Rasagilin Glenmark (Rasagiline)
MAO-B inhibitor for the treatment of Parkinson's disease in adults
Rasagilin Glenmark contains the active substance rasagiline, a selective and irreversible monoamine oxidase type B (MAO-B) inhibitor used in the treatment of Parkinson's disease in adults. It can be used as monotherapy in early-stage disease or as adjunctive therapy with levodopa. By blocking the breakdown of dopamine in the brain, rasagiline helps maintain higher dopamine levels, improving motor function and reducing symptoms such as tremor, rigidity, and bradykinesia. Also available under the brand names Rasagiline Bluefish, Rasagilin Krka, Rasagilin STADA, Rasagiline Viatris, and Rasagiline Accord.
Quick Facts
Key Takeaways
- Rasagiline is a once-daily oral tablet (1 mg) used alone or with levodopa to treat Parkinson's disease in adults.
- It works by irreversibly inhibiting MAO-B, preventing dopamine breakdown and increasing dopamine availability in the brain.
- Must not be combined with other MAO inhibitors, pethidine (meperidine), or certain antidepressants (fluoxetine, fluvoxamine) due to serious interaction risks.
- Common side effects include dyskinesia, headache, flu-like symptoms, and orthostatic hypotension; rare but serious effects include stroke and heart attack.
- Regular skin checks are recommended during treatment, as rasagiline may increase the risk of melanoma (skin cancer).
What Is Rasagilin Glenmark and What Is It Used For?
Rasagilin Glenmark belongs to a class of medications known as monoamine oxidase type B (MAO-B) inhibitors. It is specifically approved for the treatment of idiopathic Parkinson's disease in adult patients. The medication can be prescribed as a standalone treatment (monotherapy) for patients in the early stages of Parkinson's disease, or as an add-on therapy alongside levodopa for patients with more advanced disease who experience motor fluctuations.
Parkinson's disease is a progressive neurodegenerative disorder characterized by the loss of dopamine-producing neurons in a region of the brain called the substantia nigra. Dopamine is a critical neurotransmitter involved in coordinating smooth, purposeful movement. As dopamine levels decline, patients develop the hallmark symptoms of Parkinson's disease: resting tremor, muscle rigidity, bradykinesia (slowness of movement), and postural instability.
Rasagiline addresses this dopamine deficiency by selectively and irreversibly inhibiting the MAO-B enzyme in the brain. MAO-B is responsible for a significant portion of dopamine metabolism in the central nervous system. By blocking this enzyme, rasagiline slows the enzymatic breakdown of dopamine, effectively increasing and sustaining dopamine levels in the striatum. This pharmacological action helps compensate for the reduced dopamine production that characterizes Parkinson's disease.
When used as monotherapy, rasagiline provides modest but clinically meaningful improvements in motor function. The TEMPO and ADAGIO clinical trials demonstrated that rasagiline monotherapy significantly improved UPDRS (Unified Parkinson's Disease Rating Scale) motor scores compared to placebo. When used as adjunctive therapy with levodopa, rasagiline reduces "off" time (periods when Parkinson's symptoms return between medication doses) by approximately 0.5 to 1 hour per day, as demonstrated in the PRESTO and LARGO trials.
Rasagiline is available as a generic medication manufactured by several pharmaceutical companies, including Glenmark Pharmaceuticals. Other available brands include Rasagiline Bluefish, Rasagilin Krka, Rasagilin STADA, Rasagiline Viatris, and Rasagiline Accord. All contain the same active substance and are therapeutically equivalent.
What Should You Know Before Taking Rasagilin Glenmark?
Contraindications
There are several important situations in which rasagiline must not be used. Understanding these contraindications is essential for safe treatment.
- You are allergic to rasagiline or any of the inactive ingredients in the tablet
- You have severe liver impairment (severe hepatic insufficiency)
- You are currently taking any other monoamine oxidase (MAO) inhibitor, including over-the-counter preparations and herbal products containing St. John's Wort (Hypericum perforatum)
- You are currently taking pethidine (meperidine), a strong opioid pain medication
If you have been taking rasagiline and need to start an MAO inhibitor or pethidine, you must wait at least 14 days after your last dose of rasagiline. This washout period is critical because rasagiline irreversibly inhibits MAO-B, and the body needs time to synthesize new MAO-B enzyme before it is safe to introduce another MAO-active drug. Failure to observe this washout period could result in dangerous interactions, including hypertensive crisis or serotonin syndrome.
Warnings and Precautions
Several important precautions should be discussed with your healthcare provider before and during treatment with rasagiline.
