Mirtazapine 45mg 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 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 serotonin receptors, and a potent antagonist of histamine H1 receptors, which contributes to its sedative effects. It has moderate peripheral alpha1-adrenergic and muscarinic cholinergic receptor antagonism.

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

Reporting Side Effects

If you have questions about side effects or want to report any, 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. 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, such as:
+ Alprazolam or diazepam, which are used to treat anxiety, sleep disorders, or other health issues.
+ Medications for depression or Parkinson's disease, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, within the last 14 days. Taking these medications with this drug may lead to very high blood pressure.
+ Linezolid or methylene blue, as these medications can interact with this drug.
Please note that this is not an exhaustive list of all potential drug interactions or health problems that may affect the safety of this medication.

To ensure your safety, it is crucial to inform your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking.
Any natural products, vitamins, or supplements you are using.
Your complete medical history, including any health problems you have or have had in the past.

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm that it is safe to do so. This will help prevent potential interactions or adverse effects.

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 other 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 reports of abnormal heart rhythms (long QT on ECG) and rare instances of sudden death in individuals taking this medication. Discuss these risks with your doctor. Additionally, this drug may cause elevated cholesterol and triglyceride levels, so it is crucial to monitor your blood work as directed by your doctor and discuss any concerns with your doctor.

Avoid consuming alcohol while taking this medication. Before using marijuana, cannabis, or prescription or over-the-counter drugs that may impair your reactions, consult your doctor. If you have phenylketonuria (PKU), discuss this with your doctor, as some products contain phenylalanine.

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

• Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of discontinuing MAOI or mirtazapine 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.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, clarithromycin, ritonavir) - increased mirtazapine plasma concentrations.
• Strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin) - decreased mirtazapine plasma concentrations.
• Warfarin - potential for minor, but clinically significant, increase in INR.

• Cimetidine - may increase mirtazapine levels.
• Diazepam - mirtazapine may potentiate the psychomotor impairment caused by diazepam.
• Drugs that prolong QT interval - theoretical risk of additive QT prolongation, though mirtazapine itself has minimal effect.

• Not available

• Worsening depression
• Suicidal thoughts or behavior
• Unusual changes in behavior or mood (e.g., agitation, irritability, anxiety, panic attacks, insomnia, aggression, 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) due to rare agranulocytosis
• Excessive sedation or dizziness
• Weight gain
• Dry mouth
• Constipation

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Limited human data suggest low risk, but animal studies show adverse effects. Neonates exposed to antidepressants in late third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.

L3 (Moderately Safe). Mirtazapine is excreted into breast milk in low amounts. Monitor breastfed infants for sedation, poor feeding, and poor weight gain. Consider alternative agents or close monitoring.

Not approved for Major Depressive Disorder in pediatric patients (<18 years) due to lack of established efficacy and increased risk of suicidality (Black Box Warning).

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

• Often preferred for patients with depression who also experience insomnia, significant anxiety, or poor appetite/weight loss due to its sedating and appetite-stimulating effects.
• Less likely to cause sexual dysfunction compared to SSRIs/SNRIs.
• Take at bedtime due to its sedating properties.
• Orally disintegrating tablets are useful for patients who have difficulty swallowing pills.
• Monitor for weight gain, especially in long-term use.
• Onset of antidepressant effect may take several weeks, but sleep and appetite improvements often occur sooner.

• 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
• Other antidepressants with different mechanisms of action

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. It is important 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.

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.