Sindop (Syndopa)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceLevodopa + CarbidopaLevodopa + Carbidopa
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    • Dosage form: & nbspPills.
    Composition:
    One tablet contains:
    active ingredients: levodopa - 250.00 mg, carbidopa - 25.00 mg (in the form of carbidopa monohydrate 26.85 mg);
    Excipients: lactose - 95.00 mg, corn starch - 48.848 mg, microcrystalline cellulose - 50.00 mg, dye crimson [Ponso 4R] - 0.30 mg, povidone-K30 -12.00 mg, butyl hydroxy anisole - 0.01 mg, talcum powder - 10.00 mg, magnesium stearate - .5.00 mg, silicon dioxide colloid - 2.00 mg, sodium carboxymethyl starch (type A) -20.00 mg, corn starch (dried) - 5.00 mg.
    Description:Round flat cylindrical pills of light pink color with inclusions, with a facet and two overlapping risks on one side and engraving "Syndopa" on the other side.
    Pharmacotherapeutic group:An antiparkinsonian agent (dopamine precursor + decarboxylase peripheral inhibitor)
    ATX: & nbsp

    N.04.B.A.02   Levodopa and a decarboxylase inhibitor

    Pharmacodynamics:The structure of levodopa is an amino acid formed from L-tyrosine. Dopamine is formed directly from levodopa with the participation of the cytoplasmic enzyme - decarboxylase, aromatic L-amino acids. The end result of dopamine is the inhibition of neuronal activity in the striatum of the brain. Levodopa rapidly decarboxylated in peripheral tissues under the influence of aromatic amino acids, dependent on pyridoxine decarboxyase, turning into dopamine, which, however, does not penetrate the blood-brain barrier.
    Carbidopa inhibits the decarboxylation process of levodopa in peripheral tissues without penetrating the blood-brain barrier and does not affect the conversion of levodopa to dopamine in the central nervous system. Thus, a combination of carbidopa. and levodopa allows to increase the amount of levodopa entering the brain. When combined ingestion of carbidopa doubles the bioavailability of levodopa. The introduction of carbidopa never leads to complete inhibition of decarboxylase of aromatic L-amino acids.
    Pharmacokinetics:
    Carbidopa
    Suction
    After ingestion of carbidopa in a single dose in patients with Parkinson's disease, the maximum plasma concentration (Tmax) is from 1.5 h to 5 h.
    Metabolism and excretion
    Metabolised in the liver. Among the metabolites excreted in the urine, the main ones are alpha-methyl-3-methoxy-4-hydroxyphenylpropionic acid, as well as alpha-methyl-3.4-dihydroxyphenylpropionic acid, which constitute about 14% and 10% of excreted metabolites, respectively. In smaller amounts, two other metabolites are found. One of them is identified as 3.4-dihydroxyphenyl-acetone, the other is preliminarily as N-methyl-carbidopa. The content of each of these substances is not more than 5% of the total amount of metabolites. In the urine, unchanged carbidopa is also found. Conjugates have not been identified.
    Excretion in the urine of the unchanged drug basically ends within 7 hours and is 35%.
    Levodopa
    Suction
    Levodopa is rapidly absorbed from the gastrointestinal tract and is actively metabolized. Despite the fact that more than 30 different metabolites are formed, basically levodopa is transformed into dopamine, epinephrine, norepinephrine.
    After oral administration of levodopa in a single dose in patients with Parkinson's disease, Tmax is 1.5-2 hours and is maintained at the therapeutic level for 4-6 hours.
    Excretion
    Metabolites are rapidly excreted in the urine - within about 2 hours, about 1/3 of the dose is excreted.
    The half-life (T1 / 2) of levodopa is about 50 minutes. When taking a combination of carbidopa and levodopa T1 / 2 levodopa increases to about 1.5 h
    Effect of carbidopa on the metabolism of levodopa
    Carbidopa increases the concentration of levodopa in the blood plasma. With the previous intake of carbidopa, the concentration of levodopa in the blood plasma is increased approximately 5-fold, and the time of maintenance of the therapeutic concentration in the plasma increases from 4 to 8 hours. With the simultaneous administration of carbidopa and levodopa, similar results were obtained. In patients with Parkinson's disease who had previously taken carbidopa, levodopa was increased from 3 to 15 hours with levodopa in a single dose of T1 / 2 levodopa. The concentration of levodopa increased due to carbidopa at least 3-fold. The concentration of dopamine and homovanilic acid in blood plasma and in urine decreases with the preliminary intake of carbidopa.
    Indications:Disease or Parkinson's syndrome of known etiology (due to encephalitis, cerebrovascular disorders, intoxication with toxic substances, including carbon monoxide or manganese).
    Contraindications:
    Hypersensitivity to any component of the drug, lactase deficiency, lactase intolerance, glucose-galactose malabsorption, angle-closure glaucoma, severe psychosis or neurosis, pregnancy and breastfeeding period, melanoma or suspicion of it, skin diseases of unknown etiology; Huntington's disease, an essential tremor.
    Contraindicated simultaneous use of the drug with non-selective monoamine oxidase (MAO) inhibitors, and if the period after the end of the intake of MAO inhibitors is less than 2 weeks.
    It should not be used for the treatment of secondary parkinsonism caused by the use of antipsychotics (neuroleptics). It is not recommended to appoint patients under 18 years.
    Carefully:The drug is taken with caution in case of erosive and ulcerative lesions of the stomach and / or duodenum, epileptic seizures in the anamnesis, myocardial infarction with heart rhythm disturbances in the anamnesis,cardiac insufficiency, severe lung diseases (including bronchial asthma), endocrine system diseases (including diabetes mellitus), severe psychosis and neurotic disorders, as well as severe violations of the liver and kidneys.
    Dosing and Administration:
    Inside, with a small amount of food or after a meal, washing down with water and not chewing. Since there is competition between aromatic amino acids and levodopa during absorption, during the use of the drug, a large number of proteins should be avoided. The average daily dose of carbidopa, necessary to suppress peripheral conversion of levodopa, is 70-100 mg. Excess of 200 mg of carbidopa does not entail a further increase in the therapeutic effect. The daily dose of levodopa should not exceed 2 g.
    The initial dose - 1/2 tablets 2 times a day, if necessary, you can increase by 1/2 tablets a day or a day to achieve the optimal effect. The therapeutic effect is observed on the first day, and sometimes after the first dose. The full effect of the drug is achieved within 7 days. As a rule, at the beginning of replacement therapy, the daily dose should not exceed 3 tablets per day (1 tablet 3 times a day).The use in this dose is recommended at the beginning of treatment of severe cases of parkinsonism. The daily dose of the drug as an exception can be increased with monotherapy, but should not exceed 8 tablets (1 tablet 8 times a day). Use in quantities of more than 6 tablets per day should be done with great care.
    When switching from levodopa preparations, the administration of the latter should be stopped, at least 12 hours before the start of treatment with Sindopa (in the case of taking prolonged forms - for 24 hours). The daily dose of Sindop should provide about 20% of the previous daily dose of levodopa.
    For patients taking more than 1.5 g of levodopa, the initial dose of Sindopa is 1 tablet 3-4 times a day.

