Mirtazapine 30mg Oral Dsntgrt Tabs

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, 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 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
+ 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 attention 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 have questions about side effects or experience any other symptoms that bother you or don't go away, contact your doctor for medical 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
* This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have.

To ensure your safety, consult with your doctor and pharmacist about all your medications and health issues to confirm that it is safe to take this medication. Never start, stop, or adjust 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. 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 experiencing side effects. If you need to discontinue this drug, your doctor will instruct you on how to gradually taper off the medication to minimize potential risks.

Until you are familiar with 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.

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 promptly report these symptoms to your doctor.

This medication has been linked to abnormal heart rhythms (long QT on ECG) and, in rare cases, sudden death. Discuss these risks 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 products, or prescription or over-the-counter medications that may impair your reactions, consult with your doctor. If you have phenylketonuria (PKU), discuss this with your doctor, as some products contain phenylalanine.

If you are 65 years or older, exercise caution when taking this medication, as you may be more susceptible to side effects. If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the potential benefits and risks to you and your baby with your doctor.

• Monoamine Oxidase Inhibitors (MAOIs) concurrently or within 14 days of discontinuing MAOIs (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) - additive CNS depression, increased sedation.
• Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, some antipsychotics, macrolide antibiotics) - theoretical risk, though mirtazapine itself has low risk of QT prolongation.

• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, protease inhibitors) - increased mirtazapine plasma concentrations.
• Strong CYP1A2 inhibitors (e.g., cimetidine, fluvoxamine) - increased mirtazapine plasma concentrations.
• Strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) - increased mirtazapine plasma concentrations.
• CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin) - decreased mirtazapine plasma concentrations, reduced efficacy.
• Warfarin - potential for minor changes in INR, monitor closely.

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

• Worsening depression
• Suicidal thoughts or behavior
• Unusual changes in behavior or mood (e.g., agitation, irritability, anxiety, panic attacks, insomnia, aggression, impulsivity, hypomania, mania)
• Sedation/drowsiness
• Increased appetite/weight gain
• Dry mouth
• Constipation
• Dizziness
• Orthostatic hypotension
• Flu-like symptoms, sore throat, fever (rare, agranulocytosis)

Mirtazapine is Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Limited human data suggest no increased risk of major congenital malformations, but some studies suggest a possible association with persistent pulmonary hypertension of the newborn (PPHN) when SSRIs are used late in pregnancy (though Mirtazapine is not an SSRI, caution is warranted with any antidepressant).

Mirtazapine is excreted into breast milk in small amounts. The relative infant dose (RID) is generally low (estimated 1-3%). Monitor breastfed infants for sedation, poor feeding, and poor weight gain. Use with caution, weighing benefits to mother against potential risks to infant.

Safety and efficacy have not been established in pediatric patients for Major Depressive Disorder. A black box warning exists regarding increased risk of suicidality in children, adolescents, and young adults treated with antidepressants. Use is generally not recommended.

Use with caution. Elderly patients may have reduced renal and/or hepatic function, leading to higher plasma concentrations and increased risk of adverse effects (e.g., sedation, dizziness, orthostatic hypotension). Consider lower starting doses and slower titration. Monitor closely for falls and cognitive impairment.

• Mirtazapine is often chosen for depression when insomnia, anxiety, or significant weight loss are prominent symptoms, due to its sedative and appetite-stimulating effects.
• The sedative effect is more pronounced at lower doses (e.g., 7.5-15 mg) due to saturation of H1 receptors. At higher doses (30-45 mg), the noradrenergic effects become more prominent, which can counteract some of the sedation.
• Unlike many other antidepressants, mirtazapine has a low incidence of sexual dysfunction.
• Weight gain is a common and significant side effect, which can be beneficial for underweight patients but problematic for others.
• Agranulocytosis is a rare but serious adverse effect; patients should be advised to report any signs of infection (fever, sore throat) immediately.
• Orally disintegrating tablets (ODT) are useful for patients who have difficulty swallowing pills or for whom adherence might be an issue.

• Selective Serotonin Reuptake Inhibitors (SSRIs) e.g., escitalopram, sertraline, fluoxetine
• Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) e.g., venlafaxine, duloxetine
• Bupropion (NDRI)
• Tricyclic Antidepressants (TCAs) e.g., amitriptyline, nortriptyline
• Other atypical antidepressants e.g., vortioxetine, vilazodone
• Electroconvulsive Therapy (ECT)
• Transcranial Magnetic Stimulation (TMS)
• Psychotherapy (e.g., Cognitive Behavioral Therapy)

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, 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 about its use. It is essential to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.

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 detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.