Mirtazapine

Mirtazapine is indicated in adults for the treatment of episodes of major depression.

REMERON® (mirtazapine) is indicated for: • the symptomatic relief of depressive illness. Long-term use of REMERON® The efficacy of REMERON® in maintaining a response in patients with major depressive disorder for up to 40 weeks following 8 - 12 weeks of initial open-label treatment was demonstrated in a placebo-controlled trial.

Nevertheless, the physician who elects to use REMERON® for extended periods should periodically evaluate the long-term response of the individual patient to the drug. 1 Pediatrics Pediatrics (< 18 years of age): REMERON® is not indicated for use in patients below the age of 18 years (see WARNINGS AND PRECAUTIONS, General, Potential Association with Behavioural and Emotional Changes, Including Self-Harm; see also ADVERSE REACTIONS/Pediatrics, DOSAGE AND ADMINISTRATION and ACTION AND CLINICAL PHARMACOLOGY Special Populations and Conditions/Pediatrics).

2 Geriatrics Geriatrics (> 65 years of age): Evidence from clinical trials and experience suggests that use in geriatric populations may be associated with differences in safety or effectiveness. A brief discussion can be found in the appropriate sections [see WARNINGS AND PRECAUTIONS, Neurologic, Somnolence; Special Populations, Geriatrics (> 65 years of age); DOSAGE AND ADMINISTRATION; ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions, Geriatrics].

1 INDICATIONS AND USAGE Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14) ]. Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults.

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