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AG-LEVOCARB is a brand name for Levodopa, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AG-Levocarb (levodopa and carbidopa tablets) is indicated for the treatment of Parkinson's disease. AG-Levocarb 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 patients under 18 years…
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 AG-Levocarb (levodopa and carbidopa tablets) must be individualized AG-Levocarb (Levodopa and Carbidopa Tablets) Page 6 of 38 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 AG-Levocarb 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 AG-Levocarb, levodopa must be discontinued at least twelve hours or more before therapy with AG-Levocarb is initiated.
• 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 AG-Levocarb than with levodopa. • AG-Levocarb tablets are available in a 4:1 ratio (AG-Levocarb 100 mg / 25 mg) and in a 10:1 ratio of levodopa to carbidopa (AG-Levocarb 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. • Dividing the tablets along the score line may not give exact equal half doses. • 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. , less than 700 mg, AG- Levocarb 100 mg / 25 mg may be helpful.
2 Recommended Dose and Dosage Adjustment • Induction of Therapy in Patients Not Receiving Levodopa Dosage is best initiated with one tablet of AG-Levocarb 100 mg / 25 mg three times a day. This dosage schedule provides 75 mg of carbidopa per day.
). Literature and postmarketing 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:
Epidemiological studies have shown that patients with Parkinson’s disease have a higher risk (2- to approximately 6-fold higher) of developing melanoma than the general population. Whether the increased risk observed was due to Parkinson’s disease or other AG-Levocarb (Levodopa and Carbidopa Tablets) Page 12 of 38 factors, such as drugs used to treat Parkinson’s disease, is unclear.
For the reasons stated above, patients and healthcare providers are advised to monitor for melanomas frequently and on a regular basis when using AG-Levocarb for any indication. , dermatologists). 1 Pregnant Women Although the effects of AG-Levocarb on human pregnancy and lactation are unknown, both levodopa and combinations of carbidopa and levodopa have caused visceral and skeletal malformations in rabbits (see 16 NON-CLINICALTOXICOLOGY, Teratologic and Reproductive Studies).
Therefore, use of AG-Levocarb in women of child-bearing potential requires that the anticipated benefits of the drug be weighed against possible hazards to the mother and to the fetus. 2 Breast-feeding It is not known whether carbidopa is excreted in human milk.
In a study of one nursing mother with Parkinson’s disease, excretion of levodopa in breast milk was reported. AG-Levocarb should not be given to nursing mothers unless the anticipated benefits to the mother outweigh the potential hazards to the infant.
General When patients already receiving levodopa are switched to AG-Levocarb, levodopa must be discontinued for at least 12 hours or more before AG-Levocarb is started. AG-Levocarb should be substituted at a dosage that will provide approximately 20% of the previous levodopa dosage (see 4 DOSAGE AND ADMINISTRATION).
Patients who are taking AG-Levocarb should be instructed not to take additional levodopa unless it is prescribed by the physician. Periodic evaluations of hepatic, hematopoietic, cardiovascular and renal function are AG-Levocarb (Levodopa and Carbidopa Tablets) Page 10 of 38 recommended during extended therapy with AG-Levocarb (levodopa and carbidopa tablets).
Physical Activity:
Patients who improve while on therapy with AG-Levocarb 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 AG-Levocarb 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. Gastrointestinal AG-Levocarb should be administered cautiously to patients with a history of peptic ulcer disease due to the possibility of upper gastrointestinal hemorrhage.
Neurologic The levodopa induced involuntary movements and 'on and off' phenomenon may appear earlier with combination therapy. As with levodopa, AG-Levocarb 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 AG-Levocarb than with levodopa. The occurrence of dyskinesias may require dosage reduction.
• AG-Levocarb 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 of the product monograph.
• Nonselective monoamine oxidase (MAO) inhibitors are contraindicated for use with AG- Levocarb. These inhibitors must be discontinued at least two weeks prior to initiating therapy with AG-Levocarb. g. selegiline HCl) (see 9 DRUG INTERACTIONS, Drug-Drug Interactions, Psychoactive Drugs) at the manufacturer’s recommended dose which maintains selectivity for MAO type B.
