Generic Sinemet Tablets for Treatment of Parkinson's Disease and Symptoms

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Generic Sinemet Tablets

Generic Sinemet (Syndopa Tablets) is a combination of Carbidopa and Levodopa used for the treatment of Parkinson's disease and syndrome.


Chemical Structure - Carbidopa


Chemical Structure - Levodopa


Generic Sinemet is indicated in the treatment of the symptoms of idiopathic Parkinson's disease (paralysis agitans), post-encephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication. Generic Sinemet 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 (vitamin B6).

Indications


The active pharmaceutical ingredients contained in Generic Sinemet Tablets (Syndopa Tablets) are Carbidopa and Levodopa

Active Ingredient


The Generic Sinemet (Syndopa) is supplied as tablets in four strengths:Syndopa 110 mg (Levodopa 100mg & Carbidopa 10mg) or Generic Sinemet 10-100Syndopa 125 mg (Levodopa 100mg & Carbidopa 25mg) or Generic Sinemet 25-100Syndopa 250 mg (Levodopa 200mg & Carbidopa 50mg) or Generic Sinemet 50-250Syndopa 275 mg (Levodopa 250mg & Carbidopa 25mg) or Generic Sinemet 25-250

Strengths


The recommended dosage of Generic Sinemet (Syndopa Tablets) is given below:Syndopa 125 mg (Levodopa 100mg & Carbidopa 25mg) : The recommended starting dosage is one tablet of Generic Sinemet 25-100 (Levodopa 100mg & Carbidopa 25mg) three times a day. This dosage schedule provides 75 mg of carbidopa per day. Dosage may be increased by one tablet every day or every other day, as necessary, until a dosage of eight tablets of Generic Sinemet 25-100 a day is reached.

Recommended Dosage


The recommended dosage of Generic Sinemet (Syndopa Tablets) is given below: Syndopa 110 mg (Levodopa 100mg & Carbidopa 10mg): The recommended starting dosage of Generic Sinemet 10-100 (Levodopa 100mg & Carbidopa 10mg) is one tablet three or four times a day. However, this will not provide an adequate amount of carbidopa for many patients. Dosage may be increased by one tablet every day or every other day until a total of eight tablets (2 tablets four times a day) is reached.

Recommended Dosage

Contraindications

Generic Sinemet is contraindicated in patients with the following conditions:

Known hypersensitivity to Carbidopa or Levodopa or any inactive component of this medication.

Generic Sinemet should not be used in patients with suspicious, undiagnosed skin lesions or a history of melanoma

Nonselective monoamine oxidase (MAO) inhibitors are contraindicated for use with Generic Sinemet.

Side Effects of Generic Sinemet Tablets

The most common adverse effects of Generic Sinemet are dyskinesias including choreiform, dystonic, and other involuntary movements and nausea. Muscle twitching and blepharospasm may be taken as early signs to consider reduction. Other adverse effects reported in clinical trials or in post-marketing experience are as follows: Body as a whole: syncope, chest pain, anorexia. Cardiovascular: cardiac irregularities and/or palpitation, orthostatic effects including hypotensive episodes, hypertension, phlebitis.

Side Effects of Generic Sinemet Tablets

Gastrointestinal: vomiting, gastrointestinal bleeding, development of duodenal ulcer, diarrhoea, dark saliva. Haematologic: leukopenia, haemolytic and non-haemolytic anaemia, thrombocytopenia, agranulocytosis. Hypersensitivity: angioedema, urticaria, pruritus, Henoch-Schonlein purpura. Respiratory: dyspnoea. Skin: alopecia, rash, dark sweat. Urogenital: dark urine. Rarely convulsions have occurred;

Side Effects of Generic Sinemet Tablets

Nervous System/Psychiatric: neuroleptic malignant syndrome, bradykinetic episodes (the "on-off" phenomenon), dizziness, somnolence including very rarely excessive daytime somnolence and sudden sleep onset episodes, paresthesia, psychotic episodes including delusions, hallucinations and paranoid ideation, depression with or without development of suicidal tendencies, dementia, dream abnormalities, agitation, confusion.

Side Effects of Generic Sinemet Tablets

Other adverse effects that have been reported with Levodopa or Levodopa/Carbidopa combinations and may be potential adverse effects with Generic Sinemet are listed below: Nervous System/Psychiatric: asthenia, decreased mental acuity, disorientation, ataxia, numbness, increased hand tremor, muscle cramps, trismus, activation of latent Horner's syndrome, insomnia, anxiety, euphoria, falling and gait abnormalities. Gastrointestinal: dyspepsia, dry mouth, bitter taste, sialorrhoea, dysphagia, bruxism, hiccups, abdominal pain and distress, constipation, flatulence, burning sensation of tongue.

Side Effects of Generic Sinemet Tablets

Metabolic: weight gain or loss, oedema. Skin: flushing, increased sweating, pigmentation of teeth and skin. Urogenital: urinary retention, urinary incontinence, priapism. Special Senses: diplopia, blurred vision, dilated pupils, oculogyric crises. Miscellaneous: weakness, faintness, fatigue, headache, hoarseness, malaise, hot flashes, sense of stimulation, bizarre breathing patterns, malignant melanoma.

Warnings And Precautions

When Generic Sinemet (Carbidopa-Levodopa) is to be given to patients who are being treated with levodopa, levodopa must be discontinued at least twelve hours before therapy with Generic Sinemet (Carbidopa-Levodopa) is started.

Levodopa alone, as well as Generic Sinemet, is associated with dyskinesias. The occurrence of dyskinesias may require dosage reduction

As with levodopa, Generic Sinemet may cause mental disturbances. These reactions are thought to be due to increased brain dopamine following administration of levodopa. All patients should be observed carefully for the development of depression with concomitant suicidal tendencies.

Warnings And Precautions

Generic Sinemet should be administered cautiously to patients with severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease.

As with levodopa, care should be exercised in administering Generic Sinemet to patients with a history of myocardial infarction who have residual 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.

Warnings And Precautions

As with levodopa, treatment with Generic Sinemet may increase the possibility of upper gastrointestinal hemorrhage in patients with a history of peptic ulcer.

Neuroleptic Malignant Syndrome (NMS): Sporadic cases of a symptom complex resembling NMS have been reported in association with dose reductions or withdrawal of therapy with Generic Sinemet. Therefore, patients should be observed carefully when the dosage of Generic Sinemet (Syndopa Tablets) is reduced abruptly or discontinued, especially if the patient is receiving neuroleptics.

Overdose Symptoms

Reported symptoms two hours after ingestion of 60 tablets of 25-250 Generic Sinemet were sinus tachycardia, nausea and vomiting. Supportive therapy has to be instituted.Electrocardiographic monitoring should be instituted and the patient carefully observed for the possible development of arrhythmias; if required, appropriate antiarrhythmic therapy should be given.

Syndopa Tablets from Sun Pharmaceutical Industries Ltd., India

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Generic Sinemet Tablets

The Swiss Pharmacy, Geneva Switzerland