Label Changes for:
Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- The addition of LODOSYN with carbidopa-levodopa reduces the peripheral effects (nausea, vomiting) due to decarboxylation of levodopa; however, LODOSYN does not decrease the adverse reactions due to the central effects of levodopa. Because LODOSYN permits more levodopa to reach the brain and more dopamine to be formed, certain adverse central nervous system (CNS) effects, e.g., dyskinesias (involuntary movements), may occur at lower dosages and sooner with levodopa in combination with LODOSYN than with levodopa alone.
- Falling Asleep During Activities of Daily Living and Somnolence
- Neuroleptic Malignant Syndrome (NMS) section revised into Hyperpyrexia and Confusion
- Impulse Control/Compulsive Behaviors
- Hallucinations/Psychotic Like Behavior
- Melanoma Information for Patients
- LODOSYN and iron salts or multi vitamins containing iron salts should be co administered with caution. Iron salts can form chelates with levodopa and carbidopa and consequently reduce the bioavailability of carbidopa and levodopa.
USE IN SPECIFIC POPULATIONS
- Geriatric use added
- Nervous System/Psychiatric: section edited