Product image of Mirtazapine Smelttab Viatris (Mirtazapine) supplied by GNH India

Mirtazapine Smelttab Viatris

Active Ingredient:
Mirtazapine
Origin:
EU

Mirtazapine Smelttab Viatris (Mirtazapine)

Mirtazapine, the active ingredient in Mirtazapine Smelttab Viatris, is a noradrenergic and specific serotonergic antidepressant (NaSSA) presented as an oral tablet for oral use. It is indicated for the treatment of major depressive disorder in adult patients.

GNH India supplies Mirtazapine Smelttab Viatris as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides regulatory‑compliant documentation for global distribution.

Manufacturer / TM Owner

Viatris Limited

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Indications & Clinical Uses

Mirtazapine is used primarily in the depressive disorder pathway to improve mood and functional outcomes.

  • Major depressive disorder: alleviates depressive symptoms and improves overall mood.

How It Works

  • Mirtazapine antagonises central presynaptic α2‑adrenergic receptors, increasing norepinephrine and serotonin release. It also blocks postsynaptic 5‑HT2 and 5‑HT3 receptors and potently antagonises histamine H1 receptors, resulting in enhanced neurotransmission in mood‑regulating pathways and a sedative effect.

Side Effects

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

Common Side Effects

  • Sedation or somnolence
  • Increased appetite and weight gain
  • Dry mouth
  • Constipation
  • Dizziness
  • Fatigue

Serious or Rare Side Effects

  • Agranulocytosis or severe neutropenia
  • Stevens‑Johnson syndrome or toxic epidermal necrolysis
  • Hepatic dysfunction or jaundice
  • Seizures
  • Suicidal ideation or behavior
  • Severe allergic reactions (anaphylaxis)

Precautions & Warnings

Before initiating therapy, clinicians should evaluate several safety considerations.

  • Assess hepatic function: adjust use in severe impairment
  • Monitor for suicidal thoughts: especially during early treatment
  • Caution in cardiovascular disease: may cause orthostatic hypotension
  • Avoid abrupt discontinuation: risk of withdrawal symptoms
  • Pregnancy and lactation: use only if benefits outweigh risks
  • Store below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

Mirtazapine can interact with other medicines, requiring careful management.

Major Interactions (Avoid)

  • Monoamine oxidase inhibitors (MAOIs): risk of hypertensive crisis
  • Strong CYP2D6 inhibitors (e.g., fluoxetine): increased mirtazapine levels
  • Central nervous system depressants (e.g., alcohol, benzodiazepines): enhanced sedation

Moderate Interactions (Monitor Closely)

  • Antihypertensive agents: additive hypotensive effect
  • Anticoagulants (e.g., warfarin): possible alteration of INR

Frequently Asked Questions

Mirtazapine Smelttab Viatris is a prescription medication containing the active ingredient mirtazapine, classified as a noradrenergic and specific serotonergic antidepressant (NaSSA). It is indicated for the treatment of major depressive disorder in adult patients, helping to improve mood, sleep, and appetite. The product is supplied in tablet form for oral administration.

Mirtazapine works by blocking central presynaptic α2‑adrenergic receptors, which increases the release of norepinephrine and serotonin. It also antagonises postsynaptic 5‑HT2 and 5‑HT3 receptors and strongly blocks histamine H1 receptors. This combined receptor activity enhances neurotransmission in brain pathways that regulate mood and produces a sedative effect that can aid sleep.

The appropriate dose is determined individually by the prescribing clinician based on the patient’s clinical condition, response, and tolerability. Dosage may be started at a low level and titrated upward as needed, but exact strength and regimen should follow the prescriber’s written order and local prescribing guidelines. No generic dosing information is provided here.

Safety data for mirtazapine during pregnancy and lactation are limited. It should only be used when the potential benefit to the mother outweighs any possible risk to the fetus or infant. Healthcare providers should discuss the risk‑benefit profile with the patient and consider alternative therapies if appropriate. Breastfeeding mothers should consult a physician before use.

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, and will request verification of trade or institutional credentials. After confirmation, the sales team provides pricing, availability, shipping details (including any temperature requirements), and assists with 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. Unlike tricyclic antidepressants, it has fewer anticholinergic and cardiac side effects. However, individual response varies, and clinicians choose the agent based on symptom profile, comorbidities, and tolerability.

Mirtazapine Smelttab Viatris tablets should be stored at temperatures below 25 °C (77 °F). Keep the product in its original container, protect it from moisture and direct sunlight, and ensure the packaging is tightly closed. Do not store in a bathroom or near heat sources. Follow any additional handling instructions provided by the supplier to maintain product stability.

The medication is taken orally, usually once daily in the evening due to its sedative properties. Tablets should be swallowed whole with a glass of water and may be taken with or without food, as directed by the prescriber. Patients should not crush, chew, or split the tablets unless specifically instructed, and they should follow the dosing schedule prescribed to achieve optimal therapeutic effect.

Although uncommon, serious adverse reactions can include agranulocytosis, severe neutropenia, hepatic dysfunction, and rare cases of Stevens‑Johnson syndrome or toxic epidermal necrolysis. Patients should be monitored for signs of infection, unexplained fever, jaundice, or severe skin reactions and seek immediate medical attention if these occur. Additionally, any emergence of suicidal thoughts, especially during the initial treatment phase, warrants urgent evaluation.

Mirtazapine is contraindicated in patients who have a known hypersensitivity to the drug or any of its excipients. It should also be avoided in individuals currently taking monoamine oxidase inhibitors (MAOIs) or who have used an MAOI within the past 14 days due to the risk of hypertensive crisis. Caution is advised for patients with severe hepatic impairment, uncontrolled cardiovascular disease, or a history of seizures, and the prescriber should assess suitability before initiating therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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