The european commission granted a marketing authorisation valid throughout the european union for azilect to teva pharma gmbh on 21 february 2005. Jan 07, 2019 what is the most important information i should know about rasagiline azilect. For hardcopy releases, please see enclosed full prescribing information. Highlights of prescribing information these highlights do not include all the information needed to use nuvigil safely and effectively. Xadago is a prescription medicine known as a monoamine oxidase type b maob inhibitor. Oxtellar xr oxcarbazepine extendedrelease tablets, for oral use initial u. Spironolactone acts both as a diuretic and as an antihypertensive drug by this mechanism. Elderly patients with dementiarelated psychosis treated with antipsychotic drugs are at an increased risk of death.
The azilect prescribing information contains a warning regarding concomitant use with antidepressants. Highlights of prescribing information valcytefor oral. Rasagiline azilect is a monoamine oxidase maob inhibitor maoi. These highlights do not include all the information needed to use neupro safely and effectively. Do not azilect if you have used a mao inhibitor in the past 14 days, such as isocarboxazid, linezolid. Azilect is indicated for the treatment of parkinsons disease pd. This document contains side effect information about rasagiline. Fda approved labeling text for nda 021641s002s003s004s. Azilect 1 mg tablets summary of product characteristics. Sections or subsections omitted from the full prescribing information are not listed. Azilect is sometimes used with another medicine called levodopa. Highlights of prescribing information these highlights do not include all the information needed to use azilect safely and effectively.
Unitedhealthcare pharmacy clinical pharmacy programs. Mirapex pramipexole dihydrochloride tablets, for oral use initial u. Due to rasagiline metabolism through cyp1a2, information regarding the. One important information source that pharmacists as well as other practitioners have access to, but sometimes overlook, is the drugs label, also known as the prescribing. Zelapar selegiline hydrochloride us prescribing information. Therefore, to be consistent and thorough, the following class language was added to the warnings and precautions section of the azilect prescribing information. White to offwhite, round, flat, beveled tablets, debossed with gil 0. Tell your doctor about all medicines you have used in the 2week period before you start taking rasagiline. Some of the dosage forms listed on this page may not apply to the brand name azilect. Since that warning the early literature has been updated. Administer once daily by mouth, consistently with or without food.
The early drug company literature says not to take ssris with azilect but many people do with no problems. Highlights of prescribing information cardiac dysfunction. Montelukast sodium tablets and available montelukast sodium chewable tablets, for oral use. Azilect reference guide for safe and effective use from the american society of healthsystem pharmacists ahfs di. It has also shown to be neuroprotective in invitro and invivo studies. Rasagiline is contraindicated for use with meperidine, tramadol, methadone, propoxyphene, and mao inhibitors maois, including other selective maob inhibitors, because of risk of serotonin syndrome see warnings and precautions. Rasagiline has demonstrated efficacy in early pd and as an adjunctive therapy in advanced pd. This medicine is available only with a doctors prescription. Serotonin syndrome is a potentially serious condition, which can result in death. Full prescribing information 1 indications and usage azilect rasagiline tablets is indicated for the treatment of parkinsons disease pd. See below for a comprehensive list of adverse effects.
Apr 22, 2019 in pregnant rabbits dosed orally throughout the period of organogenesis with rasagiline alone 3 mgkg or in combination with levodopacarbidopa rasagiline. Azilect rasagiline side effects, images, uses, dosage. Highlights of prescribing information these highlights do not include all the information needed to use zelapar safely and effectively. Clinical trials have demonstrated no efficacy advantage for higher doses of rasagiline. Successful use of rasagiline in combination with two.
Azilect is used to treat symptoms of parkinsons disease stiffness, tremors, spasms, poor muscle control azilect is sometimes used with another medicine called levodopa important information. Teva announces first patient enrolled in largest clinical. Azilect is used to treat the symptoms of parkinsons disease. The product catalog provides you with a full listing of tevas brand and generic product lines. Azilect rasagiline works by increasing the levels of certain chemicals in the brain. These highlights do not include all the information needed. White to offwh ite, 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. Reviews, revisions, and approvals date approval date policy created. Abilify is not approved for the treatment of patients with dementiarelated psychosis. Thus, when searching for drug information, many times the problem facing a pharmacist is not a lack of resources, but rather too many resources from which to choose. Fda approved labeling text for nda 021641s002s003s. Highlights of prescribing information these highlights do not include all the information needed to use mirapex safely and effectively. Evista raloxifene hydrochloridetabletfor oral use initial u.
See 17 for patient counseling information and medication guide. Highlights of prescribing information these highlights do not include all the information needed to use montelukast sodium tabletssafely and effectively. Nuvigil armodafinil tablets, for oral use, civ initial u. Do not azilect if you have used a mao inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine. Azilect is indicated for the treatment of idiopathic parkinsons disease pd as. Pd patients in both monotherapy and adjunct therapy and no dosage adjustments are required for the elderly.
