ropinirole (Rx)

Brand and Other Names:Requip, Requip XL
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 0.25mg
  • 0.5mg
  • 1mg
  • 2mg
  • 3mg
  • 4mg
  • 5mg

tablet, extended release

  • 2mg
  • 4mg
  • 6mg
  • 8mg
  • 12mg
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Parkinson Disease

Immediate release

  • 0.25 mg PO q8hr for 1 week initially, then increased weekly by 0.25 mg q8hr; if necessary, after week 4, may be increased weekly by 1.5 mg/day up to 9 mg/day, then increased weekly by 3 mg/day up to 24 mg/day  
  • See Administration for discontinuation instructions

Extended release

  • 2 mg/day PO initially for 1-2 weeks; increased by 2 mg/day at intervals >1 week; not to exceed 24 mg/day
  • See Administration for discontinuation instructions

Restless Legs Syndrome (Moderate-Severe)

Immediate release: 0.25 mg/day PO 1-3 hours before bedtime; after day 2, may be increased to 0.5 mg/day PO; at end of week 1, increased to 1 mg/day, then increased weekly by 0.5 mg/day up to 4 mg/day 

See Administration for discontinuation instructions

Dosing Modifications

Renal impairment

  • CrCl 30-50 mL/min: Dose adjustment not necessary
  • CrCl <30 mL/min: Safety and efficacy not established; use with caution; use of ropinirole XL not studied
  • End-stage renal disease on hemodialysis: Maximum recommended dose is 18 mg/day in Parkinson disease and 3 mg/day in restless legs syndrome

Hepatic impairment

  • Safety and efficacy not established; use with caution

Safety and efficacy not established

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Interactions

Interaction Checker

and ropinirole

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Nausea (40-60%)

            Dizziness (6-40%)

            Somnolence (11-40%)

            Syncope (1-12%)

            Vomiting (12%)

            Fatigue (8-11%)

            Viral infection (11%)

            Dyspepsia (10%)

            Falls (10%)

            1-10%

            Hypertension (5%)

            Flushing (3%)

            Orthostasis (1-6%)

            Chest pain (4%)

            Palpitation (3%)

            Extrasystoles (2%)

            Tachycardia (2%)

            Hyperhidrosis (3%)

            Abnormal pain (3-7%)

            Anorexia (4%)

            Flatulence (3%)

            Malaise (3%)

            Hypoesthesia (4%)

            Urinary tract infection (5%)

            Impotence (3%)

            Alkaline phosphatase (3%)

            Abnormal vision (6%)

            Xerophthalmia (2%)

            Increased diaphoresis (3-6%)

            <1%

            Agitation

            Aneurysm

            Aphasia

            Bradycardia

            Cardiac arrest

            Valvulopathy

            Cellulitis

            Colitis

            Delusion

            Delirium

            Diaphoresis

            Dyspnea

            Ulceration

            Glaucoma

            Psychotic-like behavior

            Impulse control/compulsive behavior

            Withdrawal-emergent hyperpyrexia and confusion

            Melanoma

            Fibrotic complications

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            Warnings

            Contraindications

            Known hypersensitivity/allergic reaction (including urticaria, angioedema, rash, pruritus) to ropinirole or to any of the excipients

            Cautions

            Risk of somnolence associated with use for restless legs syndrome, as well as (rare) risk of syncope, hypotension, and hallucinations

            May cause psychotic-like behavior; abnormal thinking and behavior can consist of one or more of a variety of manifestations including paranoid ideation, delusions, hallucinations, confusion, disorientation, aggressive behavior, agitation, and delirium; risk may be increased in the elderly

            Risk of orthostatic hypotension with extended-release formulation

            Possible risk of erratic behavior associated with dopamine agonists, compulsive behavior including urge to gamble and increased sexual urges

            Dyskinesia seen with concurrent use of levodopa

            Increased risk of melanoma development and pleural retroperitoneal fibrosis reported, but causation not established; monitoring warranted 

            Use caution in patients with history of hepatic/renal impairment, psychotic disorders, dyskinesias, restless leg syndrome

            Abrupt withdrawal or significant dosage reduction associated with syndrome resembling neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability); see Administration section for how to gradually discontinue drug

            Augmentation and rebound in restless leg syndrome

            • Augmentation is a phenomenon in which dopaminergic medication causes a worsening of symptom severity above and beyond the level at the time the medication was started
            • Augmentation symptoms may include earlier onset of symptoms in the evening (or even the afternoon), increase in symptoms, and spread of symptoms to involve other extremities
            • Rebound refers to new onset of symptoms in the early morning hr
            • Therapy should be reviewed and dosage adjustment or discontinuation of treatment considered with augmentation and early-morning rebound in restless syndrome; when discontinuing therapy in patients with restless leg syndrome, gradual reduction of the daily dose is recommended whenever possible
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            Pregnancy & Lactation

            Pregnancy: There are no adequate data on the developmental risk associated with therapy in pregnant women; background risk of major birth defects and miscarriage is unknown

            Lactation: Unknown if excreted in milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from ropinirole or from underlying maternal condition

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Potent nonergoline dopamine agonist specific for D2 and D3 subtypes, possibly within caudate putamen in brain

            Absorption

            Bioavailability: 55%

            Peak plasma time: Immediate release, 1-2 hr; extended release, 6-10 hr

            Distribution

            Protein bound: 40%

            Vd: 525 L

            Metabolism

            Metabolized in liver by CYP1A2

            Elimination

            Half-life: 6 hr (extended release)

            Total body clearance: 47 L/hr

            Excretion: Urine

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            Administration

            Oral Administration

            May take with or without food

            If a significant interruption in therapy has occurred, retitration of the drug is warranted

            Conversion from immediate-release to extended-release formulation

            • Choose extended-release strength that most closely matches total daily dose of immediate-release formulation

            Discontinuation

            • Abrupt withdrawal or significant dosage reduction associated with syndrome resembling neuroleptic malignant syndrome (see Cautions)
            • Parkinson disease: Discontinued gradually over a 7-day period; administration frequency should be reduced from TID to BID for 4 days, and then once daily for the remaining 3 days prior to completely withdrawing the drug
            • Restless leg syndrome: Gradually reduce the daily dose
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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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