Carbidopa Tablets, 25 mg

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Overview

What is Carbidopa Tablets, 25 mg?

Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as Benzenepropanoic acid, α- hydrazino-3,4-dihydroxy-α-methyl-,monohydrate,((–)-L-α –hydrazino-3,4- dihydroxy-α-methylhydrocinnamic acid monohydrate.Its empirical formula is CHNO•HO, and its structural formula is:

Carbidopa Tablets contain 25 mg of carbidopa. Inactive ingredients are corn starch, FD&C Yellow #6 Aluminum Lake, microcrystalline cellulose, and magnesium stearate.

Tablet content is expressed in terms of anhydrous carbidopa which has a molecular weight of 226.23.

What does Carbidopa Tablets, 25 mg look like?

What are the available doses of Carbidopa Tablets, 25 mg?

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What should I talk to my health care provider before I take Carbidopa Tablets, 25 mg?

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How should I use Carbidopa Tablets, 25 mg?

Carbidopa Tablets are indicated for use with carbidopa-levodopa or with levodopa in the treatment of the symptoms of idiopathic Parkinson’s disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism, which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication.

Carbidopa Tablets are for use with carbidopa-levodopa in patients for whom the dosage of carbidopa-levodopa provides less than adequate daily dosage (usually 70 mg daily) of carbidopa.

Carbidopa Tablets are for use with levodopa in the occasional patient whose dosage requirement of carbidopa and levodopa necessitates separate titration of each medication.

Carbidopa Tablets are used with carbidopa-levodopa or with levodopa to permit the administration of lower doses of levodopa with reduced nausea and vomiting, more rapid dosage titration, and with a somewhat smoother response. However, patients with markedly irregular (“on-off”) responses to levodopa have not been shown to benefit from the addition of carbidopa.

Since carbidopa prevents the reversal of levodopa effects caused by pyridoxine, supplemental pyridoxine (vitamin B) can be given to patients when they are receiving carbidopa and levodopa concomitantly or as carbidopa-levodopa.

Although the administration of Carbidopa Tablets permits control of parkinsonism and Parkinson’s disease with much lower doses of levodopa, there is no conclusive evidence at present that this is beneficial other than in reducing nausea and vomiting, permitting more rapid titration, and providing a somewhat smoother response to levodopa.

Certain patients who responded poorly to levodopa alone have improved when carbidopa and levodopa were given concurrently. This was most likely due to decreased peripheral decarboxylation of levodopa rather than to a primary effect of carbidopa on the peripheral nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa.

In deciding whether to give Carbidopa Tablets with carbidopa-levodopa or with levodopa to patients who have nausea and/or vomiting, the physician should be aware that, while many patients may be expected to improve, some may not. Since one cannot predict which patients are likely to improve, this can only be determined by a trial of therapy. It should be further noted that in controlled trials comparing carbidopa and levodopa with levodopa alone, about half the patients with nausea and/or vomiting on levodopa alone improved spontaneously despite being retained on the same dose of levodopa during the controlled portion of the trial.

Whether given with carbidopa-levodopa or with levodopa, the optimal daily dosage of Carbidopa Tablets 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 Tablets 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 Tablets 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 Tablets may be given with any dose of 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 of carbidopa and levodopa administration, there may be an occasional patient who requires individually titrated doses of these two drugs. , Health care providers who prescribe separate doses of Carbidopa Tablets 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 Tablets and levodopa are given concomitantly than when levodopa is given without Carbidopa Tablets. 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 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 .)

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.

What interacts with Carbidopa Tablets, 25 mg?

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What are the warnings of Carbidopa Tablets, 25 mg?

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What are the precautions of Carbidopa Tablets, 25 mg?

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What are the side effects of Carbidopa Tablets, 25 mg?

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What should I look out for while using Carbidopa Tablets, 25 mg?

Carbidopa Tablets are contraindicated in patients with known hypersensitivity to any component of this drug.

Nonselective monoamine oxidase (MAO) inhibitors are contraindicated for use with levodopa or carbidopa-levodopa combination products with or without Carbidopa Tablets. These inhibitors must be discontinued at least two weeks prior to initiating therapy with levodopa. Carbidopa-levodopa, or levodopa may be administered concomitantly with the manufacturer’s recommended dose of an MAO inhibitor with selectivity for MAO type B (e.g., selegiline HCl) (see ).

