levodopa inhaled (Rx)

Brand and Other Names:Inbrija
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule, inhalation powder

  • 42mg/capsule
  • Capsule for oral inhalation only and only used with the Inbrija inhaler

Parkinson Disease

Indicated for intermittent treatment of OFF episodes in patients with Parkinson disease treated with carbidopa/levodopa

Initiate when OFF period symptoms start to return

84 mg inhaled orally via supplied inhaler as needed; not to exceed 5 doses/day (420 mg/day)

Shown to be effective only in combination with carbidopa/levodopa

Safety and efficacy not established

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Interactions

Interaction Checker

and levodopa inhaled

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Contraindicated (3)

            • isocarboxazid

              levodopa inhaled increases effects of isocarboxazid by dopaminergic effects. Contraindicated. Levodopa may enhance risk for acute hypertensive episode if coadministered with nonselective MAOIs. Discontinue use of any nonselective MAO inhibitors at least 2 weeks before initiating levodopa inhaled.

            • phenelzine

              levodopa inhaled increases effects of phenelzine by dopaminergic effects. Contraindicated. Levodopa may enhance risk for acute hypertensive episode if coadministered with nonselective MAOIs. Discontinue use of any nonselective MAO inhibitors at least 2 weeks before initiating levodopa inhaled.

            • tranylcypromine

              levodopa inhaled increases effects of tranylcypromine by dopaminergic effects. Contraindicated. Levodopa may enhance risk for acute hypertensive episode if coadministered with nonselective MAOIs. Discontinue use of any nonselective MAO inhibitors at least 2 weeks before initiating levodopa inhaled.

            Serious - Use Alternative (24)

            • aripiprazole

              aripiprazole decreases effects of levodopa inhaled by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Atypical (2nd generation) antipsychotics inhibit dopamine D2 receptors in varying degrees (clozapine and quetiapine are lower risk). .

            • asenapine

              asenapine decreases effects of levodopa inhaled by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Atypical (2nd generation) antipsychotics inhibit dopamine D2 receptors in varying degrees (clozapine and quetiapine are lower risk). .

            • asenapine transdermal

              asenapine transdermal decreases effects of levodopa inhaled by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Atypical (2nd generation) antipsychotics inhibit dopamine D2 receptors in varying degrees (clozapine and quetiapine are lower risk). .

            • cariprazine

              cariprazine decreases effects of levodopa inhaled by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Atypical (2nd generation) antipsychotics inhibit dopamine D2 receptors in varying degrees (clozapine and quetiapine are lower risk). .

            • chlorpromazine

              chlorpromazine decreases effects of levodopa inhaled by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Phenothiazine/1st generation antipsychotics inhibit dopamine D2 receptors in varying degrees.

            • clozapine

              clozapine decreases effects of levodopa inhaled by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Atypical (2nd generation) antipsychotics inhibit dopamine D2 receptors in varying degrees (clozapine and quetiapine are lower risk). .

            • droperidol

              droperidol decreases effects of levodopa inhaled by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid coadministration of dopamine D2 receptor antagonists with levodopa inhaled.

            • fluphenazine

              fluphenazine decreases effects of levodopa inhaled by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Phenothiazine/1st generation antipsychotics inhibit dopamine D2 receptors in varying degrees.

            • iloperidone

              iloperidone decreases effects of levodopa inhaled by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Atypical (2nd generation) antipsychotics inhibit dopamine D2 receptors in varying degrees (clozapine and quetiapine are lower risk). .

            • lurasidone

              lurasidone decreases effects of levodopa inhaled by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Atypical (2nd generation) antipsychotics inhibit dopamine D2 receptors in varying degrees (clozapine and quetiapine are lower risk). .

            • metoclopramide

              metoclopramide decreases effects of levodopa inhaled by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid coadministration of dopamine D2 receptor antagonists with levodopa inhaled.

            • metoclopramide intranasal

              metoclopramide intranasal, levodopa inhaled. dopaminergic effects. Avoid or Use Alternate Drug. Opposing effects of metoclopramide and the interacting drug on dopamine. Potential exacerbation of symptoms (eg, parkinsonian symptoms) or decreased therapeutic effects of metoclopramide.

            • olanzapine

              olanzapine decreases effects of levodopa inhaled by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Atypical (2nd generation) antipsychotics inhibit dopamine D2 receptors in varying degrees (clozapine and quetiapine are lower risk). .

            • paliperidone

              paliperidone decreases effects of levodopa inhaled by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Atypical (2nd generation) antipsychotics inhibit dopamine D2 receptors in varying degrees (clozapine and quetiapine are lower risk). .

            • perphenazine

              perphenazine decreases effects of levodopa inhaled by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Phenothiazine/1st generation antipsychotics inhibit dopamine D2 receptors in varying degrees.

