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

Mirtazapina Generis

Active Ingredient:
Mirtazapine
Origin:
EU

Mirtazapina Generis (Mirtazapine)

Mirtazapine, the active ingredient in Mirtazapina Generis, is a NaSSA (noradrenergic and specific serotonergic antidepressant) presented as an oral tablet for oral use. It is indicated for the treatment of major depressive disorder in adult patients.
GNH India supplies Mirtazapina Generis as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Generis Farmacêutica, S.A.

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Indications & Clinical Uses

Mirtazapine is used within the antidepressant class to address mood disorders and related symptoms.

  • Major depressive disorder: alleviates depressive symptoms and improves sleep quality.
  • Depressive episodes in major depressive disorder: provides a rapid onset of antidepressant effect.
  • Adjunctive therapy for major depressive disorder with inadequate response: enhances overall treatment response when other antidepressants are insufficient.

How It Works

  • Mirtazapine acts as an antagonist at central presynaptic α2‑adrenergic receptors, which increases norepinephrine release. It also blocks 5‑HT2 and 5‑HT3 serotonin receptors and H1 histamine receptors, resulting in enhanced serotonergic and noradrenergic neurotransmission while producing sedative and appetite‑stimulating effects.

Side Effects

Mirtazapine may cause a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Sedation: drowsiness, especially at treatment initiation.
  • Increased appetite: often leading to weight gain.
  • Dry mouth: reduced salivation.
  • Constipation: slowed gastrointestinal motility.
  • Dizziness: light‑headedness on standing.
  • Orthostatic hypotension: mild blood pressure drop upon standing.

Serious or Rare Side Effects

  • Agranulocytosis: severe reduction in white blood cells.
  • Hepatic dysfunction: elevated liver enzymes or hepatitis.
  • Severe hypersensitivity: rash, angioedema, or anaphylaxis.
  • Suicidal ideation: emergence of suicidal thoughts, particularly early in therapy.
  • Serotonin syndrome: rare when combined with other serotonergic agents.
  • Hematologic abnormalities: neutropenia or thrombocytopenia.

Precautions & Warnings

Before prescribing Mirtazapine, clinicians should consider several safety aspects.

  • Monitor weight: patients may experience increased appetite and weight gain.
  • Assess for suicidal thoughts: especially during the first weeks of treatment.
  • Evaluate hepatic function: use caution in patients with liver disease.
  • Review concomitant CNS depressants: increased sedation risk.
  • Consider pregnancy status: safety data are limited; weigh risks and benefits.
  • Store below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

Mirtazapine can interact with other medicines, requiring careful management.

Major Interactions (Avoid)

  • MAO inhibitors: risk of hypertensive crisis and serotonin syndrome.
  • Other CNS depressants (e.g., benzodiazepines, alcohol): may cause excessive sedation.
  • Strong CYP2D6 inhibitors: can increase mirtazapine plasma levels.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., carbamazepine): may reduce efficacy.
  • Antihypertensive agents: additive hypotensive effect.
  • Anticholinergic drugs: may worsen dry mouth and constipation.
  • Other antidepressants: monitor for additive serotonergic effects.

Frequently Asked Questions

Mirtazapina Generis contains the active ingredient mirtazapine, which is prescribed to treat major depressive disorder in adult patients. It helps improve mood, sleep, and overall functional capacity by enhancing norepinephrine and serotonin neurotransmission.

Mirtazapine works by blocking presynaptic α2‑adrenergic receptors, which increases norepinephrine release, and by antagonizing 5‑HT2, 5‑HT3, and H1 receptors. This combined action boosts serotonergic and noradrenergic signaling while providing sedative and appetite‑stimulating effects.

The appropriate dose of Mirtazapina Generis is determined by the prescribing clinician based on the patient’s clinical condition, response, and tolerability. Dosage adjustments are individualized and should follow the prescriber’s instructions.

Safety data for mirtazapine in pregnancy and lactation are limited. The drug should only be used if the potential benefit justifies any potential risk to the fetus or infant. Healthcare providers must evaluate each case carefully.

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, confirming 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 α2‑adrenergic and specific serotonin receptors. It often provides stronger sedative effects and appetite stimulation, making it useful for patients with insomnia or weight loss, whereas SSRIs may have less sedation.

Mirtazapina Generis should be stored below 25 °C in its original packaging, protected from moisture and direct sunlight. Keep the product out of reach of children and avoid exposure to extreme temperatures.

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

Serious risks include agranulocytosis, severe hepatic dysfunction, suicidal ideation especially early in treatment, and rare cases of serotonin syndrome when combined with other serotonergic agents. Patients should be monitored closely for any signs of these conditions.

Mirtazapina Generis is contraindicated in patients with known hypersensitivity to mirtazapine or any excipients, and in those currently taking monoamine oxidase inhibitors (MAOIs). Caution is also advised for individuals with severe hepatic impairment or uncontrolled hypertension.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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