Mirtazapine 7.5mg 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 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: A Medical Emergency

This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious conditions. These reactions can be deadly and may affect other organs. 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: Monitor and Report

While many people may not experience side effects or only have mild ones, it's essential to monitor your body's response to this medication. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

Dizziness
Drowsiness
Fatigue
Weakness
Constipation
Dry mouth
Increased appetite
Weight gain
* Vivid or unusual dreams

Remember, this is not an exhaustive list of potential side effects. If you have concerns or questions, consult 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, it is essential to inform your doctor about the following:

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, including:
+ Anxiety or sleep aids like alprazolam or diazepam
+ Medications for depression or Parkinson's disease, 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
It is crucial to note that this is not an exhaustive list of all potential interactions. Therefore, you must disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you are experiencing.
Your doctor and pharmacist need to be aware of all your medications and health issues to ensure it is safe for you to take this medication. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.

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), which can increase the risk of sudden death. Discuss this risk 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, 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 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 MAOI or mirtazapine)
• Linezolid (reversible non-selective 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, sedating antihistamines) - additive CNS depression.
• Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, antipsychotics, macrolide antibiotics) - theoretical risk of QT prolongation (though mirtazapine itself has minimal effect).

• CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, cimetidine, protease inhibitors) - may increase mirtazapine plasma concentrations.
• CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin) - may decrease mirtazapine plasma concentrations.
• CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) - may increase mirtazapine plasma concentrations (to a lesser extent than CYP3A4 inhibitors).
• Warfarin - rare reports of increased INR/PT.

• Not specifically categorized as minor, but general caution with any drug affecting CNS or hepatic metabolism.

• Worsening depression
• Suicidal thoughts or behavior
• Unusual changes in behavior (e.g., agitation, irritability, aggression, panic attacks, insomnia, 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, chills, mouth sores) - rare, but indicates potential agranulocytosis
• Excessive sedation or dizziness
• Significant weight gain

Mirtazapine is Pregnancy Category C. Studies in animals have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Exposure during the third trimester may lead to neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding.

Mirtazapine is excreted into breast milk in small amounts. The American Academy of Pediatrics considers mirtazapine to be compatible with breastfeeding. However, monitor breastfed infants for sedation, poor feeding, and poor weight gain.

Safety and efficacy have not been established for the treatment of Major Depressive Disorder in pediatric patients. A Black Box Warning exists regarding increased risk of suicidality in children, adolescents, and young adults treated with antidepressants.

Use with caution in elderly patients. Start with lower doses and titrate slowly due to potential for increased sensitivity to adverse effects (e.g., sedation, dizziness, orthostatic hypotension, hyponatremia) and reduced renal/hepatic clearance. Increased risk of falls.

• Mirtazapine's potent H1 antagonism makes it highly sedating, especially at lower doses (e.g., 7.5mg, 15mg). This can be beneficial for patients with insomnia or anxiety accompanying depression.
• Lower doses (e.g., 7.5mg, 15mg) tend to be more sedating due to saturation of H1 receptors, while higher doses (30mg, 45mg) may have less sedation as noradrenergic effects become more prominent.
• It is often chosen for patients with depression who also experience significant insomnia, anxiety, or poor appetite/weight loss, as it can improve these symptoms.
• Unlike many other antidepressants, mirtazapine has minimal sexual side effects, making it a good option for patients who experience or are concerned about sexual dysfunction.
• Weight gain and increased appetite are common side effects and should be discussed with patients upfront.

• Selective Serotonin Reuptake Inhibitors (SSRIs) e.g., fluoxetine, sertraline, escitalopram
• Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) e.g., venlafaxine, duloxetine
• Atypical antidepressants e.g., bupropion, vortioxetine, vilazodone
• Tricyclic Antidepressants (TCAs) e.g., amitriptyline, nortriptyline (less common first-line due to side effects)
• Other alpha2-adrenergic antagonists (e.g., mianserin - not available in US)

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, a patient fact sheet that provides crucial information. 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 amount, and the time it occurred.