Sindopa, tablets 250 mg+25 mg 50 pcs

Antiparkinsonian combined agent is a combination of carbidopa (aromatic amino acid decarboxylase inhibitor) and levodopa (dopamine precursor). It eliminates hypokinesia, rigidity, tremor, dysphagia, salivation. Antiparkinsonian action of levodopa is caused by its conversion into dopamine directly in CNS, which leads to replenishment of dopamine deficiency in CNS.

Dopamine formed in peripheral tissues does not participate in realization of the antiparkinsonian effect of levodopa (it does not penetrate into CNS) and is responsible for the majority of levodopa side effects. Carbidopa is a peripheral dopa-decarboxylase inhibitor and reduces dopamine formation in peripheral tissues, which indirectly leads to increased amount of levodopa entering CNS. The optimal combination of levodopa and carbidopa is 4:1 or 10:1.

The action of the drug is seen within the first day of administration, sometimes after the first dose. The full effect is achieved within 7 days.

Indications

Parkinson’s disease and parkinsonism syndrome of known etiology (due to encephalitis, cerebrovascular disorders, intoxication with toxic substances, including carbon monoxide or manganese).

Pharmacological effect

Antiparkinsonian combination drug – a combination of carbidopa (an inhibitor of aromatic amino acid decarboxylase) and levodopa (a dopamine precursor). Eliminates hypokinesia, rigidity, tremor, dysphagia, salivation. The antiparkinsonian effect of levodopa is due to its conversion to dopamine directly in the central nervous system, which leads to replenishment of dopamine deficiency in the central nervous system.

Dopamine formed in peripheral tissues is not involved in the antiparkinsonian effect of levodopa (does not penetrate the central nervous system) and is responsible for most of the side effects of levodopa. Carbidopa, an inhibitor of peripheral dopa decarboxylase, reduces the formation of dopamine in peripheral tissues, which indirectly leads to an increase in the amount of levodopa entering the central nervous system. The optimal combination of levodopa and carbidopa is 4:1 or 10:1.

The effect of the drug manifests itself during the first day from the start of administration, sometimes after taking the first dose. The full effect is achieved within 7 days.

Special instructions

Should not be used in cases of secondary parkinsonism (Parkinson’s syndrome) caused by the use of antipsychotics (neuroleptics).

Treatment should be discontinued gradually, since sudden discontinuation of the drug may result in the development of a symptom complex reminiscent of neuroleptic malignant syndrome (muscle rigidity, increased body temperature, increased CPK levels in the blood serum). Monitoring of patients who need to suddenly reduce the dose of the drug or interrupt its use is necessary. The absorption of levodopa in elderly patients is higher than in young ones. These data confirm the information about a decrease in dopadecarboxylase activity in tissues with age, as well as with long-term administration of levodopa.

In case of erosive and ulcerative lesions of the stomach and/or duodenum, a history of epileptic seizures, a history of myocardial infarction with rhythm disturbances, heart failure, diabetes mellitus, bronchial asthma, diseases of the endocrine system, mental disorders, as well as severe impairment of liver or kidney function, the drug should be taken with caution. In such cases, patients should be closely monitored.

With long-term treatment, it is necessary to periodically monitor the function of the liver, kidneys, hematopoiesis and cardiovascular systems, and monitoring the patient’s mental status is also necessary.

For general anesthesia during surgical operations, Sindopa is prescribed without reducing the dose if the patient is able to take drugs and liquids orally. When using halothane and cyclopropane, the drug is discontinued at least 8 hours before surgery. Treatment is continued after surgery at the same dose.

Patients with glaucoma while taking the drug should regularly monitor intraocular pressure.

Impact on the ability to drive vehicles and operate machinery

It is necessary to refrain from driving, as well as activities that require rapid psychomotor reactions.

