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PMS-LEVODOPA-CARBIDOPA is a brand name for Carbidopa, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: pms-LEVODOPA-CARBIDOPA (levodopa and carbidopa tablets) is indicated for the treatment of Parkinson's disease. pms-LEVODOPA-CARBIDOPA is not recommended for the treatment of drug-induced extrapyramidal reactions. 1.1 Pediatrics Pediatrics (< 18 years of age): The safety and effectiveness of levodopa and carbidopa in…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • In order to reduce the incidence of adverse reactions and achieve maximal benefit, therapy with pms-LEVODOPA-CARBIDOPA must be individualized and drug administration must be continuously matched to the needs and tolerance of the patient.
It should be borne in mind that the therapeutic range of pms-LEVODOPA- CARBIDOPA is narrower than that of levodopa alone because of its greater milligram potency. Therefore, titration and adjustment of dosage should be made in small steps and the dosage ranges recommended should usually not be exceeded.
The appearance of involuntary movements should be regarded as a sign of levodopa toxicity and as an indication of overdosage, requiring dose reduction. Treatment should, therefore, aim at maximal benefit without dyskinesias. • If a patient being treated with levodopa is switched to therapy with pms-LEVODOPA- CARBIDOPA, levodopa must be discontinued at least twelve hours or more before therapy with pms-LEVODOPA-CARBIDOPA is initiated.
2 Recommended Dose and Dosage Adjustment, Adults, Induction of Therapy in Patients Receiving Levodopa) Although the administration of carbidopa permits control of Parkinson’s disease with much lower doses of levodopa, there is no conclusive evidence at present that this is beneficial other than reducing nausea and vomiting, permitting more rapid titration, and providing a somewhat smoother response to levodopa.
Carbidopa does not decrease adverse reactions due to central effects of levodopa. , dyskinesias, may occur at lower dosages and sooner during therapy with pms-LEVODOPA-CARBIDOPA than with levodopa. 4 Administration). • Studies have shown that peripheral dopa decarboxylase is saturated by carbidopa at doses between 70 to 150 mg per day.
Patients receiving less than 70 mg per day of carbidopa are more likely to experience nausea and vomiting. Experience with total daily dosages of carbidopa greater than 200 mg is limited. 2 Recommended Dose and Dosage Adjustment General pms-LEVODOPA-CARBIDOPA tablets are available in a 4:1 ratio (pms-LEVODOPA-CARBIDOPA 100 mg / 25 mg) and in a 10:1 ratio of levodopa to carbidopa (pms-LEVODOPA-CARBIDOPA 100 mg / 10 mg and 250 mg / 25 mg).
Tablets of the two ratios may be given separately or combined as needed to provide the optimal dosage. Adults Induction of Therapy in Patients Not Receiving Levodopa • Dosage is best initiated with one tablet of pms-LEVODOPA-CARBIDOPA 100 mg / 25 mg three times a day.
1 Adverse Reaction Overview Adverse reactions that occur frequently in patients receiving levodopa and carbidopa are those due to the central neuro pharmacologic activity of dopamine. These reactions usually can be diminished by dosage reduction.
The most common side effects are dyskinesias, including choreiform, dystonic, and other involuntary movements and nausea. Muscle twitching and blepharospasm may be taken as early signs to consider dosage reduction. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials therefore, 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 real-world use.
The most common serious adverse reactions occurring with levodopa and carbidopa are dyskinesias, including choreiform, dystonic and other involuntary movements, and nausea. Other serious adverse reactions are mental changes including paranoid ideation and psychotic episodes, depression with or without development of suicidal tendencies, and dementia.
Convulsions also have occurred; however, a causal relationship with levodopa and carbidopa has not been established. 5 Post-Market Adverse Reactions): Blood and lymphatic system: Leukopenia, hemolytic and non-hemolytic anemia, thrombocytopenia, agranulocytosis.
Cardiac:
Cardiac irregularities and/or palpitation, hypotension, orthostatic effects including hypotensive episodes, hypertension, phlebitis, syncope, chest pain.
Gastrointestinal:
See 3 SERIOUS WARNINGS AND PRECAUTIONS BOX General Physical Activity:
Patients who improve while on therapy with pms-LEVODOPA-CARBIDOPA 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 pms-LEVODOPA-CARBIDOPA to patients with a history of myocardial infarction or who have 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. Driving and Operating Machinery Certain side effects that have been reported with levodopa and carbidopa 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 pms-LEVODOPA-CARBIDOPA.
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 pms-LEVODOPA-CARBIDOPA should be administered cautiously to patients with a history of peptic ulcer disease due to the possibility of upper gastrointestinal hemorrhage.
