Brintellix pills 10 mg 28 pcs
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Active ingredients
Vortioxetine
Release form
Pills
Composition
Vortioxetine hydrobromide 12.71 mg, which corresponds to the content of vortioxetine 10 mg. Excipients: mannitol - 104.29 mg, microcrystalline cellulose - 22.5 mg, hyprolosis - 4.5 mg, carboxymethyl starch sodium (type A) - 4.5 mg, magnesium stearate - 1.5 mg. The composition of the film shell: Opadry yellow - 4.5 mg (hypromellose - 2.813 mg, titanium dioxide (E171) - 1.35 mg, macrogol 400 - 0.281 mg, iron oxide yellow (E172) - 0.056 mg).
Indications
Major depressive episodes in adults (treatment).
Contraindications
Hypersensitivity to the active substance or any component of the drug. Simultaneous use with non-selective monoamine oxidase inhibitors (IMAO) or selective IMAO a (see "interaction"). Children and adolescents under 18 years of age (safety and efficacy not established). With care: severe renal and hepatic failure. Mania and hypomania. Pharmacologically uncontrolled epilepsy, seizures in history. Severe suicidal behavior. Cirrhosis of the liver. Tendency to bleed. Simultaneous treatment with MAO inhibitors in (selegiline, rasagiline), serotonergic drugs, drugs to lower the seizure threshold, lithium, tryptophan, pharmaceutical preparations containing St. John's wort, oral anticoagulants and drugs affecting platelet function drugs that can cause hyponatremia , electroconvulsive therapy, advanced age.
Dosage and administration
Inside, regardless of the meal. Dosing regimen. The initial and recommended dose of Brintellix in adult patients younger than 65 years is 10 mg once daily. Depending on the patient's individual response, the daily dose of vortioxetine can be increased to a maximum dose of 20 mg 1 time per day or reduced to a minimum dose of 5 mg 1 time per day. After the full resolution of the symptoms of depression, it is recommended to continue treatment for at least 6 months to consolidate the antidepressant effect. Termination of treatment. Patients receiving treatment with Brinetelex can stop taking it at once without needing to gradually lower the dose (see “Pharmacodynamics”). Special patient groups Elderly patients.In patients with & # 8805 .65 years, as a starting dose, you should always use the minimum effective dose of Brintellix 5 mg once a day. Care must be taken when treating patients & # 8805 .65 years with the use of doses higher than 10 mg of vortioxetine once a day, because data on the use of the drug in this group of patients is limited (see "Special Instructions"). Inhibitors of cytochrome P450. Depending on the patient's individual response, it may be necessary to reduce the dose of Brintellix in case of therapy being added with strong inhibitors of the CYP2D6 isoenzyme (for example, bupropion, quinidine, fluoxetine, paroxetine) (see “Interaction”). Inductors of cytochrome P450. Depending on the patient's individual response, it may be necessary to adjust the dose of Brintellix in case of therapy with a wide range of cytochrome P450 inducers (for example, rifampicin, carbamazepine, phenytoin) (see "Interaction"). Children and teenagers (under 18). The safety and efficacy of Brintellix in children and adolescents under 18 years of age have not been established There are no data on this group of patients (see “Special Instructions”).
Side effects
Security profile summary. The most common adverse reaction was nausea. Adverse reactions were usually mild or moderate and were observed only during the first 2 weeks of treatment. Adverse reactions were usually temporary and, in general, were not the reason for drug withdrawal. Adverse Gastrointestinal adverse reactions, such as nausea, were more common in women than in men. The adverse reactions listed below are distributed in frequency as follows very often (& # 8805 .1 / 10). often (from & # 8805 .1 / 100 to less than 1/10). Infrequently (from & # 8805 .1 / 1000 to less than 1/100). rarely (from & # 8805 .1 / 10,000 to less than 1/1000). Very rarely (less than 1/10000), the frequency is unknown (the frequency cannot be estimated based on the available data). A list of unwanted reactions. Body systems. Frequency. Unwanted reaction. Mental disorders, often unusual dreams. Nervous system Often Dizziness, frequency unknown Serotonin syndrome. On the part of the vessels Infrequently Tides. From the side of the gastrointestinal tract. Very often Nausea. Frequently Diarrhea, constipation, vomiting. On the part of the skin and subcutaneous tissues Often, itching, incl. generalizedFrequently Night sweat.Description of individual adverse reactions Elderly patients For doses of vortioxetine 10 mg and above 1 time per day, the dropout rate from studies was higher in patients in the age of 65 years. For the dose of vortioxetine 20 mg 1 time per day, cases of nausea and constipation were higher in patients aged в 8805 .65 years (42 and 15% respectively) compared with patients less than 65 years old (27 and 4% respectively) (see "Special instructions"). Sexual dysfunction. In clinical studies, sexual dysfunction was assessed using ASEX. Doses from 5 to 15 mg did not show a difference from placebo. However, taking a dose of vortioxetine 20 mg was associated with an increase in the incidence rate (TESD) (see Pharmacodynamics). Class-specific effect. Epidemiological studies, mainly involving patients aged 50 years and older, have shown an increased risk of bone fractures in patients taking medication belonging to the appropriate pharmacological classes of antidepressants (tricyclic (TCA) and SSRIs). The mechanism leading to this risk is unknown, and it is also unknown if this risk applies to vortioxetine.
special instructions
Security profile summary. The most common adverse reaction was nausea. Adverse reactions were usually mild or moderate and were observed only during the first 2 weeks of treatment. Adverse reactions were usually temporary and, in general, were not the reason for drug withdrawal. Adverse Gastrointestinal adverse reactions, such as nausea, were more common in women than in men. The adverse reactions listed below are distributed in frequency as follows very often (& # 8805 .1 / 10). often (from & # 8805 .1 / 100 to less than 1/10). Infrequently (from & # 8805 .1 / 1000 to less than 1/100). rarely (from & # 8805 .1 / 10,000 to less than 1/1000). Very rarely (less than 1/10000), the frequency is unknown (the frequency cannot be estimated based on the available data). A list of unwanted reactions. Body systems. Frequency. Unwanted reaction. Mental disorders, often unusual dreams. Nervous system Often Dizziness, frequency unknown Serotonin syndrome. On the part of the vessels Infrequently Tides. From the side of the gastrointestinal tract. Very often Nausea. Frequently Diarrhea, constipation, vomiting. On the part of the skin and subcutaneous tissues Often, itching, incl. generalizedFrequently Night sweat.Description of individual adverse reactions Elderly patients For doses of vortioxetine 10 mg and above 1 time per day, the dropout rate from studies was higher in patients in the age of 65 years. For the dose of vortioxetine 20 mg 1 time per day, cases of nausea and constipation were higher in patients aged в 8805 .65 years (42 and 15% respectively) compared with patients less than 65 years old (27 and 4% respectively) (see "Special instructions"). Sexual dysfunction. In clinical studies, sexual dysfunction was assessed using ASEX. Doses from 5 to 15 mg did not show a difference from placebo. However, taking a dose of vortioxetine 20 mg was associated with an increase in the incidence rate (TESD) (see Pharmacodynamics). Class-specific effect. Epidemiological studies, mainly involving patients aged 50 years and older, have shown an increased risk of bone fractures in patients taking medication belonging to the appropriate pharmacological classes of antidepressants (tricyclic (TCA) and SSRIs). The mechanism leading to this risk is unknown, and it is also unknown if this risk applies to vortioxetine.