What are the possible side effects of Madopar-F?
Get emergency medical help if you have signs of an allergic reaction to Madopar-F: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using Madopar-F and call your doctor or seek emergency medical attention if you have a wheezing, chest tightness, or trouble breathing after inhaling this medicine.
Call your doctor at once if you have:
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extreme drowsiness, falling asleep suddenly (even after feeling alert);
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nausea, sweating, and a light-headed feeling (like you might pass out);
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uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
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confusion, paranoia, hallucinations (seeing or hearing things that are not real);
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unusual thoughts or behavior;
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trouble sleeping, or increased dreaming;
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agitation, aggression; or
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increased sexual urges, unusual urges to gamble, or other intense urges.
Some people using this medicine have fallen asleep during normal daytime activities such as working, talking, eating, or driving. This side effect has occurred up to 1 year after the start of treatment with Madopar-F. Tell your doctor if you have any problems with daytime drowsiness.
Common Madopar-F side effects may include:
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cough;
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cold symptoms such as stuffy nose, sneezing, sore throat;
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nausea; or
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sweat, urine, or saliva that appears dark in color.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Madopar-F side effects (more detail)
Side effects of Madopar-F in details
The following serious adverse reactions are discussed below and elsewhere in the labeling:
- Falling Asleep During Activities of Daily Living and Somnolence
- Withdrawal-Emergent Hyperpyrexia and Confusion
- Hallucinations/Psychosis
- Impulse Control/Compulsive Behaviors
- Dyskinesia
- Bronchospasm in Patients with Lung Disease
- Glaucoma
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Adverse Reactions in Study 1
Table 1 lists the adverse reactions that occurred in at least 2% of patients with Parkinson's disease who were treated with Madopar-F 84 mg and higher than placebo for OFF periods in Study 1. Study 1 was a double-blind, placebo-controlled study, in which 114 patients received Madopar-F 84 mg (two 42 mg capsules) for an average of 2 doses per day, to a maximum of 5 times a day, and 112 patients received placebo. Madopar-F-treated patients were 45-82 years of age (mean 63.5 years of age) and were predominantly male (72%) and white (94%). All patients were also treated with oral carbidopa/Madopar-F. The most common adverse reactions (≥ 5% and higher than placebo) in Study 1 were cough, nausea, upper respiratory tract infection, and sputum discolored.
| Adverse Reactions | Madopar-F 84 mg N=114 % | Placebo N=112 % |
|---|---|---|
| Respiratory, thoracic and mediastinal disorders | ||
| Cough | 15 | 2 |
| Sputum discolored | 5 | 0 |
| Nasal discharge discoloration | 2 | 0 |
| Oropharyngeal pain | 2 | 0 |
| Gastrointestinal disorders | ||
| Nausea | 5 | 3 |
| Vomiting | 3 | 0 |
| Infections and infestations | ||
| Upper respiratory tract infection | 6 | 3 |
| Nasopharyngitis | 3 | 2 |
| Bronchitis/pneumonia | 2 | 0 |
| Nervous system disorders | ||
| Dyskinesia | 4 | 1 |
| Headache | 2 | 0 |
| Injury, poisoning and procedural complications | ||
| Fall | 3 | 2 |
| Laceration | 2 | 0 |
| Skin abrasion | 2 | 0 |
| General disorders and administration site conditions | ||
| Chest discomfort | 2 | 0 |
| Investigations | ||
| Blood bilirubin increased | 2 | 0 |
| Red blood cell count decreased | 2 | 0 |
| Musculoskeletal and connective tissue disorders | ||
| Pain in extremity | 2 | 1 |
| Psychiatric disorders | ||
| Insomnia | 2 | 1 |
| Vascular disorders | ||
| Orthostatic hypotension/blood pressure decreased | 2 | 0 |
Adverse Reactions Leading to Discontinuation in Study 1
In Study 1, 6 of 114 patients (5%) in the Madopar-F 84 mg group and 3 of 112 patients (3%) in the placebo group discontinued because of adverse reactions. The most common of these adverse reactions was cough, which lead to discontinuation in 2% of patients in the Madopar-F 84 mg group and none in the placebo group.
What is the most important information I should know about Madopar-F?
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
Madopar-F contraindications
Monoamine oxidase (MAO) inhibitors and Madopar-F should not be given concomitantly and these inhibitors must be discontinued 2 weeks prior to initiating therapy with Madopar-F. Madopar-F is contraindicated in patients with known hypersensitivity to the drug and in narrow angle glaucoma.
Because Madopar-F may activate a malignant melanoma, it should not be used in patients with suspicious, undiagnosed skin lesions or a history of melanoma.
References
- DailyMed. "CARBIDOPA; ENTACAPONE; LEVODOPA: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DTP/NCI. "levodopa: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "Levodopa: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Madopar-F are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Madopar-F. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported side effects
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Information checked by Dr. Sachin Kumar, MD Pharmacology
