Syndopa 275

Syndopa 275

carbidopa + levodopa

Manufacturer:

Sun Pharma

Distributor:

DKLL

Marketer:

Ranbaxy
Full Prescribing Info
Contents
Levodopa, carbidopa.
Description
Each tablet of Syndopa 275 contains Levodopa BP 250 mg and Carbidopa BP (Anhydrous) 25 mg.
Action
Pharmacology: Levodopa: On oral administration, levodopa is rapidly converted to dopamine in extracerebral tissues. Only large doses of levodopa (if given alone) are effective since only a small portion of it penetrates unchanged into the brain.
Carbidopa: This is an inhibitor of dopa decarboxylase present in peripheral tissues. Its administration with levodopa prevents unnecessary peripheral decarboxylation of levodopa. Thus, Syndopa 275 reduces the amount of levodopa required by about 75% and increases both plasma levels and the plasma half-life of levodopa.
Mechanism of Action: Symptoms of Parkinson's disease are currently believed to be attributed to depletion of dopamine in the corpus striatum. Levodopa (in Syndopa) is the metabolic precursor of dopamine which crosses the blood-brain barrier and is converted in basal ganglia to the active metabolite. The dopamine thus available relieves the symptoms of Parkinson's disease.
Indications/Uses
Syndopa 275 is advocated in the management of idiopathic Parkinson's disease (paralysis agitans), postencephalitic parkinsonism and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide or manganese intoxication.
Syndopa 275 is indicated in these conditions to permit the administration of lower doses of levodopa with reduced nausea and vomiting, with more rapid dosage titration, with a somewhat smoother response and with supplemental pyridoxine.
Dosage/Direction for Use
Patients Not Presently Receiving Levodopa: When it is evident that more levodopa is needed, Syndopa 275, at a dosage of 1 tablet 3-4 times a day, should be substituted.
If further titration is still necessary, dosage with Syndopa 275 may be increased by ½ or 1 tablet every 1-2 days to a maximum of 8 tablets per day; alternatively, dosage may be titrated to 6 tablets of Syndopa 275 a day and further adjusted with increments of levodopa.
Patients Receiving Levodopa: When patients are receiving levodopa, it must be discontinued at least 8 hours before Syndopa is started. A daily dosage of Syndopa should be chosen that will provide approximately 25% of the previous levodopa daily dosage.
Levodopa Requirement >1500 mg/day: For most patients, the suggested starting dose is 1 tablet of Syndopa 275, 3-4 times a day.
Adjustment in dosage may be made as necessary by adding or omitting ½ or 1 tablet a day.
Current evidence indicates that other antiparkinsonian drugs may be continued while Syndopa is being administered but their dosage may have to be adjusted.
Contraindications
Syndopa 275 is not advocated in individuals hypersensitive to its ingredients, narrow-angle glaucoma, suspicious, undiagnosed skin lesion or a history of melanoma (since levodopa is known to activate a malignant melanoma), nursing mothers and in those taking monoamine oxidase inhibitors.
Warnings
Syndopa 275 permits more levodopa to reach the brain and thus dyskinesias may occur at lower dosage and sooner as compared to levodopa therapy. Monoamine oxidase inhibitors, if taken by patients, must be discontinued at least 2 weeks prior to institution of Syndopa 275 therapy.
As with levodopa, periodic evaluations of hepatic, hematopoietic, cardiovascular and renal function are recommended during extended therapy with Syndopa 275. The occurrence of blepharospasm is a sign of overdosage with Syndopa 275.
Special Precautions
Syndopa 275 should be administered with caution in severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease and in presence of peptic ulcer or chronic wide-angle glaucoma.
If general anaesthesia is required, therapy with Syndopa 275 may be continued as long as the patient is permitted to take fluids and medications 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.
Use in Pregnancy: Use of Syndopa 275 in women of childbearing potential requires that the anticipated benefits of the drug be weighed against possible hazards to the mother and child.
Use in Children: Safety of the formulation has not been established in patients under 18 years of age.
Use In Pregnancy & Lactation
Use of Syndopa 275 in women of childbearing potential requires that the anticipated benefits of the drug be weighed against possible hazards to the mother and child.
Adverse Reactions
The most common adverse reaction with Syndopa 275 are nausea, choreiform dystonia and other involuntary movements. Other significant reactions are convulsions, dementia and mental changes. The mental changes include paranoid ideation, psychotic episodes and depression with or without suicidal tendencies.
Other less frequent adverse reactions with Syndopa 275 include burning sensation of tongue, bitter taste, dry mouth, dysphagia, sialorrhoea, hiccups, gastrointestinal disturbances, ulceration and bleeding; cardiac irregularities, orthostatic hypotensive episodes, hypertension, phlebitis, blood dyscrasias; nervous system manifestations like ataxia, headache, dizziness or faintness, numbness, weakness, bruxism, confusion, insomnia and nightmares, hallucinations and delusions, agitation and anxiety, euphoria, muscle twitching and blepharospasm (which may be taken as an early sign of excess dosage; consideration of dosage reduction may be made at this time). Other troublesome effects are weight gain or loss, hypersensitivity, increased sweating, flushing, edema, loss of hair, trismus, bizarre breathing patterns, hoarseness, urinary complaints, disturbances of vision and activation of latent Horner's syndrome, oculogyric crisis and priapism.
Drug Interactions
Syndopa 275 can cause symptomatic postural hypotension and hence must be given cautiously to patients on antihypertensive drugs. Since phenothiazines, butyrophenones, phenytoin and papaverine may reduce the therapeutic effects of levodopa, concomitant administration of these drugs with Syndopa 275 should be advocated with care.
Storage
Store in a cool dry place, protected from light (preferable between 15°C-30°C).
MIMS Class
Antiparkinsonian Drugs
ATC Classification
N04BA02 - levodopa and decarboxylase inhibitor ; Belongs to the class of dopa and dopa derivative dopaminergic agents. Used in the management of Parkinson's disease.
Presentation/Packing
Form
Syndopa 275 tab
Packing/Price
5 × 10's
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