Description

Rasagiline Tablets (0.5 mg / 1 mg)

Healthy Inc is a specialized global supplier and exporter of advanced neurology, central nervous system (CNS), and geriatric therapeutics. We provide ultra-high-purity, kinetically stabilized Rasagiline (as Mesylate) Tablets (0.5 mg / 1 mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Irreversible Selective MAO-B Inhibitor” is a highly lucrative, premium export to neurology centers, geriatric care networks, retail pharmacy chains, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated intervention for the continuous symptomatic control and potential neuroprotection of idiopathic Parkinson’s Disease.

Product Overview

This highly advanced formulation contains Rasagiline, a potent, second-generation propargylamine derivative that fundamentally changes the environment of the brain by shutting down the specific enzyme responsible for destroying dopamine.

The “Dopamine Preserver & MAO-B” Specialist:

• Mechanism 1 (The Enzymatic Blockade): In Parkinson’s Disease, the brain’s supply of dopamine is severely depleted. Whatever dopamine is naturally produced, or supplied via Levodopa therapy, is quickly destroyed by an enzyme called Monoamine Oxidase type B (MAO-B). Rasagiline acts as an irreversible “suicide inhibitor.” It permanently binds to and disables the MAO-B enzyme. This allows dopamine levels to pool and rise significantly in the striatum, dramatically improving the patient’s motor function, reducing tremors, and alleviating rigidity.
• Mechanism 2 (The “Cheese Effect” Shield): Older, non-selective MAO inhibitors blocked both MAO-B and MAO-A. Blocking MAO-A in the gut is dangerous because it prevents the breakdown of tyramine (found in aged cheese, red wine, and cured meats), leading to a massive, fatal spike in blood pressure (Hypertensive Crisis). At the standard 1 mg clinical dose, Rasagiline is highly selective only for MAO-B, allowing patients to enjoy a normal diet without strict tyramine restrictions.
• The Dual-Phase Champion: Neurologists heavily prescribe Rasagiline as an early, first-line monotherapy to delay the need for Levodopa. In advanced stages, it is used as a powerful adjunct to Levodopa to completely eliminate the severe “wearing-off” motor fluctuations that occur between Levodopa doses.

Product Composition & Strength

We supply this product as a Precision-Blended Uncoated or Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips to ensure the absolute chemical stability of the highly sensitive mesylate salt.

*Pack Sizes: 10×10 Alu-Alu Blisters or 3×10 Unit-Dose Blisters (Optimized specifically for strict high-compliance 30-day chronic neurology dispensing regimens).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Neurology Distributors, and Hospital Procurement Boards.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Precision Micro-Dose Geometric Blending: Manufacturing a 0.5 mg or 1 mg dose requires elite pharmaceutical engineering. Distributing a sub-milligram amount of API uniformly throughout a standard tablet matrix presents a severe blending challenge. Our facilities utilize advanced high-shear homogenizers and strict geometric dilution protocols, verified by rigorous HPLC content uniformity testing, to guarantee that every single tablet delivers the exact fractional milligram dose, completely eliminating the risk of sub-therapeutic failures or localized CNS toxicity.

Therapeutic Indications (Human Use)

Indicated for the targeted management of degenerative neurological motor dysfunction:

• Parkinson’s Disease (Monotherapy): Treatment of the signs and symptoms of idiopathic Parkinson’s disease as initial monotherapy.
• Parkinson’s Disease (Adjunct Therapy): As an adjunct to levodopa/carbidopa in patients with advanced Parkinson’s disease experiencing “wearing-off” motor fluctuations.

Dosage & Administration

Recommended Dosage (Strictly as per Neurologist Guidelines):

• Monotherapy: 1 mg taken orally once daily.
• Adjunct Therapy (with Levodopa): Initially 0.5 mg once daily. If a sufficient clinical response is not achieved, the dose may be increased to 1 mg once daily.
• Administration: Tablets can be taken with or without food and should be swallowed whole.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• FATAL Serotonin Syndrome (Absolute Contraindication): Rasagiline must NEVER be co-administered with SSRI/SNRI antidepressants (like Fluoxetine or Venlafaxine), Tricyclic antidepressants, Tramadol, Methadone, or Dextromethorphan. Combining these drugs causes a massive buildup of serotonin in the brain, leading to fatal Serotonin Syndrome (hyperthermia, seizures, coma, and death). A strict 14-day washout period is required when switching between these medications.
• Tyramine Caution (Hypertensive Crisis): While selective at 1 mg, exceeding this dose can cause Rasagiline to lose its selectivity and inhibit MAO-A. Patients should still be advised to avoid massively consuming tyramine-rich foods (very old cheeses, air-dried meats, tap beers) to prevent sudden, severe blood pressure spikes.
• Hepatic Impairment: Rasagiline is extensively metabolized by the liver (CYP1A2). It is contraindicated in patients with severe hepatic impairment, and the dose must be strictly limited to 0.5 mg in patients with mild hepatic impairment.
• Melanoma Risk: Epidemiological studies have shown that patients with Parkinson’s disease have a higher risk (2- to approximately 6-fold higher) of developing melanoma than the general population. Routine dermatological screenings are recommended.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Retail Pharmacy Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Neurological Formulations. Whether you are looking for a reliable Hospital Tender Supplier for CNS clinics in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Bulk Indenting, ensuring that every Authorized Medicine Wholesaler receives WHO-GMP certified products at competitive rates.