    Side effects:
    From the nervous system: dyskinesia, including choreoathetosis, dystonia, with prolonged use of the "on-off" syndrome, malignant neuroleptic syndrome, dizziness, dystonic involuntary movements, convulsions, sedation, drowsiness, confusion, nightmares, nervous tension, headache, increased excitability, anxiety, insomnia,change in mental status, including paranoid effects and transient psychoses, hallucinations, depression with or without suicidal intent, hypomania, increased libido, dementia.
    From the digestive system: anorexia, nausea, vomiting, constipation, diarrhea, epigastric pain, dry mouth, darkening of saliva, ulcerogenic effect in predisposed patients, gastrointestinal bleeding.
    From the cardiovascular system: Orthostatic hypotension, collapse, arrhythmias, tachycardia, increased blood pressure, phlebitis.
    From the hematopoiesis: leukopenia, anemia (including hemolytic), thrombocytopenia, agranulocytosis.
    From the respiratory system: shortness of breath, upper respiratory tract infection.
    From the urinary system: urinary tract infections, frequent urination, darkening of urine.
    Allergic reactions: angioedema, urticaria, skin itch, skin rash, Shenlaine-Henoch disease.
    Laboratory indicators: changes in the activity of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, lactate dehydrogenase, urea nitrogen concentration,bilirubin, iodine bound to protein, hyperuricemia, hypercreatinemia, positive direct Coombs test.
    Other: fainting, chest pain.

