Mirtazapinedosage

Starting dose: 15 mg once daily; may increase up to maximum recommended dose of 45 mg once daily. Administer orally once daily, preferably in the evening prior to sleep. Administer mirtazapine orally disintegrating tablets immediately after removal from blister pack or container pack. Reduce dose gradually when discontinuing mirtazapine orally disintegrating tablets.

2.1 Recommended

Dosage The recommended starting dose of mirtazapine orally disintegrating tablets 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.

2.2 Administration of

Mirtazapine Orally Disintegrating Tablets The tablet should remain in the blister pack or container pack until the patient is ready to take it. The patient or caregiver should use dry hands to open the blister or container. As soon as the blister or container is opened, the tablet should be removed and placed on the patient’s tongue. Use mirtazapine orally disintegrating tablets immediately after removal from its blister or container; 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 Mirtazapine Orally Disintegrating Tablets Prior to initiating treatment with mirtazapine orally disintegrating tablets or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania.

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 mirtazapine orally disintegrating tablets. In addition, at least 14 days must elapse after stopping mirtazapine orally disintegrating tablets before starting an MAOI antidepressant.

2.5 Dosage Modifications

Due to Drug Interactions Strong CYP3A Inducers An increase in dosage of mirtazapine orally disintegrating tablets may be needed with concomitant strong CYP3A inducer (e.g., carbamazepine, phenytoin, rifampin) use. Conversely, a decrease in dosage of mirtazapine orally disintegrating tablets may be needed if the CYP3A inducer is discontinued. Strong CYP3A Inhibitors A decrease in dosage of mirtazapine orally disintegrating tablets may be needed with concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin). Conversely, an increase in dosage of mirtazapine orally disintegrating tablets may be needed if the CYP3A4 inhibitor is discontinued. Cimetidine A decrease in dosage of mirtazapine orally disintegrating tablets may be needed with concomitant use of cimetidine. Conversely, an increase in dosage of mirtazapine orally disintegrating tablets may be needed if cimetidine is discontinued.

2.6 Discontinuation of

Mirtazapine Orally Disintegrating Tablets Treatment Adverse reactions may occur upon discontinuation or dose reduction of mirtazapine orally disintegrating tablets. Gradually reduce the dosage of mirtazapine orally disintegrating tablets rather than stopping abruptly whenever possible.