Antiparkinsonian agent.
For treatment of Parkinson’s disease and syndrome. Levomed is useful in relieving many of the symptoms of parkinsonism, particularly rigidity and bradykinesia. It is frequently helpful in the management of tremor, dysphagia, sialorrhoea, and postural instability associated with Parkinson’s disease and syndrome.
When response to levodopa alone is irregular, and signs and symptoms of Parkinson’s disease are not controlled evenly throughout the day, substitution of Levomed usually reduces fluctuations in response. By reducing some of the adverse reactions produced by levodopa alone, Levomed permits more patients to obtain adequate relief from the symptoms of Parkinson’s disease.
Levomed may be given to patients with Parkinson’s disease and syndrome who are taking vitamin preparations that contain pyridoxine hydrochloride (Vitamin B6).
Method of administration
To be taken orally.
The optimum daily dosage of Levomed must be determined by careful titration in each patient.
Levomed Tablets are available as:
Levomed 100/10 mg tablets containing 10 mg of carbidopa and 100 mg levodopa.
Levomed 100/25 mg tablets containing 25 mg of carbidopa and 100 mg levodopa.
Levomed 250/25 mg tablets containing 25 mg of carbidopa and 250 mg levodopa.
Dosage should be titrated to individual patient needs, and this may require adjusting both the individual dose and the frequency of administration.
Studies show that the peripheral dopa-decarboxylase is saturated by carbidopa at approximately 70 to 100 mg a day. Patients receiving less than this amount of carbidopa are more likely to experience nausea and vomiting. The formulations of Levomed are designed to provide a range of doses with sufficient carbidopa to inhibit peripheral dopadecarboxylase and thus exert optimal therapy.
Standard antiparkinsonian drugs, other than levodopa alone, may be continued while Levomed is being administered.
Dosage is best initiated with one tablet of Levomed 25/100 three times a day. This dosage schedule provides 75 mg of carbidopa per day. Dosage may be increased by one tablet or every other day, as necessary, until a dosage equivalent of eight tablets of Levomed 25/100 a day is reached.
Levomed 10/100 may be used to facilitate dosage titration according to the needs of the individual patient.
If Levomed 10/100 is used, dosage may be initiated with one tablet three or four times a day. However, this may not provide the optimal amount of carbidopa needed by many patients. Titration upward may be required in some patients to achieve optimum dosage of carbidopa. The dosage may be increased by one tablet every day or every other day until a total of eight tablets (two tablets four times a day) is reached.
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.
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.
Discontinue levodopa at least 12 hours (24 hours for slow-release preparations of levodopa) before starting therapy with Levomed. A daily dosage of Levomed should be chosen that will provide approximately 20% of the previous daily dosage of levodopa.
Patients who are taking less than 1,500 mg levodopa a day should be started on one tablet of Levomed 25/100 three or four times a day. The suggested starting dose for most patients taking more than 1,500 mg levodopa a day is one tablet of Levomed 25/250 three or four times a day.
Therapy with Levomed should be individualised and adjusted according to the desired therapeutic response. At least 70 to 100 mg of carbidopa per day should be provided for optimal inhibition of extra-cerebral decarboxylation of levodopa. When a greater proportion of carbidopa is required, one tablet of Levomed 25/100 may be substituted for each tablet of Levomed 10/100.
Levomed 25/100 may be helpful, especially for patients with nausea and vomiting.
When more levodopa is required, Levomed 25/250 should be substituted for Levomed 25/100 or Levomed 10/100g. If necessary, the dosage of Levomed 25/250 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 carbidopa is limited.
Eight tablets of Levomed 25/250 per day (200 mg of carbidopa and 2 g of levodopa). This is about 3 mg/kg of carbidopa, and 30 mg/kg of levodopa in a patient weighing 70 kg.
When transferring a patient to Levomed from levodopa combined with another decarboxylase inhibitor, its dosage should be discontinued 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.
The safety of Levomed in patients under 18 years of age has not been established and its use in patients below the age of 18 is not recommended.
In the elderly, dosage should generally be low with slow and minimal increments.
Management of acute overdosage with Levomed is basically the same as management of acute overdosage with levodopa; however pyridoxine is not effective in reversing the actions of Levomed. ECG monitoring should be instituted, and the patient carefully observed for the possible development of arrhythmias; if required, appropriate anti-arrhythmic therapy should be given. The possibility that the patient may have taken other drugs as well as Levomed should be taken into consideration.
To date, no experience has been reported with dialysis, and hence its value in the treatment of overdosage is not known.
5 years.
Store below 30°C in the original package, in order to protect from light.
PVC/AL blister packs 100 tablets.
Levomed 250/25mg tablets are also marketed in PVC/AL blister packs of 30.
Levomed 100/25mg tablets are also marketed in PVC/AL blister packs of 10, 50.
Not all pack sizes may be marketed.
Not applicable.
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