Xadago Tablets / Film-coated
Safinamide
50mg
ZAMBON S.P.A
| Pack size | 30's(10's Blister x 3) |
|---|---|
| Dispensing mode | POM |
| Source | ITALY |
| Agent | PHARMALINK |
| Retail Price | 735.00 AED |
Available as:
Indications
Xadago Tablets / Film-coated is used for:
Parkinson Disease
Adult Dose
Parkinson Disease
Indicated as add-on treatment for patients with Parkinson disease who are currently taking levodopa/carbidopa and experiencing “off” episodes
Initial: 50 mg PO qDay
After 2 weeks, may increase dose to 100 mg PO qDay, based on individual need and tolerability
Doses >100 mg/day have not shown additional benefit
Hepatic impairment
Moderate (Child-Pugh B: 7-9): Not to exceed 50 mg/day
Severe (Child-Pugh C: 10-15): Contraindicated
Child Dose
Renal Dose
Administration
May take with or without food
Contra Indications
History of hypersensitivity to safinamide; reactions include swelling of the tongue and oral mucosa, and dyspnea
Severe hepatic impairment (Child-Pugh C: 10-15)
Precautions
May cause or exacerbate hypertension; monitor patients for new onset hypertension or hypertension not adequately controlled after initiating therapy; medication adjustment may be necessary if blood pressure elevation is sustained
May cause serotonin syndrome when used with MAOIs, antidepressants, or opioid drugs (see Contraindications)
May cause falling asleep during activities of daily living
May cause or exacerbate dyskinesia; consider levodopa dose reduction to mitigate dyskinesia
May cause hallucinations and psychotic behavior; consider dosage reduction or stopping medication if patient develops hallucinations or psychotic-like behaviors while on therapy
May cause problems with impulse control/compulsive behaviors; consider dose reduction or stopping medication if a patient develops compulsive behavior while on therapy
May cause withdrawal-emergent hyperpyrexia and confusion
Retinal degeneration and loss of photoreceptor cells observed in animal studies (albino and pigmented rats); periodically monitor patients for visual changes in patients with a history of retinal/macular degeneration, uveitis, inherited retinal conditions, family history of hereditary retinal disease, albinism, retinitis pigmentosa, or any active retinopathy
Pregnancy-Lactation
Pregnancy
There are no adequate and well-controlled studies of safinamide in pregnant women
Animal studies
Developmental toxicity, including teratogenic effects, was observed when safinamide was administered during pregnancy at clinically relevant doses
Developmental toxicity was observed at safinamide doses lower than those used clinically when safinamide was administered during pregnancy in combination with levodopa/carbidopa
Lactation
Unknown if distributed in human breast milk
Interactions
Coadministration with other monoamine oxidase inhibitors (MAOIs) or drugs that are potent inhibitors of MAO (eg, linezolid); combination may result in increased blood pressure, including hypertensive crisis
Coadministration with opioids (eg, meperidine and its derivatives, methadone, tramadol); serotonin-norepinephrine reuptake inhibitors (SNRIs); tricyclic, tetracyclic, or triazolopyridine antidepressants; cyclobenzaprine; methylphenidate, amphetamine, and their derivatives; or St John’s wort; combination could result in life-threatening serotonin syndrome
Coadministration with dextromethorphan; combination of MAOIs and dextromethorphan has been reported to cause episodes of psychosis or abnormal behavior
Adverse Effects
Side effects of Safinamide :
>10%
Dyskinesia (17-21%)
1-10%
Hypertension (5-7%)
ALT or AST increased to >ULN (5-7%)
Fall (4-6%)
Nausea (3-6%)
Insomnia (1-4%)
Orthostatic hypotension (2%)
Anxiety (2%)
Cough (2%)
Dyspepsia (2%)
Mechanism of Action
The precise mechanism by which safinamide exerts its effect in PD is unknown
Inhibition of MAO-B activity, by blocking the catabolism of dopamine, is thought to result in an increase in dopamine levels and a subsequent increase in dopaminergic activity in the brain
Note
Xadago 50mg Tablets / Film-coated manufactured by ZAMBON S.P.A. Its generic name is Safinamide. Xadago is availble in United Arab Emirates.
Farmaco UAE drug index information on Xadago Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.