Remeron 30mg Tablets

Manufacturer ORGANON Active Ingredient Mirtazapine 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
Tetracyclic Antidepressant; Alpha-2 Adrenergic Antagonist
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Pregnancy Category
Category C
FDA Approved
Oct 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 in the brain. It can also help with sleep and appetite, which are often affected by depression. It's usually taken once a day, typically at bedtime, because it can cause drowsiness.
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How to Use This Medicine

Taking Your Medication

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. If this medication makes you sleepy, take it at bedtime. You can take it with or without food.

It's essential to continue taking this medication as directed by your doctor or healthcare provider, even if you start feeling well. Don't stop taking it without consulting your doctor first.

Storing and Disposing of Your Medication

To keep your medication effective and safe:

Store it at room temperature, away from light and moisture.
Keep it in a dry place, such as a closet or drawer.
Avoid storing it in a bathroom, where it may be exposed to heat and humidity.
Keep all medications in a safe and secure location, out of the reach of children and pets.
If you have unused or expired medication, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist or healthcare provider.
Check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
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Lifestyle & Tips

  • Avoid alcohol and other CNS depressants (e.g., sedatives, tranquilizers) as they can increase drowsiness and dizziness.
  • Be cautious when driving or operating machinery until you know how this medication affects you.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking, especially St. John's Wort.
  • Do not stop taking mirtazapine suddenly without consulting your doctor, as this can cause withdrawal symptoms.
  • Monitor your weight, as weight gain can be a side effect.

Dosing & Administration

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Adult Dosing

Standard Dose: 15 mg once daily at bedtime, titrate as needed
Dose Range: 15 - 45 mg

Condition-Specific Dosing:

Major Depressive Disorder (MDD): Initial: 15 mg once daily at bedtime. Titrate every 1-2 weeks by 15 mg/day increments based on clinical response and tolerability. Target dose range: 15-45 mg/day. Max: 45 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established (Safety and efficacy not established for MDD; Black Box Warning for increased risk of suicidal thoughts and behavior in children, adolescents, and young adults)
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment generally needed (CrCl 50-80 mL/min)
Moderate: Consider 30% dose reduction (CrCl 10-50 mL/min)
Severe: Consider 50% dose reduction (CrCl <10 mL/min)
Dialysis: Data limited; significant reduction likely needed, monitor closely.

Hepatic Impairment:

Mild: No specific adjustment, monitor closely.
Moderate: Consider 30% dose reduction.
Severe: Consider 50% dose reduction.

Pharmacology

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Mechanism of Action

Mirtazapine is a tetracyclic antidepressant that enhances central noradrenergic and serotonergic activity. It acts as an antagonist at 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 a potent antagonist of histamine H1 receptors, which contributes to its sedative effects. It has moderate antagonism at peripheral alpha-1 adrenergic receptors and muscarinic cholinergic receptors.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 50%
Tmax: Approximately 2 hours
FoodEffect: Food has 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 (average 26 hours)
Clearance: Not readily available as a single value, but primarily hepatic metabolism and renal excretion.
ExcretionRoute: Approximately 75% renal, 15% fecal
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: Sedative effects may be seen within 30-60 minutes. Antidepressant effects typically begin within 1-2 weeks, with full effect in 4-6 weeks.
PeakEffect: Antidepressant peak effect typically 4-6 weeks.
DurationOfAction: Due to long half-life, once-daily dosing is sufficient.

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 Attention 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 help 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. If you experience any of the following symptoms, call your doctor immediately:

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: Seek Medical Help Right Away

This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. These conditions can be life-threatening and may affect other organs. If you notice any of the following symptoms, seek medical help immediately:

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

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical help if they bother you or do not go away:

Dizziness
Drowsiness
Fatigue
Weakness
Constipation
Dry mouth
Increased appetite
Weight gain
* Strange or vivid dreams

