Remeron 30mg Tablets
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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.
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)
Before Using This Medicine
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.
Precautions & Cautions
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.
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
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of discontinuing MAOI or mirtazapine)
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
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
Minor Interactions
- Not readily categorized as minor, most interactions are significant.
Monitoring
Baseline Monitoring
Rationale: To establish baseline and track treatment response.
Timing: Prior to initiation
Rationale: Risk assessment, especially in young adults.
Timing: Prior to initiation
Rationale: Rare risk of agranulocytosis/neutropenia. Baseline is prudent, especially if patient has history of blood dyscrasias.
Timing: Prior to initiation (consider)
Rationale: Mirtazapine is hepatically metabolized; baseline is useful for patients with pre-existing hepatic impairment.
Timing: Prior to initiation (consider in at-risk patients)
Rationale: Mirtazapine is renally excreted; baseline is useful for dose adjustment in renal impairment.
Timing: Prior to initiation (consider in at-risk patients)
Rationale: Mirtazapine can cause weight gain.
Timing: Prior to initiation
Routine Monitoring
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.
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.
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.
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.
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.
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
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:
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.
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.
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
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).
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)