Carbidopa

Carbidopa Manufacturers

• Merck Sharp & Dohme Corp.
  

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  Carbidopa | Remedyrepack Inc.

  

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  There is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with metformin hydrochloride or any other pharmacologic agent. Dosage of metformin hydrochloride must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses. The maximum recommended daily dose of metformin hydrochloride is 2550 mg in adults and 2000 mg in pediatric patients (10 to 16 years of age).

  Metformin hydrochloride should be given in divided doses with meals. Metformin hydrochloride should be started at a low dose, with gradual dose escalation, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient.

  During treatment initiation and dose titration (see Recommended Dosing Schedule), fasting plasma glucose should be used to determine the therapeutic response to metformin hydrochloride and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately three months. The therapeutic goal should be to decrease both fasting plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of metformin hydrochloride, either when used as monotherapy or in combination with sulfonylurea or insulin.

  Monitoring of blood glucose and glycosylated hemoglobin will also permit detection of primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication, and secondary failure, i.e., loss of an adequate blood glucose lowering response after an initial period of effectiveness.

  Short-term administration of metformin hydrochloride may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone.

  Recommended Dosing Schedule

  Adults – In general, clinically significant responses are not seen at doses below 1500 mg per day. However, a lower recommended starting dose and gradually increased dosage is advised to minimize gastrointestinal symptoms.

  The usual starting dose of metformin hydrochloride is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increments of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. Patients can also be titrated from 500 mg twice a day to 850 mg twice a day after 2 weeks. For those patients requiring additional glycemic control, metformin hydrochloride may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals.

  If higher doses of metformin are required, metformin hydrochloride should be used at total daily doses up to 2550 mg administered in divided daily doses, as described above. (See CLINICAL PHARMACOLOGY: Clinical Studies.)

  Pediatrics – The usual starting dose of metformin hydrochloride is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses.

  Transfer From Other Antidiabetic Therapy

  When transferring patients from standard oral hypoglycemic agents other than chlorpropamide to metformin hydrochloride, no transition period generally is necessary. When transferring patients from chlorpropamide, care should be exercised during the first two weeks because of the prolonged retention of chlorpropamide in the body, leading to overlapping drug effects and possible hypoglycemia.

  Concomitant Metformin Hydrochloride and Oral Sulfonylurea Therapy in Adult Patients

  If patients have not responded to four weeks of the maximum dose of metformin hydrochloride monotherapy, consideration should be given to gradual addition of an oral sulfonylurea while continuing metformin hydrochloride at the maximum dose, even if prior primary or secondary failure to a sulfonylurea has occurred. Clinical and pharmacokinetic drug-drug interaction data are currently available only for metformin plus glyburide (glibenclamide).

  With concomitant metformin hydrochloride and sulfonylurea therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug. In a clinical trial of patients with type 2 diabetes and prior failure on glyburide, patients started on metformin hydrochloride 500 mg and glyburide 20 mg were titrated to 1000/20 mg, 1500/20 mg, 2000/20 mg or 2500/20 mg of metformin hydrochloride and glyburide, respectively, to reach the goal of glycemic control as measured by FPG, HbA1c and plasma glucose response (see CLINICAL PHARMACOLOGY: Clinical Studies). However, attempts should be made to identify the minimum effective dose of each drug to achieve this goal. With concomitant metformin hydrochloride and sulfonylurea therapy, the risk of hypoglycemia associated with sulfonylurea therapy continues and may be increased. Appropriate precautions should be taken. (See Package Insert of the respective sulfonylurea.)

  If patients have not satisfactorily responded to one to three months of concomitant therapy with the maximum dose of metformin hydrochloride and the maximum dose of an oral sulfonylurea, consider therapeutic alternatives including switching to insulin with or without metformin hydrochloride.

  Concomitant Metformin Hydrochloride and Insulin Therapy in Adult Patients

  The current insulin dose should be continued upon initiation of metformin hydrochloride therapy. Metformin hydrochloride therapy should be initiated at 500 mg once daily in patients on insulin therapy. For patients not responding adequately, the dose of metformin hydrochloride should be increased by 500 mg after approximately 1 week and by 500 mg every week thereafter until adequate glycemic control is achieved. The maximum recommended daily dose is 2500 mg for metformin hydrochloride. It is recommended that the insulin dose be decreased by 10% to 25% when fasting plasma glucose concentrations decrease to less than 120 mg/dL in patients receiving concomitant insulin and metformin hydrochloride. Further adjustment should be individualized based on glucose-lowering response.

  Specific Patient Populations

  Metformin hydrochloride is not recommended for use in pregnancy. Metformin hydrochloride is not recommended in patients below the age of 10 years.

  The initial and maintenance dosing of metformin hydrochloride should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dosage adjustment should be based on a careful assessment of renal function. Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of metformin hydrochloride.

  Monitoring of renal function is necessary to aid in prevention of lactic acidosis, particularly in the elderly. (See WARNINGS.)

   

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• Sun Pharma Global Fze
  

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  Carbidopa | Sun Pharma Global Fze

  

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  Carbidopa, levodopa and entacapone tablets should be used as a substitute for patients already stabilized on equivalent doses of carbidopa/levodopa and entacapone. However, some patients who have been stabilized on a given dose of carbidopa/levodopa may be treated with carbidopa, levodopa and entacapone tablets if a decision has been made to add entacapone (see below). Therapy should be individualized and adjusted according to the desired therapeutic response.

  2.1 Dosing Information

  The optimum daily dosage of carbidopa, levodopa and entacapone tablets must be determined by careful titration in each patient.

