AZILECT PACKAGE INSERT PDF
Easy to read FDA package insert, drug facts, dosage and administration, and adverse effects for Azilect (rasagiline). 21/06/ Azilect – EMEA/H/C/ – IA//G. List item. Azilect: EPAR – Product Information (PDF/ KB) of the marketing authorisation; Annex IIIA – Labelling; Annex IIIB – Package leaflet. PACKAGE LEAFLET: INFORMATION FOR THE USER. AZILECT 1 mg tablets. Rasagiline. Read all of this leaflet carefully before you start.
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Rasagiline for Parkinson’s disease (Azilect) | Patient
Results of a tyramine challenge study indicate that rasagiline at recommended doses is relatively selective for inhibiting MAO-B and can be used without dietary tyramine restriction. It must also not be used with pethidine a painkiller.
May cause hypertension including severe hypertensive syndromes at recommended doses May cause serotonin syndrome when used with antidepressants May cause falling asleep during activities of daily living, daytime drowsiness, and somnolence May cause hypotension, especially orthostatic May cause or exacerbate dyskinesia. Azilect must not be used in patients who have severe problems with their liver. In subjects with moderate hepatic impairment Child-Pugh scoreAUC and Cmax were increased by 7 fold and 2 fold, respectively, compared to healthy subjects.
Take one tablet each day. Inform patients that they should contact their healthcare provider if they take ciprofloxacin or a similar drug that could increase blood levels of rasagiline.
These results indicate that rasagiline is unlikely to cause any clinically significant interference with substrates of these enzymes. Home Product Detail print. Inform patients that hallucinations or other manifestations of psychotic-like behavior can occur when taking rasagiline. The precise mechanisms of action of rasagiline are unknown.
Feeling or being sick, indigestion, tummy abdominal pain, wind Eat simple meals – avoid rich or spicy foods Feeling dizzy when you stand up Try getting up more slowly.
Changes since initial authorisation of medicine List item. The results of a clinical trial designed to examine the effects of inssert drug on blood pressure when it is administered with increasing doses of tyramine indicates the functional selectivity can be incomplete when healthy subjects ingest large amounts of tyramine while receiving recommended doses of rasagiline.
Advise patients about the potential for sedating effects associated with rasagiline, including somnolence and particularly to the possibility of falling asleep while engaged in activities of daily living. Treatments for psychosis may decrease the effectiveness of rasagiline. For details see our conditions. Thank you, we just sent a survey email to confirm your preferences.
No additional in vivo trials have investigated the effect of rasagiline pacoage other drugs metabolized by the cytochrome P enzyme system. Date of issue of marketing authorisation valid throughout the European Union. About Us Disclaimer Contact Us.
Dated April 22, This was compared with a rise of 4. Patients with mild liver problems should use Azilect with caution and should stop treatment if their liver problems get worse. Glucuronide conjugation of rasagiline and its metabolites, with subsequent urinary excretion, is the major elimination pathway. Advise healthcare provider if any new urges develop or increase in frequency.
Tell patients to contact their healthcare provider if they wish to discontinue treatment. This aazilect include excessive shopping or spending, gambling or an increased sex drive. Studies aazilect healthy subjects and in Parkinson’s disease patients have shown that rasagiline inhibits platelet MAO-B irreversibly. Signs and symptoms may not appear immediately – may have delays of up to 12 hours after ingestion of inert and the appearance of signs.
Effect of Other Drugs on the Metabolism of rasagiline: Never take more than the prescribed dose. We’d love to send you our articles and latest news by email, giving you the best opportunity to stay up to date with expert written health and lifestyle content. John’s Wort, cyclobenzaprine or another selective or non-selective MAO inhibitor. Do not keep out-of-date or unwanted medicines.
These usually improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following side-effects continue or become troublesome.
Azilect is a medicine that contains the active substance rasagiline. There should be at least 14 days between stopping treatment with Azilect and starting treatment with another monoamine-oxidase inhibitor or with pethidine. Caution patients against standing up rapidly after sitting or lying down, especially if they have been doing so for prolonged periods, and especially, at the initiation of treatment.
They should contact their healthcare provider before taking analgesics. The patients then lose their ability to control their movements reliably. Support respiration; monitor body temperature; intensive management of hyperpyrexia may be required; maintenance of fluid and electrolyte balance is essential. The pharmacokinetic profile of rasagiline is similar in men and women. This is known as an ‘end-of-dose fluctuation’. Initial marketing-authorisation documents List item.
There is the potential for inhibitors of this enzyme to alter rasagiline clearance when coadministered. If packaage experience any other symptoms which you think may be due to this medicine, speak with your doctor or pharmacist. In ex vivo animal studies in brain, liver, and intestinal tissues, rasagiline was shown to be inxert potent, irreversible monoamine oxidase type B MAO-B selective inhibitor. If the pharmacy doesn’t regularly stock a certain medication from Teva, ask if it can be ordered for you at no innsert cost.