Remeron 15mg Soltabs

Manufacturer ORGANON Active Ingredient Mirtazapine Orally Disintegrating Tablets(mir TAZ a peen) Pronunciation mir TAZ a peen
WARNING: Drugs like this one have raised the chance of suicidal thoughts or actions in children and young adults. The risk may be greater in people who have had these thoughts or actions in the past. All people who take this drug need to be watched closely. Call the doctor right away if signs like depression, nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.This drug is not approved for use in children. Talk with the doctor. @ COMMON USES: It is used to treat depression.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antidepressant
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Pharmacologic Class
Tetracyclic antidepressant; Alpha-2 adrenergic antagonist
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Pregnancy Category
Category C
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FDA Approved
Sep 1996
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Mirtazapine is a medication used to treat depression. It works by helping to restore the balance of certain natural substances (neurotransmitters) in the brain. It can also help with sleep and appetite, which are often affected by depression.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely.

Take your medication at bedtime if it makes you sleepy.
You can take your medication with or without food.
When opening the foil packaging, do not push the tablet out. Instead, use dry hands to remove it from the foil.
Place the tablet on your tongue and let it dissolve. You do not need to drink water with it. Do not swallow the tablet whole, and do not chew, break, or crush it.
Only remove the medication from the blister pack when you are ready to take it. Take the medication immediately after opening the blister pack, and do not store the removed medication for later use.

Continuing Your Medication

Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light and moisture. Do not store it in a bathroom.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also have access to drug take-back programs in your area.

Missing a Dose

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Take Mirtazapine exactly as prescribed, usually once daily at bedtime due to its sedating effects.
  • Do not stop taking Mirtazapine suddenly without talking to your doctor, as this can cause withdrawal symptoms.
  • Avoid alcohol and other CNS depressants (e.g., sedatives, pain medications) while taking Mirtazapine, as this can increase drowsiness and dizziness.
  • Be cautious when driving or operating machinery until you know how Mirtazapine affects you, as it can cause drowsiness.
  • Monitor your weight and diet, as Mirtazapine can cause increased appetite and weight gain.
  • Report any unusual changes in mood or behavior, especially suicidal thoughts, to your doctor immediately.

Dosing & Administration

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Adult Dosing

Standard Dose: 15 mg orally once daily at bedtime
Dose Range: 15 - 45 mg

Condition-Specific Dosing:

majorDepressiveDisorder: Initial 15 mg once daily at bedtime. Titrate gradually based on clinical response and tolerability, typically in increments of 15 mg, up to a maximum of 45 mg/day. Allow at least 1-2 weeks between dose adjustments.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for major depressive disorder; use generally not recommended due to Black Box Warning regarding suicidality.
Adolescent: Not established for major depressive disorder; use generally not recommended due to Black Box Warning regarding suicidality.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required.
Moderate: Consider a 30% reduction in total daily dose (e.g., 30 mg/day instead of 45 mg/day).
Severe: Consider a 50% reduction in total daily dose (e.g., 15 mg/day instead of 30 mg/day).
Dialysis: Mirtazapine is not significantly removed by hemodialysis. Dose adjustments similar to severe renal impairment may be necessary.

Hepatic Impairment:

Mild: No specific dose adjustment required.
Moderate: Consider a 30% reduction in total daily dose (e.g., 30 mg/day instead of 45 mg/day).
Severe: Consider a 50% reduction in total daily dose (e.g., 15 mg/day instead of 30 mg/day).
Confidence: Medium

Pharmacology

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Mechanism of Action

Mirtazapine enhances central noradrenergic and serotonergic activity. It acts as a potent antagonist of central presynaptic alpha-2 adrenergic autoreceptors and heteroreceptors, leading to an increase in norepinephrine and serotonin release. It is also a potent antagonist of 5-HT2 and 5-HT3 serotonin receptors, and H1 histamine receptors. It has moderate antagonism of peripheral alpha-1 adrenergic receptors and muscarinic cholinergic receptors.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 50%
Tmax: Approximately 2 hours (for orally disintegrating tablets)
FoodEffect: Food has a minimal effect on the rate and extent of absorption.

