Rytary
- Generic Name: carbidopa and levodopa capsules
- Brand Name: Rytary
Rytary (Carbidopa and Levodopa Capsules) side effects drug center
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- nausea,
- dizziness,
- headache,
- insomnia,
- abnormal dreams,
- dry mouth,
- involuntary movements,
- anxiety,
- constipation,
- vomiting, and
- low blood pressure and dizziness upon standing (orthostatic hypotension)
- uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
- worsening of tremors (uncontrolled shaking);
- severe or ongoing vomiting or diarrhea;
- confusion, hallucinations, unusual changes in mood or behavior;
- depression or suicidal thoughts; or
- severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.
- jerky or twisting muscle movements;
- headache, dizziness;
- low blood pressure (feeling light-headed);
- sleep problems, strange dreams;
- dry mouth;
- muscle contractions; or
- nausea, vomiting, constipation.
- Falling asleep during activities of daily living and somnolence [see WARNINGS AND PRECAUTIONS]
- Withdrawal-emergent hyperpyrexia and confusion [see WARNINGS AND PRECAUTIONS]
- Cardiovascular ischemic events [see WARNINGS AND PRECAUTIONS]
- Hallucinations/psychosis [see WARNINGS AND PRECAUTIONS]
- Impulse control/compulsive behaviors [see WARNINGS AND PRECAUTIONS]
- Dyskinesia [see WARNINGS AND PRECAUTIONS]
- Peptic Ulcer Disease [see WARNINGS AND PRECAUTIONS]
- Glaucoma [see WARNINGS AND PRECAUTIONS]
- Melanoma [see WARNINGS AND PRECAUTIONS]
What Is Rytary?
Rytary (carbidopa and levodopa) is a combination an inhibitor of aromatic amino acid decarboxylation and an aromatic amino acid, used for the treatment of Parkinson's disease, post-encephalitic Parkinsonism, and Parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.
What Are Side Effects of Rytary?
Common side effects of Rytary include:
Dosage for Rytary
The recommended starting dosage of Rytary is 23.75 mg/95 mg taken orally three times a day for the first 3 days. On the fourth day of treatment, the dosage of Rytary may be increased to 36.25 mg/145 mg taken three times a day.
What Drugs, Substances, or Supplements Interact with Rytary?
Rytary may interact with MAO inhibitors, phenothiazines, butyrophenones, risperidone, metoclopramide, isoniazid, iron salts, or multi-vitamins containing iron salts. Tell your doctor all medications and supplements you use.
Rytary During Pregnancy and Breastfeeding
During pregnancy, Rytary should be used only if prescribed. These drugs may pass into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Rytary (carbidopa and levodopa) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
Some people taking carbidopa and levodopa have fallen asleep during normal daytime activities such as working, talking, eating, or driving. Tell your doctor if you have any problems with daytime sleepiness or drowsiness.
You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.
You may notice that your sweat, urine, or saliva appears dark in color, such as red, brown, or black. This is not a harmful side effect, but it may cause staining of your clothes or bed sheets.
Common side effects may include:
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.
Read the entire detailed patient monograph for Rytary (Carbidopa and Levodopa Capsules)
SIDE EFFECTS
The following serious adverse reactions are discussed below and elsewhere in the labeling:
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.
The safety population consisted of a total of 978 Parkinson's disease patients who received at least one dose of RYTARY, and had an average duration of exposure of 40 weeks.
Adverse Reactions In Early Parkinson's Disease
In a placebo-controlled clinical study in patients with early Parkinson's disease (Study 1), the most common adverse reactions with RYTARY (in at least 5% of patients and more frequently than in placebo) were nausea, dizziness, headache, insomnia, abnormal dreams, dry mouth, dyskinesia, anxiety, constipation, vomiting, and orthostatic hypotension.
Table 2 lists adverse reactions occurring in at least 5% of RYTARY-treated patients and at a higher rate than placebo in Study 1.
Table 2: Adverse Reactions in Study 1 in Patients with Early Stage Parkinson's Disease
| Placebo | RYTARY 36.25 mg carbidopa 145 mg Levodopa TID |
RYTARY 61.25 mg carbidopa 245 mg Levodopa TID |
RYTARY 97.5 mg carbidopa 390 mg Levodopa TID |
|
| (N=92) % |
(N=87) % |
(N=104) % |
(N=98) % |
|
| Nausea | 9 | 14 | 19 | 20 |
| Dizziness | 5 | 9 | 19 | 12 |
| Headache | 11 | 7 | 13 | 17 |
| Insomnia | 3 | 2 | 9 | 6 |
| Abnormal Dreams | 0 | 2 | 6 | 5 |
| Dry Mouth | 1 | 3 | 2 | 7 |
| Dyskinesia | 0 | 2 | 4 | 5 |
| Anxiety | 0 | 2 | 3 | 5 |
| Constipation | 1 | 2 | 6 | 2 |
| Vomiting | 3 | 2 | 2 | 5 |
| Orthostatic | ||||
| Hypotension | 1 | 1 | 1 | 5 |
Adverse Reactions Leading to Discontinuation in Study 1
In Study 1, 12% of patients discontinued RYTARY early due to adverse reactions; a higher proportion of patients in the 61.25 mg / 245 mg RYTARY-treated group (14%) and in the 97.5 mg / 390 mg RYTARY-treated group (15%) experienced adverse reactions leading to early discontinuation compared to (4%) in the placebo group. The most common adverse reactions resulting in early discontinuation were nausea, dizziness, and vomiting.
Adverse Reactions In Advanced Parkinson's Disease
In an active-controlled clinical study in patients with advanced Parkinson's disease (Study 2), the most common adverse reactions with RYTARY that occurred during dose conversion or maintenance (in at least 5% of patients and more frequently than on oral immediate-release carbidopa-levodopa) were nausea and headache.
Table 3 lists adverse reactions occurring in at least 5% of RYTARY-treated patients and at a higher rate than oral immediate-release carbidopa-levodopa in Study 2.
Table 3: Adverse Reactions in Study 2 in Patients with Advanced Parkinson's Disease
| Period | RYTARY (N=201) |
Immediate-Release carbidopa-levodopa (N=192) |
||
| Dose Convers ion* | Maintenance | Dose Convers ion* | Maintenance | |
| % | % | % | % | |
| Nausea | 4 | 3 | 6 | 2 |
| Headache | 5 | 1 | 3 | 2 |
| *All patients were converted to RYTARY in the open label Dose Conversion period and then received randomized treatment during maintenance. | ||||
Adverse Reactions Leading to Discontinuation in Study 2
In Study 2, 5% of patients discontinued treatment due to adverse reactions during conversion to RYTARY. The common adverse reactions leading to discontinuation during dose conversion were dyskinesia, anxiety, dizziness, and on and off phenomenon.
Read the entire FDA prescribing information for Rytary (Carbidopa and Levodopa Capsules)
© Rytary Patient Information is supplied by Cerner Multum, Inc. and Rytary Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
