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  Zep Alcohol Sanitizer | Zydus Pharmaceuticals (usa) Inc.

  

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  2.1 General Dosing Considerations

  Pramipexole dihydrochloride tablets are taken orally, with or without food.

  If a significant interruption in therapy with pramipexole dihydrochloride tablets has occurred, re-titration of therapy may be warranted.

  2.2 Dosing for Parkinson’s Disease

  In all clinical studies, dosage was initiated at a subtherapeutic level to avoid intolerable adverse effects and orthostatic hypotension. Pramipexole dihydrochloride tablets should be titrated gradually in all patients. The dose should be increased to achieve a maximum therapeutic effect, balanced against the principal side effects of dyskinesia, hallucinations, somnolence, and dry mouth.

  Dosing in Patients with Normal Renal Function

  Initial Treatment

  Doses should be increased gradually from a starting dose of 0.375 mg/day given in three divided doses and should not be increased more frequently than every 5 to 7 days. A suggested ascending dosage schedule that was used in clinical studies is shown in Table 1:

  Table 1Ascending Dosage Schedule of Pramipexole Dihydrochloride Tablets for Parkinson’s Disease Week
  Dosage (mg)
  Total Daily Dose (mg)
  1
  0.125 three times a day
  0.375
  2
  0.25 three times a day
  0.75
  3
  0.5 three times a day
  1.50
  4
  0.75 three times a day
  2.25
  5
  1 three times a day
  3
  6
  1.25 three times a day
  3.75
  7
  1.5 three times a day
  4.50
  

  Maintenance Treatment

  Pramipexole dihydrochloride tablets were effective and well tolerated over a dosage range of 1.5 to 4.5 mg/day administered in equally divided doses three times per day with or without concomitant levodopa (approximately 800 mg/day).

  In a fixed-dose study in early Parkinson's disease patients, doses of 3 mg, 4.5 mg, and 6 mg per day of pramipexole dihydrochloride tablets were not shown to provide any significant benefit beyond that achieved at a daily dose of 1.5 mg/day. However, in the same fixed-dose study, the following adverse events were dose related: postural hypotension, nausea, constipation, somnolence, and amnesia. The frequency of these events was generally 2-fold greater than placebo for pramipexole doses greater than 3 mg/day. The incidence of somnolence reported with pramipexole at a dose of 1.5 mg/day was comparable to placebo.

  When pramipexole dihydrochloride tablets are used in combination with levodopa, a reduction of the levodopa dosage should be considered. In a controlled study in advanced Parkinson's disease, the dosage of levodopa was reduced by an average of 27% from baseline.

  Dosing in Patients with Renal Impairment

  The recommended dosing of pramipexole dihydrochloride tablets in Parkinson's disease patients with renal impairment is provided in Table 2.

  Table 2Dosing of Pramipexole Dihydrochloride Tablets in Parkinson’s Disease Patients with Renal Impairment Renal Status
  Starting Dose (mg)
  Maximum Dose (mg)
  Normal to mild impairment (creatinine Cl > 50 mL/min)
  0.125 three times a day
  1.5 three times a day
  Moderate impairment (creatinine Cl = 30 to 50 mL/min)
  0.125 twice a day
  0.75 three times a day
  Severe impairment (creatinine Cl = 15 to < 30 mL/min)
  0.125 once a day
  1.5 once a day 
  Very severe impairment (creatinine Cl < 15 mL/min and hemodialysis patients)
  The use of pramipexole dihydrochloride tablets has not been adequately studied in this group of patients.
  

  Discontinuation of Treatment

  Pramipexole dihydrochloride tablets may be tapered off at a rate of 0.75 mg per day until the daily dose has been reduced to 0.75 mg. Thereafter, the dose may be reduced by 0.375 mg per day.

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