ROPINIROLE 1 mg Tablet, Film Coated, 100-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Nonergot Dopamine Agonist class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Ropinirole is used to treat two conditions: Parkinson's disease and moderate-to-severe Restless Legs Syndrome (RLS). For Parkinson's disease, both the regular tablet and the extend...
- Yes, and it's one of the most important things to know. Some people on ropinirole have fallen asleep suddenly during everyday activities — including driving — sometimes without fee...
- I heard ropinirole can make you fall asleep suddenly — is that really true?
- Please don't stop it suddenly without talking to your doctor first — especially if you're taking it for Parkinson's disease. Stopping abruptly can cause a serious reaction that inc...
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.048 | $4.77 / 100 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.2061 | $20.61 / 100 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.1218 | $12.18 / 100 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ropinirole 1 mg 00904-6374-61 | Major | 1 tablet | $0.048 | AB | Availability likely | — |
| ropinirole hydrochloride 1 mg 43547-0270-10 | SOLCO | 100 tablets | $0.048 | AB | Availability likely | — |
| ropinirole hydrochloride 1 mg 50268-0743-15 | AvPAK | 1 tablet | $0.048 | AB | Availability likely | — |
| ropinirole hydrochloride 1 mg 60687-0588-01 | American | 1 tablet | $0.048 | AB | Availability likely | — |
| Ropinirole 1 mgthis 62332-0032-31 | Alembic | 100 tablets | $0.048 | AB | Availability likely | — |
| ropinirole 1 mg 68462-0255-01 | Glenmark | 100 tablets | $0.048 | AB | Availability likely | — |
| Ropinirole 1 mg 69452-0358-20 | Bionpharma | 100 tablets | $0.048 | AB | Availability likely | — |
| ropinirole 1 mg 16729-0234-01 | Accord | 100 tablets | $0.058 | AB | FDA listed | +21% |
| Ropinirole Hydrochloride 1 mg 00615-8190-39 | NCS | 30 tablets | — | AB | FDA listed | — |
| Ropinirole 1 mg 10135-0675-01 | Marlex | 100 tablets | — | AB | FDA listed | — |
| ropinirole hydrochloride 1 mg 43547-0597-10 | SOLCO | 100 tablets | — | AB | FDA listed | — |
| Ropinirole 1 mg 46708-0032-30 | Alembic | 30 tablets | — | AB | FDA listed | — |
| ropinirole hydrochloride 1 mg 50090-4348-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| ropinirole 1 mg 50090-4684-00 | A-S | 30 tablets | — | AB | FDA listed | — |
| Ropinirole 1 mg 55154-7633-00 | Cardinal | 1 tablet | — | AB | FDA listed | — |
| ropinirole 1 mg 70518-3482-00 | REMEDYREPACK | 30 tablets | — | AB | FDA listed | — |
| ropinirole 1 mg 71335-0447-01 | Bryant | 30 tablets | — | AB | Discontinued | — |
| Ropinirole Hydrochloride 1 mg 71335-0829-01 | Bryant | 30 tablets | — | AB | Discontinued | — |
| ropinirole hydrochloride 1 mg 71335-1434-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| ropinirole 1 mg 71335-1982-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Ropinirole 1 mg 71335-9656-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Ropinirole 1 mg 72189-0222-30 | DIRECT | 30 tablets | — | AB | FDA listed | — |
| Ropinirole 1 mg 72189-0494-30 | Direct_Rx | 30 tablets | — | AB | FDA listed | — |
| Ropinirole 1 mg 87063-0200-01 | ASCLEMED | 100 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 62332-0032-30 | 30 TABLET, FILM COATED in 1 BOTTLE (62332-032-30) | — | — | 2016-01-29 | Active |
| 62332-0032-31 You're viewing this | 100 TABLET, FILM COATED in 1 BOTTLE (62332-032-31) | $0.0477 / ea | $4.77 | 2016-01-29 | Active |
You're viewing the largest of 2 pack sizes for this product.
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 62332-0032-31?
What is the difference between NDC 62332-0032-31 and NDC 62332-0032-30?
