Remeron 30mg Soltabs

Manufacturer ORGANON Active Ingredient Mirtazapine Orally Disintegrating Tablets(mir TAZ a peen) Pronunciation mir-TAZ-uh-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
Noradrenergic and specific serotonergic antidepressant (NaSSA)
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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. This medication is an orally disintegrating tablet, meaning it dissolves quickly in your mouth without water.
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How to Use This Medicine

Taking Your Medication

To take this medication correctly, follow your doctor's instructions and read all the information provided. Take your dose at bedtime if it makes you sleepy. You can take it with or without food. When opening the foil packaging, do not push the tablet out. Instead, use dry hands to remove it and place it on your tongue, allowing it to dissolve. You do not need water, and do not swallow the tablet whole. Also, do not chew, break, or crush it.

Only remove the medication from the blister pack when you are ready to take it, and take it immediately after opening. Do not store the removed medication for later use. Continue taking this medication as directed by your doctor or healthcare provider, even if you feel well.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light, and in a dry place. Do not store it in a bathroom. Keep all medications in a safe location, 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 the tablet at bedtime, as it can cause drowsiness.
  • Do not chew or crush the tablet; allow it to dissolve on your tongue.
  • Avoid alcohol and other medications that cause drowsiness, as mirtazapine can increase these effects.
  • Be aware of potential weight gain and increased appetite; monitor your diet and exercise.
  • Do not stop taking this medication suddenly without consulting your doctor, as withdrawal symptoms can occur.
  • Be cautious when driving or operating machinery until you know how this medication affects you.

Dosing & Administration

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Adult Dosing

Standard Dose: 15 mg once daily at bedtime, increasing to 30 mg after 1-2 weeks, then up to 45 mg/day based on response and tolerability.
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 increasing to 30 mg after 1-2 weeks, and then up to a maximum of 45 mg/day. The full antidepressant effect may take 1-4 weeks to develop.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for major depressive disorder (MDD). Use is generally not recommended due to increased risk of suicidal thoughts and behaviors.
Adolescent: Not established for major depressive disorder (MDD). Use is generally not recommended due to increased risk of suicidal thoughts and behaviors.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: Consider a 30% reduction in total daily dose (e.g., 15 mg every other day or 7.5 mg daily).
Severe: Consider a 50% reduction in total daily dose (e.g., 7.5 mg every other day).
Dialysis: Mirtazapine is not significantly removed by hemodialysis. Dose adjustment based on renal function is still necessary.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: Consider a 30% reduction in total daily dose (e.g., 15 mg every other day or 7.5 mg daily).
Severe: Consider a 50% reduction in total daily dose (e.g., 7.5 mg every other day).
Confidence: Medium

Pharmacology

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Mechanism of Action

Mirtazapine is a noradrenergic and specific serotonergic antidepressant (NaSSA). Its antidepressant activity is believed to be mediated by its antagonism of central presynaptic alpha2-adrenergic autoreceptors and heteroreceptors, which results in an increase in central noradrenergic and serotonergic neurotransmission. Mirtazapine is also a potent antagonist of 5-HT2 and 5-HT3 serotonin receptors, and a potent antagonist of histamine H1 receptors, which contributes to its sedative effects.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 50%
Tmax: Approximately 2 hours
FoodEffect: Food has a minimal effect on the rate and extent of absorption, but can slightly delay Tmax.

Distribution:

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

Elimination:

HalfLife: 20-40 hours (average 26 hours)
Clearance: Not available (highly variable due to metabolism)
ExcretionRoute: Urine (approximately 75%), Feces (approximately 15%)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: Sedative effects may be seen within days. Antidepressant effects typically begin within 1-2 weeks, with full effect often seen in 2-4 weeks.
PeakEffect: Antidepressant peak effect typically 2-4 weeks.
DurationOfAction: Due to its long half-life, effects persist for at least 24 hours, allowing for once-daily dosing.
Confidence: Medium

Safety & Warnings

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BLACK BOX WARNING

Antidepressants increased the risk compared to placebo of suicidal thoughts 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. Mirtazapine is not approved for use in pediatric patients.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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 immediate medical attention:

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: Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)

This medication may cause severe skin reactions, including SJS and TEN, which can be life-threatening. 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

Most people experience few or no side effects. However, some common side effects may occur, including:

