Remeron SolTab

Episodes of major depression.

Adult & elderly 15-45 mg daily. Starting dose: 15 or 30 mg. May be increased up to max dose, if there is insufficient response.

May be taken with or without food: Place tab on the tongue to dissolve then swallow w/o water.

Hypersensitivity. Concomitant use w/ MAOIs.

Discontinue if jaundice & serotonin syndrome occurs; seizure develops. Increased risk of suicidal thoughts, self-harm & suicide (suicide-related events). Monitor for any clinical worsening, suicidal behavior or thoughts & unusual changes in behavior. Patients w/ epilepsy & organic brain syndrome; cardiac diseases eg, conduction disturbances, angina pectoris & recent MI; low BP; DM; schizophrenia or other psychotic disturbances; history of mania/hypomania; micturition disturbances eg, prostate hypertrophy & acute narrow-angle glaucoma & increased IOP; known CV disease or family history of QT prolongation; phenylketonuria. Bone marrow depression, usually granulocytopenia or agranulocytosis; worsening of psychotic symptoms; akathisia/psychomotor restlessness. Fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. Avoid abrupt discontinuation. Concomitant use w/ other medicinal products prolonging QTc interval. May affect ability to drive & use machines. Moderate (10 mL/min ≤CrCl <40 mL/min) & severe (CrCl <10 mL/min) renal impairment. Pregnancy & lactation. Not be used in childn & adolescents <18 yr. Hyponatremia in elderly.

Increased wt & appetite; somnolence, sedation, headache; dry mouth. Abnormal dreams, confusion, anxiety, insomnia; lethargy, dizziness, tremor; orthostatic hypotension; nausea, diarrhea, vomiting, constipation; exanthema; arthralgia, myalgia, back pain; peripheral oedema; fatigue.

MAOIs. Serotonin syndrome may occur w/ serotonergic active substances (eg, L-tryptophan, triptans, tramadol, linezolid, methylene blue, SSRIs, venlafaxine, lithium & St. John's wort). Increased sedating properties of benzodiazepines & other sedatives (eg, antipsychotics, histahime H₁-antagonists, opioids). Increased CNS depressant effect of alcohol. Increased INR w/ warfarin. Increased risk of QT prolongation &/or ventricular arrhythmias w/ QTc interval prolonging drugs (eg, some antipsychotics & antibiotics). Increased clearance w/ CYP3A4 inducers eg, carbamazepine & phenytoin. Increased peak plasma levels & AUC w/ potent CYP3A4 inhibitors eg, ketoconazole. Increased mean plasma conc w/ potent CYP3A4 inhibitors, HIV PIs, azole antifungals, erythromycin, cimetidine or nefazodone.

Antidepressants

N06AX11 - mirtazapine ; Belongs to the class of other antidepressants.

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