PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 25 mg/100 mg
NDC 62332-332-30 Syndopa and Levodopa Extended-Release Tablets, USP 25 mg /100 mg Rx only 30 Tablets Alembic
* For dosing ranges not shown in the table see DOSAGE AND ADMINISTRATION, Initial Dosage — Patients currently treated with conventional Syndopa levodopa preparations.
Patients currently treated with levodopa without a decarboxylase inhibitor: Levodopa must be discontinued at least twelve hours before therapy with Syndopa and Levodopa extended-release tablet is started. Syndopa and Levodopa extended-release tablets should be substituted at a dosage that will provide approximately 25% of the previous levodopa dosage. In patients with mild to moderate disease, the initial dose is usually 1 tablet of Syndopa and Levodopa extended-release tablet 50 mg/200 mg b.i.d.
Patients not receiving levodopa: In patients with mild to moderate disease, the initial recommended dose is 1 tablet of Syndopa and Levodopa extended-release tablet 50 mg/200 mg b.i.d. Initial dosage should not be given at intervals of less than 6 hours.
Titration with Syndopa and Levodopa Extended-Release Tablets
Following initiation of therapy, doses and dosing intervals may be increased or decreased depending upon therapeutic response. Most patients have been adequately treated with doses of Syndopa and Levodopa extended-release tablets that provide 400 to 1600 mg of levodopa per day, administered as divided doses at intervals ranging from 4 to 8 hours during the waking day. Higher doses of Syndopa and Levodopa extended-release tablets (2400 mg or more of levodopa per day) and shorter intervals (less than 4 hours) have been used, but are not usually recommended.
When doses of Syndopa and Levodopa extended-release tablets are given at intervals of less than 4 hours, and/or if the divided doses are not equal, it is recommended that the smaller doses be given at the end of the day.
An interval of at least 3 days between dosage adjustments is recommended.
Because Parkinson’s disease is progressive, periodic clinical evaluations are recommended; adjustment of the dosage regimen of Syndopa and Levodopa extended-release tablets may be required.
Addition of Other Antiparkinson Medications
Anticholinergic agents, dopamine agonists, and amantadine can be given with Syndopa and Levodopa extended-release tablets. Dosage adjustment of Syndopa and Levodopa extended-release tablets may be necessary when these agents are added.
A dose of Syndopa levodopa immediate release 25 mg/100 mg or 10 mg/100 mg (one half or a whole tablet) can be added to the dosage regimen of Syndopa and Levodopa extended-release tablets in selected patients with advanced disease who need additional immediate-release levodopa for a brief time during daytime hours. Interruption of Therapy
Sporadic cases of hyperpyrexia and confusion have been associated with dose reductions and withdrawal of Syndopa and Levodopa tablets or Syndopa and Levodopa extended-release tablets.
Patients should be observed carefully if abrupt reduction or discontinuation of Syndopa and Levodopa extended-release tablet is required, especially if the patient is receiving neuroleptics. (See WARNINGS.)
If general anesthesia is required, Syndopa and Levodopa extended-release tablets may be continued as long as the patient is permitted to take oral medication. If therapy is interrupted temporarily, the patient should be observed for symptoms resembling NMS, and the usual dosage should be administered as soon as the patient is able to take oral medication.
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What is carb >
Syndopa is used with another medicine called levodopa to treat the symptoms of Parkinson's disease (stiffness, tremors, spasms, poor muscle control). Symptoms of Parkinson's disease may be caused by low levels of a chemical called dopamine (DOE pa meen) in the brain.
Levodopa is converted to dopamine in the brain. Syndopa helps prevent the breakdown of levodopa before it can reach the brain and take effect.
Syndopa is only used in combination with levodopa. Syndopa has no effect when used alone.
Syndopa is also used with levodopa to treat muscle symptoms similar to Parkinson's disease that are caused by certain drugs such as chlorpromazine (Thorazine), fluphenazine (Prolixin), perphenazine (Trilafon), and others.
Syndopa may also be used for purposes not listed in this medication guide.
Levodopa interactions with other medicines
When you are taking levodopa, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Levodopa is always combined with Syndopa (a dopa decarboxylase inhibitor) to reduce peripheral side effects and enhance absorption.
Administration of levodopa with nonspecific inhibitors of monoamine oxidase inhibitor (MAO), such as phenelzine and tranylcypromine, markedly accentuates the actions of levodopa & may precipitate life-threatening hypertensive crisis & hyperpyrexia; nonspecific monoamine oxidase inhibitors always should be discontinued at least 14 days before levodopa is admin (note that this prohibition does not include the monoamine oxidase-B subtype-specific inhibitor selegiline, which, as discussed below, often is admin safely in combination with levodopa). Abrupt withdrawal of levodopa or other dopaminergic medications may precipitate the neuroleptic malignant syndrome more commonly observed after treatment with dopamine antagonists.
