Neupro

Neupro Dosage/Direction for Use

rotigotine

Manufacturer:

UCB

Distributor:

Zuellig Pharma

Marketer:

Abbott
Full Prescribing Info
Dosage/Direction for Use
Posology: The dose recommendations made are in nominal dose.
Dosing in patients with early-stage Parkinson's disease: A single daily dose should be initiated at 2 mg/24 h and then increased in weekly increments of 2 mg/24 h to an effective dose up to a maximum dose of 8 mg/24 h.
4 mg/24 h may be an effective dose in some patients. For most patients an effective dose is reached within 3 or 4 weeks at doses of 6 mg/24 h or 8 mg/24 h, respectively.
The maximum dose is 8 mg/24 h.
Dosing in patients with advanced stage Parkinson's disease with fluctuations: A single daily dose should be initiated at 4 mg/24 h and then increased in weekly increments of 2 mg/24 h to an effective dose up to a maximum dose of 16 mg/24 h.
4 mg/24 h or 6 mg/24 h may be effective doses in some patients. For most patients an effective dose is reached within 3 to 7 weeks at doses of 8 mg/24 h up to a maximum dose of 16 mg/24 h.
For doses higher than 8 mg/24 h multiple patches may be used to achieve the final dose e.g. 10 mg/24 h may be reached by combination of a 6 mg/24 h and a 4 mg/24 h patch.
Neupro is applied once a day. The patch should be applied at approximately the same time every day. The patch remains on the skin for 24 hours and will then be replaced by a new one at a different site of application.
If the patient forgets to apply the patch at the usual time of the day or if the patch becomes detached, another patch should be applied for the remainder of the day.
Treatment discontinuation: Neupro should be discontinued gradually. The daily dose should be reduced in steps of 2 mg/24 h with a dose reduction preferably every other day, until complete withdrawal of Neupro (see Precautions).
Special populations: Hepatic impairment: Adjustment of the dose is not necessary in patients with mild to moderate hepatic impairment. Caution is advised when treating patients with severe hepatic impairment, which may result in lower rotigotine clearance. Neupro has not been investigated in this patient group. A dose reduction might be needed in case of worsening of the hepatic impairment.
Renal impairment: Adjustment of the dose is not necessary in patients with mild to severe renal impairment, including those requiring dialysis. Unexpected accumulation of rotigotine levels may also occur at acute worsening of renal function (see Pharmacology: Pharmacokinetics under Actions).
Paediatric population: There is no relevant use of Neupro in the paediatric population in Parkinson's disease.
Method of administration: Neupro is for transdermal use.
The patch should be applied to clean, dry, intact healthy skin on the abdomen, thigh, hip, flank, shoulder, or upper arm. Reapplication to the same site within 14 days should be avoided. Neupro should not be placed on skin that is red, irritated or damaged. (See Precautions.)
Use and handling: Each patch is packed in a sachet and should be applied directly after the sachet has been opened. One half of the release liner should be removed and the sticky side should be applied and pressed firmly to the skin. Then, the patch is folded back and the second part of the release liner is removed. The sticky side of the patch should not be touched. The patch should be pressed down firmly with the palm of the hand for about 30 seconds, so that it sticks well.
The patch should not be cut into pieces.
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