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AA-LEVOCARB CR is a brand name for Levodopa, supplied as a tablet (extended-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AA-LEVOCARB CR (levodopa and carbidopa controlled-release tablets) is indicated for the treatment of Parkinson's disease. AA-LEVOCARB CR is not recommended for the treatment of drug-induced extrapyramidal reactions. 1.1 Pediatrics Pediatrics (< 18 years of age): The safety and efficacy of AA-LEVOCARB CR in pediatric…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment, Titration). • Patients should be monitored closely during the dose adjustment period, particularly with regard to appearance or worsening of nausea or abnormal involuntary movements, including dyskinesias, chorea and dystonia.
AA-LEVOCARB CR (levodopa and carbidopa) Page 6 of 39 • Standard antiparkinson drugs, other than levodopa alone, may be continued while AA- LEVOCARB CR is being administered although their dosage may have to be adjusted. The delayed onset of action with AA-LEVOCARB CR may require the supplemental use of conventional levodopa/carbidopa immediate-release tablets s for optimal control in the mornings.
• When patients are receiving levodopa monotherapy or levodopa/carbidopa immediate- release tablets, this medication must be discontinued at least 8 hours before therapy with AA-LEVOCARB CR is started. 2 Recommended Dose and Dosage Adjustment General • AA-LEVOCARB CR tablets contain a 4:1 ratio of levodopa to carbidopa.
AA-LEVOCARB CR 200 mg/50 mg contains levodopa 200 mg/carbidopa 50 mg per tablet. AA-LEVOCARB CR 100 mg/25 mg contains levodopa 100 mg/carbidopa 25 mg per tablet. Adults Initial Dosage and Titration for Patients Currently Treated with Conventional Levodopa/Carbidopa Combinations: • Dosage with AA-LEVOCARB CR 200 mg/50 mg should be substituted at an amount that eventually provides approximately 10 to 30 percent more levodopa per day.
The interval between doses should be prolonged by 30 to 50 percent. Initially, patients should receive AA- LEVOCARB CR 200 mg/50 mg at a dosage that provides the same amount of levodopa, but with a longer dosing interval. Depending on clinical response, the dosage may be increased.
d. d. d. m. m. m. m. 2 Recommended Dose and Dosage Adjustment • AA-LEVOCARB CR 100 mg/25 mg is available to facilitate titration when 100 mg steps are required and as an alternative to the half tablet of AA-LEVOCARB CR 200 mg/50 mg tablets.
Initial Dosage for Patients Currently Treated with Levodopa Alone: • Levodopa must be discontinued at least eight hours before therapy with AA-LEVOCARB CR 200 mg/50 mg is started. AA-LEVOCARB CR 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 AA-LEVOCARB CR 200 mg/50 mg two times daily. Initial Dosage for Patients Without Prior Levodopa Therapy: • AA-LEVOCARB CR 100 mg/25 mg tablets may be used in early-stage patients who have not had prior levodopa therapy or to facilitate titration when necessary in patients receiving AA- LEVOCARB CR 200 mg/50 mg tablets.
8%). Occasionally, prolonged, and at times, severe afternoon dyskinesias have occurred in some patients. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. Therefore, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in AA-LEVOCARB CR (levodopa and carbidopa) Page 13 of 39 real-world use. In controlled clinical trials involving 748 patients with moderate to severe motor fluctuations, levodopa/carbidopa controlled-release tablets did not produce side effects which were unique to the controlled-release formulation.
8%). 8%). 9%). 8%). 9%). 5%). 8%). 5%). 5 Post-Market Adverse Reactions): Cardiac disorders: Cardiac irregularities, myocardial infarction, syncope.
Eye disorders:
Blurred vision.
Gastrointestinal disorders:
Dark saliva, dysphagia, heartburn, taste alterations.
Musculoskeletal and connective tissue disorders:
Back pain, leg pain, shoulder pain.
Nervous system disorders:
Increased tremor, neuroleptic malignant syndrome (see 7 WARNINGS AND PRECAUTIONS, Neurologic, Neuroleptic Malignant Syndrome), peripheral neuropathy.
Psychiatric disorders:
Nervousness, sleep disorders, psychotic episodes including delusions and paranoid ideation.
, Neurologic, Neuroleptic Malignant Syndrome). • If general anesthesia is required, AA-LEVOCARB CR 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.
Pediatrics (<18 years of age) • Health Canada has not authorized an indication for pediatric use. 2 Recommended Dose and Dosage Adjustment, Adults). 4 Administration • AA-LEVOCARB CR 200 mg/50 mg may be administered as a whole or as half tablets.