What NDC number is used to bill for this package of ROPINIROLE 1 mg Tablet, Film Coated?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Ropinirole Tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). ( 1.1 , 1.2 ).
1.1Parkinson's Disease Ropinirole tablets are indicated for the treatment of Parkinson’s disease.
1.2Restless Legs Syndrome Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • Ropinirole tablets can be taken with or without food. ( 2.1 ) • Retitration of ropinirole tablets may be warranted if therapy is interrupted. ( 2.1 ) Parkinson’s Disease: • The recommended starting dose is 0.25 mg taken three times daily; titrate to a maximum daily dose of 24 mg.
( 2.2 ) • Renal Impairment: The maximum recommended dose is 18 mg/day in patients with end-stage renal disease on hemodialysis. ( 2.2 ) Restless Legs Syndrome: • The recommended starting dose is 0.25 mg once daily, 1 to 3 hours before bedtime, titrate to a maximum recommended dose of 4 mg daily. ( 2.3 ) • Renal Impairment: The maximum recommended dose is 3 mg/day in patients with end-stage renal disease on hemodialysis.
( 2.3 )
2.1General Dosing Recommendations Ropinirole tablets can be taken with or without food [see Clinical Pharmacology (12.3)] . If a significant interruption in therapy with ropinirole tablets have occurred, retitration of therapy may be warranted.
2.2Dosing for Parkinson's Disease Week Dosage Total Daily Dose 1 0.25 mg 3 times daily 0.75 mg 2 0.5 mg 3 times daily 1.5 mg 3 0.75 mg 3 times daily 2.25 mg 4 1 mg 3 times daily 3 mg Ropinirole tablets should be discontinued gradually over a 7-day period in patients with Parkinson’s disease [see Warnings and Precautions (5.8)]. The frequency of administration should be reduced from three times daily to twice daily for 4 days. For the remaining 3 days, the frequency should be reduced to once daily prior to complete withdrawal of ropinirole tablets.
Renal Impairment No dose adjustment is necessary in patients with moderate renal impairment (creatinine clearance of 30 to 50 mL/min). The recommended initial dose of ropinirole for patients with end-stage renal disease on hemodialysis is 0.25 mg three times a day. Further dose escalations should be based on tolerability and need for efficacy.
The recommended maximum total daily dose is 18 mg/day in patients receiving regular dialysis. Supplemental doses after dialysis are not required. The use of ropinirole tablets in patients with severe renal impairment without regular dialysis has not been studied.
2.3Dosing for Restless Legs Syndrome The recommended adult starting dose for RLS is 0.25 mg once daily 1 to 3 hours before bedtime. After 2 days, if necessary, the dose can be increased to 0.5 mg once daily, and to 1 mg once daily at the end of the first week of dosing, then as shown in Table 2 as needed to achieve efficacy. Titration should be based on individual patient therapeutic response and tolerability, up to a maximum recommended dose of 4 mg daily.
For RLS, the safety and effectiveness of doses greater than 4 mg once daily have not been established. Table 2. Dose Titration Schedule of ropinirole tablets for Restless Legs Syndrome Day/Week Dose to be taken once daily 1 to 3 hours before bedtime Days 1 and 2 0.25 mg Days 3 to 7 0.5 mg Week 2 1 mg Week 3 1.5 mg Week 4 2 mg Week 5 2.5 mg Week 6 3 mg Week 7 4 mg When discontinuing ropinirole tablets in patients with RLS, gradual reduction of the daily dose is recommended [see Warnings and Precautions (5.8, 5.9)].
Renal Impairment No dose adjustment is necessary in patients with moderate renal impairment (creatinine clearance of 30 to 50 mL/min). The recommended initial dose of ropinirole for patients with end-stage renal disease on hemodialysis is 0.25 mg once daily. Further dose escalations should be based on tolerability and need for efficacy.
