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

Mirtazapin Actavis

Active Ingredient:
Mirtazapine
Origin:
EU

Mirtazapin Actavis (Mirtazapine)

Mirtazapine, the active ingredient in Mirtazapin Actavis, is a noradrenergic and specific serotonergic antidepressant (NaSSA) 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 Actavis as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Actavis Group Ptc Ehf.

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Indications & Clinical Uses

Mirtazapin Actavis, a NaSSA antidepressant, is used within the depressive disorder therapeutic pathway.

  • Major depressive disorder: improves mood, sleep quality and appetite in adults.
  • Major depressive disorder (adjunctive therapy): enhances response when first‑line agents are insufficient.
  • Major depressive disorder (maintenance): helps sustain remission and prevent relapse.

How It Works

  • Mirtazapine acts as an antagonist at central presynaptic α2‑adrenergic receptors, which increases norepinephrine release, and blocks 5‑HT2 and 5‑HT3 serotonin receptors while also antagonising histamine H1 receptors. This combined activity enhances noradrenergic and serotonergic neurotransmission, contributing to its antidepressant effect.

Side Effects

Mirtazapin Actavis may cause a range of adverse reactions.

Common Side Effects

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

Serious or Rare Side Effects

  • Agranulocytosis or severe neutropenia
  • Severe hypersensitivity reactions (e.g., Stevens‑Johnson syndrome)
  • Suicidal thoughts or behavior, especially early in treatment
  • Serotonin syndrome when combined with other serotonergic agents
  • Hepatotoxicity in rare cases

Precautions & Warnings

Before initiating therapy, clinicians should consider several safety aspects.

  • Psychiatric assessment: evaluate baseline mood and suicidal risk.
  • Hepatic function: adjust use in patients with moderate to severe liver impairment.
  • Elderly patients: monitor for excessive sedation and falls.
  • Discontinuation: avoid abrupt cessation to reduce withdrawal phenomena.
  • Concomitant CNS depressants: use cautiously due to additive sedation.
  • Store at ambient temperature: keep in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Mirtazapin Actavis can interact with several drug classes, requiring careful management.

Major Interactions (Avoid)

  • Monoamine oxidase inhibitors (MAOIs): risk of hypertensive crisis; a washout period is required.
  • Other serotonergic agents (e.g., SSRIs, SNRIs, tramadol): potential for serotonin syndrome.
  • Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): may increase mirtazapine plasma concentrations.

Moderate Interactions (Monitor Closely)

  • Central nervous system depressants (alcohol, benzodiazepines): additive sedation and respiratory depression.
  • Antihistamines: increased drowsiness.
  • Anticholinergic drugs: may exacerbate constipation and dry mouth.

Frequently Asked Questions

Mirtazapin Actavis contains mirtazapine, a noradrenergic and specific serotonergic antidepressant (NaSSA) that is prescribed primarily for the treatment of major depressive disorder in adult patients. It helps improve mood, sleep and appetite as part of a comprehensive depression management plan.

Mirtazapine blocks presynaptic α2‑adrenergic receptors, leading to increased release of norepinephrine, and antagonises 5‑HT2, 5‑HT3 and H1 receptors. This dual action enhances noradrenergic and serotonergic neurotransmission while reducing histamine‑mediated sedation, producing an overall antidepressant effect.

The appropriate dose of Mirtazapin Actavis is determined by the prescribing clinician based on the individual’s clinical condition, response to therapy and tolerability. Dosage adjustments are made during treatment, and patients should follow the prescriber’s instructions without self‑adjusting the amount.

Safety data for mirtazapine in pregnancy and lactation are limited. The prescriber must weigh potential benefits against possible risks to the fetus or infant. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss the use of Mirtazapin Actavis with their healthcare provider.

To request Mirtazapin Actavis, 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.

Mirtazapin Actavis belongs to the NaSSA class, which differs from selective serotonin reuptake inhibitors (SSRIs) and serotonin‑norepinephrine reuptake inhibitors (SNRIs) by its receptor‑blocking profile. It often provides stronger sedative and appetite‑stimulating effects, making it useful when insomnia or weight loss are prominent concerns.

Mirtazapin Actavis should be stored at ambient temperature, below 25 °C. Keep the product in its original packaging, protect it from moisture and direct sunlight, and ensure the container is tightly closed to maintain stability.

Mirtazapin Actavis is taken orally, usually once daily in the evening to take advantage of 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 or severe neutropenia, hypersensitivity reactions such as Stevens‑Johnson syndrome, emergence or worsening of suicidal thoughts, and rare cases of serotonin syndrome when combined with other serotonergic drugs. Prompt medical attention is required if any of these occur.

Mirtazapin Actavis is contraindicated in patients who have a known hypersensitivity to mirtazapine or any of its excipients, and in those currently receiving monoamine oxidase inhibitors (MAOIs) without an appropriate washout period. Caution is also advised for individuals with severe hepatic impairment or a history of blood dyscrasias.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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