Drugplain

RYTARY 61.25 mg/1

Carbidopa and Levodopa · CAPSULE, EXTENDED RELEASE · Amneal Pharmaceuticals LLC

No Recall History
Plain English

RYTARY is a capsule, extended release containing carbidopa and levodopa at 61.25 mg/1, taken oral. Manufactured by Amneal Pharmaceuticals LLC.

Key Facts

Brand Name
RYTARY
Generic Name
Carbidopa and Levodopa
NDC Code (Product)
64896-664
Manufacturer
Amneal Pharmaceuticals LLC
Strength
61.25 mg/1
Dosage Form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
NDA203312
Drug Class
Aromatic Amino Acid [EPC]
Marketing Start
01/12/2015

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective2,253 reports
tremor2,022 reports
hallucination1,717 reports
fall1,683 reports
dyskinesia1,559 reports
dizziness1,347 reports
nausea1,221 reports
death1,027 reports
parkinson^s disease967 reports
somnolence930 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE RYTARY is indicated for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. RYTARY is a combination of carbidopa (an aromatic amino acid decarboxylation inhibitor) and levodopa (an aromatic amino acid) indicated for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Evaluate vitamin B6 levels prior to starting treatment with carbidopa/levodopa therapies. ( 2.1 ) Levodopa-naïve patients: Starting dose is 23.75 mg/95 mg three times daily; may increase to 36.25 mg/145 mg three times daily on the fourth day of treatment. ( 2.2 ) See Table 1 for instructions for converting patients taking immediate-release carbidopa-levodopa to an initial dose of RYTARY. Dosages of RYTARY are not interchangeable with other carbidopa-levodopa products. ( 2.3 ) The maximum recommended daily dose of RYTARY is 612.5 mg/2,450 mg. ( 2.2 , 2.3 ) RYTARY may be taken with or without food; do not chew, divide or crush. ( 2.5 , 12.3 ) 2.1 Management of Vitamin B6 Levels Evaluate vitamin B6 levels prior to initiating carbidopa/levodopa therapies, including RYTARY, periodically during treatment, and as clinically indicated [see Warnings and Precautions (5.7) ]. If vitamin B6 levels are low, supplement to sufficient levels per standard of care. Patients may initiate and continue treatment with RYTARY while supplementing vitamin B6. 2.2 Dosage in Patients Naïve to Levodopa Therapy The recommended starting dosage of RYTARY in levodopa-naïve patients is …

Contraindications

4 CONTRAINDICATIONS RYTARY is contraindicated in patients: Currently taking a nonselective monoamine oxidase (MAO) inhibitor (e.g., phenelzine and tranylcypromine) or have recently (within 2 weeks) taken a nonselective MAO inhibitor. Hypertension can occur if these drugs are used concurrently [see Drug Interactions (7.1) ] . Nonselective MAO inhibitors. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Iron salts and dopamine D2 antagonists including metoclopramide: May reduce the effectiveness of RYTARY. ( 7.2 , 7.3 ) 7.1 Monoamine Oxidase (MAO) Inhibitors The use of nonselective MAO inhibitors with RYTARY is contraindicated [see Contraindications (4) ] . Discontinue use of any nonselective MAO inhibitors at least two weeks prior to initiating RYTARY. The use of selective MAO-B inhibitors (e.g., rasagiline and selegiline) with RYTARY may be associated with orthostatic hypotension. Monitor patients who are taking these drugs concurrently. 7.2 Dopamine D2 Receptor Antagonists and Isoniazid Dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone, metoclopramide) and isoniazid may reduce the effectiveness of levodopa. Monitor patients for worsening Parkinson's symptoms. 7.3 Iron Salts Iron salts or multivitamins containing iron salts can form chelates with levodopa and carbidopa and can cause a reduction in the bioavailability of RYTARY. If iron salts or multivitamins containing iron salts are co-administered with RYTARY, monitor patients for worsening Parkinson's symptoms.

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are discussed below and elsewhere in the labeling: Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions (5.1) ] Withdrawal-Emergent Hyperpyrexia and Confusion [see Warnings and Precautions (5.2) ] Cardiovascular Ischemic Events [see Warnings and Precautions (5.3) ] Hallucinations/Psychosis [see Warnings and Precautions (5.4) ] Impulse Control/Compulsive Behaviors [see Warnings and Precautions (5.5) ] Dyskinesia [see Warnings and Precautions (5.6) ] Vitamin B6 Deficiency and Seizures [see Warnings and Precautions (5.7) ] Peptic Ulcer Disease [see Warnings and Precautions (5.8) ] Glaucoma [see Warnings and Precautions (5.9) ] Early Parkinson's disease: Most common adverse reactions (incidence ≥ 5% and greater than placebo) are nausea, dizziness, headache, insomnia, abnormal dreams, dry mouth, dyskinesia, anxiety, constipation, vomiting, and orthostatic hypotension. ( 6.1 ) Advanced Parkinson's disease: Most common adverse reactions (incidence ≥ 5% and greater than oral immediate-release carbidopa-levodopa) are nausea and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact…

Frequently Asked Questions

What is RYTARY used for?

RYTARY contains Carbidopa and Levodopa. It is a capsule, extended release taken oral. Consult your doctor for specific uses.

Is RYTARY a controlled substance?

RYTARY is not classified as a controlled substance by the DEA.

What is the generic name for RYTARY?

The generic name for RYTARY is Carbidopa and Levodopa. There are 11 other brand versions of Carbidopa and Levodopa.

What is the NDC code for RYTARY 61.25 mg/1?

The NDC (National Drug Code) for RYTARY 61.25 mg/1 is 64896-664, listed by Amneal Pharmaceuticals LLC.

Product NDC

64896-664

Package NDC

64896-664-01

Other RYTARY Dosages

Other Carbidopa Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)