Rasagiline (Rasagiline)

Trade Name : Rasagiline

Teva Pharmaceuticals USA, Inc.

TABLET

Strength 0.5 mg/1

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

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

Rasagiline (Rasagiline) 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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No data

Rasagiline tablets are indicated for the treatment of Parkinsonu2019s disease (PD).
Rasagiline, a monoamine oxidase (MAO)-B inhibitor (MAOI), is indicated for the treatment of Parkinsonu2019s disease

No data

Monotherapy: rasagiline 1 mg once daily ()
As adjunct without levodopa: rasagiline 1 mg once daily ()
As adjunct to levodopa: rasagiline 0.5 mg once daily. Increase dose to 1 mg daily as needed for sufficient clinical response ()
Patients taking ciprofloxacin or other CYP1A2 inhibitors: rasagiline 0.5 mg once daily (, )
Patients with mild hepatic impairment: rasagiline 0.5 mg once daily. Rasagiline should not be used in patients with moderate or severe hepatic impairment (, )

Rasagiline 0.5 mg Tablets: White to off-white, round, flat, beveled tablets, debossed with u201cGIL 0.5u201d on one side and plain on the other side.
Rasagiline 1 mg Tablets: White to off-white, round, flat, beveled tablets, debossed with u201cGIL 1u201d on one side and plain on the other side.

Rasagiline 0.5 mg tablets ()
Rasagiline 1 mg tablets ()

Rasagiline 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 . At least 14 days should elapse between discontinuation of rasagiline and initiation of treatment with these medications.
Rasagiline is contraindicated for use with St. Johnu2019s wort and with cyclobenzaprine.
Rasagiline is 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

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. Decreasing the levodopa dose may lessen or eliminate this side effect ()
May cause hallucinations and psychotic-like behavior ()
May cause impulse control/compulsive behaviors ()
May cause withdrawal-emergent hyperpyrexia and confusion ()

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, Parkinsonu2019s disease patients received rasagiline 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 treatment, but also in the severity and duration of their disease, the adverse reactions are presented separately for each study.
Monotherapy Use of Rasagiline
In Study 1, approximately 5% of the 149 patients treated with rasagiline discontinued treatment due to adverse reactions compared to 2% of the 151 patients who received placebo.
The only adverse reaction that led to the discontinuation of more than one patient was hallucinations.
The most commonly observed adverse reactions in Study 1 (incidence in rasagiline-treated patients 3% or greater than the incidence in placebo-treated patients) included flu syndrome, arthralgia, depression, and dyspepsia. Table 1 lists adverse reactions that occurred in 2% or greater of patients receiving rasagiline as monotherapy and were numerically more frequent than in the placebo group in Study 1.
*Incidence 2% or greater in rasagiline 1 mg group and numerically more frequent than in placebo group
There were no significant differences in the safety profile based on age or gender.
Adjunct Use of Rasagiline
Rasagiline was studied as an adjunct therapy without levodopa (Study 2), or as an adjunct therapy to levodopa, with some patients also taking dopamine agonists, COMT inhibitors, anticholinergics, or amantadine (Study 3 and Study 4).
In Study 2, approximately 8% of the 162 patients treated with rasagiline discontinued treatment due to adverse reactions compared to 4% of the 164 patients who received placebo.
Adverse reactions that led to the discontinuation of more than one patient were nausea and dizziness.
The most commonly observed adverse reactions in Study 2 (incidence in rasagiline-treated patients 3% or greater than incidence in placebo-treated patients) included peripheral edema, fall, arthralgia, cough, and insomnia. Table 2 lists adverse reactions that occurred in 2% or greater in patients receiving rasagiline as adjunct therapy without levodopa and numerically more frequent than in the placebo group in Study 2.
*Incidence 2% or greater in rasagiline 1 mg group and numerically more frequent than in placebo group
There were no significant differences in the safety profile based on age or gender.
In Study 3, adverse event reporting was considered more reliable than Study 4; therefore, only the adverse event data from Study 3 are presented below.
In Study 3, approximately 9% of the 164 patients treated with rasagiline 0.5 mg/day and 7% of the 149 patients treated with rasagiline 1 mg/day discontinued treatment due to adverse reactions, compared to 6% of the 159 patients who received placebo. The adverse reactions that led to discontinuation of more than one rasagiline-treated patient were diarrhea, weight loss, hallucination, and rash.
The most commonly observed adverse reactions in Study 3 (incidence in rasagiline-treated patients 3% or greater than the incidence in placebo-treated patients) included dyskinesia, accidental injury, weight loss, postural hypotension, vomiting, anorexia, arthralgia, abdominal pain, nausea, constipation, dry mouth, rash, abnormal dreams, fall, and tenosynovitis.
Table 3 lists adverse reactions that occurred in 2% or greater of patients treated with rasagiline 1 mg/day and that were numerically more frequent than the placebo group in Study 3.
*Incidence 2% or greater in rasagiline 1 mg group and numerically more frequent than in placebo group
Several of the more common adverse reactions seemed dose-related, including weight loss, postural hypotension, and dry mouth.
There were no significant differences in the safety profile based on age or gender.
During all Parkinsonu2019s disease phase 2/3 clinical trials, the long-term safety profile was similar to that observed with shorter duration exposure.
Most common adverse reactions (incidence 3% or greater than placebo):