  
  
  

  Clinical experience with daily doses above 1,600 mg of entacapone is limited. The maximum recommended daily dose of carbidopa, levodopa and entacapone tablets depends on the strength used. Studies show that peripheral dopa decarboxylase is saturated by carbidopa at approximately 70 mg per day to 100 mg per day. Patients receiving less than this amount of carbidopa are more likely to experience nausea and vomiting.

  
  
  Table 1: Maximum Recommended Dose of Carbidopa, Levodopa and Entacapone Tablets in a 24 hour Period Carbidopa, Levodopa and Entacapone Tablets Dosage Strength
  Maximum Number of Tablets in a 24‑hour Period
  25 mg/100 mg/200 mg
  37.5 mg/150 mg/200 mg
  8
  
  
  
  
  2.2 Converting Patients from Carbidopa, Levodopa, and Entacapone to Carbidopa, Levodopa and Entacapone Tablets

  Patients currently treated with entacapone 200 mg with each dose of non-extended release carbidopa/levodopa tablet, can switch to the corresponding strength of carbidopa, levodopa and entacapone tablets containing the same amounts of levodopa and carbidopa. For example, patients receiving one tablet of carbidopa/levodopa 25 mg/100 mg and one tablet of entacapone 200 mg at each administration can switch to a single carbidopa, levodopa and entacapone tablet 25 mg/100 mg/200 mg (containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone).

  2.3 Converting Patients from Carbidopa and Levodopa Products to Carbidopa, Levodopa and Entacapone Tablets

  There is no experience in transferring patients currently treated with extended release formulations of carbidopa/levodopa, or carbidopa/levodopa products that are not combined in a 1:4 ratio of carbidopa to levodopa.

  
  

  Patients with a history of moderate or severe dyskinesias or taking more than 600 mg of the levodopa component per day are likely to require a reduction in their daily levodopa dose when entacapone is added. Because dose adjustment of the individual carbidopa or levodopa component is not possible with fixed-dose products, initially titrate patients to a dose that is tolerated and that meets their individual therapeutic need using a separate carbidopa/levodopa tablet (1:4 ratio) plus an entacapone tablet. Once the patient’s individual dose of carbidopa/levodopa plus entacapone dose has been established using two separate tablets; switch the patient to a corresponding single tablet of carbidopa, levodopa and entacapone.

  
  

  When less levodopa is required, reduce the total daily dosage of carbidopa/levodopa either by decreasing the strength of carbidopa, levodopa and entacapone tablets at each administration or by decreasing the frequency of administration by extending the time between doses.

  2.4 Concomitant Use with Other Anti-Parkinson's Disease Drugs

  Anticholinergic agents, dopamine agonists, monoamine oxidase (MAO) - B inhibitors, amantadine, and other standard drugs for Parkinson's disease may be used concomitantly while carbidopa, levodopa and entacapone tablets are being administered; however, dosage adjustments of the concomitant medication or carbidopa, levodopa and entacapone tabletsmay be required.

  2.5 Decrease or Interruption of Dosing

  Avoid interruption of carbidopa, levodopa and entacapone tabletsdosing because hyperpyrexia has been reported in patients who suddenly discontinue or reduce their use of levodopa [see Warnings and Precautions (5.7)].

  2.6 Important Administration Instructions

  Do not split, crush or chew carbidopa, levodopa and entacapone tablets. Administer only one tablet at each dosing interval. All strengths of carbidopa, levodopa and entacapone tablets contain 200 mg of entacapone. Combining multiple tablets or portions of tablets to achieve a higher levodopa dose may lead to an overdose of entacapone.
  
  Administer carbidopa, levodopa and entacapone tablets with or without food. However, a high-fat, high-calorie meal may delay the absorption of levodopa by about 2 hours[see Clinical Pharmacology (12.3)].

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• Wockhardt Limited
  

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  Carbidopa | Wockhardt Limited

  

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  Individual tablets should not be fractionated and only one tablet should be administered at each dosing interval.

  Generally speaking, carbidopa, levodopa and entacapone tablets should be used as a substitute for patients already stabilized on equivalent doses of carbidopa-levodopa and entacapone. However, some patients who have been stabilized on a given dose of carbidopa-levodopa may be treated with a combination of carbidopa, levodopa and entacapone if a decision has been made to add entacapone (see below).

  The optimum daily dosage of carbidopa, levodopa and entacapone tablets must be determined by careful titration in each patient. Carbidopa, levodopa and entacapone tablets are available in six strengths, each in a 1:4 ratio of carbidopa to levodopa and combined with 200 mg of entacapone in a standard release formulation (carbidopa, levodopa and entacapone tablet, containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone; 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone; 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone; 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone; 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone; and 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone).

  Therapy should be individualized and adjusted according to the desired therapeutic response.

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

  Clinical experience with daily doses above 1,600 mg of entacapone is limited. It is recommended that no more than one carbidopa, levodopa and entacapone tablet be taken at each dosing administration.

  Thus the maximum recommended daily dose of carbidopa, levodopa and entacapone tablets, containing 50 mg, 75 mg, 100 mg, 125 mg and 150 mg of levodopa, defined by the maximum daily dose of entacapone, is eight tablets per day. Because there is limited experience with total daily doses of carbidopa greater than 300 mg, the maximum recommended daily dose of carbidopa, levodopa and entacapone tablets containing 200 mg of levodopa is six tablets per day.

  How to transfer patients taking carbidopa-levodopa preparations and entacapone tablets to carbidopa, levodopa and entacapone tablets

  There is no experience in transferring patients currently treated with formulations of carbidopa-levodopa other than immediate-release carbidopa-levodopa with a 1:4 ratio (controlled-release formulations, or standard-release presentations with a 1:10 ratio of carbidopa-levodopa) and entacapone to carbidopa, levodopa and entacapone tablets.