Reporting Side Effects

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

  • New or worsening depression, anxiety, or panic attacks
  • Thoughts about suicide or harming yourself
  • Unusual changes in behavior (e.g., agitation, restlessness, aggression, irritability, impulsivity, mania)
  • Fever, sore throat, mouth sores, or other signs of infection (could indicate a serious blood problem)
  • Rash or hives
  • Swelling of the face, tongue, or throat
  • Difficulty breathing or swallowing
  • Symptoms of serotonin syndrome: agitation, hallucinations, confusion, fast heartbeat, fever, sweating, shivering, muscle stiffness or twitching, loss of coordination, nausea, vomiting, diarrhea
  • Unexplained muscle pain, tenderness, or weakness (rare, but can be serious)
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Before Using This Medicine

Before taking this medication, it is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. 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:
+ Benzodiazepines like alprazolam or diazepam, which are used to treat anxiety, sleep disorders, or other health issues.
+ Monoamine oxidase inhibitors (MAOIs) like isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, which are used to treat depression or Parkinson's disease. Note that taking this medication within 14 days of stopping an MAOI can lead to severely high blood pressure.
+ Other medications like linezolid or methylene blue.
It is crucial to disclose all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as well as any health problems you have. This will enable your doctor and pharmacist to assess potential interactions and ensure safe treatment.
Do not initiate, discontinue, or modify 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 taper off the medication 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 examination to assess your risk. If you experience eye pain, changes in vision, or swelling and redness around the eye, contact your doctor immediately.

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 to monitor your condition.

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

If you are 65 years or older, exercise caution when taking this medication, as you may be more susceptible to side effects. Pregnant or breastfeeding women, or those planning to become pregnant, should discuss the potential benefits and risks of this medication with their doctor.
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Overdose Information

Overdose Symptoms:

  • Disorientation
  • Drowsiness
  • Impaired memory
  • Tachycardia
  • Sedation
  • Hypotension
  • Rarely, cardiac arrhythmias, severe hypotension, respiratory depression, or coma.

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive and symptomatic.

Drug Interactions

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Contraindicated Interactions

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

  • Serotonergic drugs (e.g., SSRIs, SNRIs, triptans, fentanyl, lithium, tramadol, St. John's Wort) - increased risk of serotonin syndrome
  • CNS depressants (e.g., alcohol, benzodiazepines, opioids, sedatives, hypnotics) - increased CNS depression
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, clarithromycin, ritonavir) - increased mirtazapine levels
  • Strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin) - decreased mirtazapine levels
  • Drugs that prolong QT interval (e.g., certain antiarrhythmics, antipsychotics, macrolides) - theoretical risk, monitor
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Moderate Interactions

  • Cimetidine (CYP1A2, 2D6, 3A4 inhibitor) - may increase mirtazapine levels
  • Warfarin - mirtazapine may cause a small, but statistically significant, increase in INR; monitor INR
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Minor Interactions

  • Not readily categorized as minor, most interactions are significant.

Monitoring

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Baseline Monitoring

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

Rationale: To establish baseline and track treatment response.

Timing: Prior to initiation

Suicidal ideation/behavior

Rationale: Risk assessment, especially in young adults.

Timing: Prior to initiation

Complete Blood Count (CBC) with differential

Rationale: Rare risk of agranulocytosis/neutropenia. Baseline is prudent, especially if patient has history of blood dyscrasias.

Timing: Prior to initiation (consider)

Liver function tests (LFTs)

Rationale: Mirtazapine is hepatically metabolized; baseline is useful for patients with pre-existing hepatic impairment.

Timing: Prior to initiation (consider in at-risk patients)

Renal function (CrCl)

Rationale: Mirtazapine is renally excreted; baseline is useful for dose adjustment in renal impairment.

Timing: Prior to initiation (consider in at-risk patients)

Weight/BMI

Rationale: Mirtazapine can cause weight gain.

Timing: Prior to initiation

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Routine Monitoring

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

Frequency: Weekly for first 4-6 weeks, then monthly or as clinically indicated

Target: Reduction in score indicating improvement

Action Threshold: Lack of improvement or worsening symptoms may indicate need for dose adjustment or alternative therapy.

Suicidal ideation/behavior

Frequency: Weekly for first 4-6 weeks, then monthly or as clinically indicated

Target: Absence of ideation/behavior

Action Threshold: Any new or worsening suicidal thoughts/behavior requires immediate clinical assessment and intervention.

