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 tetracyclic antidepressant presented as an oral dosage form for oral use. It is indicated for the treatment of 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
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Indications & Clinical Uses

Mirtazapine is a tetracyclic antidepressant used primarily in depressive disorders.

  • Major depressive disorder: reduces depressive symptoms and improves functional outcomes.
  • Depressive episodes in bipolar disorder (off‑label): may alleviate the depressive phase when other options are limited.
  • Anxiety symptoms associated with depression (off‑label): can help lower concurrent anxiety and improve sleep quality.

How It Works

  • Mirtazapine acts as an antagonist at central presynaptic α2‑adrenergic receptors, which disinhibits norepinephrine release. It also blocks 5‑HT2 and 5‑HT3 receptors, leading to increased serotonergic transmission while reducing serotonergic side‑effects. The combined effect enhances both norepinephrine and serotonin availability in key brain pathways involved in mood regulation.

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
  • Fatigue

Serious or Rare Side Effects

  • Agranulocytosis or severe neutropenia
  • Suicidal thoughts or behavior, especially early in treatment
  • Severe hypersensitivity reactions (rash, angioedema)
  • Serotonin syndrome when combined with other serotonergic agents
  • Cardiac arrhythmias (QT prolongation) in susceptible individuals
  • Hepatotoxicity (rare liver injury).

Precautions & Warnings

Before initiating therapy, clinicians should evaluate individual risk factors and monitor patients regularly.

  • Monitor weight: watch for significant gain and metabolic changes.
  • Assess suicidal ideation: especially during the first weeks of treatment.
  • Evaluate liver function: adjust if hepatic impairment is present.
  • Use caution in the elderly: increased sensitivity to sedation and orthostatic hypotension.
  • Avoid abrupt discontinuation: taper gradually to reduce withdrawal symptoms.
  • Store at room temperature: keep in the original pack, protect from moisture and direct sunlight.

Avoid Interactions

Mirtazapine can interact with several drug classes, requiring careful management.

Major Interactions (Avoid)

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

Moderate Interactions (Monitor Closely)

  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): may increase mirtazapine plasma levels.
  • Antihypertensive drugs: additive hypotensive effect may occur.
  • Alcohol: can worsen sedation and impair psychomotor performance.

Frequently Asked Questions

Mirtazapin Hexal contains the active ingredient mirtazapine, which is prescribed to treat major depressive disorder in adult patients. It helps alleviate depressive symptoms and can improve mood, sleep, and overall functioning when used under medical supervision.

Mirtazapine blocks presynaptic α2‑adrenergic receptors, increasing norepinephrine release, and antagonizes 5‑HT2 and 5‑HT3 receptors, enhancing serotonin availability while reducing certain serotonergic side‑effects. This dual action supports mood regulation in depressive states.

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

Safety data for mirtazapine in pregnancy and lactation are limited. Clinicians weigh potential benefits against possible risks before prescribing to pregnant or nursing women, and the decision is made on a case‑by‑case basis.

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, and any necessary import documentation.

Mirtazapine differs from selective serotonin reuptake inhibitors (SSRIs) by its dual antagonism of α2‑adrenergic and specific serotonin receptors, often resulting in stronger sedative effects and appetite stimulation. This profile 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 product from moisture, excessive heat, and direct sunlight to maintain stability and potency.

The medication is taken orally, usually once daily in the evening, with or without food. Patients should follow the prescribing clinician’s instructions regarding timing and whether to swallow tablets whole or with a small amount of water.

Serious risks include the potential for suicidal thoughts, especially early in treatment, agranulocytosis or severe neutropenia, serotonin syndrome when combined with other serotonergic drugs, and rare severe allergic reactions. Prompt medical attention is required if any of these occur.

Mirtazapin Hexal is contraindicated in patients currently taking monoamine oxidase inhibitors, those with known hypersensitivity to mirtazapine, and individuals with severe hepatic impairment without dose adjustment. Clinicians should also exercise caution in patients with a history of bipolar disorder, as it may trigger manic episodes.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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