Tablets containing 100mg Levodopa and 25mg of anhydrous Carbidopa.
LEVOMED is a combination of Carbidopa, an aromatic amino acid decarboxylase inhibitor, and Levodopa, the metabolic precursor of dopamine, for the treatment of Parkinson's disease and syndrome.
Levodopa relieves the symptoms of Parkinson's disease presumably by being decarboxylated to dopamine in the brain. Carbidopa, which does not cross the blood-brain barrier, inhibits only the extracerebral decarboxylation of Levodopa, making more Levodopa available for transport to the brain and subsequent conversion to dopamine; This obviates the necessity for large doses of Levodopa at frequent intervals. The lower dosage reduces or eliminates many adverse reactions some of which are attributable to dopamine being formed in extracerebral tissues.
When used as recommended, LEVOMED improves overall therapeutic response as compared to Levodopa.
LEVOMED provides effective long-lasting Levodopa plasma levels at doses that are approximately 80 percent lower than those needed with Levodopa alone.
While pyridoxine hydrochloride (Vitamin B6) is known to accelerate the peripheral metabolism of Levodopa to dopamine, Carbidopa prevents this action. In a study in which patients received 100 to 500mg of pyridoxine a day while being treated with Carbidopa and Levodopa in combination, there was no reversal of antiparkinsonian effect.
Clinical Advantages: LEVOMED usually reduces and in some patients eliminates certain side effects found most frequently in patients on Levodopa: anorexia, nausea, vomiting, cardiac arrhythmia, postural hypotension and dizziness.
By reducing certain of the dose-limiting side effects produced by Levodopa alone, LEVOMED permits more patients to obtain adequate relief of the symptoms of Parkinson's disease.
LEVOMED offers prompt therapeutic response. Response to LEVOMED has been observed in one day; sometimes after one dose.
LEVOMED minimizes the slow individual dosage titrations which were needed with Levodopa therapy.
Fully effective doses are usually reached within seven days compared to weeks or months with Levodopa.
Following administration of LEVOMED, plasma levels of Levodopa were increased approximately five times over those found when the same dosage of Levodopa was given alone.
Levodopa-responders can be transferred to LEVOMED.
LEVOMED reduces the fluctuations of patient response often seen with Levodopa.
LEVOMED may be used with other standard antiparkinsonian drugs, where needed.
LEVOMED may be given to patients taking multivitamin preparations that include pyridoxine (Vitamin B6).
LEVOMED is indicated for the treatment of Parkinson's disease and syndrome. It is useful in relieving many of the symptoms of parkinsonism, particularly rigidity and bradykinesia. LEVOMED frequently is helpful in the management of tremor, dysphagia, sialorrhea, and postural instability associated with Parkinson's disease and syndrome.
When therapeutic response to Levodopa alone is irregular, and signs and symptoms of Parkinson's disease are not evenly controlled throughout the day, substitution of LEVOMED usually is effective in reducing fluctuations in response.
By reducing certain adverse reactions produced by Levodopa alone, LEVOMED permits more patients to obtain adequate relief of the symptoms of Parkinson's disease.
LEVOMED is indicated for patients with Parkinson's disease and syndrome who are taking vitamin preparations that contain pyridoxine.
Dosage should be titrated to the individual patient needs and this may require adjusting both the individual dose and the frequency of administration.
Each tablet of LEVOMED is designed to divide in half with minimal pressure.
Response has been observed in one day, and sometimes after one dose. Fully effective doses usually are reached within seven days as compared to weeks or months with Levodopa alone.
Studies show that the peripheral enzyme dopa decarboxylase is fully inhibited (saturated) by Carbidopa at doses between 70 and 150mg daily. Patients receiving less than this amount of Carbidopa are more likely to experience nausea and vomiting.
Because both therapeutic and adverse responses occur more rapidly with LEVOMED than when Levodopa is given, patients should be monitored closely during the dose adjustment period. Specifically, involuntary movements will occur more rapidly with LEVOMED 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.
Patients Not Receiving Levodopa: An occasional patient may need more Levodopa. NO advantage will be gained by increasing the amount of Carbidopa above 200mg per day.
Patients Receiving Levodopa: Levodopa should be discontinued at least 12 hours before LEVOMED is started (24 hours for slow-release preparations of Levodopa). A daily dosage of LEVOMED should be chosen that will provide approximately 20% of the previous Levodopa daily dosage.
Patients Receiving Levodopa and Another Decarboxylase inhibitor: When transferring a patient to LEVOMED from Levodopa combined with another decarboxylase inhibitor, discontinue dosage at least 12 hours before LEVOMED is started.
Begin with a dosage of LEVOMED that will provide the same amount of Levodopa as contained in the other Levodopa/decarboxylase inhibitor combination.
Patients Receiving Other Standard Antiparkinsonian Drugs: Current evidence indicates that other standard antiparkinsonian drugs may be continued although dosage may have to be adjusted.
Monoamine oxidase inhibitors and LEVOMED should not be given concomitantly, and these inhibitors must be discontinued at least two weeks prior to initiating therapy with LEVOMED.
