Product Specification
Brand | Life Pharma FZE |
Condition | New |
Product Descriptions
Pramipexole has some of the same effects as a chemical called dopamine, which occurs naturally in your body. Low levels of dopamine in the brain are associated with Parkinson's disease.
Pramipexole is used to treat symptoms of Parkinson's disease (stiffness, tremors, muscle spasms, and poor muscle control). Pramipexole is also used to treat restless legs syndrome (RLS).
Only immediate-release pramipexole (Mirapex) is approved to treat either Parkinson symptoms or RLS. Extended-release pramipexole (Mirapex ER) is approved only to treat Parkinson symptoms.
Common side effects may include:
Side effects such as confusion or hallucinations may be more likely in older adults.
You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine.
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muscle spasm or muscle weakness;
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drowsiness, dizziness, weakness;
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confusion, memory problems;
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dry mouth;
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nausea, constipation;
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increased urination; or
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sleep problems (insomnia), unusual dreams.
Pramipexole dosing information
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.
Store:
Store at room temperature away from moisture, heat, and light.