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

Mirtazapina Aurobindo

Active Ingredient:
Mirtazapine
Origin:
EU

Mirtazapina Aurobindo (Mirtazapine)

Mirtazapine, the active ingredient in Mirtazapina Aurobindo, is a 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 ineffective.

GNH India supplies Mirtazapina Aurobindo as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides regulatory documentation to support global distribution through.

Manufacturer / TM Owner

Aurovitas Spain,s.A.U.

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Indications & Clinical Uses

Mirtazapine is an antidepressant that acts on noradrenergic and serotonergic pathways to alleviate depressive symptoms.

  • Major depressive disorder: reduction of depressive symptoms and improvement in overall mood.
  • Treatment‑resistant depression: augmentation of therapeutic response when other antidepressants have not achieved sufficient effect.
  • Depression‑related anxiety: alleviation of anxiety symptoms and improvement of sleep quality in patients with co‑occurring anxiety.
  • Bipolar depression (as adjunct): helps stabilize the depressive phase when used with mood stabilizers.
  • Insomnia associated with depression: promotes sleep onset and maintenance due to antihistaminic effect.

How It Works

  • Mirtazapine blocks central presynaptic α2‑adrenergic receptors, increasing the release of norepinephrine and serotonin. It also antagonizes postsynaptic 5‑HT2 and 5‑HT3 receptors, enhancing serotonergic transmission while reducing associated side effects. Additionally, potent H1‑receptor antagonism contributes to its sedative and appetite‑stimulating properties, collectively producing antidepressant and anxiolytic effects.

Side Effects

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

Common Side Effects

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

Serious or Rare Side Effects

  • Agranulocytosis or severe neutropenia
  • Stevens‑Johnson syndrome or toxic epidermal necrolysis
  • Suicidal thoughts or behavior, especially early in treatment

Precautions & Warnings

When prescribing mirtazapine, clinicians should consider several precautionary measures to ensure patient safety.

  • Assess hepatic function: evaluate liver enzymes before initiating therapy.
  • Monitor weight: regular checks due to potential significant weight gain.
  • Evaluate for suicidal ideation: especially during the first weeks of treatment.
  • Avoid abrupt discontinuation: taper the dose under medical supervision to prevent withdrawal symptoms.
  • Use caution in elderly patients: increased sensitivity to sedation and orthostatic hypotension.
  • Store at ambient temperature: keep in the original container, protect from moisture and light.

Avoid Interactions

Mirtazapine can interact with other medicines, altering its efficacy or safety profile.

Major Interactions (Avoid)

  • Monoamine oxidase inhibitors (MAOIs): concurrent use may cause hypertensive crisis.
  • Other serotonergic agents (e.g., SSRIs, SNRIs, tramadol): risk of serotonin syndrome.
  • Central nervous system depressants (e.g., benzodiazepines, alcohol): additive sedation and respiratory depression.

Moderate Interactions (Monitor Closely)

  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): may increase mirtazapine plasma levels.
  • Anticholinergic drugs (e.g., diphenhydramine): can enhance anticholinergic burden.
  • Diuretics: may exacerbate orthostatic hypotension.

Frequently Asked Questions

Mirtazapina Aurobindo contains the antidepressant mirtazapine and is indicated for the treatment of major depressive disorder in adult patients. It helps to alleviate depressive symptoms, improve sleep quality, and may also reduce associated anxiety and appetite disturbances.

Mirtazapine works by blocking presynaptic α2‑adrenergic receptors, which increases the release of norepinephrine and serotonin. It also antagonises postsynaptic 5‑HT2 and 5‑HT3 receptors and strongly blocks H1 histamine receptors, producing antidepressant, anxiolytic and sedative effects.

The appropriate dose of Mirtazapina Aurobindo is determined by the prescribing clinician based on the individual’s medical condition, response to therapy, and tolerability. Dosage may be started low and adjusted gradually; patients should follow the specific instructions provided by their healthcare professional.

Safety data for mirtazapine during pregnancy and lactation are limited, and the drug is classified as having an unknown pregnancy category. It should only be used if the potential benefit justifies the potential risk to the fetus or infant, and the decision must be made by a qualified healthcare provider.

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 across international markets, and will request verification of trade or institutional credentials before providing pricing, availability, shipping details and any necessary import documentation.

Mirtazapine belongs to the NaSSA class, whereas many other antidepressants are selective serotonin reuptake inhibitors (SSRIs). Compared with SSRIs, mirtazapine often produces stronger 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.

Mirtazapina Aurobindo tablets should be stored at ambient temperature, below 25 °C, in their original packaging. Protect them from moisture, direct sunlight and excessive heat. Keep the container tightly closed and out of reach of children.

The medication is taken orally, usually once daily in the evening due to its sedative properties. Tablets should be swallowed whole with a glass of water and may be taken with or without food, following the dosing schedule prescribed by the treating clinician.

Serious adverse effects include agranulocytosis or severe neutropenia, Stevens‑Johnson syndrome or toxic epidermal necrolysis, and the emergence or worsening of suicidal thoughts, particularly during the initial weeks of therapy. Patients should seek immediate medical attention if they notice signs of infection, severe skin reactions, or mood changes.

Mirtazapina Aurobindo is contraindicated in patients with known hypersensitivity to mirtazapine or any of its excipients. It should also be avoided in individuals currently taking monoamine oxidase inhibitors (MAOIs) or who have a history of severe allergic reactions to similar antidepressants. Caution is advised in patients with hepatic impairment or uncontrolled hypertension.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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