Rasator 0.5/Rasator 1

Rasator 0.5/Rasator 1

rasagiline

Manufacturer:

Torrent Pharmaceuticals

Distributor:

Torrent
Concise Prescribing Info
Contents
Rasagiline
Indications/Uses
Idiopathic Parkinson's disease in adults as monotherapy (w/o levodopa) or adjunct therapy (w/ levodopa) in patients w/ end of dose fluctuations.
Dosage/Direction for Use
Patient not taking levodopa Monotherapy or adjunct therapy Initially 1 mg once daily. Patient taking levodopa, w/ or w/o other Parkinson's disease drug eg, dopamine agonist, amantadine, anticholinergic 500 mcg once daily, may be increased to 1 mg daily if patient tolerates daily recommended dose but a clinical response is not achieved. Patient w/ hepatic impairment Do not exceed 500 mcg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Co-administration w/ meperidine, tramadol, methadone, & propoxyphene; St. John's wort & cyclobenzaprine. Not recommended for concomitant use w/ dextromethorphan. Patients w/ severe hepatic impairment.
Special Precautions
Monitor patients for new onset HTN or HTN that is not adequately controlled after starting treatment. Reports of new or worsening mental status & behavioral changes, which may be severe, including psychotic-like behavior during treatment or after starting or increasing dose. Consider dose reduction &/or discontinuation if patient develops increased sexual urges, intense urges to gamble, spend money, binge eating, &/or other intense urges, & the inability to control these urges. Reports of symptom complex resembling NMS, w/ no other obvious etiology, in association w/ rapid dose reduction, w/drawal of, or changes in drugs that increase central dopaminergic tone; somnolence. Higher risk of skin cancer (not exclusively melanoma). Evaluate any suspicious skin lesion. Increased risk of serotonin syndrome w/ meperidine, tramadol, methadone, propoxyphene, antidepressants, & non-selective MAOIs. May potentiate dopaminergic side effects & exacerbate preexisting dyskinesia when used as adjunct to levodopa. Avoid driving & other potentially dangerous activities. Not to be used in patients w/ moderate to severe hepatic impairment. Use in pregnancy only if potential benefit justifies potential fetal risk. Exercise caution when administering to a breast-feeding mother. Rasator 1 Reports of hypotension/orthostatic hypotension. Not to be used to treat patients w/ major psychotic disorder.
Adverse Reactions
Hallucinations; neck pain. Monotherapy: Flu; skin carcinoma; leucopenia; allergy; depression; conjunctivitis; vertigo; angina pectoris; rhinitis; dermatitis; musculoskeletal pain, arthritis; urinary urgency; fever, malaise. Adjunct therapy: Skin melanoma; decreased appetite; abnormal dreams; dystonia, carpal tunnel syndrome, balance disorder; orthostatic hypotension; abdominal pain, constipation, nausea & vomiting, dry mouth; rash; arthralgia; decreased wt; fall.
Drug Interactions
Risk of non-selective MAO inhibition that may lead to hypertensive crises w/ other MAOIs including medicinal & natural products w/o prescription eg, St. John's wort. Serious adverse reactions w/ pethidine; SSRIs, SNRIs, TCAs/tetracyclic antidepressants. Severe hypertensive reactions w/ sympathomimetics eg, nasal & oral decongestants or cold medicinal products containing ephedrine or pseudoephedrine. Brief episodes of psychosis or bizarre behavior w/ dextromethorphan. Increased exposure w/ ciprofloxacin (CYP1A2 inhibitor). Increased oral clearance w/ entacapone. Effectiveness may be diminished w/ antipsychotics or metoclopramide. Risk of decreased plasma levels w/ smoking. Rasator 1 Potential hypertensive reaction w/ foods containing very high amounts of tyramine.
MIMS Class
Antiparkinsonian Drugs
ATC Classification
N04BD02 - rasagiline ; Belongs to the class of dopaminergic agents, monoamine oxidase B inhibitors. Used in the management of Parkinson's disease.
Presentation/Packing
Form
Rasator 0.5 tab 500 mcg
Packing/Price
30's (P2,550/box)
Form
Rasator 1 tab 1 mg
Packing/Price
30's (P4,200/box)