Strattera capsules 25 mg 7 pcs
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Description
Stratter capsules - centrally acting sympathomimetic. Atomoksetin is a highly selective potent inhibitor of presynaptic carriers of norepinephrine. Atomoksetin has minimal affinity for other noradrenergic receptors or for other neurotransmitter carriers or receptors. Atomoksetin 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.
Active ingredients
Atomoksetin
Composition
Atomoksetin (in the form of hydrochloride) 25 mg. Excipients: Dimethicone, pregelatinized starch. The composition of the capsule shell: titanium dioxide, sodium lauryl sulfate, gelatin, indigo carmine dye.
Indications
Attention deficit hyperactivity disorder (ADHD) in children 6 years and older, adolescents and adults.
Precautionary measures
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 (identified in more than one social environment, for example, both at home and at school) can manifest themselves 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. While taking 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 trials, one suicide attempt was reported, there were no completed suicides. In rare cases, patients taking Stratter, had allergic reactions - rash, angioedema, urticaria. Atomoksetin should not be prescribed for at least 2 weeks after discontinuation of MAO inhibitors.Treatment with MAO inhibitors should not begin within 2 weeks after discontinuation of atomoxetine. In many patients taking atomoxetine, there was 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). In most cases, these changes had no clinically significant effect. Cases of orthostatic hypotension are also noted. 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 severe heart disease. Rare cases of serious liver damage have been reported in patients receiving atomoxetine (two cases of 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 incidence of urinary retention was higher compared to the placebo group. Complaints of urinary retention can potentially be regarded as the result of the use of atomoxetine
Dosage and administration
The drug is taken orally, regardless of the meal or during meals, 1 time / in the morning. In the case of adverse events when taking the drug 1 time / patients can recommend taking 2, dividing the dose into the morning and taking the reception in the late afternoon or early evening. With the abolition of the drug does not require a gradual dose reduction. For children and adolescents weighing 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 in no earlier than 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 starting the drug. The recommended maintenance dose is approximately 1.2 mg / kg / 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 in excess of 1.8 mg / kg has not been systematically evaluated. For children and adolescents weighing more than 70 kg and for adults, the recommended initial daily dose is 40 mg and is increased 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 (Child-Pugh class B), 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 should 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 more slowly than in healthy individuals. However, there was no difference in dose adjustment. Therefore, the drug Strattera can be prescribed for patients with ADHD with chronic renal failure, including the terminal stage, using the usual dosing regimen. Atomoksetin can cause hypertension in patients with end-stage renal failure. Capsule rules Strattera capsules are 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
On the part of the digestive system: very often (> 10%) - abdominal pain (18%, including abdominal discomfort, pain and discomfort in the epigastrium, discomfort in the stomach), loss of appetite (16%), vomiting (11%) , 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 or moderate, are temporary and do not cause discontinuation of treatment in a significant number of cases. Since the cardiovascular system: sometimes (0.1-1%) - a feeling of heartbeat, sinus tachycardia. In placebo-controlled studies in children receiving stratter, there was an average increase in heart rate of 6 beats / min, and an average increase in systolic and diastolic pressure - by 2 mm Hg. compared to placebo.
Overdose
In monotherapy, drowsiness, agitation, hyperactivity, behavioral disturbances and gastrointestinal symptoms are most common. Most of the manifestations were mild and moderate severity. Signs and symptoms of mild to moderate sympathetic nervous system activation were also noted.
Interaction with other drugs
With simultaneous use of Stratters with 2-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 / for 5 days did not lead to the enhancement of these effects of albuterol. The heart rate after multiple inhalations of albuterol at a dose of 800 μg was characterized by similar values in terms of monotherapy and in combination with the use of atomoxetine.The simultaneous appointment of atomoxetine with drugs that cause prolongation of the QT interval (antipsychotics, antiarrhythmics, moxifloxacin, erythromycin, tricyclic antidepressants, lithium carbonate), as well as drugs that cause electrolyte imbalance (diuretics).