Carbidopa And Levodopa

Carbidopa And Levodopa

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Questions & Answers

Side Effects & Adverse Reactions

When patients are receiving levodopa without a decarboxylase inhibitor, levodopa must be discontinued at least twelve hours before carbidopa and levodopa extended-release tablets are started. In order to reduce adverse reactions, it is necessary to individualize therapy. Carbidopa and levodopa extended-release tablets should be substituted at a dosage that will provide approximately 25% of the previous levodopa dosage (see DOSAGE AND ADMINISTRATION).
Carbidopa does not decrease adverse reactions due to central effects of levodopa. By permitting more levodopa to reach the brain, particularly when nausea and vomiting is not a dose-limiting factor, certain adverse CNS effects, e.g., dyskinesias, will occur at lower dosages and sooner during therapy with carbidopa and levodopa extended-release tablets than with levodopa alone.
Patients receiving carbidopa and levodopa extended-release tablets may develop increased dyskinesias compared to carbidopa and levodopa tablets. Dyskinesias are a common side effect of carbidopa and levodopa treatment. The occurrence of dyskinesias may require dosage reduction.
As with levodopa, carbidopa and levodopa extended-release tablets may cause mental disturbances. These reactions are thought to be due to increased brain dopamine following administration of levodopa. All patients should be observed carefully for the development of depression with concomitant suicidal tendencies. Patients with past or current psychoses should be treated with caution.
Carbidopa and levodopa extended-release tablets should be administered cautiously to patients with severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease.
As with levodopa, care should be exercised in administering carbidopa and levodopa extended-release tablets to patients with a history of myocardial infarction who have residual atrial, nodal, or ventricular arrhythmias. In such patients, cardiac function should be monitored with particular care during the period of initial dosage adjustment, in a facility with provisions for intensive cardiac care.
As with levodopa, treatment with carbidopa and levodopa extended-release tablets may increase the possibility of upper gastrointestinal hemorrhage in patients with a history of peptic ulcer.

Neuroleptic Malignant Syndrome (NMS):

Sporadic cases of a symptom complex resembling NMS have been reported in association with dose reductions or withdrawal of carbidopa and levodopa tablets and carbidopa and levodopa extended-release tablets.

Therefore, patients should be observed carefully when the dosage of carbidopa and levodopa extended-release tablets is reduced abruptly or discontinued, especially if the patient is receiving neuroleptics.
NMS is an uncommon but life-threatening syndrome characterized by fever or hyperthermia. Neurological findings, including muscle rigidity, involuntary movements, altered consciousness, mental status changes; other disturbances, such as autonomic dysfunction, tachycardia, tachypnea, sweating, hyper- or hypotension; laboratory findings, such as creatine phosphokinase elevation, leukocytosis, myoglobinuria, and increased serum myoglobin have been reported.

The early diagnosis of this condition is important for the appropriate management of these patients. Considering NMS as a possible diagnosis and ruling out other acute illnesses (e.g., pneumonia, systemic infection, etc.) is essential. This may be especially complex if the clinical presentation includes both serious medical illness and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system (CNS) pathology.

The management of NMS should include: 1) intensive symptomatic treatment and medical monitoring and 2) treatment of any concomitant serious medical problems for which specific treatments are available. Dopamine agonists, such as bromocriptine, and muscle relaxants, such as dantrolene, are often used in the treatment of NMS; however, their effectiveness has not been demonstrated in controlled studies.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Carbidopa and levodopa extended-release tablets are indicated 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.

History

There is currently no drug history available for this drug.

Other Information

Carbidopa and levodopa extended-release tablets are extended-release combination of carbidopa and levodopa for the treatment of Parkinson's disease and syndrome.
Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as (-)-L-α-hydrazino-α-methyl-β-(3,4-dihydroxybenzene) propanoic acid monohydrate. Its molecular formula is C10H14N2O4·H2O and its structural formula is:

carbidopa-structure

Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.3.
Levodopa, an aromatic amino acid, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 197.2. It is designated chemically as (-)-L-α-amino-β-(3,4-dihydroxybenzene) propanoic acid. Its molecular formula is C9H11NO4 and its structural formula is:

levodopa-structure

Carbidopa  and levodopa extended-release tablets are supplied as extended-release tablets containing either 50 mg of carbidopa USP and 200 mg of levodopa USP, or 25 mg of carbidopa USP and 100 mg of levodopa USP. Inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, hypromellose, hydroxypropyl cellulose, magnesium stearate, red ferric oxide and D&C Yellow 10 Aluminum lake.

The 50 mg/200 mg tablet is supplied as an oval, scored, biconvex, compressed tablet debossed “457” on one side and scored on other side that is buff colored with mottled appearance. The 25 mg/100 mg tablet is supplied as an oval, biconvex, compressed tablet debossed “461” on one side and plain on other side that is buff colored with mottled appearance. Carbidopa and levodopa extended-release tablet is a polymeric-based drug delivery system that controls the release of carbidopa and levodopa as it slowly erodes. Carbidopa and levodopa extended-release tablet 25 mg/100 mg is available to facilitate titration when 100 mg steps are required.

