Ludiomil25 mg

Ludiomil is a tetracyclic antidepressant indicated for the treatment of:

• Major depressive disorder (established use): including depression associated with anxiety, in outpatients as well as hospitalized patients with moderate to severe depressive illness.
• Endogenous and involutional depression (guideline/clinically supported use): Ludiomil has long been used for classic melancholic-type depression where sedative and anxiolytic properties are beneficial.

Ludiomil is generally reserved for patients who have not responded adequately to, or cannot tolerate, first-line antidepressants such as SSRIs, given its side-effect profile. It is not indicated for bipolar mania, and use in other psychiatric conditions is not established.

Each tablet contains Maprotiline Hydrochloride equivalent to the labelled strength (commonly available as 25 mg, 50 mg, and 75 mg tablets of Maprotiline Hydrochloride, expressed as maprotiline base).

Ludiomil is a tetracyclic antidepressant (TeCA) chemically distinct from, but pharmacologically similar to, the tricyclic antidepressants. It is used in the management of major depressive disorder, including depression accompanied by anxiety symptoms.

Ludiomil is available in oral tablet form and is typically dosed once daily or in divided doses depending on the clinical situation and patient tolerability.

Ludiomil belongs to the class of Tetracyclic Antidepressants (TeCAs), a group of drugs related to but structurally distinct from tricyclic antidepressants (TCAs), used in the treatment of major depressive disorder.

Maprotiline Hydrochloride works primarily by inhibiting the reuptake of norepinephrine (noradrenaline) at the presynaptic neuron, thereby increasing the availability of norepinephrine in the synaptic cleft. It has only a weak effect on serotonin reuptake, distinguishing it from many tricyclic antidepressants.

Maprotiline Hydrochloride also possesses significant antihistaminic (H1) and anticholinergic (antimuscarinic) properties, which account for its sedative effect and for adverse effects such as dry mouth, blurred vision, constipation, and urinary retention. The precise mechanism by which increased noradrenergic activity translates into antidepressant effect is not fully understood, but is thought to involve downstream adaptive changes in receptor sensitivity over several weeks of treatment.

Ludiomil tablets are taken orally, with or without food, generally as a single daily dose (often at bedtime because of its sedative effect) or in divided doses if better tolerated. Swallow the tablet whole with water; do not crush or chew unless directed by a physician.

Ludiomil has several clinically significant drug interactions:

• Monoamine oxidase inhibitors (MAOIs): Concurrent use, or use within 14 days of stopping an MAOI, can precipitate a hypertensive crisis, hyperpyrexia, seizures, or serotonergic toxicity; concurrent use is contraindicated (see Contraindications).
• CNS depressants and alcohol: Ludiomil can potentiate the sedative effects of alcohol, benzodiazepines, opioids, and other CNS depressants, increasing the risk of excessive sedation and respiratory depression.
• Other anticholinergic drugs: Combining Ludiomil with other agents having anticholinergic activity (e.g. antihistamines, antipsychotics) can increase the risk of dry mouth, urinary retention, constipation, and confusion.
• QT-prolonging drugs: Co-administration with other drugs known to prolong the QT interval (certain antiarrhythmics, antipsychotics, some antibiotics) may increase the risk of cardiac arrhythmia.
• CYP2D6 inhibitors: Drugs that inhibit the CYP2D6 enzyme (e.g. fluoxetine, paroxetine, quinidine) can increase plasma levels of Ludiomil, raising the risk of dose-related toxicity, including seizures.
• Sympathomimetic agents: Ludiomil may enhance the pressor (blood-pressure-raising) effect of directly-acting sympathomimetic amines.

Side effects of Ludiomil are generally dose-related and most pronounced early in treatment or with dose increases.

• Very common/common: Drowsiness/sedation, dry mouth, blurred vision, constipation, dizziness, weight gain, tremor, sweating.
• Less common: Orthostatic hypotension, urinary retention/hesitancy, nausea, skin rash, increased appetite.
• Serious (require prompt medical attention): Seizures (dose-dependent risk), cardiac conduction abnormalities/arrhythmia, allergic skin reactions, and worsening depression or emergence of suicidal thoughts (see Precautions and Warnings).

