Strattera - instructions for use, dose, side effects, contraindications

Active substanceAtomoxetineAtomoxetine

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Dysmaxin

capsules inwards

Pharmaceutical factory "POLFARMA" JSC Poland

Stratter®

capsules inwards

Eli Lilly East SA Switzerland

Dosage form: & nbspcapsules

Composition:

Each capsule contains:

For the dosage of 10 mg:

Contents of the capsule:

Active substance - Atomoxetine hydrochloride, equivalent to the base of atomoxetine, 10 mg / capsule.

Excipients dimethicone 1.15 mg / capsule, pregelatinized starch 217.42 mg / capsule.

Capsule shell - titanium dioxide 1.554 mg / capsule, sodium lauryl sulfate 0.069 mg / capsule, gelatin qs 50 mg / capsule.

For a dosage of 18 mg:

Contents of the capsule:

Active substance - Atomoxetine hydrochloride equivalent to the base of atomoxetine, 18 mg / capsule.

Excipients - dimethicone 1,15 mg / capsule, pregelatinized starch 208.28 mg / capsule.

Capsule shell - titanium dioxide 0.932 mg / capsule, sodium lauryl sulfate 0.070 mg / capsule, gelatin qs 50 mg / capsule, iron oxide dye yellow 0,173 mg / capsule.

For dosage of 25 mg:

Contents of the capsule:

Active substance - Atomoxetine hydrochloride, equivalent to the base of atomoxetine, 25 mg / capsule.

Excipients - dimethicone 1,15 mg / capsule, pregelatinized starch 200.28 mg / capsule.

Capsule shell - titanium dioxide 1,230 mg / capsule, sodium lauryl sulfate 0.070 mg / capsule, gelatin qs 50 mg / capsule, dye indigo carmine 0,029 mg / capsule.

For a dosage of 40 mg:

Contents of the capsule:

Active substance - Atomoxetine hydrochloride, equivalent to the base of atomoxetine. 40 mg / capsule.

Excipients - dimethicone 1,15mg / capsule, pregelatinized starch 183.14 mg / capsule.

Capsule shell - titanium dioxide 0.745 mg / capsule, sodium lauryl sulfate 0.071 mg / capsule, gelatin qs 50 mg / capsule, indigo carmine dye 0,072 mg / capsule.

For the dosage of 60 mg:

Contents of the capsule:

Active substance - Atomoxetine hydrochloride, equivalent to the base of atomoxetine, 60 mg / capsule.

Excipients - dimethicone 1.55 mg / capsule, pregelatinized starch 239.89 mg / capsule.

Capsule shell - titanium dioxide 0.376 mg / capsule, sodium lauryl sulfate 0.089 mg / capsule, gelatin qs 63 mg / capsule, iron oxide dye yellow 0.326 mg / capsule, indigo carmine dye 0.036 mg / capsule.

Description:

Capsules 10 mg: opaque, white / white, hard gelatin capsules (size 3) with a dosage applied on them "10 mg" and identification code "Lilly 3227";

Capsules 18 mg: opaque, yellow / white, hard gelatin capsules (size 3) with a dosage applied on them "18 mg" and identification code "Lilly 3238";

Capsules 25 mg: opaque, blue / white, hard gelatin capsules (size 3) with a dosage of 25 mg" and identification code "Lilly 3228";

Capsules 40 mg: opaque, blue / blue, hard gelatin capsules (size 3) with a dosage of 40 mg" and identification code "Lilly 3229";

Capsules 60 mg: opaque, blue / yellow, hard gelatin capsules (size 2) with a dosage of 60 mg" and identification code "Lilly 3239".

The contents of all capsules: powder from white to almost white.

Pharmacotherapeutic group:Sympathomimetic means of central action.

ATX: & nbsp

N.06.B.A Sympathomimetics of central action

N.06.B.A.09 Atomoxetine

Pharmacodynamics:

Atomoxetine is a highly selective potent inhibitor of presynaptic norepinephrine carriers. Atomoxetine has minimal affinity for adrenergic receptors or other carriers or receptors of neurotransmitters. Atomoxetine is not a psychostimulant and is not an amphetamine derivative. In clinical trials, when the drug was withdrawn, there was no increase in symptoms of the disease or any undesirable phenomena associated with the withdrawal syndrome.In the study of the duration of the QT / QTc interval in adult healthy volunteers with a low activity of the CYP2D6 isoenzyme, atomoxetine dose to 60 mg twice daily, it was shown that, with the maximum expected concentration of atomoxetine in the blood, the effect of atomoxetine on the duration of the QTc interval did not differ significantly from the placebo effect. There was a slight prolongation of the QTc interval with an increase in the concentration of atomoxetine in the blood.

