Azilect

Azilect

rasagiline

Manufacturer:

Lundbeck

Distributor:

DKSH
/
Four Star
Concise Prescribing Info
Contents
Rasagiline mesilate
Indications/Uses
Idiopathic Parkinson's disease as monotherapy (w/o levodopa) or as adjunct therapy (w/ levodopa) in patients w/ end of dose fluctuations.
Dosage/Direction for Use
1 mg once daily w/ or w/o levodopa.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use w/ other MAOIs (including St. John's wort) or pethidine; at least 14 days must elapse between discontinuation of rasagiline & initiation of treatment w/ MAOIs or pethidine. Severe hepatic impairment.
Special Precautions
The concomitant use of rasagiline & fluoxetine or fluvoxamine should be avoided. At least 5 wk off fluoxetine before using rasagiline. At least 14 days off rasagiline before using fluoxetine or fluvoxamine. Impulse control disorders (ICDs) can occur in patients treated w/ dopamine agonists &/or dopaminergic treatments. Similar reports of ICDs have also been received post-marketing w/ rasagiline. Patients should be regularly monitored for the development of impulse control disorders. Patients & carers should be made aware of the behavioural symptoms of impulse control disorders that were observed in patients treated w/ rasagiline, including cases of compulsions, obsessive thoughts, pathological gambling, increased libido, hypersexuality, impulsive behaviour & compulsive spending or buying. Since rasagiline potentiates the effects of levodopa, the adverse effects of levodopa may be increased & pre-existing dyskinesia exacerbated. Decreasing the dose of levodopa may ameliorate this side effect. There have been reports of hypotensive effects when rasagiline is taken concomitantly w/ levodopa. Patients w/ Parkinson's disease are particularly vulnerable to the adverse effects of hypotension due to existing gait issues. The concomitant use of rasagiline & dextromethorphan or sympathomimetics such as those present in nasal & oral decongestants or cold medicinal product containing ephedrine or pseudoephedrine is not recommended. The data collected suggests that Parkinson's disease, & not any medicinal products in particular, is associated w/ a higher risk of skin cancer (not exclusively melanoma). Suspicious skin lesions require specialist evaluation. Caution should be used when initiating treatment w/ rasagiline in patients w/ mild hepatic impairment. Rasagiline use in patients w/ moderate hepatic impairment should be avoided. In case patients progress from mild to moderate hepatic impairment, rasagiline should be stopped. Rasagiline may cause daytime drowsiness, somnolence, & occasionally, especially if used w/ other dopaminergic medications, falling asleep during activities of daily living. Patients must be informed of this & advised to exercise caution while driving or operating machines during treatment w/ rasagiline. Patients who have experienced somnolence &/or an episode of sudden sleep onset must refrain from driving or operating machines. There are no data from the use of rasagiline in pregnant women. Animal studies do not direct or indirect harmful effects w/ respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of rasagiline during pregnancy. Non-clinical data indicate that rasagiline inhibits prolactin secretion & thus, may inhibit lactation. It is not known whether rasagiline is excreted in human milk. Caution should be exercised when rasagiline is administered to a breast-feeding mother. No human data on the effect of rasagiline on fertility are available. Non-clinical data indicate that rasagiline has no effect on fertility. Not recommended in childn & adolescents <18 yr.
Adverse Reactions
Monotherapy: Headache. Flu; skin carcinoma; leucopenia; allergy; depression, hallucinations; conjunctivitis; vertigo; angina pectoris; rhinitis; flatulence; dermatitis; musculoskeletal pain, neck pain, arthritis; urinary urgency; fever, malaise. Adjunct therapy: Dyskinesia. Decreased appetite; hallucinations, abnormal dreams; dystonia, carpal tunnel syndrome, balance disorder; orthostatic hypotension; abdominal pain, constipation, nausea & vomiting, dry mouth; rash; arthralgia, neck pain; decreased wt; fall.
Drug Interactions
Rasagiline must not be administered along w/ other MAOIs (including medicinal & natural products w/o prescription eg, St. John's Wort) as there may be a risk of non-selective MAO inhibition that may lead to hypertensive crises. Serious adverse reactions have been reported w/ the concomitant use of pethidine & MAOIs including another selective MAO-B inhibitor. The concomitant administration of rasagiline & pethidine is contraindicated. Serious adverse reactions have been reported w/ the concomitant use of SSRIs, SNRIs, tricyclic, tetracyclic antidepressants & MAOIs. Antidepressants should be administered w/ caution.
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
Azilect tab 1 mg
Packing/Price
30's
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Sign up for free
Already a member? Sign in