Steel pills pills.ob.100mg + 25mg + 200mg N30

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Description

Composition of Levodopa 100 mg carbidopa (in the form of monohydrate) 25 mg entacapone 200 mg Excipients: corn starch - 85 mg, mannitol - 86.1 mg, croscarmellose sodium - 23.7 mg, povidone - 39.7 mg, magnesium stearate - 8.5 mg. The composition of the shell: hypromellose - 10.82 mg, sucrose - 1.55 mg, titanium dioxide - 2.16 mg, iron yellow oxide - 0.15 mg, iron red oxide - 0.46 mg, magnesium stearate - 0.77 mg, polysorbate 80 - 0.31 mg, glycerol 85% - 77 mg. Pharmacological action Stalevo is a combined anti-Parkinsonian drug, which is a combination of levodopa, a metabolic precursor of dopamine, carbidopa, an aromatic amino acid decarboxylase inhibitor, and entacapone, a catechol O-methyltransferase inhibitor (COMT). Levodopa increases the content of dopamine in the brain. Dopamine is formed directly from levodopa with the participation of aromatic amino acid decarboxylase. The anti-parkinsonian effect of levodopa is due to its transformation into dopamine directly in the central nervous system. Levodopa is rapidly decarboxylated in peripheral tissues, turning into dopamine, which, however, does not penetrate through the BBB. Carbidopa inhibits the process of decarboxylation of levodopa and the formation of dopamine in peripheral tissues, which indirectly leads to an increase in the amount of levodopa entering the central nervous system. As a result of inhibition of dopa-decarboxylase, levodopa biotransformed with the participation of catechol-O-methyltransferase (COMT) into the potentially dangerous metabolite 3-O-methyldopa (3-OMD). Entacapone is a reversible, specific inhibitor of COMT, mainly of peripheral action. Entacapone slows down the clearance of levodopa from the bloodstream, which leads to an increase in the bioavailability of levodopa, prolonging its therapeutic effect.

Dosage and administration

The drug is taken orally, regardless of the meal, without dividing the tablet into parts. The optimal daily dose is determined by careful individual selection. It is recommended to use one of the three existing types of dosage of the drug (50 / 12.5 / 200 mg, 100/25/200 mg or 150 / 37.5 / 200 mg levodopa / carbidopa / entacapone). As a single dose, only 1 tablet of any dosage should be taken. The maximum daily dose is 1.5 g of levodopa, 2 g of entacapone, 375 mg of carbidopa (corresponds to 10 pills of Stalevo 150 / 37.5 / 200 mg).If necessary, the introduction of more levodopa reduce the interval between doses of the drug and / or transfer the patient to treatment with Stalevo at a higher dosage (always within the recommended dose). If a smaller amount of levodopa is required, then increase the intervals between taking the drug and / or transfer the patient to Stalevo treatment at a lower dosage. If other drugs containing levodopa are used simultaneously with Stalevo, then the recommendations for the total daily dose of the drug should be carefully followed. Precautions During the period of treatment may worsen psoriasis. With pheochromocytoma, propranolol can be used only after taking an alpha blocker. After a long course of treatment, propranolol should be discontinued gradually, under the supervision of a physician. Against the background of treatment with propranolol, IV administration of verapamil, diltiazem should be avoided. A few days before anesthesia, you must stop taking propranolol or pick up a remedy for anesthesia with minimal negative inotropic effects. Influence on the ability to drive vehicles and control mechanisms In patients whose activities require increased attention, the question of the use of propranolol on an outpatient basis should be addressed only after evaluating the individual response of the patient. Side Effects Specific instructions Stalevo is not intended to eliminate extrapyramidal reactions caused by medication. Before planned general anesthesia, the drug can be taken as long as the patient is allowed oral administration. In the case of long-term therapy, Stalevo requires periodic monitoring of the functions of the liver, the system of hemopoiesis, kidneys, and the cardiovascular system. Control of the function of the cardiovascular system is required during the entire period of the initial dose adjustment of the drug. The use of the drug in open-angle glaucoma is possible only with careful control of intraocular pressure. When replacing Stalevo with levodopa + carbidopa therapy (without entacapone), an increase in the dose of levodopa will be required. Cancellation Stalevo spend slowly, if necessary, increasing the dose of levodopa. Therapy with Stalevo does not preclude the use of other anti-Parkinsonian drugs. The daily dose of seleginin, while taking it with the drug Stalevo, should not exceed 10 mg.Impact on the ability to drive vehicles and control mechanisms: entacapone in combination with levodopa causes drowsiness and episodic instant sleep. It is necessary to refuse to drive a car and work with machines and mechanisms during the period of taking the drug Stalevo. Use during pregnancy and lactation The drug is contraindicated for use during pregnancy (except in cases where the potential positive effect from taking the drug outweighs the possible risk for the development of the fetus) and during lactation. Type: Drug Quantity per pack, pcs: 30 Shelf life: 36 months Active ingredient: Carbidopa (CARBIDOPA), Levodopa, Entacapone (Entacapone) Method of administration: Oral Vacation schedule: Prescription: Release form: Prescription Storage conditions: In a dry place, In a place protected from the sun, Keep out of the reach of children Maximum storage temperature, ° С: 25 Pharmacological group: N04BA03 Levodopa, decarboxylase inhibitor and catechol-o-methyltransferase inhibitor Minimum age: 18 years