    Other side effects that may occur with taking levodopa, which should be taken into account when using the drug levodopa+ carbidopa:
    From the digestive system: dyspepsia, heartburn, sialorrhea, dysphagia, bruxism, hiccups, pain and discomfort in the abdomen, flatulence, a burning sensation of the tongue.
    From the side of metabolism: edema, increased or decreased body weight.
    From the sense organs: diplopia, blurred vision, impaired taste, oculogic crises.
    From the respiratory system: sore throat, cough.
    From the nervous system: weakness, fainting, fatigue, asthenia, decreased mental activity, disorientation, ataxia, numbness, increased tremor of hands, muscle cramps, trismus, activation of latent Bernard-Horner syndrome, insomnia, anxiety, euphoria, psychomotor agitation, gait unsteadiness, peripheral neuropathy, blepharospasm.
    From the urinary system: urinary retention, urinary incontinence.
    Other: hoarseness of voice, malaise, "hot flashes" of blood to the skin of the face, neck and chest, malignant melanoma, priapism.
    Laboratory indicators: the drug may cause a false positive reaction to ketone bodies in the urine, if test strips are used to determine ketonuria. This reaction will not change after boiling urine samples. False negative results can be obtained by using a glucose oxidase method for determining glucosuria.
    Overdose:
    Symptoms: first increase, and then lowering blood pressure, sinus tachycardia, heart rhythm disturbance, confusion, psychomotor agitation, anorexia, insomnia, anxiety. Orthostatic hypotension may also develop. Symptoms of anorexia and insomnia may persist for several days.
    Treatment: gastric lavage, reception of activated carbon. If necessary, symptomatic treatment, in a hospital. There is no specific antidote. At present, there is no data on the use of dialysis.
    Interaction:
    - Simultaneous use with antihypertensive drugs requires special attention in connection with the danger of postural hypotension.
    - When combined, with tricyclic antidepressants, there may be an increase in blood pressure and dyskinesia, as does the bioavailability of levodopa.
    - Combined, the use of blockers of D2-dopamine receptors and the preparation of Sindop reduces the effect of the latter.
    - The drug Sindopa can not be administered together with nonselective MAO inhibitors, as the hypertensive crisis can develop. Treatment with MAO inhibitors should be discontinued at least 14 days before the appointment of the drug. The exception is selegiline (selective MAO-B inhibitor), which can be used as an adjuvant in the treatment with levodopa.
    - May increase the effect of sympathomimetics, in this connection it is recommended to reduce their dose. With the simultaneous use of levodopa with β-adrenomimetics, the means for inhalation anesthesia may increase the risk of heart rhythm disturbances.
    - When using amantadine with levodopa, a mutually potentiating effect is noted.
    - Methyldopa and levodopa can potentiate side effects of each other.
    - Pyridoxine is a cofactor of dofadecarboxylase, an enzyme responsible for the peripheral decarboxylation of levodopa and the formation of dopamine.When he is prescribed to patients receiving levodopa (without inhibitors of dopadecarboxylase), there is an increase in peripheral metabolism of levodopa and a smaller amount of it penetrates the blood-brain barrier. In this way, pyridoxine reduces the therapeutic effect of levodopa, unless additional inhibitors of peripheral dofadecarboxylase are prescribed.
    - With the additional appointment of dopadecarboxylase inhibitors, the daily dose of levodopa can be reduced by 70-80% while maintaining the same clinical result.
    - Joint use with diazepam, phenytoin, clonidine, thioxanthene derivatives, papaverine, reserpine, m-holinoblokatorami - possible reduction of antiparkinsonian action.
    Special instructions:
    It should not be used in cases of secondary parkinsonism (Parkinson's syndrome) caused by the use of antipsychotics (neuroleptics).
    Discontinue treatment should be gradual, as with a sudden discontinuation of the drug may develop a symptom complex that resembles a malignant neuroleptic syndrome (muscle rigidity, fever, increased activity of creatine phosphokinase (CK) in the blood serum).
    It is necessary to monitor patients who suddenly needed to lower the dose of the drug or interrupt its reception. Absorption of levodopa in elderly patients is higher than in young patients. These data confirm the information about the decrease in the activity of dofadecarboxylase in tissues with age, as well as with the long-term administration of levodopa.
    In patients with erosive and ulcerative lesions of gastric and / or duodenal ulcer, epileptic seizures in history, severe diseases of the cardiovascular system (including myocardial infarction with cardiac arrhythmias in the history of cardiac failure), diseases of the endocrine system (including diabetes mellitus) , severe lung diseases (including asthma), mental disorders, as well as severe liver and renal function should take the drug with caution. In such cases, patients should be closely monitored.
    Epidemiological studies have shown that patients with Parkinson's disease have a higher risk (approximately 2-6 fold higher) of developing melanoma than the general population. It connected whether the observed increased risk of melanoma with Parkinson's disease or other factors, such as taking medicines to treat Parkinson's disease, is unclear.Therefore, patients and doctors, who often and on a regular basis use Cindopa for necessary indications, are recommended to monitor the development of melanoma. Ideally, periodic examinations of the skin should be performed by qualified specialists (for example, dermatologists). With prolonged treatment, periodic monitoring of liver function, kidney function, hematopoiesis and cardiovascular system is necessary, as well as monitoring of the patient's mental status.
    When performing surgical operations, if general anesthesia is required, the drug is prescribed without lowering the dose, if the patient is able to take drugs and liquid inside. When using halothane and cyclopropane, the drug is discontinued at least 8 hours before the operation. Treatment continues after the operation in the same dose.
    Patients with open-angle glaucoma against the background of taking the drug should regularly monitor intraocular pressure.
    Effect on the ability to drive transp. cf. and fur:It is necessary to refrain from managing transport and engaging in other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:
    Tablets 250 mg + 25 mg.
    Packaging:10 tablets per strip of aluminum foil.
    For 5 strips, together with the instructions for use are placed in a cardboard box.
    Storage conditions:
    In a dry, the dark place at a temperature of no higher than 30 ° C.
    Keep out of the reach of children.


    Shelf life:
    4 years.
    Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:П N011440 / 01
    Date of registration:П N011440 / 01
    The owner of the registration certificate:San Pharmaceutical Industries Co., Ltd.San Pharmaceutical Industries Co., Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspSAN PHARMACEUTICAL INDUSTRIES LTD. SAN PHARMACEUTICAL INDUSTRIES LTD. India
    Information update date: & nbsp23.08.2015
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