what is modopar?

Answer 1

Madopar (levodopa plus benserazide)

Brief prescribing information
Indications:
Parkinsonism - idiopathic, postencephalitic

Dosage and Administration:
Dosage is variable and the data sheet for Madopar should be consulted for full details. Take with, or immediately after meals. Patients not previously treated with levodopa: Recommended initial dose is one capsule or dispersible tablet of Madopar 62.5 three or four times daily. The effective daily dose of Madopar usually lies between four and eight capsules or dispersible tablets of Madopar 125 ( two to four capsules of Madopar 250) daily in divided doses, most patients requiring no more than six capsules or dispersible tablets of Madopar 125 daily. It is rarely necessary to give more than ten capsules or dispersible tablets of Madopar 125 (five capsules of Madopar 250) per day. Madopar 62.5 capsules or dispersible tablets may be used to facilitate adjustment of dosage to the needs of the patient. In some elderly patients initial treatment with one capsule or dispersible tablet every third or fourth day, may suffice. Patients previously treated with levodopa: Discontinue levodopa. Initiate patient on a total of one less Madopar 125 capsule or dispersible tablet daily than the total number of 500mg levodopa tablets or capsules previously taken. Increase the dose if necessary after one week. Patients previously treated with other levodopa/decarboxylase inhibitor combinations: Previous therapy should be withdrawn for 12 hours. The initial Madopar dose should be one capsule or dispersible tablet of Madopar 62.5 three or four times daily.

Contra-indications:
Narrow-angle glaucoma, severe psychoneuroses or psychoses. Severe endocrine, renal, hepatic or cardiac disorders. Pregnancy and breast-feeding. Patients under 25 years. It should not be given in conjunction with monoamine oxidase inhibitors, except selective MAO-B inhibitors, or within two weeks of their withdrawal. Patients who have a history of, or who may be suffering from, a malignant melanoma.

Precautions:
Drugs which interfere with central amine mechanisms and anesthesia with cyclopropane or halothane should be avoided. Endocrine, renal, pulmonary or cardiovascular disease, psychiatric disturbances, hepatic disorder, peptic ulcer, osteomalacia, sympathomimetic drugs, antihypertensive drugs. Patients who improve on Madopar therapy should be advised to resume normal activities gradually as rapid mobilisation may increase the risk of injury. Periodic evaluation of hepatic, haemopoietic, renal and cardiovascular function is advised. Sudden discontinuation of Madopar, without close supervision, or 'drug holidays' should be avoided.

Side-effects and Adverse Reactions:
Nausea and vomiting, loss of appetite, cardiovascular disturbances, psychiatric disturbances, involuntary movements, gastro-intestinal bleeding, flushing, sweating, drowsiness. Rare instances of blood dyscrasis. Isolated cases of hypertensive crisis with concomitant use of tricyclic drugs. Fluctuations in therapeutic response may occur with long term administration. Levodopa may interfere with several diagnostic tests and also with the response to protirelin in tests of thyroid function.

Legal Category:
POM

Presentation and Basic NHS Costs:
Madopar contains a combination of levodopa and the decarboxylase inhibitor benserazide in the ratio 4:1. Madopar 62.5 capsules or dispersible tablets, containing 50mg levodopa and 14.2mg benserazide hydrochloride (equivalent to 12.5mg of the base). Madopar 62.5 capsules in packs of 100 £7.76 or dispersible tablets in packs of 100 £8.29. Madopar 125 capsules or dispersible tablets, containing 100mg levodopa and 28.5mg benserazide hydrochloride (equivalent to 25mg of the base). Madopar 125 capsules in packs of 100 £10.81 or dispersible tablets in packs of 100 £14.70. Madopar 250 capsules, containing 200mg levodopa and 57mg benserazide hydrochloride (equivalent to 50mg of the base). Madopar 250 capsules in packs of 100 £18.43.

Product Licence Numbers:
PL 0031/0125 (62.5 capsules): PL 0031/0220 (62.5 dispersible tablets);
PL 0031/0073R (125 capsules): PL 0031/0221 (125 dispersible tablets);
PL 0031/0074R (250 capsules).