Distribution:

Vd: Approximately 2.5 L/kg
ProteinBinding: Approximately 85%
CnssPenetration: Yes

Elimination:

HalfLife: 20-40 hours (mean 26 hours)
Clearance: Not available (highly variable)
ExcretionRoute: Urine (approximately 75%), Feces (approximately 15%)
Unchanged: Less than 10%
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Pharmacodynamics

OnsetOfAction: Within 1-2 weeks for antidepressant effects, sedative effects may be apparent sooner.
PeakEffect: Typically 2-4 weeks for full antidepressant effect.
DurationOfAction: Due to long half-life, effects persist for at least 24 hours with once-daily dosing.

Safety & Warnings

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BLACK BOX WARNING

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Mirtazapine or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.
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Side Effects

Urgent Side Effects: Seek Medical Help Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels, including:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ Weakness
+ Seizures
+ Changes in balance
Redness or irritation of the palms of hands or soles of feet
Flu-like symptoms
Mouth irritation or mouth sores
Restlessness
Fast or abnormal heartbeat
Severe dizziness or fainting
Joint pain

Serotonin Syndrome: A Potentially Life-Threatening Condition

There is a risk of developing serotonin syndrome, a severe and potentially deadly condition, especially when taking certain other medications. Seek medical help immediately if you experience:

Agitation
Changes in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache

Severe Skin Reactions: A Medical Emergency

This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be deadly. Seek medical help immediately if you notice:

Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in your mouth, throat, nose, eyes, genitals, or any areas of skin
Fever
Chills
Body aches
Shortness of breath
Swollen glands

Other Side Effects: Monitor and Report

While many people may not experience side effects or only have mild ones, it's essential to monitor your body's response to the medication. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Feeling dizzy, sleepy, tired, or weak
Constipation
Dry mouth
Increased appetite
Weight gain
Strange or odd dreams

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Worsening depression or anxiety
  • New or worsening suicidal thoughts or behavior
  • Agitation, restlessness, panic attacks, irritability, aggression
  • Unusual changes in behavior
  • Fever, sore throat, mouth sores, or other signs of infection (rare, but serious)
  • Severe dizziness or fainting (especially when standing up)
  • Muscle stiffness, twitching, or uncontrolled movements
  • Confusion, hallucinations, rapid heart rate, sweating (signs of serotonin syndrome)
  • Unexplained rash or hives
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
If you are currently taking or have recently taken certain medications, including:
+ Anxiety or sleep aids like alprazolam or diazepam
+ Depression or Parkinson's disease medications, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, within the last 14 days, as this may lead to very high blood pressure
+ Linezolid or methylene blue, as these can interact with this medication
Note that this is not an exhaustive list of all potential drug interactions or health problems that may affect your use of this medication.

To ensure safe use, it is crucial to inform your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking
Any natural products, vitamins, or supplements you are using
Your complete medical history, including any health problems you have

Do not start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. The full effects of this drug may not be apparent for several weeks.

Do not abruptly stop taking this medication without consulting your doctor, as this may increase your risk of side effects. If you need to discontinue this drug, your doctor will instruct you on how to gradually stop taking it to minimize potential risks.

Until you are familiar with how this medication affects you, avoid driving and engaging in activities that require alertness. Certain individuals may be at a higher risk of developing eye problems while taking this drug. Your doctor may recommend an eye exam to assess your risk. Immediately contact your doctor if you experience eye pain, changes in vision, or swelling and redness in or around the eye.

This medication has been associated with rare cases of low white blood cell counts, which can increase the risk of infection. If you have a history of low white blood cell counts, inform your doctor. Be vigilant for signs of infection, such as fever, chills, or sore throat, and contact your doctor promptly if you experience any of these symptoms.

There have been reports of abnormal heart rhythms (long QT on ECG) and rare instances of sudden death in individuals taking this medication. Discuss these risks with your doctor. Additionally, this drug may cause elevated cholesterol and triglyceride levels. Consult with your doctor and undergo regular blood tests as directed.

