Mirtazapine

Renal or Hepatic Impairment The clearance of mirtazapine is reduced in patients with moderate to severe renal or hepatic impairment. Consequently, plasma mirtazapine levels may be increased in these patient groups, compared to levels observed in patients without renal or hepatic impairment. Dosage decrease may be necessary when administering mirtazapine orally disintegrating tablets to patients with moderate to severe renal or hepatic impairment [see Warnings and Precautions , Use in Specific Populations , and Clinical Pharmacology ].

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.