Dexit0.5 mg+10 mg

Established Use

Dexit is used for the symptomatic treatment of mild-to-moderate depressive and anxiety states, particularly conditions with mixed anxiety-depressive features, including psychogenic depression, depressive neurosis, masked depression, and asthenia (marked lack of energy and motivation). Dexit is also used for psychosomatic conditions accompanied by anxiety and for menopausal-related depressive symptoms.

Adjunct / Other Use

Dexit has also been used as an adjunct for dysphoria and low mood occurring in patients recovering from alcohol or other substance use disorders, under specialist supervision.

Not Indicated For

Dexit is not a treatment for severe major depression, psychotic depression, or schizophrenia as a primary agent, and it is not recommended for excitable, agitated, or overactive patients (see Contraindications). It is not indicated for use in children or adolescents.

Flupentixol + Melitracen is available as a film-coated oral tablet combining two active ingredients in a fixed low-dose ratio: flupentixol (as flupentixol dihydrochloride, commonly 0.5 mg per tablet) and melitracen (as melitracen hydrochloride, commonly 10 mg per tablet). This fixed low-dose combination is formulated specifically for mild-to-moderate depressive and anxiety states rather than for use as a standalone antipsychotic or standalone antidepressant at higher doses.

Dexit is a fixed-dose combination product pairing a low dose of flupentixol, a thioxanthene-derivative antipsychotic that produces mood-elevating and anxiolytic effects at low doses, with melitracen, a tricyclic antidepressant with an activating profile. Together, Dexit provides combined antidepressant, anxiolytic (anti-anxiety), and mildly activating effects, and is used for the short-to-medium term symptomatic relief of mild-to-moderate depression, anxiety, and asthenia, particularly when anxiety and depressive symptoms occur together. Dexit is taken by mouth and is not an antibiotic or antimicrobial agent.

Fixed-dose combination of a thioxanthene antipsychotic (flupentixol) and a tricyclic antidepressant (melitracen); classified as a combination antidepressant-anxiolytic product. Dexit is not classified as an antibiotic.

Mechanism: Flupentixol + Melitracen combines two agents with complementary central nervous system actions. Flupentixol, at the low doses used in Flupentixol + Melitracen, predominantly blocks presynaptic dopamine autoreceptors, which is thought to increase dopaminergic and noradrenergic neurotransmission and produce mood-elevating, activating, and anxiolytic effects rather than the antipsychotic (postsynaptic D2-blocking) effects seen at higher antipsychotic doses. Melitracen, a dibenzocycloheptadiene tricyclic antidepressant, inhibits presynaptic reuptake of noradrenaline and, to a lesser extent, serotonin, increasing the availability of these neurotransmitters in the synaptic cleft, and also has some antihistaminic and anticholinergic activity. The combination in Flupentixol + Melitracen is intended to provide a rapid onset of anxiolytic and mood-elevating effect from flupentixol together with sustained antidepressant activity from melitracen.

Pharmacokinetics: Both components of Flupentixol + Melitracen are well absorbed after oral administration, with peak plasma concentrations reached in approximately 3-8 hours. Flupentixol has an elimination half-life of approximately 35 hours, while melitracen has an elimination half-life of approximately 19 hours; both undergo hepatic metabolism (flupentixol substantially via CYP2D6) with excretion mainly via bile/faeces and urine. The long half-lives support twice-daily dosing of Flupentixol + Melitracen.

• Take Dexit by mouth, swallowing the tablet whole with water.
• Dexit is usually taken in the morning and at noon; avoid taking the noon or later doses too close to bedtime, as it may be mildly activating and interfere with sleep in some patients.
• Dexit can be taken with or without food.
• Do not increase the dose of Dexit or take it more often than prescribed, even if symptoms do not improve immediately; the mood-elevating effect of Dexit is often noticed sooner than the full antidepressant effect, which may take one to a few weeks.
• Do not stop taking Dexit abruptly after regular use; consult the prescribing physician, who will advise on gradual dose reduction (see Precautions and Warnings).
• If a dose of Dexit is missed, take it as soon as remembered unless it is close to the time of the next dose; do not double the dose.

