Product Description:

• 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.


• Parkinson's and RLS are two separate disorders. Having one of these conditions will not cause you to have the other condition.


• Pramipexole may also be used for purposes not listed in this medication guide.

Pramipexole Side Effects:

• serious side effects:


• a light-headed feeling, like you might pass out


• Hallucinations (seeing or hearing things that are not real)


• extreme drowsiness, falling asleep suddenly, even after feeling alert


• Tremors, twitching or uncontrollable muscle movements


• unexplained muscle pain, tenderness, or weakness


• vision problems or


• posture changes you cannot control, such as involuntary bending forward of your neck, bending forward at the waist, or tilting sideways when you sit, stand, or walk.


• Common side effects:


• muscle spasm or muscle weakness


• drowsiness, dizziness, weakness


• confusion, memory problems


• dry mouth


• nausea, constipation


• increased urination or


• sleep problems (insomnia), unusual dreams.

Warnings:

• Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine:

• You should not use pramipexole if you are allergic to it.


• Tell your doctor if you have ever had:


• low blood pressure;


• dizziness after getting up too fast;


• daytime drowsiness;


• kidney disease; or


• problems controlling your muscle movements.


• People with Parkinson's disease may have a higher risk of skin cancer (melanoma). Talk to your doctor about this risk and what skin symptoms to watch for.


• It is not known whether pramipexole will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using pramipexole.


• It is not known whether pramipexole passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Pramipexole Dosage:

• 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 every 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


• 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.


• 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


• 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.

How should I take pramipexole?

• Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.


• If you are taking immediate-release pramipexole (Mirapex) you should not take extended-release pramipexole (Mirapex ER) at the same time.


• The dose and timing of pramipexole in treating Parkinson's disease is different from the dose and timing in treating RLS. Follow the directions on your prescription label. Ask your pharmacist if you have any questions about the kind of pramipexole you receive at the pharmacy.


• Pramipexole can be taken with or without food. Take the medication with food if it upsets your stomach.


• Do not crush, chew, or break an extended-release tablet (Mirapex ER). Swallow it whole.


• If you are taking this medication for RLS, tell your doctor if your symptoms get worse, if they occur in the morning or earlier than usual in the evening, or if you feel restless symptoms in your hands or arms.


• Do not stop using pramipexole suddenly, or you could have unpleasant withdrawal symptoms. Follow your doctor's instructions about tapering your dose.


• Store at room temperature away from moisture, heat, and light.