mirtazapine (Rx)

Brand and Other Names:Remeron, Remeron SolTab
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 7.5mg
  • 15mg
  • 30mg
  • 45mg

disintegrating tablet

  • 15mg
  • 30mg
  • 45mg
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Depression

15 mg PO qHS; may increase no more frequently than q1-2Weeks; not to exceed 45 mg qHS

Post-traumatic Stress Disorder (Off-label)

15 mg PO qHS; may increase no more frequently than q1-2Weeks; not to exceed 60 mg qHS

Hot Flashes (Off-label)

7.5-60 mg PO qDay

Insomnia (Off-label)

15-45 mg PO qHS

Dosing Modifications

Renal impairment (CrCl <39 mL/min): Clearance is reduced; monitor closely

Hepatic impairment: Clearance is reduced; monitor closely

Safety and efficacy not established

Depression

7.5 mg/day PO qHS; increase by 7.5-15 mg/day no more frequently than q1-2Weeks; not to exceed 45 mg/day

Alzheimer Dementia-related Depression

7.5 mg/day PO qHS; increase by 7.5-15 mg/day no more frequently than q1-2Weeks; not to exceed 60 mg/day

Dosing Considerations

The elderly have reduced clearance of mirtazapine and, as a result, may have increased plasma levels of the drug

Use with caution

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Interactions

Interaction Checker

and mirtazapine

No Results

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Somnolence (54%)

            Weight gain (>7% increase in <49% of pediatric patients)

            Xerostomia (25%)

            Increased appetite (17%)

            Constipation (13%)

            1-10%

            Asthenia (8%)

            Weakness (8%)

            Weight gain (>7% increase in 8% of adults)

            Dizziness (7%)

            Serum TGs increased (6%)

            Dream disorder (4%)

            Disturbance in thinking (3%)

            ALT increased (2%)

            Peripheral edema (2%)

            Myalgia (2%)

            Confusion (2%)

            Urinary frequency (2%)

            Tremor (2%)

            Back pain (2%)

            Dyspnea (1%)

            <1%

            Mania (0.2%)

            Grand mal seizure (less than 0.1%)

            Frequency Not Defined

            Depression exacerbation

            Status epilepticus

            Suicidal thoughts, suicide (rare)

            Agranulocytosis

            Neutropenia

            Postmarketing Reports

            Severe skin reactions

            • Stevens-Johnson syndrome
            • Bullous dermatitis
            • Erythema multiforme
            • Toxic epidermal necrolysis
            • Increased creatine kinase blood levels
            • Rhabdomyolysis
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            Warnings

            Black Box Warnings

            In short-term studies, antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults (<24 years) taking antidepressants for major depressive disorders and other psychiatric illnesses

            This increase was not seen in patients >24 years

            A slight decrease in suicidal thinking was seen in adults >65 years

            In children and young adults, risks must be weighed against the benefits of taking antidepressants

            Patients should be monitored closely for changes in behavior, clinical worsening, and suicidal tendencies

            This should be done during the initial 1-2 months of therapy and dosage adjustments; the patient’s family should communicate any abrupt changes in behavior to the healthcare provider

            Worsening behavior and suicidal tendencies that are not part of the presenting symptoms may require discontinuation of therapy

            This drug is not approved for use in pediatric patients

            Contraindications

            Hypersensitivity

            Within 14 days of administration of MAOIs (serotonin syndrome)

            Patients receiving linezolid or methylene blue IV

            Cautions

            Start slowly in hepatic or renal dysfunction and in the elderly

            Clinical worsening and suicidal ideation may occur despite medication

            Rare reports of serotonin syndrome, particularly when coadministered with other serotonergic drugs

            Abrupt discontinuation may cause dizziness, abnormal dreams, sensory disturbances (including paresthesia and electric shock sensations), agitation, anxiety, fatigue, confusion, headache, tremor, nausea, vomiting, and sweating

            Bone fractures reported with therapy; consider possibility of fragility fracture if patient complains of bone pain, swelling, or bruising

            Akathisia and psychomotor restlessness associated with antidepressant use

            Rare reports of hyponatremia; caution in elderly or if coadministered with other drug known to cause hyponatremia

            Risk for potentially life-threatening serotonin syndrome and neuroleptic malignant syndrome-like reactions has been reported with SSRIs, SNRIs, MAOIs, and other serotonergic drugs used as monotherapy, but particularly with concomitant use of the following agents: serotonergic drugs (including triptans), drugs that impair metabolism of serotonin (including MAOIs), antipsychotics, dopamine antagonists, and nonpsychiatric MAOIs (eg, linezolid, IV methylene blue)

            May cause anticholinergic effects; use with caution in patients with xerostomia, BPH, paralytic ileus, or decreased intestinal motility

            Risk of mydriasis; may trigger angle closure attack in patients with angle closure glaucoma with anatomically narrow angles without a patent iridectomy

            May increase serum triglycerides and cholesterol levels

            May cause orthostatic hypotension (low risk); use with caution in patients at risk

            Sexual dysfunction may occur (incidence lower compared to SSRIs)

            May worsen psychosis in some patients or precipitate mania or hypomania in patients with bipolar disorder

            Use with caution in patients with history of seizures, head trauma, alcoholism, brain damage, and patients on medictions that may lower seizure treshold

            QTc prolongation, ventricular fibrillation, and torsade de pointes rarely reported; use caution in patients with history of QTc prolongation, receiving QTc prolongent agents concomitantly, or with cardiovascular disease

            Discontinue therapy if neutropenia/agrunolocytosis occur

            May cause CNS depression, which may impair abilities to perform hazardous tasks that require mental alertness

            May increase serum cholesterol and triglyceride levels

            May increase appetite and cause weight gain

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Avoid

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Tetracyclic structure different from SSRIs, TCAs and MAOIs; through its central presynaptic alpha2-adrenergic antagonist effects, stimulates norepinephrine and serotonin release; potent antagonist of 5-HT2 and 5-HT3 serotonin and histamine receptors; is a moderate alpha1 adrenergic and muscarinic antagonist

            Absorption

            Bioavailability: 50%

            Peak serum time: 2 hr

            Distribution

            Protein bound: 85%

            Vd: 4.5 L/kg

            Metabolism

            Hepatic CYP450 enzymes CYP1A2, CYP2D6, CYP3A4

            Metabolites: Inactive

            Elimination

            Half-life: 20-40 hr

            Excretion: Urine (75%); feces (15%)

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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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