Parkinson's Disease Treatments

Ropinirole hydrochloride is contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients.

The following adverse reactions are described in more detail in other sections of the label:

The symptoms of overdose with ropinirole hydrochloride 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.

Ropinirole tablets, USP are an orally administered non-ergoline dopamine agonist. It is the hydrochloride salt of 4-[2-(dipropylamino) ethyl]-1, 3-dihydro-2H-indol-2-one monohydrochloride and has an empirical formula of C

The structural formula is:

Ropinirole hydrochloride is an off white to light yellow, crystalline powder with a melting range of 243° to 250°C and a solubility of 133 mg/mL in water.

Each pentagonal film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg.

Inactive ingredients consist of: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, and one or more of the following: carmine, ferric ferrous oxide, ferric oxide red, ferric oxide yellow and indigotine aluminum lake.

Meets USP Dissolution Test #2

Ropinirole Tablet, USP 0.25 mg are white pentagonal tablets engraved “ROP” over “.25” on one side, “MLX” on the other side. They are supplied as follows:

Bottles of 100s: NDC 10135-0673-01

Ropinirole Tablet, USP 0.5 mg are yellow pentagonal tablets engraved “ROP” over “.5” on one side, “MLX” on the other side. They are supplied as follows:

Bottles of 100s: NDC 10135-0674-01

Ropinirole Tablet, USP 1 mg are green pentagonal tablets engraved “ROP” over “1” on one side, “MLX” on the other side. They are supplied as follows:

Bottles of 100s: NDC 10135-0675-01

Ropinirole Tablet, USP 2 mg are pink pentagonal tablets engraved “ROP” over “2” on one side, “MLX” on the other side. They are supplied as follows:

Bottles of 100s: NDC 10135-0676-01

Ropinirole Tablet, USP 3 mg are purple pentagonal tablets engraved “ROP” over “3” on one side, “MLX” on the other side. They are supplied as follows:

Bottles of 100s: NDC 10135-0677-01

Ropinirole Tablet, USP 4 mg are pale brown pentagonal tablets engraved “ROP” over “4” on one side, “MLX” on the other side. They are supplied as follows:

Bottles of 100s: NDC 10135-0678-01

Ropinirole Tablet, USP 5 mg are blue pentagonal tablets engraved “ROP” over “5” on one side, “MLX” on the other side. They are supplied as follows:

Bottles of 100s: NDC 10135-0679-01

Store at room temperature between 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Close container tightly after each use.

Advise the patient to read the FDA-approved patient labeling (

Instruct patients to take ropinirole hydrochloride only as prescribed. If a dose is missed, advise patients not to double their next dose. Ropinirole hydrochloride can be taken with or without food

Ropinirole is the active ingredient in both Ropinirole Hydrochloride XL and Ropinirole Hydrochloride tablets (the immediate-release formulation). Ask your patients if they are taking another medication containing ropinirole.

Advise patients about the potential for developing a hypersensitivity/allergic reaction including manifestations such as urticaria, angioedema, rash, and pruritus when taking any ropinirole product. Inform patients who experience these or similar reactions to immediately contact their healthcare professional

Alert patients to the potential sedating effects caused by ropinirole hydrochloride, including somnolence and the possibility of falling asleep while engaged in activities of daily living. Because somnolence is a frequent adverse reaction with potentially serious consequences, patients should not drive a car, operate machinery, or engage in other potentially dangerous activities until they have gained sufficient experience with ropinirole hydrochloride to gauge whether or not it adversely affects their mental and/or motor performance. Advise patients that if increased somnolence or episodes of falling asleep during activities of daily living (e.g., conversations, eating, driving a motor vehicle, etc.) are experienced at any time during treatment, they should not drive or participate in potentially dangerous activities until they have contacted their physician.

Advise patients of possible additive effects when patients are taking other sedating medications, alcohol, or other central nervous system depressants (e.g., benzodiazepines, antipsychotics, antidepressants, etc.) in combination with ropinirole hydrochloride or when taking a concomitant medication (e.g., ciprofloxacin) that increases plasma levels of ropinirole

Advise patients that they may experience syncope and may develop hypotension with or without symptoms such as dizziness, nausea, syncope, and sometimes sweating while taking ropinirole hydrochloride, especially if they are elderly. Hypotension and/or orthostatic symptoms may occur more frequently during initial therapy or with an increase in dose at any time (cases have been seen after weeks of treatment). Postural/orthostatic symptoms may be related to sitting up or standing.

Accordingly, caution patients against standing rapidly after sitting or lying down, especially if they have been doing so for prolonged periods and especially at the initiation of treatment with ropinirole hydrochloride

Inform patients that they may experience hallucinations (unreal visions, sounds, or sensations), and that other psychotic-like behavior can occur while taking ropinirole hydrochloride. The elderly are at greater risk than younger patients with Parkinson’s disease. This risk is greater in patients who are taking ropinirole hydrochloride with L-dopa or taking higher doses of ropinirole hydrochloride and may also be further increased in patients taking any other drugs that increase dopaminergic tone. Tell patients to report hallucinations or psychotic-like behavior to their healthcare provider promptly should they develop

Inform patients that ropinirole hydrochloride may cause and/or exacerbate pre-existing dyskinesias

Advise patients that they may experience impulse control and/or compulsive behaviors while taking 1 or more of the medications (including ropinirole hydrochloride) that increase central dopaminergic tone, that are generally used for the treatment of Parkinson’s disease. Advise patients to inform their physician or healthcare provider if they develop new or increased gambling urges, sexual urges, uncontrolled spending, binge or compulsive eating, or other urges while being treated with ropinirole hydrochloride. Physicians should consider dose reduction or stopping the medication if a patient develops such urges while taking ropinirole hydrochloride

Advise patients that withdrawal symptoms may occur during or after discontinuation or dose reduction of ropinirole hydrochloride. Advise patients who have been prescribed a lower dose or who have been withdrawn from the drug to notify their healthcare provider if they have withdrawal symptoms such as apathy, anxiety, depression, fatigue, insomnia, sweating, or pain. Notify patients that in case of severe withdrawal symptoms, a trial re-administration of a dopamine agonist at the lowest effective dose may be considered

Advise patients that withdrawal symptoms may occur during or after discontinuation or dose reduction of ropinirole hydrochloride. Advise patients who have been prescribed a lower dose or who have been withdrawn from the drug to notify their healthcare provider if they have withdrawal symptoms such as apathy, anxiety, depression, fatigue, insomnia, sweating, or pain. Notify patients that in case of severe withdrawal symptoms, a trial re-administration of a dopamine agonist at the lowest effective dose may be considered

Inform patients with RLS that augmentation and/or rebound may occur after starting treatment with ropinirole hydrochloride

Because of the possibility that ropinirole may be excreted in breast milk, discuss the developmental and health benefits of breastfeeding along with the mother’s clinical need for ropinirole hydrochloride tablets and any potential adverse effects on the breastfed child from ropinirole or from the underlying maternal condition

Because experience with ropinirole in pregnant women is limited and ropinirole has been shown to have adverse effects on embryofetal development in animals, including teratogenic effects, advise patients of this potential risk. Advise patients to notify their physician if they become pregnant or intend to become pregnant during therapy

Rev.1 09/21 IT

NDC 10135-0673-01

NDC 10135-0674-01

NDC 10135-0675-01

NDC 10135-0676-01

NDC 10135-0677-01

NDC 10135-0678-01

NDC 10135-0679-01