Levodopa or carbidopa-levodopa products, with or without Carbidopa Tablets, are contra-indicated in patients with narrow-angle glaucoma.

Carbidopa Tablets

has no antiparkinsonian effect when given alone. It is indicated for use with carbidopa-levodopa or levodopa. Carbidopa Tablets

does not decrease adverse reactions due to central effects of levodopa.

When Carbidopa Tablets are to be given to carbidopa-naive patients who are being treated with levodopa alone, the two drugs should be given at the same time. At least twelve hours should elapse between the last dose of levodopa and initiation of therapy with Carbidopa Tablets and levodopa in combination. Start with no more than one-fifth (20%) to one-fourth (25%) of the previous daily dosage of levodopa when given without Carbidopa Tablets. See the section before initiating therapy.

The addition of Carbidopa Tablets with levodopa or carbidopa-levodopa reduces the peripheral effects (nausea, vomiting) due to decarboxylation of levodopa; however, Carbidopa Tablets do not decrease the adverse reactions due to the central effects of levodopa. Because Carbidopa Tablets permit more levodopa to reach the brain and more dopamine to be formed, certain adverse central nervous system (CNS) effects, e.g., dyskinesias (involuntary movements), may occur at lower dosages and sooner with levodopa in combination with Carbidopa Tablets than with levodopa alone.

What might happen if I take too much Carbidopa Tablets, 25 mg?

No reports of overdose with Carbidopa Tablets have been received. Management of overdosage with carbidopa is the same as that with levodopa or carbidopa-levodopa preparations.

In the event of overdosage, general supportive measures should be employed, along with immediate gastric lavage. Intravenous fluids should be administered judiciously, and an adequate airway maintained. Electrocardiographic monitoring should be instituted and the patient carefully observed for the development of arrhythmias; if required, appropriate antiarrhythmic therapy should be given. The possibility that the patient may have taken other drugs as well as Carbidopa Tablets should be taken into consideration. To date, no experience has been reported with dialysis; hence, its value in overdosage is not known. Pyridoxine is not effective in reversing the actions of Carbidopa Tablets.

Based on studies in which high doses of levodopa and/or carbidopa were administered, a significant proportion of rats and mice given single oral doses of levodopa of approximately 1500-2000 mg/kg are expected to die. A significant proportion of infant rats of both sexes are expected to die at a dose of 800 mg/kg. A significant proportion of rats are expected to die after treatment with similar doses of carbidopa. The addition of carbidopa in a 1:10 ratio with levodopa increases the dose at which a significant proportion of mice are expected to die to 3360 mg/kg.

How should I store and handle Carbidopa Tablets, 25 mg?

