Neupro 4 mg/24 h

Parkinson's Disease (PD)

Neupro 4 mg/24 h (Neupro 4 mg/24 h Transdermal System) is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.

The effectiveness of Neupro 4 mg/24 h was demonstrated in randomized, controlled trials in patients with early-stage Parkinson's disease who were not receiving concomitant levodopa therapy as well as in patients with advanced-stage Parkinson's disease on concomitant levodopa.

Restless Legs Syndrome (RLS)

Neupro 4 mg/24 h (Neupro 4 mg/24 h Transdermal System) is indicated for the treatment of moderate-to-severe primary restless legs syndrome.

Neupro 4 mg/24 h has some of the same effects as a chemical called dopamine, which occurs naturally in your body. Low levels of dopamine in the brain are associated with Parkinson's disease.

Neupro 4 mg/24 h transdermal (skin patch) is used to treat symptoms of Parkinson's disease, such as stiffness, tremors, muscle spasms, and poor muscle control. Neupro 4 mg/24 h is also used to treat restless legs syndrome (RLS).

Neupro 4 mg/24 h may also be used for purposes not listed in this medication guide.

Dosage in Parkinson's Disease

Early-Stage Parkinson's Disease

In patients with early-stage Parkinson's disease, the recommended starting dose for Neupro 4 mg/24 h is 2 mg/24 hours. Based upon individual patient clinical response and tolerability, Neupro 4 mg/24 h dosage may be increased weekly by 2 mg/24 hours if additional therapeutic effect is needed. The lowest effective dose is 4 mg/24 hours. The maximum recommended dose for early-stage Parkinson's disease is 6 mg/24 hours.

Advanced-Stage Parkinson's Disease

In patients with advanced-stage Parkinson's disease, the recommended starting dose for Neupro 4 mg/24 h is 4 mg/24 hours. Based upon individual patient clinical response and tolerability, Neupro 4 mg/24 h dosage may be increased weekly by 2 mg/24 hours if additional therapeutic effect is needed. The maximum recommended dose for advanced-stage Parkinson's disease is 8 mg/24 hours.

Dosage in Restless Legs Syndrome

In patients with Restless Legs Syndrome, the recommended starting dose for Neupro 4 mg/24 h is 1 mg/24 hours. Based upon individual patient clinical response and tolerability, Neupro 4 mg/24 h dosage may be increased weekly by 1 mg/24 hours if additional therapeutic effect is needed. The lowest effective dose is 1 mg/24 hours. The maximum recommended dose is 3 mg/24 hours.

Administration Information

Neupro 4 mg/24 h is applied once a day. The adhesive side of the transdermal system should be applied to clean, dry, intact healthy skin on the front of the abdomen, thigh, hip, flank, shoulder, or upper arm. The transdermal system should be applied at approximately the same time every day, at a convenient time for the patient. Because Neupro 4 mg/24 h is administered transdermally, food is not expected to affect absorption and it can be applied irrespective of the timing of meals. The application site for Neupro 4 mg/24 h should be moved on a daily basis (for example, from the right side to the left side and from the upper body to the lower body). Neupro 4 mg/24 h should not be applied to the same application site more than once every 14 days and should not be placed on skin that is oily, irritated, or damaged, or where it will be rubbed by tight clothing. If it is necessary to apply Neupro 4 mg/24 h to a hairy area, the area should be shaved at least 3 days prior to Neupro 4 mg/24 h application. The system should be applied immediately after opening the pouch and removing the protective liner. The system should be pressed firmly in place for 30 seconds, making sure there is good contact, especially around the edges. If the patient forgets to replace Neupro 4 mg/24 h, or if the transdermal system becomes dislodged, another transdermal system should be applied for the remainder of the day. The prescribed dose may be achieved using single or multiple patches.

Discontinuation of Neupro 4 mg/24 h

For discontinuation of Neupro 4 mg/24 h in patients with Parkinson's disease, reduce the daily dose by a maximum of 2 mg every 24 hours preferably every other day, until complete withdrawal of Neupro 4 mg/24 h is achieved.