Liver problems: If you have mild to moderate liver impairment, your doctor will need to carefully consider whether rasagiline is appropriate for you. The medication is metabolized primarily by the liver enzyme CYP1A2, and reduced liver function may lead to increased drug exposure. Rasagiline is contraindicated in patients with severe hepatic impairment.
Skin cancer risk: Treatment with rasagiline may potentially increase the risk of melanoma (skin cancer). This association has been observed in epidemiological studies, although it is unclear whether this is related to the medication itself, Parkinson's disease, or other confounding factors. Patients on rasagiline should have regular dermatological examinations and should report any new or suspicious skin changes to their doctor promptly.
Impulse control disorders: Rasagiline, like other dopaminergic medications used in Parkinson's disease, may cause impulse control disorders. These are behavioral changes where patients cannot resist the urge to perform certain activities that could be harmful. Reported impulse control disorders include pathological gambling, compulsive shopping or spending, binge eating, compulsive sexual behavior, and an abnormally high sex drive. If you or your family members notice any such behavioral changes, contact your healthcare provider immediately, as dose adjustment or treatment discontinuation may be necessary.
Drowsiness and sudden sleep onset: Rasagiline may cause somnolence (excessive daytime sleepiness) and episodes of suddenly falling asleep during daily activities. This risk is particularly elevated when rasagiline is combined with other dopaminergic medications. Patients should exercise caution when driving or operating machinery, especially during the initial treatment period and any time the dose of concomitant dopaminergic therapy is adjusted.
Pregnancy and Breastfeeding
The safety of rasagiline during pregnancy has not been established in clinical studies. Animal studies are insufficient to fully assess reproductive toxicity. Because the potential risk to the developing fetus is unknown, rasagiline should be avoided during pregnancy unless the potential benefit clearly outweighs the possible risk. Women of childbearing potential should discuss appropriate contraceptive measures with their healthcare provider.
It is not known whether rasagiline or its metabolites are excreted in human breast milk. Given the potential for adverse effects in nursing infants, a decision should be made whether to discontinue breastfeeding or to discontinue rasagiline therapy, taking into account the importance of the medication to the mother. Consult your doctor for personalized advice.
Children and Adolescents
Rasagiline is not indicated for use in children and adolescents under 18 years of age. Parkinson's disease is exceedingly rare in this population, and the safety and efficacy of rasagiline have not been studied in pediatric patients. There is no relevant use of rasagiline in the pediatric population for its approved indication.
How Does Rasagilin Glenmark Interact with Other Drugs?
Drug interactions with rasagiline can be clinically significant and potentially dangerous. The mechanism of action of rasagiline as an MAO-B inhibitor means it interacts with the serotonergic and adrenergic systems, creating the potential for serious pharmacodynamic interactions with a range of medications. Always inform your doctor or pharmacist about all medications you are taking, including over-the-counter products and herbal supplements.
Major Interactions (Contraindicated or Avoid)
| Drug / Drug Class | Risk | Recommendation |
|---|---|---|
| Other MAO inhibitors (including St. John's Wort) | Hypertensive crisis, serotonin syndrome | Contraindicated. Wait 14 days after stopping rasagiline. |
| Pethidine (meperidine) | Severe reactions (stupor, coma, circulatory collapse) | Contraindicated. Wait 14 days after stopping rasagiline. |
| Fluoxetine | Serotonin syndrome | Avoid. Wait 5 weeks after stopping fluoxetine before starting rasagiline; 14 days vice versa. |
| Fluvoxamine | Serotonin syndrome; CYP1A2 inhibition increases rasagiline levels | Avoid. Wait 14 days after stopping rasagiline before starting fluvoxamine. |
Moderate Interactions (Use with Caution)
| Drug / Drug Class | Risk | Recommendation |
|---|---|---|
| SSRIs / SNRIs (other than fluoxetine/fluvoxamine) | Potential serotonin syndrome | Use with caution under medical supervision. |
| Tricyclic / tetracyclic antidepressants | Potential serotonin syndrome | Use with caution; monitor for symptoms. |
| Dextromethorphan (cough suppressant) | Potential serotonin syndrome, psychosis | Avoid concurrent use. |
| Sympathomimetics (ephedrine, pseudoephedrine) | Potential hypertensive reaction | Avoid nasal decongestants and cold medications containing these agents. |
| Ciprofloxacin | CYP1A2 inhibition increases rasagiline plasma levels | Use with caution; consider alternative antibiotic. |
Tobacco smoking induces CYP1A2 activity, which can reduce rasagiline plasma levels. If you smoke or plan to quit smoking, inform your doctor, as this may affect the amount of rasagiline in your blood and potentially require dose reassessment.
