Tablet carbidopa 25 mg, levodopa 100 mg. Sun Pharmaceutical Industries Ltd
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Indications
This tablet is used to treat Parkinson's disease and Parkinson's syndrome. It helps to alleviate many of the symptoms of Parkinson's disease, especially rigidity and bradykinesia. Tremor, dysphagia, sialorrhea, and postural instability are common symptoms of Parkinson's disease and syndrome, and this tablet can assist. Prior to physiotherapy, levodopa + carbidopa improves motor recovery after a stroke.
Pharmacology
The combination of levodopa and carbidopa is used to treat Parkinson's disease and Parkinson's-like symptoms that can occur after encephalitis (brain swelling) or a nervous system injury caused by carbon monoxide poisoning or manganese poisoning. Tremors (shaking), stiffness, and slowness of movement are all symptoms of Parkinson's disease, which is caused by a shortage of dopamine, a natural substance found in the brain. Levodopa belongs to a class of drugs known as central nervous system agents. It functions by converting dopamine in the brain. Carbidopa belongs to the class of drugs known as decarboxylase inhibitors. It works by blocking the breakdown of levodopa before it reaches the brain. This enables a lower dose of levodopa to be used, resulting in less nausea and vomiting.
Dosage
Patients currently treated with conventional levodopa/decarboxylase inhibitor combinations: Dosage with Levodopa-Carbidopa prolonged-release tablet should be substituted initially at an amount that provides no more than approximately 10% more levodopa per day when higher dosages are given (more than 900 mg per day). The dosing interval between doses should be prolonged by 30 to 50% at intervals ranging from 4 to 12 hours. It is recommended to give the smaller dose, if divided doses are not equal, at the end of the day. The dose needs to be titrated further depending on clinical response, as indicated below under 'Titration'. Dosages that provide up to 30% more levodopa per day may be necessary. A guide for substitution of Levodopa Carbidopa prolonged-release tablet treatment for conventional levodopa/decarboxylase inhibitor combinations is shown in the table below:
Guideline for conversion from conventional Levodopa/Carbidopa tablet to Levodopa-Carbidopa prolonged-release tablet:
Conventional tablet: Daily Dosage of Levodopa 300-400 mg
Controlled Release tablet: Daily Dosage of Levodopa 400 mg. Dosage Regimen: 1 tablet 2x daily.
Conventional tablet: Daily Dosage of Levodopa 500-600 mg
Controlled Release tablet: Daily Dosage of Levodopa 600 mg. Dosage Regimen: 1 tablet 3x daily.
Conventional tablet: Daily Dosage of Levodopa 700-800 mg
Controlled Release tablet: Daily Dosage of Levodopa 800 mg. Dosage Regimen: 4 tablets in 3 or 4 divided doses.
Conventional tablet: Daily Dosage of Levodopa 900-1000 mg
Controlled Release tablet: Daily Dosage of Levodopa 1000 mg. Dosage Regimen: 5 tablets in 3 or more divided doses.
Conventional tablet: Daily Dosage of Levodopa 1100-1200 mg
Controlled Release tablet: Daily Dosage of Levodopa 1200 mg. Dosage Regimen: 6 tablets in 3 or more divided doses.
Conventional tablet: Daily Dosage of Levodopa 1300-1400 mg
Controlled Release tablet: Daily Dosage of Levodopa 1400 mg. Dosage Regimen: 7 tablets in 3 or more divided doses.
Conventional tablet: Daily Dosage of Levodopa 1500-1600 mg
Controlled Release tablet: Daily Dosage of Levodopa 1600 mg. Dosage Regimen: 8 tablets in 3 or more divided doses.
Administration
Patients currently treated with levodopa alone: Levodopa must be discontinued at least eight hours before therapy with this CR tablet is started. In patients with mild to moderate disease, the initial recommended dose is one tablet of this CR tablet twice daily.
Patients not receiving levodopa: In patients with mild to moderate disease, the initial recommended dose is one tablet of this CR tablet twice daily. Initial dosages should not exceed 600 mg per day of levodopa, nor be given at intervals of less than six hours.
Titration: Following initiation of therapy, doses and dosing intervals may be increased or decreased, depending upon therapeutic response. Most patients have been adequately treated with two to eight tablets per day of this CR tablet administered as divided doses at intervals ranging from four to twelve hours during the waking day. Higher doses (up to 12 tablets) and shorter intervals (less than four hours) have been used, but are not usually recommended. When doses of this CR tablet are given at intervals of less than four hours, or if the divided doses are not equal, it is recommended that the smaller doses be given at the end of the day. In some patients the onset of effect of the first morning dose may be delayed for up to one hour compared with the response usually obtained from the first morning dose of conventional levodopa-carbidopa tablet. An interval of at least three days between dosage adjustments is recommended.