Store at USP controlled room temperature 68°F to 77°F (20°C to 25°C) with excursions permitted between 15°C (59°F) and 30°C (86°F). Contents under pressure. Do not puncture or incinerate. Avoid contact with eyes or other mucous membranes. Keep out of reach of children. Carbidopa Tablets, 25 mg, are orange, round, scored tablet, with “ALV” bisect ”332” on one side and plain on the other.They are supplied as follows:NDCNDC NDC StorageStore at 25°C (77°F), excursions permitted to 15–30°C (59–86°F). [see USP Controlled Room Temperature]Made in USADistributed by:Alvogen, Inc.Pine Brook, NJ 07058 USARev: 07/2015PI332-00Carbidopa Tablets, 25 mg, are orange, round, scored tablet, with “ALV” bisect ”332” on one side and plain on the other.They are supplied as follows:NDCNDC NDC StorageStore at 25°C (77°F), excursions permitted to 15–30°C (59–86°F). [see USP Controlled Room Temperature]Made in USADistributed by:Alvogen, Inc.Pine Brook, NJ 07058 USARev: 07/2015PI332-00Carbidopa Tablets, 25 mg, are orange, round, scored tablet, with “ALV” bisect ”332” on one side and plain on the other.They are supplied as follows:NDCNDC NDC StorageStore at 25°C (77°F), excursions permitted to 15–30°C (59–86°F). [see USP Controlled Room Temperature]Made in USADistributed by:Alvogen, Inc.Pine Brook, NJ 07058 USARev: 07/2015PI332-00Carbidopa Tablets, 25 mg, are orange, round, scored tablet, with “ALV” bisect ”332” on one side and plain on the other.They are supplied as follows:NDCNDC NDC StorageStore at 25°C (77°F), excursions permitted to 15–30°C (59–86°F). [see USP Controlled Room Temperature]Made in USADistributed by:Alvogen, Inc.Pine Brook, NJ 07058 USARev: 07/2015PI332-00Carbidopa Tablets, 25 mg, are orange, round, scored tablet, with “ALV” bisect ”332” on one side and plain on the other.They are supplied as follows:NDCNDC NDC StorageStore at 25°C (77°F), excursions permitted to 15–30°C (59–86°F). [see USP Controlled Room Temperature]Made in USADistributed by:Alvogen, Inc.Pine Brook, NJ 07058 USARev: 07/2015PI332-00Carbidopa Tablets, 25 mg, are orange, round, scored tablet, with “ALV” bisect ”332” on one side and plain on the other.They are supplied as follows:NDCNDC NDC StorageStore at 25°C (77°F), excursions permitted to 15–30°C (59–86°F). [see USP Controlled Room Temperature]Made in USADistributed by:Alvogen, Inc.Pine Brook, NJ 07058 USARev: 07/2015PI332-00Carbidopa Tablets, 25 mg, are orange, round, scored tablet, with “ALV” bisect ”332” on one side and plain on the other.They are supplied as follows:NDCNDC NDC StorageStore at 25°C (77°F), excursions permitted to 15–30°C (59–86°F). [see USP Controlled Room Temperature]Made in USADistributed by:Alvogen, Inc.Pine Brook, NJ 07058 USARev: 07/2015PI332-00Carbidopa Tablets, 25 mg, are orange, round, scored tablet, with “ALV” bisect ”332” on one side and plain on the other.They are supplied as follows:NDCNDC NDC StorageStore at 25°C (77°F), excursions permitted to 15–30°C (59–86°F). [see USP Controlled Room Temperature]Made in USADistributed by:Alvogen, Inc.Pine Brook, NJ 07058 USARev: 07/2015PI332-00Carbidopa Tablets, 25 mg, are orange, round, scored tablet, with “ALV” bisect ”332” on one side and plain on the other.They are supplied as follows:NDCNDC NDC StorageStore at 25°C (77°F), excursions permitted to 15–30°C (59–86°F). [see USP Controlled Room Temperature]Made in USADistributed by:Alvogen, Inc.Pine Brook, NJ 07058 USARev: 07/2015PI332-00Carbidopa Tablets, 25 mg, are orange, round, scored tablet, with “ALV” bisect ”332” on one side and plain on the other.They are supplied as follows:NDCNDC NDC StorageStore at 25°C (77°F), excursions permitted to 15–30°C (59–86°F). [see USP Controlled Room Temperature]Made in USADistributed by:Alvogen, Inc.Pine Brook, NJ 07058 USARev: 07/2015PI332-00

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Current evidence indicates that symptoms of Parkinson’s disease are related to depletion of dopamine in the corpus striatum. Administration of dopamine is ineffective in the treatment of Parkinson’s disease apparently because it does not cross the blood-brain barrier. However, levodopa, the metabolic precursor of dopamine, does cross the blood-brain barrier, and presumably is converted to dopamine in the brain. This is thought to be the mechanism whereby levodopa relieves symptoms of Parkinson’s disease.

Non-Clinical Toxicology

Carbidopa Tablets are contraindicated in patients with known hypersensitivity to any component of this drug.

Nonselective monoamine oxidase (MAO) inhibitors are contraindicated for use with levodopa or carbidopa-levodopa combination products with or without Carbidopa Tablets. These inhibitors must be discontinued at least two weeks prior to initiating therapy with levodopa. Carbidopa-levodopa, or levodopa may be administered concomitantly with the manufacturer’s recommended dose of an MAO inhibitor with selectivity for MAO type B (e.g., selegiline HCl) (see ).