Monitoring and Laboratory Tests Periodic evaluations of hepatic, hematopoietic, cardiovascular and renal function are recommended during extended therapy with pms-LEVODOPA-CARBIDOPA. pms-LEVODOPA-CARBIDOPA 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). pms-LEVODOPA-CARBIDOPA (levodopa / carbidopa) Page 11 of 39 Protected B / Protégé B Neurologic Dyskinesia: The levodopa induced involuntary movements and 'on and off' phenomenon may appear earlier with combination therapy.
pms-LEVODOPA-CARBIDOPA is 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 nonselective monoamine oxidase (MAO).
These inhibitors must be discontinued at least two weeks prior to initiating therapy with pms-LEVODOPA-CARBIDOPA. 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. pms-LEVODOPA-CARBIDOPA (levodopa / carbidopa) Page 5 of 39 Protected B / Protégé B
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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This dosage schedule provides 75 mg of carbidopa per day. Dosage may be carefully increased by one tablet every three days until the optimal dosage has been reached which does not produce dyskinesias. • While increasing the dosage during the induction period, the doses should be divided, aiming at a frequency of dosing of at least four times a day.
If further titration is necessary after a daily dosage level of six tablets of pms-LEVODOPA-CARBIDOPA 100 mg / 25 mg has been reached, tablets of pms-LEVODOPA-CARBIDOPA 100 mg / 10 mg or 250 mg / 25mg may be used as needed to provide the optimal dosage.
• Usually no patient should receive more than 1500 mg of levodopa a day. Some patients, including those with post encephalitic parkinsonism, are more sensitive to levodopa and require specially careful dosage adjustment. Induction of Therapy in Patients Receiving Levodopa • Levodopa must be discontinued at least twelve hours or more before pms-LEVODOPA- CARBIDOPA is started.
A dosage of pms-LEVODOPA-CARBIDOPA should be used that will provide approximately 20% of the previous levodopa daily dosage; this can be started in the morning after the day in which the treatment with levodopa has been stopped. For example, if a patient is receiving 4,000 mg of levodopa per day, the dosage of pms- LEVODOPA-CARBIDOPA should not provide more than 750 mg of levodopa per day divided into four to six doses.
• pms-LEVODOPA-CARBIDOPA 100 mg / 25 mg tablets should be used to start medication for patients requiring lower dosages of levodopa. Adjustment and Maintenance of Therapy • Therapy should be individualized and adjusted according to the desired therapeutic response.
At least 70 to 100 mg of carbidopa per day should be provided. When a greater proportion of carbidopa is required, one tablet of pms-LEVODOPA-CARBIDOPA 100 mg / 25 mg may be substituted for each tablet of pms-LEVODOPA-CARBIDOPA 100 mg / 10 mg.
When more levodopa is required, pms-LEVODOPA-CARBIDOPA pms-LEVODOPA-CARBIDOPA (levodopa / carbidopa) Page 8 of 39 Protected B / Protégé B 250 mg / 25 mg should be substituted for pms-LEVODOPA-CARBIDOPA 100 mg / 25 mg or 100 mg / 10 mg.
If necessary, the dosage of pms-LEVODOPA-CARBIDOPA 250 / 25 may be increased by one tablet every day or every other day to a maximum of eight tablets a day. , less than 700 mg, pms-LEVODOPA-CARBIDOPA 100 mg / 25 mg may be helpful. • Experience with total daily dosages of carbidopa greater than 200 mg is limited.
• Because both therapeutic and adverse responses occur more rapidly with levodopa and carbidopa than with levodopa alone, patients should be monitored closely during the dose adjustment period. Specifically, involuntary movements will occur more rapidly with levodopa and carbidopa than with levodopa.
The occurrence of involuntary movements may require dosage reduction. Blepharospasm may be a useful early sign of excess dosage in some patients. • Current evidence indicates that other standard antiparkinsonian drugs may be continued while […]
Vomiting, gastrointestinal bleeding, development of duodenal ulcer, diarrhea, dark saliva, constipation, dyspepsia, dry mouth, taste alterations. General disorders and administration site conditions: asthenia. Immune System: angioedema, urticaria.
Metabolism and nutrition: anorexia.
Musculoskeletal and connective tissue:
Back pain, shoulder pain, muscle cramps. Neoplasms benign, malignant and unspecified (including cysts and polyps): malignant melanoma (see 2 CONTRAINDICATIONS; 7 WARNINGS AND PRECAUTIONS, Skin, Melanoma).
Nervous System:
Neuroleptic malignant syndrome (see 7 WARNINGS AND PRECAUTIONS, Neurologic), bradykinetic episodes (the “on-off” phenomenon), dizziness, somnolence including very rarely excessive daytime somnolence and sudden sleep onset episodes, paresthesia, , headache, insomnia, dementia, agitation, confusion.
Psychiatric:
Psychotic episodes including delusions, hallucinations and paranoid ideation, dream abnormalities including nightmares, depression with or without development of suicidal tendencies.
Renal and urinary:
Dark urine, urinary frequency, urinary tract infection.
Respiratory:
Dyspnea, upper respiratory infection.
Skin and subcutaneous tissue:
Alopecia, rash, increased sweating, dark sweat pruritus, bullous lesions (including pemphigus-like reactions).
