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Levodopa (Oral Inhalation)

Medically reviewed by Drugs.com. Last updated on Nov 26, 2018.

Pronunciation

See also: Gocovri

(lee voe DOE pa)

Index Terms

  • Inbrija

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Inhalation:

Inbrija: 42 mg per inhalation

Brand Names: U.S.

  • Inbrija

Pharmacologic Category

  • Anti-Parkinson Agent, Dopamine Precursor

Pharmacology

Parkinson disease symptoms are due to a lack of striatal dopamine; levodopa circulates in the plasma to the blood-brain-barrier (BBB), where it crosses, to be converted by striatal enzymes to dopamine (Lloyd 1975).

Distribution

Vz/F: 168 L

Metabolism

Extensively metabolized by decarboxylation and O-methylation

Time to Peak

Median 0.5 hours (range: 0.17 to 2 hours)

Half-Life Elimination

2.3 hours

Use: Labeled Indications

Parkinson disease: Intermittent treatment of OFF episodes in patients with Parkinson disease treated with carbidopa/levodopa

Contraindications

Concurrent use or within 14 days of nonselective MAOIs (eg, phenelzine, tranylcypromine) use

Dosing: Adult

Parkinson disease (as an adjunct to carbidopa/levodopa): Oral inhalation: 84 mg up to 5 times daily as needed when symptoms of an OFF period return; maximum: 84 mg/dose and 420 mg/day

Dosing: Geriatric

Refer to adult dosing.

Administration

Oral inhalation: Capsules are for oral inhalation only and should only be used with the Inbrija inhaler. Use 1 capsule per inhalation; discard used capsules. Do not swallow.

Storage

Store between 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from moisture. Store capsules in blister packaging and only remove immediately before use.

Drug Interactions

Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Alizapride: May diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Avoid combination

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When amifostine is used at chemotherapy doses, blood pressure lowering medications should be withheld for 24 hours prior to amifostine administration. If blood pressure lowering therapy cannot be withheld, amifostine should not be administered. Consider therapy modification

Amisulpride: May diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Anti-Parkinson Agents (Dopamine Agonist) may diminish the therapeutic effect of Amisulpride. Avoid combination

Antipsychotic Agents (First Generation [Typical]): May diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Anti-Parkinson Agents (Dopamine Agonist) may diminish the therapeutic effect of Antipsychotic Agents (First Generation [Typical]). Management: Avoid concomitant therapy if possible and monitor for decreased effects of both agents when these combinations cannot be avoided. Atypical antipsychotics such as clozapine and quetiapine may be less likely to reduce the effects of anti-Parkinson agents. Consider therapy modification

Antipsychotic Agents (Second Generation [Atypical]): May diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Management: Consider using an alternative antipsychotic agent when possible in patients with Parkinson disease. If an atypical antipsychotic is necessary, consider using clozapine or quetiapine, which may convey the lowest interaction risk. Consider therapy modification

Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Biperiden: May enhance the adverse/toxic effect of Levodopa-Containing Products. Specifically, the risk of choreic movements or dyskinesias may be increased. Monitor therapy

Blood Pressure Lowering Agents: May enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy

Blood Pressure Lowering Agents: May enhance the hypotensive effect of Levodopa-Containing Products. Monitor therapy

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Bromopride: May diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Monitor therapy

Bromperidol: Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Bromperidol may diminish the hypotensive effect of Blood Pressure Lowering Agents. Avoid combination

BuPROPion: Anti-Parkinson Agents (Dopamine Agonist) may enhance the adverse/toxic effect of BuPROPion. Monitor therapy

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Monitor therapy

Fosphenytoin-Phenytoin: May diminish the therapeutic effect of Levodopa-Containing Products. Monitor therapy

Glycopyrrolate (Systemic): May decrease the serum concentration of Levodopa-Containing Products. Monitor therapy

Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy

Isoniazid: May diminish the therapeutic effect of Levodopa-Containing Products. Monitor therapy

Levodopa-Containing Products: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Containing Products. Monitor therapy

Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Macimorelin: Levodopa-Containing Products may diminish the diagnostic effect of Macimorelin. Avoid combination

Methionine: May diminish the therapeutic effect of Levodopa-Containing Products. Management: Avoid large daily doses of methionine in patients receiving levodopa (clinical studies showing interaction used 4.5 g methionine daily). More typical doses of methionine (eg, 500 mg) may not cause a problem. Consider therapy modification

Methylphenidate: May enhance the adverse/toxic effect of Anti-Parkinson Agents (Dopamine Agonist). Monitor therapy

Metoclopramide: May diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Monitor therapy

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Monoamine Oxidase Inhibitors: Levodopa-Containing Products may enhance the adverse/toxic effect of Monoamine Oxidase Inhibitors. Of particular concern is the development of hypertensive reactions when levodopa is used with nonselective MAOI. Management: The concomitant use of nonselective monoamine oxidase inhibitors (MAOIs) and levodopa is contraindicated. Discontinue the nonselective MAOI at least two weeks prior to initiating levodopa. Monitor patients taking a selective MAOIs and levodopa. Consider therapy modification

Multivitamins/Fluoride (with ADE): May diminish the therapeutic effect of Levodopa-Containing Products. Management: Concurrent use of a multivitamin and levodopa (without carbidopa) should be avoided. Consider therapy modification

Multivitamins/Minerals (with ADEK, Folate, Iron): May diminish the therapeutic effect of Levodopa (Oral Inhalation). Consider therapy modification

Multivitamins/Minerals (with AE, No Iron): May diminish the therapeutic effect of Levodopa-Containing Products. Management: Concurrent use of a multivitamin and levodopa (without carbidopa) should be avoided. Consider therapy modification

Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Monitor therapy

Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Consider therapy modification

