levodopa inhaled (Rx)

Brand and Other Names:Inbrija
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule, inhalation powder

  • 42mg/capsule

Parkinson Disease

Indicated for intermittent treatment of OFF episodes in patients with Parkinson diseased who are treated with carbidopa/levodopa

Initiate when an OFF period symptoms start to return

84 mg inhaled PO prn; not to exceed 5 doses/day (420 mg/day)

Safety and efficacy not established

Next:

Interactions

Interaction Checker

and levodopa inhaled

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 
            Previous
            Next:

            Adverse Effects

            >10%

            Cough (15%)

            1-10%

            Upper respiratory tract infection (6%)

            Discolored sputum (5%)

            Nausea (5%)

            Dyskinesia (4%)

            Fall (3%)

            Vomiting (3%)

            Nasopharyngitis (3%)

            Chest discomfort (2%)

            Increased bilirubin (2%)

            Decreased RBC count (2%)

            Headache (2%)

            Insomnia (2%)

            Orthostatic hypotension/decreased blood pressure (2%)

            Laceration (2%)

            Skin abrasion (2%)

            Bronchitis/pneumonia (2%)

            Discolored nasal discharge (2%)

            Oropharyngeal pain (2%)

            Previous
            Next:

            Warnings

            Contraindications

            Currently or recently (within 2 weeks) taking a nonselective monoamine oxidase (MAO) inhibitor (eg, phenelzine, tranylcypromine)

            Cautions

            Falling asleep while engaged in activities of daily living, including driving, reported; many patients report somnolence, while other had no warnings signs (sleep attack); some events reported >1 yr after initiating treatment

            Rapid dose reduction, withdrawal of, or changes in dopaminergic therapy may result in a symptom complex that resembles neuroleptic malignant syndrome (elevated temperature, muscular rigidity, altered consciousness, autonomic instability)

            Hallucinations may occur, accompanied by confusion, insomnia, and excessive dreaming; abnormal thinking and behavior may also occur, including, paranoid ideation, delusion, confusion, psychoticlike behavior, disorientation, aggressive behavior, agitation, and delirium

            Decreased impulse control and compulsive behaviors may emerge, including, gambling, sexual urges, spending money, binge eating, and/or other intense urges; patients may not recognize these as abnormal

            May cause or exacerbate dyskinesias

            Owing to bronchospasm risk, not recommended for patients with asthma, COPD, or other chronic lung disease

            May increase intraocular pressure in patients with glaucoma

            Laboratory test abnormalities

            • May elevate liver function tests, including alkaline phosphatase, AST, ALT, LDH, and bilirubin
            • Patients taking levodopa or carbidopa/levodopa may have increased catecholamines levels and their metabolites in plasma and urine, giving false-positive results suggesting pheochromocytoma

            Drug interaction overview

            • Nonselective MAO inhibitors are contraindicated during or within 2 weeks before initiating levodopa
            • MAO-B inhibitors may be associated with orthostatic hypotension
            • Dopamine D2 receptor antagonists (eg, phenothiazine, butyrophenones, risperidone, metoclopramide) and isoniazid may reduce levodopa effect
            • Iron salts can form chelates with levodopa and reduce bioavailability
            Previous
            Next:

            Pregnancy

            Pregnancy

            There are no available data regarding use in pregnant women

            Animal data

            • Carbidopa/levodopa caused both visceral and skeletal malformations in rabbits when administered throughout organogenesis
            • No teratogenic effects were observed when administered to pregnant mice throughout organogenesis
            • Number of live pups decreased delivered by rats receiving carbidopa/levodopa during organogenesis

            Lactation

            Levodopa detected in human milk; no data are available on effects in the breastfed infant

            The prolactin-lowering action of dopamine suggests that levodopa may interfere with lactation, although there are limited data on the effects of levodopa on milk production in lactating women

            The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child or from the 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.

            more...
            Previous
            Next:

            Pharmacology

            Mechanism of Action

            Metabolic precursor of dopamine, a neurotransmitter depleted in Parkinson disease; crosses blood-brain barrier to be converted by striatal enzymes to dopamine

            The inhaled product enters the body through the lungs and then reaches the brain, bypassing the digestive system and therefore providing a quick and reliable onset of action

            Absorption

            Peak plasma time: 0.5 hr

            Bioavailability: ~70% relative to immediate-release oral tablets

            Peak plasma concentration: ~50% of that following immediate-release oral tablets

            Distribution

            Vd: 168 L

            Metabolism

            Extensively metabolized; the 2 major metabolic pathways are decarboxylation by dopa decarboxylase and O-methylation by catechol-O-methyltransferase (COMT)

            Previous
            Next:

            Administration

            Oral Inhalation

            Capsules are for oral inhalation only and should be used only with the Inbrija inhaler; intended effect will not be obtained if capsules are swallowed

            A complete dose (ie, 84 mg) is 2 capsules (42 mg/capsule)

            Load 1 capsule into inhaler and breathe in (inhale); then, remove used capsule and load a second capsule and repeat inhalation

            Storage

            Store in a dry place between 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)

            Store in original blister package and remove immediately before use

            Do not store capsule inside the inhaler

            Previous
            Next:

            Images

            Previous
            Next:

            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.
            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous
            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.