Weight/BMI

Frequency: Monthly for first few months, then quarterly or as clinically indicated

Target: Stable weight or within acceptable range

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

Signs/symptoms of serotonin syndrome

Frequency: Continuously, especially when initiating or increasing dose, or with concomitant serotonergic drugs

Target: Absence of symptoms (e.g., agitation, hallucinations, tachycardia, fever, hyperreflexia, incoordination, N/V/D)

Action Threshold: Presence of symptoms requires immediate discontinuation of mirtazapine and supportive care.

Signs/symptoms of agranulocytosis/neutropenia

Frequency: Patient education for self-monitoring; CBC if symptoms occur

Target: Absence of symptoms (e.g., fever, sore throat, stomatitis, other signs of infection)

Action Threshold: Any signs of infection require immediate CBC with differential; discontinue mirtazapine if neutrophil count falls below 1000/mm³.

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Symptom Monitoring

  • Worsening depression
  • Suicidal thoughts or behavior
  • Unusual changes in behavior (e.g., agitation, irritability, anxiety, panic attacks, insomnia, impulsivity, aggression, mania/hypomania)
  • Serotonin syndrome (agitation, confusion, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness/spasms, nausea, vomiting, diarrhea)
  • Signs of infection (fever, sore throat, mouth sores) - potential agranulocytosis
  • Dizziness or lightheadedness (orthostatic hypotension)
  • Excessive sedation/drowsiness
  • Weight gain
  • Dry mouth
  • Constipation

Special Patient Groups

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Pregnancy

Category C. Mirtazapine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Limited human data suggest low risk, but animal studies show some adverse effects. Neonates exposed to antidepressants in late third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.

Trimester-Specific Risks:

First Trimester: Limited data, but generally not associated with major congenital malformations.
Second Trimester: Limited data.
Third Trimester: Potential for neonatal withdrawal symptoms (e.g., respiratory distress, feeding difficulties, jitteriness, irritability) if exposed late in pregnancy. Monitor neonate.
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Lactation

L3 (Moderately Safe). Mirtazapine is excreted into breast milk in small amounts. While generally considered low risk, monitor breastfed infants for sedation, poor feeding, and poor weight gain. Use with caution, especially in preterm or unstable infants.

Infant Risk: Low to moderate. Monitor for sedation, irritability, poor feeding, and weight gain.
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Pediatric Use

Not approved for use in pediatric patients for MDD due to increased risk of suicidal thoughts and behavior (Black Box Warning). Safety and efficacy have not been established. Use in children and adolescents should be carefully considered and monitored by a specialist.

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Geriatric Use

Lower starting doses (e.g., 7.5 mg) and slower titration are recommended due to increased sensitivity to side effects (e.g., sedation, orthostatic hypotension) and potential for reduced clearance. Monitor closely for adverse effects and clinical response.

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 sedative and appetite-stimulating effects.
  • Lower doses (e.g., 7.5-15 mg) tend to be more sedating due to prominent H1 antagonism, while higher doses (30-45 mg) may have less sedation as noradrenergic effects become more pronounced.
  • Take at bedtime due to sedative effects.
  • Warn patients about potential for significant weight gain and increased appetite.
  • Monitor for signs of agranulocytosis (fever, sore throat) as this is a rare but serious side effect.
  • Avoid abrupt discontinuation to prevent withdrawal symptoms (e.g., dizziness, abnormal dreams, agitation, anxiety, headache, nausea).
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Alternative Therapies

  • Selective Serotonin Reuptake Inhibitors (SSRIs) (e.g., escitalopram, sertraline, fluoxetine)
  • Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) (e.g., venlafaxine, duloxetine)
  • Bupropion (NDRI)
  • Tricyclic Antidepressants (TCAs) (e.g., amitriptyline, nortriptyline)
  • Other atypical antidepressants (e.g., vortioxetine, vilazodone)
  • Electroconvulsive Therapy (ECT)
  • Transcranial Magnetic Stimulation (TMS)
  • Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)
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Cost & Coverage

Average Cost: $15 - $50 per 30 tablets (30mg generic)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic) or Tier 2 (Generic), Tier 3 (Brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's 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. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to 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 incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.