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

Mirtazapina Mylan

Active Ingredient:
Mirtazapine
Origin:
EU

Mirtazapina Mylan (Mirtazapine)

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

Manufacturer / TM Owner

Viatris Limited

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Indications & Clinical Uses

Mirtazapina Mylan is a NaSSA antidepressant that modulates norepinephrine and serotonin pathways to improve mood in depressive conditions.

  • Major depressive disorder: reduces depressive symptoms and improves functional capacity.
  • Depressive episodes with insomnia: promotes sleep onset and continuity.
  • Depressive episodes with anxiety: alleviates anxiety components associated with depression.

How It Works

  • Mirtazapine antagonises central presynaptic α2‑adrenergic receptors, enhancing norepinephrine release, and blocks postsynaptic 5‑HT2 and 5‑HT3 receptors, increasing serotonergic transmission. It also inhibits histamine H1 receptors, contributing to its sedative properties.

Side Effects

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

Common Side Effects

  • Drowsiness or sedation.
  • Increased appetite and weight gain.
  • Dry mouth.
  • Constipation.
  • Dizziness.
  • Peripheral edema.

Serious or Rare Side Effects

  • Agranulocytosis or severe neutropenia.
  • Seizures.
  • Severe hypersensitivity reactions (e.g., Stevens‑Johnson syndrome).
  • Hepatic dysfunction.
  • Suicidal thoughts, especially early in treatment.
  • Orthostatic hypotension.

Precautions & Warnings

Before initiating therapy, clinicians should evaluate patient history and monitor for specific risks.

  • Pregnancy: safety not established; avoid unless benefit outweighs risk.
  • Breastfeeding: unknown excretion; consider alternatives.
  • Elderly: start at low dose and monitor for excessive sedation.
  • Hepatic or renal impairment: dose adjustment may be required.
  • Store at ambient temperature: keep below 25 °C, retain in original container, protect from moisture and light.

Avoid Interactions

Mirtazapine can affect or be affected by several concomitant medicines.

Major Interactions (Avoid)

  • MAO inhibitors: risk of serotonin syndrome.
  • Strong CYP1A2 inhibitors (e.g., fluvoxamine): may increase plasma levels.
  • CNS depressants (e.g., benzodiazepines, alcohol): additive sedation.

Moderate Interactions (Monitor Closely)

  • CYP2D6 substrates (e.g., metoprolol): possible altered metabolism.
  • Anticholinergic agents: may exacerbate dry mouth and constipation.
  • Warfarin: monitor INR for potential changes.

Frequently Asked Questions

Mirtazapina Mylan contains the active ingredient mirtazapine, a NaSSA antidepressant prescribed primarily for the management of major depressive disorder in adults. 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 the release of norepinephrine, and by antagonising postsynaptic 5‑HT2 and 5‑HT3 receptors, thereby boosting serotonergic activity. Its additional H1‑histamine blockade contributes to its sedative effect.

The appropriate dose of Mirtazapina Mylan is determined by the prescribing clinician based on the patient’s clinical condition, response, and tolerability. Dosage adjustments may be needed for elderly patients or those with hepatic or renal impairment.

Safety data for mirtazapine in pregnancy and lactation are limited. It should only be used when the potential benefit justifies the potential risk to the fetus or infant, and clinicians should discuss alternatives and monitoring strategies with the patient.

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.

Compared with selective serotonin reuptake inhibitors (SSRIs), mirtazapine offers a distinct mechanism that can be beneficial for patients with insomnia or poor appetite. It may cause more sedation but less sexual dysfunction, making it a useful alternative when SSRIs are not well tolerated.

Mirtazapina Mylan should be stored at ambient temperature, preferably 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.

The medication is taken orally, usually once daily in the evening to take advantage of its sedative effect. It should be swallowed whole with water and not crushed or chewed unless otherwise directed by a healthcare professional.

Serious risks include agranulocytosis, severe hepatic dysfunction, seizures, and rare hypersensitivity reactions such as Stevens‑Johnson syndrome. Patients should be monitored for signs of infection, liver injury, or unusual skin reactions, and the drug should be discontinued if these occur.

Mirtazapina Mylan is contraindicated in patients who have taken monoamine oxidase inhibitors within the past 14 days, those with known hypersensitivity to mirtazapine, and individuals with severe hepatic impairment where the drug cannot be safely metabolised.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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