Remeron, Remeron SolTab
Classifications: psychotherapeutic agent; antidepressant, tetracyclic; anxiolytic agent; Therapeutic: antidepressant, tetracyclic; antianxiety
Pregnancy Category: C
15 mg, 30 mg, 45 mg tablets and orally disintegrating tablets
Tetracyclic antidepressant pharmacologically and therapeutically similar to tricyclic antidepressants. Tetracyclics enhance
central nonadrenergic and serotonergic activity; thought to be due to normalizing of neurotransmission efficacy. Mirtazapine
is a potent antagonist of 5-HT2 and 5-HT3 serotonin receptors.
Acts as antidepressant. Effectiveness is indicated by mood elevation.
Treatment of depression.
Hypersensitivity to mirtazapine or mianserin; hypersensitivity to other antidepressants (e.g., tricyclic antidepressants
and MAOI depressants), acute MI; fever, infection; agranulocytosis, neutropenia, hematologic disease; suicidal ideation; jaundice,
ethanol intoxication; pregnancy (category C), lactation.
History of cardiovascular or GI disorders; BPH, urinary retention; narrow-angle glaucoma, increased intraocular pressure;
hepatic or renal impairment, renal failure; hypercholesterolemia, hypertriglyceridemia, thrombocytopenia; older adults; angina,
cardiac arrhythmias, anticholinergic medications; bipolar disorder, mania, bone marrow suppression, PKU, history of MI;
cerebrovascular disease, seizure disorder, seizures, stroke; depression; hypovolemia, surgery; closed-angle glaucoma; ileus,
GI obstruction, dehydration; diabetes mellitus, diabetic ketoacidosis. Safety and effectiveness in children are not established.
Route & Dosage
Adult: PO 15 mg/d in single dose h.s., may increase q12wk (max: 45 mg/d)
Geriatric: PO Use lower doses
Renal or Hepatic Impairment
Use lower doses.
- Give preferably prior to sleep to minimize injury potential.
- Begin drug no sooner than 14 d after discontinuation of an MAO inhibitor.
- Reduce dosage as warranted with severe renal or hepatic impairment and in older adults.
- Store at 20°25° C (68°77° F) in tight, light-resistant container.
Adverse Effects (≥1%)Body as a Whole:
Asthenia, flu syndrome
, back pain, general and peripheral edema, malaise
. CNS: Somnolence,
dizziness, abnormal dreams, abnormal thinking, tremor, confusion, depression
, agitation, vertigo, twitching. CV:
Hypertension, vasodilation. GI:
Nausea, vomiting, abdominal pain, increased appetite
/weight gain, dry mouth, constipation,
anorexia, cholecystitis, stomatitis
, abnormal liver function tests. Respiratory: Dyspnea
, cough, sinusitis
Pruritus, rash. Urogenital:
Additive cognitive and motor impairment with alcohol
; increase risk of hypertensive crisis with maoi
s. Herbal: Kava, valerian
may potentiate sedative effects.
Rapidly absorbed from GI tract, 50% reaches systemic circulation. Peak:
2 h. Distribution:
85% protein bound. Metabolism:
In liver by cytochrome P450 system (CYP2D6, CYP1A2, CYP3A). Elimination:
75% in urine, 15% in feces. Half-Life:
Assessment & Drug Effects
- Lab tests: Monitor WBC count with differential, lipid profile, and ALT/AST periodically.
- Patients should be monitored for worsening of depression or emergence of suicidality.
- Assess for weight gain and excessive somnolence or dizziness.
- Monitor for orthostatic hypotension with a history of cardiovascular or cerebrovascular disease. Periodically monitor ECG
especially in those with known cardiovascular disease.
- Monitor those with a history of increased intraocular pressure or urinary retention carefully for worsening or recurrence.
- Monitor those with history of seizures for lowering of the seizure threshold.
Patient & Family Education
- Do not drive or engage in potentially hazardous activities until response to drug is known.
- Do not use alcohol while taking drug.
- Report immediately unexplained fever or S&S of infection, especially flu-like symptoms, to physician.
- Do not take other prescription or OTC drugs without consulting physician.
- Make position changes slowly especially from lying or sitting to standing. Report dizziness, palpitations, and fainting.
- Notify (women) physician immediately if you become pregnant.
- Monitor weight periodically and report significant weight gains.