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REQUIP
Overview
What is REQUIP?
REQUIP XL contains ropinirole, a non‑ergoline dopamine agonist as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is CHNO•HCl. The molecular weight is 296.84 (260.38 as the free base).
The structural formula is:
Ropinirole hydrochloride is a white to yellow solid with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water.
REQUIP XL extended-release tablets are formulated as a 3-layered tablet with a central, active-containing, slow-release layer, and 2 placebo outer layers acting as barrier layers that control the surface area available for drug release. Each biconvex, capsule-shaped tablet contains 2.28, 4.56, 6.84, 9.12, or 13.68 mg of ropinirole hydrochloride equivalent to ropinirole 2, 4, 6, 8, or 12 mg, respectively. Inactive ingredients consist of carboxymethylcellulose sodium, colloidal silicon dioxide, glyceryl 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.
What does REQUIP look like?
What are the available doses of REQUIP?
Tablets: 2 mg, 4 mg, 6 mg, 8 mg, and 12 mg ()
What should I talk to my health care provider before I take REQUIP?
Pregnancy: Based on animal data, may cause fetal harm. ()
How should I use REQUIP?
REQUIP XL is indicated for the treatment of Parkinson’s disease.
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What interacts with REQUIP?
Sorry No Records found
What are the warnings of REQUIP?
Sorry No Records found
What are the precautions of REQUIP?
Sorry No Records found
What are the side effects of REQUIP?
Sorry No records found
What should I look out for while using REQUIP?
REQUIP XL is contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or any of the excipients.
What might happen if I take too much REQUIP?
The symptoms of overdose with REQUIP XL are related to its dopaminergic activity. General supportive measures are recommended. Vital signs should be maintained, if necessary.
In clinical trials, there have been patients who accidentally or intentionally took more than their prescribed dose of ropinirole. The largest overdose reported with immediate-release ropinirole in clinical trials was 435 mg taken over a 7-day period (62.1 mg/day). Of patients who received a dose greater than 24 mg/day, reported symptoms included adverse events commonly reported during dopaminergic therapy (nausea, dizziness), as well as visual hallucinations, hyperhidrosis, claustrophobia, chorea, palpitations, asthenia, and nightmares. Additional symptoms reported for overdoses included vomiting, increased coughing, fatigue, syncope, vasovagal syncope, dyskinesia, agitation, chest pain, orthostatic hypotension, somnolence, and confusional state.
How should I store and handle REQUIP?
Each biconvex, capsule-shaped, film-coated tablet contains ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows:StorageStore at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Each biconvex, capsule-shaped, film-coated tablet contains ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows:StorageStore at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Each biconvex, capsule-shaped, film-coated tablet contains ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows:StorageStore at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.Each biconvex, capsule-shaped, film-coated tablet contains ropinirole hydrochloride equivalent to the labeled amount of ropinirole as follows:StorageStore at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Ropinirole is a non-ergoline dopamine agonist. The precise mechanism of action of ropinirole as a treatment for Parkinson’s disease is unknown, although it is thought to be related to its ability to stimulate dopamine D receptors within the caudate-putamen in the brain.
Non-Clinical Toxicology
REQUIP XL is contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or any of the excipients.Patients treated with REQUIP XL have reported falling asleep while engaged in activities of daily living, including driving or operating machinery, which sometimes resulted in accidents. Although many of these patients reported somnolence while on ropinirole, some perceived that they had no warning signs, such as excessive drowsiness, and believed that they were alert immediately prior to the event. Some have reported these events more than 1 year after initiation of treatment.
Among the 613 patients who received REQUIP XL in flexible-dose clinical trials (Study 1 and Study 3), <1% of patients reported sudden onset of sleep and <1% of patients reported a motor vehicle accident in which it is not known if falling asleep was a contributing factor.
In a placebo-controlled fixed-dose trial in patients with advanced Parkinson’s disease (Study 2), sudden onset of sleep was reported in 4% of 276 patients on REQUIP XL compared with 3% of 74 patients on placebo. In a placebo-controlled fixed-dose trial in patients with early Parkinson’s disease (Study 4), sudden onset of sleep was reported in 5% of 146 patients on REQUIP XL compared with 0% of 40 patients on placebo . The incidence of sudden onset of sleep was not dose-related in either trial.
During a placebo-controlled flexible-dose trial in patients with advanced Parkinson’s disease (Study 1), somnolence was reported in 7% of 202 patients on REQUIP XL compared with 4% of 191 patients on placebo. During a flexible-dose, active-control, crossover trial in early Parkinson’s disease (Study 3), somnolence was reported in 11% of 140 patients on REQUIP XL compared with 15% of 149 patients on an immediate-release formulation of REQUIP .
In a placebo-controlled fixed-dose trial in patients with advanced Parkinson’s disease (Study 2), somnolence was reported in 8% of 276 patients on REQUIP XL compared with 5% of 74 patients on placebo. In a placebo-controlled fixed-dose trial in patients with early Parkinson’s disease (Study 4), somnolence was reported in 10% of 146 patients on REQUIP XL compared with 5% of 40 patients on placebo . The frequency of reported somnolence was not dose-related.
It has been reported that falling asleep while engaged in activities of daily living usually occurs in a setting of pre-existing somnolence, although patients may not give such a history. For this reason, prescribers should reassess patients for drowsiness or sleepiness, especially since some of the events occur well after the start of treatment. Prescribers should also be aware that patients may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or sleepiness during specific activities.
Before initiating treatment with REQUIP XL, patients should be advised of the potential to develop drowsiness and specifically asked about factors that may increase the risk with REQUIP XL such as concomitant sedating medications or alcohol, the presence of sleep disorders, and concomitant medications that increase ropinirole plasma levels (e.g., ciprofloxacin) . If a patient develops significant daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g., driving a motor vehicle, conversations, eating), REQUIP XL should ordinarily be discontinued . If a decision is made to continue REQUIP XL, patients should be advised to not drive and to avoid other potentially dangerous activities. There is insufficient information to establish that dose reduction will eliminate episodes of falling asleep while engaged in activities of daily living.
The following adverse reactions are described in more detail in other sections of the label:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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