Mirtazapine Sandoz B.V. (Mirtazapine)

Mirtazapine works by blocking central presynaptic α2‑adrenergic receptors, which increases the release of norepinephrine. It also antagonizes postsynaptic 5‑HT2 and 5‑HT3 receptors and histamine H1 receptors. This combined activity enhances noradrenergic and serotonergic neurotransmission while providing sedative effects, contributing to its antidepressant action.

The appropriate dose of mirtazapine is determined by the prescribing clinician based on the individual’s clinical condition, response, and tolerability. Dosing typically starts at a low dose and may be adjusted gradually, but exact regimens should only be set by a qualified healthcare professional.

Safety data for mirtazapine during pregnancy and lactation are limited. The drug should only be used if the potential benefit to the mother outweighs any possible risk to the fetus or infant. Healthcare providers will evaluate the risk‑benefit profile before prescribing to pregnant or nursing women.

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Compared with selective serotonin reuptake inhibitors (SSRIs), mirtazapine has a distinct receptor profile that often results in stronger sedative and appetite‑stimulating effects. This can be advantageous for patients with insomnia or weight loss, but may be less desirable for those who prefer a non‑sedating option. Its side‑effect spectrum differs, making it a useful alternative when SSRIs are ineffective or poorly tolerated.

Mirtazapine tablets should be stored at ambient temperature, below 25 °C, in the original container to protect from moisture and light. Keep the product out of reach of children and avoid storing in bathrooms or other humid environments.

Mirtazapine 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 the potential for agranulocytosis, severe neutropenia, hepatotoxicity, seizures, hyponatremia (especially in older adults), and the emergence or worsening of suicidal thoughts, particularly during the initial weeks of therapy. Patients should be monitored closely for any of these events and seek immediate medical attention if they occur.

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 those who have experienced severe adverse reactions to similar antidepressants. Clinicians must assess each patient’s medical history before initiating therapy.