The recommended maximum total daily dose is 3 mg/day in patients receiving regular dialysis. Supplemental doses after dialysis are not required. The use of ropinirole tablets in patients with severe renal impairment without regular dialysis has not been studied.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 0.25 mg, white tablets debossed with “H” on one side and “121” on other side 0.5 mg, yellow tablets debossed with “H” on one side and “122” on other side 1 mg, green tablets debossed with “H” on one side and “123” on other side 2 mg, Peach tablets debossed with “H” on one side and “124” on other side 3 mg, Purple tablets debossed with “H” on one side and “125” on other side 4 mg, Pale brown tablets debossed with “H” on one side and “126” on other side 5 mg, Blue tablets debossed with “H” on one side and “127” on other side Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, and 5 mg ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Ropinirole tablets are contraindicated in patients known to have a hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients. History of hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Sudden onset of sleep and somnolence may occur ( 5.1 ) • Syncope may occur ( 5.2 ) • Hypotension, including orthostatic hypotension may occur ( 5.3 ) • May cause hallucinations and psychotic-like behaviors ( 5.4 ) • May cause or exacerbate dyskinesia ( 5.5 ) • May cause problems with impulse control or compulsive behaviors ( 5.6 )
5.1Falling Asleep during Activities of Daily Living and Somnolence Patients treated with ropinirole tablets 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 tablets, 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 tablets and was more frequent in Parkinson's disease (up to 40% ropinirole tablets, 6% placebo) than in Restless Legs Syndrome (12% ropinirole tablets, 6% placebo) [see Adverse Reactions (6.1)] . 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 tablets 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) [see Drug Interactions (7.1)] .
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 [see Dosage and Administration (2.2, 2.3)] . 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 .
5.2Syncope Syncope, sometimes associated with bradycardia, was observed in association with treatment with ropinirole in both patients with Parkinson’s disease and patients with RLS. In controlled clinical trials in patients with Parkinson’s disease, syncope was observed more frequently in patients receiving ropinirole tablets than in patients receiving placebo (early Parkinson’s disease without levodopa [L-dopa]: ropinirole tablets 12%, placebo 1%; advanced Parkinson’s disease: ropinirole tablets 3%, placebo 2%). Syncope was reported in 1% of patients treated with ropinirole tablets for RLS in 12-week, placebo-controlled clinical trials compared with 0.2% of patients treated with placebo [see Adverse Reactions (6.1)] .
Most cases occurred more than 4 weeks after initiation of therapy with ropinirole tablets, and were usually associated with a recent increase in dose. Because the trials conducted with ropinirole tablets excluded patients with significant cardiovascular disease, patients with significant cardiovascular disease should be treated with caution. Approximately 4% of patients with Parkinson’s disease enrolled in Phase 1 trials had syncope following a 1-mg dose of ropinirole tablets.
In two trials in…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are described in more detail in other sections of the label: Hypersensitivity [see Contraindications (4)] Falling asleep during activities of daily living and somnolence [see Warnings and Precautions (5.1)] Syncope [see Warnings and Precautions (5.2)] Hypotension/orthostatic hypotension [see Warnings and Precautions (5.3)] Hallucinations/psychotic-like behavior [see Warnings and Precautions (5.4)] Dyskinesia [see Warnings and Precautions (5.5)] Impulse control/compulsive behaviors [see Warnings and Precautions (5.6)] Withdrawal-emergent hyperpyrexia and confusion [see Warnings and Precautions (5.7)] Withdrawal Symptoms [see Warnings and Precautions (5.8)] Augmentation and early-morning rebound in RLS [see Warnings and Precautions (5.9)] Fibrotic complications [see Warnings and Precautions (5.10)] Retinal pathology [see Warnings and Precautions (5.11)] Most common adverse reactions (incidence with ropinirole tablets at least 5% greater than placebo) in the respective indications were: Early PD: Nausea, somnolence, dizziness, syncope, asthenic condition, viral infection, leg edema, vomiting, and dyspepsia.
( 6.1 ) Advanced PD: Dyskinesia, somnolence, nausea, dizziness, confusion, hallucinations, sweating, and headache. ( 6.1 ) RLS: Nausea, vomiting, somnolence, dizziness, and asthenic condition. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug (or of another development program of a different formulation of the same drug) and may not reflect the rates observed in practice. Parkinson’s Disease During the premarketing development of ropinirole tablets, patients received ropinirole tablets either without L-dopa (early Parkinson’s disease trials) or as concomitant therapy with L-dopa (advanced Parkinson’s disease trials).