  Patients who are currently treated with an entacapone 200 mg tablet with each dose of standard-release carbidopa-levodopa, can be directly switched to the corresponding strength of carbidopa, levodopa and entacapone tablet containing the same amounts of levodopa and carbidopa. For example, patients receiving one tablet of standard-release carbidopa-levodopa 25 mg/100 mg and one tablet of entacapone 200 mg at each administration can be switched to a single carbidopa, levodopa and entacapone tablet (containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone).

  How to transfer patients not currently treated with entacapone tablets from carbidopa-levodopa to carbidopa, levodopa and entacapone tablets

  In patients with Parkinson’s disease who experience the signs and symptoms of end-of-dose "wearing-off" on their current standard-release carbidopa-levodopa treatment, clinical experience shows that patients with a history of moderate or severe dyskinesias or taking more than 600 mg of levodopa per day are likely to require a reduction in daily levodopa dose when entacapone is added to their treatment. Since dose adjustment of the individual components is impossible with fixed-dose products, it is recommended that patients first be titrated individually with a carbidopa-levodopa product (ratio 1:4) and an entacapone product, and then transferred to a corresponding dose of carbidopa, levodopa and entacapone tablet once the patient’s status has stabilized.

  In patients who take a total daily levodopa dose up to 600 mg, and who do not have dyskinesias, an attempt can be made to transfer to the corresponding daily dose of carbidopa, levodopa and entacapone tablets. Even in these patients, a reduction of carbidopa-levodopa or entacapone may be necessary however, the provider is reminded that this may not be possible with carbidopa, levodopa and entacapone tablets. Since entacapone prolongs and enhances the effects of levodopa, therapy should be individualized and adjusted if necessary according to the desired therapeutic response.

  Maintenance of Carbidopa, Levodopa and Entacapone Tablet Treatment

  Therapy should be individualized and adjusted for each patient according to the desired therapeutic response.

  When less levodopa is required, the total daily dosage of carbidopa-levodopa should be reduced by either decreasing the strength of carbidopa, levodopa and entacapone tablets at each administration or by decreasing the frequency of administration by extending the time between doses.

  When more levodopa is required, the next higher strength of carbidopa, levodopa and entacapone tablets should be taken and/or the frequency of doses should be increased, up to a maximum of 8 times daily of carbidopa, levodopa and entacapone tablets, containing 50 mg, 75 mg, 100 mg, 125 mg, and 150 mg of levodopa, and a maximum of 6 times daily of carbidopa, levodopa and entacapone tablet, containing 200 mg of levodopa.

  Addition of Other Antiparkinsonian Medications

  Standard drugs for Parkinson’s disease may be used concomitantly while of carbidopa, levodopa and entacapone tablets are being administered, although dosage adjustments may be required.

  Interruption of Therapy

  Sporadic cases of a symptom complex resembling Neuroleptic Malignant Syndrome (NMS) have been associated with dose reductions and withdrawal of levodopa preparations. Patients should be observed carefully if abrupt reduction or discontinuation of carbidopa, levodopa and entacapone tablet is required, especially if the patient is receiving neuroleptics. (See WARNINGS.)

  If general anesthesia is required, carbidopa, levodopa and entacapone tablets may be continued as long as the patient is permitted to take fluids and medication by mouth. If therapy is interrupted temporarily, the patient should be observed for symptoms resembling NMS, and the usual daily dosage may be administered as soon as the patient is able to take oral medication.

  Special Populations

  Patients With Impaired Hepatic Function:

  Patients with hepatic impairment should be treated with caution. The AUC and Cmax of entacapone approximately doubled in patients with documented liver disease, compared to controls. However, these studies were conducted with single-dose entacapone without levodopa/dopa decarboxylase inhibitor coadministration, and therefore the effects of liver disease on the kinetics of chronically administered entacapone have not been evaluated (see CLINICAL PHARMACOLOGY, Pharmacokinetics of Entacapone).

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• Sun Pharma Global Fze
  

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  Carbidopa | Sun Pharma Global Fze

  

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  Carbidopa, levodopa and entacapone tablets should be used as a substitute for patients already stabilized on equivalent doses of carbidopa/levodopa and entacapone. However, some patients who have been stabilized on a given dose of carbidopa/levodopa may be treated with carbidopa, levodopa and entacapone tablets if a decision has been made to add entacapone (see below). Therapy should be individualized and adjusted according to the desired therapeutic response.

  2.1 Dosing Information

  The optimum daily dosage of carbidopa, levodopa and entacapone tablets must be determined by careful titration in each patient.

  
  
  

  Clinical experience with daily doses above 1,600 mg of entacapone is limited. The maximum recommended daily dose of carbidopa, levodopa and entacapone tablets depends on the strength used. The maximum number of tablets to be used in a 24-hour period is less with the highest strength (carbidopa, levodopa and entacapone tablets 50 mg/200 mg/200 mg) than with lower strengths (see Table 1). Studies show that peripheral dopa decarboxylase is saturated by carbidopa at approximately 70 mg per day to 100 mg per day. Patients receiving less than this amount of carbidopa are more likely to experience nausea and vomiting.