Pharmacokinetics:

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.

Suction. Atomoxetine quickly and almost completely absorbed after ingestion, reaching a maximum concentration (C_m_Oh) in the plasma after about 1 to 2 hours. Atomoxetine is administered regardless of food intake or during meals.

Distribution. Atomoxetine is well distributed in the body. Atomoxetine has a high affinity for plasma proteins, primarily albumin.

Metabolism. Atomoxetine Primarily passes biotransformation through the enzymatic cycle of cytochrome P450 2D6 (CYP2D6). The main oxidized metabolite, 4-hydroxyatomoxetine, is rapidly glucuronized. 4-hydroxyatomoxetine is equivalent in its action to atomoxetine, but circulates in plasma at much lower concentrations.

Although 4-hydroxyatomoxetine is primarily formed by CYP2D6, in people with inadequate activity CYP2D6 4-hydroxyatomoxetine may be formed by some other enzymes of cytochrome P450, but more slowly.

Atomoxetine does not inhibit or enhance the cycle CYP2D6.

Excretion. The average half-life of atomoxetine after ingestion is 3.6 hours in patients with severe metabolism and 21 hours in patients with reduced metabolism. Atomoxetine mainly excreted in the urine as 4-hydroxyatomoxetine-O-glucuronide.

Indications:

Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents and adults.

Contraindications:- Hypersensitivity to the drug

- Simultaneous use with monoamine oxidase inhibitors (MAOI) (see section "Special instructions")

- Closed-angle glaucoma

- Severe cardiovascular diseases (see section "Special instructions")

- Pheochromocytoma

Carefully:In patients with hypertension, tachycardia, cardiovascular diseases, severe physical overload, simultaneous reception of psychostimulants, sudden cardiac death in a family history, cerebral circulation disorder, convulsive fits in the anamnesis, and also in conditions that can lead to hypotension (see section "Special instructions").

Pregnancy and lactation:

Due to inadequate experience with the use of atomoxetine during pregnancy, the drug should be administered during pregnancy only if the potential benefit to the patient is significantly greater than the potential risk to the fetus.

It is not known whether atomoxetine with breast milk. Care should be taken when prescribing the drug to a nursing woman.

Dosing and Administration:

For oral administration.

The drug Strattera® can be administered as a single daily dose in the morning. In case of occurrence of undesirable phenomena at reception of a preparation in the form of a single daily dose, patients can be recommended to take the drug twice a day, sharing the dose for morning reception and reception late in the afternoon or early evening.

Children and adolescents with a body weight of up to 70 kg. The recommended initial daily dose is approximately 0.5 mg / kg and increases to a therapeutic daily dose of about 1.2 mg / kg no earlier than 3 days later. In the absence of improvement in the patient's condition, the total daily dose may be increased to a maximum dose of 1.8 mg / kg no 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 with a body weight of up to 70 kg, the safety of a single and total daily dose exceeding 1.8 mg / kg was not systematically evaluated.

Children and adolescents with a body weight of 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 not earlier than 3 days later. In the absence of improvement in the patient's condition, the total daily dose may be increased to a maximum dose of 120 mg not earlier than 2-4 weeks after the start of the drug.

The recommended maintenance dose is 80 mg. The recommended maximum daily dose is 120 mg.

In children and adolescents with a mass of 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.

Treatment should be conducted under the supervision of a doctor who has experience with patients with attention deficit hyperactivity disorder.

The drug Strattera ® can be taken regardless of food intake or during meals. The withdrawal of the drug does not require a gradual dose reduction.

Instructions for use of capsules

Capsules of Stratter ® are not intended for opening. Atomoxetine causes eye irritation. In case of contact with the contents of the capsule in the eye, immediately flush eyes with water and consult a doctor. Hand and contact surfaces should be rinsed with water.

Special patient groups

Liver failure. In patients with moderate hepatic impairment (Class B by Child-Pugh) the initial and maintenance therapeutic dose should be reduced to 50% of the usual recommended dose. In patients with severe impairment of liver function (Class C by Child-Pugh) the initial and maintenance therapeutic dose should be reduced to 25% of the usual dose.

Renal failure. In patients with severe impairment of renal function (terminal stage of chronic renal failure, chronic renal failure), atomoxetine is excreted from the body more slowly than in healthy individuals. However, when adjusting the dose, no differences were noted. Therefore, the Strattera ® preparation can be administered to ADHD patients with end-stage renal disease or with a lesser degree of renal failure using the usual dosing regimen. Atomoxetine can cause hypertension in patients with terminal stage of CRF.

