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

Mirtazapină Aurobindo

Active Ingredient:
Mirtazapine
Origin:
EU

Mirtazapină Aurobindo (Mirtazapine)

Mirtazapine, the active ingredient in Mirtazapină Aurobindo, is a NaSSA (noradrenergic and specific serotonergic antidepressant) presented as an oral dosage form for oral use. It is used to treat major depressive disorder in adult patients.
GNH India supplies Mirtazapină Aurobindo as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Aurobindo Pharma România S.R.L.

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Indications & Clinical Uses

Mirtazapine is indicated for major depressive disorder, a condition affecting mood and functioning. It helps improve depressive symptoms and overall quality of life.

  • Major depressive disorder: alleviates depressive symptoms and improves mood.
  • Treatment‑resistant depression: may be added when first‑line agents are insufficient.
  • Co‑morbid anxiety in depression: can reduce anxiety symptoms associated with depression.

How It Works

  • Mirtazapine acts as an antagonist at central presynaptic α2‑adrenergic receptors, increasing noradrenergic transmission, and blocks serotonergic 5‑HT2 and 5‑HT3 receptors while strongly antagonizing histamine H1 receptors. This combined activity enhances noradrenergic and serotonergic neurotransmission, contributing to its antidepressant effects.

Side Effects

Mirtazapine may cause a range of adverse reactions, from mild to serious.

Common Side Effects

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

Serious or Rare Side Effects

  • Agranulocytosis or severe neutropenia
  • Severe allergic reactions (e.g., Stevens‑Johnson syndrome)
  • Suicidal thoughts or behavior, especially early in treatment
  • Hepatotoxicity or liver injury
  • Seizures in predisposed individuals

Precautions & Warnings

When prescribing mirtazapine, clinicians should consider several safety aspects.

  • Pregnancy: Category B; use only if potential benefit justifies the risk.
  • Elderly patients: increased sensitivity to sedation and orthostatic hypotension.
  • Discontinuation: avoid abrupt stopping to reduce withdrawal symptoms.
  • Weight monitoring: assess for significant appetite increase and weight gain.
  • Suicidality: monitor for emergent suicidal ideation, particularly at treatment initiation.
  • Store at room temperature: keep in the original container, protect from moisture.

Avoid Interactions

Mirtazapine can interact with various medications, requiring careful management.

Major Interactions (Avoid)

  • MAO inhibitors: risk of hypertensive crisis; discontinue MAOIs at least 14 days prior.
  • Other CNS depressants (e.g., benzodiazepines, alcohol): additive sedation and respiratory depression.
  • Serotonergic agents (e.g., SSRIs, SNRIs, tramadol): potential serotonin syndrome.

Moderate Interactions (Monitor Closely)

  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): may increase mirtazapine plasma levels.
  • Antihistamines: may enhance sedative effects.
  • Alcohol: can intensify central nervous system depression.

Frequently Asked Questions

Mirtazapină Aurobindo contains the active ingredient mirtazapine, which is prescribed for the treatment of major depressive disorder in adult patients. It helps alleviate depressive symptoms and can improve overall mood and functioning.

Mirtazapine works by blocking presynaptic α2‑adrenergic receptors, which increases the release of norepinephrine, and by antagonizing specific serotonin receptors (5‑HT2 and 5‑HT3). Its strong antihistamine activity also contributes to its therapeutic profile.

The appropriate dose of Mirtazapină Aurobindo is determined by the prescribing healthcare professional based on the patient’s clinical condition, response to therapy, and tolerability. Dosage adjustments are made individually and should follow the prescriber’s instructions.

Mirtazapine is classified as Pregnancy Category B, indicating that animal studies have not shown risk, but there are no adequate human studies. It should be used during pregnancy only if the potential benefit justifies the risk. Limited data are available for breastfeeding, so a risk‑benefit assessment is required.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams worldwide, and will request verification of trade or institutional credentials before providing pricing, availability, shipping details, and necessary import documentation.

Mirtazapine belongs to the NaSSA class, differing from SSRIs and SNRIs by its dual antagonism of specific serotonin receptors and strong antihistamine effect. This profile often results in pronounced sedation and appetite stimulation, which can be advantageous for patients with insomnia or weight loss, but may be less suitable for those concerned about weight gain.

Mirtazapină Aurobindo should be stored at room temperature, below 25 °C, in its original packaging. Protect the product from moisture and direct sunlight to maintain its stability and potency.

The medication is taken orally, usually once daily in the evening due to its sedative properties. It should be swallowed whole with water and not crushed or chewed unless otherwise directed by a healthcare professional.

Serious risks include the potential for agranulocytosis or severe neutropenia, severe allergic reactions such as Stevens‑Johnson syndrome, and the emergence or worsening of suicidal thoughts, particularly during the initial treatment period. Patients should be monitored closely for these events.

Mirtazapine is contraindicated in patients with known hypersensitivity to the drug or any of its components. It should also be avoided in individuals currently taking monoamine oxidase inhibitors (MAOIs) or those with a history of severe agranulocytosis. Caution is advised for patients with hepatic impairment or uncontrolled epilepsy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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