Product Licence Holder:
Roche Products Limited, PO Box 8, Welwyn Garden City, Hertfordshire, AL7 3AY.

Date of Preparation:
June 1996
Full prescribing information is available on request.
Madopar is a registered trade mark.



Madopar CR (levodopa plus benserazide)

Brief prescribing information
Indications
Treatment of all stages of Parkinson's disease.

Dosage and Administration:
Dosage is variable and the Summary of Product Characteristics for Madopar CR should be consulted for full details. Swallow Madopar CR capsules whole, preferably with a little water, with or without food. Patients not currently treated with levodopa: In patients with mild to moderate disease, the initial recommended dose is one capsule of Madopar CR three times daily with meals. The initial dosages should not exceed 600mg per day of levodopa. Patients currently treated with levodopa: Madopar CR should be substituted for the standard levodopa-decarboxylase inhibitor preparation by one capsule Madopar CR 125 per 100mg levodopa. With Madopar CR, on average, a 50% increase in daily levodopa dosage compared with previous therapy has been found to be appropriate. The dosage should be titrated every two to three days using dosage increments of Madopar CR 125 capsules for a period of up to four weeks. Continue with the same frequency of doses as previously. Some patients may require a supplementary dose of conventional Madopar together with the first morning dose of Madopar CR. Total daily doses of Madopar CR plus any supplementary conventional Madopar should not exceed a dose corresponding to 1,200mg levodopa.

Contra-indications:
Narrow-angle glaucoma, severe psychoneuroses or psychoses. Severe endocrine, renal, hepatic or cardiac disorders. Pregnancy and breast-feeding. Patients under 25 years. It should not be given in conjunction with monoamine oxidase inhibitors, except selective MAO-B inhibitors, or within two weeks of their withdrawal. Patients who have a history of, or who may be suffering from, a malignant melanoma.

Precautions:
Drugs which interfere with central amine mechanisms, antacids and anaesthesia with cyclopropane or halothane should be avoided. Endocrine, renal, pulmonary or cardiovascular disease, psychiatric disturbances, hepatic disorder, peptic ulcer, osteomalacia, sympathomimetic drugs, antihypertensive drugs. Patients who improve on Madopar therapy should be advised to resume normal activities gradually as rapid mobilisation may increase the risk of injury. Periodic evaluation of hepatic, haemopoietic, renal and cardiovascular function is advised. Levodopa may interfere with several diagnostic tests and also with the response to protirelin in tests of thyroid function. Sudden discontinuation of Madopar, without close supervision, or 'drug holidays' should be avoided.

Side-effects and Adverse Reactions:
Nausea and vomiting, loss of appetite, cardiovascular disturbances, psychiatric disturbances, involuntary movements, gastro-intestinal bleeding, flushing, sweating, drowsiness. Rare instances of blood dyscrasias. Isolated cases of hypertensive crisis with concomitant use of tricyclic drugs. Transient rises in SGOT, SGPT and alkaline phosphatase and occasionally increased levels of serum uric acid and blood urea nitrogen.

Legal Category:
POM

Presentation and Basic NHS Costs:
Madopar CR 125 capsules containing 100mg levodopa and 28.5mg benserazide hydrochloride (equivalent to 25mg of the base). Madopar CR capsules in bottles of 100 £17.97.

Marketing Authorization Number:
PL 0031/0227

Marketing Authorization Holder:
Roche Products Limited, PO Box 8, Welwyn Garden City, Hertfordshire AL7 3AY.

Date of Preparation:
June 1996 Full prescribing information is available on request. Madopar is a registered trade mark.





Important Safety Warning for Madopar, Active Substance Levodopa
for all Parkison Patients driving a car or operating maschinery



Madopar is sold by Roche AG, also under the names:
Modopar (France)
Prolopa (Belgium, Brasil, Canada, Chile)
Madopark (Sweden)



www.madopar.org and www.levodopa.org

Answer 2

Madopar 125

Answer 3

Madopar Side Effects