For discontinuation of Neupro 4 mg/24 h in patients with Restless Legs Syndrome, reduce the daily dose by 1 mg every 24 hours preferably every other day, until complete withdrawal of Neupro 4 mg/24 h is achieved.

See also:
What is the most important information I should know about Neupro 4 mg/24 h?

Hypersensitivity to Neupro 4 mg/24 h or to any of the excipients of Neupro 4 mg/24 h.

Magnetic resonance imaging or cardioversion.

Use in pregnancy: There are no adequate data from the use of Neupro 4 mg/24 h in pregnant women. Animal studies do not indicate any teratogenic effects in rats and rabbits, but embryo-toxicity was observed in rats and mice at materno-toxic doses. The potential risk for humans is unknown. Neupro 4 mg/24 h should not be used during pregnancy.

Use Neupro 4 mg/24 h as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Neupro 4 mg/24 h. Talk to your pharmacist if you have questions about this information.
• Apply Neupro 4 mg/24 h only to clean, dry, intact skin on the front of the stomach, thigh, hip, side of the body between the ribs and hip, shoulder, or upper arm as directed by your doctor or on the package labeling.
• Do not apply Neupro 4 mg/24 h to hairy, oily, red, irritated, or damaged skin or where it will be rubbed by tight clothing or under a waistband. Do not apply to skin folds. If you must apply Neupro 4 mg/24 h to a hairy area of skin, shave the hair from the area at least 3 days before you apply Neupro 4 mg/24 h to that area.
• Do not apply creams, lotions, ointments, oils, or powders to the skin where the patch will be applied. Never cut or tear the patch.
• To use Neupro 4 mg/24 h, gently wash the application site with soap and warm water. Rinse until all soap is removed. Dry the area with a clean, dry towel.
• Remove the patch from its sealed pouch and peel away one side of the protective liner. Apply the sticky side of the patch to the skin immediately after opening the pouch. Peel away the rest of the liner so that the patch lies flat against the skin. There should be no bumps or folds in the patch. Press the patch against your skin firmly with the palm of your hand for 30 seconds to make sure there is good contact with the skin, especially around the edges.
• Wash your hands thoroughly with soap and water after applying Neupro 4 mg/24 h. Do not touch your eyes until after you have washed your hands.
• After 24 hours, remove the used patch and fold it in half with the sticky sides together. Discard out of the reach of children and away from pets. Wash the area with mild soap and warm water to remove any adhesive remaining on the skin. Baby or mineral oil may also be used to remove adhesive. Do not use alcohol or nail polish remover to remove adhesive. Apply a new patch to a different area of skin. Use a new application site each time you apply a new patch. Do not apply a patch to the same area of skin within 14 days.
• You may bathe, shower, or swim while wearing your patch.
• Do not suddenly stop using Neupro 4 mg/24 h without checking with your doctor. You may have an increased risk of side effects (eg, fever; confusion; muscle stiffness, pain, or weakness; kidney problems). If you need to stop Neupro 4 mg/24 h, your doctor should gradually lower your dose.
• Apply Neupro 4 mg/24 h 1 time each day at about the same time to get the most benefit from it.
• Continue to use Neupro 4 mg/24 h even if you feel well. Do not miss any doses.
• If the edges of your patch lift, you may tape them down with bandaging tape. If your patch falls off, apply a new patch for the rest of the day.
• If you miss a dose of Neupro 4 mg/24 h or forget to change your patch, remove the old patch and apply a new patch to a different area of skin. Then change the patch according to your regular dosing schedule. Do not wear 2 patches at once.

Ask your health care provider any questions you may have about how to use Neupro 4 mg/24 h.

Use: Labeled Indications

Parkinson disease: For the treatment of Parkinson disease.

Restless legs syndrome: For the treatment of moderate to severe primary restless legs syndrome.

See also:
What other drugs will affect Neupro 4 mg/24 h?

Because Neupro 4 mg/24 h is a dopamine agonist, it is assumed that dopamine antagonists eg, neuroleptics (eg, phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish the effectiveness of Neupro 4 mg/24 h and co-administration should be avoided. Because of possible additive effects, caution should be advised when patients are taking sedating medicinal products or other CNS depressants (eg, benzodiazepines, antipsychotics, antidepressants) or alcohol in combination with Neupro 4 mg/24 h.