  
  
  Table 1: Maximum Recommended Dose of Carbidopa, Levodopa and Entacapone Tablets in a 24 hour Period Carbidopa, Levodopa and Entacapone Tablets Dosage Strength
  Maximum Number of Tablets in a 24‑hour Period
  12.5 mg/50 mg/200 mg
  18.75 mg/75 mg/200 mg
  25 mg/100 mg/200 mg
  31.25 mg/125 mg/200 mg
  37.5 mg/150 mg/200 mg
  8
  50 mg/200 mg/200 mg
  6
  
  
  
  
  2.2 Converting Patients from Carbidopa, Levodopa, and Entacapone to Carbidopa, Levodopa and Entacapone Tablets

  Patients currently treated with entacapone 200 mg with each dose of non-extended release carbidopa/levodopa tablet, can switch to the corresponding strength of carbidopa, levodopa and entacapone tablets containing the same amounts of levodopa and carbidopa. For example, patients receiving one tablet of carbidopa/levodopa 25 mg/100 mg and one tablet of entacapone 200 mg at each administration can switch to a single carbidopa, levodopa and entacapone tablet 25 mg/100 mg/200 mg (containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone).

  2.3 Converting Patients from Carbidopa and Levodopa Products to Carbidopa, Levodopa and Entacapone Tablets

  There is no experience in transferring patients currently treated with extended release formulations of carbidopa/levodopa, or carbidopa/levodopa products that are not combined in a 1:4 ratio of carbidopa to levodopa.

  
  

  Patients with a history of moderate or severe dyskinesias or taking more than 600 mg of the levodopa component per day are likely to require a reduction in their daily levodopa dose when entacapone is added. Because dose adjustment of the individual carbidopa or levodopa component is not possible with fixed-dose products, initially titrate patients to a dose that is tolerated and that meets their individual therapeutic need using a separate carbidopa/levodopa tablet (1:4 ratio) plus an entacapone tablet. Once the patient’s individual dose of carbidopa/levodopa plus entacapone dose has been established using two separate tablets; switch the patient to a corresponding single tablet of carbidopa, levodopa and entacapone.

  
  

  When less levodopa is required, reduce the total daily dosage of carbidopa/levodopa either by decreasing the strength of carbidopa, levodopa and entacapone tablets at each administration or by decreasing the frequency of administration by extending the time between doses.

  2.4 Concomitant Use with Other Anti-Parkinson's Disease Drugs

  Anticholinergic agents, dopamine agonists, monoamine oxidase (MAO) - B inhibitors, amantadine, and other standard drugs for Parkinson's disease may be used concomitantly while carbidopa, levodopa and entacapone tablets are being administered; however, dosage adjustments of the concomitant medication or carbidopa, levodopa and entacapone tabletsmay be required.

  2.5 Decrease or Interruption of Dosing

  Avoid interruption of carbidopa, levodopa and entacapone tabletsdosing because hyperpyrexia has been reported in patients who suddenly discontinue or reduce their use of levodopa [see Warnings and Precautions (5.7)].

  2.6 Important Administration Instructions

  Do not split, crush or chew carbidopa, levodopa and entacapone tablets. Administer only one tablet at each dosing interval. All strengths of carbidopa, levodopa and entacapone tablets contain 200 mg of entacapone. Combining multiple tablets or portions of tablets to achieve a higher levodopa dose may lead to an overdose of entacapone.
  
  Administer carbidopa, levodopa and entacapone tablets with or without food. However, a high-fat, high-calorie meal may delay the absorption of levodopa by about 2 hours[see Clinical Pharmacology (12.3)].

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• Mylan Pharmaceuticals Inc.
  

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  Carbidopa | Mylan Pharmaceuticals Inc.

  

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  Carbidopa, levodopa and entacapone tablets should be used as a substitute for patients already stabilized on equivalent doses of carbidopa/levodopa and entacapone. However, some patients who have been stabilized on a given dose of carbidopa/levodopa may be treated with carbidopa, levodopa and entacapone tablets if a decision has been made to add entacapone (see below). Therapy should be individualized and adjusted according to the desired therapeutic response.

  2.1 Dosing Information

  The optimum daily dosage of carbidopa, levodopa and entacapone tablets must be determined by careful titration in each patient.

  Clinical experience with daily doses above 1,600 mg of entacapone is limited. The maximum recommended daily dose of carbidopa, levodopa and entacapone tablets depends on the strength used. The maximum number of tablets to be used in a 24-hour period is less with the highest strength (carbidopa, levodopa and entacapone tablets, 50 mg per 200 mg per 200 mg) than with lower strengths (see Table 1). Studies show that peripheral dopa decarboxylase is saturated by carbidopa at approximately 70 mg per day to 100 mg per day. Patients receiving less than this amount of carbidopa are more likely to experience nausea and vomiting.

  Table 1: Maximum Recommended Dose of Carbidopa, Levodopa and Entacapone Tablets in a 24-hour Period

  Carbidopa, Levodopa and Entacapone Tablets Dosage Strength

  Maximum Number of Tablets in a 24-hour Period

  12.5 mg per 50 mg per 200 mg,

  18.75 mg per 75 mg per 200 mg,

  25 mg per 100 mg per 200 mg,

  31.25 mg per 125 mg per 200 mg,

  37.5 mg per 150 mg per 200 mg

  8

  50 mg per 200 mg per 200 mg

  6

  2.2 Converting Patients from Carbidopa, Levodopa, and Entacapone to Carbidopa, Levodopa and Entacapone Tablets

  Patients currently treated with entacapone 200 mg with each dose of non-extended release carbidopa/levodopa tablet, can switch to the corresponding strength of carbidopa, levodopa and entacapone tablets containing the same amounts of levodopa and carbidopa. For example, patients receiving one tablet of carbidopa/levodopa 25 mg/100 mg and one tablet of entacapone 200 mg at each administration can switch to a single carbidopa, levodopa and entacapone tablet (containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone).

