Pramipexole — uses, dosing, side effects & the brands that sell it · pharmaranks
Pramipexole: uses, dosing, side effects & brands
Pramipexole is a nonergot dopamine agonist sold in the U.S. under 3 brand and generic names, for depressive disorder and parkinson disease. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
By the pharmaranks editorial team·Reviewed against the FDA (openFDA label, NDC Directory & Enforcement) sources·How we research
Key facts
Drug class
Nonergot Dopamine Agonist
Treats
Depressive Disorder and Parkinson Disease
Available as
Tablet · Tablet, extended release
Sold as
3 products — Mirapex, Mirapex ER and Pramipexole Dihydrochloride
Prescription?
Prescription only
Generic available?
Yes
Typical price
about $2 for a 30-count supply
How pramipexole is dosed
From the FDA label for Mirapex (application NDA020667). Other pramipexole products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Pramipexole dihydrochloride extended-release tablets are taken once daily, with or without food (2.1) •Tablets must be swallowed whole and must not be chewed, crushed, or divided (2.1) •Starting dose is 0.375 mg given once daily (2.2) •Dose may be increased gradually, not more frequently than every 5 to 7 days, first to 0.75 mg per day and then by 0.75 mg increments up to a maximum recommended dose of 4.5 mg per day. Assess therapeutic response and tolerability at a minimal interval of 5 days or longer after each dose increment (2.2) •Patients may be switched overnight from immediate-release pramipexole tablets to pramipexole dihydrochloride extended-release tablets at the same daily dose. Dose adjustment may be needed in some patients (2.3) •Pramipexole dihydrochloride extended-release tablets should be discontinued gradually (2.2) 2.1 General Dosing Considerations Pramipexole dihydrochloride extended-release tablets are taken orally once daily, with or without food. Pramipexole dihydrochloride extended-release tablets must be swallowed whole and must not be chewed, crushed, or divided. If a significant interruption in therapy with pramipexole dihydrochloride extended-release tablets has occurred, re-titration of therapy may be warranted. 2.2 Recommended Dosage The starting dose is 0.375 mg given once per day. Based on efficacy and tolerability,…
Pramipexole side effects
The following adverse reactions are discussed in greater detail in other sections of the labeling: • Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions (5.1)] • Symptomatic Orthostatic Hypotension [see Warnings and Precautions (5.2)] • Impulse Control/Compulsive Behaviors [see Warnings and Precautions (5.3)] • Hallucinations and Psychotic-like Behavior [see Warnings and Precautions (5.4)] • Dyskinesia [see Warnings and Precautions (5.5)] • Postural Deformity [see Warnings and Precautions (5.6)] • Rhabdomyolysis [see Warnings and Precautions (5.8)] • Retinal Pathology [see Warnings and Precautions (5.9)] • Events Reported with Dopaminergic Therapy [see Warnings and Precautions (5.10)] • Withdrawal Symptoms [see Warnings and Precautions (5.11)] Most common adverse reactions (incidence ≥5% and greater than placebo): · Early PD without levodopa: somnolence, nausea, constipation, dizziness, fatigue, hallucinations, dry mouth, muscle spasms, and peripheral edema (6.1) · Advanced PD with levodopa: dyskinesia, nausea, constipation, hallucinations, headache, and anorexia (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates…
Every pramipexole product we track (3)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Pramipexole pill imprints
Imprint
Strength
Colour
Shape
Maker
P1
0.125 mg
white
round
—
P2
0.25 mg
white
oval
—
P3
0.5 mg
white
oval
—
p4
0.75 mg
white
oval
—
p5
1 mg
white
round
—
P6
1.5 mg
white
Frequently asked questions
What is pramipexole?
Pramipexole dihydrochloride extended-release tablets contain pramipexole dihydrochloride (as a monohydrate). Pramipexole is, a non-ergot dopamine agonist. The chemical name of pramipexole dihydrochloride monohydrate is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate. Its empirical formula is C 10 H 17 N 3 S ·2HCl·H 2 O, and its molecular weight is 302.26. The structural formula is: Pramipexole dihydrochloride monohydrate USP is a white to almost white crystalline powder. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride monohydrate USP is freely soluble in water, soluble in methanol, slightly soluble in alcohol, practically insoluble in methylene chloride. Pramipexole Dihydrochloride Extended-Release Tablets 0.375 mg: Each extended-release tablet contains 0.375 mg pramipexole dihydrochloride monohydrate equivalent to 0.352 mg pramipexole dihydrochloride. Pramipexole Dihydrochloride Extended-Release Tablets 0.75 mg: Each extended-release tablet contains 0.75 mg pramipexole dihydrochloride monohydrate equivalent to 0.705 mg pramipexole dihydrochloride. Pramipexole Dihydrochloride Extended-Release Tablets 1.5 mg: Each extended-release tablet contains 1.5 mg pramipexole dihydrochloride monohydrate equivalent to 1.41 mg pramipexole dihydrochloride. Pramipexole Dihydrochloride Extended-Release…
What kind of drug is pramipexole?
The FDA classifies pramipexole as a nonergot dopamine agonist. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take pramipexole with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run pramipexole against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is pramipexole sold under?
We track 3 pramipexole-containing products in the U.S.: Mirapex, Mirapex ER and Pramipexole Dihydrochloride. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Who shouldn’t take pramipexole
None. None (4)
Pramipexole drug interactions
Dopamine antagonists: May diminish the effectiveness of pramipexole (7.1) 7.1 Dopamine Antagonists Since pramipexole is a dopamine agonist, it is possible that dopamine antagonists, such as the neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish the effectiveness of pramipexole dihydrochloride extended-release tablets.
Across the brands we track, pramipexole is currently marketed as tablet and tablet, extended release, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic pramipexole?
Yes. Our catalog lists 1 generic pramipexole product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.