Rasagiline monotherapy: flu syndrome, arthralgia, depression, dyspepsia ()
Rasagiline used as adjunct without levodopa: peripheral edema, fall, arthralgia, cough, and insomnia ()
Rasagiline 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 ()

No data

Meperidine: Risk of serotonin syndrome (, )
Dextromethorphan: Risk of psychosis or bizarre behavior (, )
MAO inhibitors: Risk of non-selective MAO inhibition and hypertensive crisis (, )

No data

Pregnancy: Based on animal data, may cause fetal harm. ()

No data

In a dose escalation study in patients on chronic levodopa therapy treated with 10 mg of rasagiline 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 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 overdose. The following suggestions are offered based upon the assumption that rasagiline 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, 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 in a suicide attempt. Another patient who was treated in error with 4 mg rasagiline daily and tramadol also developed a serotonin syndrome. One patient who was treated in error with 3 mg rasagiline 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: 1H-Inden-1-amine, 2, 3-dihydro-N-2-propynyl-, (1R)-, methanesulfonate. The empirical formula of rasagiline mesylate is CHNu2022CHSO and its molecular weight is 267.34.
Its structural formula is:
Rasagiline mesylate is a white to off-white powder, freely soluble in water or ethanol and sparingly soluble in isopropanol. Each rasagiline tablet for oral administration containsu00a00.5 mg or 1 mg of rasagiline (equivalent to 0.78 mgu00a0or 1.56 mg of rasagiline mesylate).u00a0
Each rasagiline tablet also contains the following inactive ingredients: mannitol, starch, pregelatinized starch, colloidal silicon dioxide, stearic acid, and talc.

No data

Carcinogenesis
Two-year carcinogenicity studies were conducted in mice at oral doses of 0, 1, 15, and 45 mg/kg/day and in rats at oral doses of 0.3, 1, and 3 mg/kg/day (males) or 0, 0.5, 2, 5, and 17 mg/kg/day (females). In rats, there was no increase in tumors at any dose tested. Plasma exposures (AUC) at the highest dose tested were approximately 33 and 260 times, in male and female rats, respectively, that in humans at the maximum recommended human dose (MRHD) of 1 mg/day.
In mice, there was an increase in lung tumors (combined adenomas/carcinomas) at 15 and 45 mg/kg in males and females. At the lowest dose tested, plasma AUCs were approximately 5 times those expected in humans at the MRHD.
The carcinogenic potential of rasagiline administered in combination with levodopa/carbidopa has not been examined.
Mutagenesis
Rasagiline was reproducibly clastogenic in chromosomal aberration assays in human lymphocytes in the presence of metabolic activation and was mutagenic and clastogenic in the mouse lymphoma tk assay in the absence and presence of metabolic activation. Rasagiline was negative in the bacterial reverse mutation (Ames) assay and in the micronucleus assay in mice. Rasagiline was also negative in the micronucleus assay in mice when administered in combination with levodopa/carbidopa.
Impairment of Fertility
Rasagiline had no effect on mating performance or fertility in rats treated prior to and throughout the mating period and continuing in females through gestation day 17 at oral doses of up to 3 mg/kg/day (approximately 30 times the plasma AUC in humans at the MRHD). The effect of rasagiline administered in combination with levodopa/carbidopa on mating and fertility has not been examined.

The effectiveness of rasagiline 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 0.5 mg Tablets:
White to off-white, round, flat, beveled tablets, debossed with u201cGIL 0.5u201d on one side and plain on the other side. Supplied as bottles of 30 tablets (NDC 0093-3060-56).
Rasagiline 1 mg Tablets:
White to off-white, round, flat, beveled tablets, debossed with u201cGIL 1u201d on one side and plain on the other side. Supplied as bottles of 30 tablets (NDC 0093-3061-56).
Storage:
Store at 25u00b0C (77u00b0F) with excursions permitted to 15u00b0-30u00b0C (59u00b0-86u00b0F).

