rytary
Pharmaranks rates Rytary 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Rytary is a combination medicine containing Carbidopa and Levodopa.
Carbidopa and Levodopa · by Impax
Available as a generic: Carbidopa and Levodopa
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Carbidopa and Levodopa
- Form
- Capsule, extended release
- Strength
- Carbidopa 23.75MG; Levodopa 95MG · Carbidopa 36.25MG; Levodopa 145MG · Carbidopa 48.75MG; Levodopa 195MG · Carbidopa 61.25MG; Levodopa 245MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Impax
- Half-life
- about 50 minutes (extended to about 1.5 hours when taken with carbidopa) (how long it stays in your system)
- What the pharmacy pays
- ~$20.52 for 30 — not your price
- FDA application
- NDA203312
What is Rytary?
From the FDA label:Carbidopa and levodopa extended-release capsule is a combination of carbidopa, an inhibitor of aromatic amino acid decarboxylation, and levodopa, an aromatic amino acid, in extended-release capsules for oral use. Carbidopa is a white to creamy white powder, slightly soluble in water, with a molecular weight of 244.2. It is designated chemically as (-)-L-α-hydrazino-3, 4-dihydroxy-α-methylhydrocinnamic acid monohydrate. Its molecular formula is C 10 H 14 N 2 O 4 • H 2 O and its structural formula is: Capsule content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.2. Levodopa is a white to off-white, crystalline powder, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (−)-3-(3, 4-Dihydroxyphenyl)-L-alanine. Its molecular formula is C 9 H 11 NO 4 and its structural formula is: Each extended-release capsule contains 23.75 mg carbidopa, USP and 95 mg levodopa USP, 36.25 mg carbidopa, USP and 145 mg levodopa USP, 48.75 mg carbidopa, USP and 195 mg levodopa USP, or 61.25 mg carbidopa, USP and 245 mg levodopa USP. The inactive ingredients are microcrystalline cellulose, mannitol, tartaric acid, ethyl cellulose, hypromellose, sodium starch glycolate, sodium lauryl sulfate, povidone, talc, methacrylic acid copolymers, triethyl citrate, croscarmellose sodium, and magnesium stearate. All capsule shells contain…
How to use
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 ( 2.1 ) See Table 1 for instructions for converting patients taking immediate-release carbidopa-levodopa to an initial dose of carbidopa and levodopa extended-release capsules. Dosages of carbidopa and levodopa extended-release capsules are not interchangeable with other carbidopa-levodopa products ( 2.2 ) The maximum recommended daily dose of carbidopa and levodopa extended-release capsules is 612.5 mg/2,450 mg ( 2.1 , 2.2 ) Carbidopa and levodopa extended-release capsules may be taken with or without food; do not chew, divide or crush ( 2.4 , 12.3 ) 2.1 Dosage in Patients Naïve to Levodopa Therapy The recommended starting dosage of carbidopa and levodopa extended-release capsules in levodopa-naïve patients 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 carbidopa and levodopa extended-release capsules may be increased to 36.25 mg/145 mg taken three times a day. Based upon individual patient clinical response and tolerability, the carbidopa and levodopa extended-release capsules dose may be increased up to a maximum recommended dose of 97.5 mg/390 mg taken three times a day. The dosing frequency may be changed from three times a day to a maximum of…
Side effects
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 )] Peptic Ulcer Disease [see Warnings and Precautions ( 5.7 )] Glaucoma [see Warnings and Precautions ( 5.8 )] 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 Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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…
Warnings
Important safety information
May cause falling asleep during activities of daily living ( 5.1 ) Avoid sudden discontinuation or rapid dose reduction to reduce the risk of withdrawal-emergent hyperpyrexia and confusion ( 5.2 ) Cardiovascular Events: Monitor patients with a history of cardiovascular disease ( 5.3 ) Hallucinations/Psychosis may occur ( 5.4 ) Impulse Control Disorders: Consider dose reduction or stopping carbidopa and levodopa extended-release capsules if occurs ( 5.5 ) May cause or exacerbate dyskinesia: Consider dose reduction ( 5.6 ) 5.1 Falling Asleep During Activities of Daily Living and Somnolence Patients treated with levodopa, a component of carbidopa and levodopa extended-release capsules, have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes resulted in accidents. Although many of these patients reported somnolence while on levodopa, some perceived that they had no warning signs (sleep attack), such as excessive drowsiness, and believed that they were alert immediately prior to the event. Some of these events have been reported more than 1 year after initiation of treatment. It has been reported that falling asleep while engaged in activities of daily living usually occurs in a setting of pre-existing somnolence, although patients may not give such a history. For this reason, prescribers should reassess patients for drowsiness or sleepiness in carbidopa and levodopa extended-release capsules-treated patients, especially since some of the events occur well after the start of treatment. Prescribers should also be aware that patients may not acknowledge drowsiness or sleepiness until directly questioned about drowsiness or sleepiness during specific activities. Before initiating treatment with carbidopa and levodopa extended-release capsules, advise patients of the potential to develop