Strattera capsules 10 mg 7 pcs
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Active ingredients
Atomoksetin
Release form
Capsules
Composition
Atomoksetin (in the form of hydrochloride) 10 mg; Excipients: Dimethicone, pregelatinized starch.; Capsule shell composition: titanium dioxide, sodium lauryl sulfate, gelatin.
Pharmacological effect
Sympathomimetic central action. Atomoksetin is a highly selective potent inhibitor of presynaptic carriers of norepinephrine. Atomoksetin has a minimal affinity for other noradrenergic receptors or other neurotransmitter carriers or receptors. Atomoxetine does not belong to psychostimulants and is not a derivative of amphetamine. In clinical studies with the abolition of the drug, there was no increase in the symptoms of the disease or any adverse events associated with withdrawal syndrome.
Pharmacokinetics
Absorption; After oral administration, atomoxetine is rapidly and almost completely absorbed, reaching Cmax in plasma after about 1-2 hours. Atomoxetine is administered independently of food intake or during meals. Distribution; Atomoxetine is well distributed in the body. It has a high affinity for plasma proteins, primarily albumin.; Metabolism; Atomoxetine undergoes primary metabolism with the participation of the CYP2D6 isoenzyme. The main oxidized metabolite formed, 4-hydroxyatomoxetine, is rapidly glucuronized. According to pharmacological activity, 4-hydroxyatomoxetine is equivalent to atomoxetine, but circulates in plasma at much lower concentrations. Although 4-hydroxyatomoxetine is primarily formed with the participation of CYP2D6, in people with insufficient activity of CYP2D6, 4-hydroxyatomoxetine can be formed by some other cytochrome P450 isoenzymes, but .; Atomoksetin does not inhibit and does not enhance the cycle of CYP2D6.; Elimination; The average T1 / 2 of atomoxetine after oral administration is 3.6 hours in patients with pronounced metabolism and 21 hours in patients with reduced m metabolism. Atomoksetin mainly excreted in the urine in the form of 4-hydroxyatomoxetine-O-glucuronide.; Pharmacokinetics in special clinical situations; Pharmacokinetics in children and adolescents is similar to pharmacokinetics in adults. The pharmacokinetics of atomoxetine in children under 6 years of age has not been studied.
Indications
- Attention deficit hyperactivity disorder (ADHD) in children 6 years and older, adolescents and adults.
Contraindications
- angle-closure glaucoma; - severe heart damage; - simultaneous use with MAO inhibitors; - hypersensitivity to the drug.; The drug should be used with caution in patients with arterial hypertension, tachycardia, cardiovascular diseases, severe physical exertion, concurrent use of psychostimulants, sudden cardiac death in the family history, cerebral circulation disorder, convulsive attacks of anamnes, anamnesis, a history of heart failure, anemia, anemia, anemia, anemia, heart failure, obstructive heart attacks, anamnesis, family history also in conditions that can lead to arterial hypotension.
Use during pregnancy and lactation
Clinical experience with Stratters during pregnancy is insufficient, so the drug should be prescribed during pregnancy only if the expected benefit of therapy for the mother greatly exceeds the potential risk to the fetus. It is not known whether atomoxetine is excreted in breast milk. If necessary, the appointment of the drug nursing mother requires caution.