• AA-LEVOCARB CR 100 mg/25 mg should only be administered as whole tablets. • To maintain the controlled-release properties of the product, tablets should not be chewed or crushed. Addition of Other Antiparkinsonian Medications • Anticholinergic agents, dopamine agonists, amantadine and lower doses of selective MAO-B inhibitors can be given with levodopa/carbidopa controlled-release tablets.
When combining therapies, dosage adjustments may be necessary. 5 Missed Dose If a dose is missed, it should be taken as soon as possible. If it is almost time to take the next dose, the missed dose should not be taken, and the normal schedule should be resumed.
5 OVERDOSAGE Management of acute overdosage with AA-LEVOCARB CR is basically the same as management AA-LEVOCARB CR (levodopa and carbidopa) Page 9 of 39 of acute overdosage with levodopa; however, pyridoxine is not effective in reversing the actions of AA-LEVOCARB CR.
Electrocardiographic monitoring should be instituted and the patient observed carefully 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 levodopa/carbidopa controlled-release tablets should be taken into consideration.
To date, no experience has been reported with dialysis; hence, its value in overdosage is not known. For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 2 – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Controlled-release tablet 100 mg/25 mg Levodopa /carbidopa Hydroxypropyl methylcellulose, magnesium stearate, red ferric oxide Oral Controlled-release tablet 200 mg/50 mg Levodopa /carbidopa Hydroxypropyl methylcellulose, magnesium stearate, yellow ferric oxide AA-LEVOCARB CR is a controlled-release formulation of levodopa and carbidopa, in a ratio of 4:1.
AA-LEVOCARB CR are contraindicated in patients: • who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• taking non-selective monoamine oxidase inhibitors (MAOIs). These inhibitors must be discontinued at least two weeks prior to initiating therapy with AA-LEVOCARB CR. g. 4 Drug-Drug Interactions) at the manufacturer’s recommended dose which maintains selectivity for MAO type B.
• with clinical or laboratory evidence of uncompensated cardiovascular, endocrine, hematologic, hepatic, pulmonary (including bronchial asthma), or renal disease. • with narrow angle glaucoma. , epinephrine, norepinephrine, amphetamines or isoproterenol).
• with suspicious, undiagnosed skin lesions or a history of melanoma; because levodopa may activate a malignant melanoma. AA-LEVOCARB CR (levodopa and carbidopa) Page 5 of 39
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Levodopa in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
The initial recommended dose is 1 tablet of AA- LEVOCARB CR 100 mg/25 mg twice daily. For patients who require more levodopa, a daily dose of 1 to 4 tablets of AA-LEVOCARB CR 100 mg/25 mg twice a day is generally well- tolerated. • When appropriate, levodopa therapy may also be initiated with AA-LEVOCARB CR 200 mg/50 mg.
The initial recommended dose in patients with mild to moderate disease is 1 tablet of AA-LEVOCARB CR 200 mg/50 mg two times daily. Initial dosages should not exceed 600 mg per day of levodopa or be given at intervals of less than 6 hours.
Titration: • Doses and dosing intervals must be adjusted on an individual basis, depending upon therapeutic response. An interval of at least 3 days between dosage adjustments is recommended. Most patients have been adequately treated with 2 to 8 levodopa/carbidopa AA-LEVOCARB CR (levodopa and carbidopa) Page 8 of 39 controlled-release tablets 200 mg/50 mg per day, administered as divided doses at intervals ranging from 4 to 12 hours during the waking day.
• If the divided doses of AA-LEVOCARB CR 200 mg/50 mg are not equal, it is recommended that the smaller doses be given at the end of the day. Maintenance: • Because Parkinson's disease is progressive, periodic clinical evaluations are recommended and adjustment of the dosage regimen of AA-LEVOCARB CR may be required.
Discontinuation: • Patients should be observed carefully if abrupt reduction or discontinuation of AA-LEVOCARB CR is required, especially if the patient is receiving neuroleptics 7 WARNINGS AND PRECAUTIONS, Neurologic, Neuroleptic Malignant Syndrome).
• If general anesthesia is required, AA-LEVOCARB CR 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.
Pediatrics (<18 years of age) • Health Canada has not authorized an indication for pediatric use. 2 Recommended Dose and Dosage Adjustment, Adults). 4 Administration • AA-LEVOCARB CR 200 mg/50 mg may be administered as a whole or […]
Renal and urinary disorders:
Dark urine, urinary incontinence, urinary frequency, urinary tract AA-LEVOCARB CR (levodopa and carbidopa) Page 15 of 39 infection.
Respiratory, thoracic and mediastinal disorders:
Cough, common cold, pharyngeal pain, upper respiratory infection.
Skin and subcutaneous tissue disorders:
Angioedema, urticaria, pruritus, bullous lesions (including pemphigus-like reactions), flushing, alopecia, rash, dark sweat, malignant melanoma (see 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS, Skin).