  2.3 Converting Patients from Carbidopa and Levodopa Products to Carbidopa, Levodopa and Entacapone Tablets

  There is no experience in transferring patients currently treated with extended release formulations of carbidopa/levodopa, or carbidopa/levodopa products that are not combined in a 1:4 ratio of carbidopa to levodopa.

  Patients with a history of moderate or severe dyskinesias or taking more than 600 mg of the levodopa component per day are likely to require a reduction in their daily levodopa dose when entacapone is added. Because dose adjustment of the individual carbidopa or levodopa component is not possible with fixed-dose products, initially titrate patients to a dose that is tolerated and that meets their individual therapeutic need using a separate carbidopa/levodopa tablet (1:4 ratio) plus an entacapone tablet. Once the patient’s individual dose of carbidopa/levodopa plus entacapone dose has been established using two separate tablets; switch the patient to a corresponding single tablet of carbidopa, levodopa and entacapone.

  When less levodopa is required, reduce the total daily dosage of carbidopa/levodopa either by decreasing the strength of carbidopa, levodopa and entacapone tablets at each administration or by decreasing the frequency of administration by extending the time between doses.

  2.4 Concomitant Use with Other Anti-Parkinson’s Disease Drugs

  Anticholinergic agents, dopamine agonists, monoamine oxidase (MAO) - B inhibitors, amantadine, and other standard drugs for Parkinson's disease may be used concomitantly while carbidopa, levodopa and entacapone tablets are being administered; however, dosage adjustments of the concomitant medication or carbidopa, levodopa and entacapone tablets may be required.

  2.5 Decrease or Interruption of Dosing

  Avoid interruption of carbidopa, levodopa and entacapone tablets dosing because hyperpyrexia has been reported in patients who suddenly discontinue or reduce their use of levodopa [see Warnings and Precautions (5.7)].

  2.6 Important Administration Instructions

  Do not split, crush or chew carbidopa, levodopa and entacapone tablets. Administer only one tablet at each dosing interval. All strengths of carbidopa, levodopa and entacapone tablets contain 200 mg of entacapone. Combining multiple tablets or portions of tablets to achieve a higher levodopa dose may lead to an overdose of entacapone.

  Administer carbidopa, levodopa and entacapone tablets with or without food. However, a high-fat, high-calorie meal may delay the absorption of levodopa by about 2 hours [see Clinical Pharmacology (12.3)].

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• Wockhardt Usa Llc.
  

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  Carbidopa | Wockhardt Usa Llc.

  

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  Individual tablets should not be fractionated and only one tablet should be administered at each dosing interval.

  Generally speaking, carbidopa, levodopa and entacapone tablets should be used as a substitute for patients already stabilized on equivalent doses of carbidopa-levodopa and entacapone. However, some patients who have been stabilized on a given dose of carbidopa-levodopa may be treated with a combination of carbidopa, levodopa and entacapone if a decision has been made to add entacapone (see below).

  The optimum daily dosage of carbidopa, levodopa and entacapone tablets must be determined by careful titration in each patient. Carbidopa, levodopa and entacapone tablets are available in six strengths, each in a 1:4 ratio of carbidopa to levodopa and combined with 200 mg of entacapone in a standard release formulation (carbidopa, levodopa and entacapone tablets containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone; carbidopa, levodopa and entacapone tablets containing 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone; carbidopa, levodopa and entacapone tablets containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone; carbidopa, levodopa and entacapone tablets containing 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone; carbidopa, levodopa and entacapone tablets containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone; and carbidopa, levodopa and entacapone tablets containing 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone).

  Therapy should be individualized and adjusted according to the desired therapeutic response.

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

  Clinical experience with daily doses above 1,600 mg of entacapone is limited. It is recommended that no more than one carbidopa, levodopa and entacapone tablet be taken at each dosing administration.

  Thus the maximum recommended daily dose of carbidopa, levodopa and entacapone tablets containing 50 mg, 75 mg, 100 mg, 125 mg and 150 mg of levodopa, defined by the maximum daily dose of entacapone, is eight tablets per day. Because there is limited experience with total daily doses of carbidopa greater than 300 mg, the maximum recommended daily dose of carbidopa, levodopa and entacapone tablets containing 200 mg of levodopa is six tablets per day.

  How to transfer patients taking carbidopa-levodopa preparations and entacapone tablets to carbidopa, levodopa and entacapone tablets

  There is no experience in transferring patients currently treated with formulations of carbidopa-levodopa other than immediate-release carbidopa-levodopa with a 1:4 ratio (controlled-release formulations, or standard-release presentations with a 1:10 ratio of carbidopa-levodopa) and entacapone to carbidopa, levodopa and entacapone tablets.

  Patients who are currently treated with an entacapone 200 mg tablet with each dose of standard-release carbidopa-levodopa, can be directly switched to the corresponding strength of carbidopa, levodopa and entacapone tablet containing the same amounts of levodopa and carbidopa. For example, patients receiving one tablet of standard-release carbidopa-levodopa 25 mg/100 mg and one tablet of entacapone 200 mg at each administration can be switched to a single carbidopa, levodopa and entacapone tablet (containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone).

  How to transfer patients not currently treated with entacapone tablets from carbidopa-levodopa to carbidopa, levodopa and entacapone tablets

  In patients with Parkinson's disease who experience the signs and symptoms of end-of-dose "wearing-off" on their current standard-release carbidopa-levodopa treatment, clinical experience shows that patients with a history of moderate or severe dyskinesias or taking more than 600 mg of levodopa per day are likely to require a reduction in daily levodopa dose when entacapone is added to their treatment. Since dose adjustment of the individual components is impossible with fixed-dose products, it is recommended that patients first be titrated individually with a carbidopa-levodopa product (ratio 1:4) and an entacapone product, and then transferred to a corresponding dose of carbidopa, levodopa and entacapone tablet once the patient's status has stabilized.

