Introduction to the instructions and marketing status of Pramipexole Hydrochloride/Pramipexole Tablets

1. Name: Pramipexole Hydrochloride Tablets, Pramipexole

2. Indications:

Pramipexole (Pramipexole) is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease (PD), alone (without levodopa) or in combination with Levodopa is used in combination, that is, throughout the course of the disease, although in advanced stages, the effect of levodopa gradually disappears or becomes inconsistent, and the therapeutic effect fluctuates (end of dose or“on-off” fluctuations).

Pramipexole is also indicated for the symptomatic treatment of moderate to severe idiopathic restless legs syndrome in doses up to 0.54 mg base (0.75 mg salt).

3. Usage and dosage:

For Parkinson's disease, the starting dose is one 0.088 mg immediate-release tablet three times a day or one 0.26 mg extended-release tablet once a day. The dose should be increased every five to seven days until symptoms are controlled without causing intolerable side effects. The maximum daily dose is three 1.1 mg immediate-release tablets or one 3.15 mg extended-release tablet. Patients can switch from the immediate-release tablets to the extended-release tablets overnight, but the dose may need to be adjusted based on patient response. Patients with kidney problems must take pramipexole less frequently. If treatment is discontinued for any reason, the dose should be gradually reduced.

For restless legs syndrome, pramipexole immediate-release tablets should be taken once daily, two to three hours before bed. The recommended starting dose is 0.088 mg, however, if necessary, it can be increased every four to seven days to further reduce symptoms, up to a maximum dose of 0.54 mg. The patient's response and need for further treatment should be assessed after three months. Extended-release tablets are not used for restless legs syndrome.

Pramipexole tablets should be swallowed with water. Extended-release tablets should not be chewed, divided, or crushed and should be taken at approximately the same time each day.

4. Adverse reactions:

In clinical studies of pramipexole, common side effects included headache, peripheral edema, hyperalgesia (body pain), nausea and vomiting, sedation and drowsiness, decreased appetite and subsequent weight loss, orthostatic hypotension, insomnia, hallucinations, convulsions, twisting or other unusual body movements, unusual fatigue or weakness.

5. Supply and storage:

Sealed, Store below 30°C in a dark place. Keep out of reach of children.

6. Taboo:

Contraindicated in patients allergic to the active substance or any of its excipients.

7. Mechanism of action:

The active substance in Pramipexole is a dopamine agonist (a substance that mimics the effects of dopamine). Dopamine is a messenger substance in the part of the brain that controls movement and coordination. In people with Parkinson's disease, dopamine-producing cells begin to die and the amount of dopamine in the brain decreases. The patient then loses the ability to reliably control his movements. Pramipexole stimulates the brain like dopamine, so patients can control their movements and reduce signs and symptoms of Parkinson's disease, such as tremors, stiffness, and slowness of movement.

The mode of action of pramipexole in restless legs syndrome is not fully understood. The syndrome is thought to be caused by problems with the way dopamine works in the brain, which pramipexole can correct.

8. Listing situation:

In July 1997, the United States approved it for sale under the trade name MIRAPEX; The same yearIn September, the European Union approved it for sale, and it was sold under the trade nameSifrol in some regions (Germany, Finland, Sweden, the Netherlands and Denmark); in February 1998, the United Kingdom approved it for sale under the trade name Mirapexin. In October 2019, China approved its listing, with the trade name Sifrol.

Reference materials:https://en.wikipedia.org/wiki/Pramipexole