This combination capsule is used for the management of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may develop following carbon monoxide or manganese poisoning.

Levodopa: Levodopa acts as a metabolic precursor of dopamine. It is able to cross the blood-brain barrier and is then converted into dopamine within the brain. This process is responsible for reducing the symptoms associated with Parkinson’s disease.

Carbidopa: After oral administration, levodopa is rapidly converted into dopamine outside the brain, which limits the amount reaching the central nervous system. Carbidopa blocks this peripheral conversion, allowing a greater amount of levodopa to reach the brain and enhance its therapeutic effect.

Dosage in Patients Naive to Levodopa Therapy: The recommended starting dosage of RYTARY in levodopa-naive patients is RYTARY 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 145 mg taken three times a day. Based upon individual patient clinical response and tolerability, the RYTARY dose may be increased up to a maximum recommended dose of 390 mg taken three times a day. The dosing frequency may be changed from three times a day to a maximum of five times a day if more frequent dosing is needed and if tolerated. Maintain patients on the lowest dosage required to achieve symptomatic control and to minimize adverse reactions such as dyskinesia and nausea. The maximum recommended daily dose of RYTARY is 2450 mg.

Converting from Immediate-Release Carbidopa-Levodopa to RYTARY: The dosages of other carbidopa and levodopa products are not interchangeable on a 1:1 basis with the dosages of RYTARY. To convert patients from immediate-release carbidopa-levodopa to RYTARY, first calculate the patient’s current total daily dose of levodopa. The starting total daily dose of RYTARY is as recommended in below mentioned chart. After conversion, any combination of the four RYTARY dosage strengths can be used to achieve an optimal dosing. Adjust the dose and dosing frequency as necessary to maintain patient tolerance and sufficient symptomatic control. Administration of concomitant Parkinson’s disease medications should remain stable while adjusting the RYTARY dose. In clinical trials, RYTARY was administered in divided doses of three to five times a day. The maximum recommended total daily dose of RYTARY is 612.5 mg / 2,450 mg. For patients currently treated with carbidopa and levodopa plus a catechol-O-methyl transferase (COMT) inhibitor (such as entacapone), the initial total daily dose of levodopa in RYTARY described in Table 1 may need to be increased. Use of RYTARY in combination with other levodopa products has not been studied.

Conversion from Immediate Release Carbidopa–Levodopa to RYTARY-

Iron-containing products and dopamine D2 receptor antagonists such as metoclopramide may decrease the effectiveness of this medication.

This medication should not be used in patients who are currently receiving nonselective monoamine oxidase (MAO) inhibitors (e.g., phenelzine, tranylcypromine) or who have taken such drugs within the past 2 weeks. Concurrent use may lead to the development of hypertension.

Early Parkinson’s disease: Common side effects (≥5% incidence and more than placebo) include nausea, dizziness, headache, insomnia, abnormal dreams, dry mouth, dyskinesia, anxiety, constipation, vomiting, and orthostatic hypotension.

Advanced Parkinson’s disease: Frequently reported side effects (≥5% incidence and more than immediate-release formulation) are nausea and headache.

Pregnancy: There is insufficient information regarding the developmental risk of this medicine in pregnant women. Animal studies have shown that the combination may cause developmental toxicity, including birth defects, at clinically relevant doses.

Lactation: Levodopa has been detected in human breast milk after administration. Data on the presence of carbidopa in human milk are not available. The potential effects on the breastfed infant and milk production are unknown; however, levodopa may reduce prolactin levels and interfere with lactation. Carbidopa has been found in animal milk.

Patients may experience sudden sleep episodes during daily activities, along with drowsiness. Withdrawal-related conditions such as hyperpyrexia and confusion (marked by high temperature, muscle stiffness, altered consciousness, and autonomic instability) may occur. Other concerns include cardiovascular events, hallucinations or psychosis, impulse control disorders, dyskinesia, peptic ulcer disease, and glaucoma.

Pediatric use: Safety and effectiveness in children have not been established.

Antiparkinson drugs

Keep in a cool, dry place, protected from light, and out of reach of children.