Active ingredients

Levodopa + Entakapon + [Carbidopa]

Release form

Pills

Composition

Levodopa 100 mg carbidopa (in the form of monohydrate) 25 mg entacapone 200 mg Excipients: corn starch - 85 mg, mannitol - 86.1 mg, croscarmellose sodium - 23.7 mg, povidone - 39.7 mg, magnesium stearate - 8.5 mg. The composition of the shell: hypromellose - 10.82 mg, sucrose - 1.55 mg, titanium dioxide - 2.16 mg, iron yellow oxide - 0.15 mg, iron red oxide - 0.46 mg, magnesium stearate - 0.77 mg, polysorbate 80 - 0.31 mg, glycerol 85% - 77 mg.

Pharmacological effect

Steel - combined anti-parkinsonian drug, which is a combination of levodopa - metabolic precursor of dopamine, carbidopa - an aromatic amino acid decarboxylase inhibitor and entacapone - catechol-O-methyltransferase inhibitor (COMT). Levodopa increases the content of dopamine in the brain. Dopamine is formed directly from levodopa with the participation of aromatic amino acid decarboxylase. The anti-parkinsonian effect of levodopa is due to its transformation into dopamine directly in the central nervous system. Levodopa is rapidly decarboxylated in peripheral tissues, turning into dopamine, which, however, does not penetrate through the BBB. Carbidopa inhibits the process of decarboxylation of levodopa and the formation of dopamine in peripheral tissues, which indirectly leads to an increase in the amount of levodopa entering the central nervous system.As a result of inhibition of dopa-decarboxylase, levodopa biotransformed with the participation of catechol-O-methyltransferase (COMT) into the potentially dangerous metabolite 3-O-methyldopa (3-OMD). Entacapone is a reversible, specific inhibitor of COMT, mainly of peripheral action. Entacapone slows down the clearance of levodopa from the bloodstream, which leads to an increase in the bioavailability of levodopa, prolonging its therapeutic effect.

Indications

Parkinson's disease and parkinsonism (with the exception of drug) in cases where the use of a combination of levodopa + carbidopa is ineffective.

Contraindications

- Severe abnormal liver function. - angle-closure glaucoma. - Pheochromocytoma. - Combined use with non-selective MAO inhibitors of types A and B (for example, phenelzine, tranylcypromine). - Combined use with selective MAO inhibitors of types A and B. - Neuroleptic malignant syndrome and / or atraumatic acute rhabdomyolysis (including in history). - Children's and teenage age up to 18 years. - Pregnancy. - Lactation period (breastfeeding). - Hypersensitivity to the drug. With caution should use the drug for: - Severe cardiovascular and pulmonary insufficiency. - Bronchial asthma. - Liver disease. - Kidney disease. - Diabetes and other decompensated endocrine diseases. - Erosive and ulcerative lesions of the digestive tract. - Convulsions (in history). - With a myocardial infarction in history (with persistent cardiac arrhythmias). - Psychosis in history and / or during treatment. - Depression with suicidal tendencies. - Asocial behavior. - Open-angle glaucoma. Caution should be exercised in the simultaneous use of Stalevo with: - Drugs that can cause orthostatic hypotension. - With neuroleptics that block dopamine (especially dopamine D2 receptor antagonists). - With tricyclic antidepressants, desipramine, maprolitine, venlafaxine. - With warfarin and COMT metabolizable drugs (paroxetine).

Use during pregnancy and lactation

The drug is contraindicated for use in pregnancy (except in cases where the potential positive effect from taking the drug outweighs the possible risk to the development of the fetus) and during lactation.

Dosage and administration

The drug is taken orally, regardless of the meal, without dividing the tablet into parts. The optimal daily dose is determined by careful individual selection. It is recommended to use one of the three existing types of dosage of the drug (50 / 12.5 / 200 mg, 100/25/200 mg or 150 / 37.5 / 200 mg levodopa / carbidopa / entacapone). As a single dose, only 1 tablet of any dosage should be taken. The maximum daily dose is 1.5 g of levodopa, 2 g of entacapone, 375 mg of carbidopa (corresponds to 10 pills of Stalevo 150 / 37.5 / 200 mg). If necessary, the introduction of more levodopa reduce the interval between doses of the drug and / or transfer the patient to treatment with Stalevo at a higher dosage (always within the recommended dose). If a smaller amount of levodopa is required, then increase the intervals between taking the drug and / or transfer the patient to Stalevo treatment at a lower dosage. If other drugs containing levodopa are used simultaneously with Stalevo, then the recommendations for the total daily dose of the drug should be carefully followed.

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