Vascular:
Henoch-Schönlein purpura. pms-LEVODOPA-CARBIDOPA (levodopa / carbidopa) Page 15 of 39 Protected B / Protégé B Other adverse reactions that have been reported with levodopa alone and with various levodopa carbidopa formulations, and may occur with pms-LEVODOPA-CARBIDOPA are: Cardiac: Myocardial infarction.
Eye:
Diplopia, blurred vision, dilated pupils, oculogyric crisis.
Gastrointestinal:
Sialorrhea, dysphagia, bruxism, hiccups, abdominal pain and distress, flatulence, burning sensation of tongue, gastrointestinal pain, heartburn.
General disorders and administration site conditions:
Fatigue, malaise, hot flashes, sense of stimulation.
Metabolism and nutrition:
Weight gain or loss, edema.
Musculoskeletal and connective tissue:
Leg pain, muscle twitching.
Nervous System:
Decreased mental acuity, disorientation, ataxia, numbness, increased hand tremor, blepharospasm (which may be taken as an early sign of excess dosage, consideration of dosage reduction may be made at this time), trismus, activation of latent Horner’s syndrome, falling and gait abnormalities, extrapyramidal disorder, memory impairment, peripheral neuropathy, faintness, hoarseness.
Psychiatric:
Anxiety, euphoria, nervousness.
Renal and urinary:
Urinary retention, urinary incontinence, priapism.
Respiratory:
Pharyngeal pain, cough, bizarre breathing patterns.
Skin and subcutaneous tissue:
Flushing. 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 positive 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 pms-LEVODOPA-CARBIDOPA (levodopa / carbidopa) Page 16 of 39 Protected B / Protégé B been reported with levodopa alone and with various levodopa-carbidopa formulations, and may occur with pms-LEVODOPA-CARBIDOPA.
5 Post-Market Adverse Reactions In post-marketing use, pathological (compulsive) gambling, increased libido, hyper sexuality, 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 and carbidopa (See 7 WARNINGS AND PRECAUTIONS, Psychiatric, Behavioural Changes).
As with levodopa, pms-LEVODOPA-CARBIDOPA may cause involuntary movements and mental disturbances. These reactions are thought to be due to increased brain dopamine following administration of levodopa. Because carbidopa permits more levodopa to reach the brain and thus, more dopamine to be formed, dyskinesias may occur at lower dosages and sooner with pms-LEVODOPA-CARBIDOPA than with levodopa.
The occurrence of dyskinesias may require dosage reduction. Seizures: pms-LEVODOPA-CARBIDOPA should be used cautiously in patients who have a history of seizures or have conditions associated with seizure or have a lowered seizure threshold.
Neuroleptic Malignant Syndrome:
A symptom complex resembling the neuroleptic malignant syndrome including muscular rigidity, elevated body temperature, altered consciousness, mental changes, autonomic instability and increased serum creatine phosphokinase has been reported in association with rapid dose reduction, withdrawal of, or changes in antiparkinsonian therapy.
Therefore, patients should be observed carefully when the dosage of pms-LEVODOPA-CARBIDOPA is reduced abruptly or discontinued, especially if the patient is receiving neuroleptics. Ophthalmologic Use in Patients with Glaucoma: pms-LEVODOPA-CARBIDOPA is contraindicated in patients with narrow angle glaucoma (see 2 CONTRAINDICATIONS).
Pupillary dilatation and activation of latent Horner’s syndrome have been reported during levodopa treatment. Patients with chronic wide angle glaucoma should therefore be treated cautiously with pms-LEVODOPA- CARBIDOPA. The intraocular pressure should be well controlled and the patient monitored carefully for changes in intraocular pressure during therapy.
Peri-Operative Considerations If general anesthesia is required, therapy with pms-LEVODOPA-CARBIDOPA may be continued as long as the patient is permitted to take fluids and medication by mouth. 2 Recommended Dose and Dosage Adjustment).
Psychiatric Depression:
Patients should be monitored carefully for the development of depression pms-LEVODOPA-CARBIDOPA (levodopa / carbidopa) Page 12 of 39 Protected B / Protégé B with suicidal tendencies. Patients with past or current psychoses should be treated with caution.
Behavioural Changes:
Patients and caregivers should be advised to adhere to dosage instructions given by the physician. Patients should be regularly monitored for the development of impulse control disorders. 2 Clinical Trial Adverse Reactions). Literature and post marketing reports have described a very rare addictive pattern of dopamine replacement therapy, in which patients use doses in excess of those required to control their motor symptoms.
Review of treatment is recommended if such symptoms develop.
Hallucinations:
Hallucinations and confusion are known side effects of treatment with dopaminergic agents, including levodopa. Patients should be aware of the fact that hallucinations (mostly visual) can occur.
Skin Melanoma:
Because levodopa may activate a malignant melanoma, APO-LEVOCARB is contraindicated in patients with suspicious, undiagnosed […]