Because these two populations may have differential risks for various adverse reactions, this section will in general present adverse reaction data for these two populations separately. Early Parkinson’s Disease (without L-dopa) In the double-blind, placebo-controlled trials in patients with early-stage Parkinson’s disease, the most commonly observed adverse reactions in patients treated with ropinirole tablets (incidence at least 5% greater than placebo) were nausea, somnolence, dizziness, syncope, asthenic condition (i.e., asthenia, fatigue, and/or malaise), viral infection, leg edema, vomiting, and dyspepsia.
Approximately 24% of patients treated with ropinirole tablets who participated in the double-blind, placebo-controlled early Parkinson’s disease (without L-dopa) trials discontinued treatment due to adverse reactions compared with 13% of patients who received placebo. The most common adverse reactions in patients treated with ropinirole tablets (incidence at least 2% greater than placebo) of sufficient severity to cause discontinuation were nausea and dizziness. Table 3 lists treatment-emergent adverse reactions that occurred in at least 2% of patients with early Parkinson’s disease (without L-dopa) treated with ropinirole tablets participating in the double-blind, placebo-controlled trials and were numerically more common than the incidence for placebo-treated patients.
In these trials, either ropinirole tablets or placebo was used as early therapy (i.e., without L-dopa). Table 3. Treatment-Emergent Adverse Reaction Incidence in Double-blind, Placebo-Controlled Early Parkinson’s Disease (without L-dopa) Trials (Events ≥2% of Patients Treated with ropinirole tablets and Numerically More Frequent than the Placebo Group) a Body System/ Adverse Reaction Ropinirole Tablets (n = 157) (%) Placebo (n = 147) (%) Autonom…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS • Inhibitors or inducers of CYP1A2: May alter the clearance of ropinirole tablets; dose adjustment of ropinirole tablets may be required ( 7.1 , 12.3 ) • Hormone replacement therapy(HRT): Starting or stopping HRT may require dose adjustment of ropinirole tablets ( 7.2 , 12.3 ) • Dopamine antagonists (e.g., neuroleptics, metoclopramide): May reduce efficacy of ropinirole tablets ( 7.3 )
7.1Cytochrome P450 1A2 Inhibitors and Inducers In vitro metabolism studies showed that CYP1A2 is the major enzyme responsible for the metabolism of ropinirole. There is thus the potential for inducers or inhibitors of this enzyme to alter the clearance of ropinirole. Therefore, if therapy with a drug known to be a potent inducer or inhibitor of CYP1A2 is stopped or started during treatment with ropinirole tablets, adjustment of the dose of ropinirole tablets may be required.
Coadministration of ciprofloxacin, an inhibitor of CYP1A2, increases the AUC and C max of ropinirole [see Clinical Pharmacology (12.3)]. Cigarette smoking is expected to increase the clearance of ropinirole since CYP1A2 is known to be induced by smoking [see Clinical Pharmacology (12.3)].
7.2Estrogens Population pharmacokinetic analysis revealed that higher doses of estrogens (usually associated with hormone replacement therapy [HRT]) reduced the clearance of ropinirole. Starting or stopping HRT may require adjustment of dosage of ropinirole tablets [see Clinical Pharmacology (12.3)] .
7.3Dopamine Antagonists Because ropinirole is a dopamine agonist, it is possible that dopamine antagonists such as neuroleptics (e.g., phenothiazines, butyrophenones, thioxanthenes) or metoclopramide may reduce the efficacy of ropinirole tablets.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 )
8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of ropinirole tablets in pregnant women. In animal studies, ropinirole had adverse effects on development when administered to pregnant rats at doses similar to (neurobehavioral impairment) or greater than (teratogenicity and embryolethality at >36 times) the maximum recommended human dose (MRHD) for Parkinson’s disease. Ropinirole doses associated with teratogenicity and embryolethality in pregnant rats were associated with maternal toxicity.
In pregnant rabbits, ropinirole potentiated the teratogenic effects of L-dopa when these drugs were administered in combination [see Data] . In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage in the indicated populations is unknown.