Avoid consuming alcohol while taking this medication. Before using marijuana, cannabis products, or prescription or over-the-counter medications that may impair your reactions, consult with your doctor. If you have phenylketonuria (PKU), discuss this with your doctor, as some products contain phenylalanine.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women, or those planning to become pregnant, should discuss the benefits and risks of this medication with their doctor to ensure the best possible outcome for both mother and baby.
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Overdose Information

Overdose Symptoms:

  • Disorientation
  • Drowsiness
  • Impaired memory
  • Tachycardia
  • Sedation
  • Hypotension
  • Respiratory depression (rare)
  • Coma (rare)

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive and symptomatic. There is no specific antidote.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of discontinuing MAOI)
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Major Interactions

  • Other serotonergic drugs (e.g., SSRIs, SNRIs, triptans, tramadol, fentanyl, lithium, St. John's Wort) - increased risk of serotonin syndrome.
  • CNS depressants (e.g., alcohol, benzodiazepines, opioids, sedatives, hypnotics) - additive CNS depression.
  • Drugs that inhibit CYP1A2 (e.g., cimetidine, fluvoxamine) - increased mirtazapine levels.
  • Drugs that inhibit CYP2D6 (e.g., quinidine, fluoxetine, paroxetine) - increased mirtazapine levels.
  • Drugs that inhibit CYP3A4 (e.g., ketoconazole, erythromycin, protease inhibitors) - increased mirtazapine levels.
  • Drugs that induce CYP1A2, CYP2D6, or CYP3A4 (e.g., carbamazepine, phenytoin, rifampin) - decreased mirtazapine levels.
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Moderate Interactions

  • Warfarin (potential for increased INR, though data is limited and inconsistent).
  • Drugs that prolong QT interval (theoretical risk, monitor ECG in susceptible patients).
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Minor Interactions

  • Not specifically identified as minor, but general caution with any drug affecting CNS or hepatic metabolism.

Monitoring

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Baseline Monitoring

Depression severity (e.g., HAM-D, PHQ-9)

Rationale: To establish baseline and assess treatment efficacy.

Timing: Prior to initiation

Suicidal ideation/behavior

Rationale: To assess risk, especially in young adults and adolescents, due to Black Box Warning.

Timing: Prior to initiation

Complete Blood Count (CBC) with differential

Rationale: Although rare, agranulocytosis/neutropenia can occur. Baseline helps identify pre-existing conditions.

Timing: Prior to initiation (consider, especially if patient has history of blood dyscrasias)

Weight and BMI

Rationale: Mirtazapine can cause significant weight gain.

Timing: Prior to initiation

Blood pressure and heart rate

Rationale: Risk of orthostatic hypotension.

Timing: Prior to initiation

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Routine Monitoring

Depression severity and clinical response

Frequency: Weekly for first 4 weeks, then every 2-4 weeks, then periodically as clinically indicated.

Target: Reduction in symptom scores, improved mood and functioning.

Action Threshold: Lack of improvement after adequate trial, worsening symptoms, or emergence of new symptoms.

Suicidal ideation/behavior

Frequency: Weekly for first 4 weeks, then every 2-4 weeks, then periodically, especially during dose changes.

Target: Absence of suicidal thoughts or plans.

Action Threshold: Emergence or worsening of suicidal thoughts/behavior; immediate clinical assessment and intervention.

Weight and BMI

Frequency: Monthly for first few months, then every 3-6 months.

Target: Stable weight or within healthy range.

Action Threshold: Significant or rapid weight gain; consider dietary counseling or alternative therapy.

Complete Blood Count (CBC) with differential

Frequency: If patient develops fever, sore throat, or other signs of infection.

Target: Normal WBC and neutrophil counts.

Action Threshold: Significant decrease in WBC or neutrophil count (e.g., agranulocytosis, neutropenia); discontinue drug immediately.

Blood pressure and heart rate

Frequency: Periodically, especially during dose titration.

Target: Within normal limits.

