Remeron 45mg Tablets

Mirtazapine is a noradrenergic and specific serotonergic antidepressant (NaSSA). Its antidepressant activity is believed to be mediated by its antagonism of central presynaptic alpha2-adrenergic autoreceptors and heteroreceptors, which results in an increase in central noradrenergic and serotonergic neurotransmission. It is also a potent antagonist of 5-HT2 and 5-HT3 serotonin receptors, and H1 histamine receptors. It has moderate antagonism of alpha1-adrenergic receptors and no significant affinity for muscarinic cholinergic or dopaminergic 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. Seek medical help immediately if you experience:

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. 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 skin
Fever
Chills
Body aches
Shortness of breath
Swollen glands

Other Side Effects

Most people experience few or no side effects. However, some common side effects may occur, including:

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

If any of these side effects or other symptoms bother you or do not go away, contact your doctor for advice. 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.
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
* Note that this is not an exhaustive list of interacting medications or health conditions. Therefore, it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist to ensure safe use.

To guarantee your safety, always verify with your doctor before starting, stopping, or adjusting the dosage of any medication.

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 aware of 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 drug has been linked to abnormal heart rhythms (long QT on ECG), which can be life-threatening. Sudden deaths have occurred in rare cases. Discuss this risk with your doctor.

Additionally, this medication may cause elevated cholesterol and triglyceride levels. Consult with your doctor about monitoring your blood work as directed. It is also recommended to avoid consuming alcohol while taking this drug.

Before using marijuana, cannabis, or prescription or over-the-counter medications 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 benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.

• Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of discontinuing MAOIs due to risk of serotonin syndrome)

• Other serotonergic drugs (e.g., SSRIs, SNRIs, triptans, tramadol, fentanyl, lithium, St. John's Wort, tryptophan) - increased risk of serotonin syndrome.
• CNS depressants (e.g., alcohol, benzodiazepines, opioids, sedatives, hypnotics) - increased CNS depression (sedation, respiratory depression).
• Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, some antipsychotics, macrolide antibiotics) - theoretical risk of QT prolongation, though mirtazapine's effect is minimal.
• Strong CYP1A2 inhibitors (e.g., fluvoxamine) - increased mirtazapine levels.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) - increased mirtazapine levels.
• Strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin) - decreased mirtazapine levels.

• Antihypertensives (e.g., alpha-blockers) - additive hypotensive effects.
• Anticholinergic drugs - potential for additive anticholinergic effects (e.g., dry mouth, constipation, urinary retention).
• Warfarin - rare reports of increased INR/PT; monitor coagulation parameters.

• Not readily categorized as minor due to potential for significant clinical impact.

• Worsening depression
• Suicidal ideation or attempts
• Unusual changes in behavior (e.g., agitation, irritability, hostility, impulsivity)
• Emergence of mania or hypomania
• Symptoms of serotonin syndrome (e.g., agitation, hallucinations, rapid heart beat, fever, sweating, shivering, muscle rigidity, twitching, incoordination, nausea, vomiting, diarrhea)
• Signs of allergic reaction (e.g., rash, hives, swelling)
• Signs of blood dyscrasias (e.g., fever, sore throat, other signs of infection, especially during the first 4-6 weeks of treatment)

Mirtazapine is Pregnancy Category C. Use 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.

Mirtazapine is excreted into breast milk in low amounts. The American Academy of Pediatrics considers it compatible with breastfeeding. Monitor breastfed infants for sedation, poor feeding, and poor weight gain.

Not FDA approved for major depressive disorder in pediatric patients. A Black Box Warning exists regarding increased risk of suicidal thoughts and behaviors 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.

Start with lower doses (e.g., 7.5 mg/day) and titrate slowly due to potential for decreased renal and hepatic clearance, increased sensitivity to side effects (e.g., sedation, orthostatic hypotension, hyponatremia), and increased risk of falls. Monitor closely for adverse effects.

• Often chosen for patients with depression who also experience insomnia and/or significant weight loss/poor appetite, due to its sedating and appetite-stimulating effects.
• Can cause significant weight gain, which may be a limiting factor for some patients.
• Less likely to cause sexual dysfunction compared to SSRIs/SNRIs.
• Has a relatively rapid onset of sedative effects, which can be beneficial for sleep disturbances associated with depression.
• Withdrawal symptoms can occur if discontinued abruptly; taper dose gradually over several weeks.

• Selective Serotonin Reuptake Inhibitors (SSRIs) (e.g., escitalopram, sertraline, fluoxetine)
• 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 - generally reserved for refractory cases)
• Psychotherapy (e.g., Cognitive Behavioral Therapy - CBT, Interpersonal Therapy - IPT)
• Electroconvulsive Therapy (ECT) for severe or refractory depression

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 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 incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.