pramipexole (Rx)Brand and Other Names:Mirapex, Mirapex ER

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 0.125mg
  • 0.25mg
  • 0.5mg
  • 0.75mg
  • 1mg
  • 1.5mg

tablet, extended release

  • 0.375mg
  • 0.75mg
  • 1.5mg
  • 2.25mg
  • 3mg
  • 3.75mg
  • 4.5mg
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Parkinson Disease

Immediate-release: 0.125 mg PO q8hr initially; gradually titrated upward at weekly intervals to target range of 1.5-4.5 mg/day PO divided q8hr

Extended-release: 0.375 mg/day PO initially; if necessary, may be increased every 5-7 days, first to 0.75 mg/day and then by increments of 0.75 mg/day; not to exceed 4.5 mg/day

Restless Legs Syndrome

0.125 mg/day PO 2-3 hr before bedtime initially; may be increased every 4-7 days up to 0.5 mg/day (every 14 days if CrCl 20-60 mL/min)

Dosage Modifications

Hepatic impairmet: No dosage adjustments provided in the manufacturer's labeling; adjustment not expected; undergoes minimal hepatic metabolism

Renal Impairment

Parkinson disease

  • Immediate release
    • CrCl >50 mL/min: Dosage adjustment not necessary
    • CrCl 30-50 mL/min: 0.125 mg twice daily initially; not to exceed 0.75 mg TID
    • CrCl 15-29 mL/min: 0.125 mg qDay; not to exceed 1.5 mg qDay
    • CrCl <15 mL/min: Dosage adjustment not provided in manufacturer's labeling; not studied
    • ESRD requiring hemodialysis: Dosage adjustment not provided in manufacturer's labeling; not studied
  • Extended release
    • CrCl >50 mL/min: Dosage adjustment not necessary
    • CrCl 30-50 mL/min: 0.375 every other day; may increase to 0.375 mg qDay no sooner than 1 wk after initiating therapy; may increase by 0.375 mg/dose not more frequently than every 7 days; not to exceed 2.25 mg qDay
    • CrCl <30 mL/min: Not recommended
    • ESRD requiring hemodialysis: Not recommended

Restless legs syndrome

  • Immediate release
    • CrCl >60 mL/min: Dosasge adjustment not necessary
    • CrCl 20-60 mL/min: Dosage adjustment not necessary but duration between titration should be increased to 14 days
    • CrCl<20 mL/min: Dosage adjustment not provided by manufacturer's labeling; not studied

Dosing Considerations

May switch overnight from immediate-release to extended-release tablets at same daily dose; dose adjustments may be required for some patients

Administration

Extended-release: Swallow whole; do not chew, crush, or divide

Discontinuing immediate- or extended-release: Taper off at a rate of 0.75 mg/day until the daily dose has been reduced to 0.75 mg; thereafter, the dose may be reduced by 0.375 mg/day

Dosage Forms & Strengths

tablet

  • 0.125mg
  • 0.25mg
  • 0.5mg
  • 0.75mg
  • 1mg
  • 1.5mg

tablet, extended release

  • 0.375mg
  • 0.75mg
  • 1.5mg
  • 2.25mg
  • 3mg
  • 3.75mg
  • 4.5mg
more...

Tourette Syndrome (Orphan)

Treatment of Tourette syndrome in pediatric patients

Orphan indication sponsor

  • Boehringer-Ingelheim Pharmaceuticals, Inc; 900 Ridgebury Road; Ridgefield, CT 06877
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Interactions

Interaction Checker

pramipexole and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Some variations between early Parkinson, advanced Parkinson, and restless legs syndrome

            Incidence of some adverse drug reactions (eg, dizziness, accidental injury) >10% but comparable to placebo

            >10%

            Somnolence

            Dyskinesia

            Hallucinations

            Insomnia

            Dizziness

            Postural hypotension

            Nausea

            Constipation

            1-10% (partial list)