  In patients who take a total daily levodopa dose up to 600 mg, and who do not have dyskinesias, an attempt can be made to transfer to the corresponding daily dose of carbidopa, levodopa and entacapone tablets. Even in these patients, a reduction of carbidopa-levodopa or entacapone may be necessary however, the provider is reminded that this may not be possible with carbidopa, levodopa and entacapone tablets. Since entacapone prolongs and enhances the effects of levodopa, therapy should be individualized and adjusted if necessary according to the desired therapeutic response.

  Maintenance of Carbidopa, Levodopa and Entacapone Tablet Treatment

  Therapy should be individualized and adjusted for each patient according to the desired therapeutic response.

  When less levodopa is required, the total daily dosage of carbidopa-levodopa should be reduced by either decreasing the strength of carbidopa, levodopa and entacapone tablets at each administration or by decreasing the frequency of administration by extending the time between doses.

  When more levodopa is required, the next higher strength of carbidopa, levodopa and entacapone tablets should be taken and/or the frequency of doses should be increased, up to a maximum of 8 times daily of carbidopa, levodopa and entacapone tablets containing 50 mg, 75 mg, 100 mg, 125 mg, and 150 mg of levodopa, and a maximum of 6 times daily of carbidopa, levodopa and entacapone tablets, containing 200 mg of levodopa.

  Addition of Other Antiparkinsonian Medications

  Standard drugs for Parkinson’s disease may be used concomitantly while of carbidopa, levodopa and entacapone tablets are being administered, although dosage adjustments may be required.

  Interruption of Therapy

  Sporadic cases of a symptom complex resembling Neuroleptic Malignant Syndrome (NMS) have been associated with dose reductions and withdrawal of levodopa preparations. Patients should be observed carefully if abrupt reduction or discontinuation of carbidopa, levodopa and entacapone tablet is required, especially if the patient is receiving neuroleptics. (See WARNINGS.)

  If general anesthesia is required, carbidopa, levodopa and entacapone tablets may be continued as long as the patient is permitted to take fluids and medication by mouth. If therapy is interrupted temporarily, the patient should be observed for symptoms resembling NMS, and the usual daily dosage may be administered as soon as the patient is able to take oral medication.

  Special Populations

  Patients With Impaired Hepatic Function:

  Patients with hepatic impairment should be treated with caution. The AUC and Cmax of entacapone approximately doubled in patients with documented liver disease, compared to controls. However, these studies were conducted with single-dose entacapone without levodopa and dopa decarboxylase inhibitor coadministration, and therefore the effects of liver disease on the kinetics of chronically administered entacapone have not been evaluated (see CLINICAL PHARMACOLOGY, Pharmacokinetics of Entacapone).

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• Amerigen Pharmaceuticals Inc.
  

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  Carbidopa | Amerigen Pharmaceuticals Inc.

  

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  Whether given with carbidopa-levodopa or with levodopa, the optimal daily dosage of carbidopa must be determined by careful titration. Most patients respond to a 1:10 proportion of carbidopa and levodopa, provided the daily dosage of carbidopa is 70 mg or more a day. The maximum daily dosage of carbidopa should not exceed 200 mg, since clinical experience with larger dosages is limited. If the patient is taking carbidopa-levodopa, the amount of carbidopa in carbidopa-levodopa should be considered when calculating the total amount of carbidopa to be administered each day.

  Patients Receiving Carbidopa-Levodopa Who Require Additional Carbidopa

  Some patients taking carbidopa-levodopa may not have adequate reduction in nausea and vomiting when the dosage of carbidopa is less than 70 mg a day, and the dosage of levodopa is less than 700 mg a day. When these patients are taking carbidopa-levodopa, 25 mg of carbidopa may be given with the first dose of carbidopa-levodopa each day. Additional doses of 12.5 mg or 25 mg may be given during the day with each dose of carbidopa-levodopa. Carbidopa may be given with any dose carbidopa-levodopa as required for optimum therapeutic response. The maximum daily dosage of carbidopa, given as carbidopa tablets and as carbidopa-levodopa, should not exceed 200 mg.

  Patients Requiring Individual Titration of Carbidopa and Levodopa Dosage

  Although carbidopa-levodopa is the most frequently used method of carbidopa and levodopa administration, there may be an occasional patient who requires individually titrated doses of these two drugs. In these patients, carbidopa tablets should be initiated at a dosage of 25 mg three or four times a day. The two drugs should be given at the same time, starting with no more than one-fifth (20%) to one-fourth (25%) of the previous or recommended daily dosage of levodopa when given without carbidopa. In patients already receiving levodopa therapy, at least twelve hours should elapse between the last dose of levodopa and initiation of therapy with carbidopa and levodopa. A convenient way to initiate therapy in these patients is in the morning following a night when the patient has not taken levodopa for at least twelve hours. Health care providers who prescribe separate doses of carbidopa and levodopa should be thoroughly familiar with the directions for use of each drug.

  Dosage Adjustment

  Dosage of carbidopa tablets may be adjusted by adding or omitting one-half or one tablet a day. Because both therapeutic and adverse responses occur more rapidly with combined therapy than when only levodopa is given, patients should be monitored closely during the dose adjustment period. Specifically, involuntary movements will occur more rapidly when carbidopa and levodopa are given concomitantly than when levodopa is given without carbidopa. The occurrence of involuntary movements may require dosage reduction. Blepharospasm may be a useful early sign of excess dosage in some patients.

