Levodopa Inhaled

Levodopa Inhaled is a prescription medication used for intermittent treatment of  OFF episodes in patients with Parkinson's disease treated with carbidopa-levodopa. 

• Levodopa Inhaled is available under the following different brand names: Inbrija.

Common side effects of Levodopa Inhaled include:

• Cough
• Upper respiratory tract infection
• Nausea
• Change the color of the saliva or spit.

Serious side effects of Levodopa Inhaled include:

• Fever, 
• Sweating, 
• Stiff muscles, and loss of consciousness
• Chest pain or discomfort
• Difficulty breathing
• New or worsening sudden uncontrollable movements.
• Hallucinations (seeing things or hearing voices that do not exist)
• Feeling that others are harming.
• Difficulty falling asleep or staying asleep.
• Aggressive behavior
• Dreaming more than usual
• Confusion
• Abnormal behavior
• Agitation

Rare side effects of Levodopa Inhaled include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Capsule, inhalation powder

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

Parkinson Disease

Adult dosage

• 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.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Levodopa Inhaled has severe interactions with the following drugs:
  • isocarboxazid
  • phenelzine
  • tranylcypromine
• Levodopa Inhaled has serious interactions with at least 25 other drugs.
• Levodopa Inhaled has moderate interactions with the following drugs:
  • ferric pyrophosphate DIALYSATE
  • isoniazid
  • linezolid
  • methylene blue
  • procarbazine
  • rasagiline
  • safinamide
  • solriamfetol
  • tedizolid
• Levodopa Inhaled has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice or health questions or concerns.

Contraindications

• Currently or recently (within 2 weeks) taking a nonselective monoamine oxidase (MAO) inhibitor (e.g., phenelzine, tranylcypromine)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Levodopa Inhaled?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Levodopa Inhaled?”

Cautions

• Falling asleep while engaged in activities of daily living, including driving, was reported; many patients report somnolence, while others had no warning signs (sleep attack); some events were reported above 1 year after initiating treatment.
• Rapid dose reduction, withdrawal of, or changes in dopaminergic therapy may result in a symptom complex that resembles neuroleptic malignant syndrome (. g, 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 another 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 (. g, phenothiazine, butyrophenones, risperidone, metoclopramide) and isoniazid may reduce the levodopa effect.
  • Iron salts can form chelates with levodopa and reduce bioavailability.

Pregnancy and Lactation

• There are no available data regarding use in pregnant women.
• Lactation
  • Levodopa was detected in human milk; no data are available on its 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.