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 NaSSA (noradrenergic and specific serotonergic antidepressant) presented as a tablet for oral use. It treats major depressive disorder in adults.

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

Mirtazapine is used to treat depressive disorders by modulating noradrenergic and serotonergic neurotransmission.

  • Major depressive disorder: reduces depressive symptoms and improves sleep and overall mood.
  • Depressive episodes in bipolar disorder (adjunct): helps alleviate the depressive phase when prescribed by a specialist.
  • Anxiety associated with depression: may lessen anxiety symptoms in patients with co‑existing depressive illness.

How It Works

  • Mirtazapine antagonises central presynaptic α2‑adrenergic receptors, increasing norepinephrine release, and blocks postsynaptic 5‑HT2 and 5‑HT3 receptors, enhancing serotonergic transmission while reducing serotonergic side‑effects. This combined action raises synaptic concentrations of norepinephrine and serotonin, contributing to its antidepressant effect.

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
  • Somnolence

Serious or Rare Side Effects

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

Precautions & Warnings

Before prescribing Mirtazapine, clinicians should consider several safety factors.

  • Pregnancy: safety not established; avoid unless benefit outweighs risk.
  • Breastfeeding: unknown excretion; consider alternative therapy.
  • Elderly: increased sensitivity to sedation and risk of falls.
  • Concomitant CNS depressants: may enhance sedative effects.
  • Alcohol: avoid as it can intensify CNS depression.
  • Store at room temperature: keep in the original container, protect from moisture and light.

Avoid Interactions

Mirtazapine can interact with other medicines, requiring careful management.

Major Interactions (Avoid)

  • Monoamine oxidase inhibitors (MAOIs): risk of hypertensive crisis.
  • Other serotonergic agents (e.g., SSRIs, SNRIs, tramadol): potential serotonin syndrome.
  • Potent CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): may increase mirtazapine plasma levels.

Moderate Interactions (Monitor Closely)

  • Alcohol: enhances CNS depression.
  • Antihistamines: additive sedation.
  • Carbamazepine or phenytoin: may reduce mirtazapine effectiveness.
  • Warfarin: possible alteration of INR.
  • Benzodiazepines: increased sedative effect.

Frequently Asked Questions

Mirtazapin Actavis contains the active ingredient mirtazapine, which is prescribed primarily for the treatment of major depressive disorder in adults. It helps alleviate depressive symptoms, improve sleep, and enhance overall mood by influencing norepinephrine and serotonin pathways.

Mirtazapine works by blocking presynaptic α2‑adrenergic receptors, which increases the release of norepinephrine, and by antagonising postsynaptic 5‑HT2 and 5‑HT3 receptors. This dual action raises serotonin and norepinephrine levels while reducing certain serotonergic side‑effects, producing an antidepressant effect.

The appropriate dose of Mirtazapin Actavis is determined by the prescribing clinician based on the patient’s medical condition, response to therapy, and tolerability. Dosage adjustments are made individually; patients should follow the prescriber’s instructions and not alter the dose on their own.

Safety data for mirtazapine in pregnancy and lactation are limited. The product is classified as having an unknown pregnancy category, and its excretion in breast milk is not well defined. Use only if the potential benefit justifies the potential risk, and discuss alternatives with a healthcare professional.

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 (including any cold‑chain needs), and required import documentation.

Mirtazapin Actavis belongs to the NaSSA class, which differs from SSRIs and SNRIs by its combined α2‑adrenergic antagonism and selective serotonin receptor blockade. This profile often results in pronounced sedative and appetite‑stimulating effects, making it useful for patients with insomnia or weight loss, whereas other antidepressants may have different side‑effect patterns.

Mirtazapin Actavis should be stored at room temperature, below 25 °C. Keep the tablets in the original packaging, protect them from moisture and direct light, and ensure they are out of reach of children.

Mirtazapin Actavis 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 a prescriber provides specific instructions for an alternative method.

Serious risks include the potential for agranulocytosis, severe neutropenia, Stevens‑Johnson syndrome, and the emergence of suicidal thoughts, particularly during the initial weeks of therapy. Patients should be monitored closely for signs of infection, skin reactions, or worsening mood, and seek immediate medical attention if such symptoms appear.

Mirtazapin Actavis is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) within the past 14 days, those with known hypersensitivity to mirtazapine, and individuals with severe hepatic impairment. Caution is also advised for patients with a history of bipolar disorder, as it may precipitate manic episodes.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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