  Current evidence indicates other standard antiparkinsonian drugs may be continued while carbidopa and levodopa are being administered. However, the dosage of such other standard antiparkinsonian drugs may require adjustment.

  Interruption of Therapy

  Sporadic cases of hyperpyrexia and confusion have been associated with dose reductions and withdrawal of carbidopa-levodopa or carbidopa-levodopa extended release. Patients should be observed carefully if abrupt reduction or discontinuation of carbidopa-levodopa or carbidopa-levodopa extended release is required, especially if the patient is receiving neuroleptics. (See WARNINGS.)

  If general anesthesia is required, therapy may be continued as long as the patient is permitted to take fluids and medication by mouth. When therapy is interrupted temporarily, the patient should be observed for symptoms resembling NMS, and the usual daily dosage may be resumed as soon as the patient is able to take medication orally.

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• Oceanside Pharmaceuticals
  

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  Carbidopa | Oceanside Pharmaceuticals

  

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  Whether given with carbidopa-levodopa or with levodopa, the optimal daily dose of Carbidopa must be determined by careful titration. Most patients respond to a 1:10 proportion of carbidopa and levodopa, provided the daily dosage of carbidopa is 70 mg or more a day. The maximum daily dosage of carbidopa should not exceed 200 mg, since clinical experience with larger dosages is limited. If the patient is taking carbidopa-levodopa, the amount of carbidopa in carbidopa-levodopa should be considered when calculating the total amount of Carbidopa to be administered each day.

  Patients Receiving Carbidopa-Levodopa Who Require Additional Carbidopa

  Some patients taking carbidopa-levodopa may not have adequate reduction in nausea and vomiting when the dosage of carbidopa is less than 70 mg a day, and the dosage of levodopa is less than 700 mg a day. When these patients are taking carbidopa-levodopa, 25 mg of Carbidopa may be given with the first dose of carbidopa-levodopa each day. Additional doses of 12.5 mg or 25 mg may be given during the day with each dose of carbidopa-levodopa. Carbidopa may be given with any dose carbidopa-levodopa as required for optimum therapeutic response. The maximum daily dosage of carbidopa, given as Carbidopa and as carbidopa-levodopa), should not exceed 200 mg.

  Patients Requiring Individual Titration of Carbidopa and Levodopa Dosage

  Although carbidopa-levodopa is the most frequently used of carbidopa and levodopa administration, there may be an occasional patient who requires individually titrated doses of these two drugs. In these patients, Carbidopa should be initiated at a dosage of 25 mg three or four times a day. The two drugs should be given at the same time, starting with no more than one-fifth (20%) to one-fourth (25%) of the previous or recommended daily dosage of levodopa when given without Carbidopa. In patients already receiving levodopa therapy, at least twelve hours should elapse between the last dose of levodopa and initiation of therapy with Carbidopa and levodopa. A convenient way to initiate therapy in these patients is in the morning following a night when the patient has not taken levodopa for at least twelve hours. Health care providers who prescribe separate doses of Carbidopa and levodopa should be thoroughly familiar with the directions for use of each drug.

  Dosage Adjustment

  Dosage of Carbidopa may be adjusted by adding or omitting one-half or one tablet a day. Because both therapeutic and adverse responses occur more rapidly with combined therapy than when only levodopa is given, patients should be monitored closely during the dose adjustment period. Specifically, involuntary movements will occur more rapidly when Carbidopa and levodopa are given concomitantly than when levodopa is given without Carbidopa. The occurrence of involuntary movements may require dosage reduction. Blepharospasm may be a useful early sign of excess dosage in some patients.

  Current evidence indicates other standard antiparkinsonian drugs may be continued while carbidopa and levodopa are being administered. However, the dosage of such other standard antiparkinsonian drugs may require adjustment.

  Interruption of Therapy

  Sporadic cases of hyperpyrexia and confusion have been associated with dose reductions and withdrawal of carbidopa-levodopa or carbidopa-levodopa Extended Release. Patients should be observed carefully if abrupt reduction or discontinuation of carbidopa-levodopa or carbidopa-levodopa Extended-Release is required, especially if the patient is receiving neuroleptics. (See WARNINGS.)

  If general anesthesia is required, therapy may be continued as long as the patient is permitted to take fluids and medication by mouth. When therapy is interrupted temporarily, the patient should be observed for symptoms resembling NMS, and the usual daily dosage may be resumed as soon as the patient is able to take medication orally.

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• Sandoz Inc
  

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  Carbidopa | Sandoz Inc

  

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  Individual tablets should not be fractionated and only one tablet should be administered at each dosing interval.

  Generally speaking, carbidopa, levodopa and entacapone tablets should be used as a substitute for patients already stabilized on equivalent doses of carbidopa-levodopa and entacapone. However, some patients who have been stabilized on a given dose of carbidopa-levodopa may be treated with carbidopa, levodopa and entacapone tablets if a decision has been made to add entacapone (see below).

  The optimum daily dosage of carbidopa, levodopa and entacapone tablets must be determined by careful titration in each patient. Carbidopa, levodopa and entacapone tablets are available in six strengths, each in a 1:4 ratio of carbidopa to levodopa and combined with 200 mg of entacapone in a standard release formulation (carbidopa, levodopa and entacapone tablets containing 12.5 mg of carbidopa, 50 mg of levodopa and 200 mg of entacapone; carbidopa, levodopa and entacapone tablets containing 18.75 mg of carbidopa, 75 mg of levodopa and 200 mg of entacapone; carbidopa, levodopa and entacapone tablets containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone; carbidopa, levodopa and entacapone tablets containing 31.25 mg of carbidopa, 125 mg of levodopa and 200 mg of entacapone; carbidopa, levodopa and entacapone tablets containing 37.5 mg of carbidopa, 150 mg of levodopa and 200 mg of entacapone; and carbidopa, levodopa and entacapone tablets containing 50 mg of carbidopa, 200 mg of levodopa and 200 mg of entacapone).

