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Pramipexole (Mirapex, Mirapexin, Sifrol, Pramipex, Pramirol) is a dopamine agonist of the non-ergoline class indicated for treating Parkinson’s disease (PD) and restless legs syndrome (RLS).

Pramipex / Pramirol tablets contain pramipexole, a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C₁₀H₁₇N₃S •2HCl•H₂O, and its molecular weight is 302.26. The structural formula is:

 

Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane.

Pramipex / Pramirol tablets, for oral administration, contain 0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1 mg, or 1.5 mg of pramipexole dihydrochloride monohydrate. Inactive ingredients consist of mannitol, corn starch, colloidal silicon dioxide, povidone, and magnesium stearate.

Usual Adult Dose for Parkinson’s Disease

Immediate-release:
Initial dose: 0.125 mg orally three times a day
Titration: Increase gradually in small dose increments no more frequently than ever 5 to 7 days
Maintenance dose: 1.5 to 4.5 mg per day based on efficacy and tolerability
Maximum dose: 4.5 mg per day

Comment: The following dose titration was used in clinical trials:
Week 2, 0.25 mg 3 times a day
Week 3, 0.5 mg 3 times a day
Week 4, 0.75 mg 3 times a day
Week 5, 1 mg 3 times a day
Week 6, 1.25 mg 3 times a day
Week 7, 1.5 mg 3 times a day.
-When used in combination with levodopa, the levodopa dose was reduced by an average of 27% from baseline providing a concomitant dose of approximately 800 mg per day.

Extended-release:
Initial dose: 0.375 mg orally once a day
Titration: Increase gradually no more frequently than every 5 to 7 days, first dose increase should be to 0.75 mg once a day followed by incremental increases of 0.75 mg; assess therapeutic response and tolerability at a minimum of 5 days after each dose increase.
Maximum dose: 4.5 mg per day

SWITCHING FROM IMMEDIATE-RELEASE TO EXTENDED-RELEASE:
-Patients may be switched overnight from immediate-release tablets to extended-release tablets at the same daily dose; monitor closely to determine if dose adjustments may be necessary.

Comments:
-If a significant interruption in therapy occurs, re-titration may be necessary; upon discontinuation, doses should be tapered.

Use: Treatment of Parkinson’s disease

Usual Adult Dose for Restless Legs Syndrome

Immediate-release:
Initial dose: 0.125 mg orally once a day 2 to 3 hours before bedtime
Titration: If needed, dose may be titrated upwards by increments of 0.125 mg every 4 to 7 days.
Maximum dose: 0.5 mg orally once a day

Comments:
-Extended-release tablets are not indicated for Restless Legs Syndrome.
-Doses of 0.75 mg once a day were used in clinical trials, but were not found to provide additional benefit as compared to the 0.5 mg dose.

Use: For the treatment of moderate to severe primary Restless Legs Syndrome.

Common side effects of pramipexole may include:

• Headache
• Peripheral edema (Tan EK, Ondo W. Clinical characteristics of pramipexole-induced peripheral edema. Arch Neurol.
• Hyperalgesia (body aches and pains)
• Nausea and vomiting
• Sedation and somnolence
• Decreased appetite and subsequent weight loss
• Orthostatic hypotension (resulting in dizziness, lightheadedness, and possibly fainting, especially when standing up)
• Insomnia
• Hallucinations (seeing, hearing, smelling, tasting or feeling things that are not there)
• Twitching, twisting, or other unusual body movements
• Unusual tiredness or weakness