Product image of Mirtazapin Hexal (Mirtazapine) supplied by GNH India

Mirtazapin Hexal

Active Ingredient:
Mirtazapine
Origin:
EU

Mirtazapin Hexal (Mirtazapine)

Mirtazapine, the active ingredient in Mirtazapin Hexal, is a NaSSA (noradrenergic and specific serotonergic antidepressant) presented as an oral tablet for oral use. It is prescribed for major depressive disorder in adult patients.

GNH India supplies Mirtazapin Hexal as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Hexal A/S

1
Pack/s
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Indications & Clinical Uses

Mirtazapine is indicated for depressive disorders that involve dysregulation of noradrenergic and serotonergic pathways.

  • Major depressive disorder: reduces depressive symptoms and improves mood in adult patients.
  • Depression with prominent insomnia: helps restore sleep quality while treating mood symptoms.
  • Depression with anxiety features: alleviates both depressive and anxiety symptoms in the same therapeutic regimen.

How It Works

  • Mirtazapine acts as an antagonist at central presynaptic α2‑adrenergic receptors, which enhances the release of norepinephrine and serotonin. It also blocks 5‑HT2 and 5‑HT3 receptors and exhibits strong H1‑receptor antagonism, leading to increased noradrenergic and serotonergic neurotransmission while producing sedative effects.

Side Effects

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

Common Side Effects

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

Serious or Rare Side Effects

  • Agranulocytosis or severe neutropenia
  • Life‑threatening hypersensitivity reactions
  • Serotonin syndrome when combined with other serotonergic agents
  • Suicidal ideation, especially early in treatment
  • Hepatic dysfunction or jaundice
  • Severe rash or Stevens‑Johnson syndrome

Precautions & Warnings

When prescribing or dispensing Mirtazapine, consider the following safety measures.

  • Assess hepatic function: adjust use in patients with liver impairment.
  • Monitor mood changes: watch for worsening depression or emergence of suicidal thoughts.
  • Use caution in cardiovascular disease: may cause orthostatic hypotension.
  • Avoid abrupt discontinuation: taper to reduce withdrawal symptoms.
  • Evaluate for hypersensitivity: discontinue if severe allergic reaction occurs.
  • Store at room temperature: keep in the original pack, protect from moisture.

Avoid Interactions

Mirtazapine can interact with several drug classes; awareness helps prevent adverse outcomes.

Major Interactions (Avoid)

  • Monoamine oxidase inhibitors (MAOIs): risk of serotonin syndrome.
  • Other serotonergic agents (e.g., SSRIs, SNRIs, tramadol): increase serotonin toxicity.
  • Central nervous system depressants (e.g., benzodiazepines, alcohol): enhanced sedation.
  • Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): raise mirtazapine plasma levels.
  • Alcohol: may intensify sedative effects.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inhibitors or inducers: may alter drug concentration.
  • Antihypertensive agents: additive blood‑pressure lowering.
  • Anticholinergic drugs: increase anticholinergic burden.
  • Non‑steroidal anti‑inflammatory drugs (NSAIDs): heightened risk of gastrointestinal bleeding.
  • Lithium: monitor for neurotoxicity when combined.

Frequently Asked Questions

Mirtazapin Hexal contains mirtazapine, an antidepressant indicated for the treatment of major depressive disorder in adult patients. It helps improve mood, sleep, and appetite by modulating noradrenergic and serotonergic neurotransmission.

Mirtazapine blocks presynaptic α2‑adrenergic receptors, which increases the release of norepinephrine and serotonin. It also antagonises 5‑HT2 and 5‑HT3 receptors and strongly blocks H1 histamine receptors, resulting in enhanced mood and a sedative effect.

The appropriate dose of Mirtazapin Hexal is determined by the prescribing clinician based on the individual’s clinical condition, response, and tolerability. Dosage adjustments are made according to professional guidelines and patient needs.

Safety data for mirtazapine in pregnancy and lactation are limited. The medication should only be used if the potential benefit justifies any potential risk to the fetus or infant, and the decision must be made by a qualified healthcare professional.

To place an order, submit an enquiry on the product page at gnhindia.com with 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 and any 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 and appetite‑stimulating effects, which can be advantageous for patients with insomnia or weight loss, but may be less suitable for those concerned about weight gain.

Mirtazapin Hexal should be stored at room temperature, below 25 °C, in its original packaging. Protect the tablets from moisture and direct sunlight to maintain potency throughout the shelf life.

Mirtazapin Hexal 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 the potential for agranulocytosis, severe hypersensitivity reactions, serotonin syndrome when combined with other serotonergic drugs, and emergence or worsening of suicidal thoughts, particularly during the initial weeks of therapy.

Mirtazapin Hexal is contraindicated in patients with known hypersensitivity to mirtazapine or any of its excipients, and in individuals currently taking monoamine oxidase inhibitors. Caution is also advised for patients with severe hepatic impairment or uncontrolled cardiovascular disease.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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