Co-administration of enzyme inducing active substances (eg, rifampicin, phenobarbital, carbamazepine, phenytoin, St. John's wort/Hypericum perforatum) has not been investigated.

Co-administration of L-dopa and carbidopa with Neupro 4 mg/24 h had no effect on the pharmacokinetics of Neupro 4 mg/24 h, and Neupro 4 mg/24 h had no effect on the pharmacokinetics of L-dopa and carbidopa.

Co-administration of domperidone with Neupro 4 mg/24 h had no effect on the pharmacokinetics of Neupro 4 mg/24 h.

Co-administration of omeprazole (inhibitor of CYP2C19), in doses of 40 mg/day, had no effect on the pharmacokinetics and metabolism of Neupro 4 mg/24 h in healthy volunteers.

Neupro 4 mg/24 h may potentiate the dopaminergic adverse reaction of L-dopa and may cause and/or exacerbate preexisting dyskinesia, as described with other dopamine agonists.

Co-administration of Neupro 4 mg/24 h (3 mg/24 hrs) did not affect the pharmacodynamics and pharmacokinetics of oral contraceptives (ethinylestradiol 0.03 mg, levonorgestrel 0.15 mg).

Interactions with other forms of hormonal contraception have not been investigated.

Incompatibilities: Not applicable.

See also:
What are the possible side effects of Neupro 4 mg/24 h?

Based on the analysis of pooled placebo-controlled clinical trials comprising a total of 1083 Neupro 4 mg/24 h- and 508 placebo-treated patients, 73% of the patients on Neupro 4 mg/24 h and 56.3% of patients on placebo reported at least 1 adverse reaction.

At the beginning of therapy, dopaminergic adverse reactions eg, nausea and vomiting may occur. These are usually mild or moderate in intensity and transient even if treatment is continued.

Adverse drug reactions (ADRs) reported in >10% of patients treated with Neupro 4 mg/24 h patch are nausea, dizziness, somnolence and application site reactions.

In trials where the application sites were rotated as reflected in the instructions provided, 35.7% of 830 patients using the Neupro 4 mg/24 h patch experienced application site reactions. The majority of these reactions were mild or moderate in intensity, limited to the application areas and resulted in discontinuation of treatment with Neupro 4 mg/24 h in only 4.3% of all subjects receiving Neupro 4 mg/24 h.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

The following table covers adverse drug reactions from all studies in patients with Parkinson's disease.

Neupro 4 mg/24 h has been associated with somnolence including excessive daytime somnolence and sudden sleep onset episodes. In isolated cases, "sudden onset of sleep" occurred while driving and resulted in motor vehicle accidents..

Patients treated with dopamine agonists for treatment of Parkinson's disease, including Neupro 4 mg/24 h, have been reported as exhibiting signs of pathological gambling, increased libido and hypersexuality, generally reversible upon reduction of the dose or treatment discontinuation.

Neupro 4 mg/24 h 2 mg/24 hrs contains Rotigotine 4.5 mg, 4 mg/24 hrs contains Rotigotine 9 mg, 6 mg/24 hrs contains Rotigotine 13.5 mg and 8 mg/24 hrs contains Rotigotine 18 mg.

Neupro 4 mg/24 h also contains the following excipients: Poly(dimethylsiloxane, trimethylsilyl silicate)-copolymerisate, povidone K90, sodium metabisulphite (E223), ascorbyl palmitate (E304) and DL-α-tocopherol (E307). Backing Layer: Polyester film, siliconized, aluminized, colour-coated with a pigment (titanium dioxide (E171), yellow pigment 95, red pigment 166) layer and imprinted (red pigment 144, yellow pigment 95, black pigment 7). Release Liner: Transparent fluoropolymer-coated polyester film.

The outside of the backing layer is tan-coloured and imprinted with Neupro 4 mg/24 h 2 mg/24 h, Neupro 4 mg/24 h 4 mg/24 h, Neupro 4 mg/24 h 6 mg/24 h or Neupro 4 mg/24 h 8 mg/24 h.