Serotonin syndrome is a potentially life-threatening condition that can occur when serotonergic medications are combined with MAO inhibitors. Symptoms include agitation, confusion, rapid heart rate, elevated blood pressure, dilated pupils, muscle twitching, tremor, hyperthermia, and sweating. If you experience any combination of these symptoms while taking rasagiline, seek immediate medical attention.
What Is the Correct Dosage of Rasagilin Glenmark?
Adults
Standard Adult Dosage
The recommended and maximum dose of rasagiline is 1 mg (one tablet) taken once daily. This dose applies to both monotherapy and adjunctive therapy with levodopa. The tablet should be swallowed whole with a glass of water and can be taken at any time of day, with or without food. Consistent timing is recommended to maintain steady drug levels.
Unlike some Parkinson's medications, rasagiline does not require dose titration. The starting dose is the maintenance dose. Clinical trials have shown that 1 mg once daily provides optimal efficacy without increasing the risk of adverse effects compared to lower doses. In the TEMPO trial, 2 mg daily did not provide additional benefit over 1 mg and was associated with more side effects.
Elderly Patients
No dose adjustment is required for elderly patients. Rasagiline has been extensively studied in older adults, as Parkinson's disease predominantly affects this population. The pharmacokinetics of rasagiline are not significantly altered by age. However, elderly patients may be more susceptible to orthostatic hypotension and should be monitored accordingly, particularly during the initial weeks of treatment.
Hepatic Impairment
Patients with mild hepatic impairment should use rasagiline with caution, as drug metabolism may be reduced. Rasagiline is contraindicated in patients with severe hepatic impairment. For moderate hepatic impairment, the decision to use rasagiline should be made on an individual basis by the treating physician, weighing the benefits against the risks of increased drug exposure.
Children
Rasagiline is not indicated for use in children or adolescents under 18 years of age. There are no clinical data to support its use in this population.
Missed Dose
If you forget to take your daily dose of rasagiline, do not take a double dose to make up for the missed one. Simply take the next dose at the usual scheduled time. Because rasagiline irreversibly inhibits MAO-B, a single missed dose is unlikely to cause a significant return of symptoms, as the enzyme inhibition persists until new MAO-B is synthesized.
Overdose
If you or someone else takes too much rasagiline, contact your local poison control center or emergency services immediately. Bring the medication packaging with you to the hospital.
Symptoms reported following rasagiline overdose include mild euphoria (a mild form of mania), extremely elevated blood pressure, and serotonin syndrome. Serotonin syndrome symptoms may include agitation, confusion, tremor, rapid heart rate, high body temperature, and excessive sweating. Treatment of overdose is supportive and symptomatic, with monitoring of vital signs and cardiac function. There is no specific antidote for rasagiline overdose.
Stopping Treatment
Do not stop taking rasagiline without first consulting your doctor. While abrupt discontinuation of rasagiline is generally not associated with a withdrawal syndrome (unlike some other dopaminergic medications), stopping therapy may lead to worsening of Parkinson's disease symptoms. Your doctor will advise you on how to manage your treatment plan if discontinuation is necessary.
What Are the Side Effects of Rasagilin Glenmark?
Like all medicines, rasagiline can cause side effects, although not everyone experiences them. The type and frequency of side effects may differ depending on whether rasagiline is used alone or in combination with levodopa. When used with levodopa, dyskinesia (involuntary movements) is the most commonly reported side effect, as the increased dopamine levels from MAO-B inhibition enhance the effects of levodopa.
- Impulse control disorders: compulsive gambling, shopping, eating, or sexual behavior
- Hallucinations: seeing or hearing things that are not there
- Signs of serotonin syndrome: hallucinations, fever, restlessness, tremor, and sweating occurring together
Very Common
Affects more than 1 in 10 patients
- Involuntary movements (dyskinesia)
- Headache
Common
Affects up to 1 in 10 patients
- Abdominal pain, nausea, and vomiting
- Constipation and dry mouth
- Flatulence (gas)
- Falls
- Allergic reactions
- Fever and flu-like symptoms
- General malaise (feeling unwell)
- Neck pain and chest pain (angina pectoris)
- Low blood pressure when standing (orthostatic hypotension)
- Decreased appetite and weight loss
- Abnormal blood test results (leukopenia)
- Joint pain (arthralgia) and joint inflammation (arthritis)
- Musculoskeletal pain
- Carpal tunnel syndrome
- Abnormal dreams and depression
- Dizziness (vertigo) and abnormal muscle tone (dystonia)
- Balance problems
- Runny nose (rhinitis)
- Skin irritation (dermatitis) and rash
- Eye inflammation (conjunctivitis)
- Urinary urgency
Uncommon
Affects up to 1 in 100 patients
- Stroke (cerebrovascular accident)
- Heart attack (myocardial infarction)
- Skin rash with blistering (vesiculobullous rash)
Frequency Not Known
Cannot be estimated from available data
- Elevated blood pressure
- Excessive daytime sleepiness (somnolence)
- Sudden sleep episodes
If you notice any side effects, including any not listed above, inform your healthcare provider. Reporting suspected adverse reactions after marketing authorization is important, as it allows ongoing monitoring of the benefit-risk balance of the medicine. You can report side effects to your national health authority or through your healthcare provider.
