Mirtazapine 30mg 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 H1 histamine receptors. Its antagonism of 5-HT2 and 5-HT3 receptors is thought to contribute to its antidepressant and anxiolytic effects, while H1 antagonism contributes to its sedative properties.

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: Seek Medical Help Right Away

This medication may cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions. These conditions can be deadly and may also affect internal 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 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 may cause side effects. While many people experience no 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

These are not all the possible side effects of this medication. 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. Describe the allergic reaction you experienced, including the symptoms that occurred.
If you are currently taking or have recently taken certain medications, such as:
+ Anxiety or sleep aids like alprazolam or diazepam
+ Medications for depression or Parkinson's disease, 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
* Other medications, including prescription and over-the-counter drugs, natural products, and vitamins, as this is not an exhaustive list of potential interactions

To ensure your safety, it is crucial to discuss all your medications and health problems with your doctor and pharmacist. They will help determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dosage of any medication without consulting your doctor first.

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.

To minimize the risk of side effects, do not abruptly stop taking this medication without consulting your doctor. If you need to discontinue this drug, your doctor will instruct you on how to gradually taper off the dosage to ensure a safe transition.

Until you are familiar with how this medication affects you, exercise caution when engaging in activities that require alertness, such as driving.

Certain individuals may be at a higher risk of developing eye problems while taking this medication. Your doctor may recommend an eye exam to assess your risk. If you experience eye pain, changes in vision, or swelling and redness in or around the eye, contact your doctor immediately.

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 is a risk of abnormal heart rhythms (long QT on ECG) associated with this medication, which can increase the risk of sudden death. Discuss this risk with your doctor.

Additionally, this medication may cause elevated cholesterol and triglyceride levels. Consult with your doctor to discuss the potential risks and benefits.

Regular blood tests will be necessary to monitor your condition. Adhere to your doctor's recommendations for blood work and follow their guidance.

It is recommended that you avoid consuming alcohol while taking this medication. Before using marijuana, cannabis, or any prescription or over-the-counter drugs that may cause drowsiness, 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 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, fentanyl, lithium, tramadol, St. John's Wort) - increased risk of serotonin syndrome.
• CNS depressants (e.g., alcohol, benzodiazepines, opioids, sedatives, hypnotics) - additive CNS depression.
• CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, cimetidine, protease inhibitors) - increased mirtazapine plasma concentrations.
• CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin) - decreased mirtazapine plasma concentrations.

• Warfarin (minor increases in INR reported in some cases).
• Drugs with anticholinergic properties (e.g., tricyclic antidepressants, antihistamines) - additive anticholinergic effects.
• CYP1A2 inhibitors (e.g., ciprofloxacin) - potential for increased mirtazapine levels.
• CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) - potential for increased mirtazapine levels.

• Not many specific minor interactions; general caution with other medications.

• Worsening depression
• Emergence or worsening of suicidal thoughts or behavior
• Unusual changes in behavior or mood (e.g., agitation, irritability, panic attacks, insomnia, impulsivity, hypomania, mania)
• Symptoms 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, stomatitis, flu-like symptoms) which could indicate agranulocytosis (rare but serious adverse effect)
• Severe skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)

Category C. Mirtazapine should be used during pregnancy only 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.

L3 (Moderately safe). Mirtazapine is excreted into breast milk in small amounts. The relative infant dose (RID) is low (estimated 1-2%). 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 (ages 18-24) with MDD and other psychiatric disorders. Use in this population should be carefully considered and closely monitored.

Start with a lower dose (e.g., 7.5 mg or 15 mg daily) and titrate slowly due to increased sensitivity to adverse effects (e.g., sedation, orthostatic hypotension) and potential for reduced renal and hepatic clearance. Monitor closely for falls, cognitive changes, and hyponatremia.

• Mirtazapine is often chosen for patients with depression who also experience significant insomnia, anxiety, or poor appetite/weight loss due to its sedating and appetite-stimulating properties.
• The sedating effect is often more pronounced at lower doses (e.g., 15 mg) due to saturation of H1 receptors, while higher doses (e.g., 30-45 mg) may be less sedating as noradrenergic effects become more prominent.
• Unlike many other antidepressants, mirtazapine has a low incidence of sexual dysfunction.
• Weight gain is a common and often dose-limiting side effect.
• Rare but serious adverse effects include agranulocytosis (monitor for signs of infection) and serotonin syndrome (especially with concomitant serotonergic agents).

• 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)
• Monoamine Oxidase Inhibitors (MAOIs) (e.g., phenelzine, tranylcypromine - generally reserved for refractory cases)
• 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 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 amount, and the time it occurred.