sudden unexplained death have been reported for flupentixol.
Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs- Frequency unknown
Abrupt discontinuation of flupentixol may be accompanied by withdrawal symptoms. The most common symptoms are nausea, vomiting, anorexia, diarrhoea, rhinorrhoea, sweating, myalgias, paraesthesias, insomnia, restlessness, anxiety, and agitation. Patients may also experience vertigo, alternate feelings of warmth and coldness, and tremor. Symptoms generally begin within 1 to 4 days of withdrawal and abate within 7 to 14 days.
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