REMERON Tablet / Orally disintegrating tablet Ref.[10621] Active ingredients: Mirtazapine

2.1 Recommended Dosage

The recommended starting dose of REMERON/REMERONSolTab is 15 mg once daily, administered orally, preferably in the evening prior to sleep. If patients do not have an adequate response to the initial 15 mg dose, increase the dose up to a maximum of 45 mg per day. Dose changes should not be made in intervals of less than 1 to 2 weeks to allow sufficient time for evaluation of response to a given dose [see Clinical Pharmacology (12.3)].

2.2 Administration of REMERONSolTab

• The tablet should remain in the blister pack until the patient is ready to take it.
• The patient or caregiver should use dry hands to open the blister.
• As soon as the blister is opened, the tablet should be removed and placed on the patient’s tongue.
• Use REMERONSolTab immediately after removal from its blister; once removed, it cannot be stored.
• The whole tablet should be placed on the tongue and allowed to disintegrate without chewing or crushing. Do not attempt to split the tablet.
• The tablet will disintegrate in saliva so that it can be swallowed.

2.3 Screen for Bipolar Disorder Prior to Starting REMERON/REMERONSolTab

Prior to initiating treatment with REMERON/REMERONSolTab or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.8)].

2.4 Switching Patients to or from a Monoamine Oxidase Inhibitor Antidepressant

At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of REMERON/REMERONSolTab. In addition, at least 14 days must elapse after stopping REMERON/REMERONSolTab before starting an MAOI antidepressant [see Contraindications (4) and Warnings and Precautions (5.3)].

2.5 Dosage Modifications Due to Drug Interactions

Strong CYP3A Inducers

An increase in dosage of REMERON/REMERONSolTab may be needed with concomitant strong CYP3A inducer (e.g., carbamazepine, phenytoin, rifampin) use. Conversely, a decrease in dosage of REMERON/REMERONSolTab may be needed if the CYP3A inducer is discontinued [see Drug Interactions (7)].

Strong CYP3A Inhibitors

A decrease in dosage of REMERON/REMERONSolTab may be needed with concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin). Conversely, an increase in dosage of REMERON/REMERONSolTab may be needed if the CYP3A4 inhibitor is discontinued [see Drug Interactions (7)].

Cimetidine

A decrease in dosage of REMERON/REMERONSolTab may be needed with concomitant use of cimetidine. Conversely, an increase in dosage of REMERON/REMERONSolTab may be needed if cimetidine is discontinued [see Drug Interactions (7)].

2.6 Discontinuation of REMERON / REMERONSolTab Treatment

Adverse reactions may occur upon discontinuation or dose reduction of REMERON/REMERONSolTab [see Warnings and Precautions (5.13)]. Gradually reduce the dosage of REMERON/REMERONSolTab rather than stopping abruptly whenever possible.

Human Experience

In premarketing clinical studies, there were reports of REMERON overdose alone or in combination with other pharmacological agents. Signs and symptoms reported in association with overdose included disorientation, drowsiness, impaired memory, and tachycardia.

Based on postmarketing reports, serious outcomes (including fatalities) may occur at dosages higher than the recommended doses, especially with mixed overdoses. In these cases, QT prolongation and Torsades de Pointes have also been reported [see Warnings and Precautions (5.5), Adverse Reactions (6.2), and Drug Interactions (7)].

Overdose Management

No specific antidotes for mirtazapine are known.

Contact Poison Control (1-800-222-1222) for the latest recommendations.

REMERON tablets: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture.

REMERON SolTab orally disintegrating tablets: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Use immediately upon opening individual tablet blister.