Antipsychotic drugs, such as phenothiazines, butyrophenones and reserpine can produce a parkinsonism-like syndrome, and since these drugs interfere with the therapeutic effects of levodopa, they are contraindicated. Therefore the phenothiazines should not be used to combat the emetic effect of levodopa. Nonspecific monoamine oxidase inhibitors interfere with inactivation of dopamine, norepinephrine and other catecholamines. Hence, they unpredictably exaggerate the central effects of levodopa and its catecholamine metabolites. Hypertensive crisis and hyperpyrexia are very real and dangerous sequelae of concurrent administration of two such drugs.
Using levodopa with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Methylene Blue
Using levodopa with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using levodopa with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
For patients taking levodopa by itself:
- Swallow the tablet whole without crushing or chewing, unless your doctor tells you not to. If your doctor tells you to, you may break the tablet in half.
- Periodic evaluations of hepatic, hematopoietic, cardiovascular, and renal function.
- Psychiatric: Development of new or increased gambling urges, sexual urges, or other intense urges.
- what (if any) positive effects that Syndopa/levodopa has on your symptoms
- how long it takes for a dose to take effect
- how long the effects of a dose last for you
- the side effects that the medication is causing (which includes but is not limited to: nausea, low blood pressure, hallucinations, fatigue, and Syndopa/levodopa -induced dyskinesias. Remember, each potential side effect only occurs in a subset of people on the medication)
- Pregnancy Category C (all Trimesters): Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
- Studies suggest that levodopa may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.
Nervous system side effects
Symptoms related to neuroleptic malignant syndrome are characterized by fever or hyperthermia. Other findings include neurological symptoms such as muscle rigidity, involuntary movements, altered consciousness, mental status changes, other disturbances such as autonomic dysfunction, tachycardia, tachypnea, sweating, hyper- or hypotension, and laboratory findings such as elevated creatine phosphokinase, leukocytosis, myoglobinuria, and increased serum myoglobin.
A causal relationship with concomitant Syndopa and levodopa and the reported side effect of convulsions has not been established.
Frequency not reported: Bradykinetic episodes (“on-off” phenomenon), convulsions, dizziness, dyskinesias such as choreiform, dystonic and other involuntary movements, headache, neuroleptic malignant syndrome, oculogyric crises, paresthesia, peripheral neuropathy, somnolence, syncope, taste alterations
Syndopa levodopa dosage
Take levodopa only as directed. Do not take more or less of it, and do not take it more often than your doctor ordered.
For patients taking Syndopa and levodopa extended-release tablets:
Some people must take levodopa for several weeks or months before full benefit is received. Do not stop taking it even if you do not think it is working. Instead, check with your doctor.
What is the maximum dose of Syndopa/levodopa that can be used for PD?
Syndopa/levodopa doses vary significantly between people. Patients could be on 300 mg a day, and a rare few are on as much as 3,000 mg a day. In order to determine the right dose for you (which means how much medication to take in one dose, how many doses to take a day and how much time should be between each dose), you and your physician should discuss:
Based on the answers to these questions, your dose can be adjusted.
Decreased hemoglobin and hematocrit; abnormalities in alkaline phosphatase, SGOT (AST), SGPT (ALT), LDH, bilirubin, BUN, Coombs test; elevated serum glucose; white blood cells, bacteria, and blood in the urine.
Other adverse reactions that have been reported with levodopa alone and with various Syndopa levodopa formulations, and may occur with SINEMET are:
Before using levodopa precautions
In deciding to use levodopa, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make.
Levodopa may cause some people to become dizzy, confused, or have blurred or double vision. Make sure you know how you react to levodopa before you drive, use machines, or do anything else that could be dangerous if you are not alert or not able to see well.
Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.
For levodopa, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to levodopa or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Studies on levodopa have been done only in adult patients, and there is no specific information comparing use of levodopa or Syndopa in children with use in other age groups.
Elderly people are especially sensitive to the effects of levodopa. This may increase the chance of side effects during treatment.
Patients with diabetes
Levodopa may cause test results for urine sugar or ketones to be wrong. Check with your doctor before depending on home tests using the paper-strip or tablet method.
I have had PD for about 10 years. Over the years, the length of time that a particular dose of Syndopa/levodopa works has gotten shorter. One dose used to last five hours, but recently, it lasts closer to three hours. In addition, sometimes my dose does not work at all. What is going on?
This shifting response to medication is known as motor fluctuations and can be a very significant challenge in the treatment of PD as the disease progresses. There are many strategies that your doctor can use to try to lengthen a dose of medication and even out your response to medication throughout the day. These strategies include changing the timing or strength of a dose, using different formulations of Syndopa/levodopa, or adding other medications. All of these strategies are summarized in a recent APDA webinar on enhancing communication.