Sinemet 25mg+100mg (Carbidopa+Levodopa) - Generic

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SYNDOPA PLUS is the international generic and equivalent of Sinemet

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Sinemet 25mg+100mg (Carbidopa+Levodopa) - Generic



What is Generic Sinemet (Carbidopa+Levodopa) ?
Levodopa is converted to a chemical called dopamine (DOE pa meen) in the brain. Symptoms of Parkinson's disease may be caused by low levels of dopamine in the brain.Carbidopa helps prevent the breakdown of levodopa before it can reach the brain and take effect.The combination of carbidopa and levodopa is used to treat Parkinson symptoms such as muscle stiffness, tremors, spasms, and poor muscle control. This medication is also used to treat Parkinson symptoms caused by carbon monoxide poisoning or manganese intoxication.Carbidopa and levodopa may also be used for other purposes not listed in this medication guide.
 


What is the most important information I should know about Generic Sinemet (Carbidopa+Levodopa) ?
If you are already taking levodopa (Larodopa, Dopar), you must stop taking it at least 12 hours before you start taking carbidopa and levodopa. Talk with your doctor if your symptoms do not improve after a few weeks of treatment.Also tell your doctor if the effects of this medication seem to wear off quickly in between doses. Do not crush, chew, or break an extended-release tablet (Sinemet CR). Swallow the pill whole. This medication may cause you to fall asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Tell your doctor if you have any problems with daytime sleepiness or drowsiness. You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medication. Talk with your doctor if you believe you have any intense or unusual urges while taking carbidopa and levodopa.
 


What should I discuss with my healthcare provider before taking Generic Sinemet (Carbidopa+Levodopa) ?
Do not take carbidopa and levodopa if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take carbidopa and levodopa before the MAO inhibitor has cleared from your body. You should not take this medication if you are allergic to carbidopa (Lodosyn) or levodopa (Larodopa), or if you have:narrow-angle glaucoma;unusual skin lesions that have not been checked by a doctor; ora history of malignant melanoma (skin cancer).If you have any of these other conditions, you may need a dose adjustment or special tests:heart disease, high blood pressure, coronary artery disease, a heart rhythm disorder, or a prior heart attack;asthma, chronic obstructive pulmonary disease (COPD), or other breathing disorder;liver or kidney disease; an endocrine (hormonal) disease;a stomach or intestinal ulcer;wide-angle glaucoma; ordepression or other mental illness.Carbidopa and levodopa may cause you to fall asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Tell your doctor if you have any problems with daytime sleepiness or drowsiness. 


You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking carbidopa and levodopa. It is not known whether the medicine actually causes this effect. Talk with your doctor if you believe you have any intense or unusual urges while taking carbidopa and levodopa.Some people taking medicines for Parkinson's disease have developed skin cancer (melanoma). However, people with Parkinson's disease may have a higher risk than most people for developing melanoma. Talk to your doctor about your specific risk and what skin symptoms to watch for. You may need to have regular skin exams.FDA pregnancy category C. It is not known whether carbidopa and levodopa will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Carbidopa and levodopa may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. The disintegrating tablet (such as Parcopa) may contain phenylalanine. Talk to your doctor before using this form of carbidopa and levodopa if you have phenylketonuria (PKU).


How should I take Generic Sinemet (Carbidopa+Levodopa) ?
If you are already taking levodopa (Larodopa, Dopar), you must stop taking it at least 12 hours before you start taking carbidopa and levodopa. Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.Carbidopa and levodopa can be taken with or without food. Take your doses at regular intervals to keep a steady amount of the drug in your body at all times.Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. Breaking or opening the pill may cause too much of the drug to be released at one time. The regular tablet can be broken or crushed if needed to make it easier to swallow.
To take the orally disintegrating tablet (Parcopa):
Keep the tablet in its blister pack until you are ready to take the medicine. Open the package and peel back the foil from the tablet blister. Do not push a tablet through the foil or you may damage the tablet.Using dry hands, remove the tablet and place it in your mouth. It will begin to dissolve right away.
Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing. Swallow several times as the tablet dissolves.It may take up to several weeks of using carbidopa and levodopa before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after a few weeks of treatment. Also tell your doctor if the effects of this medication seem to wear off quickly in between doses. To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your heart, liver, and kidney function may also need to be tested. Visit your doctor regularly.This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using carbidopa and levodopa.


