Parkinson's disease

Active Ingredient: Rotigotine

Indication for Rotigotine

Population group: only adults (18 years old or older)
Therapeutic intent: Adjunct - intent

Neupro is indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease in combination with levodopa, i.e. over the course of the disease, through to late stages when the effect of levodopa wears off or becomes inconsistent and fluctuations of the therapeutic effect occur (end of dose or ‘on-off’ fluctuations).

For this indication, competent medicine agencies globally authorize below treatments:

4 mg/24 h once daily and then increased in weekly increments of 2 mg/24 h to a maximum dose of 16 mg/24 h

For:

Dosage regimens

Transdermal, 4 milligrams rotigotine, daily, over the duration of 1 week. Afterwards, transdermal, 6 milligrams rotigotine, daily, over the duration of 1 week. Afterwards, transdermal, 8 milligrams rotigotine, daily, over the duration of 1 week. Afterwards, transdermal, 10 milligrams rotigotine, daily, over the duration of 1 week. Afterwards, transdermal, 12 milligrams rotigotine, daily, over the duration of 1 week. Afterwards, transdermal, 14 milligrams rotigotine, daily, over the duration of 1 week. Afterwards, transdermal, 16 milligrams rotigotine, daily. The maximum allowed total dose is 16 milligrams rotigotine daily.

Detailed description

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.

Rotigotine patch 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

Restless Legs Syndrome

Rotigotine should be discontinued gradually. The daily dose should be reduced in steps of 1 mg/24 h with a dose reduction preferably every other day, until complete withdrawal of rotigotine. Following this procedure, rebound (worsening of symptoms beyond initial intensity after discontinuation of treatment) has not been observed.

Dosage considerations

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. Rotigotine patch should not be placed on skin that is red, irritated or damaged.

Active ingredient

Rotigotine

Rotigotine is a non-ergolinic dopamine agonist for the treatment of signs and symptoms of Parkinson’s disease and Restless Legs Syndrome.

Read more about Rotigotine

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