Data Animal Data : Oral administration of ropinirole (0, 20, 60, 90, 120, or 150 mg/kg/day) to pregnant rats during organogenesis resulted in embryolethality, increased incidence of fetal malformations (digit, cardiovascular, and neural tube defects) and variations, and decreased fetal weight at the two highest doses. These doses were also associated with maternal toxicity. The highest no-effect dose for adverse effects on embryofetal development (90 mg/kg/day) is approximately 36 times the MRHD for Parkinson’s disease (24 mg/day) on a body surface area (mg/m 2 ) basis.
No effect on embryofetal development was observed in rabbits when ropinirole was administered alone during organogenesis at oral doses of 0, 1, 5, or 20 mg/kg/day (up to 16 times the MRHD on a mg/m 2 basis). In pregnant rabbits, there was a greater incidence and severity of fetal malformations (primarily digit defects) when ropinirole (10 mg/kg/day) was administered orally during gestation in combination with L-dopa (250 mg/kg/day) than when L-dopa was administered alone. This drug combination was also associated with maternal toxicity.
Oral administration of ropinirole (0, 0.1, 1, or 10 mg/kg/day) to rats during late gestation and continuing throughout lactation resulted in neurobehavioral impairment (decreased startle response) and decreased body weight in offspring at the highest dose. The no-effect dose of 1 mg/kg/day is less than the MRHD on a mg/m 2 basis.
8.2Lactation Risk Summary There are no data on the presence of ropinirole in human milk, the effects of ropinirole on the breastfed infant, or the effects of ropinirole on milk production. However, inhibition of lactation is expected because ropinirole inhibits secretion of prolactin in humans. Ropinirole or metabolites, or both, are present in rat milk.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ropinirole tablets and any potential adverse effects on the breastfed infant from ropinirole or from the underlying maternal condition.
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
8.5Geriatric Use Dose adjustment is not necessary in elderly (65 years and older) patients, as the dose of ropinirole tablets are individually titrated to clinical therapeutic response and tolerability . Pharmacokinetic trials conducted in patients demonstrated that oral clearance of ropinirole is reduced by 15% in patients older than 65 years compared with younger patients [see Clinical Pharmacology (12.3)] . In flexible-dose clinical trials of extended-release ropinirole for Parkinson’s disease, 387 patients were 65 years and older and 107 patients were 75 years and older.
Among patients receiving extended-release ropinirole, hallucination was more common in elderly patients (10%) compared with non-elderly patients (2%). In these trials the incidence of overall ad…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of ropinirole tablets in pregnant women. In animal studies, ropinirole had adverse effects on development when administered to pregnant rats at doses similar to (neurobehavioral impairment) or greater than (teratogenicity and embryolethality at >36 times) the maximum recommended human dose (MRHD) for Parkinson’s disease. Ropinirole doses associated with teratogenicity and embryolethality in pregnant rats were associated with maternal toxicity.
In pregnant rabbits, ropinirole potentiated the teratogenic effects of L-dopa when these drugs were administered in combination [see Data] . In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage in the indicated populations is unknown.
Data Animal Data : Oral administration of ropinirole (0, 20, 60, 90, 120, or 150 mg/kg/day) to pregnant rats during organogenesis resulted in embryolethality, increased incidence of fetal malformations (digit, cardiovascular, and neural tube defects) and variations, and decreased fetal weight at the two highest doses. These doses were also associated with maternal toxicity. The highest no-effect dose for adverse effects on embryofetal development (90 mg/kg/day) is approximately 36 times the MRHD for Parkinson’s disease (24 mg/day) on a body surface area (mg/m 2 ) basis.
No effect on embryofetal development was observed in rabbits when ropinirole was administered alone during organogenesis at oral doses of 0, 1, 5, or 20 mg/kg/day (up to 16 times the MRHD on a mg/m 2 basis). In pregnant rabbits, there was a greater incidence and severity of fetal malformations (primarily digit defects) when ropinirole (10 mg/kg/day) was administered orally during gestation in combination with L-dopa (250 mg/kg/day) than when L-dopa was administered alone. This drug combination was also associated with maternal toxicity.