Store at room temperature away from moisture, heat, and light. 


What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?
Seek emergency medical attention.Overdose can cause uneven heart rate.


What should I avoid while taking Generic Sinemet (Carbidopa+Levodopa) ?
Avoid taking iron supplements or eating a diet that is high in protein (protein sources include meat, eggs, and cheese). These things can make it harder for your body to digest and absorb carbidopa and levodopa. Talk with your doctor or nutrition counselor about the best foods to eat while you are taking this medication.If you are unsure of how this medicine will affect you, be careful if you drive or do anything that requires you to be awake and alert. 


Side effects of Generic Sinemet (Carbidopa+Levodopa)
You may notice that your sweat, urine, or saliva appears dark in color, such as red, brown, or black. This is not a harmful side effect, but it may cause staining of your clothes or bed sheets.Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: restless muscle movements in your eyes, tongue, jaw, or neck;worsening of tremors (uncontrolled shaking);high fever, stiff muscles, sweating, fast or uneven heartbeats, rapid breathing, feeling like you might pass out;seizure (convulsions);painful or difficult urination;severe nausea, vomiting, or diarrhea;uneven heart rate or fluttering in your chest;confusion, hallucinations, anxiety, agitation, depressed mood, thoughts of suicide or hurting yourself;chest pain or heavy feeling, pain spreading to the arm or shoulder.
Less serious side effects may include:mild nausea, dry mouth, loss of appetite, heartburn, diarrhea, constipation;headache, dizziness, drowsiness, blurred vision;sneezing, stuffy nose, cough, or other cold symptoms;sleep problems (insomnia), strange dreams;muscle pain, numbness or tingly feeling; orskin rash or itching.


What other drugs will affect Generic Sinemet (Carbidopa+Levodopa) ?
Tell your doctor about all other medicines you use, especially:other Parkinson's medications;metoclopramide (Reglan);isoniazid (Nydrazid);phenytoin (Dilantin);papaverine (Pavabid, Papacon, Pavagen, Pavacot);blood pressure medication;an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), nortriptyline (Pamelor), and others; ormedicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), prochlorperazine (Compazine), risperidone (Risperdal), and others;



Generic Name Carbidopa+Levodopa
Search Name SYNDOPA PLUS GENERIC 25mg+100mg Tab
Supply Name SYNDOPA PLUS
Brand Generic GENERIC
Presentation Foil in Box
Dosage Tab
USA Brand Sinemet
Manufacture Sun Pharma
Strength 25mg+100mg
Search Terms Sinemet ,SYNDOPA PLUS ,Carbidopa+Levodopa
Origin India

Use spaces to separate tags. Use single quotes (') for phrases.

For the Consumer

Applies to carbidopa / levodopa: oral conventional tablets, oral extended-release tablets, oral orally disintegrating tablets

Side effects include:

Dyskinesias (choreiform, dystonic, other adventitious movements), nausea.
USUAL ADULT DOSE FOR PARKINSON'S DISEASE

Initial: 1 tablet of carbidopa 25 mg/levodopa 100 mg orally 3 times a day, or 1 tablet of 10 mg carbidopa/100 mg levodopa orally 3 to 4 times a day. The dose may be increased by 1 tablet orally every 1 to 2 days to a dose of 8 tablets/day (2 tablets orally 4 times a day).

Switch from Immediate to Extended Release:
Levodopa must be discontinued at least 12 hours before starting carbidopa-levodopa. Dosage with extended release should be substituted at an amount that provides approximately 25% of the previous levodopa dosage. Patients who are taking less than 1500 mg of levodopa a day should be started on 1 tablet of carbidopa-levodopa 25-100 three or four times a day. The suggested starting dosage for most patients taking more than 1500 mg of levodopa is one tablet of carbidopa-levodopa 25-250 three or four times a day.