Levodopa or carbidopa-levodopa products, with or without Carbidopa Tablets, are contra-indicated in patients with narrow-angle glaucoma.

Carbidopa Tablets

has no antiparkinsonian effect when given alone. It is indicated for use with carbidopa-levodopa or levodopa. Carbidopa Tablets

does not decrease adverse reactions due to central effects of levodopa.

When Carbidopa Tablets are to be given to carbidopa-naive patients who are being treated with levodopa alone, the two drugs should be given at the same time. At least twelve hours should elapse between the last dose of levodopa and initiation of therapy with Carbidopa Tablets and levodopa in combination. Start with no more than one-fifth (20%) to one-fourth (25%) of the previous daily dosage of levodopa when given without Carbidopa Tablets. See the section before initiating therapy.

The addition of Carbidopa Tablets with levodopa or carbidopa-levodopa reduces the peripheral effects (nausea, vomiting) due to decarboxylation of levodopa; however, Carbidopa Tablets do not decrease the adverse reactions due to the central effects of levodopa. Because Carbidopa Tablets permit more levodopa to reach the brain and more dopamine to be formed, certain adverse central nervous system (CNS) effects, e.g., dyskinesias (involuntary movements), may occur at lower dosages and sooner with levodopa in combination with Carbidopa Tablets than with levodopa alone.

Symptomatic postural hypotension has occurred when Carbidopa Tablets, given with levodopa or carbidopa-levodopa combination products, was added to the treatment of a patient receiving antihypertensive drugs. Therefore, when therapy with Carbidopa Tablets, given with or without levodopa or carbidopa-levodopa combination products, is started, dosage adjustment of the antihypertensive drug may be required.

For patients receiving monoamine oxidase inhibitors (Type A or B), see . Concomitant therapy with selegiline or rasgiline and Carbidopa Tablets and carbidopa-levodopa may be associated with severe orthostatic hypotension not attributable to carbidopa-levodopa alone (see ).

There have been rare reports of adverse reactions, including hypertension and dyskinesia, resulting from the concomitant use of tricyclic antidepressants and carbidopa-levodopa preparations.

Dopamine D receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone) and isoniazid may reduce the therapeutic effects of levodopa. In addition, the beneficial effects of levodopa in Parkinson’s disease have been reported to be reversed by phenytoin and papaverine. Patients taking these drugs with Carbidopa Tablets and levodopa or carbidopa-levodopa combination products should be carefully observed for loss of therapeutic response.

Carbidopa Tablets and iron salts or multi vitamins containing iron salts should be co administered with caution. Iron salts can form chelates with levodopa and carbidopa and consequently reduce the bioavailability of carbidopa and levodopa.

Although metoclopramide may increase the bioavailability of levodopa by increasing gastric emptying, metoclopramide may also adversely affect disease control by its dopamine receptor antagonistic properties.

As with levodopa alone, periodic evaluations of hepatic, hematopoietic, cardiovascular, and renal function are recommended during extended concomitant therapy with Carbidopa Tablets and levodopa, or with Carbidopa Tablets and carbidopa-levodopa or any combination of these drugs.

Carbidopa has not been demonstrated to have any overt pharmacodynamic actions in the recommended doses. The only adverse reactions that have been observed have been with concomitant use of carbidopa with other drugs such as levodopa, and with carbidopa-levodopa combination products.

When Carbidopa Tablets are administered concomitantly with levodopa or carbidopa-levodopa combination products, the most common adverse reactions have included dyskinesias such as choreiform, dystonic, and other involuntary movements, and nausea. Other adverse reactions reported with Carbidopa Tablets when administered concomitantly with levodopa alone or carbidopa-levodopa combination products were psychotic episodes including delusions, hallucinations, and paranoid ideation, depression with or without development of suicidal tendencies, and dementia. Convulsions also have occurred; however, a causal relationship with concomitant use of Carbidopa Tablets and levodopa has not been established.

The following other adverse reactions have been reported with levodopa and carbidopa-levodopa combination products. These same adverse reactions may also occur when Carbidopa Tablets are administered with these products.

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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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