drowsiness and specifically ask about factors that may increase the risk for somnolence with carbidopa and levodopa extended-release capsules such as concomitant sedating medications or the presence of a sleep disorder. Consider discontinuing carbidopa and levodopa extended-release capsules in patients who report significant daytime sleepiness or episodes of falling asleep during activities that require active participation (e.g., conversations, eating, etc.). If a decision is made to continue carbidopa and levodopa extended-release capsules, patients should be advised not to drive and to avoid other potentially dangerous activities that might result in harm if the patients become somnolent. There is insufficient information to establish that dose reduction will eliminate episodes of falling asleep while engaged in activities of daily living. 5.2 Withdrawal-Emergent Hyperpyrexia and Confusion A symptom complex that resembles neuroleptic malignant syndrome (characterized by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious etiology, has been reported in association with rapid dose reduction, withdrawal of, or changes in dopaminergic therapy. Avoid sudden discontinuation or rapid dose reduction in patients taking carbidopa and levodopa extended-release capsules. If the decision is made to discontinue carbidopa and levodopa extended-release capsules, the dose should be tapered to reduce the risk of hyperpyrexia and confusion [see Dosage and Administration ( 2.4 )] . 5.3 Cardiovascular Ischemic Events Cardiovascular ischemic events have occurred in patients taking carbidopa and levodopa extended-release capsules. In a placebo controlled clinical study in patients with early Parkinson's disease, 7/289 (2.4%) of carbidopa and levodopa extended-release capsules-treated patients experienced cardiovascular ischemic adverse reactions compared to 1/92 (1.1%) of placebo-treated patients. In an active-controlled clinical study in patients with advanced Parkinson's disease, 3/450 (0.7%) of carbidopa and levodopa extended-release capsules-treated patients experienced cardiovascular ischemic adverse reactions compared to 0/471 oral immediate-release carbidopa-levodopa-treated patients. These patients all had a previous history of ischemic heart disease or risk factors for ischemic heart disease. In patients with a history of myocardial infarction who have residual atrial, nodal, or ventricular arrhythmias, cardiac function should be monitored in an intensive cardiac care facility during the period of initial dosage adjustment. 5.4 Hallucinations/Psychosis There is an increased risk for hallucinations and psychosis in patients taking carbidopa and levodopa extended-release capsules. In a controlled clinical trial in patients with advanced Parkinson's disease, 9/201 (4%) of carbidopa and levodopa extended-release capsules-treated patients reported hallucinations or psychosis compared to 2/192 (1%) of oral immediate-release carbidopa-levodopa-treated patients. Hallucinations present shortly after the initiation of therapy and may be responsive to dose reduction in levodopa. Hallucinations may be accompanied by confusion, insomnia, and excessive dreaming. Abnormal thinking and behavior may present with one or more symptoms, including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behavior, disorientation, aggressive behavior, agitation, and delirium. Because of the risk of exacerbating psychosis, patients with a major psychotic disorder should not be treated with carbidopa and levodopa extended-release capsules. In addition, medications that antagonize the effects of dopamine used to treat psychosis may exacerbate the symptoms of Parkinson's disease and may decrease the effectiveness of carbidopa and levodopa extended-release capsules [see Drug Interactions ( 7.2 )]. 5.5 Impulse Control/Compulsive Behaviors Case reports suggest that patients can experience intense urges to gamble, increased sexual urges, intense urges to spend money, binge eating, and/or other intense urges, and the inability to control these urges while taking one or more of the medications, including carbidopa and levodopa extended-release capsules, that increase central dopaminergic tone and that are generally used for the treatment of Parkinson's disease. In some cases, although not all, these urges were reported to have stopped when the dose was reduced or the medication was discontinued. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to specifically ask patients or their caregivers about the development of new or increased gambling urges, sexual urges, uncontrolled spending or other urges while being treated with carbidopa and levodopa extended-release capsules. Consider a dose reduction or stopping the medication if a patient develops such urges while taking carbidopa and levodopa extended-release capsules. 5.6 Dyskinesia Carbidopa and levodopa extended-release capsules can cause dyskinesias that may require a dosage reduction of carbidopa and levodopa extended-release capsules or other medications used for the treatment of Parkinson's disease. 5.7 Peptic Ulcer Disease Treatment with carbidopa and levodopa extended-release capsules may increase the possibility of upper gastrointestinal hemorrhage in patients with a history of peptic ulcer. 5.8 Glaucoma Carbidopa and levodopa extended-release capsules may cause increased intraocular pressure in patients with glaucoma. Monitor intraocular pressure in patients with glaucoma after starting carbidopa and levodopa extended-release capsules.