Maintenance: May be increased or decreased depending upon therapeutic response. At least 70 to 100 mg of carbidopa per day should be provided. When a greater proportion of carbidopa is required, 1 tablet of carbidopa-levodopa 25-100 may be substituted for each tablet of carbidopa-levodopa 10-100. When more levodopa is required, carbidopa-levodopa 25-250 should be substituted for carbidopa-levodopa 25-100 or carbidopa-levodopa 10-100. If necessary, the dosage of carbidopa/levodopa 25-250 may be increased by 1/2 to 1 tablet every day or every other day to a maximum of 8 tablets per day. Experience with total daily dosages of carbidopa greater than 200 mg is limited.

Because both therapeutic and adverse responses occur more rapidly with carbidopa-levodopa than with levodopa alone, patients should be monitored closely during the dose adjustment period. Specifically, involuntary movements will occur more rapidly with carbidopa-levodopa than with levodopa. The occurrence of involuntary movements may require dosage reduction. Blepharospasm may be a useful early sign of excess dosage in some patients. Most patients have been adequately treated with 400 to 1600 mg of levodopa/day, administered as divided doses at intervals ranging from 4 to 8 hours during the waking day. Higher doses (2400 mg or more of levodopa/day) and shorter intervals (less than 4 hours) have been used, but are not usually recommended. The maximum daily dosage of carbidopa should not exceed 200 mg.

USUAL ADULT DOSE FOR NEUROLEPTIC MALIGNANT SYNDROME

Case Report:
Carbidopa 25 mg/levodopa 250 mg three times daily via nasogastric tube for 2 days.

USUAL PEDIATRIC DOSE FOR GTP-CH DEFICIENCY

Case Reports:
Greater than 1 year:
Initial: 5 mg/kg/day of carbidopa/levodopa, then titrated slowly downward with the aim of maintaining control of extrapyramidal syndrome.

RENAL DOSE ADJUSTMENTS

Data not available

LIVER DOSE ADJUSTMENTS

Data not available

DOSE ADJUSTMENTS

When a greater proportion of carbidopa is required, a 25-100 tablet may be substituted for a 10-100 tablet. When more levodopa is required, a 25-250 tablet should be substituted for a 25-100 or 10-100 tablet.

Patients Currently Treated With Levodopa Without A Decarboxylase Inhibitor: Levodopa must be discontinued at least eight hours before therapy with carbidopa-levodopa extended-release is started. carbidopa-levodopa extended-release 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 carbidopa-levodopa extended-release orally 2 times a day.

Patients Not Receiving Levodopa: In patients with mild to moderate disease, the initial recommended dose is 1 tablet of carbidopa-levodopa extended-release 50-200 twice daily. Initial dosage should not be given at intervals of less than 6 hours.

Titration with carbidopa-levodopa extended-release:

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 carbidopa-levodopa extended-release 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 carbidopa-levodopa extended-release (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 carbidopa-levodopa extended-release 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.

Maintenance

A dose of carbidopa-levodopa 25-100 or 10-100 (1/2 to 1 tablet) can be added to the dosage regimen of carbidopa-levodopa extended-release in selected patients with advanced disease who need additional immediate release levodopa for a brief time during daytime hours.

In patients already on levodopa, allow 12 hours between the last dose of levodopa and the initiation of therapy with carbidopa-levodopa.

PRECAUTIONS

Studies show that peripheral dopa decarboxylase is saturated by carbidopa at approximately 70 to 100 mg a day. Patients receiving less than this amount of carbidopa are more likely to experience nausea and vomiting.

When a greater proportion of carbidopa is required, a 25-100 tablet may be substituted for a 10-100 tablet. When more levodopa is required, a 25-250 tablet should be substituted for a 25-100 or 10-100 tablet.

Patients Currently Treated With Levodopa Without A Decarboxylase Inhibitor: Levodopa must be discontinued at least eight hours before therapy with carbidopa-levodopa extended-release is started. carbidopa-levodopa extended-release 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 carbidopa-levodopa extended-release orally 2 times a day.