            Abnormal dreams, thoughts, or vision

            Amnesia

            Confusion

            Paranoia or delusion

            Akathisia

            Asthenia

            Dry mouth

            Urinary frequency

            Postmarketing Reports

            Neurologic: Abnormal behavior, abnormal dreams, compulsive shopping, fatigue, hallucinations (all kinds), headache, pathologic gambling

            Cardiovascular: Hypotension (including syncope and postural hypotension)

            Metabolic: Increased eating (including binge eating, compulsive eating, and hyperphagia), weight gain, SIADH

            Dermatologic: Skin reactions, including rythema, rash, pruritus, urticaria

            Gastrointestinal: Vomiting

            Genitourinary: Libido disorders (including increased or decreased libido and hypersexuality)

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            May cause sudden daytime "sleep attacks;" inquire about factors that may increase risk of falling asleep, including sleep disorders or taking sedating medications; caution patients about performing tasks requiring mental alertness; discontinue if there is evidence of sleep attacks; if decision is made to continue therapy, advice patient not to perform dangerous activities requiring mental alertness

            Orthostatic hypotension may occur, particularly during dose escalation; monitor closely Parkinson patients being treated with dopaminergic agonists, especially during dose escalation

            Possibility of unusual behavioral impulse patterns (eg, compulsive gambling) may occur; hallucinations and psychotic-like behavior may occur; risk increases with age; dose reduction or discontinuation may reverse these behaviors but not in all cases

            In early Parkinson, dosages higher than 1.5 mg q8hr provided no additional benefit but increased adverse events

            Use with caution in renal impairment; dose adjustment may be necessary; do not administer extended release tablets to patients with CrCl<30 mL/min or ESRD requiring hemodialysis

            Augmentation or rebound of restless legs syndrome (RLS) may occur with therapy in RLS patients

            The elderly may be more prone to adverse effects

            Swallow whole; do not chew, crush, or divide extended release tablets

            Events reported with dopaminergic therapy include hyperpyrexia and confusion

            Fibrotic complications reported with use; monitor closely for signs and symptoms of fibrosis; discontinuation of therapy may resolve complications but not in all cases

            Rsk of melanoma increases in Parkinson disease patients; monitor closely and perform periodic skin examination

            Pathologic degenerative changes observed in retinas of albino rats during studies; significance in humans unclear

            May cause or exacerbate dyskinesia; use with caution in patients with preexisting dyskinesias

            Symptoms resembling neuroleptic malignant syndrome, including elevated temperature, muscular rigidity, altered consciousness, and autonomic instability reported with rapid dose reduction, discontinuation, or changes in therapy; taper dose to decrease risk of hyperpyrexia and confusion

            Gradual discontinuance required over period of 1 week or longer; symptoms resembling neuroleptic malignant syndrome may occur on abrupt withdrawal

            Risk of new-onset heart failure undergoing FDA evaluation (FDA safety announcement 9/19/2012)

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            Pregnancy & Lactation

            There are no adequate data on the developmental risk associated with therapy in pregnant women; no adverse developmental effects reported in animal studies in which pramipexole was administered to rabbits during pregnancy; effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures

            In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively; background risk of major birth defects and miscarriage for the indicated population is unknown

            Lactation: Not known if drug secreted in breast milk; may inhibit milk production; discontinue drug, or do not nurse

            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

            Non-ergot dopamine D2 receptor agonist; strong affinity for D2 and D3 receptors; binding to these receptors increases dopamine activity on nerves of striatum and substantia nigra

            Absorption

            Bioavailability: >90%

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

            Distribution

            Protein bound: 15%

            Vd: 500 L

            Metabolism

            <10% metabolized

            Elimination

            Half-life: 8.5 hr (12 hr in elderly)

            Renal clearance: 400 mL/min

            Excretion: Urine (90%)

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            Formulary

            FormularyPatient Discounts

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            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
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            OR Other Restrictions
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