Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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 (25)
- amisulpride
amisulpride, levodopa inhaled. Either decreases effects of the other by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid use of amisulpride, a dopamine receptor antagonist, with dopamine agonists.
- 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)
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%)
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
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.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)
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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