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

Depression

Indicated for treatment of major depressive disorder

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

Dosage 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

Indicated for treatment of major depressive disorder

Initiate with lower dose for patients aged ≥65 yr

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

Dosing Considerations

Geriatric patients may 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

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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

            Arrythmia Torsades de Pointes

            Hyperprolactenemia and related symptoms galactorrhea and gynecomastia

            Sonambulism (complex behaviors)

            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 (aged <24 years) taking antidepressants for major depressive disorders and other psychiatric illnesses

            This increase was not seen in patients aged ≥24 years

            A slight decrease in suicidal thinking was seen in adults aged ≥65 years compared with placebo

            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

            Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs

            Screen for bipolar disorder; MDD episode may be the initial presentation of bipolar disorder; generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase precipitation of mixed/manic episode in patients at risk for bipolar disorder

            Rare reports of activation of mania/hypomania

            Agranulocytosis reported; if sign/symptoms develop (eg, sore throat, fever, stomatitis, infection with low WBC count), discontinue mirtazapine and closely monitor

            Potentially life-threatening serotonin syndrome reported with SNRIs and SSRIs alone, but also if coadministered with other serotonergic drugs

            Pupillary dilation that occurs with antidepressant drugs may trigger an angle-closure attack in patients with anatomically narrow angles who have not had iridectomy

            Upon discontinuation (particularly when abrupt), the following symptoms may occur: dizziness, abnormal dreams, sensory disturbances (including paresthesia and electric shock sensations), agitation, anxiety, fatigue, confusion, headache, tremor, nausea, vomiting, and sweating

            Akathisia, characterized by subjectively unpleasant or distressing restlessness and need to move, often accompanied by an inability to sit or stand still; most likely to occur within first few weeks; increasing dose may be detrimental

            Hyponatremia (rare) reported

            Somnolence reported in ~50% of patients

            Dizziness, increased appetite/weight gain, and transaminase elevations reported

            Postmarketing reports of QT prolongation, torsades de pointes, ventricular tachycardia, and sudden death; majority reported in association with overdose or in patients with other risk factors for QT prolongation, including concomitant use of QTc-prolonging medicines

            Drug interaction overview

            • Caution if coadministered with other drugs that prolong QT interval
            • Monitor INR if higher doses of mirtazapine are coadministered with warfarin
            • Avoid use with alcohol and other CNS depressants; may cause additive somnolence and dizziness
            Risk of serotonin syndrome
            • Contraindicated with MAOIs; do not start mirtazapine if being treated with IV methylene blue or linezolid
            • Caution with other serotonergic drugs
            CYP inducers
            • Strong CYP inducers (eg, phenytoin, carbamazepine, rifampin) may increase mirtazapine clearance by ~2-fold
            • If coadministered with strong CYP inducers, mirtazapine dose may need to be increased; conversely, if strong CYP inducer is stopped, decrease mirtazapine dose
            Strong CYP3A4 inhibitors
            • Strong CYP3A4 inhibitor increase mirtazapine peak plasma levels and AUC
            • Caution if coadministered; mirtazapine dose may need to be lowered
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            Pregnancy & Lactation

            Pregnancy

            Apregnancy exposure registry monitors pregnancy outcomes in women exposed to antidepressants during pregnancy; healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.

            Prolonged experience with therapy in pregnant women, based on published observational studies and postmarketing reports, has not reliably identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes

            Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants; this finding is from a prospective, longitudinal study that followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at beginning of pregnancy

            Consider risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum; it should be used during pregnancy only if clearly needed

            Animal studies

            • Reproduction studies in pregnant rats and rabbits at doses up to 100 mg/kg and 40 mg/kg, respectively (20 and 17 times the maximum recommended human dose [MRHD] on an mg/m2 basis, respectively), have revealed no evidence of teratogenic effects
            • However, in rats, there was an increase in postimplantation losses in dams treated with mirtazapine

            Lactation

            Data from published literature report presence of drug in human milk at low levels with relative infant doses ranging between 0.6 and 2.8% of the maternal weight-adjusted dose; no adverse effects on breastfed infant reported in most cases of maternal use of drug; there are no data on effects of drug on milk production.