Dosage and administration
The drug is taken orally, regardless of the meal or during meals, 1 time per day, in the morning. In the event of adverse events when taking the drug 1 time / day, patients can be advised to take 2 times / day, dividing the dose into the morning and taking it in the late afternoon or early evening.; With the abolition of the drug does not require a gradual dose reduction.; Children and adolescents with weight For a body up to 70 kg, the recommended initial daily dose is about 500 μg / kg and increases to a therapeutic daily dose of about 1.2 mg / kg no earlier than after 3 days. If there is no improvement in the patient's condition, the total daily dose may be increased to a maximum dose of 1.8 mg / kg not earlier than 2-4 weeks after the start of the drug. The recommended maintenance dose is approximately 1.2 mg / kg / day. The recommended maximum daily dose is 1.8 mg / kg or 120 mg. In children and adolescents weighing up to 70 kg, the safety of a single and total daily dose exceeding 1.8 mg / kg has not been systematically evaluated.; Children and adolescents weighing more than 70 kg and adults the recommended initial daily dose is 40 mg and increases to a therapeutic daily dose of about 80 mg no earlier than after 3 days.If there is no improvement in the patient’s condition, the total daily dose may be increased to a maximum dose of 120 mg no earlier than 2-4 weeks after starting the drug. The recommended maintenance dose is 80 mg. The recommended maximum daily dose is 120 mg. In children and adolescents weighing more than 70 kg, as well as in adults, the safety of a single dose of more than 120 mg and a total daily dose of more than 150 mg has not been systematically evaluated. In patients with moderate hepatic impairment (class In the Child-Pugh scale, the initial and maintenance therapeutic dose should be reduced to 50% of the usual recommended dose. In patients with severely impaired liver function (Child-Pugh class C), the initial and maintenance therapeutic dose must be reduced to 25% of the usual dose. In patients with severely impaired renal function (end-stage chronic renal failure), atomoxetine is eliminated from the body slower than healthy individuals. However, there was no difference in dose adjustment. Therefore, the drug Strattera; ADHD patients with chronic renal failure, including the terminal stage, can be prescribed using the normal dosing regimen. Atomoksetin can cause hypertension in patients with end-stage renal disease.; Rules for the use of capsules; Strattera capsules; not intended to be opened. Atomoksetin causes eye irritation. If the contents of the capsule get into the eyes, immediately rinse the eyes with water and consult a doctor. Rinse hands and contact surfaces with water.
Side effects
Children and adolescents; From the digestive system: very often (> 10%) - abdominal pain (18%; including abdominal discomfort, pain and epigastric discomfort, discomfort in the stomach), loss of appetite (16%), vomiting (eleven%); often (1-10%) - constipation, dyspepsia, nausea (9%), anorexia. These adverse reactions are temporary and, as a rule, do not require discontinuation of the drug. In connection with reduced appetite, some patients experienced a decrease in body weight at the beginning of treatment (about 0.5 kg on average), and the loss of body weight was greater at higher doses. After the primary weight loss in patients taking Stratter, there was a slight increase in body weight during prolonged therapy.Growth rates (weight and height) after two years of treatment were close to normal.; Nausea (9%) and vomiting (11%) are most likely during the first month of treatment, usually mild to moderate, are temporary and are not the cause cancellation of treatment in a significant number of cases. From the side of the cardiovascular system: sometimes (0.1-1%) - feeling of heartbeat, sinus tachycardia.; In placebo-controlled studies in children who received Stratter, there was an average increase in heart rate of 6 beats / min and the mean increase in systolic and dias olicheskogo pressure - 2 mmHg compared with placebo. Orthostatic hypotension (0.2%, n = 7) and syncope (0.8%, n = 26) were observed in patients receiving atomoxetine, due to its effect on noradrenergic tone.; CNS: very often (> 10%) - drowsiness (including sedative effect); often (1-10%) - irritability, mood swings, dizziness; sometimes (0.1-1%) - early morning awakening. On the part of the organ of vision: often (1-10%) - mydriasis;; Dermatological reactions: often (1-10%) - dermatitis, rash; sometimes (0.1-1%) - itching.; Other: often (1-10%) - influenza, fatigue, weight loss; sometimes (0.1-1%) - weakness.; Side effects in patients with slow metabolism of substrates of CYP2D6, observed in 2% of cases and at the same time 2 times more often, and also statistically significantly more often than in patients with rapid metabolism of substrates of CYP2D6: tremor (4.5% and 0.9% respectively), excoriation (3.9% and 1.7% respectively), syncope (2.5% and 0.7% respectively), conjunctivitis (2.5% and 1.2% respectively), early morning awakening (2.3% and 0.8% respectively) , mydriasis (2% and 0.6%, respectively); Adults; In adults, the most frequent side effects associated with taking the atom Zetina were on the gastrointestinal tract and urogenital tract. Serious adverse events during a short or prolonged treatment with atomoxetine were not observed. On the part of the digestive system: very often (> 10%) - loss of appetite, dry mouth, nausea; often (1-10%) - abdominal pain (including symptoms of abdominal discomfort, pain and discomfort in the epigastrium, discomfort in the stomach), constipation, dyspepsia, flatulence.; CNS: very often (> 10%) - insomnia (includes difficulty in falling asleep and sleep disturbance in the middle of the night); often (1-10%) - decreased libido, dizziness, impaired quality of sleep, sinus headache; sometimes (0.1-1%) - early morning awakening; very rarely (<0.01%) - syncope. From the side of the cardiovascular system: often (1-10%) - flushing (blood), feeling of heartbeat,tachycardia; infrequently (0.1-1.0%) - feeling of cold in the lower extremities; very rarely (<0.01%), according to spontaneous (post-marketing reports), peripheral vascular reactions and / or Raynaud’s syndrome and the risk of Raynaud’s syndrome recurrence; min, and the average increase in systolic (about 3 mm Hg) and diastolic (about 1 mm Hg) blood pressure compared with placebo. From the urinary system: often (1-10%) - dysuria, urinary retention . From the reproductive system: often (1-10%) - dysmenorrhea, impaired ejaculate and, lack of ejaculation, erectile dysfunction, erectile dysfunction, menstrual disorders, prostate; very rarely (<0.01%) according to spontaneous (post-marketing) messages - painful or prolonged erection, pain in the region of the external genital organs in men. From the skin and subcutaneous tissue: often (1-10%) - dermatitis, excessive sweating. ; Other: often (1-10%) - fatigue, chills, weight loss.
