Mirtazapine 15mg Oral Dsntgrt Tabs

Manufacturer CITRON 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
Tetracyclic Antidepressant; Alpha-2 Adrenergic Antagonist; 5-HT2 and 5-HT3 Antagonist; H1 Antagonist
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Pregnancy Category
Category C
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FDA Approved
Jul 2001
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Mirtazapine is an antidepressant 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 improve sleep and appetite, which are often affected by depression.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, and follow these guidelines:

If this medication makes you sleepy, take it at bedtime.
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, where it will dissolve. You do not need water, and do not swallow the tablet whole. Avoid chewing, breaking, or crushing 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.

Continuing Your Medication

Continue taking this medication as instructed by your doctor or healthcare provider, even if you feel well.

Storing and Disposing of Your Medication

To store your medication:
Keep it at room temperature, away from light.
Store it in a dry place, avoiding bathrooms.
Keep all medications in a safe location, out of reach of children and pets.

To dispose of your medication:
Throw away any unused or expired medication.
Do not flush it down the toilet or pour it 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.
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 medications that cause drowsiness (e.g., cold/allergy medicines, pain relievers, sleeping pills) while taking Mirtazapine, as this can worsen sedation.
  • Be careful when driving or operating machinery until you know how Mirtazapine affects you, as it can cause dizziness and drowsiness.
  • Report any unusual changes in mood or behavior, especially suicidal thoughts, to your doctor immediately.
  • Mirtazapine may cause weight gain and increased appetite; monitor your diet and exercise.

Dosing & Administration

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Adult Dosing

Standard Dose: 15 mg orally once daily at bedtime, may increase every 1-2 weeks
Dose Range: 15 - 45 mg

Condition-Specific Dosing:

Major Depressive Disorder: Initial: 15 mg orally once daily at bedtime. Titrate based on clinical response and tolerability, typically in increments of 15 mg/day, up to a maximum of 45 mg/day. Doses are usually given once daily at bedtime due to sedative effects.
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Pediatric Dosing

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

Renal Impairment:

Mild: No adjustment needed
Moderate: Consider 30% dose reduction (e.g., max 30 mg/day)
Severe: Consider 50% dose reduction (e.g., max 22.5 mg/day)
Dialysis: Not well studied; use with caution and monitor closely. Dose adjustment likely needed.

Hepatic Impairment:

Mild: No adjustment needed
Moderate: Consider 30% dose reduction (e.g., max 30 mg/day)
Severe: Consider 50% dose reduction (e.g., max 22.5 mg/day)

Pharmacology

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Mechanism of Action

Mirtazapine enhances central noradrenergic and serotonergic activity. It acts as an antagonist at central presynaptic alpha-2 adrenergic inhibitory autoreceptors and heteroreceptors, leading to an increase in norepinephrine and serotonin release. It is also a potent antagonist of 5-HT2 and 5-HT3 receptors. Additionally, it has potent antagonism of H1 histamine receptors, contributing to its sedative effects, and moderate antagonism of peripheral alpha-1 adrenergic receptors and muscarinic 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 20-40 hours)
Clearance: Not available
ExcretionRoute: Approximately 75% via urine, 15% via feces
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: Sedative effects: within 1 hour. Antidepressant effects: typically 1-2 weeks, full effect may take 4-6 weeks.
PeakEffect: Antidepressant effects: 4-6 weeks
DurationOfAction: Due to long half-life, effects persist for 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 older than 24 years; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 years 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 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. If you experience any of the following symptoms, contact 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: Contact Your Doctor if Concerned

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 contact your doctor if you're concerned about any of the following:

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:

  • New or worsening depression or anxiety
  • Thoughts about suicide or harming yourself
  • Panic attacks, agitation, restlessness, irritability
  • Aggressive or violent behavior
  • Extreme increase in activity and talking (mania)
  • Unusual changes in behavior
  • Symptoms of serotonin syndrome: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness or twitching, loss of coordination, nausea, vomiting, diarrhea.
  • Signs of infection: fever, chills, sore throat, mouth sores (rare, but serious side effect of agranulocytosis).
  • Severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis): rash, blistering, peeling skin.
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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 increase the risk of very high blood pressure)
+ Linezolid or methylene blue
* 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 drugs, natural products, and vitamins, as well as any health problems you are experiencing.

To ensure your safety, consult with your doctor and pharmacist to verify that it is safe to take this medication with your existing medications and health conditions. Do not initiate, terminate, or adjust the dosage 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. Some 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 about monitoring your blood work as directed.

Avoid consuming alcohol while taking this medication. Before using marijuana, cannabis products, or prescription or over-the-counter drugs 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. If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

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

What to Do:

Seek immediate medical attention or call 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 an MAOI 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 depression.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, clarithromycin, ritonavir) - increased mirtazapine plasma concentrations.
  • Strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin) - decreased mirtazapine plasma concentrations.
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Moderate Interactions

  • Warfarin - rare reports of increased INR and prothrombin time.
  • Cimetidine - may increase mirtazapine levels (CYP1A2/2D6 inhibition).
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

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

Rationale: To establish baseline and monitor treatment efficacy.

