Safinamide Medication Information

Discover comprehensive details about Safinamide, including its pronunciation, uses, dosage instructions, indications, and guidelines on how and when to take it or avoid it.

The updated prescription information covers potential side effects, precautions, warnings, and storage recommendations.

Additionally, explore the Safinamide brands available in India and internationally, along with pricing information. For personalized advice, consult your healthcare provider.

Generic Name : Safinamide

Pronunciation : sa-FIN-a-mide

Brand Names or Trade Names of Safinamide

India :

Xadago

Overview of Safinamide

• Safinamide is a monoamine oxidase type B (MAO-B) inhibitor which was approved by the US FDA in March 2017 to use along with the levodopa and carbidopa combination as add-on treatment for Parkinson's disease patients who experience off episodes.

Why is Safinamide Prescribed? (Indications)

Safinamide is prescribed as an adjunctive treatment along with the combination of levodopa and carbidopa to treat idiopathic Parkinson's disease during ‘off’ episodes (loss of muscle control and the appearance of muscle stiffness) when levodopa’s efficacy is reduced.

Safinamide increases the amount of dopamine in the brain by inhibiting the monoamine oxide (MAO-B) enzyme and preventing its breakdown.

It is not used as a monotherapy but only with the combination of levodopa and carbidopa.

When should Safinamide not be taken? (Contraindications)

Safinamide is not recommended in the following conditions:

• Allergy to safinamide or its excipients
• Eye disorders such as uveitis and retinitis pigmentosa. Patients with albinism are particularly prone to this adverse effect
• Severe diabetic neuropathy
• Severe liver impairment
• Pregnancy and breastfeeding
• Hallucination or other major psychotic disorder
• Concomitant intake with the following drugs:
Monoamine oxidase inhibitor drugs
Antidepressants
Opioid drugs
Dextromethorphan (results in psychosis when taken along with safinamide)
Herbal supplements containing St.John’s wort

What is the dosage of Safinamide?

The recommended adult dose as an add-on treatment for Parkinson's disease is:

• The initial dose of safinamide is 50mg once a day
• The dose can be increased after two weeks to a maximum of 100mg once daily depending on the patient’s requirement and tolerability to the increased dose

The daily dose should not be increased above 100 mg because of the risk of adverse reactions. However, the 100mg dose should be reduced to 50mg one week before stopping safinamide.

The maximal adult dose to treat patients with moderate liver damage is 50mg once a day but it should be discontinued if the patient progresses to severe liver disease.

How should Safinamide be taken?

• Safinamide comes as a tablet to be taken by mouth either with or without food once daily.
• It should be swallowed with sufficient quantity of water usually around the same time each day.

What are the warnings and precautions for Safinamide?

• Patients should be informed that safinamide can increase blood pressure even at the recommended dose of safinamide.

• Tyramine-containing foods such as aged, smoked or fermented meats, cheese, pickled foods, and eggs should be avoided as they may elevate the blood pressure in patients taking the recommended dose of safinamide.

• Patients on safinamide are at a risk of drowsiness, therefore patients should be advised not to drive or operate heavy machinery or work at heights while on the medication.

• Patients should be asked to report to the physician immediately if they experience a compulsive behavior such as the urge to gamble, spend more money, binge eating or sexual urge. In this case, either dose reduction or stopping the therapy is advised.

Safinamide therapy may cause a condition of uncontrolled involuntary muscle movements (dyskinesia) or worsen existing cases; therefore, the dose should be reduced according to the patient’s reaction to the drug.

• Sudden withdrawal or rapid dose reduction is not advised as it may lead to increased temperature, altered consciousness, and rigidity of muscles.

What are the side effects of Safinamide?

Gastrointestinal: Nausea, vomiting, diarrhea, stomach discomfort
Central nervous system: Confusion, hallucination, agitation, seizures, dizziness, excessive drowsiness, abnormal movements, compulsive behaviors
Cardiovascular: Abnormalities in heartbeat, orthostatic hypotension
Eye: Blurred vision, retinal damage
Musculoskeletal: Twitching, poor coordination or repetitive uncontrolled movements of lips, tongue, arms or legs
Others: Fever, sweating, allergic reaction

What are the other precautions for Safinamide?

• Safinamide treatment should be stopped at least 14 days before starting the treatment with monoamine oxidase inhibitors to prevent hypertensive crisis when taken together.

What are the Drug Interactions of Safinamide?

• The intake of safinamide with other MAO inhibitors could result in a severe rise in blood pressure.
• A serious adverse reaction called serotonin syndrome may occur when safinamide is administered with drugs like opioids, antidepressants, cyclobenzaprine, methylphenidate, amphetamine or St John’s wort.
• The concentration of the anticancer drugs like methotrexate, irinotecan, and topotecan may increase in the blood when taken together with safinamide.
• Metoclopramide and some antipsychotic drugs may decrease the effect of safinamide which may result in worsening of Parkinson's disease.
• Isoniazid and safinamide should not be taken together because of the possible rise in blood pressure.
• Nasal, oral or ophthalmic decongestants used along with safinamide may result in hypertension and therefore caution is required when administered at the same time.

What are the storage conditions for Safinamide?

• Safinamide tablets should be stored at a room temperature between 15°C and 25°C.
• Keep away from moisture and excessive heat.
• Keep out of the reach of children.