Papaverine: May enhance the hypotensive effect of Levodopa-Containing Products. Papaverine may diminish the therapeutic effect of Levodopa-Containing Products. Monitor therapy

Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Pyridoxine: May diminish the therapeutic effect of Levodopa-Containing Products. Management: The concomitant use of pyridoxine and levodopa (in the absence of a dopa decarboxylase inhibitor (DDI)) should be avoided. Use of a DDI (eg, carbidopa) with levodopa will essentially eliminate the risk of this interaction. Consider therapy modification

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Sapropterin: May enhance the adverse/toxic effect of Levodopa-Containing Products. Monitor therapy

Solriamfetol: Anti-Parkinson Agents (Dopamine Agonist) may enhance the hypertensive effect of Solriamfetol. Monitor therapy

Sulpiride: May diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Avoid combination

Test Interactions

False diagnosis for pheochromocytoma (rare) based on plasma and urine levels of catecholamines

Adverse Reactions

>10%: Respiratory: Cough (15% to 60%)

1% to 10%:

Cardiovascular: Chest discomfort (2%), decreased blood pressure (≤2%), orthostatic hypotension (≤2%)

Central nervous system: Falling (3%), headache (2%), insomnia (2%), hallucination (<2%)

Dermatologic: Excoriation of skin (2%)

Gastrointestinal: Nausea (5%), vomiting (3%)

Hematologic & oncologic: Decreased red blood cells (2%)

Hepatic: Increased serum bilirubin (2%)

Neuromuscular & skeletal: Dyskinesia (4%), limb pain (2%)

Respiratory: Upper respiratory tract infection (6%), discoloration of sputum (5%), nasopharyngitis (3%), oropharyngeal pain (2%), rhinorrhea (discoloration: 2%), bronchitis (≤2%), pneumonia (≤2%)

Miscellaneous: Laceration (2%)

<1%, postmarketing, and/or case reports: Abnormal behavior, abnormality in thinking, drowsiness, hemolytic anemia, impulse control disorder, increased blood urea nitrogen, increased lactate dehydrogenase, increased liver enzymes, increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum aspartate aminotransferase, positive direct Coombs test, sudden onset of sleep

Warnings/Precautions

Concerns related to adverse effects:

• Abnormal thinking/behavioral changes: Abnormal thinking and behavior changes have been reported and may include aggressive behavior, agitation, confusion, delirium, delusions, disorientation, paranoid ideation, and psychotic-like behavior.

• CNS depression: May cause CNS depression (eg, somnolence and falling asleep while engaged in activities of daily living), which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery or driving). Symptom onset may occur well after initiation of treatment and without any warning signs; some events have occurred more than 1 year after start of therapy. Prior to treatment initiation, evaluate for factors that may increase these risks such as concomitant sedating medications and the presence of sleep disorders. Monitor for drowsiness or sleepiness. If significant daytime sleepiness or episodes of falling asleep during activities that require active participation occurs (eg, driving, conversations, eating), discontinue the medication. There is insufficient information to suggest that dose reductions will eliminate these symptoms.

• Dyskinesias: May cause or exacerbate dyskinesias; may require dosage reduction or discontinuation.

• Hallucinations: Hallucinations may occur and be accompanied by confusion, and to a lesser extent, sleep disorder and excessive dreaming; may require dose reduction.

• Impulse control disorders: Dopamine agonists used for Parkinson disease or restless legs syndrome have been associated with compulsive behaviors and/or loss of impulse control, which has manifested as pathological gambling, increased sexual urges, intense urges to spend money, binge or compulsive eating, and/or other intense urges. Dose reduction or discontinuation of therapy have been reported to reverse these behaviors in some, but not all cases.

• Neuroleptic malignant syndrome: A symptom complex resembling neuroleptic malignant syndrome (NMS) has been reported in association with rapid dose reduction or abrupt withdrawal. Identification of more severe NMS-like reactions (eg, altered consciousness, hyperthermia, involuntary movements, muscle rigidity, autonomic instability, mental status changes) can be complex; monitor patients closely for this reaction and when the dosage of levodopa is reduced abruptly or discontinued. Discontinue treatment immediately if signs/symptoms arise.

Disease-related concerns:

• Glaucoma: May cause increased IOP in patients with glaucoma; monitor IOP.

• Psychotic disorders: May exacerbate psychosis; avoid use in patients with a major psychotic disorder.

• Respiratory disease: May cause bronchospasm; use is not recommended in patients with respiratory disease.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Other warnings/precautions:

• Body fluid discoloration: Urine, saliva, or sweat may appear dark in color (red, brown, black) during therapy.

• Discontinuation of therapy: Dopaminergic agents have been associated with a syndrome resembling neuroleptic malignant syndrome on abrupt withdrawal, rapid dose reduction, significant dosage reduction after long-term use, or changes in dopaminergic therapy. Avoid sudden discontinuation or rapid dose reduction; taper dose to reduce the risk of hyperpyrexia and confusion.

Monitoring Parameters

Hepatic function test, BUN, CBC and direct antiglobulin (as clinically indicated); intraocular pressure (as clinically indicated in patients with glaucoma)

Pregnancy Considerations

Levodopa crosses the placenta following administration of oral tablets (Seier 2017).

Although data related to the use of levodopa in pregnancy is limited, information following maternal use of the oral tablets is available (Seier 2017).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience cough, sputum discoloration, or common cold symptoms. Have patient report immediately to prescriber difficulty breathing, behavioral changes, hallucinations, confusion, agitation, restlessness, difficulty sleeping, nightmares, uncontrollable urges, difficulty moving, dizziness, passing out, severe nausea, vomiting, sweating a lot, vision changes, eye pain, severe fatigue, or narcolepsy (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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