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Safinamide

Safinamide

Safinamide is a medication primarily used in the treatment of Parkinson's disease. It belongs to the class of drugs known as monoamine oxidase B (MAO-B) inhibitors. The exact mechanism of action involves the inhibition of MAO-B, leading to increased levels of dopamine in the brain, thereby alleviating symptoms associated with Parkinson's disease. Safinamide is selective and reversible MAO-B-inhibitor which block voltage dependent sodium channels leading to modulation of abnormal glutamate release.

Indications

-Safinamide is indicated for the management of Parkinson's disease as an adjunctive treatment to levodopa/carbidopa in patients experiencing "off" episodes. -It is used as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.


Dosage

-The recommended starting dose is typically 50 mg once daily, which may be increased to 100 mg once daily based on individual patient response and tolerability. -Oral; 50-100mg per day once a day.


Contra-Indications

-Safinamide is contraindicated in patients with a history of hypersensitivity to the drug or any of its components. Additionally, it should not be used in individuals with severe hepatic impairment. -Hypersensitivity to safinamide, other MAO inhibitors, pethidine, severe hepatic impairment.


Special Precautions

-Caution is advised in patients with mild to moderate hepatic impairment. -Patients should be monitored for symptoms of serotonin syndrome when safinamide is used in combination with other drugs affecting serotonin levels. -Abrupt discontinuation should be avoided, and the dose should be tapered gradually. Paediatric: Safety and efficacy have not been established under 18 years . Pregnancy: Category C. Lactation: It is not known if safinamide is excreted in human milk. Skin discoloration is seen in animal model during lactation period. Elderly: No dosage adjustment is required for patients over 75 years of age.


Side Effects

-Common side effects may include insomnia, nausea, dizziness, dyskinesia, and orthostatic hypotension. Serious but rare side effects may include hallucinations, serotonin syndrome, and hypersensitivity reactions. -Dyskinesia, fall, nausea, insomnia, Urinary Tract Infection, Basal Cell Carcinoma, Anaemia, leukopenia, red blood cell abnormality,Decreased appetite, hypertriglyceridaemia, increased appetite, hypercholesterolaemia, hyperglycaemia,Hallucination, depression, abnormal dreams, anxiety, confusional state, affect lability, libido increased, psychotic disorder, restlessness, sleep disorder, somnolence, dizziness, headache, Parkinson’s disease, Cataract, Vision blurred, scotoma, diplopia, photophobia, retinal disorder, conjunctivitis, glaucoma,Vertigo, Hypertension ,Serotonin Syndrome , Psychotic Behavior, Impulse Control / Compulsive Behaviors .


Drug Interactions

Safinamide may interact with other medications, including but not limited to: -MAO inhibitors -Antidepressants (particularly SSRIs and SNRIs) -Cyclobenzaprine -Tramadol -Dextromethorphan -It is crucial to inform healthcare providers about all medications, including over-the-counter drugs and herbal supplements, to avoid potential interactions. -MAO inhibitors, pethidine, sympathomimetic medicine, dextromethrphane, serotonergic drugs, Breast cancer resistance proteins.


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XAFINACT Sun Pharmaceutical Industries Ltd.
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