Oral administration of ropinirole (0, 0.1, 1, or 10 mg/kg/day) to rats during late gestation and continuing throughout lactation resulted in neurobehavioral impairment (decreased startle response) and decreased body weight in offspring at the highest dose. The no-effect dose of 1 mg/kg/day is less than the MRHD on a mg/m 2 basis.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Dose adjustment is not necessary in elderly (65 years and older) patients, as the dose of ropinirole tablets are individually titrated to clinical therapeutic response and tolerability . Pharmacokinetic trials conducted in patients demonstrated that oral clearance of ropinirole is reduced by 15% in patients older than 65 years compared with younger patients [see Clinical Pharmacology (12.3)] . In flexible-dose clinical trials of extended-release ropinirole for Parkinson’s disease, 387 patients were 65 years and older and 107 patients were 75 years and older.
Among patients receiving extended-release ropinirole, hallucination was more common in elderly patients (10%) compared with non-elderly patients (2%). In these trials the incidence of overall adverse reactions increased with increasing age for both patients receiving extended-release ropinirole and placebo. In the fixed-dose clinical trials of extended-release ropinirole, 176 patients were 65 years and older and 73 were 75 and older.
Among patients with advanced Parkinson’s disease receiving extended-release ropinirole, vomiting and nausea were more common in patients greater than 65 years (5% and 9%, respectively) compared with patients less than 65 (1% and 7%, respectively).
🆘 Overdosage ▾
10 OVERDOSAGE The symptoms of overdose with ropinirole tablets are related to its dopaminergic activity. General supportive measures are recommended. Vital signs should be maintained, if necessary.
In the 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action 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 D2 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.
12.2Pharmacodynamics Clinical experience with dopamine agonists, including ropinirole, suggests an association with impaired ability to regulate blood pressure resulting in orthostatic hypotension, especially during dose escalation. In some patients in clinical trials, blood pressure changes were associated with the emergence of orthostatic symptoms, bradycardia, and, in one case in a healthy volunteer, transient sinus arrest with syncope [see Warnings and Precautions (5.2, 5.3)] . The mechanism of orthostatic hypotension induced by ropinirole is presumed to be due to a D 2 -mediated blunting of the noradrenergic response to standing and subsequent decrease in peripheral vascular resistance.
Nausea is a common concomitant symptom of orthostatic signs and symptoms. At oral doses as low as 0.2 mg, ropinirole suppressed serum prolactin concentrations in healthy male volunteers. Ropinirole had no dose-related effect on ECG wave form and rhythm in young, healthy, male volunteers in the range of 0.01 to 2.5 mg.
Ropinirole had no dose-or exposure-related effect on mean QT intervals in healthy male and female volunteers titrated to doses up to 4 mg/day. The effect of ropinirole on QTc intervals at higher exposures achieved either due to drug interactions, hepatic impairment, or at higher doses has not been systematically evaluated.
12.3Pharmacokinetics Ropinirole displayed linear kinetics over the dosing range of 1 to 8 mg three times daily. Steady-state concentrations are expected to be achieved within 2 days of dosing. Accumulation upon multiple dosing is predictive from single dosing.
Absorption Ropinirole is rapidly absorbed after oral administration, reaching peak concentration in approximately 1 to 2 hours. In clinical trials, more than 88% of a radiolabeled dose was recovered in urine and the absolute bioavailability was 45% to 55%, indicating approximately 50% first-pass effect. Relative bioavailability from a tablet compared with an oral solution is 85%.
Food does not affect the extent of absorption of ropinirole, although its T max is increased by 2.5 hours and its C max is decreased by approximately 25% when the drug is taken with a high-fat meal. Distribution Ropinirole is widely distributed throughout the body, with an apparent volume of distribution of
7.5L/kg. It is up to 40% bound to plasma proteins and has a blood-to-plasma ratio of 1:1. Metabolism Ropinirole is extensively metabolized by the liver.
The major metabolic pathways are N-despropylation and hydroxylation to form the inactive N-despropyl metabolite and hydroxy metabolites. The N-despropyl metabolite is converted to carbamyl glucuronide, carboxylic acid, and N-despropyl hydroxy metabolites. The hydroxy metabolite of ropinirole is rapidly glucuronidated.