Timing: Prior to initiation

Suicidal ideation/behavior

Rationale: To assess risk, especially in young adults, and monitor for worsening.

Timing: Prior to initiation

Liver function tests (ALT, AST, bilirubin)

Rationale: Mirtazapine is hepatically metabolized; assess baseline function, especially if impairment is suspected.

Timing: Prior to initiation (if clinically indicated)

Renal function (SCr, eGFR)

Rationale: Mirtazapine is renally excreted; assess baseline function, especially if impairment is suspected.

Timing: Prior to initiation (if clinically indicated)

Weight

Rationale: Mirtazapine can cause weight gain.

Timing: Prior to initiation

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Routine Monitoring

Depression severity and clinical response

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

Target: Reduction in symptoms

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 weeks, then every 2 weeks for next 4 weeks, then monthly for 6 months, then periodically

Target: Absence of new or worsening ideation/behavior

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

Weight

Frequency: Monthly for first few months, then periodically

Target: Stable weight or acceptable gain

Action Threshold: Significant or undesirable weight gain may necessitate intervention or change in therapy.

Adverse effects (e.g., sedation, dry mouth, constipation, dizziness)

Frequency: Regularly, especially during dose titration

Target: Tolerable side effect profile

Action Threshold: Intolerable side effects may require dose reduction or discontinuation.

Complete Blood Count (CBC) with differential

Frequency: If patient develops fever, sore throat, or other signs of infection (due to rare risk of agranulocytosis)

Target: Normal white blood cell count

Action Threshold: Significant decrease in WBC count (especially neutrophils) requires immediate discontinuation and further investigation.

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Symptom Monitoring

  • Worsening depression
  • Emergence of suicidal thoughts or behavior
  • Unusual changes in behavior or mood (e.g., agitation, irritability, anxiety, panic attacks, insomnia, impulsivity, hypomania, mania)
  • Symptoms of serotonin syndrome (e.g., agitation, hallucinations, rapid heart rate, fever, sweating, shivering, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea)
  • Signs of infection (e.g., fever, sore throat, mouth sores) due to rare risk of agranulocytosis
  • Excessive sedation or somnolence
  • Significant weight gain

Special Patient Groups

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Pregnancy

Mirtazapine is classified as Pregnancy Category C. Studies in animals have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates exposed to antidepressants in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.

Trimester-Specific Risks:

First Trimester: Limited human data, animal studies show some risk. Generally, avoid if possible, or use with caution after weighing risks/benefits.
Second Trimester: Limited human data, continue to weigh risks/benefits.
Third Trimester: Risk of neonatal withdrawal symptoms (e.g., respiratory distress, feeding difficulties, irritability, tremor, hypotonia, persistent pulmonary hypertension of the newborn) if exposed late in pregnancy.
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Lactation

Mirtazapine is excreted into breast milk in small amounts. The American Academy of Pediatrics considers it compatible with breastfeeding. However, monitor the infant for sedation, poor feeding, and weight gain. Use with caution, especially in preterm or unstable infants.

Infant Risk: Low risk, but monitor for adverse effects.
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Pediatric Use

Not FDA-approved for pediatric depression. A Black Box Warning exists regarding increased risk of suicidal thoughts and behavior in children, adolescents, and young adults (up to 24 years of age) taking antidepressants. Use in this population should be carefully considered and closely monitored.

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Geriatric Use

Elderly patients may be more sensitive to the effects of mirtazapine, particularly sedation and orthostatic hypotension. A lower starting dose (e.g., 7.5 mg/day) and slower titration are recommended. Monitor closely for adverse effects, especially falls.

Clinical Information

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Clinical Pearls

  • Mirtazapine is often chosen for patients with depression who also experience significant insomnia and/or poor appetite/weight loss, due to its sedating and appetite-stimulating effects.
  • Unlike many other antidepressants (SSRIs/SNRIs), mirtazapine is generally associated with a lower incidence of sexual dysfunction.
  • The sedating effect is more pronounced at lower doses (e.g., 15 mg) due to prominent H1 antagonism. At higher doses (e.g., 30-45 mg), the noradrenergic effects become more prominent, which can counteract some of the sedation.
  • Patients should be advised about potential weight gain and increased appetite.
  • Oral disintegrating tablets (ODT) are useful for patients who have difficulty swallowing pills or for whom adherence might be an issue.
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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
  • Monoamine Oxidase Inhibitors (MAOIs) e.g., phenelzine, tranylcypromine (reserved for refractory cases)
  • Psychotherapy (e.g., Cognitive Behavioral Therapy, Interpersonal Therapy)
  • Electroconvulsive Therapy (ECT) for severe or refractory depression
  • Transcranial Magnetic Stimulation (TMS)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (generic 15mg ODT)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic)
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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 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 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 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.