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ropinirole
Overview
What is ropinirole?
Ropinirole Tablets USP contain ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP 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, USP is a pale cream to yellow powder with a melting range of 243° to 250°C and a solubility of 133 mg/mL in water.
Each circular film-coated tablet with beveled edges contains ropinirole hydrochloride, USP equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of citric acid anhydrous powder, croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The ingredients of the film coating for each tablet are as follows:
0.25 mg:
0.5 mg:
1 mg:
2 mg:
3 mg:
4 mg:
5 mg:
The product meets USP Dissolution Test 2.
What does ropinirole look like?
What are the available doses of ropinirole?
Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, and 5 mg ()
What should I talk to my health care provider before I take ropinirole?
Pregnancy: Based on animal data, may cause fetal harm. ()
How should I use ropinirole?
Ropinirole tablets are indicated for the treatment of Parkinson’s disease.
Ropinirole can be taken with or without food [].
If a significant interruption in therapy with ropinirole has occurred, retitration of therapy may be warranted.
What interacts with ropinirole?
Sorry No Records found
What are the warnings of ropinirole?
Sorry No Records found
What are the precautions of ropinirole?
Sorry No Records found
What are the side effects of ropinirole?
Sorry No records found
What should I look out for while using ropinirole?
Ropinirole is contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients.
What might happen if I take too much ropinirole?
The symptoms of overdose with ropinirole 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 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 in cases of overdose included vomiting, increased coughing, fatigue, syncope, vasovagal syncope, dyskinesia, agitation, chest pain, orthostatic hypotension, somnolence, and confusional state.
How should I store and handle ropinirole?
VFEND I.V. for Injection unreconstituted vials should be stored at 15° – 30°C (59° – 86°F) [see USP Controlled Room Temperature]. VFEND is a single dose unpreserved sterile lyophile. From a microbiological point of view, following reconstitution of the lyophile with Water for Injection, the reconstituted solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2° to 8°C (36° to 46°F). Chemical and physical in-use stability has been demonstrated for 24 hours at 2° to 8°C (36° to 46°F). This medicinal product is for single use only and any unused solution should be discarded. Only clear solutions without particles should be used .Product: 50436-0255NDC: 50436-0255-1 1 TABLET, FILM COATED in a POUCH / 50 in a BOX, UNIT-DOSE Product: 50436-0255NDC: 50436-0255-1 1 TABLET, FILM COATED in a POUCH / 50 in a BOX, UNIT-DOSE
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. The precise mechanism of action of ropinirole as a treatment for Restless Legs Syndrome is unknown, although it is thought to be related to its ability to stimulate dopamine receptors.
Non-Clinical Toxicology
Ropinirole is contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients.See for a listing of drugs that may significantly alter voriconazole concentrations. Also, see for a listing of drugs that may interact with voriconazole resulting in altered pharmacokinetics or pharmacodynamics of the other drug [see and ].
Patients treated with ropinirole 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.
In controlled clinical trials, somnolence was commonly reported in patients receiving ropinirole and was more frequent in Parkinson’s disease (up to 40% ropinirole, 6% placebo) than in Restless Legs Syndrome (12% ropinirole, 6% placebo) [
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 ropinirole tablets, patients should be advised of the potential to develop drowsiness and specifically asked about factors that may increase the risk with ropinirole such as concomitant sedating medications or alcohol, the presence of sleep disorders (other than RLS), 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), ropinirole tablets should ordinarily be discontinued [ If a decision is made to continue ropinirole tablets, 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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