MEET-15/30 (MIRTAZAPINE TABLETS)
DESCRIPTION
Mirtazapine is used to treat depression. It improves mood and feelings of well-being. Mirtazapine is an antidepressant that works by restoring the balance of natural chemicals (neurotransmitters) in the brain.
DOSAGE
The recommended starting dose for REMERON® (mirtazapine) Tablets is 15 mg/day, administered in a single dose, preferably in the evening prior to sleep. In the controlled clinical trials establishing the efficacy of REMERON in the treatment of major depressive disorder, the effective dose range was generally 15 to 45 mg/day. While the relationship between dose and satisfactory response in the treatment of major depressive disorder for REMERON has not been adequately explored.
CLINICAL PHARMACOLOGY
The mechanism of action of REMERON® (mirtazapine) Tablets, as with other drugs effective in the treatment of major depressive disorder, is unknown. Evidence gathered in preclinical studies suggests that mirtazapine enhances central noradrenergic and serotonergic activity. These studies have shown that mirtazapine acts as an antagonist at central presynaptic α2 adrenergic inhibitory autoreceptors and heteroreceptors, an action that is postulated to result in an increase in central noradrenergic and serotonergic activity.
INDICATIONS
REMERON® (mirtazapine) Tablets are indicated for the treatment of major depressive disorder. The efficacy of REMERON in the treatment of major depressive disorder was established in 6week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders – 3rd edition (DSM-III) category of major depressive disorder.
CONTRA INDICATIONS
REMERON (mirtazapine) Tablets are contraindicated in patients with a known hypersensitivity to mirtazapine or to any of the excipients. The concomitant use of REMERON Tablets and a monoamine oxidase (MAO) inhibitor is contraindicated. REMERON should not be used within 14 days of initiating or discontinuing therapy with a monoamine oxidase inhibitor
SIDE EFFECTS
Dizziness, drowsiness, lightheadedness, increased appetite, weight gain, dry mouth, or constipation may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute.
DRUG INTERACTIONS
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.
AVAILABILITY
MEET-15/30 is available in strips of ten capsules containing MIRTAZAPINE TABLETS.