At least 14 days should elapse between discontinuation of rasagiline and initiation of treatment with these medications. The catalog displays all strengths and sizes along with the description, imprint code, ndc and photo for each product. Many drugs can interact with rasagiline, and some drugs should not be used together. Azilect 1 mg tablets patient information leaflet pil by teva. Dec 07, 2010 in a doubleblind, placebocontrolled trial study 1 conducted in patients treated with azilect as adjunct to levodopa therapy, approximately 9% of the 164 patients treated with azilect 0. Fda approves expanded label for azilect for treatment across. Tell your physician if you are taking, or planning to take, any prescription or overthecounter drugs.
Pd and antidepressants and rasageline azilect azilect has been available since 2005. Highlights of prescribing information these highlights do not include all the information needed to use sprycel safely and effectively. Adjust the rapamune maintenance dose to achieve sirolimus trough concentrations within the targetrange. Instructions for azilect azilect rasagiline tablets.
Interactions between azilect oral and rasagilineselegiline. Azilect and antidepressants treatments and therapies. See 17 for patient counseling information and fdaapproved patient labeling. Azilect works by increasing the levels of certain chemicals in the brain. The racemic form of the drug was invented by aspro nicholas in the early 1970s. Data sources include ibm watson micromedex updated 10 apr 2020, cerner multum updated 6 apr. Xadago is used with levodopacarbidopa to treat adults with parkinsons disease pd who are having off episodes. See full prescribing information for rasagiline tablets. Searle llc division of pfizer inchighlights of prescribing information. Comtan entacapone tablets rx only prescribing information description comtan entacapone is available as tablets containing 200 mg entacapone.
Pdf icon download leaflet view the patient leaflet in pdf format. Policycriteria provider must submit documentation such as office chart notes, lab results or other clinical information supporting that member has met all approval criteria. It may be given alone or with other diuretic agents that act more proximally in the renal tubule. May 14, 2019 azilect package insert pdf admin may 14, 2019 no comments easy to read fda package insert, drug facts, dosage and administration, and adverse effects for azilect rasagiline. Important safety information do not take azilect if you are taking meperidine as it could result in a. Spironolactone causes increased amounts of sodium and water to be excreted, while potassium is retained. Patients falling asleep during activities of daily living impulse controlcompulsive behaviors. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. In a doubleblind, placebocontrolled trial study 1 conducted in patients treated with azilect as adjunct to levodopa therapy, approximately 9% of the 164 patients treated with azilect 0. The marketing authorisation was renewed on 21 february 2010. Azilect is used to treat symptoms of parkinsons disease stiffness, tremors, spasms, poor muscle control. See full prescribing information for complete boxed warning. Rasagiline azilect, azipron is an irreversible inhibitor of monoamine oxidaseb used as a monotherapy to treat symptoms in early parkinsons disease or as an adjunct therapy in more advanced cases. Azilect is indicated for the treatment of parkinsons disease.
Ropinirole has moderate in vitro affinity for opioid receptors. Home rasagiline just for chemists rasagiline wikipedia rasagiline azilect, azilect depression and antidepressants rasagiline azilect prescribing information pdf. Policycriteria provider must submit documentation including office chart notes and lab results supporting that member has met all approval criteria. These highlights do not include all the information needed to use uloric safely and effectively. Development history and fda approval process for azilect. These highlights do not include all the information needed to use aldactone safely and effectively. Azilect rasagiline is a monoamine oxidase b inhibitor administered oncedaily as initial monotherapy in early parkinsons disease pd and as adjunct therapy to levodopa in moderatetoadvanced disease. Highlights of prescribing information these highlights do not include all the information needed to use rasagiline tablets safely and effectively. Rasagiline azilect, azipron is an irreversible inhibitor of monoamine oxidaseb used as a monotherapy to treat symptoms in early parkinsons disease or as an adjunct therapy in more advanced cases the racemic form of the drug was invented by aspro nicholas in the early 1970s. Azilect 1 mg tablets patient information leaflet pil emc. Jun 09, 2014 azilect rasagiline tablets is indicated for the treatment of parkinsons disease pd. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication education rems cme, and.
Program step therapy azilect change control date change 102016 new program. Feb 04, 2019 azilect is used to treat symptoms of parkinsons disease stiffness, tremors, spasms, poor muscle control. Highlights of prescribing information these highlights do not include all the information needed to use evista safely and effectively. Fda approved indications azilect is indicated for the treatment of parkinsons disease pd. Administer the initial dose as soon as possible after transplantation and 4 hours after csa 2. The recommended dose of rasagiline is 1 mg one tablet of azilect once daily, to be taken with or. Patients should inform their physician if they are taking, or planning to take, any prescription or. Prescribing information, including boxed warning and medication guide april 14, 2020 teva introduces romidepsin injection in a strength of 27. Entacapone is an inhibitor of catecholomethyltransferase comt, used in the treatment of parkinsons disease as an adjunct to levodopa and carbidopa therapy.
The committee recommended that azilect be given marketing authorisation. Azilect is indicated in adults for the treatment of idiopathic parkinsons disease as monotherapy without levodopa or as adjunct therapy with levodopa in patients with end of dose fluctuations. Requip is a nonergoline dopamine agonist with high relative in vitro specificity and full intrinsic activity at the d 2 and d 3 dopamine receptor subtypes, binding with higher affinity to d 3 than to d 2 or d 4 receptor subtypes. Department of health and human services food and drug. Highlights of prescribing information these highlights do not include all the information needed to use oxtellar xr safely and effectively.
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