Mirtazapine 15mg Tablets

Mirtazapine is a tetracyclic antidepressant that 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, and a potent antagonist of histamine H1 receptors, which contributes to its sedative 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

If you're experiencing any side effects that bother you or don't 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 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use.

To guarantee your safety, do not start, stop, or adjust the dosage of any medication without first consulting your doctor. It is your responsibility to verify that it is safe to take this medication with all 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. 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 instances of abnormal heart rhythms (long QT on ECG) and rare cases 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 also important to 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.

• 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, 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., Class IA and III antiarrhythmics, antipsychotics, macrolide antibiotics) - theoretical risk of QT prolongation
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) - increased mirtazapine levels
• Strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin) - decreased mirtazapine levels

• Warfarin (potential for increased INR, monitor closely)
• Cimetidine (may increase mirtazapine levels)
• Diazepam (additive psychomotor impairment)

• Not available

• Worsening depression
• Suicidal thoughts or behavior
• Unusual changes in behavior or mood (e.g., agitation, irritability, anxiety, panic attacks, insomnia, impulsivity, aggression, mania/hypomania)
• Sedation/drowsiness
• Dizziness
• Increased appetite/weight gain
• Dry mouth
• Constipation
• Nausea
• Peripheral edema
• Flu-like symptoms (rare, but monitor for agranulocytosis, especially if fever, sore throat, or other signs of infection occur)

Category C. Mirtazapine should be used during pregnancy only 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 relative infant dose (RID) is low (typically < 5%). Monitor breastfed infants for sedation, poor feeding, and poor weight gain.

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

Lower starting doses (e.g., 7.5 mg) and slower titration are recommended due to potential for increased sensitivity to side effects (e.g., sedation, dizziness) and reduced renal/hepatic clearance. Monitor closely for adverse effects and clinical response.

• Mirtazapine is often chosen for patients with depression who also experience significant insomnia, poor appetite, or weight loss due to its sedative and appetite-stimulating effects.
• The sedative effect is often more pronounced at lower doses (e.g., 7.5 mg or 15 mg) due to saturation of H1 receptors, while higher doses (e.g., 30-45 mg) may have less sedation as noradrenergic effects become more prominent.
• It has a relatively low risk of sexual dysfunction compared to SSRIs/SNRIs.
• Can be useful in patients who cannot tolerate SSRIs/SNRIs due to gastrointestinal side effects (e.g., nausea, diarrhea) as it is a 5-HT3 antagonist.
• Monitor for agranulocytosis (very rare but serious) if patient develops fever, sore throat, or other signs of infection.

• 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 - generally reserved for refractory cases)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, 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, we encourage you to discuss them 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. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.