Xadago 50mg Tablets

Safinamide is a selective and reversible inhibitor of monoamine oxidase B (MAO-B). It is thought to increase the extracellular levels of dopamine in the striatum by inhibiting the metabolism of dopamine. Safinamide also modulates glutamatergic neurotransmission by inhibiting voltage-dependent sodium channels and calcium channels, which may contribute to its antiparkinsonian 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 high blood pressure, including:
+ Severe headache
+ Dizziness
+ Fainting
+ Changes in eyesight
New or worsening trouble controlling body movements
Hallucinations (seeing or hearing things that are not there)
Changes in behavior
Feeling confused or agitated
Strong, uncontrollable urges (such as eating, gambling, sex, or spending money)
Changes in eyesight
Falls

Serotonin Syndrome: A Potentially Life-Threatening Condition

If you take this medication with certain other drugs, you may be at risk for a severe and potentially deadly condition called serotonin syndrome. 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
Upset stomach
Vomiting
Severe headache

Other Possible Side Effects

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 discuss any concerns with your doctor. If you experience any of the following side effects or any others that bother you or do not go away, contact your doctor:

Upset stomach
Trouble sleeping

Reporting Side Effects

If you have questions about side effects or want to report any, you can:

Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
* Report side effects 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 conditions and situations to ensure safe treatment:

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 and its symptoms.
If you have liver disease, as this may affect the medication's safety and efficacy.
If you have taken certain medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this can increase the risk of very high blood pressure.
If you are currently taking linezolid or methylene blue, as these medications can interact with this drug.
* If you are taking any other medications, including prescription and over-the-counter (OTC) drugs, natural products, or vitamins, that should not be taken with this medication. This includes certain medications for cough, cold, depression, mood problems, or pain, as there are many drugs that can interact with this medication.

Please note that this is not an exhaustive list of all potential interactions or health problems that may affect the safety of this medication. Therefore, it is crucial to inform your doctor and pharmacist about all your medications, health problems, and concerns to ensure it is safe for you to take this medication. Do not start, stop, or change the dose 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. Until you understand how this drug affects you, avoid driving and other activities that require alertness.

Monitor your blood pressure regularly, as directed by your doctor, since this medication can cause high blood pressure. Certain foods and beverages, such as cheese and red wine, may trigger a sudden and severe increase in blood pressure, which can be life-threatening. Discuss your risk with your doctor and obtain a list of foods and drinks to avoid. Refrain from consuming these items for the duration specified by your doctor, even after you stop taking this medication.

Be aware that some individuals have experienced sudden sleep episodes while engaging in activities like driving, eating, or conversing. These episodes can occur without warning, even if you feel alert, and may happen up to 1 year after starting this medication. If you experience sudden sleepiness or fall asleep during activities, do not drive or participate in tasks that require alertness. Immediately contact your doctor if you experience excessive sleepiness or sudden sleep episodes.

Do not abruptly discontinue this medication without consulting your doctor, as this may increase your risk of side effects. If you need to stop taking this drug, your doctor will provide guidance on gradually tapering off the medication.

Before consuming alcohol, marijuana, or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions, consult with your doctor. Additionally, inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the potential benefits and risks to both you and your baby.

• Other MAO inhibitors (e.g., phenelzine, tranylcypromine, isocarboxazid, selegiline, rasagiline, linezolid, methylene blue) - risk of hypertensive crisis, serotonin syndrome
• Meperidine
• Tramadol
• Methadone
• Propoxyphene
• Cyclobenzaprine
• St. John's Wort
• Dextromethorphan
• Sympathomimetics (e.g., pseudoephedrine, phenylephrine, ephedrine, amphetamines)
• Triptans (e.g., sumatriptan, zolmitriptan)

• SSRIs (e.g., fluoxetine, sertraline, citalopram)
• SNRIs (e.g., venlafaxine, duloxetine)
• TCAs (e.g., amitriptyline, imipramine)
• Bupropion
• Other antidepressants (risk of serotonin syndrome)
• Levodopa (may exacerbate dyskinesia)

• Opioids (other than contraindicated ones, e.g., fentanyl, oxycodone - monitor for serotonin syndrome)
• Antihypertensives (monitor blood pressure)

• Hypertensive crisis symptoms (e.g., severe headache, blurred vision, chest pain, nausea, vomiting, sweating, anxiety)
• Serotonin syndrome symptoms (e.g., agitation, hallucinations, coma, rapid heart rate, fluctuating blood pressure, fever, sweating, shivering, tremor, muscle rigidity, twitching, incoordination, nausea, vomiting, diarrhea)
• Dyskinesia (involuntary movements)
• Hallucinations or psychotic behavior
• Impulse control/compulsive behaviors (e.g., gambling, hypersexuality, binge eating, compulsive shopping)
• Orthostatic hypotension
• Retinal changes (e.g., visual disturbances)

There are no adequate data on the developmental risk associated with the use of safinamide in pregnant women. Animal studies have shown adverse effects on embryofetal development at clinically relevant exposures. Xadago should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is unknown if safinamide or its metabolites are excreted in human milk. Safinamide and/or its metabolites were excreted in the milk of lactating rats. Because of the potential for serious adverse reactions in breastfed infants, including the potential for MAO-B inhibition, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

The safety and effectiveness of Xadago in pediatric patients have not been established. It is not indicated for use in this population.

No overall differences in safety or effectiveness were observed between elderly (≥65 years) and younger patients. No dose adjustment is required based on age alone, but monitor for increased sensitivity to adverse effects.

• Xadago is an add-on therapy for Parkinson's patients experiencing 'off' episodes while on levodopa/carbidopa.
• Unlike non-selective MAO inhibitors, safinamide's MAO-B selectivity at recommended doses generally means strict tyramine dietary restrictions are not required, but caution with very large amounts of tyramine-rich foods is still advised.
• Careful monitoring for serotonin syndrome is crucial, especially when co-administered with other serotonergic drugs.
• Patients should be educated on the signs and symptoms of impulse control disorders and advised to report them to their physician.
• Dyskinesia may worsen, and levodopa dose reduction may be necessary.

• Other MAO-B inhibitors (e.g., rasagiline, selegiline)
• COMT inhibitors (e.g., entacapone, opicapone)
• Dopamine agonists (e.g., pramipexole, ropinirole, rotigotine)
• Amantadine (for dyskinesia or 'off' time)
• Istradefylline (adenosine A2A receptor antagonist)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, 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 medication taken, the amount, and the time it happened.