Dizziness
Drowsiness
Fatigue
Weakness
Constipation
Dry mouth
Increased appetite
Weight gain
* Vivid or unusual dreams

If you experience any of these side effects or any other symptoms that concern you, contact your doctor for advice. 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 suicidal thoughts, especially at the beginning of treatment or after a dose change.
  • Unusual changes in behavior, such as agitation, restlessness, panic attacks, irritability, aggression, impulsivity, or severe insomnia.
  • Signs of an allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing).
  • Signs of serotonin syndrome (e.g., agitation, confusion, rapid heart rate, fever, sweating, muscle stiffness or twitching, loss of coordination, severe nausea/vomiting/diarrhea).
  • Signs of infection, such as fever, chills, sore throat, or mouth sores (rare, but can indicate a serious blood problem).
  • Severe dizziness or fainting when standing up (orthostatic hypotension).
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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, including any symptoms that occurred.
If you are currently taking or have recently taken certain medications, such as:
+ Anxiety or sleep aids like alprazolam or diazepam
+ Depression or Parkinson's disease medications, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, within the last 14 days (as this may increase the risk of very high blood pressure)
+ Linezolid or methylene blue
Please note that this is not an exhaustive list of all potential interactions. Therefore, it is crucial to disclose all your medications, including:
+ Prescription and over-the-counter (OTC) drugs
+ Natural products
+ Vitamins
Additionally, inform your doctor about any existing health problems. This information will help your doctor determine whether it is safe for you to take this medication with your other medications and health conditions.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor.
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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 understand 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 is a risk of abnormal heart rhythms (long QT on ECG) associated with this medication, which has rarely led to sudden deaths. Discuss this risk with your doctor. Additionally, this drug may cause elevated cholesterol and triglyceride levels; consult with your doctor about this potential side effect.

Regular blood tests will be necessary to monitor your condition, as directed by your doctor. It is recommended that you avoid consuming alcohol while taking this medication. Before using marijuana, cannabis, or prescription or over-the-counter drugs that may cause drowsiness, consult with your doctor.

If you have phenylketonuria (PKU), discuss this with your doctor, as some products contain phenylalanine. Individuals 65 years or older should exercise caution when taking this medication, as they may be more susceptible to side effects.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Disorientation
  • Drowsiness
  • Impaired memory
  • Tachycardia
  • Sedation

What to Do:

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

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs): Concomitant use or within 14 days of discontinuing an MAOI (or starting an MAOI within 14 days of discontinuing mirtazapine) due to risk of serotonin syndrome.
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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 depressant effects (sedation, respiratory depression).
  • CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, cimetidine, protease inhibitors): Increased mirtazapine plasma concentrations, potentially leading to increased adverse effects.
  • CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin): Decreased mirtazapine plasma concentrations, potentially reducing efficacy.
  • Warfarin: Mirtazapine may cause a small but statistically significant increase in INR in some patients.
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Moderate Interactions

  • Anticholinergic drugs (e.g., atropine, tricyclic antidepressants): Potentiation of anticholinergic effects (e.g., dry mouth, constipation, urinary retention, blurred vision).
  • Alpha-1 adrenergic blockers (e.g., prazosin): Increased risk of orthostatic hypotension.
  • Drugs metabolized by CYP2D6 (e.g., tricyclic antidepressants, risperidone): Mirtazapine is a weak inhibitor of CYP2D6, potentially increasing concentrations of co-administered drugs.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Mood and Suicidality Assessment

Rationale: To establish baseline severity of depression and suicidal ideation, and to monitor for worsening symptoms or emergence of suicidality, especially in young adults.

Timing: Prior to initiation of therapy.

Weight and BMI

Rationale: Mirtazapine is associated with weight gain.

Timing: Prior to initiation of therapy.

Blood Pressure

Rationale: To establish baseline and monitor for orthostatic hypotension.

Timing: Prior to initiation of therapy.

Complete Blood Count (CBC) with differential

Rationale: Although rare, agranulocytosis has been reported. Baseline CBC is prudent, especially if patient has a history of blood dyscrasias.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Mood and Suicidality Assessment

Frequency: Weekly for the first 4 weeks, then every 2 weeks for the next 4 weeks, then monthly or as clinically indicated, especially during dose changes.