Vascular disorders:
Orthostatic effects, hypertension, hypotensive episodes. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Laboratory tests which have been reported to be abnormal are alkaline phosphatase, SGOT (AST), SGPT (ALT), lactic dehydrogenase, bilirubin, blood urea nitrogen, creatinine, uric acid, and Coomb's test.
Decreased hemoglobin and hematocrit, elevated serum glucose, and white blood cells bacteria and blood in the urine have been reported. Decreased white blood cell count and serum potassium; protein and glucose in urine have been reported with levodopa alone and with various levodopa-carbidopa formulations, and may occur with AA-LEVOCARB CR.
5 Post-Market Adverse Reactions In post-marketing use, pathological (compulsive) gambling, increased libido, hypersexuality, compulsive spending/buying, and binge/compulsive eating have been reported with dopamine agonists and/or other dopaminergic treatments, and rarely in patients treated with levodopa, including levodopa/carbidopa controlled-release tablets (see 7 WARNINGS AND PRECAUTIONS, Psychiatric).
Other adverse reactions that have been reported with levodopa or levodopa/carbidopa immediate-release tablets and may be potential side effects with AA-LEVOCARB CR are listed below.
Blood and lymphatic system disorders:
Leukopenia, hemolytic and non-hemolytic anemia, thrombocytopenia, agranulocytosis.
Cardiac disorders:
Arrhythmias.
Eye disorders:
Diplopia, dilated pupils, oculogyric crisis.
Gastrointestinal disorders:
Sialorrhea, bruxism, hiccups, gastrointestinal bleeding, flatulence, burning sensation of tongue, development of duodenal ulcer.
General disorders and administration site conditions:
Edema, malaise, hot flashes.
Immune system disorders:
Henoch-Schonlein purpura.
AA-LEVOCARB CR (levodopa and carbidopa) Page 16 of 39 Investigations:
Non-specific ECG changes, weight gain.
Nervous system disorders:
Ataxia, numbness, increased hand tremor, muscle twitching, blepharospasm (which may be taken as an early sign of excess dosage, consideration of dosage reduction may be needed at this time), trismus, activation of latent Horner's syndrome, bradykinetic episodes, […]
The tablet contains a polymer-based drug delivery system which controls the release of levodopa and carbidopa as it slowly erodes.
AA-LEVOCARB CR 100 mg/25 mg:
Each oval, pink, biconvex tablet engraved "100" over "25" on one side, contains 100 mg of levodopa and 25 mg of anhydrous carbidopa. Available in bottles of 100 tablets.
AA-LEVOCARB CR 200 mg/50 mg:
Each oval, peach, biconvex tablet scored and engraved "200" over "50" on one side, contains 200 mg of levodopa and 50 mg of anhydrous carbidopa. Available in bottles of 100 tablets. 7 WARNINGS AND PRECAUTIONS See 3 SERIOUS WARNINGS AND PRECAUTIONS BOX General Physical Activity: Patients who improve while on therapy with AA-LEVOCARB CR should increase physical activities gradually, with caution, consistent with other medical considerations such as the presence of osteoporosis or phlebothrombosis.
Cardiovascular Care should be exercised in administering AA-LEVOCARB CR to patients with a history of recent AA-LEVOCARB CR (levodopa and carbidopa) Page 10 of 39 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 administration and titration, in a facility with provisions for intensive cardiac care.
Driving and Operating Machinery Psychomotor Performance:
Certain side effects that have been reported with AA-LEVOCARB CR may affect some patients’ ability to drive or operate machinery. Given the reported cases of somnolence and sudden onset of sleep (not necessarily preceded by somnolence), physicians should caution patients about the risk of operating hazardous machinery, including driving motor vehicles, while taking AA-LEVOCARB CR.
If drowsiness or sudden onset of sleep should occur, patients should be informed to refrain from driving or operating machines and to immediately contact their physician (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX). Gastrointestinal AA-LEVOCARB CR should be administered cautiously to patients with a history of peptic ulcer disease due to the possibility of upper gastrointestinal hemorrhage.
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data). AA-LEVOCARB CR may cause a false-positive reaction for urinary ketone bodies when a tape test is used for determination of ketonuria. False-negative tests may result with the use of glucose- oxidase methods of testing for glucosuria.
7 Drug-Laboratory Test Interactions).
Neurologic Dyskinesia:
As with levodopa or levodopa/carbidopa immediate-release tablets, AA-LEVOCARB CR may cause involuntary movements and mental disturbances. These reactions are thought to be due to increased brain dopamine following administration of levodopa.
These adverse reactions may be more prolonged with AA-LEVOCARB CR than with levodopa/carbidopa immediate-release tablets. […]