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RYTARY
Overview
What is RYTARY?
RYTARY 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, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (–)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxy-benzene) propanoic acid monohydrate. Its empirical formula is CHNO∙HO and its structural formula is:
Capsule content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3.
Levodopa is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (–)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its empirical formula is CHNO and its structural formula is:
Each extended-release capsule contains 23.75 mg carbidopa and 95 mg levodopa, 36.25 mg carbidopa and 145 mg levodopa, 48.75 mg carbidopa and 195 mg levodopa, or 61.25 mg carbidopa and 245 mg levodopa. 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. The capsule shells all contain gelatin and titanium dioxide. All blue capsule components contain FD&C Blue #2 and yellow iron oxide. All yellow capsule components contain yellow iron oxide. All capsules with black imprinting contain iron oxide black. All capsules with blue imprinting contain FD&C Blue #2.
What does RYTARY look like?
What are the available doses of RYTARY?
Extended-release capsules: Carbidopa and levodopa 23.75 mg / 95 mg, 36.25 mg / 145 mg, 48.75 mg / 195 mg, 61.25 mg / 245 mg ()
What should I talk to my health care provider before I take RYTARY?
Pregnancy: Based on animal data, may cause fetal harm ()
How should I use RYTARY?
RYTARY is indicated for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.
The recommended starting dosage of RYTARY 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 RYTARY may be increased to 36.25 mg / 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 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 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 612.5 mg / 2450 mg. The maximum recommended daily dose of TYTARY is 612.5 mg / 2450 mg.
What interacts with RYTARY?
Sorry No Records found
What are the warnings of RYTARY?
Sorry No Records found
What are the precautions of RYTARY?
Sorry No Records found
What are the side effects of RYTARY?
Sorry No records found
What should I look out for while using RYTARY?
RYTARY is contraindicated in patients:
What might happen if I take too much RYTARY?
In the active-controlled clinical study, a patient accidentally ingested 4.68 grams of carbidopa/18.7 grams of levodopa contained in RYTARY over a 2-day period. The patient experienced acute psychosis and dyskinesias. The patient recovered and completed the study on a reduced dose of RYTARY.
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.
How should I store and handle RYTARY?
Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in a tightly closed container, protected from light and moisture.Dispense in a tightly closed, light-resistant container.Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in a tightly closed container, protected from light and moisture.Dispense in a tightly closed, light-resistant container.Each white, round, scored, debossed “TEVA” on one side and “2203” above the score on the other side, compressed metoclopramide tablet, USP contains metoclopramide hydrochloride, USP equivalent to 10 mg metoclopramide. Available in bottles of 20 (NDC 66267-286-20), 30 (NDC 66267-286-30), and 60 (NDC 66267-286-60).Dispense in a tight, light-resistant container.This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.Tablets should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured In Croatia By:PLIVA HRVATSKA d.o.o.Zagreb, CroatiaManufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. P 9/2015Each white, round, scored, debossed “TEVA” on one side and “2203” above the score on the other side, compressed metoclopramide tablet, USP contains metoclopramide hydrochloride, USP equivalent to 10 mg metoclopramide. Available in bottles of 20 (NDC 66267-286-20), 30 (NDC 66267-286-30), and 60 (NDC 66267-286-60).Dispense in a tight, light-resistant container.This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.Tablets should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured In Croatia By:PLIVA HRVATSKA d.o.o.Zagreb, CroatiaManufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. P 9/2015Each white, round, scored, debossed “TEVA” on one side and “2203” above the score on the other side, compressed metoclopramide tablet, USP contains metoclopramide hydrochloride, USP equivalent to 10 mg metoclopramide. Available in bottles of 20 (NDC 66267-286-20), 30 (NDC 66267-286-30), and 60 (NDC 66267-286-60).Dispense in a tight, light-resistant container.This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.Tablets should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured In Croatia By:PLIVA HRVATSKA d.o.o.Zagreb, CroatiaManufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. P 9/2015Each white, round, scored, debossed “TEVA” on one side and “2203” above the score on the other side, compressed metoclopramide tablet, USP contains metoclopramide hydrochloride, USP equivalent to 10 mg metoclopramide. Available in bottles of 20 (NDC 66267-286-20), 30 (NDC 66267-286-30), and 60 (NDC 66267-286-60).Dispense in a tight, light-resistant container.This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.Tablets should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured In Croatia By:PLIVA HRVATSKA d.o.o.Zagreb, CroatiaManufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. P 9/2015Each white, round, scored, debossed “TEVA” on one side and “2203” above the score on the other side, compressed metoclopramide tablet, USP contains metoclopramide hydrochloride, USP equivalent to 10 mg metoclopramide. Available in bottles of 20 (NDC 66267-286-20), 30 (NDC 66267-286-30), and 60 (NDC 66267-286-60).Dispense in a tight, light-resistant