Pramipexole Dihydrochloride

Pramipexole dihydrochloride extended-release tablets are indicated for the treatment of Parkinson's disease. Pramipexole dihydrochloride extended-release tablet is a non-ergot dopamine agonist indicated for the treatment of Parkinson’s disease (PD) (1)

• 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 and tolerability at a minimal interval of 5 days or longer after each dose increment
• Patients may be switched overnight from immediate-release pramipexole tablets to extended-release pramipexole tablets at the same daily dose
• Dose adjustment may be needed in some patients Pramipexole dihydrochloride extended-release tablets should be discontinued gradually
• 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
• Recommended Dosage The starting dose is 0.375 mg given once per day
• Based on efficacy and tolerability, dosages 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. …

0. 375 mg: Off white, round shaped, biconvex, uncoated tablet, debossed with 'RDY' on one side and '611' on other side. Each extended-release tablet contains 0.375 mg pramipexole dihydrochloride monohydrate equivalent to 0.352 mg Pramipexole Dihydrochloride, USP. 0.75 mg: Off white, round shaped, biconvex, uncoated tablet, debossed with 'RDY' on one side and '612' on other side. …

• Safety and effectiveness of pramipexole dihydrochloride extended-release tablets
• In pediatric patients have not been evaluated

Pramipexole total oral clearance is approximately 30% lower in subjects older than 65 years compared with younger subjects, because of a decline in pramipexole renal clearance due to an age-related reduction in renal function. This resulted in an increase in elimination half-life from approximately 8.5 hours to 12 hours. …

• Advise the patient to read the FDA-approved patient labeling (Patient Information)
• Dosing Instructions Instruct patients to take pramipexole dihydrochloride extended-release tablets only as prescribed
• If a dose is missed, pramipexole dihydrochloride extended-release tablets should be taken as soon as possible, but no later than 12 hours after the regularly scheduled time
• After 12 hours, the missed dose should be skipped and the next dose should be taken on the following day at the regularly scheduled time
• Pramipexole dihydrochloride extended-release tablets can be taken with or without food. …

• None
• None

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.

Falling Asleep During Activities of Daily Living: Sudden onset of sleep may occur without warning; advise patients to report symptoms. (5.1) Symptomatic Orthostatic Hypotension: Monitor closely especially during dose escalation. (5.2) Impulse Control/Compulsive Behaviors: Patients may experience compulsive behaviors and other intense urges. (5.3) Hallucinations and Psychotic-like Behavior: May occur; risk increases with age. (5.4) Dyskinesia: May be caused or exacerbated by pramipexole dihydrochloride extended-release. (5.5) Postural Deformity: Consider reducing the dose or discontinuing pramipexole dihydrochloride extended-release tablets if postural deformity occurs. …

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 War …

8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of pramipexole dihydrochloride extended-release in pregnant women. No adverse developmental effects were observed in animal studies in which pramipexole was administered to rabbits during pregnancy. …

There is no clinical experience with significant overdosage. One patient took 11 mg/day of pramipexole for 2 days in a clinical trial for an investigational use. Blood pressure remained stable, although pulse rate increased to between 100 and 120 beats/minute. No other adverse reactions were reported related to the increased dose. There is no known antidote for overdosage of a dopamine agonist. …

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