It is worth noting that many of these side effects overlap with the symptoms of Parkinson's disease itself. For example, falls, depression, and orthostatic hypotension are common in Parkinson's patients regardless of medication use. Your doctor will help distinguish between disease-related symptoms and medication-related side effects.
Can You Drive While Taking Rasagilin Glenmark?
Both Parkinson's disease itself and treatment with rasagiline can affect your ability to safely drive a vehicle or operate machinery. Rasagiline may cause dizziness, drowsiness, and in some cases, episodes of suddenly falling asleep during normal daily activities without warning or without feeling drowsy beforehand.
The risk of somnolence and sudden sleep episodes is particularly increased when rasagiline is combined with other dopaminergic medications commonly used in Parkinson's disease, or when patients consume alcohol. If you have experienced somnolence or sudden sleep attacks at any time during rasagiline treatment, you should not drive or operate machinery.
Before starting rasagiline, discuss with your doctor whether you can safely continue driving. You are personally responsible for assessing whether you are fit to drive or perform tasks requiring alertness. Your ability may be affected by the medication's effects and side effects as described throughout this article. If you are uncertain, consult your doctor or pharmacist.
How Should You Store Rasagilin Glenmark?
Proper storage of rasagiline is important to maintain the medication's efficacy and safety. The tablets should be stored at a temperature not exceeding 25°C (77°F). Keep the medication in its original packaging (blister pack or bottle) to protect it from moisture and light.
If your rasagiline comes in a bottle, note that the shelf life after first opening is 2 months. After this period, any remaining tablets should be discarded even if the printed expiration date has not passed. Write the date of first opening on the bottle to help you track this.
Always keep this medication out of the sight and reach of children. Do not use rasagiline after the expiration date (EXP) printed on the carton, blister, or bottle. The expiration date refers to the last day of that month.
Do not dispose of medications via wastewater or household waste. Ask your pharmacist about proper disposal methods for medications that are no longer needed or have expired. These measures help protect the environment.
What Does Rasagilin Glenmark Contain?
Each Rasagilin Glenmark tablet contains 1 mg of rasagiline, present as the tartrate salt (rasagiline tartrate). Rasagiline is the pharmacologically active component responsible for MAO-B inhibition.
The inactive ingredients (excipients) that make up the tablet formulation are:
- Microcrystalline cellulose — a common tablet filler and binder
- Citric acid — used as a pH modifier and stabilizer
- Pregelatinized maize starch — acts as a binder and disintegrant to help the tablet dissolve
- Colloidal anhydrous silica — a flow agent that prevents ingredients from clumping
- Stearic acid — a lubricant that prevents the tablet from sticking to manufacturing equipment
- Talc — an additional lubricant and glidant
Rasagilin Glenmark tablets are white to off-white, round, flat tablets with "771" embossed on one side and "G" on the other side, approximately 8 mm in diameter. The tablets are available in blister packs of 7, 10, 28, 30, 60, 100, and 112 tablets, or in a bottle (with or without a child-resistant cap) containing 30 tablets. Not all pack sizes may be marketed in every country.
If you are allergic to any of these ingredients, do not take Rasagilin Glenmark and inform your doctor so they can prescribe an alternative rasagiline formulation or a different MAO-B inhibitor.
Frequently Asked Questions
Rasagilin Glenmark is used to treat Parkinson's disease in adults. It can be used as the sole treatment (monotherapy) in early Parkinson's disease, or as an add-on to levodopa therapy in patients with more advanced disease who experience motor fluctuations. It works by inhibiting the MAO-B enzyme, which increases dopamine levels in the brain and helps control symptoms such as tremor, stiffness, and slowness of movement.
