Product image of Mirtazapine Milpharm Limited (Mirtazapine) supplied by GNH India

Mirtazapine Milpharm Limited

Active Ingredient:
Mirtazapine
Origin:
EU

Mirtazapine Milpharm Limited (Mirtazapine)

Mirtazapine, the active ingredient in Mirtazapine Milpharm Limited, is a tetracyclic antidepressant presented as an oral tablet for oral use. It is prescribed for the treatment of major depressive disorder in adults.

GNH India supplies Mirtazapine Milpharm Limited as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Milpharm Limited

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Indications & Clinical Uses

  • Mirtazapine is used in the management of depressive disorders by modulating neurotransmitter activity.
  • Major depressive disorder: reduces depressive symptoms and improves mood in adult patients.
  • Depressive symptoms with insomnia: helps restore sleep quality alongside mood improvement.
  • Depressive symptoms with anxiety: may alleviate associated anxiety while treating core depression.

How It Works

  • Mirtazapine acts as an antagonist of central presynaptic α2‑adrenergic receptors, thereby increasing norepinephrine release. It also blocks 5‑HT2 and 5‑HT3 serotonin receptors and antagonizes H1 histamine receptors, resulting in enhanced serotonergic and noradrenergic neurotransmission and a sedative effect that contributes to its antidepressant activity.

Side Effects

Mirtazapine may cause a range of adverse reactions, from mild to serious.

Common Side Effects

  • Increased appetite and weight gain.
  • Sedation or drowsiness, especially at treatment initiation.
  • Dry mouth.
  • Constipation.
  • Dizziness.
  • Edema of the lower extremities.

Serious or Rare Side Effects

  • Agranulocytosis or severe neutropenia.
  • Hepatotoxicity with elevated liver enzymes.
  • Severe hypersensitivity reactions, including rash or angioedema.
  • Suicidal thoughts, particularly in young adults.
  • Seizures in predisposed individuals.
  • Uncontrolled hypertension.

Precautions & Warnings

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

  • Pregnancy: safety not established; weigh potential benefits against risks.
  • Breastfeeding: excreted in milk; consider alternatives.
  • Hepatic impairment: dose adjustment may be required.
  • Elderly patients: increased sensitivity to sedation and falls.
  • Concomitant CNS depressants: monitor for additive sedation.
  • Store at ambient temperature: keep in original container, 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 serotonin syndrome.
  • CYP1A2 inhibitors (e.g., fluvoxamine): may increase mirtazapine plasma levels.
  • CNS depressants (e.g., benzodiazepines, alcohol): enhanced sedation and respiratory depression.

Moderate Interactions (Monitor Closely)

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

Frequently Asked Questions

Mirtazapine Milpharm Limited contains the antidepressant mirtazapine, which is prescribed primarily for the treatment of major depressive disorder in adult patients. It helps improve mood, sleep, and overall functional status by enhancing norepinephrine and serotonin neurotransmission.

Mirtazapine works by blocking central presynaptic α2‑adrenergic receptors, which increases the release of norepinephrine. It also antagonizes 5‑HT2 and 5‑HT3 serotonin receptors and H1 histamine receptors, leading to heightened serotonergic activity and a sedative effect that contributes to its antidepressant properties.

The appropriate dose of mirtazapine is determined by the prescribing clinician based on the individual patient's condition, response, and tolerability. Dosage may be adjusted over time, and patients should follow the specific instructions provided by their healthcare professional.

Safety data for mirtazapine in pregnancy are limited, and the medication is generally not recommended unless the potential benefit outweighs the risk. Mirtazapine is excreted in breast milk, so breastfeeding mothers should discuss alternatives with their physician.

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 has a distinct receptor profile that often results in greater sedation and appetite stimulation, which can be advantageous for patients with insomnia or weight loss. However, its side‑effect profile differs, and choice of therapy should be individualized.

Mirtazapine Milpharm Limited should be stored at ambient temperature, below 25 °C, in its original packaging to protect it from moisture and light. Keep the product out of reach of children and avoid storing in humid or excessively hot environments.

Mirtazapine is administered orally, typically as a tablet taken once daily, preferably in the evening due to its sedative effect. Patients should swallow the tablet whole with water and follow any specific instructions from their prescriber regarding food intake.

Serious risks include agranulocytosis, severe liver injury, hypersensitivity reactions, and the emergence or worsening of suicidal thoughts, especially in younger adults. Patients should be monitored for signs of infection, liver dysfunction, allergic reactions, and changes in mood or behavior.

Mirtazapine is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) within 14 days, those with known hypersensitivity to the drug, and individuals with severe hepatic impairment without dose adjustment. Caution is also advised for patients with a history of bipolar disorder, as it may precipitate mania.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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