LEVOMED is contraindicated in patients with known hypersensitivity to this drug, and in narrow angle glaucoma.
Because Levodopa may activate a malignant melanoma, it should not be used in patients with suspicious undiagnosed skin lesions or a history of melanoma.
LEVOMED may be given to patients already receiving Levodopa alone; however, the Levodopa alone must be discontinued at least 12 hours before LEVOMED is started.
LEVOMED should be substituted at a dosage that will provide approximately 20 percent of the previous Levodopa dosage.
LEVOMED is not recommended for the treatment of drug-induced extrapyramidal reactions.
LEVOMED should be administered cautiously to patients with severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease.
All patients should be monitored carefully for the development of mental changes, depression with suicidal tendencies, or other serious antisocial behaviour.
Patients with current psychoses should be treated with caution.
Patients with a history of severe involuntary movements or psychotic episodes when treated with Levodopa alone should be observed carefully when LEVOMED is substituted.
These reactions are thought to be due to increased brain dopamine following administration of Levodopa, and use of LEVOMED may cause a recurrence.
If concomitant administration of psychoactive drugs such as phenothiazines and butyrophenones is necessary, such drugs should be administered with caution and patients carefully observed for loss of antiparkinsonian effect.
Patients with a history of convulsions should be treated with caution.
The beneficial effects of Levodopa in Parkinson's disease have also been reported to be reversed by phenytoin and by papaverine.
Patients with chronic wide angle glaucoma may be treated cautiously with LEVOMED, provided the intraocular pressure is well controlled and the patient monitored carefully for changes in intraocular pressure during therapy.
Care should be exercised in administering LEVOMED to patients with a history of myocardial infarction who have atrial, nodal, or ventricular arrhythmia. In such patients, cardiac function should be monitored with particular care during the period of initial dosage adjustment.
Symptomatic postural hypotension has been reported occasionally. For this reason, LEVOMED should be given cautiously to patients on antihypertensive drugs. When LEVOMED is started, dosage adjustment of the antihypertensive drug may be required. (For patients receiving pargyline, see the contraindication on monoamine oxidase inhibitors).
As with Levodopa there is a possibility of upper gastrointestinal hemorrhage in patients with a history of peptic ulcer.
If general anesthesia is required, therapy with LEVOMED 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.
Transient abnormalities in laboratory tests which, however, have not been associated with clinical evidence of disease include elevations of blood urea nitrogen, SGOT, SGPT, LDH, bilirubin, alkaline phosphatase or protein bound iodine.
Positive Coombs tests have been reported both with LEVOMED and with Levodopa alone, but haemolytic anemia is extremely rare.
Use in Children: The safety of LEVOMED in patients under 18 years of age has not been established.
Although the effects of LEVOMED on human pregnancy and lactation are unknown, both Levodopa and combinations of Carbidopa and Levodopa have caused visceral and skeletal malformations in rabbits. Therefore, use of LEVOMED in women of childbearing potential requires that the anticipated benefits of the drug be weighed against possible hazards should pregnancy occur. LEVOMED should not be given to nursing mothers.
Side effects that occur frequently in patients receiving LEVOMED are those due to the central neuropharmacologic activity of dopamine. These reactions usually can be diminished by dosage reduction. The most common are choreiform, dystonic, and other involuntary movements.
Muscle twitching and blepharospasm may be taken as early signs to consider dosage reduction.
Less common are mental changes including paranoid ideation and psychotic episodes; depression with or without development of suicidal tendencies; and dementia. Convulsions have occurred; however, a causal relationship with LEVOMED has not been established.
Less frequent side effects are cardiac irregularities and/or palpitations, orthostatic hypotensive episodes, bradykinetic episodes (the "on-off" phenomenon), anorexia, nausea, vomiting and dizziness.
Gastrointestinal bleeding, development of duodenal ulcer, hypertension, phlebitis, leukopenia, and agranulocytosis have occurred rarely.
Positive Coombs test have been reported both with LEVOMED and with Levodopa alone, but hemolytic anemia is extremely rare.
Other side effects that have been reported include: Psychiatric: Euphoria, lethargy, sedation, stimulation, fatigue and malaise, confusion, insomnia, nightmares, hallucinations and delusions, agitation and anxiety.
Neurologic: Ataxia, faintness, headache, increased hand tremor, trismus, oculogyric crisis, weakness, numbness, bruxism.
Gastrointestinal: Constipation; diarrhoea, epigastric and abdominal distress and pain; flatulence; hiccups, sialorrhea; difficulty in swallowing; bitter taste, dry mouth; burning sensation of the tongue.
Dermatologic: Sweating, edema, hair loss, rash, bad odor, dark sweat.
Respiratory: Hoarseness, bizarre breathing pattern.
Urogenital: Urinary retention, incontinence, hematuria, dark urine, priapism.
Special Senses: Blurred vision, diplopia, dilated pupils, activation of latent Horner's syndrome.
Other: Hot flashes, weight gain or loss, flushing, abnormalities in laboratory tests.
N04BA02 - levodopa and decarboxylase inhibitor ; Belongs to the class of dopa and dopa derivative dopaminergic agents. Used in the management of Parkinson's disease.
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