Rasagiline has important interactions with certain antidepressants. Fluoxetine and fluvoxamine must be avoided entirely. Other SSRIs, SNRIs, and tricyclic or tetracyclic antidepressants should only be used with caution under close medical supervision. If switching between rasagiline and fluoxetine, specific washout periods apply: wait at least 5 weeks after stopping fluoxetine, or 14 days after stopping rasagiline. Always consult your doctor before combining rasagiline with any antidepressant medication.
The most common side effects (affecting more than 1 in 10 patients) are involuntary movements (dyskinesia) and headache. Common side effects (up to 1 in 10) include flu-like symptoms, abdominal pain, nausea, falls, orthostatic hypotension (dizziness when standing), depression, abnormal dreams, joint pain, and weight loss. Most side effects are mild to moderate. Seek immediate medical attention if you experience hallucinations, impulse control problems, or signs of serotonin syndrome (fever, confusion, tremor, sweating).
Rasagiline begins inhibiting MAO-B enzyme activity within hours of the first dose. However, clinically meaningful improvements in Parkinson's symptoms typically develop over several weeks. In clinical trials, significant motor function improvements were observed within 4 to 6 weeks of starting treatment. Because rasagiline irreversibly inhibits MAO-B, its effect accumulates over time as more enzyme becomes blocked. Your doctor may assess your response after 4 to 8 weeks.
No. Rasagiline and selegiline are both MAO-B inhibitors used in Parkinson's disease, but they are distinct drugs with different chemical structures and metabolic profiles. Rasagiline is a second-generation MAO-B inhibitor that does not produce amphetamine-like metabolites (a notable disadvantage of selegiline). Rasagiline is taken once daily without food restrictions, and studies have suggested possible neuroprotective properties. Both are effective treatments, but the choice between them depends on individual patient factors and physician judgment.
At the standard dose of 1 mg daily, rasagiline is selective for MAO-B and does not typically require the strict tyramine-restricted diet associated with non-selective MAO inhibitors. Most patients can eat a normal diet. However, consuming very large amounts of tyramine-rich foods (aged cheeses, fermented meats, draft beer, fermented soy products) is generally not recommended as a precaution. Discuss any dietary concerns with your healthcare provider for personalized guidance.
References
This article is based on international peer-reviewed medical literature, regulatory documents, and clinical practice guidelines. All sources conform to Evidence Level 1A standards.
- European Medicines Agency (EMA). Rasagiline — Summary of Product Characteristics (SmPC). EMA, 2023.
- Parkinson Study Group. A randomized placebo-controlled trial of rasagiline in levodopa-treated patients with Parkinson disease and motor fluctuations: the PRESTO study. Archives of Neurology. 2005;62(2):241–248.
- Olanow CW, et al. A double-blind, delayed-start trial of rasagiline in Parkinson's disease (ADAGIO study). New England Journal of Medicine. 2009;361(13):1268–1278.
- Rascol O, et al. Rasagiline as an adjunct to levodopa in patients with Parkinson's disease and motor fluctuations (LARGO, Lasting Effect in Adjunct therapy with Rasagiline Given Once daily, study). The Lancet. 2005;365(9463):947–954.
- Fox SH, et al. International Parkinson and Movement Disorder Society evidence-based medicine review: Update on treatments for the motor symptoms of Parkinson's disease. Movement Disorders. 2018;33(8):1248–1266.
- National Institute for Health and Care Excellence (NICE). Parkinson's disease in adults: diagnosis and management. NICE Guideline NG71. Updated 2024.
- World Health Organization (WHO). Model List of Essential Medicines, 23rd List. WHO, 2023.
- U.S. Food and Drug Administration (FDA). Azilect (rasagiline) prescribing information. FDA, 2023.
- Connolly BS, Lang AE. Pharmacological treatment of Parkinson disease: a review. JAMA. 2014;311(16):1670–1683.
- Stocchi F, et al. Initiating levodopa/carbidopa therapy with and without entacapone in early Parkinson disease: the STRIDE-PD study. Annals of Neurology. 2010;68(1):18–27.
Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, consisting of licensed physicians and pharmacists specializing in neurology, movement disorders, and clinical pharmacology.
iMedic Clinical Pharmacology Team — specialists in neuropharmacology and drug information with extensive experience in patient education materials.
iMedic Medical Review Board — independent panel of board-certified neurologists and movement disorder specialists who verify accuracy according to EMA, FDA, and MDS guidelines.
All content follows the GRADE evidence framework and adheres to international medical guidelines (WHO, EMA, FDA, NICE, MDS). No pharmaceutical company funding or sponsorship. Content is reviewed and updated at least annually.