            • pimavanserin

              pimavanserin decreases effects of levodopa inhaled by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Atypical (2nd generation) antipsychotics inhibit dopamine D2 receptors in varying degrees (clozapine and quetiapine are lower risk). .

            • prochlorperazine

              prochlorperazine decreases effects of levodopa inhaled by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Phenothiazine/1st generation antipsychotics inhibit dopamine D2 receptors in varying degrees.

            • quetiapine

              quetiapine decreases effects of levodopa inhaled by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Atypical (2nd generation) antipsychotics inhibit dopamine D2 receptors in varying degrees (clozapine and quetiapine are lower risk). .

            • risperidone

              risperidone decreases effects of levodopa inhaled by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Atypical (2nd generation) antipsychotics inhibit dopamine D2 receptors in varying degrees (clozapine and quetiapine are lower risk). .

            • selegiline

              levodopa inhaled increases effects of selegiline by dopaminergic effects. Avoid or Use Alternate Drug. Levodopa may enhance risk for acute hypertensive episode if coadministered with nonselective MAOIs. High dose PO selegiline (>10 mg/day tab/cap or >2.5 mg/day ODT) or transdermal selegiline exhibits nonselective MAOI activity.

            • selegiline transdermal

              levodopa inhaled increases effects of selegiline transdermal by dopaminergic effects. Avoid or Use Alternate Drug. Levodopa may enhance risk for acute hypertensive episode if coadministered with nonselective MAOIs. High dose PO selegiline (>10 mg/day tab/cap or >2.5 mg/day ODT) or transdermal selegiline exhibits nonselective MAOI activity.

            • thioridazine

              thioridazine decreases effects of levodopa inhaled by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Phenothiazine/1st generation antipsychotics inhibit dopamine D2 receptors in varying degrees.

            • trifluoperazine

              trifluoperazine decreases effects of levodopa inhaled by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Phenothiazine/1st generation antipsychotics inhibit dopamine D2 receptors in varying degrees.

            • ziprasidone

              ziprasidone decreases effects of levodopa inhaled by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Atypical (2nd generation) antipsychotics inhibit dopamine D2 receptors in varying degrees (clozapine and quetiapine are lower risk). .

            Monitor Closely (9)

            • ferric pyrophosphate DIALYSATE

              ferric pyrophosphate DIALYSATE will decrease the level or effect of levodopa inhaled by Other (see comment). Use Caution/Monitor. Iron salts can form chelates with levodopa and consequently reduce levodopa bioavailability.

            • isoniazid

              isoniazid decreases effects of levodopa inhaled by altering metabolism. Use Caution/Monitor. Isoniazid may inhibit dopa-decarboxylase in the brain; thereby, preventing conversion of levodopa to active dopamine.

            • linezolid

              levodopa inhaled increases effects of linezolid by dopaminergic effects. Use Caution/Monitor. Coadministration of selective MAO-B inhibitors with levodopa may be associated with orthostatic hypotension.

            • methylene blue

              levodopa inhaled increases effects of methylene blue by dopaminergic effects. Use Caution/Monitor. Coadministration of selective MAO-B inhibitors with levodopa may be associated with orthostatic hypotension.

            • procarbazine

              levodopa inhaled increases effects of procarbazine by dopaminergic effects. Use Caution/Monitor. Coadministration of selective MAO-B inhibitors with levodopa may be associated with orthostatic hypotension.

            • rasagiline

              levodopa inhaled increases effects of rasagiline by dopaminergic effects. Use Caution/Monitor. Coadministration of selective MAO-B inhibitors with levodopa may be associated with orthostatic hypotension.

            • safinamide

              levodopa inhaled increases effects of safinamide by dopaminergic effects. Use Caution/Monitor. Coadministration of selective MAO-B inhibitors with levodopa may be associated with orthostatic hypotension.

            • solriamfetol

              levodopa inhaled and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              levodopa inhaled, solriamfetol. dopaminergic effects. Use Caution/Monitor. Monitor for increased hypertensive effect of solriamfetol if coadministered with dopamine agonists.

            • tedizolid

              levodopa inhaled increases effects of tedizolid by dopaminergic effects. Use Caution/Monitor. Coadministration of selective MAO-B inhibitors with levodopa may be associated with orthostatic hypotension.

            Minor (0)

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              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%)

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              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 (eg, 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, psychotic-like 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
              • Selective 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
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              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

              Consider the development and health benefits of breastfeeding 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.

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              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)

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              Administration

              Oral Inhalation Administration

              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 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)

              Store in original blister package and remove immediately before use

              Do not store capsule inside the inhaler

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              Patient Handout

              A Patient Handout is not currently available for this monograph.
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              Formulary

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