Xadago 100mg Tablets

Safinamide is a selective and reversible monoamine oxidase-B (MAO-B) inhibitor. It also modulates altered dopamine and glutamate activity by blocking voltage-dependent sodium channels and inhibiting glutamate release. The precise mechanism by which it exerts its therapeutic effects in Parkinson's disease is not fully understood but is thought to involve both MAO-B inhibition and non-dopaminergic mechanisms.

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 high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ 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

Additionally, a severe and potentially life-threatening condition called serotonin syndrome may occur if you take this medication with certain other drugs. 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 may cause side effects. While many people experience no 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 other symptoms that bother you or do not go away, contact your doctor:

Upset stomach
Trouble sleeping

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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 conditions and situations to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. 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 drugs, natural products, or vitamins, that may interact with this medication. This is especially important for medications used to treat cough or cold, depression or other mood problems, or pain, as some of these medications may be contraindicated with this drug.

Please note that this is not an exhaustive list of all potential interactions or health problems that may affect the safety and efficacy of this medication. To ensure your safety, it is crucial to:

Inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss your health problems and medical history with your doctor.
Verify that it is safe to take this medication with all your other medications and health conditions.
* Do not start, stop, or change the dose of any medication without consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.

Monitor your blood pressure regularly, as prescribed by your doctor, since this medication can cause high blood pressure. Certain foods and beverages, including 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 during treatment and for a specified period after stopping the medication.

Be aware that some individuals have experienced sudden sleep episodes while performing daily activities like driving, eating, or conversing, even if they did not feel drowsy beforehand. These incidents have occurred up to 1 year after starting the medication. If you experience sudden sleep episodes, refrain from driving or engaging in activities that require alertness while taking this drug. Immediately contact your doctor if you fall asleep during activities or feel excessively sleepy.

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 guide you on how to gradually taper off the medication.

Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may impair your reactions, consult with your doctor. 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.

• Other monoamine oxidase inhibitors (MAOIs) (e.g., phenelzine, tranylcypromine, isocarboxazid, selegiline, rasagiline, linezolid, methylene blue)
• Meperidine
• Tramadol
• Methadone
• Propoxyphene
• Cyclobenzaprine
• St. John's Wort
• Dextromethorphan
• Sympathomimetics (e.g., pseudoephedrine, phenylephrine, ephedrine, amphetamines)
• Triptans (e.g., sumatriptan, zolmitriptan)

• Antidepressants (SSRIs, SNRIs, TCAs, bupropion) - risk of serotonin syndrome
• Opioids (other than those contraindicated) - risk of serotonin syndrome
• Dopaminergic agents (e.g., levodopa) - increased risk of dyskinesia

• Drugs metabolized by BCRP (Breast Cancer Resistance Protein) or P-glycoprotein (P-gp) (e.g., rosuvastatin, digoxin) - safinamide is a weak inhibitor of BCRP and P-gp.

• Hypertensive crisis (severe headache, blurred vision, chest pain, shortness of breath, confusion, seizures)
• Serotonin syndrome (agitation, hallucinations, delirium, coma, tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia, tremor, rigidity, myoclonus, hyperreflexia, incoordination, gastrointestinal symptoms)
• New or worsening dyskinesia
• Hallucinations or psychotic behavior
• Impulse control/compulsive behaviors (e.g., gambling, hypersexuality, binge eating, compulsive shopping)
• Orthostatic hypotension
• Vision changes (e.g., blurred vision, eye pain)

Pregnancy Category C. There are no adequate and well-controlled studies of safinamide in pregnant women. Animal studies have shown adverse developmental outcomes (e.g., skeletal malformations, reduced fetal weight) at doses higher than clinical exposure. Safinamide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is not known whether safinamide or its metabolites are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in breastfed infants from safinamide, 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 safinamide in pediatric patients have not been established. Use is not recommended.

No overall differences in safety or effectiveness were observed between patients 65 years and older and younger patients in clinical trials. No specific dose adjustment is required based on age, but older patients may be more sensitive to adverse effects.

• Xadago is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing 'off' episodes.
• It is not approved for monotherapy in Parkinson's disease.
• Patients should be carefully monitored for the development or worsening of dyskinesia, especially after starting Xadago or increasing the dose, as levodopa dose adjustment may be necessary.
• Counsel patients on the risk of serotonin syndrome and hypertensive crisis, emphasizing the importance of avoiding contraindicated medications and certain foods (if advised).
• Impulse control disorders can occur; patients and caregivers should be advised to monitor for new or increased compulsive behaviors.

• Other MAO-B inhibitors (e.g., rasagiline, selegiline)
• COMT inhibitors (e.g., entacapone, opicapone, tolcapone)
• 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's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.