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Rasagiline Mesylate (Rasagiline Mesylate)

Trade Name : Rasagiline Mesylate

Mylan Pharmaceuticals Inc.

TABLET

Strength 0.5 mg/1

RASAGILINE MESYLATE Monoamine Oxidase Inhibitor [EPC],Monoamine Oxidase Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Rasagiline Mesylate (Rasagiline Mesylate) which is also known as Rasagiline Mesylate and Manufactured by Mylan Pharmaceuticals Inc.. It is available in strength of 0.5 mg/1 per ml. Read more

Rasagiline Mesylate (Rasagiline Mesylate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Rasagiline tablets are indicated for the treatment of Parkinsonu2019s disease (PD).
  • Rasagiline tablets, a monoamine oxidase (MAO)-B inhibitor (MAOI), are indicated for the treatment of Parkinsonu2019s disease ()
  • No data
  • 2.2n- 5.4
  • 2.3n- 5.5
  • Rasagiline Tablets are available containing rasagiline mesylate equivalent to 0.5 mg or 1 mg of rasagiline.
  • Rasagiline tablets are contraindicated for use with meperidine, tramadol, methadone, propoxyphene, and MAO inhibitors (MAOIs), including other selective MAO-B inhibitors, because of risk of serotonin syndrome . At least 14 days should elapse between discontinuation of rasagiline tablets and initiation of treatment with these medications.
  • Rasagiline tablets are contraindicated for use with St. Johnu2019s wort and with cyclobenzaprine.
  • Rasagiline tablets are contraindicated for use with dextromethorphan because of risk of episode of psychosis or bizarre behavior.
  • Concomitant use of meperidine, tramadol, methadone, propoxyphene dextromethorphan, St. Johnu2019s wort, cyclobenzaprine, or another (selective or non-selective) MAO inhibitor ()
  • No data
  • The following adverse reactions are described in more detail in the section of the label:
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the incidence of adverse reactions in the clinical trials of another drug and may not reflect the rates of adverse reactions observed in practice.
  • During the clinical development of rasagiline tablets, Parkinsonu2019s disease patients received rasagiline tablets as initial monotherapy (Study 1) and as adjunct therapy (Study 2, Study 3, Study 4). As the populations in these studies differ, not only in the adjunct use of dopamine agonists or levodopa during rasagiline tablets treatment, but also in the severity and duration of their disease, the adverse reactions are presented separately for each study.
  • Most common adverse reactions (incidence 3% or greater than placebo):
  • To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Meperidine: Risk of serotonin syndrome (, )
  • 4n- 7.2
  • 4n- 7.3
  • No data
  • u2022
  • 8.1
  • No data
  • In a dose escalation study in patients on chronic levodopa therapy treated with 10 mg of rasagiline tablets there were three reports of cardiovascular side effects (including hypertension and postural hypotension) which resolved following treatment discontinuation.
  • Although no cases of overdose have been observed with rasagiline tablets during the clinical development program, the following description of presenting symptoms and clinical course is based upon overdose descriptions of nonselective MAO inhibitors.
  • The signs and symptoms of nonselective MAOI overdose may not appear immediately. Delays of up to 12 hours after ingestion of drug and the appearance of signs may occur. The peak intensity of the syndrome may not be reached until for a day following the overdose. Death has been reported following overdose; therefore, immediate hospitalization, with continuous patient observation and monitoring for at least two days following the ingestion of such drugs in overdose, is strongly recommended.
  • The severity of the clinical signs and symptoms of MAOI overdose varies and may be related to the amount of drug consumed. The central nervous and cardiovascular systems are prominently involved.
  • Signs and symptoms of MAOI overdose may include: drowsiness, dizziness, faintness, irritability, hyperactivity, agitation, severe headache, hallucinations, trismus, opisthotonos, convulsions, and coma; rapid and irregular pulse, hypertension, hypotension and vascular collapse; precordial pain, respiratory depression and failure, hyperpyrexia, diaphoresis, and cool, clammy skin.
  • There is no specific antidote for rasagiline tablets overdose. The following suggestions are offered based upon the assumption that rasagiline tablets overdose may be modeled after nonselective MAO inhibitor poisoning. Treatment of overdose with nonselective MAO inhibitors is symptomatic and supportive. Respiration should be supported by appropriate measures, including management of the airway, use of supplemental oxygen, and mechanical ventilatory assistance, as required. Body temperature should be monitored closely. Intensive management of hyperpyrexia may be required. Maintenance of fluid and electrolyte balance is essential. For this reason, in cases of overdose with rasagiline tablets, dietary tyramine restriction should be observed for several weeks to reduce the risk of hypertensive tyramine reaction.
