Remeron 45mg Soltabs

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 H1 histamine receptors. It has moderate affinity for alpha1-adrenergic 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 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: 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. If you notice any of the following symptoms, seek medical help right away:

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 do not experience severe side effects, but some may occur. If you notice any of the following side effects, contact your doctor 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 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.

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 and its symptoms.
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 lead to very high blood pressure
+ Linezolid or methylene blue, as these can interact with this medication
Note that this is not an exhaustive list of all potential interactions. Therefore, it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist.
Before starting, stopping, or changing the dose of any medication, consult with your doctor to ensure it is safe to do so in conjunction with this medication. Your doctor and pharmacist need to know about all your health problems and medications to determine if it is safe for you to take this medication.

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 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 these levels.

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, 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.

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

• 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.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, protease inhibitors) - increased mirtazapine levels.
• Strong CYP1A2 inhibitors (e.g., cimetidine, fluvoxamine) - increased mirtazapine levels.
• Strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) - increased mirtazapine levels.

• CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin) - decreased mirtazapine levels, potentially reducing efficacy.
• Warfarin - rare reports of increased INR/prothrombin time.

• Anticholinergic drugs - potential for additive anticholinergic effects (e.g., dry mouth, constipation).

• Worsening depression
• Suicidal thoughts or behavior
• Unusual changes in behavior (e.g., agitation, irritability, anxiety, panic attacks, insomnia, aggression, impulsivity, akathisia, hypomania, mania)
• Signs of serotonin syndrome (e.g., agitation, hallucinations, delirium, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea)
• Signs of infection (e.g., fever, sore throat, flu-like symptoms) due to rare risk of agranulocytosis
• Excessive sedation or dizziness
• Significant weight gain
• Dry mouth, constipation

Mirtazapine is classified as Pregnancy Category C. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Neonates exposed to antidepressants in late third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. These complications can arise immediately upon delivery.

Mirtazapine is excreted into breast milk in small amounts. The relative infant dose (RID) is generally low (e.g., 1-3%). Monitor breastfed infants for sedation, poor feeding, and poor weight gain. Weigh the benefits of breastfeeding against the potential risks to the infant.

Mirtazapine is not FDA approved for use in pediatric patients. Clinical trials in pediatric patients with MDD did not demonstrate efficacy and showed an increased risk of suicidality compared to placebo. Use in this population should be approached with extreme caution and only after careful consideration of risks vs. benefits, with close monitoring for adverse effects, especially suicidality.

Elderly patients may be more sensitive to the effects of mirtazapine, particularly sedation and orthostatic hypotension. Clearance may be reduced due to age-related decline in renal and hepatic function. Lower starting doses and slower titration are recommended. Monitor closely for adverse effects.

• Mirtazapine is often chosen for depression when insomnia, anxiety, or significant weight loss are prominent symptoms, due to its sedating and appetite-stimulating effects.
• The sedating effect is often more pronounced at lower doses (e.g., 15 mg) due to greater H1 receptor antagonism. At higher doses (e.g., 30-45 mg), the noradrenergic effects may become more prominent, potentially reducing sedation.
• Weight gain is a common and often 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 preferred choice for some patients.
• The orally disintegrating tablet (SolTab) form is useful for patients who have difficulty swallowing pills or for whom adherence might be an issue.
• Always counsel patients on the Black Box Warning regarding suicidality, especially in younger individuals, and the importance of reporting any changes in mood or behavior.

• 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)
• Other atypical antidepressants (e.g., bupropion, vortioxetine, vilazodone)
• Electroconvulsive Therapy (ECT) for severe or treatment-resistant depression
• Transcranial Magnetic Stimulation (TMS)
• Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT)

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, and avoid taking medication prescribed to someone else. This medication is accompanied by a Medication Guide, a patient fact sheet that provides important information. Please read it 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. Be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.