Action Threshold: Significant orthostatic hypotension or sustained tachycardia.

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Symptom Monitoring

  • Worsening depression
  • Suicidal thoughts or behavior
  • Unusual changes in behavior or mood (e.g., agitation, irritability, panic attacks, insomnia, aggression, impulsivity, akathisia, hypomania, mania)
  • Signs of serotonin syndrome (e.g., agitation, hallucinations, delirium, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia, tremor, rigidity, myoclonus, hyperreflexia, incoordination, gastrointestinal symptoms)
  • Signs of infection (e.g., fever, sore throat, mouth sores, flu-like symptoms) - rare, but indicates potential agranulocytosis
  • Excessive sedation or drowsiness
  • Dizziness or lightheadedness (especially upon standing)
  • Increased appetite or weight gain
  • Dry mouth
  • Constipation

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Limited human data suggest low risk, but neonatal withdrawal symptoms (e.g., respiratory distress, feeding difficulties, tremor, irritability) have been reported with third-trimester exposure to SSRIs/SNRIs, and similar effects could theoretically occur with mirtazapine.

Trimester-Specific Risks:

First Trimester: Limited data, no clear evidence of increased major congenital malformations.
Second Trimester: Limited data.
Third Trimester: Potential for neonatal withdrawal symptoms (e.g., respiratory distress, feeding difficulties, tremor, irritability) if exposed late in pregnancy. Monitor neonate.
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Lactation

L3 (Moderately safe). Mirtazapine is excreted into breast milk in low amounts. Monitor breastfed infants for sedation, poor feeding, and weight gain. Consider alternative agents or close monitoring.

Infant Risk: Low to moderate. Potential for sedation, irritability, or poor feeding in the infant, though generally considered compatible with breastfeeding with caution.
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Pediatric Use

Not FDA approved for major depressive disorder in pediatric patients. Black Box Warning regarding increased risk of suicidality in children, adolescents, and young adults. Use should be carefully considered and monitored by a specialist if deemed necessary off-label.

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Geriatric Use

Use with caution. Elderly patients may be more sensitive to the sedating and hypotensive effects of mirtazapine. Start with lower doses (e.g., 7.5 mg/day) and titrate slowly. Increased risk of falls due to sedation and orthostatic hypotension. Renal and hepatic impairment are more common in the elderly, requiring dose adjustments.

Clinical Information

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Clinical Pearls

  • Mirtazapine is often chosen for depression accompanied by insomnia, significant anxiety, or poor appetite/weight loss due to its sedating and appetite-stimulating effects.
  • The sedating effect is more pronounced at lower doses (e.g., 7.5 mg, 15 mg) due to greater H1 receptor antagonism. At higher doses (e.g., 30 mg, 45 mg), the noradrenergic effects become more prominent, which can counteract some of the sedation.
  • Unlike many other antidepressants, mirtazapine is generally associated with a lower risk of sexual dysfunction.
  • Patients should be warned about potential significant weight gain and increased appetite.
  • Rare but serious side effect: agranulocytosis. Advise patients to report any signs of infection (fever, sore throat) immediately.
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Alternative Therapies

  • Selective Serotonin Reuptake Inhibitors (SSRIs) (e.g., fluoxetine, sertraline, escitalopram)
  • Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) (e.g., venlafaxine, duloxetine)
  • Atypical antidepressants (e.g., bupropion, vortioxetine, vilazodone)
  • Tricyclic Antidepressants (TCAs) (e.g., amitriptyline, nortriptyline)
  • Other alpha-2 adrenergic antagonists (e.g., trazodone - though primarily used for insomnia at low doses)
  • Electroconvulsive Therapy (ECT)
  • Transcranial Magnetic Stimulation (TMS)
  • Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)
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Cost & Coverage

Average Cost: Varies widely, typically $30-$150 per 30 tablets (15mg)
Generic Available: Yes
Insurance Coverage: Often Tier 1 or Tier 2 for generic, Tier 3 or higher for brand-name.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the overdose, be prepared to provide details about the medication taken, the quantity, and the time it occurred.