Ropinirole hydrochloride

What is Ropinirole hydrochloride?

• Ropinirole hydrochloride (Requip; Requip XL) is an orally administered, non-ergoline dopamine agonist used in the treatment of signs and symptoms of idiopathic Parkinson’s disease.

What are the uses of this medicine?

• Ropinirole hydrochloride (Requip is a short-acting prescription medicine containing ropinirole (usually taken 3 times a day) used to treat Parkinson's disease.
• It is also used to treat a condition called Restless Legs Syndrome.
• Requip XL is a long-acting prescription medicine containing ropinirole (taken once a day) used to treat Parkinson’s disease.

How does this medicine work?

• Ropinirole (roe pin' i role") is a synthetic, non ergot derivative dopamine receptor agonist that has selective activity for the D2 class of dopamine receptors and little agonist activity for the D1 class.
• For this reason, ropinirole may be better tolerated than bromocriptine or pergolide, which act on both classes of dopamine receptors.
• The precise mechanism of action of ropinirole as a treatment for Parkinson’s disease is unknown, although it is believed to be due to stimulation of postsynaptic dopamine D2-type receptors within the caudate-putamen in the brain.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Adjustment of dosage of Requip XL may be required when used with CYP1A2 inhibitors (e.g., ciprofloxacin, fluvoxamine) or inducers (e.g., omeprazole or smoking).
• Higher doses of estrogens, usually associated with hormone replacement therapy (HRT), reduced oral clearance of ropinirole. Starting or stopping HRT treatment may require adjustment of dosage of Requip XL.
• Dopamine antagonists, such as neuroleptics (e.g., phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish effectiveness of ropinirole.

Is this medicine FDA approved?

• It was approved for medical use in the United States in 1997.

How should this medicine be used?

Recommended dosage:

• The starting dose is 2 mg taken once daily for 1 to 2 weeks, followed by increases of 2 mg/day at 1 week or longer intervals as appropriate, depending on therapeutic response and tolerability, up to a maximally recommended dose of 24 mg/day.
• Patients should be assessed for therapeutic response and tolerability at a minimal interval of 1 week or longer after each dose increment.
• Caution should be exercised during dose titration because too rapid a rate of titration can lead to dose selection that does not provide additional benefit, but that increases the risk of adverse reactions.
• Patients may be switched directly from immediate-release ropinirole to Requip XL. The initial switching dose of Requip XL should most closely match the total daily dose of immediate-release ropinirole.
• If Requip XL must be discontinued, it should be tapered gradually over a 7-day period.

Administration:

• Take REQUIP or Requip XL exactly as directed by your healthcare provider.
• Do not suddenly stop taking REQUIP or Requip XL without talking to your healthcare provider. If you stop this medicine suddenly, you may develop fever, confusion, or severe muscle stiffness.
• Before starting REQUIP or Requip XL, you should talk to your healthcare provider about what to do if you miss a dose. If you have missed the previous dose and it is time for your next dose, do not double the dose.
• Your healthcare provider will start you on a low dose of REQUIP or Requip XL. Your healthcare provider will change the dose until you are taking the right amount of medicine to control your symptoms. It may take several weeks before you reach a dose that controls your symptoms.

If you are taking REQUIP:

• REQUIP Tablets are usually taken 3 times each day for Parkinson's disease.

If you are taking Requip XL:

• Take Requip XL Tablets 1 time each day for Parkinson’s disease, preferably at or around the same time of day.
• Swallow Requip XL Tablets whole. Do not chew, crush, or split Requip XL Tablets.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 2 mg, 4 mg, 6 mg, 8 mg, and 12 mg

This medicine is available in fallowing brand namesː

• REQUIP ; Requip XL

What side effects can this medication cause?

The most common side effects of this medicine include: Common side effects in people taking REQUIP and Requip XL include:

• Fainting
• Sleepiness
• Hallucinations
• Dizziness
• Nausea or vomiting
• Uncontrolled sudden movements
• Leg swelling
• Fatigue
• Headache
• Upset stomach
• Increased sweating

REQUIP and Requip XL can cause serious side effects including:

• Falling asleep during normal activities
• Changes in blood pressure
• Fainting
• Hallucinations
• Uncontrolled sudden movements
• Unusual urges

What special precautions should I follow?

