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prescribing information download as pdf get adobe ® reader ® for free. highlights of prescribing information contents 1. indications and usage 2. dosage and administration 3. dosage forms and strengths 4. contraindications 5. warnings and precautions 6. adverse reactions 7. drug interactions 8. use in specific populations 9. drug abuse and dependence 10. overdosage 11. description 12. clinical pharmacology 13. nonclinical toxicology 14. clinical studies 16. how supplied/storage and handling 17. patient counseling information menu highlights of prescribing information these highlights do not include all the information needed to use azilect ® safely and effectively. see full prescribing information for azilect. azilect (rasagiline mesylate) tablets for oral use initial u.s. approval: 2006 recent major changes indications and usage (1) 05/2014 dosage and administration (2.1) 05/2014 warnings and precautions (5.2, 5.3, 5.6, 5.8, 5.9) 05/2014 indications and usage azilect, a monoamine oxidase (mao)-b inhibitor (maoi), is indicated for the treatment of parkinson’s disease (1) dosage and administration monotherapy: azilect 1 mg once daily (2.1) as adjunct without levodopa: azilect 1 mg once daily (2.1) as adjunct to levodopa: azilect 0.5 mg once daily. increase dose to 1 mg daily as needed for sufficient clinical response (2.1) patients taking ciprofloxacin or other cyp1a2 inhibitors: azilect 0.5 mg once daily (2.2, 5.4) patients with mild hepatic impairment: azilect 0.5 mg once daily. azilect should not be used in patients with moderate or severe hepatic impairment (2.3, 5.5) dosage forms and strengths azilect 0.5 mg tablets (containing, as the active ingredient, rasagiline mesylate equivalent to 0.5 mg of rasagiline base) (3) azilect 1 mg tablets (containing, as the active ingredient, rasagiline mesylate equivalent to 1 mg of rasagiline base) (3) contraindications concomitant use of meperidine, tramadol, methadone, propoxyphene dextromethorphan, st. john’s wort, cyclobenzaprine, or another (selective or non-selective) mao inhibitor (4) warnings and precautions may cause hypertension (including severe hypertensive syndromes) at recommended doses (5.1) may cause serotonin syndrome when used with antidepressants (5.2) may cause falling asleep during activities of daily living, daytime drowsiness, and somnolence (5.3) may cause hypotension, especially orthostatic (5.6) may cause or exacerbate dyskinesia. decreasing the levodopa dose may lessen oreliminate this side effect (5.7) may cause hallucinations and psychotic-like behavior (5.8) may cause impulse control/compulsive behaviors (5.9) may cause withdrawal-emergent hyperpyrexia and confusion (5.10) increased risk of melanoma: monitor patients for melanoma on a regular basis (5.11) adverse reactions most common adverse reactions (incidence 3% or greater than placebo): azilect monotherapy: flu syndrome, arthralgia, depression, dyspepsia (6.1) azilect used as adjunct without levodopa: peripheral edema, fall, arthralgia, cough, and insomnia (6.1) azilect used as adjunct to levodopa: dyskinesia, accidental injury, weight loss, postural hypotension, vomiting, anorexia, arthralgia, abdominal pain, nausea, constipation, dry mouth, rash, abnormal dreams, fall, and tenosynovitis (6.1) to report suspected adverse reactions, contact teva at 1‑800‑221‑4026 or fda at 1‑800‑fda‑1088 or www.fda.gov/medwatch . drug interactions meperidine: risk of serotonin syndrome (4, 7.1) dextromethorphan: risk of psychosis or bizarre behavior (4, 7.2) mao inhibitors: risk of non-selective mao inhibition and hypertensive crisis (4, 7.3) use in specific populations pregnancy: based on animal data, may cause fetal harm. do not use azilectunless the potential benefit justifies the potential risk to the fetus (8.1) see 17 for patient counseling information revised: 05/2014 full prescribing information: contents* indications and usage dosage and administration 2.1 general dosing recommendations 2.2 patients taking ciprofloxacin or other cyp1a2 inhibitors 2.3 patients with hepatic impairment dosage forms and strengths contraindications warnings and precautions 5.1 hypertension 5.2 serotonin syndrome 5.3 falling asleep during activities of daily living and somnolence 5.4 ciprofloxacin or other cyp1a2 inhibitors 5.5 hepatic impairment 5.6 hypotension / orthostatic hypotension 5.7 dyskinesia 5.8 hallucinations / psychotic-like behavior 