• Monoamine oxidase inhibitors (MAOIs): concurrent use of Dexit with MAOIs, or use within 14 days of stopping an MAOI, is contraindicated because of the risk of a hypertensive crisis or serotonin syndrome (see Contraindications).
• CNS depressants (alcohol, barbiturates, sedatives, opioids): Dexit can enhance the sedative and CNS-depressant effects of these agents, increasing the risk of excessive drowsiness and impaired coordination.
• Sympathomimetic agents (e.g., adrenaline/epinephrine, noradrenaline, decongestants): the tricyclic component of Dexit can potentiate the cardiovascular effects of sympathomimetics, increasing the risk of hypertension and arrhythmia; this combination should be avoided or used only with close monitoring.
• Adrenergic neurone blockers (e.g., guanethidine): Dexit can reduce the antihypertensive effect of these agents, so blood pressure control may need to be reassessed.
• Other anticholinergic drugs: combining Dexit with other anticholinergic medicines can potentiate anticholinergic side effects such as dry mouth, blurred vision, constipation, and urinary retention, with a risk of paralytic ileus in susceptible patients.
• Lithium and other serotonergic/CNS-active drugs: combined use with Dexit may increase the risk of neurotoxicity or serotonergic effects and requires caution and monitoring.
• Levodopa: Dexit may reduce the antiparkinsonian effect of levodopa and increase the risk of cardiac side effects; concurrent use requires caution.

Common Side Effects

• Insomnia and restlessness/agitation, particularly early in treatment with Dexit
• Dizziness, tremor, and fatigue
• Dry mouth, constipation, and accommodation disturbance (blurred near vision) from the anticholinergic activity of the tricyclic component

Less Common but Serious Side Effects (Seek Medical Attention)

• Extrapyramidal symptoms (muscle stiffness, tremor, restlessness/akathisia) or, with prolonged use, tardive dyskinesia (see Precautions and Warnings)
• New or worsening depression, agitation, or emergence of suicidal thoughts/behavior, especially in children, adolescents, and young adults or early in treatment (see Precautions and Warnings)
• Cardiac conduction changes, palpitations, or arrhythmia
• Urinary retention, especially in patients with prostatic enlargement
• Rare cholestatic hepatitis or jaundice
• Rare blood dyscrasias (e.g., agranulocytosis) presenting as fever, sore throat, or unusual bruising/bleeding
• Signs of serotonin syndrome or neuroleptic malignant syndrome (high fever, muscle rigidity, confusion, autonomic instability) — a medical emergency
• Signs of a severe allergic reaction: rash, facial/throat swelling, severe dizziness, difficulty breathing

Pregnancy

Dexit should be used during pregnancy only if clearly needed and the potential benefit to the mother justifies the potential risk to the fetus, and only under close physician supervision; human safety data specific to this fixed-dose combination are limited. If a related antipsychotic or tricyclic antidepressant is used in the third trimester, neonates may be at risk of extrapyramidal and/or withdrawal symptoms after birth (including agitation, feeding difficulty, tremor, or respiratory distress), and gradual discontinuation before delivery is generally advised where feasible, under medical guidance. Dexit should not be stopped abruptly without consulting a physician.

Breastfeeding

Both components of Dexit pass into breast milk. Breastfeeding is generally not recommended during treatment with Dexit unless a physician determines the benefit outweighs the potential risk to the infant, in which case the infant should be monitored closely for sedation, poor feeding, or irritability.

• Suicidal thoughts and behavior: as with other antidepressant-containing medicines, Dexit may be associated with an increased risk of suicidal thinking and behavior, particularly in children, adolescents, and young adults, and especially during the first few weeks of treatment or after dose changes; patients and caregivers should be alert for worsening mood, agitation, or unusual behavior changes and seek medical attention promptly if these occur.
• Extrapyramidal symptoms and tardive dyskinesia: although the antipsychotic dose in Dexit is low, extrapyramidal symptoms (tremor, rigidity, akathisia) can occur, and prolonged use carries a risk of tardive dyskinesia, which may be irreversible; the lowest effective dose should be used for the shortest necessary duration.
• Anticholinergic effects: the tricyclic component of Dexit can cause dry mouth, blurred vision, constipation, and urinary retention; use with caution in patients with prostatic hypertrophy, narrow-angle glaucoma risk, or chronic constipation.
• Cardiac effects: Dexit can affect cardiac conduction and, rarely, prolong the QT interval; use with caution in patients with pre-existing cardiac disease, and avoid in those with the cardiac contraindications listed above (see Contraindications).
• Abrupt discontinuation: Dexit should not be stopped suddenly after regular use; the dose should be tapered gradually under medical supervision to reduce the risk of discontinuation symptoms.
• Driving and operating machinery: Dexit may cause dizziness or sedation, particularly at the start of treatment or at higher doses; patients should use caution with driving or hazardous tasks until they know how Dexit affects them.
• Hepatic and renal impairment: use with caution and reduced dose in mild-to-moderate hepatic or renal impairment; Dexit is contraindicated in severe hepatic impairment (see Contraindications and Use in Special Populations).
• Elderly patients and pre-existing seizure disorders: use with caution, as both components can lower seizure threshold and elderly patients may be more sensitive to anticholinergic and cardiac effects.
• Surgery: where possible, Dexit should be discontinued several days before elective surgery requiring general anesthesia; the anesthetist should be informed if emergency surgery is unavoidable while a patient is taking Dexit.

