Product image of Mirtazapine Aurobindo (Mirtazapine) supplied by GNH India

Mirtazapine Aurobindo

Active Ingredient:
Mirtazapine
Origin:
EU

Mirtazapine Aurobindo (Mirtazapine)

Mirtazapine, the active ingredient in Mirtazapine Aurobindo, is a noradrenergic and specific serotonergic antidepressant (NaSSA) presented as an oral tablet for oral use. It is prescribed to treat major depressive disorder in adult patients, helping to improve mood, sleep and appetite, and is often selected when other antidepressants have been insufficient.

GNH India supplies Mirtazapine Aurobindo as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, providing reliable sourcing and regulatory‑aligned distribution for global markets and ensuring product integrity throughout the supply chain.

Manufacturer / TM Owner

Aurobindo Pharma (Malta) Limited

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Indications & Clinical Uses

Mirtazapine is a NaSSA‑type antidepressant that modulates noradrenergic and serotonergic pathways to treat depressive disorders.

  • Major depressive disorder: reduces depressive symptoms and improves overall mood in adults.
  • Treatment‑resistant depression: may be added when first‑line antidepressants have not achieved adequate response.
  • Depression with insomnia: helps alleviate sleep disturbances associated with depressive episodes.

How It Works

  • Mirtazapine acts as an antagonist at central presynaptic α2‑adrenergic receptors, which disinhibits norepinephrine release. It also blocks postsynaptic 5‑HT2 and 5‑HT3 receptors and strongly antagonizes histamine H1 receptors. These combined actions increase norepinephrine and serotonin neurotransmission while producing sedative and appetite‑stimulating effects, contributing to its antidepressant efficacy. The antagonism at 5‑HT2 and 5‑HT3 receptors reduces anxiety and gastrointestinal side effects, while H1 blockade accounts for the characteristic sedation and weight gain observed with therapy.

Side Effects

Mirtazapine may cause a range of adverse reactions, which are categorized by frequency.

Common Side Effects

  • Sedation or drowsiness
  • Increased appetite and weight gain
  • Dry mouth
  • Constipation
  • Dizziness
  • Fatigue

Serious or Rare Side Effects

  • Agranulocytosis or severe neutropenia
  • Serotonin syndrome, especially with other serotonergic drugs
  • Severe hypotension or syncope
  • Seizures
  • Suicidal thoughts or worsening depression
  • Hepatotoxicity (rare)

Precautions & Warnings

Before initiating therapy, clinicians should evaluate several safety considerations.

  • Assess hepatic function: adjust dose or avoid use in severe liver impairment.
  • Monitor body weight: anticipate possible weight gain and counsel on nutrition.
  • Screen for suicidal ideation: particularly during the first weeks of treatment.
  • Use caution in elderly patients: increased risk of sedation, falls and orthostatic hypotension.
  • Avoid abrupt discontinuation: taper the dose to reduce withdrawal symptoms.
  • Store at ambient temperature: keep in the original container, protect from moisture and light.

Avoid Interactions

Mirtazapine can interact with other medicines, and some combinations require avoidance while others need close monitoring.

Major Interactions (Avoid)

  • Monoamine oxidase inhibitors (MAOIs): risk of severe hypertension or serotonin syndrome.
  • Other serotonergic agents (e.g., SSRIs, SNRIs, tramadol): increase risk of serotonin syndrome.
  • Central nervous system depressants (e.g., benzodiazepines, alcohol): additive sedation and respiratory depression.
  • Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): raise mirtazapine plasma concentrations.
  • Alcohol: may enhance sedative effects and impair cognition.

Moderate Interactions (Monitor Closely)

  • Antihypertensive drugs: additive hypotensive effect.
  • Anticholinergic medications: may exacerbate anticholinergic burden.
  • Carbamazepine or other enzyme inducers: may reduce mirtazapine effectiveness.
  • Lithium: monitor for increased sedation.
  • Oral contraceptives: possible alteration of hormone levels, monitor efficacy.

Frequently Asked Questions

Mirtazapine Aurobindo is prescribed for the treatment of major depressive disorder in adult patients. It helps alleviate core depressive symptoms such as low mood, loss of interest, sleep disturbances, and changes in appetite, providing an option when other antidepressants may not have been effective.

Mirtazapine works by blocking presynaptic α2‑adrenergic receptors, which increases norepinephrine release, and by antagonising postsynaptic 5‑HT2, 5‑HT3 and histamine H1 receptors. This combined activity enhances serotonergic and noradrenergic neurotransmission while producing sedative and appetite‑stimulating effects that contribute to its antidepressant action.

The appropriate dose is determined by the prescribing clinician based on the individual’s clinical condition, response, and tolerability. Dosage may be started at a low level and adjusted as needed, but specific numbers should only be provided by a qualified healthcare professional.

Safety data for use in pregnancy and lactation are limited. The medication should only be used if the potential benefit justifies any possible risk to the fetus or infant, and decisions should be made in consultation with a healthcare provider.

To place an order, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements) and the necessary import documentation.

Unlike selective serotonin reuptake inhibitors (SSRIs), mirtazapine primarily enhances norepinephrine and serotonin release through α2‑adrenergic antagonism and also blocks histamine receptors, which can lead to greater sedation and weight gain. It may be preferred when patients need a sedating effect or have poor appetite, but the side‑effect profile differs from other classes.

Mirtazapine Aurobindo should be stored at ambient temperature, preferably below 25 °C, in its original packaging. Keep the product away from moisture, direct sunlight and heat sources to maintain stability throughout its shelf life.

The medication is supplied as an oral tablet and should be swallowed whole with water. It can be taken with or without food, but consistency with regard to meals may help reduce gastrointestinal discomfort. Follow the prescribing clinician’s instructions for timing and any dose adjustments.

Serious adverse events, although uncommon, include agranulocytosis or severe neutropenia, serotonin syndrome (especially when combined with other serotonergic drugs), severe hypotension, seizures, and the emergence or worsening of suicidal thoughts. Patients should be monitored closely for these conditions, and any concerning symptoms require immediate medical attention.

Mirtazapine should be avoided in patients with known hypersensitivity to the drug, those currently taking monoamine oxidase inhibitors (or who have taken an MAOI within the past 14 days), and individuals with severe hepatic impairment where dose adjustment is not feasible. Clinicians should also assess risk factors before prescribing to elderly patients prone to falls.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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