5.9 impulse control / compulsive behaviors 5.10 withdrawal-emergent hyperpyrexia and confusion 5.11 melanoma adverse reactions 6.1 clinical trials experience drug interactions 7.1 meperidine 7.2 dextromethorphan 7.3 mao inhibitors 7.4 sympathomimetic medications 7.5 antidepressants 7.6 ciprofloxacin or other cyp1a2 inhibitors 7.7 tyramine/rasagiline interaction 7.8 dopaminergic antagonists use in specific populations 8.1. pregnancy 8.3. nursing mothers 8.4. pediatric use 8.5. geriatric use 8.6. hepatic impairment 8.7. renal impairment drug abuse and dependence 9.1. controlled substance 9.2. abuse 9.3. dependence overdosage description clinical pharmacology 12.1. mechanism of action 12.2. pharmacodynamics 12.3. pharmacokinetics nonclinical toxicology 13.1. carcinogenesis, mutagenesis, impairment of fertility clinical studies 14.1 monotherapy use of azilect 14.2 adjunct use of azilect section removed how supplied/storage and handling patient counseling information *sections or subsections omitted from the full prescribing information are not listed. full prescribing information 1. indications and usage azilect (rasagiline tablets) is indicated for the treatment of parkinson’s disease (pd). 2. dosage and administration 2.1 general dosing recommendations 2.2 patients taking ciprofloxacin or other cyp1a2 inhibitors 2.3 patients with hepatic impairment 2.1 general dosing recommendations when azilect is prescribed as monotherapy or as adjunct therapy in patients not taking levodopa, patients may start azilect at the recommended dose of 1 mg administered orally once daily. in patients taking levodopa, with or without other pd drugs (e.g., dopamine agonist, amantadine, anticholinergics), the recommended initial dose of azilect is 0.5 mg once daily. if the patient tolerates the daily 0.5 mg dose, but a sufficient clinical response is not achieved, the dose may be increased to 1 mg once daily. when azilect is used in combination with levodopa, a reduction of the levodopa dose may be considered, based upon individual response. the recommended doses of azilect should not be exceeded because of risk of hypertension [see warnings and precautions (5.1) ] . 2.2 patients taking ciprofloxacin or other cyp1a2 inhibitors patients taking concomitant ciprofloxacin or other cyp1a2 inhibitors should not exceed a dose of azilect 0.5 mg once daily [see warnings and precautions (5.4) , drug interactions (7.6) , and clinical pharmacology (12.3) ]. 2.3 patients with hepatic impairment patients with mild hepatic impairment should not exceed a dose of azilect 0.5 mg once daily. azilect should not be used in patients with moderate or severe hepatic impairment [see warnings and precautions (5.5) , use in specific populations (8.6) , and clinical pharmacology (12.3) ]. 3. dosage forms and strengths azilect 0.5 mg tablets: white to off-white, round, flat, beveled tablets, debossed with "gil 0.5" on one side and plain on the other side containing, as the active ingredient, rasagiline mesylate equivalent to 0.5 mg of rasagiline base. azilect 1 mg tablets: white to off-white, round, flat, beveled tablets, debossed with "gil 1" on one side and plain on the other side containing, as the active ingredient, rasagiline mesylate equivalent to 1 mg of rasagiline base. 4. contraindications azilect is contraindicated for use with meperidine, tramadol, methadone, propoxyphene and mao inhibitors (maois), including other selective mao-b inhibitors, because of risk of serotonin syndrome [see warnings and precautions (5.2) ] . at least 14 days should e
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Domain Name: AZILECT.COM
Registry Domain ID: 105323409_DOMAIN_COM-VRSN
Registrar WHOIS Server: whois.domainthenet.com
Registrar URL: http://www.DomainTheNet.com
Updated Date: 2017-09-13T08:11:31Z
Creation Date: 2003-10-20T16:04:23Z
Registry Expiry Date: 2018-10-20T16:04:23Z
Registrar: Domain The Net Technologies Ltd.
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Name Server: NS4.TEVAPHARM.COM
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REGISTRAR Domain The Net Technologies Ltd.
SERVERS
SERVER com.whois-servers.net
ARGS domain =azilect.com
PORT 43
TYPE domain
RegrInfo
DOMAIN
NAME azilect.com
CHANGED 2017-09-13
CREATED 2003-10-20
STATUS
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NS3.TEVAPHARM.COM 199.7.68.228
NS4.TEVAPHARM.COM 199.7.69.228
NS5.TEVAPHARM.COM 204.74.114.228
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