  • A poison control center should be called for the most current treatment guidelines.
  • A postmarketing report described a single patient who developed a nonfatal serotonin syndrome after ingesting 100 mg of rasagiline tablets in a suicide attempt. Another patient who was treated in error with 4 mg rasagiline tablets daily and tramadol also developed a serotonin syndrome. One patient who was treated in error with 3 mg rasagiline tablets daily experienced alternating episodes of vascular fluctuations consisting of hypertension and orthostatic hypotension.
  • Rasagiline tablets contain rasagiline (as the mesylate), a propargylamine-based drug indicated for the treatment of idiopathic Parkinsonu2019s disease. Rasagiline mesylate is designated chemically as: ()--2-Propynyl-1-indanamine methanesulfonate. The molecular formula of rasagiline mesylate is CHNOS and its molecular weight is 267.34.
  • Its structural formula is:
  • Rasagiline mesylate is a white crystalline powder, freely soluble in water or ethanol and sparingly soluble in isopropanol. Each rasagiline tablet for oral administration contains 0.5 mg or 1 mg of rasagiline (equivalent to 0.78 mg or 1.56 mg of rasagiline mesylate).
  • Each rasagiline tablet also contains the following inactive ingredients: citric acid (monohydrate), colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, pregelatinized starch (corn) and stearic acid.
  • No data
  • No data
  • The effectiveness of rasagiline tablets for the treatment of Parkinsonu2019s disease was established in four 18- to 26-week, randomized, placebo-controlled trials, as initial monotherapy or adjunct therapy.
  • Rasagiline Tablets are available containing rasagiline mesylate equivalent to 0.5 mg or 1 mg of rasagiline.
  • The 0.5 mg tablets are white to off-white, round tablets debossed with on one side of the tablet and over on the other side. They are available as follows:
  • NDC 0378-1270-93bottles of 30 tablets
  • The 1 mg tablets are white to off-white, round tablets debossed with on one side of the tablet and over on the other side. They are available as follows:
  • NDC 0378-1271-93bottles of 30 tablets
  • Arrayn- Storage:u00a0
  • Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
  • Hypertension:n
  • The risk of using higher than recommended daily doses of rasagiline tablets should be explained, and a brief description of the tyramine associated hypertensive reaction provided.
  • Advise patients to avoid certain foods (e.g., aged cheese) containing a very large amount of tyramine while taking recommended doses of rasagiline tablets because of the potential for large increases in blood pressure. If patients eat foods very rich in tyramine and do not feel well soon after eating, they should contact their healthcare provider .
  • Serotonin Syndrome:n n- [see and ].
  • Falling Asleep During Activities of Daily Living and Somnolence:n
  • Because of possible additive effects, advise patients to exercise caution when patients are taking other sedating medications, alcohol, or other central nervous system depressants (e.g., benzodiazepines, antipsychotics, antidepressants) in combination with rasagiline tablets or when taking concomitant medications that increase plasma levels of rasagiline (e.g., ciprofloxacin) u00a0.
  • Ciprofloxacin or Other CYP1A2 Inhibitors:n n- [see and ].
  • Hepatic Impairment:n n- [see ]
  • Hypotension/Orthostatic Hypotension:n n- [see ]
  • Dyskinesia:n n- [see ]
  • Hallucinations/Psychotic-Like Behavior:n n- [see ]
  • Impulse Control/Compulsive Behaviors:u00a0n- [see ]
  • Withdrawal-Emergent Hyperpyrexia and Confusion:n n- [see ]
  • Missing Dose:n
  • Pregnancy:n- [see ]
  • The brands listed are trademarks of their respective owners.
  • Mylan Pharmaceuticals Inc.
  • Revised: 1/2020RASA:R4
  • NDC 0378-1270-93
  • Rasagiline n- Tabletsn- 0.5 mg
  • Rx onlyu00a0u00a0u00a0u00a0u00a030 Tablets
  • Each tablet contains rasagiline mesylate equivalent to 0.5 mg of rasagiline.
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Keep this and all medicationn- out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). n- [See USP Controlled Room n- Temperature.]
  • Usual Dosage:
  • Mylan Pharmaceuticals Inc.
  • Mylan.com
  • RM1270H
  • NDC 0378-1271-93
  • Rasagiline n- Tabletsn- 1 mg
  • Rx onlyu00a0u00a0u00a0u00a0u00a030 Tablets
  • Each tablet contains rasagiline mesylate equivalent to 1 mg of rasagiline.
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Keep this and all medicationn- out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). n- [See USP Controlled Room n- Temperature.]
  • Usual Dosage:
  • Mylan Pharmaceuticals Inc.
  • Mylan.com
  • RM1271H

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