  Therapy should be individualized and adjusted according to the desired therapeutic response.

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

  Clinical experience with daily doses above 1,600 mg of entacapone is limited. It is recommended that no more than one carbidopa, levodopa and entacapone tablet be taken at each dosing administration.

  Thus the maximum recommended daily dose of carbidopa, levodopa and entacapone tablets containing 50 mg, 75 mg, 100 mg, 125 mg and 150 mg of levodopa, defined by the maximum daily dose of entacapone, is eight tablets per day. Because there is limited experience with total daily doses of carbidopa greater than 300 mg, the maximum recommended daily dose of carbidopa, levodopa and entacapone tablets containing 200 mg of levodopa is six tablets per day.

  How to transfer patients taking carbidopa-levodopa preparations and entacapone tablets to carbidopa, levodopa and entacapone tablets

  There is no experience in transferring patients currently treated with formulations of carbidopa-levodopa other than immediate-release carbidopa-levodopa with a 1:4 ratio (controlled-release formulations, or standard-release presentations with a 1:10 ratio of carbidopa-levodopa) and entacapone to carbidopa, levodopa and entacapone tablets.

  Patients who are currently treated with entacapone 200 mg tablet with each dose of standard-release carbidopa-levodopa, can be directly switched to the corresponding strength of carbidopa, levodopa and entacapone tablet containing the same amounts of levodopa and carbidopa. For example, patients receiving one tablet of standard-release carbidopa-levodopa 25 mg/100 mg and one tablet of entacapone 200 mg at each administration can be switched to a single carbidopa, levodopa and entacapone tablet (containing 25 mg of carbidopa, 100 mg of levodopa and 200 mg of entacapone).

  How to transfer patients not currently treated with entacapone tablets from carbidopa-levodopa to carbidopa, levodopa and entacapone tablets

  In patients with Parkinson’s disease who experience the signs and symptoms of end-of-dose “wearing-off” on their current standard-release carbidopa-levodopa treatment, clinical experience shows that patients with a history of moderate or severe dyskinesias or taking more than 600 mg of levodopa per day are likely to require a reduction in daily levodopa dose when entacapone is added to their treatment. Since dose adjustment of the individual components is impossible with fixed-dose products, it is recommended that patients first be titrated individually with a carbidopa-levodopa product (ratio 1:4) and an entacapone product, and then transferred to a corresponding dose of carbidopa, levodopa and entacapone tablet once the patient’s status has stabilized.

  In patients who take a total daily levodopa dose up to 600 mg, and who do not have dyskinesias, an attempt can be made to transfer to the corresponding daily dose of carbidopa, levodopa and entacapone tablet. Even in these patients, a reduction of carbidopa-levodopa or entacapone may be necessary however, the provider is reminded that this may not be possible with carbidopa, levodopa and entacapone tablet. Since entacapone prolongs and enhances the effects of levodopa, therapy should be individualized and adjusted if necessary according to the desired therapeutic response.

  Maintenance of Carbidopa, Levodopa and Entacapone Tablets Treatment

  Therapy should be individualized and adjusted for each patient according to the desired therapeutic response.

  When less levodopa is required, the total daily dosage of carbidopa-levodopa should be reduced by either decreasing the strength of carbidopa, levodopa and entacapone tablets at each administration or by decreasing the frequency of administration by extending the time between doses.

  When more levodopa is required, the next higher strength of carbidopa, levodopa and entacapone tablet should be taken and/or the frequency of doses should be increased, up to a maximum of 8 times daily of carbidopa, levodopa and entacapone tablets containing 50 mg, 75 mg, 100 mg, 125 mg, and 150 mg of levodopa, and maximum of 6 times daily of carbidopa, levodopa and entacapone tablets, containing 200 mg of levodopa.

  Addition of Other Antiparkinsonian Medications

  Standard drugs for Parkinson’s disease may be used concomitantly while carbidopa, levodopa and entacapone tablets are being administered, although dosage adjustments may be required.

  Interruption of Therapy

  Sporadic cases of a symptom complex resembling Neuroleptic Malignant Syndrome (NMS) have been associated with dose reductions and withdrawal of levodopa preparations. Patients should be observed carefully if abrupt reduction or discontinuation of carbidopa, levodopa and entacapone tablets is required, especially if the patient is receiving neuroleptics. (See WARNINGS.)

  If general anesthesia is required, carbidopa, levodopa and entacapone tablets may be continued as long as the patient is permitted to take fluids and medication by mouth. If therapy is interrupted temporarily, the patient should be observed for symptoms resembling NMS, and the usual daily dosage may be administered as soon as the patient is able to take oral medication.

  Special Populations Patients With Impaired Hepatic Function

  Patients with hepatic impairment should be treated with caution. The AUC and Cmax of entacapone approximately doubled in patients with documented liver disease, compared to controls. However, these studies were conducted with single-dose entacapone without levodopa and dopa decarboxylase inhibitor coadministration, and therefore the effects of liver disease on the kinetics of chronically administered entacapone have not been evaluated (see CLINICAL PHARMACOLOGY: Pharmacokinetics of Entacapone).

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