Remeron 15mg Tablets

Mirtazapine is a tetracyclic antidepressant that enhances central noradrenergic and serotonergic activity. It acts as an antagonist at central presynaptic alpha2-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. It has moderate antagonism at peripheral alpha1-adrenergic receptors and muscarinic cholinergic receptors.

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 medical attention immediately:

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
+ Change 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 passing out
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
Change in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Sweating a lot
Severe diarrhea, upset stomach, or vomiting
Very bad 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 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

Most people experience no side effects or only minor side effects while taking this medication. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:

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

Reporting Side Effects

If you have questions about side effects or experience any side effects not listed here, 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.

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, as these medications can interact with this drug
Note that this is not an exhaustive list of all potential drug interactions or health problems that may affect the safety of this medication.

To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your complete medical history, including any health problems you have or have had

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm that it is safe to do so in conjunction with your other medications and health conditions.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Please note that it may take several weeks to experience the full effects of this drug.

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. 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.

Rarely, this medication has been associated with 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.

This medication has been linked to abnormal heart rhythms (long QT on ECG) and, in rare cases, sudden death. 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 are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks to you and your baby with your doctor.

• Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of stopping MAOI or starting MAOI after mirtazapine)

• Other 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) - additive CNS depression.
• Drugs that prolong QT interval (e.g., some antiarrhythmics, antipsychotics, macrolide antibiotics) - theoretical risk of QT prolongation, though mirtazapine's effect is generally minimal.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, cimetidine, protease inhibitors) - increased mirtazapine plasma concentrations.
• Strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin) - decreased mirtazapine plasma concentrations.

• Warfarin - potential for increased INR (monitor INR).
• Cimetidine - may increase mirtazapine levels.
• Diazepam - no significant pharmacokinetic interaction, but additive CNS depression.

• Not available

• Worsening depression
• Suicidal thoughts or behavior
• Unusual changes in behavior or mood (e.g., agitation, irritability, anxiety, panic attacks, insomnia, impulsivity, hypomania, mania)
• Signs of serotonin syndrome (e.g., agitation, hallucinations, rapid heart rate, fever, sweating, shivering, muscle stiffness or twitching, loss of coordination, nausea, vomiting, diarrhea)
• Signs of agranulocytosis/neutropenia (e.g., sore throat, fever, flu-like symptoms, other signs of infection)
• Allergic reactions (e.g., rash, hives, swelling)
• Orthostatic hypotension (dizziness upon standing)
• Excessive sedation or drowsiness
• Significant weight gain or increased appetite

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

Mirtazapine is excreted into breast milk in small amounts. The American Academy of Pediatrics considers it compatible with breastfeeding. Monitor breastfed infants for sedation, poor feeding, and poor weight gain. Weigh the benefits of breastfeeding against the potential risks to the infant.

Safety and efficacy have not been established in pediatric patients. Mirtazapine carries a Black Box Warning for increased risk of suicidal thoughts and behavior in children, adolescents, and young adults. Use is generally not recommended.

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 at bedtime) and slower titration are recommended. Monitor closely for adverse effects.

• Mirtazapine is often chosen for depression accompanied by insomnia, significant anxiety, or poor appetite/weight loss due to its sedating 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 (e.g., 30-45 mg) may be less sedating as noradrenergic effects become more prominent.
• Weight gain is a common and significant side effect, which can be beneficial for underweight patients but problematic for others.
• Unlike many other antidepressants, mirtazapine has minimal sexual side effects, making it a good option for patients experiencing or concerned about this issue.
• It has a relatively low risk of serotonin syndrome compared to SSRIs/SNRIs when used alone, but the risk increases significantly with co-administration of other serotonergic agents.
• Withdrawal symptoms can occur if discontinued abruptly, though generally less severe than with SSRIs/SNRIs. Tapering is recommended.

• 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, trazodone, vortioxetine, vilazodone)
• Monoamine Oxidase Inhibitors (MAOIs) (e.g., phenelzine, tranylcypromine - reserved for refractory cases)
• Electroconvulsive Therapy (ECT)
• Transcranial Magnetic Stimulation (TMS)
• Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)

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. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or 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.