rasagiline Tablets, film coated 1 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Jordan
GMP approvals
Jordan
Manufacturer #20799
It is one of the most technologically advanced manufacturing companies of high-quality drugs. It was launched in the 2010s. Professional employees and management, well-equipped technical departments up to international current Good Manufacturing Practice (cGMP), state-of-the-art manufacturing site, and a proactive, customer-oriented company on a quest to perfection. This will be the base for the mission to create value in all dimensions of health care to serve patients, medical professionals, and the communities where they operate.

Rasagiline

Rasagiline is used to treat symptoms in early Parkinson's disease as a monotherapy or in more advanced cases as an adjunct therapy. It used to treat symptoms of Parkinson's disease both alone and in combination with other drugs. It is effective in treating both early and advanced Parkinsons, especially in dealing with non-motor symptoms like fatigue. It works by irreversibly inhibiting monoamine oxidase- B. In Parkinson's disease dopamine-producing cells die, with it, neurotransmitters. An enzyme called monoamine oxidase is responsible for breaking down these neurotransmitters. Its two forms, MAO- A and MAO-B. MAO-B breaks down dopamine. Rasagiline’s actions prevent this breakdown by irreversibly binding to MAO-B. Therefore, making Dopamine available, which compensates, to certain a extent, the decrease of quantities of dopamine produced in their brains. Rasagiline is sold under the brand names Azilect, Azipron among others. Aspro Nicholas invented the racemic form in the early 1970s. However, it was approved for sale in Europe & the US in 2005 and 2006 respectively. It was identified as a potential drug for Parkinson's disease was done by Moussa B.H. Youdim, with collaborators at Technion & Teva Pharmaceutical. They identified the R-isomer as the active form of the drug. Teva markets it in partnership with Lundbeck in Europe, the US, and elsewhere.

Dosage and Administration

Rasagiline is sold as a tablet in 1mg and 0.5mg strengths. In the treatment of Parkinson's Disease, when used as monotherapy, the recommended dose is 1 mg a day and when being used as an Adjunct without Levodopa, the initial dose is 0.5 mg, which may be increased to 1 mg/day as needed and tolerated. The dosage modification should not exceed 0.5mg a day.

The price of Rasagiline

In the USA, a supply of 30 tablets of 1mg, will cost the consumer around $608.12. where as this price is significant lower at USD 0.15 for a supply of 10 tablets in India.

How does it work?

Parkinson’s patient suffers a loss in the ability to produce enough dopamine in the brain, thus decreasing the number of neurotransmitters in the brain. An enzyme called MAO-B is responsible for this decrease. Rasagiline was the first selective MAO-B inhibitor that partly metabolizes into to l- methamphetamine, one of the two methamphetamine enantiomers. These increase Rasagiline’s ability to inhibit the reuptake of the neurotransmitters dopamine and norepinephrine. This allows for the treating of orthostatic hypotension and hallucinations.

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