Carbidopa And Levodopa Manufacturers


  • Cardinal Health
    Carbidopa And Levodopa Tablet, Extended Release [Cardinal Health]
  • Ethex
    Carbidopa And Levodopa (Carbidopa And Levodopa) Tablet, Extended Release [Ethex]
  • Sun Pharmaceutical Industries Limited
    Carbidopa And Levodopa Tablet, Orally Disintegrating [Sun Pharmaceutical Industries Limited]
  • Sun Pharmaceutical Industries Limited
    Carbidopa And Levodopa Tablet [Sun Pharmaceutical Industries Limited]
  • Physicians Total Care, Inc.
    Carbidopa And Levodopa Tablet, Extended Release [Physicians Total Care, Inc.]
  • Major Pharmaceuticals
    Carbidopa And Levodopa Tablet [Major Pharmaceuticals]
  • Cardinal Health
    Carbidopa And Levodopa Tablet [Cardinal Health]
  • Global Pharmaceuticals, Division Of Impax Laboratories Inc.
    Carbidopa And Levodopa Tablet, Extended Release [Global Pharmaceuticals, Division Of Impax Laboratories Inc.]
  • Physicians Total Care, Inc.
    Carbidopa And Levodopa Tablet [Physicians Total Care, Inc.]
  • Mckesson Contract Packaging
    Carbidopa And Levodopa Tablet [Mckesson Contract Packaging]
  • Mckesson Contract Packaging
    Carbidopa And Levodopa Tablet, Extended Release [Mckesson Contract Packaging]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Carbidopa And Levodopa Tablet, Extended Release [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • Unit Dose Services
    Carbidopa And Levodopa Tablet [Unit Dose Services]
  • Major Pharmaceuticals
    Carbidopa And Levodopa Tablet [Major Pharmaceuticals]
  • Aphena Pharma Solutions – Tennessee, Inc.
    Carbidopa And Levodopa Tablet [Aphena Pharma Solutions – Tennessee, Inc.]
  • Bryant Ranch Prepack
    Carbidopa And Levodopa Tablet [Bryant Ranch Prepack]
  • Remedyrepack Inc.
    Carbidopa And Levodopa Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Carbidopa And Levodopa Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Carbidopa And Levodopa Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Carbidopa And Levodopa Tablet [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Carbidopa And Levodopa Tablet, Extended Release [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Carbidopa And Levodopa Tablet [Remedyrepack Inc. ]
  • Apotex Corp.
    Carbidopa And Levodopa Tablet, Extended Release [Apotex Corp.]
  • Preferred Pharmaceuticals, Inc.
    Carbidopa And Levodopa Tablet [Preferred Pharmaceuticals, Inc.]
  • Cardinal Health
    Carbidopa And Levodopa Tablet [Cardinal Health]
  • Accord Healthcare, Inc.
    Carbidopa And Levodopa Tablet, Extended Release [Accord Healthcare, Inc.]
  • Remedyrepack Inc.
    Carbidopa And Levodopa Tablet [Remedyrepack Inc. ]
  • Ncs Healthcare Of Ky, Inc Dba Vangard Labs
    Carbidopa And Levodopa Tablet [Ncs Healthcare Of Ky, Inc Dba Vangard Labs]
  • American Health Packaging
    Carbidopa And Levodopa Tablet, Extended Release [American Health Packaging]
  • Lake Erie Medical Dba Quality Care Products Llc
    Carbidopa And Levodopa Tablet [Lake Erie Medical Dba Quality Care Products Llc]
  • Actavis Elizabeth Llc
    Carbidopa And Levodopa Tablet [Actavis Elizabeth Llc]
  • Remedyrepack Inc.
    Carbidopa And Levodopa Tablet [Remedyrepack Inc. ]
  • Golden State Medical Supply, Inc.
    Carbidopa And Levodopa Tablet [Golden State Medical Supply, Inc.]
  • Mylan Institutional Inc.
    Carbidopa And Levodopa Tablet [Mylan Institutional Inc.]
  • Mylan Pharmaceuticals Inc.
    Carbidopa And Levodopa Tablet, Orally Disintegrating [Mylan Pharmaceuticals Inc.]
  • American Health Packaging
    Carbidopa And Levodopa Tablet [American Health Packaging]
  • Bluepoint Laboratories
    Carbidopa And Levodopa Tablet, Extended Release [Bluepoint Laboratories]
  • Remedyrepack Inc.
    Carbidopa And Levodopa Tablet [Remedyrepack Inc. ]
  • Sun Pharmaceutical Industries Limited
    Carbidopa And Levodopa Tablet, Extended Release [Sun Pharmaceutical Industries Limited ]
  • Mckesson Packaging Services A Business Unit Of Mckesson Corporation
    Carbidopa And Levodopa Tablet [Mckesson Packaging Services A Business Unit Of Mckesson Corporation]
  • Mylan Institutional Inc.
    Carbidopa And Levodopa Tablet, Extended Release [Mylan Institutional Inc.]
  • Mylan Pharmaceuticals Inc.
    Carbidopa And Levodopa Tablet [Mylan Pharmaceuticals Inc.]
  • Cardinal Health
    Carbidopa And Levodopa Tablet [Cardinal Health]
  • Mylan Pharmaceuticals Inc.
    Carbidopa And Levodopa Tablet, Extended Release [Mylan Pharmaceuticals Inc.]
  • Cardinal Health
    Carbidopa And Levodopa Tablet [Cardinal Health]
  • Teva Pharmaceuticals Usa Inc
    Carbidopa And Levodopa Tablet [Teva Pharmaceuticals Usa Inc]
  • Apotex Corp.
    Carbidopa And Levodopa (Carbidopa And Levodopa ) Tablet Carbidopa And Levodopa Tablet [Apotex Corp.]
  • Preferred Pharmaceuticals, Inc.
    Carbidopa And Levodopa Tablet [Preferred Pharmaceuticals, Inc.]
  • American Health Packaging
    Carbidopa And Levodopa Tablet, Extended Release [American Health Packaging]

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