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Remeron Soltab Generic Name & Formulations
Legal Class
Rx
General Description
Mirtazapine 15mg, 30mg, 45mg; orally-disintegrating tabs; orange flavor; contains phenylalanine.
Pharmacological Class
Central alpha-2 antagonist.
See Also
How Supplied
Tabs, SolTabs—30
Manufacturer
Remeron Soltab Indications
Indications
Major depressive disorder (MDD).
Remeron Soltab Dosage and Administration
Adult
Initially 15mg once daily at bedtime; increase at intervals of at least 1–2 weeks; max 45mg/day. SolTab: Dissolve on tongue and swallow with or without water.
Children
Not established.
Remeron Soltab Contraindications
Contraindications
During or within 14 days of MAOIs. Concomitant linezolid or IV methylene blue.
Remeron Soltab Boxed Warnings
Boxed Warning
Suicidal thoughts and behaviors.
Remeron Soltab Warnings/Precautions
Warnings/Precautions
Increased risk of suicidal thoughts and behavior in children, adolescents and young adults; monitor closely for clinical worsening or unusual changes. Screen for bipolar disorder. History of mania/hypomania. Risk of agranulocytosis; monitor for fever, infection. Monitor for serotonin syndrome; discontinue if occurs. Angle-closure glaucoma. Known cardiovascular or cerebrovascular disease. History of QT prolongation. Moderate to severe renal or hepatic impairment. Seizure disorders. Dehydration. Hypovolemia. Phenylketonuria (SolTab). Avoid abrupt cessation. Elderly. Pregnancy. Nursing mothers.
Remeron Soltab Pharmacokinetics
See Literature
Remeron Soltab Interactions
Interactions
See Contraindications. Increased risk of serotonin syndrome with other serotonergic drugs (eg, SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, St. John's Wort) or with drugs that impair serotonin metabolism (eg, MAOIs, linezolid, IV methylene blue). Increased risk of QT prolongation and/or ventricular arrhythmias with concomitant drugs known to prolong the QTc interval (eg, certain antipsychotics or antibiotics). May be potentiated by strong CYP3A inhibitors (eg, itraconazole, ritonavir, nefazodone), cimetidine. Antagonized by strong CYP3A inducers (eg, phenytoin, carbamazepine, rifampin). Avoid concomitant alcohol, benzodiazepines (eg, diazepam, alprazolam). Monitor INR with warfarin.
Remeron Soltab Adverse Reactions
Adverse Reactions
Somnolence, increased appetite, weight gain, dizziness, nausea, dry mouth, constipation, asthenia; akathisia, hypo- or hypertension, elevated cholesterol, triglycerides, or transaminases; rarely: hyponatremia (esp. elderly), agranulocytosis.
Remeron Soltab Clinical Trials
See Literature
Remeron Soltab Note
Not Applicable
Remeron Soltab Patient Counseling
See Literature