Target: Improvement in depressive symptoms, absence of suicidal ideation or behavior.

Action Threshold: Worsening depression, emergence of new or worsening suicidal thoughts/behaviors, or unusual changes in behavior warrant immediate clinical re-evaluation and potential dose adjustment or discontinuation.

Weight and BMI

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

Target: Maintain stable weight or manage weight gain.

Action Threshold: Significant or rapid weight gain may warrant dietary counseling, lifestyle modifications, or consideration of alternative therapy.

Blood Pressure (especially orthostatic)

Frequency: Periodically, especially during dose titration.

Target: Stable blood pressure, absence of symptomatic orthostasis.

Action Threshold: Symptomatic orthostatic hypotension may require dose reduction or discontinuation.

CBC with differential

Frequency: If signs/symptoms of infection (e.g., fever, sore throat, stomatitis) develop, or if patient has a history of blood dyscrasias.

Target: Normal leukocyte count.

Action Threshold: Significant decrease in white blood cell count (especially neutrophils) warrants immediate discontinuation and further investigation.

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Symptom Monitoring

  • Worsening depression
  • Suicidal thoughts or behavior (especially in young adults)
  • Unusual changes in behavior (e.g., agitation, irritability, anxiety, panic attacks, insomnia, impulsivity, aggression, mania/hypomania)
  • Sedation/drowsiness
  • Dizziness/lightheadedness (orthostatic hypotension)
  • Weight gain
  • Increased appetite
  • Dry mouth
  • Constipation
  • Signs of infection (e.g., fever, sore throat, stomatitis) - rare, but indicates potential agranulocytosis
  • Symptoms of serotonin syndrome (e.g., agitation, hallucinations, delirium, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea)

Special Patient Groups

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Pregnancy

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Mirtazapine is classified as Pregnancy Category C.

Trimester-Specific Risks:

First Trimester: Limited data, but generally no increased risk of major congenital malformations observed.
Second Trimester: Not available
Third Trimester: Exposure in late pregnancy may be associated with neonatal withdrawal symptoms (e.g., respiratory distress, feeding difficulties, irritability, tremor, hypotonia, persistent crying) and persistent pulmonary hypertension of the newborn (PPHN).
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Lactation

Mirtazapine is excreted into breast milk. The amount is generally low, but potential for infant exposure exists. Monitor breastfed infants for sedation, poor feeding, and weight gain. Use with caution, or consider alternative if possible.

Infant Risk: L3 (Moderately Safe) - Monitor infant for drowsiness, poor feeding, and weight gain. Risk of adverse effects appears low but cannot be excluded.
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Pediatric Use

Not approved for use in pediatric patients for major depressive disorder due to increased risk of suicidal thoughts and behaviors. Safety and efficacy have not been established in this population.

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Geriatric Use

Start with a lower dose (e.g., 7.5 mg/day) and titrate slowly due to increased sensitivity to adverse effects (e.g., sedation, orthostatic hypotension) and potential for reduced renal and hepatic clearance. Monitor closely for falls and cognitive impairment.

Clinical Information

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Clinical Pearls

  • Mirtazapine is often chosen for patients with depression who also experience significant insomnia, anxiety, or poor appetite/weight loss, due to its sedative and appetite-stimulating effects.
  • The sedative effect is often more pronounced at lower doses (e.g., 7.5-15 mg) due to saturation of H1 receptors. At higher doses (e.g., 30-45 mg), the noradrenergic effects become more prominent, which can counteract some of the sedation.
  • Less likely to cause sexual dysfunction compared to SSRIs/SNRIs.
  • Withdrawal symptoms can occur if discontinued abruptly, especially after prolonged use. Taper dose gradually over several weeks.
  • Monitor for rare but serious adverse effects like agranulocytosis (signs of infection) and serotonin syndrome.
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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
  • Tricyclic Antidepressants (TCAs) e.g., amitriptyline, nortriptyline
  • Atypical antidepressants e.g., bupropion, vortioxetine, vilazodone
  • Electroconvulsive Therapy (ECT)
  • Transcranial Magnetic Stimulation (TMS)
  • Psychotherapy (e.g., Cognitive Behavioral Therapy)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets (generic 30mg ODT)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic)
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. It is essential to read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about this medication, consult with your doctor, pharmacist, or other healthcare provider for clarification.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.