rotigotine (Rx)

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Brand and Other Names:Neupro

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

transdermal patch

  • 1mg/24 hr
  • 2mg/24 hr
  • 3mg/24 hr
  • 4mg/24 hr
  • 6mg/24 hr
  • 8mg/24 hr
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Parkinson Disease

Initial: Apply 2 mg/24 hr transdermal patch qDay for early-stage disease or 4 mg/24 hr for advanced-stage disease

May be increased as needed by increments of 2 mg/24 hr at weekly intervals

Not to exceed 6 mg/24 hr patch qDay for early-stage disease or 8 mg/24 hr for advanced-stage disease

To discontinue treatment, reduce dose gradually (no faster than 2 mg/24 hr every other day) until completely withdrawn

Restless Legs Syndrome

Initial: Apply 1 mg/24 hr transdermal patch qDay

May be increased as needed by increments of 1 mg/24 hr at weekly intervals and as tolerated

Not to exceed 3 mg/24 hr patch qDay

To discontinue treatment, reduce dose gradually (no faster than 1 mg/24 hr every other day) until completely withdrawn

Administration

Apply patch at same time qDay

Apply to clean, dry, intact skin on front of abdomen, high, hip, flank, shoulder, or upper arm

Press the patch firmly to the skin for 30 seconds; check the adherence to the skin, particularly around the edges

Rotate application site each day

Do not apply to the same site more than once every 14 days

Monitor: BP, ophthalmic function

Safety and efficacy not established

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Interactions

Interaction Checker

and rotigotine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10% (Early-stage Parkinson Disease)

            Nausea (34-48%)

            Application site reactions (including erythema, pruritus, irritation, burning, dermatitis, inflammation, papulae, vesicle, pain) (21-46%)

            Dizziness (14-22%)

            Somnolence (12-20%)

            Vomiting (10-20%)

            Fatigue (6-18%)

            Insomnia (5-11%)

            Hyperhidrosis (3-11%)

            1-10% (Advanced-stage Parkinson Disease)

            Application site reactions (36-46%)

            Somnolence (32%)

            Nausea (22-28%)

            Dizziness (14-23%)

            Dyskinesia (14-17%)

            Edema peripheral (9-14%)

            Insomnia (9-14%)

            Hallucinations (7-14%)

            Arthralgia (8-11%)

            1-10% (Restless Legs Syndrome)

            Application site reactions (23-43%)

            Nausea (15-23%)

            Headache (15-21%)

            Asthenia (7-14%)

            1-10% (Early-stage Parkinson Disease)

            Abnormal dreams (2-7%)

            Erythema (3-6%)

            Anorexia (2-6%)

            Depression (2-5%)

            Edema peripheral (2-4%)

            Dyspepsia (2-3%)

            EKG, T- ave abnormal (2-3%)

            Weight loss (2-3%)

            Balance disorder (2-3%)

            Tinnitus (2-3%)

            Hiccups (2-3%)

            Pruritic rash (2-3%)

            Erectile dysfunction (2-3%)

            Lethargy (1-2%)

            Orthostatic hypotension (1-2%)

            1-10% (Advanced-stage Parkinson Disease)

            Vomiting (8-10%)

            Headache (8-10%)

            Constipation (5-9%)

            Diarrhea (5-7%)

            Hypertension (3-5%)

            Nightmares (3-5%)

            Paraesthesias/Dysesthesias (3-4%)

            Tremor (3-4%)

            Asthenia (3-4%)

            Cough (3%)

            Nasal Congestion (3%)

            Sinus congestion (2-3%)

            Erythema (2-3%)

            Hyperhidrosis (1-3%)

            Musculoskeletal pain (2%)

            1-10% (Restless Legs Syndrome)

            Nasopharyngitis (5-10%)

            Somnolence (5-10%)

            Insomnia (2-10%)

            Dizziness (5-9%)

            Pruritus (3-9%)

            Xerostomia (3-7%)

            Constipation (2-6%)

            Hyperhidrosis (1-5%)

            Vomiting (2-4%)

            Muscle spasms (1-4%)

            Hypertension (1-4%)

            Hot flushes (1-4%)

            Dyspepsia (1-3%)

            Vertigo (1-3%)

            Sinusitis (1-3%)

            Abnormal dreams (1-3%)

            Sleep attacks (1-2%)

            Erythema (1-2%)

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            Warnings

            Contraindications

            Hypersensitivity

            Cautions

            May cause sudden onset of sleep while engaging in activities of daily living, compulsive disorders (eg, pathologic gambling, hypersexuality, increased libido, repetitive meaningless actions), hallucinations, and psychotic-like behavior

            Contains sodium metabisulfite that may cause allergic-type reactions Somnolence is common; falling asleep during activities of daily living observed

            May cause symptomatic hypotension and syncope

            May increase blood pressure and heart rate

            Dose dependent increases in weight and fluid retention observed

            May potentiate dopaminergic side effects of levodopa and cause or exacerbate dyskinesia

            Avoid abrupt withdrawal; symptoms resembling neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, rhabdomyolysis, and/or autonomic instability) with no other obvious etiology, has been reported in association with rapid dose reduction

            Application site reactions are frequent and dose related

            Restless leg syndrome rebound/augmentation may occur as dose wears off

            Remove patch before MRI; backing layer of patch contains aluminum

            Heat may increase absorption; avoid exposure to external heat sources (eg, heating pads, electric blankets, sauna)

            Fibrotic complication reported (eg, retroperitoneal fibrosis, pleural effusion, pericarditis)

            Binding to melanin-pigmented tissues reported

            Hallucinations/psychotic -like behavior and dyskinesia may occur

            Monitor for melanoma; increased risk reported for patients receiving therapy

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: not known if excreted in breast milk; discontinue drug or do not nurse (may inhibit lactation)

            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-ergolinic D3/D2/D1 dopamine agonist

            Effective in treating Parkinson disease by stimulating D2 receptors within the caudate-putamen in the brain

            The precise mechanism of action for treating restless legs syndrome is unknown; thought to be related dopamine receptor stimulation

            Absorption

            Bioavailability: 37%

            Peak plasma time: 15-18 hr

            Release rate: 45% in 24 hr (0.2 mg/sq.cm/24 hr)

            Distribution

            Protein Bound: 92% (in vitro); 89.5% (in vivo)

            Vd: 84 L/kg

            Metabolism

            Metabolized by N-dealkylation and direct/secondary conjugation

            Elimination

            Half-life, biphasic: 3 hr (initial); 5-7 hr (terminal)

            Excretion: 71% urine; 23% feces

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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.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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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