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Levodopa (Oral Inhalation)

Medically reviewed by Drugs.com. Last updated on Sep 20, 2020.

Pronunciation

(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.

Dosage adjustment for concomitant therapy:Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

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 used at chemotherapy doses, hold blood pressure lowering medications for 24 hours before amifostine administration. If blood pressure lowering therapy cannot be held, do not administer amifostine. Use caution with radiotherapy doses of amifostine. Consider therapy modification

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

Amisulpride (Oral): May diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Anti-Parkinson Agents (Dopamine Agonist) may diminish the therapeutic effect of Amisulpride (Oral). 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. If antipsychotic use is necessary, consider using atypical antipsychotics such as clozapine, quetiapine, or ziprasidone at lower initial doses, or a non-dopamine antagonist (eg, pimavanserin). Consider therapy modification

Antipsychotic Agents (Second Generation [Atypical]): May diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Management: Consider avoiding atypical antipsychotic use in patients with Parkinson disease. If an atypical antipsychotic is necessary, consider using clozapine, quetiapine, or ziprasidone at lower initial doses, or a non-dopamine antagonist (eg, pimavanserin). 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

Brivudine [INT]: May enhance the adverse/toxic effect of Anti-Parkinson Agents (Dopamine Agonist). Specifically, the risk of chorea may be increased. 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

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

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). Avoid combination

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. Avoid combination

Monoamine Oxidase Inhibitors (Type B): Levodopa-Containing Products may enhance the orthostatic hypotensive effect of Monoamine Oxidase Inhibitors (Type B). Monitor therapy

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). Management: Avoid concomitant use of a multivitamin containing pyridoxine (vitamin B6) and levodopa in the absence of a dopa decarboxylase inhibitor (DDI). Use of a DDI (eg, carbidopa) with levodopa largely eliminates the risk of interaction. 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: May enhance the adverse/toxic effect of Anti-Parkinson Agents (Dopamine Agonist). 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

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

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

1% to 10%:

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

Dermatologic: Excoriation of skin (2%)

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

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

Hepatic: Increased serum bilirubin (2%)

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

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

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

Miscellaneous: Laceration (2%)

Frequency not defined:

Endocrine & metabolic: Abnormal BUN, increased lactate dehydrogenase

Hematologic & oncologic: Hemolytic anemia, positive direct Coombs test

Hepatic: Increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum aspartate aminotransferase

Nervous system: Abnormal behavior, abnormality in thinking, drowsiness, impulse control disorder, sudden onset of sleep

Postmarketing: Nervous system: Choking sensation

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.

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

What is this drug used for?

• It is used to treat "off" episodes (when a dose wears off) in people with Parkinsons disease.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Cough

• Change in color of sputum

• Signs of a common cold

• Upset stomach

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Falling asleep during activities like driving, eating, or talking

• Very sleepy

• Trouble breathing that is new or worse

• Change in the way you act

• Hallucinations (seeing or hearing things that are not there)

• Feeling confused

• Feeling agitated

• Restlessness

• Trouble sleeping

• Strange or odd dreams

• Strong urges that are hard to control (such as eating, gambling, sex, or spending money)

• Trouble controlling body movements that is new or worse

• Dizziness or passing out

• Very upset stomach or throwing up

• Sweating a lot

• Change in eyesight

• Eye pain

• Choking feeling right after use

• Neuroleptic malignant syndrome like fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine’s uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

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

Frequently Asked Questions