Finished product reference
Pramipexole
Tablet · Oral · 0.088 mg
- List code
- 9238
- Salt form
- Dihydrochloride
Indications
Pramipexole dihydrochloride extended-release tablets are indicated for the treatment of Parkinson’s disease. Pramipexole dihydrochloride extended-release tablets are a non-ergot dopamine agonist indicated for the treatment of Parkinson’s disease (PD)
Dosage and administration (summary)
Pramipexole dihydrochloride extended-release tablets are taken once daily, with or without food Tablets must be swallowed whole and must not be chewed, crushed, or divided Starting dose is 0.375 mg given once daily 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 andtolerability at a minimal interval of 5 days or longer after each dose increment Patients may be switched overnight from immediate-release pramipexole tablets to pramipexole dihydrochloride extended-release tablets at the same daily dose.
Contraindications
None. None
Warnings and precautions
Falling Asleep During Activities of Daily Living: Sudden onset of sleep may occur without warning; advise patients to report symptoms Symptomatic Orthostatic Hypotension: Monitor closely especially during dose escalation Impulse Control/Compulsive Behaviors: Patients may experience compulsive behaviors and other intense urges Hallucinations and Psychotic-like Behavior: May occur.
Storage and supply
Storage and Handling Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Protect from exposure to high humidity. Store in a safe place out of the reach of children.
Source: Pramipexole Dihydrochloride (Pramipexole Dihydrochloride Extended-Release) — US FDA prescribing information, 2021-06-16, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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