Co-dopa Tablet 100mg+10mg

Product Information

CO-DOPA

Co-dopa®Carbidopa-Levodopa

Presentation

Co-dopa tablet: Green, oblong shaped, scored tablet; each tablet contains Carbidopa Monohydrate USP equivalent to Carbidopa 25 mg

and Levodopa USP 250 mg.

Indications

Co-dopa (Carbidopa-Levodopa) 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. Co-dopa (Carbidopa-Levodopa) tablet frequently is

helpful in the management of tremor, dysphagia, sialorrhea and postural instability associated with Parkinson’s disease

and syndrome.

Dosage and administration

Usual initial dose: The initial dose is Carbidopa 12.5 mg and Levodopa 125 mg (one-half Co-dopa tablet) taken once or twice daily.

However, this may not provide the optimal amount of Carbidopa needed by many patients. If necessary, add Carbidopa 12.5 mg and

Levodopa 125 mg

(half Co-dopa tablet) 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 is Carbidopa 25 mg and Levodopa 250 mg (one Co-dopa tablet) three or four times a

day.

Maintenance dose: Therapy should be individualized 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 extracerebral decarboxylation of Levodopa. If necessary, the

dosage of Carbidopa- Levodopa may be increased by Carbidopa 12.5 mg and Levodopa 125 mg (half Co-dopa tablet) or Carbidopa 25 mg

and Levodopa 250 mg (one Co-dopa tablet) every day or every other day to a maximum of Carbidopa 200 mg and Levodopa 2 g (eight

Co-dopa tablets) a day. Maximum recommended dose: Carbidopa 200 mg and Levodopa 2g (eight Co-dopa tablets) per day.

Contra-indications, warnings, etc.

Contra-indications: Carbidopa-Levodopa tablet is contra-indicated 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.

Warnings and precautions: 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 atrial, 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 well controlled and the patient monitored carefully for

changes in intraocular pressure during therapy.

Use in pregnancy and lactation: Although the effects of Carbidopa-Levodopa on human pregnancy are unknown both Levodopa

and combinations of Carbidopa and Levodopa have caused visceral and skeletal malformations in rabbits. Therefore, use of

Carbidopa-Levodopa 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.

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.

Drug interactions: Symptomatic postural hypotension has occurred when Carbidopa-Levodopa is added to the treatment of a patient

receiving antihypertensive medicines. Therefore, when therapy with Carbidopa-Levodopa is started, dosage adjustment of the

antihypertensive medicine may be required. There have been rare reports of adverse reactions, including hypertension and

dyskinesia, resulting from the concomitant use of tricyclic antidepressants and Carbidopa-Levodopa. Studies demonstrate a decrease

in the bioavailability of Carbidopa and/or Levodopa when it is ingested with ferrous sulphate or ferrous gluconate. Dopamine-2

receptor antagonists (e.g., phenothiazines, butyrophenones and risperidone) and isoniazid may reduce the therapeutic effects of

Levodopa. In addition, the beneficial effects of Levodopa in Parkinson’s disease have been reported to be reversed by phenytoin

and papaverine. Patients taking these medicines with Carbidopa-Levodopa should be carefully observed for loss of

therapeutic response. Concomitant therapy with selegiline and Carbidopa-Levodopa may be associated with severe orthostatic

hypotension not attributable to Carbidopa-Levodopa alone.

Side-effects: 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 nonhaemolytic 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.

Pharmaceutical precautions

Store in a cool and dry place, protected from light.

Packaging quantities

Co-dopa tablet: Cartons containing 30 tablets in blister.