GNH USA

Europe — EMA

Mirtazapin Krka (Mirtazapine)

GNH USA supplies Mirtazapin Krka (Mirtazapine), a NaSSA antidepressant for the treatment of major depressive disorder in adults.

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What is Mirtazapine?

Mirtazapine, the active ingredient in Mirtazapin Krka, is a NaSSA presented as an oral tablet for oral use. It is indicated for the treatment of major depressive disorder in adult patients, helping to improve mood, sleep and appetite.

GNH USA supplies Mirtazapin Krka as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, providing reliable sourcing and regulatory‑aligned distribution across EU and global markets.

What is Mirtazapine used for?

Mirtazapine is a NaSSA antidepressant that acts on neurotransmitter pathways implicated in mood disorders.

- Major depressive disorder: reduces depressive symptoms and improves overall mood in adults. - Depressive episodes with prominent anxiety: alleviates anxiety and improves sleep quality alongside mood. - Treatment‑resistant depression: used as an alternative when first‑line antidepressants are ineffective.

What are the side effects of Mirtazapine?

Mirtazapine may be associated with a range of adverse reactions, which are categorised by 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 - Severe hypersensitivity reactions (rash, angioedema) - Suicidal thoughts or behaviour, especially early in treatment - Serotonin syndrome when combined with other serotonergic agents - Hepatotoxicity - Unusual bleeding

What precautions apply to Mirtazapine?

When prescribing Mirtazapine, clinicians should consider several safety precautions to minimise risk.

- Assess hepatic function: evaluate liver enzymes before initiating therapy. - Monitor for suicidal ideation: especially during the first weeks of treatment. - Use cautiously in elderly patients: increased sensitivity to sedation and falls. - Avoid abrupt discontinuation: taper the dose to reduce withdrawal symptoms. - Adjust dose in renal impairment: consider lower doses in severe renal dysfunction. - Store at ambient temperature: keep in the original container, protect from moisture and light.

What does Mirtazapine interact with?

Mirtazapine can interact with other medicines, and the clinical relevance varies from major to moderate.

Major Interactions (Avoid): - Monoamine oxidase inhibitors (MAOIs): risk of hypertensive crisis and serotonin syndrome. - Linezolid or other reversible MAO‑A inhibitors: may precipitate serotonin excess. - Other serotonergic agents (e.g., SSRIs, SNRIs, tramadol): increased risk of serotonin syndrome.

Moderate Interactions (Monitor Closely): - Benzodiazepines or other CNS depressants: additive sedation. - CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): may increase mirtazapine plasma levels. - CYP3A4 inhibitors (e.g., ketoconazole, erythromycin): can raise drug exposure. - Alcohol: enhances central nervous system depression. - Antihistamines: may increase sedation and anticholinergic effects.

Frequently asked questions

What is Mirtazapin Krka used for?+
Mirtazapin Krka contains mirtazapine, a NaSSA antidepressant indicated for the treatment of major depressive disorder in adult patients. It helps to alleviate depressive symptoms, improve sleep quality and may increase appetite, contributing to overall mood stabilization.
How does mirtazapine work?+
Mirtazapine works by blocking presynaptic α2‑adrenergic receptors, which leads to increased release of norepinephrine and serotonin. It also antagonises postsynaptic 5‑HT2 and 5‑HT3 receptors, enhancing serotonergic activity while reducing side effects such as nausea and insomnia.
What is the usual dose of Mirtazapin Krka?+
The dose of Mirtazapin Krka is individualized by the prescribing clinician. Typically, treatment starts with a low oral dose, often 15 mg once daily, and may be adjusted based on therapeutic response and tolerability. Exact dosing should follow the prescriber’s recommendation.
Is Mirtazapin Krka safe during pregnancy or breastfeeding?+
Safety data for mirtazapine in 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. Consultation with a healthcare professional is essential before use in these populations.
How do I order Mirtazapin Krka from GNH USA?+
To order Mirtazapin Krka, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA 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.
How does Mirtazapin Krka compare with the main alternative drug or class?+
The primary alternative class for depression is selective serotonin reuptake inhibitors (SSRIs). Compared with SSRIs, mirtazapine often produces more sedation and weight gain but may be better tolerated in patients with insomnia or poor appetite. Both classes are effective, and the choice depends on individual symptom profile and side‑effect considerations.
How should Mirtazapin Krka be stored and handled?+
Mirtazapin Krka should be stored at ambient temperature, below 25 °C, in the original packaging to protect it from moisture and light. Keep the product out of reach of children and do not use it after the expiry date printed on the label.
How is Mirtazapin Krka administered?+
Mirtazapin Krka is taken orally as a tablet, usually once daily. It can be taken with or without food, and many clinicians recommend dosing in the evening because of its sedative effect, which may help improve sleep.
What are the most serious risks to watch for while taking Mirtazapin Krka?+
Serious risks include the emergence of suicidal thoughts, especially early in therapy, agranulocytosis or severe neutropenia, severe hypersensitivity reactions, and serotonin syndrome when combined with other serotonergic drugs. Patients should seek immediate medical attention if they experience fever, sore throat, rash, or sudden changes in mood.
Who should not use Mirtazapin Krka?+
Mirtazapin Krka should be avoided 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 uncontrolled hypertension or a history of bipolar disorder.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Mirtazapine
Route
Oral Use
Manufacturer
Krka, D.D., Novo Mesto
Origin
EU

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