Mirtaz 15 mg Tablet

Mirtaz 15 mg Tablets are indicated for the treatment of major depressive disorder (MDD).

Atypical anti-depressant drugs

Mirtaz 15 mg, a piperazinoazepine tetracyclic antidepressant, enhances noradrenergic and serotonergic activity through blockade of central presynaptic adrenergic α2-receptors.

Adult: Initially, 15 mg daily; may be increased gradually depending on clinical response. Change dose at intervals of at least 1-2 wk. Usual effective dose: 15-45 mg daily given as single dose, preferably at bedtime, or in 2 divided doses.Children: Safety and efficacy not established.Geriatric: Use with caution.

Adult dose: The recommended starting dose for Mirtaz 15 mg tablets is 15 mg/day, administered in a single dose, preferably in the evening or prior to sleep. The effective dose range was generally 15 to 45 mg/day and the patients not responding to the initial 15 mg dose may benefit from dose increases up to a 30 mg to maximum of 45 mg/day. Mirtaz 15 mg has an elimination half-life of approximately 20 to 40 hours; therefore, dose changes should be made at intervals of less than 1 to 2 weeks in order to allow sufficient time for the therapeutic response to a given dose.Use in children: Use in children are not recommended to Mirtaz 15 mg.Missed Dose: If anyone misses a dose of Mirtaz 15 mg, take it as soon as remember unless it is close to when the next dose is due. If anyone missed a dose of medication and it is close to the time of next dose, skip the missed dose and should take next dose at the regularly scheduled time. One should not take double or more than prescribed dose.

Mirtaz 15 mg has clinically significant drug-drug interactions with Monoamine Oxidase Inhibitors (MAOI) & other serotonergic drugs such as tryptophan, triptans, linezolid, serotonin reuptake inhibitors, venlafaxine, lithium, tramadol, or St. John's wort. Mirtaz 15 mg may interrupt the metabolism or activity of Carbamazepine, Phenytoin or Cimetidine. Patient should avoid Alcohol & Diazepam while taking Mirtaz 15 mg.

Hypersensitivity: Mirtaz 15 mg is contraindicated in patients with a known hypersensitivity to Mirtaz 15 mg or to any of the excipients.Monoamine Oxidase Inhibitors: The concomitant use of Mirtaz 15 mg and a monoamine oxidase (MAO) inhibitor is contraindicated. Mirtaz 15 mg should not be used within 14 days of initiating or discontinuing therapy with a monoamine oxidase inhibitor (MAOI).

The most common side effects of Mirtaz 15 mg are dizziness, drowsiness, dry mouth, increased appetite, weight gain etc.

Mirtaz 15 mg Should not be used during pregnancy and lactation.

Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Patients who are to receive Mirtaz 15 mg should be warned about the risk of developing agranulocytosis. Mirtaz 15 mg may impair judgment, thinking, and particularly, motor skills, because of its prominent sedative effect. Clinically significant ALT (SGPT) elevations (≥3 times the upper limit of the normal range) may occur.

Symptoms: Disorientation, drowsiness, impaired memory, tachycardia. Management: Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac functions. General supportive and symptomatic measures are also recommended. Do not induce emesis. Gastric lavage may be used if done soon after ingestion, or in symptomatic patients. Administer activated charcoal. No specific antidotes are known.

Keep away from light and moisture. Store below 30º C. Keep all medicine out of the reach of children.

Atypical anti-depressant drugs

Pharmacodynamics: The mechanism of action of Mirtaz 15 mg as with other drugs effective in the treatment of major depressive disorder is unknown. Evidence gathered in preclinical studies suggests that Mirtaz 15 mg enhances central noradrenergic and serotonergic activity. These studies have shown that Mirtaz 15 mg acts as an antagonist at central presynaptic α2-adrenergic inhibitory autoreceptors and heteroreceptors, an action that is postulated to result in an increase in central noradrenergic and serotonergic activity. Mirtaz 15 mg is a potent antagonist of 5- HT2 and 5-HT3 receptors. Mirtaz 15 mg has no significant affinity for the 5-HT1A and 5-HT1B receptors. Mirtaz 15 mg is a potent antagonist of histamine (H1) receptors, a property that may explain its prominent sedative effects. Mirtaz 15 mg is a moderate peripheral α1-adrenergic antagonist, a property that may explain the occasional orthostatic hypotension reported in association with its use. Mirtaz 15 mg is a moderate antagonist at muscarinic receptors, a property that may explain the relatively low incidence of anticholinergic side effects associated with its use.Pharmacokinetics: After oral administration of Mirtaz 15 mg tablets, the active constituent Mirtaz 15 mg is rapidly and well-absorbed, reaching peak plasma levels after about 2 hours. Binding of Mirtaz 15 mg to plasma proteins is approximately 85%. The mean half-life of elimination is 20-40 hours; (26 hours in males, 37 hours in females). The half-life of elimination is sufficient to justify once-a-day dosing. Mirtaz 15 mg displays linear pharmacokinetics within the recommended dose range. Mirtaz 15 mg is extensively metabolized and eliminated via the urine and faeces four days. Major pathways of biotransformation are demethylation and oxidation followed by conjugation.

Pregnancy Category-C. Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during Mirtaz 15 mg therapy. Patients should be advised to notify their physician if they are breastfeeding an infant.