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Sun Pharmaceutical Ltd.

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Sun Pharmaceutical Ltd.
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Syndopa 250mg + 25mg

Size: 100 Price: 1003.00
Tablet Tablet
Levodopa + Carbidopa (FC tablet)
Antiparkinson drugs
0.00 (0)



Alternate Strengths


Generic for Diseases

Generic Indications

Generic Description

Levodopa, the metabolic precursor of dopamine, crosses the blood-brain barrier and is converted to dopamine in the brain. Carbidopa is a dopa decarboxylase (DDC) inhibitor which reduces the peripheral metabolism of Levodopa to dopamine, and thus, more Levodopa becomes available to the brain.


Component

Drug Indication

This tablet 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. This tablet is frequently helpful in the management of tremor, dysphagia, sialorrhea and postural instability associated with Parkinson's disease and syndrome. Levodopa plus carbidopa before physiotherapy increases motor recovery after stroke.


Dosage Administration

If 100/10 mg tablet is used: Dosage may be initiated with one tablet three or four times a day. 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 q.d.s.) is reached.

For patients starting with 250/25 mg tablet: The initial dose is one half taken once or twice daily. However, this may not provide the optimal amount of Carbidopa needed by many patients. If necessary, add one-half every day or every other day until optimal response is reached. The suggested starting dosage for most patients taking more than 1500 mg of Levodopa a day is one tablet of 250/25 mg three or four times a day.

Maintenance dose: Therapy should be individualized and adjusted according to the desired therapeutic response. When more levodopa is requried, 250/25 mg tablet should be substituted at a dosage of one tablet three or four times a day. If necessary, the dosage of 250/25 mg tablet may be increased by half to one tablet every other day to a maximum of eight tablets a day. Experience with a total daily dosage greater than 200 mg Carbidopa is limited.


Contraindication

Carbidopa-Levodopa tablet is contraindicated in patients with hypersensitivity to Carbidopa and Levodopa, and in patients with narrow-angle glaucoma. Since Levodopa may activate a malignant melanoma, Carbidopa-Levodopa should not be used in patients with suspicious undiagnosed skin lesions or a history of melanoma.


Side Effect

Adverse effects that occur frequently in patients receiving Carbidopa-Levodopa are those due to the central neuropharmacologic activity of dopamine. These reactions usually can be diminished by dosage reduction. The most common adverse effects are dyskinesias including choreiform, dystonic, and other involuntary movements and nausea.

  • Body as a whole: syncope, chest pain, anorexia.
  • Cardiovascular: palpitation, orthostatic effects including hypotensive episodes, hypertension, phlebitis.
  • Gastrointestinal: vomiting, gastrointestinal bleeding, development of duodenal ulcer, diarrhoea, dark saliva.
  • Haemotologic: leukopenia, haemolytic and non-haemolytic anaemia, thrombocytopenia, agranulocytosis.
  • Hypersensitivity: angioedema, urticaria, pruritus, Henoch-Schonlein purpura.
  • Nervous System: dizziness, somnolence, paresthesia, delusions, hallucinations and paranoid ideation, depression with or without development of suicidal tendencies, dementia, dream abnormalities, agitation, confusion, increased libido.
  • Respiratory: dyspnea.
  • Skin: alopecia, rash, dark sweat.
  • Urogenital: dark urine.

Precaution Warning

Carbidopa-Levodopa is not recommended for the treatment of medicine-induced extrapyramidal reactions. Carbidopa Levodopa may be given to patients already taking Levodopa alone; however, the Levodopa must be discontinued at least 12 hours before Carbidopa-Levodopa started. Dyskinesias may occur in patients previously treated with Levodopa alone because Carbidopa permits more Levodopa to reach the brain and, thus, more dopamine to be formed. The occurrence of dyskinesias may require dosage reduction. All patients should be observed carefully for the development of depression with concomitant suicidal tendencies. Patients with past or current psychoses should be treated with caution. Carbidopa-Levodopa should be administered cautiously to patients with severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease, or a history of peptic ulcer disease or of convulsions.

Care should be exercised to patients with a history of myocardial infarction who have atriai, nodal, or ventricular arrhythmia. In such patients, cardiac function should be monitored with particular care during the period of initial dosage administration and titration. Patients with chronic wide-angle glaucoma may be treated cautiously with Carbidopa-Levodopa, provided the intraocular pressure is weli controlled and the patient monitored carefully for changes in intraocular pressure during therapy.

Use in Special Populations

Use in children: Safety and effectiveness of Carbidopa-Levodopa in infants and children have not been established, and its use in patients below the age of 18 years is not recommended.

Pregnancy & Lactation

Although the effects of CarbidopaLevodopa on human pregnancy are unknown both Levodopa and combinations of Carbidopa and Levodopa have caused visceral and skeletal malformations in rabbits. Therefore, use of CarbidopaLevodopa in women of childbearing potential requires that the anticipated benefits of the medicine be weighed against possible hazards should pregnancy occur. It is not known whether Carbidopa is excreted in human milk. Because many medicines are excreted in human milk and because of the potential for serious adverse reactions in infants, a decision should be made whether to discontinue nursing or to discontinue the use of Carbidopa-Levodopa, taking into account the importance of the medicine to the mother.





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