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Quentiax film-coated pills 200 mg N60,

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Description

The composition of Quetiapine fumarate is 230.26 mg, which corresponds to the content of quetiapine 200 mg. Excipients: lactose monohydrate - 36 mg, calcium hydrogen phosphate dihydrate - 20 mg, microcrystalline cellulose - 151.74 mg, povidone - 10 mg, sodium carboxymethyl starch (type A) - 40 mg, magnesium stearate - 12 mg. The composition of the shell: hypromellose - 10 mg, titanium dioxide (E171) - 4 mg, macrogol 4000 - 2 mg. Pharmacological action Antipsychotic drug (neuroleptic). Quetiapine is an atypical antipsychotic drug that exhibits a higher affinity for serotonin 5HT 2 receptors than for dopamine D 1 and D 2 brain receptors. Quetiapine has an affinity for histamine and. 1 -adrenoretseptory, and lower affinity in relation to. 2 -adrenoreceptors. No significant affinity of quetiapine for cholinergic muscarinic and benzodiazepine receptors was detected. In standard tests, quetiapine exhibits antipsychotic activity. The results of studying extrapyramidal symptoms in animals revealed that quetiapine causes weak catalepsy at a dose that effectively blocks dopamine D 2 receptors. Quetiapine causes a selective decrease in the activity of mesolimbic A10-dopaminergic neurons, in comparison with A9-nigrostriatal neurons involved in motor functions. There were no differences between the use of quetiapine (at a dose of 75-750 mg / day) and placebo in the incidence of cases of extrapyramidal syndromes and the concomitant use of anticholinergic drugs. Does not cause a prolonged increase in the concentration of prolactin in the blood plasma. Quetiapine for a long time supports clinical improvement in those patients in whom a positive effect developed at the very beginning of treatment. The duration of effects of quetiapine on serotonin 5HT 2 receptors and dopamine and D 2 receptors is less than 12 hours after taking the drug.

Dosage and administration

: The drug is administered orally, 2 times / day, regardless of the meal. In the treatment of acute and chronic psychosis, including schizophrenia, the daily dose for the first 4 days is: Day 1 - 50 mg. 2nd day - 200 mg. 3rd day - 200 mg and 4th day - 300 mg. Starting from the 4th day, the daily dose is 300 mg. Depending on the clinical effect and tolerability of the drug, its dose may individually vary from 150 mg / day to 750 mg / day.The maximum daily dose for the treatment of schizophrenia is 750 mg. When treating manic episodes with bipolar disorder, quetiapine is recommended as monotherapy or as adjuvant therapy to stabilize mood. The daily dose in the first 4 days is: 1st day - 100 mg. 2nd day - 200 mg. 3rd day - 300 mg and 4th day - 400 mg. An increase in the daily dose in the future is possible at 200 mg / day and by day 6 of therapy is 800 mg. Depending on the clinical effect and tolerability of the drug, its dose may individually vary from 200 mg / day to 800 mg / day. As a rule, the effective dose ranges from 400 mg to 800 mg / day. The maximum daily dose is 800 mg. Since plasma clearance of quetiapine in elderly patients is reduced by 30-50%, the drug should be prescribed with caution, especially at the beginning of therapy. The starting dose is 25 mg / day, followed by an increase of 25-50 mg to achieve an effective dose. In patients with renal and hepatic insufficiency, it is recommended to begin therapy with 25 mg / day. In the future, it is recommended to increase the dose daily by 25-50 mg to achieve an effective dose. 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 Classification of the incidence of side effects (WHO): very often (> 1/10), often (> 1/100, less than 1/10), infrequently (> 1/1000, less than 1/100), rarely (> 1 / 10 000, less than 1/1000), very rarely (less than 1/10 000, including individual messages). From the hematopoietic system: often - leukopenia. infrequently - eosinophilia. very rarely - neutropenia. From the central and peripheral nervous system: very often - dizziness, drowsiness,headache . often - syncopal states. infrequently - anxiety, agitation, insomnia, akathisia, tremor, convulsions, depression, paresthesias. rarely - neuroleptic malignant syndrome (hyperthermia, impaired consciousness, muscle rigidity, vegetative-vascular disorders, increased concentration of CPK). very rarely - tardive dyskinesia. Since the cardiovascular system: often - tachycardia, orthostatic hypotension, prolongation of the QT interval on the ECG. On the part of the respiratory system: rhinitis, pharyngitis. On the part of the digestive system: often - dry mouth, constipation, diarrhea, dyspepsia, increased levels of serum transaminases (ACT or ALT). rarely - jaundice, nausea, vomiting, abdominal pain. very rarely - hepatitis. Allergic reactions: rarely - skin rash, hypersensitivity reactions. very rarely - angioedema, Stevens-Johnson syndrome. On the part of the reproductive system: rarely - priapism. On the part of the endocrine system: often - an increase in body weight (mainly in the first weeks of treatment). very rarely - hyperglycemia or decompensation of diabetes. Laboratory indicators: infrequently - increase in the serum level of GGT and the content of triglycerides (not fasting), hypercholesterolemia. decrease in the level of thyroid hormones (total T4 and free T4 / in the first 4 weeks /, as well as total T3 and reverse T3 / only when taking high doses of quetiapine /). Other: often - peripheral edema, asthenia. rarely - back pain, chest pain, low-grade fever, myalgia, dry skin, impaired vision. Specific guidance The use of pregnancy and breastfeeding Safety and efficacy of quetiapine in pregnant women have not been established. Therefore, during pregnancy, quetiapine can only be used if the expected benefit justifies the potential risk. The degree of elimination of quetiapine with mother's milk has not been established. Women should be advised to avoid breastfeeding while taking quetiapine. Type: Medicine Quantity in the package, pcs: 60 Shelf life: 24 months Active ingredient: Quetiapine (Quetiapine) Route of administration: Oral Vacation procedure: Prescription Release form: Prescription Storage conditions: In a dry place, In a dark place, Keep out of reach of children Maximum storage temperature, ° C: 30 Pharmacological group: N05AH Derivatives of diazepine, thiazepine and oxazepine Minimum age: 18 years