Overdose
Symptoms: monotherapy most often - drowsiness, agitation, hyperactivity, behavioral disorders and symptoms of the gastrointestinal tract. Most of the manifestations were mild and moderate severity. There were also signs and symptoms of mild to moderate sympathetic nervous system activation (for example, mydriasis, tachycardia, dry mouth). All patients had a regression of these symptoms. In some cases, convulsions were noted.; Cases of acute overdose with a fatal outcome were reported when taking atomoxetine as part of a combination therapy (with at least one drug) .; Treatment: it is recommended to provide ventilation of the lungs, monitor cardiac activity and basic vital signs, and symptomatic and supportive treatment. Gastric lavage may be indicated if a short time has passed after taking the drug. Activated carbon may be useful to limit absorption. Since Atomoxetine has a high affinity for plasma proteins, and overdose treatment by dialysis is more likely to be inappropriate.
Interaction with other drugs
With simultaneous use of Stratters with β2-adrenoreceptor agonists, their action on the cardiovascular system may be enhanced (this combination should be used with caution).In healthy adult volunteers, the effect of salbutamol in the standard inhaled dose of 200 μg on hemodynamic parameters was insignificant compared with the effect of the indicated dose of this drug upon intravenous administration. The simultaneous use of atomoxetine at a dose of 80 mg / day for 5 days did not lead to the enhancement of these effects of albuterol. Heart rate after multiple inhalations of albuterol at a dose of 800 mcg was characterized by similar values in monotherapy and in combination with atomoxetine. Simultaneous administration of atomoxetine with drugs that prolong the QT interval (antipsychotics, antiarrhythmics, moxifloxacin, erythromycin, tripartite, anti-triggers, antioxidants, moxifloxacin, erythromycin, trihypertensives (antipsychotics, antiarrhythmics, moxifloxacin, erythromycin, tripartite, anti-triggers) ), as well as with drugs that cause electrolyte imbalance (diuretics) and CYP2D6 inhibitors, increases the risk of increasing the duration of the QT interval. Atomoksetin n Do not cause clinically significant inhibition or induction of cytochrome P450 isoenzymes, including CYP1A2, CYP3A, CYP2D6 and CYP2C9. In patients with a pronounced metabolism of CYP2D6 substrates, CYP2D6 inhibitors increase the Css of atmoxetine in the blood plasma in an equilibrium state to a level similar to that in patients with a slower metabolism of CYP2D6 substrates. On the basis of in vitro studies, it is assumed that the use of cytochrome P450 inhibitors to patients with a slower metabolism of substrates CYP2D6 does not increase plasma concentration of atomoxetine. For patients using CYP2D6 inhibitors, gradual titration of atomoxetine is recommended.; Because of the possible effect on blood pressure, Stratter should be used with caution when combined with drugs that affect blood pressure.; Preparations that increase the pH of gastric juice (magnesium hydrochloride / aluminum hydroxide, omeprazole) do not affect the bioavailability of atomoxetine.; Drugs that affect the secretion of norepinephrine should be prescribed with caution simultaneously with atomoxetine because of the possibility of enhancing or synergizing the pharmacological effect EKTA;. Atomoxetine not affect binding to plasma albumin warfarin, acetylsalicylic acid, diazepam and phenytoin;. caution is required while applying Atomoxetine with medications that lower seizure threshold activity (antidepressants, antipsychotics, mefloquine, tramadol).
