Deanxit should not be administered together with MAOIs (see Contraindications and Interactions).
Deanxit should be used with caution in patients with organic brain syndrome, convulsion, urinary retention, hyperthyroidism and advanced hepatic or cardiovascular disease.
Not recommended for excitable or overactive patients since its activating effect may lead to exaggeration of these characteristics. If the patient has previously been treated with tranquilizers or neuroleptics with sedative effect, these should be withdrawn gradually.
The possibility of development of neuroleptic malignant syndrome (hyperthermia, muscle rigidity, fluctuating consciousness, instability of the autonomous nervous system) exists with any neuroleptic.
As with other drugs belonging to the therapeutic class of antipsychotics, Deanxit may cause QT prolongation. Persistently prolonged QT intervals may increase the risk of malignant arrhythmias. Therefore, Deanxit should be used with caution in susceptible individuals (with hypokalaemia, hypomagnesia or genetic predisposition) and in patients with a history of cardiovascular disorders eg, QT prolongation, significant bradycardia (<50 beats/min), a recent acute myocardial infarction, uncompensated heart failure or cardiac arrhythmia. Concomitant treatment with other drugs which may cause QT prolongation is contraindicated (see Interactions).
Suicide/Suicidal Thoughts or Clinical Worsening: Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the 1st few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, are known to be at greater risk of suicidal thoughts or suicide attempts and should receive careful monitoring during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behavior with antidepressants compared to placebo in patients <25 years.
Close supervision of patients and in particular, those at high risk, should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
As described for other psychotropics, Deanxit may modify insulin and glucose responses calling for adjustment of the antidiabetic therapy in diabetic patients.
In patients with the rare condition of shallow anterior chamber and narrow chamber angle, attacks of acute glaucoma due to dilation of the pupil may be provoked.
Anaesthetics given during tri- or tetracyclic antidepressant therapy may increase the risk of arrhythmias and hypotension. If possible, discontinue Deanxit several days before surgery, if emergency surgery is unavoidable, the anaesthetist should be informed that the patient is being treated.
Deanxit should be used with caution in patients receiving selective serotonin reuptake inhibitors (SSRIs).
Excipients: The tablets contain lactose monohydrate and sucrose. Patients with rare hereditary problems of galactose or fructose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not receive Deanxit.
Effects on the Ability to Drive or Operate Machinery: Deanxit is a nonsedating drug in the recommended dosage range. However, patients who are prescribed psychotropic medication may be expected to have some impairment in general attention and concentration and should be cautioned about the ability to drive or operate machinery.
Impairment of Fertility: In humans, adverse events have been reported that 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 effect is reversible on discontinuation.
In preclinical fertility studies in rats, where flupentixol and melitracen were administered separately, slight effects on fertility were noted. Flupentixol slightly affected the pregnancy rate of female rats, whereas melitracen slightly repressed fertility and fecundity of male rats. Effects were seen at doses well in excess of those applied during clinical use.
Use in Pregnancy: Deanxit should not be administered during pregnancy unless the expected benefit to the patient outweighs the theoretical risk to the foetus. Due to the risk of neonatal withdrawal symptoms, it is recommended that Deanxit treatment is stopped about 14 days before delivery by tapering off the dosage.
Neonates exposed to antipsychotics (including Deanxit) during the 3rd 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 (see Pharmacology: Toxicoloy under Actions).
Use in Lactation: As flupentixol is found in breast milk in low concentrations, it is not likely to affect the infant when therapeutic doses are used. The dose ingested by the infant is <0.5% of the weight-related maternal dose (in mg/kg).
It is not known whether melitracen is excreted in breast milk. However, another tricyclic antidepressant, amitriptyline, is found in breast milk in low concentrations and it is not likely to affect the infant when therapeutic doses are used. The dose ingested by the infant is about 2% of the weight-related maternal daily dose (in mg/kg). As melitracen has the same lipophilic properties as amitriptyline, it is assumed that it occurs in breast milk in similar concentrations.
Breastfeeding can be continued during Deanxit therapy if considered of clinical importance but observation of the infant is recommended, particularly in the first 4 weeks after giving birth.
Use in Children: Children and Adolescents <18 Years: Deanxit is not recommended for use in children and adolescents due to lack of data on efficacy and safety.
Venous Thromboembolism (VTE): Cases of VTE have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Deanxit and preventive measures undertaken.
Use in the Elderly: Cerebrovascular: An approximately 3-fold increased risk of cerebrovascular adverse events have been seen in randomised placebo controlled clinical trials in the dementia population with some atypical antipsychotics. The mechanism for this increased risk is not known. An increased risk cannot be excluded for other antipsychotics or other patient populations. Deanxit should be used with caution in patients with risk factors for stroke.
Increased Mortality in Older People with Dementia: Data from 2 large observational studies showed that elderly people with dementia who are treated with antipsychotics are at a small increased risk of death compared with those who are not treated. There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known.
Deanxit is not licensed for the treatment of dementia-related behavioural disturbances.