Patients Not Receiving Levodopa: In patients with mild to moderate disease, the initial recommended dose is 1 tablet of carbidopa-levodopa extended-release 50-200 twice daily. Initial dosage should not be given at intervals of less than 6 hours.

Titration with carbidopa-levodopa extended-release:

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 carbidopa-levodopa extended-release 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 carbidopa-levodopa extended-release (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 carbidopa-levodopa extended-release 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.

Maintenance:

A dose of carbidopa-levodopa 25-100 or 10-100 (one half or a whole tablet) can be added to the dosage regimen of carbidopa-levodopa extended-release in selected patients with advanced disease who need additional immediate release levodopa for a brief time during daytime hours.

In patients already on levodopa, allow 12 hours between the last dose of levodopa and the initiation of therapy with carbidopa-levodopa.. Dosage adjustment of When a greater proportion of carbidopa is required, a 25-100 tablet may be substituted for a 10-100 tablet. When more levodopa is required, a 25-250 tablet should be substituted for a 25-100 or 10-100 tablet.

Patients Currently Treated With Levodopa Without A Decarboxylase Inhibitor: Levodopa must be discontinued at least eight hours before therapy with carbidopa-levodopa extended-release is started. carbidopa-levodopa extended-release 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 carbidopa-levodopa extended-release orally 2 times a day.

Patients Not Receiving Levodopa: In patients with mild to moderate disease, the initial recommended dose is 1 tablet of carbidopa-levodopa extended-release 50-200 twice daily. Initial dosage should not be given at intervals of less than 6 hours.

Titration with carbidopa-levodopa extended-release:

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 carbidopa-levodopa extended-release 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 carbidopa-levodopa extended-release (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 carbidopa-levodopa extended-release 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.

Maintenance

A dose of carbidopa-levodopa 25-100 or 10-100 (one half or a whole tablet) can be added to the dosage regimen of carbidopa-levodopa extended-release in selected patients with advanced disease who need additional immediate release levodopa for a brief time during daytime hours.

In patients already on levodopa, allow 12 hours between the last dose of levodopa and the initiation of therapy with carbidopa-levodopa. may be necessary when these agents are added.

Interruption Of Therapy: Patients should be observed carefully if abrupt reduction or discontinuation of When a greater proportion of carbidopa is required, a 25-100 tablet may be substituted for a 10-100 tablet. When more levodopa is required, a 25-250 tablet should be substituted for a 25-100 or 10-100 tablet.

Patients Currently Treated With Levodopa Without A Decarboxylase Inhibitor: Levodopa must be discontinued at least eight hours before therapy with carbidopa-levodopa extended-release is started. carbidopa-levodopa extended-release 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 carbidopa-levodopa extended-release orally 2 times a day.

Patients Not Receiving Levodopa: In patients with mild to moderate disease, the initial recommended dose is 1 tablet of carbidopa-levodopa extended-release 50-200 twice daily. Initial dosage should not be given at intervals of less than 6 hours.

Titration with carbidopa-levodopa extended-release:

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 carbidopa-levodopa extended-release 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 carbidopa-levodopa extended-release (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 carbidopa-levodopa extended-release 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.

Maintenance

A dose of carbidopa-levodopa 25-100 or 10-100 (one half or a whole tablet) can be added to the dosage regimen of carbidopa-levodopa extended-release in selected patients with advanced disease who need additional immediate release levodopa for a brief time during daytime hours.

In patients already on levodopa, allow 12 hours between the last dose of levodopa and the initiation of therapy with carbidopa-levodopa is required, especially if the patient is receiving neuroleptics.

DIALYSIS

Data not available

OTHER COMMENTS

Levodopa must be discontinued at least 8 hours before starting carbidopa/levodopa. A daily dose of carbidopa/levodopa should be 25% of the previous levodopa dose. Patients taking less than 1500 mg of levodopa/day should be started on one 25-100 tablet orally 3 to 4 times a day.

If general anesthesia is required, carbidopa-levodopa may be continued as long as the patient is permitted to take oral medication. If therapy is interrupted temporarily, the usual dosage should be administered as soon as the patient is able to take oral medication.