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Rytary

Last reviewed on RxList: 4/19/2018
Rytary Side Effects Center

Last reviewed on RxList 4/19/2018

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. Common side effects of Rytary include:

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. 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. During pregnancy, Rytary should be used only if prescribed. These drugs may pass into breast milk. Consult your doctor before breastfeeding.

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.

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.

Rytary Professional Information

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)

Related Resources for Rytary

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© 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.

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