            The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition

            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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            Administration

            Oral Administration

            May take with or without food

            Storage

            Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)

            Protect from light and moisture

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            mirtazapine oral
            -
            30 mg tablet
            mirtazapine oral
            -
            15 mg tablet
            mirtazapine oral
            -
            15 mg tablet
            mirtazapine oral
            -
            15 mg tablet
            mirtazapine oral
            -
            15 mg tablet
            mirtazapine oral
            -
            30 mg tablet
            mirtazapine oral
            -
            15 mg tablet
            mirtazapine oral
            -
            45 mg tablet
            mirtazapine oral
            -
            45 mg tablet
            mirtazapine oral
            -
            7.5 mg tablet
            mirtazapine oral
            -
            30 mg tablet
            mirtazapine oral
            -
            30 mg tablet
            mirtazapine oral
            -
            30 mg tablet
            mirtazapine oral
            -
            15 mg tablet
            mirtazapine oral
            -
            45 mg tablet
            mirtazapine oral
            -
            15 mg tablet
            mirtazapine oral
            -
            45 mg tablet
            mirtazapine oral
            -
            30 mg tablet
            mirtazapine oral
            -
            7.5 mg tablet
            mirtazapine oral
            -
            45 mg tablet
            mirtazapine oral
            -
            30 mg tablet
            mirtazapine oral
            -
            15 mg tablet
            mirtazapine oral
            -
            45 mg tablet
            mirtazapine oral
            -
            30 mg tablet
            mirtazapine oral
            -
            45 mg tablet
            Remeron oral
            -
            30 mg tablet
            Remeron oral
            -
            15 mg tablet
            Remeron SolTab oral
            -
            45 mg tablet
            Remeron SolTab oral
            -
            30 mg tablet
            Remeron SolTab oral
            -
            15 mg tablet

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            mirtazapine oral

            MIRTAZAPINE - ORAL

            (mer-TAZE-uh-peen)

            COMMON BRAND NAME(S): Remeron

            WARNING: Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. It is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.

            USES: Mirtazapine is used to treat depression. It improves mood and feelings of well-being. Mirtazapine is an antidepressant that works by restoring the balance of natural chemicals (neurotransmitters) in the brain.

            HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using mirtazapine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once daily at bedtime. The dosage is based on your medical condition and response to treatment.Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time each day. It may take 1 to 4 weeks to notice improvement in your symptoms. Do not increase your dose or take it more often than prescribed.Keep taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when you suddenly stop this drug. Your dose may need to be gradually decreased.Tell your doctor if your condition does not get better or if it gets worse.

            SIDE EFFECTS: See also the Warning section.Dizziness, drowsiness, lightheadedness, increased appetite, weight gain, dry mouth, or constipation may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: swelling of the hands/feet, shaking (tremor), confusion.Get medical help right away if you have any very serious side effects, including: fast/irregular heartbeat, severe dizziness, fainting, eye pain/swelling/redness, widened pupils, vision changes (such as seeing rainbows around lights at night, blurred vision).This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it, or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: history or family history of psychiatric disorders (such as bipolar/manic-depressive disorder), history or family history of suicide attempts, liver disease, kidney disease, seizures, high blood cholesterol or triglyceride levels, heart disease (such as recent heart attack, angina), stroke, severe loss of body fluids (dehydration), low blood pressure, personal or family history of glaucoma (angle-closure type).Mirtazapine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using mirtazapine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using mirtazapine safely.This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.Older adults may be more sensitive to the side effects of this drug, especially drowsiness and QT prolongation (see above).During pregnancy, this medication should be used only when clearly needed. If this medication is used during the last 3 months of pregnancy, rarely your newborn may develop symptoms including feeding or breathing difficulties, seizures, muscle stiffness, jitteriness or constant crying. Report any such symptoms to your doctor promptly. However, since untreated mental/mood disorders (such as depression) can be a serious condition, do not stop taking this medication unless your doctor directs you to do so. If you are planning pregnancy, become pregnant, or think you may be pregnant, discuss with your doctor right away the benefits and risks of using this medication during pregnancy.This drug passes into breast milk. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication. Ask your doctor when to start or stop taking this medication.The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/"ecstasy," St. John's wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), tryptophan, among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and opioid pain relievers (such as codeine, hydrocodone).Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: very fast/irregular heartbeat, severe dizziness, fainting.

            NOTES: Lab and/or medical tests should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.Do not share this medication with others.

            MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            Information last revised December 2022. Copyright(c) 2022 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

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            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.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.