Overdose of Dexit is dominated by the effects of the tricyclic (melitracen) component and can include anticholinergic features such as dilated pupils, dry mouth, rapid heartbeat, urinary retention, and reduced bowel motility, along with confusion, agitation, hallucinations, tremor, seizures, cardiac arrhythmia, and, in severe cases, respiratory depression and cardiovascular collapse. Overdose of Dexit is a medical emergency. If overdose is suspected, seek immediate emergency medical attention or contact a poison control center right away; do not attempt to manage a suspected overdose of Dexit at home. Treatment is supportive and provided in a hospital setting, typically including gastric decontamination if presenting early, continuous cardiac monitoring, and management of seizures, arrhythmia, or blood pressure changes as directed by treating physicians.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

• Hepatic impairment: use Dexit with caution and at a reduced dose in mild-to-moderate hepatic impairment, with monitoring; Dexit is contraindicated in severe hepatic impairment (see Contraindications).
• Renal impairment: limited specific data are available; use Dexit with caution and monitor for accumulation of effect in significant renal impairment.
• Elderly patients: Dexit is generally started and maintained at a lower dose (one tablet each morning) in patients over 65 years, given increased sensitivity to anticholinergic, cardiac, and sedative effects.
• Cardiac disease: use Dexit with particular caution in patients with a history of cardiac disease who do not meet the absolute contraindications, given the potential for conduction and rhythm effects (see Contraindications and Precautions and Warnings).
• Diabetes mellitus: Dexit may affect glucose metabolism in some patients; blood glucose control should be monitored and antidiabetic therapy adjusted as needed.
• Pregnant and breastfeeding women: see Pregnancy and Lactation for detailed guidance.
• Pediatric patients: see Pediatric Uses; Dexit is not recommended in children or adolescents.

The duration of treatment with Dexit is individualized by the prescribing physician based on symptom severity and response, and is typically intended for short-to-medium term symptomatic relief rather than indefinite use. Improvement in anxiety and low mood may be noticed within the first one to two weeks, but treatment is often continued for several weeks to a few months to consolidate response, with periodic medical reassessment of continued need. Dexit should not be continued for prolonged periods without review, and when treatment is stopped, the dose should be reduced gradually rather than discontinued abruptly (see Precautions and Warnings).

Thioxanthene antipsychotic (flupentixol) combined with a tricyclic antidepressant (melitracen); fixed-dose antidepressant-anxiolytic combination

Flupentixol + Melitracen combines flupentixol, which at the low doses in this combination is believed to act mainly by blocking presynaptic dopamine D2 autoreceptors and enhancing dopaminergic and noradrenergic transmission (producing mood-elevating, anxiolytic, and mildly activating effects rather than classical antipsychotic effects), with melitracen, a tricyclic antidepressant that inhibits presynaptic reuptake of noradrenaline and, to a lesser degree, serotonin, thereby increasing synaptic availability of these neurotransmitters. The combined action of Flupentixol + Melitracen is intended to produce a relatively fast-acting anxiolytic/mood-elevating effect together with sustained antidepressant benefit over the following weeks.

Dexit is not recommended for use in children and adolescents because safety and efficacy have not been established in this population, and clinical data in pediatric patients are lacking. Dexit should not be prescribed to patients under 18 years of age outside of specialist guidance, and alternative, better-studied treatments should be considered for depressive or anxiety symptoms in this age group. If a young person is already being treated with an antidepressant-containing medicine, caregivers should be aware of the increased risk of suicidal thinking and behavior in children, adolescents, and young adults, and should seek prompt medical attention for any worsening mood or unusual behavior change (see Precautions and Warnings).