container.This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.Tablets should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured In Croatia By:PLIVA HRVATSKA d.o.o.Zagreb, CroatiaManufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. P 9/2015Each white, round, scored, debossed “TEVA” on one side and “2203” above the score on the other side, compressed metoclopramide tablet, USP contains metoclopramide hydrochloride, USP equivalent to 10 mg metoclopramide. Available in bottles of 20 (NDC 66267-286-20), 30 (NDC 66267-286-30), and 60 (NDC 66267-286-60).Dispense in a tight, light-resistant container.This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.Tablets should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured In Croatia By:PLIVA HRVATSKA d.o.o.Zagreb, CroatiaManufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. P 9/2015Each white, round, scored, debossed “TEVA” on one side and “2203” above the score on the other side, compressed metoclopramide tablet, USP contains metoclopramide hydrochloride, USP equivalent to 10 mg metoclopramide. Available in bottles of 20 (NDC 66267-286-20), 30 (NDC 66267-286-30), and 60 (NDC 66267-286-60).Dispense in a tight, light-resistant container.This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.Tablets should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured In Croatia By:PLIVA HRVATSKA d.o.o.Zagreb, CroatiaManufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. P 9/2015Each white, round, scored, debossed “TEVA” on one side and “2203” above the score on the other side, compressed metoclopramide tablet, USP contains metoclopramide hydrochloride, USP equivalent to 10 mg metoclopramide. Available in bottles of 20 (NDC 66267-286-20), 30 (NDC 66267-286-30), and 60 (NDC 66267-286-60).Dispense in a tight, light-resistant container.This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.Tablets should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured In Croatia By:PLIVA HRVATSKA d.o.o.Zagreb, CroatiaManufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. P 9/2015Each white, round, scored, debossed “TEVA” on one side and “2203” above the score on the other side, compressed metoclopramide tablet, USP contains metoclopramide hydrochloride, USP equivalent to 10 mg metoclopramide. Available in bottles of 20 (NDC 66267-286-20), 30 (NDC 66267-286-30), and 60 (NDC 66267-286-60).Dispense in a tight, light-resistant container.This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.Tablets should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured In Croatia By:PLIVA HRVATSKA d.o.o.Zagreb, CroatiaManufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. P 9/2015Each white, round, scored, debossed “TEVA” on one side and “2203” above the score on the other side, compressed metoclopramide tablet, USP contains metoclopramide hydrochloride, USP equivalent to 10 mg metoclopramide. Available in bottles of 20 (NDC 66267-286-20), 30 (NDC 66267-286-30), and 60 (NDC 66267-286-60).Dispense in a tight, light-resistant container.This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.Tablets should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured In Croatia By:PLIVA HRVATSKA d.o.o.Zagreb, CroatiaManufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. P 9/2015Each white, round, scored, debossed “TEVA” on one side and “2203” above the score on the other side, compressed metoclopramide tablet, USP contains metoclopramide hydrochloride, USP equivalent to 10 mg metoclopramide. Available in bottles of 20 (NDC 66267-286-20), 30 (NDC 66267-286-30), and 60 (NDC 66267-286-60).Dispense in a tight, light-resistant container.This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.Tablets should be stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured In Croatia By:PLIVA HRVATSKA d.o.o.Zagreb, CroatiaManufactured For:TEVA PHARMACEUTICALS USA, INC.North Wales, PA 19454Rev. P 9/2015
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Non-Clinical Toxicology
RYTARY is contraindicated in patients:The effects of metoclopramide on gastrointestinal motility are antagonized by anticholinergic drugs and narcotic analgesics. Additive sedative effects can occur when metoclopramide is given with alcohol, sedatives, hypnotics, narcotics, or tranquilizers.
The finding that metoclopramide releases catecholamines in patients with essential hypertension suggests that it should be used cautiously, if at all, in patients receiving monoamine oxidase inhibitors.
Absorption of drugs from the stomach may be diminished (e.g., digoxin) by metoclopramide, whereas the rate and/or extent of absorption of drugs from the small bowel may be increased (e.g., acetaminophen, tetracycline, levodopa, ethanol, cyclosporine).
Gastroparesis (gastric stasis) may be responsible for poor diabetic control in some patients. Exogenously administered insulin may begin to act before food has left the stomach and lead to hypoglycemia. Because the action of metoclopramide will influence the delivery of food to the intestines and thus the rate of absorption, insulin dosage or timing of dosage may require adjustment.
Patients treated with levodopa, a component of RYTARY, 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 RYTARY-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 RYTARY, advise patients of the potential to develop drowsiness and specifically ask about factors that may increase the risk for somnolence with RYTARY such as concomitant sedating medications or the presence of a sleep disorder. Consider discontinuing RYTARY 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 RYTARY, 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.
The following serious adverse reactions are discussed below and elsewhere in the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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