Mitaprex

Mitaprex7.5 mg

Tablet

Mirtazapine

Incepta Pharmaceuticals Ltd.

Product Code : 10833
MRP 6.00
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Medicine overview

Indications of Mitaprex 7.5 mg

Mitaprex 7.5 mg Tablets are indicated for the treatment of major depressive disorder (MDD).

Theropeutic Class

Atypical anti-depressant drugs

Pharmacology

Mitaprex 7.5 mg, a piperazinoazepine tetracyclic antidepressant, enhances noradrenergic and serotonergic activity through blockade of central presynaptic adrenergic α2-receptors.

Dosage & Administration of Mitaprex 7.5 mg

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.

Dosage of Mitaprex 7.5 mg

Adult dose: The recommended starting dose for Mitaprex 7.5 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. Mitaprex 7.5 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 Mitaprex 7.5 mg.Missed Dose: If anyone misses a dose of Mitaprex 7.5 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.

Interaction of Mitaprex 7.5 mg

Mitaprex 7.5 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. Mitaprex 7.5 mg may interrupt the metabolism or activity of Carbamazepine, Phenytoin or Cimetidine. Patient should avoid Alcohol & Diazepam while taking Mitaprex 7.5 mg.

Contraindications

Hypersensitivity: Mitaprex 7.5 mg is contraindicated in patients with a known hypersensitivity to Mitaprex 7.5 mg or to any of the excipients.Monoamine Oxidase Inhibitors: The concomitant use of Mitaprex 7.5 mg and a monoamine oxidase (MAO) inhibitor is contraindicated. Mitaprex 7.5 mg should not be used within 14 days of initiating or discontinuing therapy with a monoamine oxidase inhibitor (MAOI).

Side Effects of Mitaprex 7.5 mg

The most common side effects of Mitaprex 7.5 mg are dizziness, drowsiness, dry mouth, increased appetite, weight gain etc.

Pregnancy & Lactation

Mitaprex 7.5 mg Should not be used during pregnancy and lactation.

Precautions & Warnings

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 Mitaprex 7.5 mg should be warned about the risk of developing agranulocytosis. Mitaprex 7.5 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.

Overdose Effects of Mitaprex 7.5 mg

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.

Storage Conditions

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

Drug Classes

Atypical anti-depressant drugs

Mode Of Action

Pharmacodynamics: The mechanism of action of Mitaprex 7.5 mg as with other drugs effective in the treatment of major depressive disorder is unknown. Evidence gathered in preclinical studies suggests that Mitaprex 7.5 mg enhances central noradrenergic and serotonergic activity. These studies have shown that Mitaprex 7.5 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. Mitaprex 7.5 mg is a potent antagonist of 5- HT2 and 5-HT3 receptors. Mitaprex 7.5 mg has no significant affinity for the 5-HT1A and 5-HT1B receptors. Mitaprex 7.5 mg is a potent antagonist of histamine (H1) receptors, a property that may explain its prominent sedative effects. Mitaprex 7.5 mg is a moderate peripheral α1-adrenergic antagonist, a property that may explain the occasional orthostatic hypotension reported in association with its use. Mitaprex 7.5 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 Mitaprex 7.5 mg tablets, the active constituent Mitaprex 7.5 mg is rapidly and well-absorbed, reaching peak plasma levels after about 2 hours. Binding of Mitaprex 7.5 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. Mitaprex 7.5 mg displays linear pharmacokinetics within the recommended dose range. Mitaprex 7.5 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

Pregnancy Category-C. Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during Mitaprex 7.5 mg therapy. Patients should be advised to notify their physician if they are breastfeeding an infant.
Disclaimer

The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.