special instructions
The drug should be used with caution in patients with hereditary, congenital or acquired prolongation of the QT interval. Symptoms of ADHD in the form of impaired attention and hyperactivity (found in more than one social environment, for example, at home and at school) may manifest as lack of concentration, distractibility, excessive impatience, impulsivity, lack of organization, restlessness and other similar behavioral disorders. The diagnosis of ADHD must meet the criteria of ICD-10.; In the background of the drug in clinical studies in children and adolescents, the likelihood of developing suicidal thoughts increased. In 12 clinical trials, 2,200 patients (including 1357 patients receiving Stratter and 851 patients receiving placebo), among them in the group receiving Stratter, in 0.37% of cases development of suicidal thoughts was detected (5 out of 1357 patients), in the placebo group no suicidal thoughts were revealed. In the course of these clinical studies, a single suicide attempt was reported, there were no completed suicides. In rare cases, patients taking Stratter had allergic reactions - rash, angioedema, urticaria;; Atomoxetine should not be administered for at least 2 weeks after discontinuation of inhibitors MAO. Treatment with MAO inhibitors should not be started within 2 weeks after discontinuation of atomoxetine. Many patients taking atomoxetine showed a slight increase in pulse (by an average of <10 beats / min) and / or an increase in blood pressure (by an average of <5 mm Hg .st.) In most cases, these changes had no clinically significant effect. Cases of orthostatic hypotension have also been observed. Against the background of the use of psychostimulants registered for the treatment of ADHD in the United States in children with a rough heart disease that violates its structure, an increased risk of sudden cardiac death was detected. Atomoksetin does not belong to the class of psychostimulants, because has an alternative mechanism of therapeutic action in the treatment of ADHD. However, given the overall recorded indication of use (ADHD), caution should be exercised when using atomoxetine in patients with severe physical exertion, co-administration of psychostimulants, and a family history of sudden cardiac death.Atomoxetine should not be used in patients with gross cardiac pathology. Rare cases of serious liver damage have been reported with atomoxetine (two cases of a marked increase in the level of liver enzymes and bilirubin per 2 million patients are described). In patients with manifestations of jaundice or identified laboratory indicators of impaired liver function, treatment with atomoxetine should be canceled. In clinical studies in adult patients with ADHD taking atomoxetine, the number of urinary retention was higher compared with the placebo group. Complaints of urinary retention can potentially be regarded as the result of the use of atomoxetine. Atomoxetine should be discontinued if seizures develop, which cannot be explained by other reasons. Caution should be taken with atomoxetine in patients with convulsive seizures in history. The effectiveness of atomoxetine treatment for more than 18 months and the safety of treatment for more than 2 years have not been systematically evaluated. Aggressive behavior or hostility is often observed in children and adolescents with ADHD. There is no conclusive evidence that atomoxetine can cause aggressive behavior or hostility. However, in clinical studies, aggressive behavior or hostility was observed more often in children and adolescents taking atomoxetine (without statistically significant differences compared with the placebo group). Patients receiving treatment for ADHD need to be monitored for their aggressive behavior or hostility. There are known cases of psychotic and manic symptoms, including hallucinations, delusions and pathological mood elevation, with the use of atomoxetine in therapeutic doses in children and adolescents . If these symptoms occur, it is recommended to evaluate the extent of their connection with atomoxetine and, if necessary, consider discontinuing the drug. The following symptoms were observed while receiving atomoxetine: anxiety, agitation, panic attacks, insomnia, irritability, impulsivity, akathisia. Patients taking atomoxetine,Observation is required regarding the development of these symptoms. Parents and relatives should carefully monitor the occurrence of all the above symptoms and suicidal thoughts in children and adolescents taking atomoxetine, and immediately report this to their doctor. Safety and effectiveness of Stratters in elderly patients have not been established. ; Use in pediatrics; Children under the age of 6 years do not have enough data on the safety and efficacy of atomoxetine.; Impact on ability to drive vehicles and control of fur isms; The drug may be accompanied by sleepiness. In this regard, patients taking Stratter, should be careful in the management of hazardous mechanical means, including by car, until they are sure that atomoxetine does not cause any disturbances.