• 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.
• 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.
• 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
• It should be swallowed with sufficient quantity of water usually around the same time each day.
Dosage & When it is to be taken
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.
When it is not to 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