Who should not take Rytary
Carbidopa and levodopa extended-release capsules are 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 )
Overdose — what happens if you take too much
In the active-controlled clinical study, a patient accidentally ingested 4.68 grams of carbidopa/18.7 grams of levodopa contained in carbidopa and levodopa extended-release capsules over a 2-day period. The patient experienced acute psychosis and dyskinesias. The patient recovered and completed the study on a reduced dose of carbidopa and levodopa extended-release capsules. Based on the limited available information, the acute symptoms of levodopa/dopa decarboxylase inhibitor overdosage can be expected to arise from dopaminergic overstimulation. Doses of a few grams may result in CNS disturbances, with an increasing likelihood of cardiovascular disturbance (e.g., hypotension, tachycardia) and more severe psychiatric problems at higher doses. An isolated report of rhabdomyolysis and another of transient renal insufficiency suggest that levodopa overdosage may give rise to systemic complications, secondary to dopaminergic overstimulation. Monitor patients and provide supportive care. Patients should receive electrocardiographic monitoring for the development of arrhythmias; if needed, appropriate antiarrhythmic therapy should be given. The possibility that the patient may have taken other drugs, increasing the risk of drug interactions (especially catechol-structured drugs) should be taken into consideration.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Iron salts and dopamine D2 antagonists including metoclopramide: May reduce the effectiveness of carbidopa and levodopa extended-release capsules ( 7.2 , 7.3 ) 7.1 Monoamine Oxidase (MAO) Inhibitors The use of nonselective MAO inhibitors with carbidopa and levodopa extended-release capsules is contraindicated [see Contraindications ( 4 )] . Discontinue use of any nonselective MAO inhibitors at least two weeks prior to initiating carbidopa and levodopa extended-release capsules. The use of selective MAO-B inhibitors (e.g., rasagiline and selegiline) with carbidopa and levodopa extended-release capsules 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 carbidopa and levodopa extended-release capsules. If iron salts or multivitamins containing iron salts are co-administered with carbidopa and levodopa extended-release capsules, monitor patients for worsening Parkinson's symptoms.
Foods & drinks to be careful with
Well-established interactions for this medicine’s drug class, summarized from public health authorities. General information, not medical advice — always confirm with your pharmacist or the label.
High-protein meals
Watch out for: meat, fish, eggs, dairy, beans and other protein-heavy foods — and protein shakes.
Levodopa is an amino acid, and it crosses the gut wall on the same transporter that carries dietary amino acids. Eat a lot of protein at the same time and the two compete: the Sinemet label states that absorption of levodopa may be impaired in some people on a high-protein diet.
What to do: This is about TIMING, not about eating less protein — you need protein. Many people take levodopa 30 to 60 minutes before a meal, and some are advised to shift most of their protein to the evening. Do not restrict protein on your own; ask your neurologist how to space doses around meals.
Source: SINEMET (carbidopa and levodopa) — FDA label, Clinical Pharmacology (DailyMed)
How long does Carbidopa and Levodopa stay in your body?
The elimination half-life of carbidopa and levodopa is about 50 minutes (extended to about 1.5 hours when taken with carbidopa) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. Per the FDA label, levodopa's plasma half-life is about 50 minutes on its own, but it is increased to about 1.5 hours when given with carbidopa (as in Sinemet) — the standard combination that prevents peripheral breakdown of levodopa. Levodopa is effectively a prodrug: it is converted to dopamine in the body/brain (unlike dopamine itself, it crosses the blood-brain barrier). Because the half-life is so short, the drug clears within a few hours, which is why Parkinson's dosing is frequent; adding a COMT inhibitor such as entacapone further prolongs levodopa exposure. Half-life reflects how the body clears the drug, not a drug-test detection window.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: SINEMET (carbidopa and levodopa) tablet — FDA label via DailyMed.
Dosage forms
Capsule, extended release
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- How is Rytary rated?
- pharmaranks gives Rytary a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Rytary cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $20.52 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Rytary?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Rytary. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Rytary?
- Rytary is marketed by Impax. You can see Impax's full profile, rating, and other products on pharmaranks.
- Is Rytary a brand-name or generic drug?
- Rytary is a brand-name product with the active ingredient Carbidopa and Levodopa. Lower-cost generic equivalents containing Carbidopa and Levodopa are available — ask your pharmacist.
- Is Rytary available over the counter?
- No. Rytary is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Rytary come in?
- Rytary is currently marketed as capsule, extended release, per the FDA's National Drug Code Directory.
- Is Rytary FDA-registered?
- Rytary is on record with the U.S. FDA under application number NDA203312. You can verify this on its official FDA label.
- Has Rytary been recalled by the FDA?
- Rytary has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Rytary safe?
- There's no single safe-or-not verdict. pharmaranks gives Rytary a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Rytary?
- Rytary's side effects are taken directly from its FDA label. From the label: 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 Ische… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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rytary
70/100