• Falling asleep during activities of daily living may occur, including the operation of motor vehicles, which sometimes resulted in accidents. Sudden onset of sleep may occur without apparent warning or daytime drowsiness. Sedating medications (such as alcohol or CNS depressants), the presence of sleeping disorders, or other medications that increase plasma levels of ropinirole, may increase the risk of somnolence or falling asleep while engaged in activities of daily living. Before initiating treatment, patients should be advised of the potential of sudden onset of sleep or to develop drowsiness and asked about risk factors they may have. If a patient develops sudden onset of sleep during activities that require active participation (e.g., conversations, eating, etc.) and/or cannot avoid high-risk activities in the future, Requip XL should ordinarily be discontinued.
• Syncope, sometimes associated with bradycardia, was observed during treatment with ropinirole in Parkinson’s disease patients.
• Dopamine agonists, in clinical studies and clinical experience, appear to impair the systemic regulation of blood pressure, with resulting postural hypotension, especially during dose escalation.
• Elevation of blood pressure and changes in heart rate may occur. Elevation of blood pressure and/or changes in heart rate in patients taking Requip XL should be considered when treating patients with cardiovascular disease.
• Hallucination may occur.
• Requip XL may potentiate the dopaminergic side effects of L-dopa and may cause and/or exacerbate preexisting dyskinesia in patients treated with L-dopa for Parkinson’s disease. Decreasing the dose of a dopaminergic drug may ameliorate this side effect.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• nausea, dizziness, as well as visual hallucination, hyperhidrosis, claustrophobia, chorea, palpitations, asthenia, and nightmares. Additional symptoms reported for doses of 24 mg or less or for overdoses of unknown amount included vomiting, increased coughing, fatigue, syncope, vasovagal syncope, dyskinesia, agitation, chest pain, orthostatic hypotension, somnolence, and confusional state.

Treatment of overdosage:

• The symptoms of overdose with ropinirole are generally related to its dopaminergic activity; these symptoms may be alleviated by appropriate treatment with dopamine antagonists such as neuroleptics or metoclopramide.
• General supportive measures are recommended.
• Vital signs should be maintained, if necessary.
• Removal of any unabsorbed material (e.g., by gastric lavage) may be considered.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• There are no adequate and well-controlled studies using ropinirole in pregnant women.
• Requip XL should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

Can this medicine be used in children?

• Safety and effectiveness in the pediatric population have not been established.

What are the active and inactive ingredients in this medicine?

REQUIP:

• Active ingredient: ropinirole (as ropinirole hydrochloride)
• Inactive ingredients: croscarmellose sodium, hydrous lactose, magnesium stearate, microcrystalline cellulose, and one or more of the following: carmine, FD&C Blue No. 2 aluminum lake, FD&C Yellow No. 6 aluminum lake, hypromellose, iron oxides, polyethylene glycol, polysorbate 80, titanium dioxide.

Requip XL:

• Active ingredient: ropinirole (as ropinirole hydrochloride)
• Inactive ingredients: carboxymethylcellulose sodium, colloidal silicon dioxide, glycerol behenate, hydrogenated castor oil, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, mannitol, povidone, and one or more of the following: FD&C Yellow No. 6 aluminum lake, FD&C Blue No. 2 aluminum lake, ferric oxides (black, red, yellow), polyethylene glycol 400, titanium dioxide.

Who manufactures and distributes this medicine?

• GlaxoSmithKline
• Research Triangle Park, NC

What should I know about storage and disposal of this medication?

• Store REQUIP Tablets between 68°-77°F (20°-25°C).
• Store Requip XL Tablets between 59°-86°F (15°-30°C).
• Store REQUIP or Requip XL at room temperature out of direct sunlight.
• Keep REQUIP or Requip XL in a tightly closed container.
• Keep REQUIP or Requip XL out of the reach of children.

• Dailymed label info on Ropinirole hydrochloride
• FDA Ropinirole hydrochloride

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