Active ingredients

Quetiapine

Release form

Pills

Composition

Quetiapine fumarate 230.26 mg, which corresponds to the content of quetiapine 200 mg. Excipients: lactose monohydrate - 36 mg, calcium hydrogen phosphate dihydrate - 20 mg, microcrystalline cellulose - 151.74 mg, povidone - 10 mg, sodium carboxymethyl starch (type A) - 40 mg, magnesium, magnesium stearate - 10 mg, sodium carboxymethyl starch (type A) - 40 mg, magnesium, magnesium stearate - 10 mg, sodium carboxymethyl starch (type A) - 40 mg, magnesium - 12 mg. The composition of the shell: hypromellose - 10 mg, titanium dioxide (E171) - 4 mg, macrogol 4000 - 2 mg.

Pharmacological effect

Antipsychotic drug (neuroleptic). Quetiapine is an atypical antipsychotic drug that exhibits a higher affinity for serotonin 5HT 2 receptors than for dopamine D 1 and D 2 brain receptors. Quetiapine has an affinity for histamine and & # 945. 1 -adrenoreceptors, and less affinity for & # 945. 2 -adrenoreceptors. No significant affinity of quetiapine for cholinergic muscarinic and benzodiazepine receptors was detected. In standard tests, quetiapine exhibits antipsychotic activity. The results of studying extrapyramidal symptoms in animals revealed that quetiapine causes weak catalepsy at a dose that effectively blocks dopamine D 2 receptors. Quetiapine causes a selective decrease in the activity of mesolimbic A10-dopaminergic neurons, in comparison with A9-nigrostriatal neurons involved in motor functions. There were no differences between the use of quetiapine (at a dose of 75-750 mg / day) and placebo in the incidence of cases of extrapyramidal syndromes and the concomitant use of anticholinergic drugs. Does not cause a prolonged increase in the concentration of prolactin in the blood plasma. Quetiapine for a long time supports clinical improvement in those patients in whom a positive effect developed at the very beginning of treatment. The duration of effects of quetiapine on serotonin 5HT 2 receptors and dopamine and D 2 receptors is less than 12 hours after taking the drug.

Indications

Contraindications

Use during pregnancy and lactation

The drug is administered orally, 2 times / day, regardless of the meal. In the treatment of acute and chronic psychosis, including schizophrenia, the daily dose for the first 4 days is: Day 1 - 50 mg. 2nd day - 200 mg. 3rd day - 200 mg and 4th day - 300 mg. Starting from the 4th day, the daily dose is 300 mg. Depending on the clinical effect and tolerability of the drug, its dose may individually vary from 150 mg / day to 750 mg / day. The maximum daily dose for the treatment of schizophrenia is 750 mg. When treating manic episodes with bipolar disorder, quetiapine is recommended as monotherapy or as adjuvant therapy to stabilize mood. The daily dose in the first 4 days is: 1st day - 100 mg. 2nd day - 200 mg. 3rd day - 300 mg and 4th day - 400 mg. An increase in the daily dose in the future is possible at 200 mg / day and by day 6 of therapy is 800 mg. Depending on the clinical effect and tolerability of the drug, its dose may individually vary from 200 mg / day to 800 mg / day. As a rule, the effective dose ranges from 400 mg to 800 mg / day. The maximum daily dose is 800 mg. Since plasma clearance of quetiapine in elderly patients is reduced by 30-50%, the drug should be prescribed with caution, especially at the beginning of therapy. The starting dose is 25 mg / day, followed by an increase of 25-50 mg to achieve an effective dose. In patients with renal and hepatic insufficiency, it is recommended to begin therapy with 25 mg / day. In the future, it is recommended to increase the dose daily by 25-50 mg to achieve an effective dose.

