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

Mirtazapina Azevedos

Active Ingredient:
Mirtazapine
Origin:
EU

Mirtazapina Azevedos (Mirtazapine)

Mirtazapine, the active ingredient in Mirtazapina Azevedos, is a NaSSA (noradrenergic and specific serotonergic antidepressant) presented as an oral tablet for oral use. It is indicated for the treatment of major depressive disorder in adult patients and is formulated according to EU quality standards under strict Good Manufacturing Practice guidelines.

GNH India supplies Mirtazapina Azevedos as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, providing reliable sourcing and regulatory support for global distribution and ensuring timely delivery.

Manufacturer / TM Owner

Laboratórios Azevedos - Indústria Farmacêutica, S.A.

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Indications & Clinical Uses

Mirtazapine, a NaSSA antidepressant, is used chiefly in the treatment of depressive illnesses. By enhancing noradrenergic and serotonergic neurotransmission, it helps to correct the neurochemical imbalances that underlie depressive symptomatology. Clinicians prescribe it for patients diagnosed with major depressive disorder, where it has demonstrated efficacy in reducing depressive scores and improving functional outcomes.

  • Major depressive disorder: reduces depressive symptoms and improves overall mood in adult patients.
  • Treatment‑resistant depression (adjunct): may be added when response to first‑line antidepressants is inadequate.

How It Works

  • Mirtazapine acts as an antagonist at central α2‑adrenergic receptors, which disinhibits norepinephrine release, and selectively blocks 5‑HT2 and 5‑HT3 serotonin receptors. This combined action increases synaptic concentrations of norepinephrine and serotonin at the 5‑HT1 receptors, enhancing mood‑regulating pathways while reducing side‑effects associated with other serotonergic agents. The drug also exhibits moderate antagonism at histamine H1 receptors, contributing to its sedative properties, and has weak anticholinergic activity.

Side Effects

Mirtazapine may cause a range of adverse reactions, which are generally categorized by frequency.

Common Side Effects

  • Sedation or drowsiness: feeling unusually sleepy, especially after the first doses.
  • Increased appetite and weight gain: heightened hunger leading to gradual weight increase.
  • Dry mouth: reduced salivation causing throat discomfort.
  • Constipation: infrequent bowel movements or hard stools.
  • Dizziness: sensation of light‑headedness or imbalance.
  • Fatigue: persistent lack of energy and motivation.

Serious or Rare Side Effects

  • Agranulocytosis or severe neutropenia: dangerously low white‑blood‑cell counts requiring monitoring.
  • Hepatic dysfunction or hepatitis: liver enzyme elevations or inflammation.

Precautions & Warnings

When prescribing mirtazapine, clinicians should observe several precautionary measures to ensure patient safety.

  • Weight monitoring: track body weight regularly due to risk of weight gain.
  • Suicidality assessment: evaluate for emerging suicidal thoughts, especially early in treatment.
  • Liver function: assess hepatic enzymes before initiation and periodically during therapy.
  • CNS depressant use: use caution when combined with alcohol or other sedatives.
  • Blood dyscrasias: monitor complete blood count if patient shows signs of infection.
  • Store at ambient temperature: keep tablets in the original container, protect from moisture and light.

Avoid Interactions

Mirtazapine can interact with several medicines; understanding the interaction level guides clinical decisions.

Major Interactions (Avoid)

  • Monoamine oxidase inhibitors (MAOIs): risk of hypertensive crisis and serotonin syndrome.
  • Other serotonergic agents (e.g., SSRIs, SNRIs, tramadol): may precipitate serotonin syndrome.
  • CNS depressants (e.g., benzodiazepines, opioids): enhanced sedation and respiratory depression.
  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): increase mirtazapine plasma concentrations.
  • Alcohol: additive central nervous system depression.

Moderate Interactions (Monitor Closely)

  • Antihypertensive drugs: additive blood‑pressure lowering effect.
  • Anticholinergic medications: may exacerbate anticholinergic burden.
  • Carbamazepine: may reduce mirtazapine levels, decreasing efficacy.
  • Warfarin: potential alteration of INR, requiring monitoring.
  • Lithium: possible increase in lithium levels, monitor serum concentration.

Frequently Asked Questions

Mirtazapina Azevedos contains the active ingredient mirtazapine, which is prescribed for the management of major depressive disorder in adult patients. It helps alleviate depressive symptoms such as low mood, loss of interest, and impaired concentration by modulating neurotransmitter activity in the brain.

Mirtazapine works by blocking central α2‑adrenergic receptors, which increases the release of norepinephrine, and by selectively antagonising 5‑HT2 and 5‑HT3 serotonin receptors. This dual action raises serotonin and norepinephrine levels at the 5‑HT1 receptors, enhancing mood‑regulating pathways while reducing certain serotonergic side effects.

The appropriate dose of Mirtazapina Azevedos is determined by the prescribing healthcare professional based on the individual’s clinical condition, response to therapy, and tolerability. Dosage adjustments are made according to the prescriber’s judgment; patients should follow the specific instructions provided by their doctor.

Safety data for mirtazapine in pregnancy and lactation are limited, and the product is classified as having an unknown pregnancy category. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss potential risks and benefits with their healthcare provider before using this medication.

To request Mirtazapina Azevedos, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams across international markets, and will ask for trade or institutional credentials before providing pricing, availability, shipping details and any necessary import documentation.

Mirtazapine belongs to the NaSSA class, differing from selective serotonin reuptake inhibitors (SSRIs) that primarily block serotonin reuptake. Its antagonism of α2‑adrenergic and specific serotonin receptors often results in a distinct side‑effect profile, including sedation and weight gain, which can be advantageous for patients with insomnia or appetite loss compared with many SSRIs.

Mirtazapina Azevedos tablets 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 throughout its shelf life.

The medication is taken orally, usually once daily in the evening, with or without food. Patients should swallow the tablet whole with a glass of water and follow the dosing schedule prescribed by their clinician. Consistency in timing helps maintain stable drug levels.

Serious adverse events include agranulocytosis or severe neutropenia, hepatic dysfunction, marked hypotension, seizures, and the emergence or worsening of suicidal thoughts, especially during early treatment. Prompt medical attention is required if any of these conditions develop.

Mirtazapina Azevedos is contraindicated in patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have a known hypersensitivity to mirtazapine or any of its excipients. Caution is also advised for individuals with severe hepatic impairment or a history of blood dyscrasias.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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