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

Mirtazapine Mylan

Active Ingredient:
Mirtazapine
Origin:
EU

Mirtazapine Mylan (Mirtazapine)

Mirtazapine, the active ingredient in Mirtazapine Mylan, 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 Mirtazapine Mylan as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Mylan Pharmaceuticals Limited

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Indications & Clinical Uses

  • Mirtazapine is a NaSSA antidepressant indicated for major depressive disorder, acting on central neurotransmitter pathways.
  • Major depressive disorder: alleviates depressive symptoms and improves mood in adult patients.

How It Works

  • Mirtazapine blocks central α2‑adrenergic receptors, increasing norepinephrine release, and antagonizes 5‑HT2 and 5‑HT3 receptors, which enhances serotonergic transmission while reducing serotonergic side effects. This combined action restores the balance of noradrenergic and serotonergic pathways implicated in depression.

Side Effects

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

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
  • Hepatic dysfunction or jaundice
  • Severe hypersensitivity reactions (rash, angioedema)
  • Suicidal thoughts or behavior, especially early in treatment
  • Serotonin syndrome when combined with other serotonergic agents

Precautions & Warnings

Before prescribing Mirtazapine, clinicians should consider several safety aspects.

  • Hepatic function: assess liver enzymes in patients with hepatic impairment.
  • Suicidal risk: monitor for emergence or worsening of suicidal thoughts, particularly during the initial treatment period.
  • Elderly patients: use caution due to increased fall risk from sedation.
  • Discontinuation: avoid abrupt cessation; taper the dose to reduce withdrawal symptoms.
  • Pregnancy and lactation: evaluate risk‑benefit, as safety data are limited.
  • Store at ambient temperature: keep below 25°C in the original container, protect from moisture and light.

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): increased risk of serotonin syndrome.
  • Central nervous system depressants (e.g., alcohol, benzodiazepines): enhanced sedation and respiratory depression.

Moderate Interactions (Monitor Closely)

  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): may raise mirtazapine plasma levels.
  • Antihypertensives: additive hypotensive effect, monitor blood pressure.

Frequently Asked Questions

Mirtazapine Mylan is a prescription oral tablet containing the antidepressant mirtazapine. It is primarily indicated for the treatment of major depressive disorder in adult patients, helping to relieve depressive symptoms and improve overall mood.

Mirtazapine works by blocking central α2‑adrenergic receptors, which increases the release of norepinephrine, and by antagonizing 5‑HT2 and 5‑HT3 serotonin receptors. This dual action enhances noradrenergic and serotonergic neurotransmission, correcting the chemical imbalances associated with depression.

The appropriate dose of Mirtazapine Mylan is determined by the prescribing clinician based on the individual patient's condition, response, and tolerability. Dosage adjustments are made according to clinical guidelines and patient-specific factors.

Safety data for mirtazapine in pregnancy and lactation are limited. Prescribers should weigh the potential benefits against possible risks and consider alternative treatments when possible. Breastfeeding mothers should consult their healthcare provider before using the medication.

To 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 belongs to the NaSSA class, differing from SSRIs and SNRIs by its combined α2‑adrenergic blockade and serotonin receptor antagonism. This profile often results in pronounced 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.

Store Mirtazapine Mylan tablets at ambient temperature, preferably below 25 °C. Keep the product in its original packaging, protect it from moisture and direct light, and ensure the container is tightly closed to maintain stability.

Mirtazapine Mylan 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 agranulocytosis or severe neutropenia, hepatic dysfunction, severe hypersensitivity reactions, emergence of suicidal thoughts especially early in therapy, and serotonin syndrome when combined with other serotonergic drugs. Patients should be monitored closely for these events.

Mirtazapine is contraindicated in patients who have taken a monoamine oxidase inhibitor 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 trigger manic episodes.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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