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Safinamide

Generic name: safinamide [ sa-FIN-amide [ sa-FIN-a-mide
Brand name: Xadago
Dosage format: oral tablet (100 mg,  50 mg)
Class of drugs: dopaminergic antiparkinsonism agents

What is Safinamide?

Safinamide is a monoamine inhibitor of oxidase type B (MAO-B). Safinamide functions by allowing the chemical dopamine (DOE pa meen) to be active for a longer period of time within the brain. Dopamine levels are low in the brain and are linked with Parkinson's disease.

Safinamide is a medication that's given along with Levodopa and Carbidopa to treat "wearing-off" episodes (muscle stiffness or loss of control of muscles) in patients suffering from Parkinson's disease.Safinamide can also be employed for other purposes that are not covered in this guideline.

Side effects of Safinamide

Contact a medical professional immediately. If you are experiencing warning signs of an allergic response, such as symptoms of hives or difficulty breathing or swelling of your lips, face, tongue, throat, or face,

Safinamide may cause serious side effects. Contact your physician immediately. If you suffer from:

  • Vision change;
  • Muscle movements that are uncontrolled or twitching
  • Insomnia, agitation, or strange thoughts or behaviors
  • Hallucinations (seeing things or hearing them that aren't real);
  • A seizure;
  • Fever, sweating, fast heart rate, overactive reflexes;
  • Nausea, vomiting, diarrhea;
  • Elevated blood pressure, severe headache, blurred vision, the pounding of your neck or ears. Anxious and nosebleeds.

You might experience more sexual urges, unusual cravings for gambling, and any other intense cravings when you are taking this medication. Discuss this with your doctor when it happens.

Common negative side effects of safinamide can include:

  • Involuntary muscle movements
  • Falls;
  • Nausea;
  • Sleep problems (insomnia).

This isn't a complete list of all possible side adverse effects. Others could happen. Contact your doctor for advice regarding medical adverse effects. You may report any adverse reactions to the FDA at 1-800-FDA-1088.

Warnings

Safinamide should not be used when you suffer from an extremely severe kidney disease.

INFORM YOUR DOCTOR OF ALL OTHER MEDICATIONS YOU USE. Certain medications can trigger unwanted or potentially dangerous side effects (including death) in the first 14 days after you first start taking safinamide.

Before you take this drug

Safinamide is not a good choice if you have an allergy to this substance or suffer from:

  • Liver disease that is severe.

Certain medications can trigger unwanted or hazardous consequences (including deaths) when taken together with safinamide. You should not take any of these medicines within 14 days prior to or 14 days following the time you took safinamide.

  • Amphetamines (Adderall, Dexedrine, and more);
  • Cough medicine, which contains the ingredient dextromethorphan;
  • Cyclobenzaprine;
  • Methylphenidate (Concerta, Ritalin, Daytrana, and more);
  • John's Wort;
  • Certain antidepressants, such as amitriptyline (Elavil), desipramine (Norpramin), desvenlafaxine (Pristiq), duloxetine (Cymbalta), levomilnacipran (Fetzima), maprotiline (Ludiomil), milnacipran (Savella), trimipramine (Surmontil), venlafaxine (Effexor), the drug vilazodone (Viibryd), and a myriad of others
  • Opioid (narcotic) medication such as meperidine (Demerol), propoxyphene, methadone (Darvon), tramadol (Ultram, Ultracet), and others.

To ensure that safinamide is suitable for you, ask your doctor if you previously had:

  • Liver disease;
  • Excessive blood pressure or lower blood pressure;
  • Bipolar disorder, schizophrenia, or psychosis;
  • Strange urges or impulses;
  • Abnormal muscle movements;
  • Problems with the retina of your eye;
  • Narcolepsy or another sleep disorder (or in the event that you take medication to aid in sleeping)

It is unclear if safinamide can harm an unborn baby. Inform your doctor if you are pregnant or planning to be pregnant.

It is unclear if the safinamide is absorbed into breast milk or the risk to nursing babies. Do not breastfeed when taking this medicine.

How to take Safinamide?

Follow the instructions on the label of your prescription. The doctor may modify your dosage. Don't take this medication in smaller or larger quantities or for longer periods than prescribed.Safinamide should be administered in conjunction with levodopa and carbidopa. It is not recommended to use it on its own.

Safinamide is usually taken one time every day in the exact same order throughout the day.Safinamide is a medicine that can be taken either with or without meals.Your blood pressure is likely to be monitored regularly.Keep it at room temperature, far from heat and moisture.

Details on dosage

Usual Adult Dose for Parkinson's Disease:

The first dose is 50 mg orally, once a day.
Maintenance dosage: After 2 weeks, you may increase the dose up to 100 mg once every day, depending on needs and tolerability.
Maximum dose: 100 mg per day.
Comment:
Higher doses haven't been proven to offer additional benefits, but they do increase the risk of adverse reactions.
This drug has been found to be effective when combined with levodopa or carbidopa.
Use: As an adjunctive treatment for patients suffering from levodopa/carbidopa PD suffering from "off" episodes.

Do I be concerned if I miss a dose?

Do the dose you missed as quickly as you remember. Avoid your missed dosage if it's nearing the time for the next dose. Do not take any additional medicine to make up for the missed dose.

What will happen if I take excessively?

Get medical attention in an emergency or contact the poison help line at 1-800-222-1222.

What should be avoided?

When taking safinamide and for the 14 days following, stop taking it. Avoid eating food items that are high in tyramine. These include pickled food (such as eggs or herring) and meats that have been aged, cured, smoked, or fermented.

Consuming tyramine when you are taking safinamide may increase your blood pressure to levels that can lead to life-threatening adverse effects. It is important to be acquainted with what foods you should stay clear of while taking the drug safinamide.

Certain people who take safinamide have experienced sleepiness during normal daily activities like driving, working, or doing other physical activities. Avoid operating machinery or driving until you are aware of what the effect of this medication will be on you.

Interaction with other drugs

Inform your doctor about all the medicines you are currently taking and any new medications you begin or stop taking, in particular:

  • Imatinib;
  • Irinotecan;
  • Lapatinib;
  • Methotrexate
  • Metoclopramide;
  • Mitoxantrone;
  • Rosuvastatin;
  • Sulfasalazine;
  • Topotecan.

This list is not comprehensive. Other medications may interact with safinamide. This includes medications that are prescribed and available over the counter, vitamins, and herbal products. There are many possible interactions that are not mentioned in this medication guide.

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*

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