Patients should report any unusual or severe symptoms to their physician promptly.

Pregnancy: The safety of Ludiomil in human pregnancy has not been firmly established. Ludiomil should be used during pregnancy only if clearly needed and if the potential benefit to the mother justifies the potential risk to the fetus. A physician should be consulted before use in pregnancy, and abrupt discontinuation should be avoided without medical guidance, as neonates exposed late in pregnancy may experience withdrawal-type symptoms.

Lactation: Ludiomil and its metabolites are excreted in breast milk. Because of the potential for adverse effects in the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother, in consultation with a physician.

Boxed warning - Suicidality: Antidepressants, including Ludiomil, may increase the risk of suicidal thinking and behavior in children, adolescents, and young adults, particularly during the early weeks of treatment or after dose changes. Patients of all ages should be monitored closely for worsening depression, unusual behavior changes, or emergence of suicidal thoughts.

Seizures: Ludiomil lowers the seizure threshold in a dose-dependent manner. Use with caution and at lower doses in patients with a history of seizure disorder, brain damage, alcohol dependence, or in those taking other drugs that lower the seizure threshold.

Cardiac effects: Ludiomil can affect cardiac conduction (including QT interval prolongation) and has been associated with arrhythmias. Use with caution in patients with cardiovascular disease, and avoid in the acute recovery phase after myocardial infarction (see Contraindications).

Anticholinergic effects: May worsen narrow-angle glaucoma, urinary retention (e.g. in benign prostatic hyperplasia), and paralytic ileus; use with caution in such patients.

Sedation: Ludiomil commonly causes drowsiness. Patients should avoid driving or operating hazardous machinery until they know how the medicine affects them, and should avoid alcohol.

Discontinuation: Abrupt discontinuation after prolonged use may cause withdrawal-type symptoms; dose should be tapered gradually under medical supervision.

Overdose with Ludiomil is potentially serious and can be life-threatening. Symptoms may include severe drowsiness progressing to coma, seizures, cardiac arrhythmias and conduction disturbances, hypotension, and respiratory depression.

Overdose is a medical emergency. Seek immediate medical attention or contact emergency services/poison control immediately if overdose is suspected. Continuous cardiac monitoring and supportive care in a hospital setting are typically required; there is no specific antidote. Do not attempt home treatment.

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

Elderly: Elderly patients are more sensitive to the anticholinergic, sedative, and cardiovascular effects of Ludiomil; lower starting doses and slower titration are recommended, with close monitoring.

Hepatic impairment: Ludiomil is metabolized by the liver; use with caution and consider dose reduction in patients with hepatic impairment.

Renal impairment: Use with caution in patients with significant renal impairment; clinical monitoring is advised.

Cardiac disease: Use with caution given potential effects on cardiac conduction (see Precautions and Warnings).

See also Pediatric Uses and Pregnancy and Lactation sections.

An initial therapeutic response to Ludiomil may take 2 to 3 weeks to become apparent. Once a response is achieved, treatment is typically continued at the lowest effective (maintenance) dose for several months to reduce the risk of relapse, as advised by the treating physician.

Ludiomil should not be stopped abruptly after prolonged use; the dose should be tapered gradually under medical supervision to reduce the risk of withdrawal-type symptoms.

Tetracyclic Antidepressants (TeCAs); Norepinephrine Reuptake Inhibitors.

Maprotiline Hydrochloride exerts its antidepressant effect primarily by inhibiting presynaptic reuptake of norepinephrine, increasing noradrenergic neurotransmission in the central nervous system, with only weak effects on serotonin reuptake. It also has notable antihistaminic and anticholinergic (antimuscarinic) activity, which contributes both to certain therapeutic effects (e.g. sedation, anxiolysis) and to its characteristic side-effect profile.

B

The safety and efficacy of Ludiomil in patients under 18 years of age have not been established. Ludiomil is not recommended for use in children or adolescents.

As with other antidepressants, there is a boxed warning regarding increased risk of suicidal thinking and behavior in children, adolescents, and young adults; if an antidepressant is considered necessary in this age group, it should only be under specialist supervision with close monitoring, and Ludiomil is generally not a first-choice agent in this population.