Maintenance: Because Parkinson’s disease is progressive, periodic clinical evaluations are recommended and adjustment of the dosage regimen of this CR tablet may be required.
Addition of other antiparkinson medication: Anticholinergic agents, dopamine agonists and amantadine can be given with this CR tablet. Dosage adjustment of this CR tablet may be necessary when these agents are added to an existing treatment regimen for this CR tablet.
Interruption of therapy: Patients should be observed carefully if abrupt reduction or discontinuation of this CR tablet is required, especially if the patient is receiving antipsychotics.
Interactions
When Carbidopa-Levodopa is introduced to the treatment of a patient on antihypertensive medications, symptomatic postural hypotension occurs. As a result, when CarbidopaLevodopa therapy begins, antihypertensive medication dosage may need to be adjusted. There have been a few reports of side effects from using tricyclic antidepressants and Carbidopa-Levodopa together, including hypertension and dyskinesia. Carbidopa and/or Levodopa bioavailability is reduced when combined with iron sulphate or ferrous gluconate, according to studies. Isoniazid with dopamine-2 receptor antagonists (such as phenothiazines, butyrophenones, and risperidone). Levodopa's therapeutic effects may be reduced. Furthermore, phenytoin and papaverine have been shown to reverse the positive benefits of Levodopa in Parkinson's disease. Patients using these medications in combination with Carbidopa-Levodopa should be monitored closely for signs of therapeutic response loss. Selegiline and Carbidopa-Levodopa therapy together may cause severe orthostatic hypotension that is not caused by Carbidopa-Levodopa alone.
Contraindications
Patients with hypersensitivity to Carbidopa and Levodopa, as well as those with narrow-angle glaucoma, should avoid taking the Carbidopa-Levodopa pill. Carbidopa-Levodopa should not be taken in people with suspected unexplained skin lesions or a history of melanoma because Levodopa can trigger a malignant melanoma.
Side Effects
The central neuropharmacologic activity of dopamine causes side effects that are common in people taking Carbidopa-Levodopa. The effects of these events are usually lessened when the dosage is reduced. Dyskinesias, such as choreiform, dystonic, and other involuntary movements, and nausea are the most common side effects.
Syncope, chest discomfort, and anorexia affect the entire body.
Palpitation, orthostatic consequences such as hypotensive episodes, hypertension, and phlebitis.
Vomiting, gastrointestinal bleeding, duodenal ulcer development, diarrhoea, and black saliva are all symptoms of a gastrointestinal problem.
Leukopenia, haemolytic and non-haemolytic anemia, thrombocytopenia, and agranulocytosis are all haemotologic conditions.
Angioedema, urticaria, pruritus, and Henoch-Schonlein purpura are all symptoms of hypersensitivity.
Dizziness, somnolence, paresthesia, delusions, hallucinations, and paranoid ideation, sadness with or without suicidal ideation, dementia, dream abnormalities, agitation, confusion, and heightened libido are all symptoms of the nervous system.
Dyspnea is a respiratory condition.
Alopecia, rash, and black perspiration on the skin.
Urogenital: urine that is dark in color.
Pregnancy & Lactation
Although the effect of carbidopa and levodopa on human pregnancy is unclear, levodopa and the combination of carbidopa and levodopa have caused rabbit visceral and skeletal malformations. Therefore, the use of carbidopa and levodopa in women of childbearing age requires a balance between the expected benefits of the drug and the potential risks of pregnancy. It is not clear whether carbidopa is excreted in human milk. Since many drugs are excreted from human milk, and because of the possibility of serious adverse reactions in nursing infants, it is necessary to decide whether to stop breastfeeding or stop using carbidopa-levodopa, taking into account the importance of the drug. Mother.
Precautions & Warnings
Carbidopa Levodopa is not recommended for the treatment of extrapyramidal reactions caused by drugs. Patients who are already taking levodopa alone can be given carbidopa and levodopa; however, levodopa should be stopped at least 12 hours before starting carbidopa and levodopa. Patients who were previously treated with levodopa alone may experience dyskinesias because carbidopa allows more levodopa to reach the brain, thereby forming more dopamine. The development of dyskinesia may require dose reduction. All patients should be carefully observed for the development of depression accompanied by suicidal tendencies. Patients with mental illness in the past or present should be treated with caution. Carbidopa and levodopa should be used with caution in patients with severe pulmonary or cardiovascular disease, bronchial asthma, kidney, liver, or endocrine disease, or a history of peptic ulcer or seizures.
Patients with atrial, nodular, or ventricular arrhythmia with a history of myocardial infarction should be treated with caution. In these patients, special care should be taken to monitor cardiac function during initial dosing and titration. Patients with chronic wide-angle glaucoma can use carbidopa and levodopa with caution, as long as the intraocular pressure is well controlled and changes in the patient's intraocular pressure are carefully monitored during treatment.
Storage Conditions
Store in a cool and dry place, protected from light.
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