In vitro studies indicate that the major cytochrome P450 enzyme involved in the metabolism of ropinirole is CYP1A2, an enzyme known to be induced by smoking and omeprazole and inhibited by, for example, fluvoxamine, mexiletine, and the older fluoroquinolones such as ciprofloxacin and norfloxacin. Elimination The clearance of ropinirole after oral administration is 47 L/h and its elimination half-life is approximately 6 hours. Less than 10% of the administered dose is excreted as unchanged drug in urine.
N-despropyl ropinirole is the predominant metabolite found in urine (40%), followed by the carboxylic acid metabolite (10%) and the glucuronide of the hydroxy metabolite (10%). Drug Interactions Digoxin: Coadm…
🧬 Mechanism of Action ▾
12.1Mechanism of Action 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 D2 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Ropinirole Tablets: Each circular, biconvex, film-coated tablet contains ropinirole as follows: 0.25 mg: white tablets debossed with “H” on one side and “121” on other side NDC 62332-030-31 bottle of 100 tablets 0.5 mg: yellow tablets debossed with “H” on one side and “122” on other side NDC 62332-031-31 bottle of 100 tablets 1 mg: green tablets debossed with “H” on one side and “123” on other side NDC 62332-032-31 bottle of 100 tablets 2 mg: Peach tablets debossed with “H” on one side and “124” on other side NDC 62332-033-31 bottle of 100 tablets 3 mg: Purple tablets debossed with “H” on one side and “125” on other side NDC 62332-034-31 bottle of 100 tablets 4 mg: Pale brown tablets debossed with “H” on one side and “126” on other side NDC 62332-035-31 bottle of 100 tablets 5 mg: Blue tablets debossed with “H” on one side and “127” on other side NDC 62332-036-31 bottle of 100 tablets STORAGE: Protect from light and moisture.
Close container tightly after each use. Store at controlled room temperature 20°-25°C (68°-77°F) [see USP].
📋 Description ▾
11 DESCRIPTION Ropinirole tablets contain 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 C 16 H 24 N 2 O•HCl. The molecular weight is 296.84 (260.38 as the free base).
The structural formula is: Ropinirole hydrochloride, USP is a white to yellow solid with a melting range of 243° to 250°C and a solubility of 133 mg/mL in water. Each circular, biconvex, film-coated tablets contains ropinirole hydrochloride USP equivalent to ropinirole free base, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg, respectively. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, 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 (iron oxide yellow, iron oxide red and iron oxide black), polyethylene glycol, polysorbate 80, titanium dioxide. structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Dosing Instructions Instruct patients to take ropinirole tablets only as prescribed. If a dose is missed, advise patients not to double their next dose.
Ropinirole tablets can be taken with or without food [see Dosage and Administration (2.1)]. Ropinirole is the active ingredient in ropinirole tablets (the immediate-release formulation). Ask your patients if they are taking another medication containing ropinirole.
Hypersensitivity/Allergic Reactions 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 [see Contraindications (4)]. Falling Asleep during Activities of Daily Living and Somnolence Alert patients to the potential sedating effects caused by ropinirole tablets, 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 tablets 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 tablets or when taking a concomitant medication (e.g., ciprofloxacin) that increases plasma levels of ropinirole [see Warnings and Precautions (5.1)]. Syncope and Hypotension/Orthostatic Hypotension 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 tablets, 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 tablets [see Warnings and Precautions (5.2, 5.3)].
Hallucinations/Psychotic-like Behavior Inform patients that they may experience hallucinations (unreal visions, sounds, or sensations), and that other psychotic-like behavior can occur while taking ropinirole tablets. In patients with Parkinson’s disease the elderly are at greater risk than younger patients. This risk is greater in patients who are taking ropinirole tablets with L-dopa or taking higher doses of ropinirole tablets 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 [see Warnings and Precautions (5.4)]. Dyskinesia Inform patients that ropinirole tablets may cause and/or exacerbate pre-existing dyskinesias [see Warnings and Precautions (5.5)]. Impulse Control/Compulsive Behaviors Advise patients that they may experience impulse control and/or compulsive behaviors while taking ropinirole…