Syndopa CR 125mg 10pcs

Indications

Idiopathic Parkinson's disease, to reduce off-period in patients who have previously been treated with levodopa/decarboxylase inhibitors or just levodopa and have exhibited motor fluctuations.

Pharmacology

According to current data, symptoms of Parkinson's disease are linked to dopamine depletion in the corpus striatum. Dopamine's metabolic precursor, levodopa, crosses the blood-brain barrier and is likely converted to dopamine in the brain. Carbidopa prevents peripheral levodopa from being decarboxylated.
Because carbidopa's decarboxylase inhibitory effect is limited to extracerebral tissues, combining it with levodopa increases the amount of levodopa accessible for delivery to the brain.

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 the 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 if abrupt reduction or discontinuation of this CR tablet is required, especially if the patient is receiving antipsychotics.

Interaction

Levodopa's effects are reversed by pyridoxine.
MAOIs of type B have a synergistic impact.
Phenothiazines, haloperidol, reserpine, pyridoxine, diazepam, oxazepam, chlordiazepoxide, and phenobarbitone all lessen the effect. Carbidopa, amantadine, anticholinergics, and amphetamine improve the effects of levodopa. Sympathomimetic drugs' effects were amplified.

Contraindications

When the following medications are used at the same time as the Levodopa-Carbidopa prolonged-release tablet, extreme caution should be used. Hypertension medicines: When levodopa/decarboxylase inhibitor combos were introduced to the treatment of individuals taking antihypertensive drugs, symptomatic postural hypotension occurred. As a result, dosage adjustments of the antihypertensive medication may be required when therapy with Levodopa-Carbidopa prolonged-release tablet is initiated.

Antidepressants: There have been a few reports of adverse responses from taking tricyclic antidepressants and carbidopa-levodopa formulations at the same time, including hypertension and dyskinesia.

Anticholinergics: Anticholinergics have the potential to influence absorption and, as a result, the patient's response.

When carbidopa and/or levodopa are combined with ferrous sulfate or ferrous gluconate, studies show that their bioavailability is reduced.

Contraindications

When a sympathomimetic amine is contraindicated, a levodopa-carbidopa prolonged-release tablet should not be used. The use of non-selective monoamine oxidase (MAO) inhibitors with Levodopa-Carbidopa prolonged release tablet is not recommended. These inhibitors must be stopped for at least two weeks before starting Levodopa-Carbidopa prolonged release tablet therapy. The manufacturer's suggested dose of an MAO inhibitor with selectivity for MAO type B can be given concurrently with the Levodopa-Carbidopa prolonged release tablet (e.g. selegiline hydrochloride).Patients with known hypersensitivity to either component of this drug, as well as those with narrow-angle glaucoma, should not take levodopa-carbidopa prolonged release tablet. Levodopa-Carbidopa prolonged release tablet should not be used in people with worrisome undiagnosed skin lesions or a history of melanoma because levodopa can trigger a malignant melanoma.

Side Effects

Dyskinesia was the most commonly reported side effect (a form of abnormal involuntary movements). Dyskinesias were more common with the Levodopa-Carbidopa prolonged-release tablet than with the Levodopa-Carbidopa tablet. Other side effects include: nausea, hallucinations, confusion, dizziness, chorea, dry mouth, dream abnormalities, dystonia, insomnia, depression, asthenia, vomiting, anorexia, chest pain, palpitation, constipation, diarrhea, dyspepsia, gastro-intestinal pain, dark saliva, angioedema, urticaria, pruritus, weight loss, neuroleptic malignant syndrome, agitation, anxiety, decreased mental acuity, paraesthesia, disorientation, fatigue, headache, extrapyramidal and movement disorders, falling, gait abnormalities, muscle cramps, on-off phenomenon, increased libido, psychotic episodes, dyspnoea, flushing, alopecia, rash, dark sweat, blurred vision, dark urine, cardiac irregularities, hypertension, phlebitis, bitter taste, sialorrhoea, dysphagia, bruxism, hiccups, gastrointestinal bleeding, flatulence, burning sensation of the tongue, development of a duodenal ulcer, leucopenia, hemolytic and non-hemolytic anemia, thrombocytopenia, agranulocytosis.

Pregnancy & Lactation

There are inadequate data to assess the substance's potential for damage when taken in human pregnancy. Carbidopa is not known to be excreted in human milk. The excretion of levodopa in breast milk was described in a study of one nursing woman with Parkinson's disease. The prolonged-release tablet of levodopa-carbidopa should not be given to pregnant or nursing women.

Precautions & Warnings

Dyskinesias have been linked to levodopa alone and in combination. If dyskinesias occur, the dosage may need to be reduced. Patients with severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic, or endocrine problems should use it with caution.

Storage Conditions

Store in a cold, dry, and light-protected location.