Neupro


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(rotigotine transdermal system, UCB Inc.)

Approved 5/9/2007

How It Works:

Rotigotine is a non-ergoline dopamine agonist extensively metabolized by conjugation and N-dealkylation. The mechanism by which rotigotine exerts its therapeutic effects in RLS is unknown, but it may be related to its ability to stimulate dopamine receptors.

Things to Look Out for:

  • Sulfite sensitivity
  • Somnolence – falling asleep during daily activities
  • Hallucinations
  • Mental status and behavioral changes
  • Symptomatic postural/orthostatic hypotension
  • Syncope
  • Reduced impulse control
  • Compulsive behaviors
  • Elevated blood pressure and heart rate
  • Weight gain/fluid retention
  • Dyskinesia
  • Application site reactions
  • Melanoma
  • Rebound or augmentation of RLS symptoms

Use in Special Populations:

  • Pregnancy: Category C. No adequate and well-controlled studies conducted in pregnant women.
  • Nursing mothers: It is not known whether this drug is excreted in human milk. Caution when administering to a nursing mother.
  • Children: Safety and effectiveness in pediatric patients has not been established.
  • Elderly: No overall differences in safety and effectiveness were observed between younger and ≥65 years of age patients.
  • Renal impairment: No dose adjustment is recommended.
  • Hepatic impairment: No dose adjustment is recommended in moderate hepatic impairment. No information is available for patients with severe hepatic impairment.

What to Tell Your Patients:

  • May have sedating effects.
  • May develop hypotension; caution against rising rapidly after sitting or lying down.
  • May experience intense urges and the inability to control these urges.
  • May elevate blood pressure and heart rate; increase in weight and fluid retention is possible.
  • Remove prior to MRI or cardioversion.
  • Avoid exposing application site to external sources of direct heat.
  • Rotate application site daily. Do not apply to same site more than once every 14 days.
  • Nausea and vomiting may occur more frequently during initial therapy.

Requip

(ropinirole hydrochloride tablets; GlaxoSmithKline)

Approved 9/19/1997

How It Works:

Ropinirole is a non-ergoline dopamine agonist with high relative in vitro specificity and full intrinsic activity at the D2 and D3 dopamine receptor subtypes, binding with higher affinity to D3 than to D2 or D4 receptor subtypes. The mechanism by which ropinirole exerts its therapeutic effects in RLS is unknown, but may involve the primary dopaminergic system.

Things to Look Out for:

  • Somnolence – falling asleep during daily activities
  • Syncope
  • Symptomatic hypotension
  • Hallucinations
  • Dyskinesia
  • Melanoma
  • Rebound or augmentation of RLS symptoms

Use in Special Populations:

  • Pregnancy: Category C. No adequate and well-controlled studies conducted in pregnant women.
  • Nursing mothers: It is not known whether this drug is excreted in human milk. Caution when administering to a nursing mother.
  • Children: Safety and effectiveness in pediatric patients has not been established.
  • Elderly: No dose adjustment is necessary.
  • Renal impairment: No dose adjustment is necessary in mild-moderate renal impairment. Use in severe renal impairment has not been studied.
  • Hepatic impairment: Titrate with caution.

What to Tell Your Patients:

  • May take with food to reduce nausea.
  • May have sedating effects.
  • May develop hypotension; caution against rising rapidly after sitting or lying down.
  • May experience intense urges and the inability to control these urges.
  • Women should notify their physician if they become pregnant, intend to become pregnant, intend to breastfeed or are breastfeeding during therapy.

For more information, visit our Restless Legs Syndrome section.