• AG-Levocarb should not be administered to patients with clinical or laboratory evidence of uncompensated cardiovascular, endocrine, hematologic, hepatic, pulmonary (including bronchial asthma), or renal disease; or to patients with narrow angle glaucoma.
, epinephrine, norepinephrine or isoproterenol). • Because levodopa may activate a malignant melanoma, AG-Levocarb should not be used in patients with suspicious, undiagnosed skin lesions or a history of melanoma. AG-Levocarb (Levodopa and Carbidopa Tablets) Page 5 of 38
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Dosage may be carefully increased by one tablet every three days until the optimal dosage has been reached AG-Levocarb (Levodopa and Carbidopa Tablets) Page 7 of 38 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 AG-Levocarb 100 mg / 25 mg has been reached, tablets of AG-Levocarb 100 mg / 10 mg or 250 mg / 25 mg 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 postencephalitic parkinsonism, are more sensitive to levodopa and require specially careful dosage adjustment. • Induction of Therapy in Patient Receiving Levodopa Levodopa must be discontinued at least twelve hours or more before AG-Levocarb is started.
A dosage of AG-Levocarb 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 AG-Levocarb should not provide more than 750 mg of levodopa per day divided into four to six doses.
AG-Levocarb 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 AG-Levocarb 100 mg / 25 mg may be substituted for each tablet of AG-Levocarb 100 mg / 10 mg. When more levodopa is required, AG-Levocarb 250 mg / 25 mg should be substituted for AG- Levocarb 100 mg / 25 mg or 100 mg / 10 mg.
If necessary, the dosage of AG-Levocarb 250 / 25 may be increased by one tablet every day or every other day to a maximum of eight tablets a day. 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 levodopa and carbidopa tablets are being administered although their AG-Levocarb (Levodopa and Carbidopa Tablets) Page 8 of 38 dosage may have to be adjusted.
If general anesthesia is required, therapy with AG-Levocarb may be continued as long as the patient is permitted to take fluids and medication by mouth. If therapy is interrupted temporarily, the usual daily dosage may be administered as soon as the patient is able to take oral medication.
3 Reconstitution • Not Applicable. 4 Administration • Not Applicable. 5 Missed […]
3 Pediatrics Pediatrics (< 18 years of age): The safety of levodopa and carbidopa in patients under 18 years of age has not been established. Monitoring and Laboratory Tests Periodic evaluations of hepatic, hematopoietic, cardiovascular and renal function are recommended during extended therapy with AG-Levocarb (levodopa and carbidopa tablets).
AG-Levocarb 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. Caution should be exercised when interpreting the plasma and urine levels of catecholamines and their metabolites in patients on levodopa or levodopa/carbidopa therapy (see
AG-Levocarb 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 AG-Levocarb is reduced abruptly or discontinued, especially if the patient is receiving neuroleptics.
Psychomotor Performance:
Certain side effects that have been reported with levodopa and carbidopa tablets 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 AG-Levocarb (Levodopa and Carbidopa Tablets) Page 11 of 38 machinery, including driving motor vehicles, while taking AG-Levocarb.
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 7 WARNINGS AND PRECAUTIONS, 3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Sudden Onset of Sleep).
Ophthalmologic Use in Patients with Glaucoma:
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 AG-Levocarb. 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 AG-Levocarb may be continued as long as the patient is permitted to take fluids and medication by mouth. If therapy is interrupted temporarily, the usual daily dosage may be administered as soon as the patient is able to take oral medication (see 4 DOSAGE AND ADMINISTRATION, Adjustment and Maintenance of Therapy).
Psychiatric Patients should be monitored carefully for the development of depression 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. Patients and caregivers should be made aware that behavioral symptoms of impulse control disorders, including pathological (compulsive) gambling, hypersexuality, increased libido, compulsive spending/buying, and binge/compulsive eating, have been reported in patients treated with dopaminergic agonists and/or other dopaminergic treatments for Parkinson's disease, including levodopa and carbidopa (see