Active ingredient

Levodopa, Carbidopa

Composition

1 tablet contains:

levodopa – 250 mg;

carbidopa – 25 mg

Excipients:

corn starch,

microcrystalline cellulose,

lactose,

dye Ponceau 4R lake,

povidone K30,

butylhydroxyanisole,

purified talc,

magnesium stearate,

silicon dioxide colloidal anhydrous,

sodium starch glycolate,

dried corn starch.

Pregnancy

Contraindicated during pregnancy and lactation.

Contraindications

hypersensitivity;
angle-closure glaucoma;
melanoma and suspicion of it and skin diseases of unknown etiology;
simultaneous use of non-selective MAO inhibitors;
age up to 18 years.

With caution: myocardial infarction with rhythm disturbances (history), chronic heart failure and severe diseases of the cardiovascular system, severe lung diseases (including bronchial asthma); epilepsy and convulsive seizures (history), erosive and ulcerative lesions of the gastrointestinal tract (risk of bleeding from the upper gastrointestinal tract), diabetes mellitus and decompensated endocrine diseases, severe liver and/or kidney failure, open-angle glaucoma, pregnancy, lactation.

Side Effects

From the nervous system: dyskinesia, including choreoathetosis, focal dystonia, with prolonged use, “on-off” syndrome, dizziness, ataxia, convulsions, anorexia, sedation, drowsiness, nightmares, nervous tension, increased excitability, anxiety, insomnia, psychotic reactions, hallucinations, depression, paranoid states, hypomania, increased libido, euphoria, dementia.

Gastrointestinal tract: nausea, vomiting, constipation, epigastric pain, dysphagia, ulcerogenic effect in predisposed patients.

From the cardiovascular system: orthostatic hypotension, collapse, cardiac arrhythmias, tachycardia.

From the hematopoietic system: moderate leukopenia, thrombocytopenia, hemolytic anemia.

Laboratory indicators: changes in the level of glutamate oxalate transaminase, glutamate pyruvate oxalase, alkaline phosphatase, lactate dehydrogenase, urea nitrogen, bilirubin, protein-bound iodine, positive direct Coombs test.

Other: blepharospasm, mydriasis, diplopia, slight increase in body weight with long-term use.

Side effects usually depend on the dose taken, as well as on the individual sensitivity of the patient. Side effects can be eliminated by temporarily reducing the dose without interruption in treatment. If side effects do not regress, then treatment is stopped gradually.

Interaction

With simultaneous use of levodopa with beta-agonists, ditilin and drugs for inhalation anesthesia, the risk of developing heart rhythm disturbances may increase; with tricyclic antidepressants – decreased bioavailability of levodopa; with diazepam, clozepine, phenytoin, clonidine, m-cholinergic blockers, antipsychotic drugs (neuroleptics) – derivatives of butyrophenone, diphenylbutylpiperidine, thioxanthene, phenothiazine, as well as with pyridoxine, papaverine, reserpine, a decrease in the antiparkinsonian effect is possible; with Li+ drugs the risk of developing dyskinesias and hallucinations increases; with methyldopa – worsening side effects.

When levodopa is used simultaneously with MAO inhibitors (except for MAO-B inhibitors), circulatory disorders are possible (taking MAO inhibitors should be discontinued 2 weeks before). This is due to the accumulation of dopamine and norepinephrine under the influence of levodopa, the inactivation of which is inhibited by MAO inhibitors, and a high likelihood of developing agitation, increased blood pressure, tachycardia, facial flushing and dizziness.

In patients receiving levodopa, the risk of a pronounced decrease in blood pressure increases when using tubocurarine.

Overdose

Symptoms: first an increase and then a decrease in blood pressure, sinus tachycardia, confusion, agitation, insomnia, anxiety. Orthostatic hypotension may also develop. Symptoms of anorexia and insomnia may persist for several days.

Treatment: gastric lavage, taking activated carbon. If necessary, provide symptomatic treatment in a hospital setting. There is no specific antidote.

Manufacturer

Sun Pharmaceutical Industries Ltd, India