Miramind

Mirtazapine USP

Presentation Miramind 7.5 mg tablet:

• Each film-coated tablet contains Mirtazapine USP 7.5 mg.

Miramind 15 mg tablet:

• Each film-coated tablet contains Mirtazapine USP 15 mg.

Description

Miramind (Mirtazapine) is a tetracyclic antidepressant that belongs to a piperazine-azepine group of compounds. The mechanism of action is unknown. Studies suggest that Mirtazapine enhances central noradrenergic and serotonergic activity. Mirtazapine acts as an antagonist at central presynaptic alpha-2 adrenergic inhibitory autoreceptors and heteroreceptors which results in an increased central noradrenergic and serotonergic activity.

Indications

• Miramind (Mirtazapine) is indicated for the treatment of depression.

Dosage and Administration

Geriatric: 7.5 mg/day orally at bedtime; increase by 7.5-15 mg/day no more frequently than every 1-2 weeks; not to exceed 45 mg/day

Initial Treatment:

The recommended starting dose of Mirtazapine is 15 mg/day, administered in a single dose, preferably in the evening before sleep.

Elderly and Patients with Renal or Hepatic Impairment:

The clearance of Mirtazapine is reduced in elderly patients and in patients with moderate to severe renal or hepatic impairment. Consequently, the prescriber should be aware that plasma Mirtazapine levels may be increased in these patient groups, compared to levels observed in younger adults without renal or hepatic impairment.

Maintenance/Extended Treatment:

• Systematic evaluation of Mirtazapine has demonstrated that its efficacy in major depressive disorder is maintained for periods of up to 40 weeks following 8 to 12 weeks of initial treatment at a dose of 15 to 45 mg/day.

Side Effects

• The most commonly reported adverse effects of Mirtazapine are an increase in appetite, weight gain, edema, drowsiness or sedation, dizziness, headache, etc.

Precautions

Mirtazapine should be used cautiously in patients with epilepsy or a history of seizures, history of mania /hypomania, patients with hepatic or renal impairment; cardiac disorders e.g. conduction disturbances, angina pectoris, recent MI, Hypotension, DM, psychoses, history of bipolar disorder. Stop treatment if jaundice develops. Monitor the patient for signs of bone marrow depression or suicidal tendencies. Avoid abrupt withdrawal. May impair the ability to drive or operate machinery.

Contraindications

Mirtazapine is contraindicated in patients with hypersensitivity. Do not use with or within 2 weeks of stopping an MAOI; at least 1 week should elapse between discontinuing Mirtazapine and initiating any drug that may provoke a serious reaction (e.g. phenelzine).

Use in Pregnancy & Lactation

• Mirtazapine should not be used during pregnancy and lactation.

Drug Interactions

Mirtazapine potentiates sedative effects with alcohol or benzodiazepines, and increases plasma levels with potent CYP3A4 inhibitors (e.g. HIV-protease inhibitors, azole antifungals including ketoconazole, erythromycin, nefazodone), reduces plasma levels with carbamazepine and other inducers of CYP3A4 and increases bioavailability with cimetidine.

Overdose

Depression of the central nervous system with disorientation and prolonged sedation have been reported together with tachycardia and mild hyper or hypotension. Cases of overdose should be treated by gastric lavage with appropriate symptomatic and supportive therapy.

Storage

• Store in a dry place, below 300 C, and protected from light. Keep out of reach of children.

Commercial Pack

• Miramind 7.5 mg tablet: Each box contains 5x10 tablets in an Alu-PVC blister pack.
• Miramind 15 mg tablet: Each box contains 5x10 tablets in an Alu-PVC blister pack

Biopharma Ltd. Produces MIRAMIND 7.5 it is a trusted product for alleviating various discomforts, and it's commonly found in pharmacies and stores.