Side effects

Classification of the incidence of side effects (WHO): very often (> 1/10), often (> 1/100, less than 1/10), infrequently (> 1/1000, less than 1/100), rarely (> 1/10 000, less than 1/1000), very rarely (less than 1/10 000, including individual messages). From the hematopoietic system: often - leukopenia. infrequently - eosinophilia. very rarely - neutropenia. From the central and peripheral nervous system: very often - dizziness, drowsiness, headache. often - syncopal states. infrequently - anxiety, agitation, insomnia, akathisia, tremor, convulsions, depression, paresthesias. rarely - neuroleptic malignant syndrome (hyperthermia, impaired consciousness, muscle rigidity, vegetative-vascular disorders, increased concentration of CPK). very rarely - tardive dyskinesia. Since the cardiovascular system: often - tachycardia, orthostatic hypotension, prolongation of the QT interval on the ECG. On the part of the respiratory system: rhinitis, pharyngitis. On the part of the digestive system: often - dry mouth, constipation, diarrhea, dyspepsia, increased levels of serum transaminases (ACT or ALT). rarely - jaundice, nausea, vomiting, abdominal pain. very rarely - hepatitis. Allergic reactions: rarely - skin rash, hypersensitivity reactions. very rarely - angioedema, Stevens-Johnson syndrome. On the part of the reproductive system: rarely - priapism. On the part of the endocrine system: often - an increase in body weight (mainly in the first weeks of treatment). very rarely - hyperglycemia or decompensation of diabetes. Laboratory indicators: infrequently - increase in the serum level of GGT and the content of triglycerides (not fasting), hypercholesterolemia. decrease in the level of thyroid hormones (total T4 and free T4 / in the first 4 weeks /, as well as total T3 and reverse T3 / only when taking high doses of quetiapine /). Other: often - peripheral edema, asthenia. rarely - back pain, chest pain, low-grade fever, myalgia, dry skin, impaired vision.

special instructions

Classification of the incidence of side effects (WHO): very often (> 1/10), often (> 1/100, less than 1/10), infrequently (> 1/1000, less than 1/100), rarely (> 1/10 000, less than 1/1000), very rarely (less than 1/10 000, including individual messages). From the hematopoietic system: often - leukopenia. infrequently - eosinophilia. very rarely - neutropenia.From the central and peripheral nervous system: very often - dizziness, drowsiness, headache. often - syncopal states. infrequently - anxiety, agitation, insomnia, akathisia, tremor, convulsions, depression, paresthesias. rarely - neuroleptic malignant syndrome (hyperthermia, impaired consciousness, muscle rigidity, vegetative-vascular disorders, increased concentration of CPK). very rarely - tardive dyskinesia. Since the cardiovascular system: often - tachycardia, orthostatic hypotension, prolongation of the QT interval on the ECG. On the part of the respiratory system: rhinitis, pharyngitis. On the part of the digestive system: often - dry mouth, constipation, diarrhea, dyspepsia, increased levels of serum transaminases (ACT or ALT). rarely - jaundice, nausea, vomiting, abdominal pain. very rarely - hepatitis. Allergic reactions: rarely - skin rash, hypersensitivity reactions. very rarely - angioedema, Stevens-Johnson syndrome. On the part of the reproductive system: rarely - priapism. On the part of the endocrine system: often - an increase in body weight (mainly in the first weeks of treatment). very rarely - hyperglycemia or decompensation of diabetes. Laboratory indicators: infrequently - increase in the serum level of GGT and the content of triglycerides (not fasting), hypercholesterolemia. decrease in the level of thyroid hormones (total T4 and free T4 / in the first 4 weeks /, as well as total T3 and reverse T3 / only when taking high doses of quetiapine /). Other: often - peripheral edema, asthenia. rarely - back pain, chest pain, low-grade fever, myalgia, dry skin, impaired vision.

Prescription

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