Hypertension
Advise patients that treatment with recommended doses of rasagiline may be associated with elevations of blood pressure. Tell patients who experience elevation of blood pressure while taking rasagiline to contact their healthcare provider.
The risk of using higher than recommended daily doses of rasagiline 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 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
Tell patients to inform their physician if they are taking, or planning to take, any prescription or over-the-counter drugs, especially antidepressants and over-the-counter cold medications, since there is a potential for interaction with rasagiline. Because patients should not use meperidine or certain other analgesics with rasagiline, they should contact their healthcare provider before taking analgesics n
Falling Asleep During Activities of Daily Living and Somnolence
Advise and alert patients about the potential for sedating effects associated with rasagiline and other dopaminergic medications, including somnolence and particularly to the possibility of falling asleep while engaged in activities of daily living. Because somnolence can be a frequent adverse reaction with potentially serious consequences, patients should neither drive a car nor engage in other potentially dangerous activities until they have gained sufficient experience with rasagiline and other dopaminergic medications to gauge whether or not it affects their mental and/or motor performance adversely. Advise patients that if increased somnolence or new episodes of falling asleep during activities of daily living (e.g., watching television, passenger in a car, etc.) are experienced at any time during treatment, they should not drive or participate in potentially dangerous activities until they have contacted their physician. Patients should not drive, operate machinery, or work at heights during treatment if they have previously experienced somnolence and/or have fallen asleep without warning prior to use of rasagiline.
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 or when taking concomitant medications that increase plasma levels of rasagiline (e.g., ciprofloxacin) .
Ciprofloxacin or Other CYP1A2 Inhibitors
Inform patients that they should contact their healthcare provider of rasagiline if they take ciprofloxacin or a similar drug that could increase blood levels of rasagiline because of the need to adjust the dose of rasagiline n
Hepatic Impairment
Tell patients who have hepatic problems to contact their healthcare provider regarding possible changes in rasagiline dosing .
Hypotension / Orthostatic Hypotension
Patients should be advised that they may develop orthostatic hypotension with or without symptoms such as dizziness, nausea, syncope, and sometimes sweating. Hypotension and/or orthostatic symptoms may occur more frequently during initial therapy or with an increase in dose at any time (cases have been seen after weeks of treatment). Accordingly, patients should be cautioned 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 with rasagiline .
Dyskinesia
Advise patients taking rasagiline as adjunct to levodopa that there is a possibility of dyskinesia or increased dyskinesia .
Hallucinations / Psychotic-Like Behavior
Inform patients that hallucinations or other manifestations of psychotic-like behavior can occur when taking rasagiline. Advise patients that, if they have a major psychotic disorder, that rasagiline should not ordinarily be used because of the risk of exacerbating the psychosis. Patients with a major psychotic disorder should also be aware that many treatments for psychosis may decrease the effectiveness of rasagiline .
Impulse Control/Compulsive Behaviors
Advise patients that they may experience intense urges to gamble, increased sexual urges, other intense urges, and the inability to control these urges while taking one or more of the medications that increase central dopaminergic tone and that are generally used for the treatment of Parkinsonu2019s disease (including rasagiline). Although it is not proven that the medications caused these events, these urges were reported to have stopped in some cases when the dose was reduced or the medication was stopped. Prescribers should ask patients about the development of new or increased gambling urges, sexual urges, or other urges while being treated with rasagiline. Patients should inform their physician if they experience new or increased gambling urges, increased sexual urges, or other intense urges while taking rasagiline. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking rasagiline .
Withdrawal-Emergent Hyperpyrexia and Confusion
Tell patients to contact their healthcare provider if they wish to discontinue rasagiline .
Missing Dose
Instruct patients to take rasagiline as prescribed. If a dose is missed, the patient should not double-up the dose of rasagiline. The next dose should be taken at the usual time on the following day.
Pregnancy
Advise patients to notify their healthcare provider if they are pregnant or plan to become pregnant n
Manufactured in Israel By:n Jerusalem, 9777402, Israel
Manufactured For:n North Wales, PA 19454
RAS-003
Rev. 1/2019

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Rasagiline (Rasagiline)

Trade Name : Rasagiline

TABLET

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Rasagiline (Rasagiline)

Trade Name : Rasagiline

TABLET

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

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Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

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