Elderly patients and children under 6 years of age. Not evaluated.

Side effects:

Children and teens

Headache, abdominal pain⁶ and decreased appetite are side effects most commonly associated with taking atomoxetine (19%, 18%, and 16%, respectively) in placebo-controlled studies in children, but they usually do not require drug withdrawal (cases of drug withdrawal according to the following indications 0.1% for headache, 0.2% for abdominal pain and 0.0% for loss of appetite). Pain in the abdomen and a decrease in appetite usually are temporary.

In clinical studies of ADHD in children and adolescents at the beginning of therapy, there was a lag in the averagesrates of weight gain and growth from the age norm among those receiving atomoxetine in connection with a reduced appetite. Later, after a long period of time, the body weight and growth parameters in these patients returned to the average age standard, determined taking into account the anthropometric data prior to initiation of treatment with atomoxetine.

Nausea, vomiting and drowsiness¹ may appear in approximately 10% and 11% of patients, respectively, especially during the first month of treatment. However, these episodes were usually of mild to moderate severity, were of a temporary nature, and were not the reason for the cancellation of treatment in a significant number of cases (cases of cancellation of the drug are <0.5%).

In placebo-controlled studies in children and adults receiving atomoxetine, there was an increase in heart rate, an increase in systolic and diastolic pressure compared with placebo.

In patients who received atomoxetine, orthostatic hypotension (0.2%) and fainting (0.8%) were noted due to its effect on sympathetic tone. Atomoxetine should be used with caution in any condition that may lead to a decrease in blood pressure.

Below are the side effects and abnormalities in laboratory indicators noted in clinical studies in children and adolescents.

Disorders from the metabolism and nutrition

Very often (> 10%): decreased appetite

Often (1-10%): anorexia (loss of appetite)

Disturbances from the nervous system

Very often (> 10%): drowsiness¹, headache

Often (1-10%): dizziness

Infrequently (0.1-1%): fainting², tremor

Disorders of the psyche

Often (1-10%): mood swings, insomnia³, depression⁴

Infrequently (0.1-1%): suicidal thoughts and behavior, aggressive behavior, hostility, emotional instability

Disturbances on the part of the organ of sight

Often (1-10%): mydriasis

Infrequently (0.1-1%): conjunctivitis

Violations from the heart and blood vessels

Very often (> 10%): increased blood pressure⁵, an increase in heart rate⁵

Infrequent (0.1-1%): palpitations, sinus tachycardia

Disorders from the gastrointestinal tract

Very often (> 10%): abdominal pain⁶, nausea, vomiting

Often (1-10%): constipation, indigestion

Disturbances from the skin and subcutaneous tissues

Often (1-10%): rash, itching

General disorders

Often (1-10%): fatigue, weight loss, irritability

Infrequently (0.1-1%): asthenia

¹ Includes sedation.

²Includes vasovagal syncope

³Includes the difficulties of falling asleep, restless sleep and early awakening.

⁴Includes major depressive disorder, depressive symptoms, depressed mood and dysphoria.

⁵The data are based on measurements of heart rate and blood pressure.

⁶Includes the phenomena of discomfort in the abdomen, pain and discomfort in the epigastric abdomen, discomfort in the stomach.

The following side effects were observed in at least 2% of children and adolescents with low activity of the CYP2D6 isoenzyme statistically significantly more often than in patients with high activity of the isoenzyme CYP2D6: weight loss (7.3% and 4.4% respectively), constipation (6.8% and 4.3% respectively), insomnia (11% and 6.1% respectively), depression (6.5% and 4.1% respectively), tremor (4.5% and 0.9% (2.5% and 0.7%, respectively), conjunctivitis (2.5% and 1.2%, respectively), early morning awakening (2, 3% and 0.8% respectively GOVERNMENTAL), mydriasis (2.0% and 0.6%, respectively), sedation (3.9% and 2.1% respectively).

Adults

In clinical studies in adults, the most frequent adverse events during the administration of atomoxetine were from the gastrointestinal tract, the nervous system and the psyche.The most common side effects (> 5%): decreased appetite (14.9%), insomnia (11.3%), headache (16.3%), dry mouth (18.4%) and nausea (26 , 7%). In most cases, all of the listed side effects were mild or moderate. Most often as severe, there were side effects: nausea, insomnia, fatigue, headache.

Complaints about a delay in urination and a difficult onset of urination may potentially be associated with taking atomoxetine.

Below are the side effects and abnormalities in laboratory indicators noted in clinical studies in adults.

Disorders from the metabolism and nutrition

Very often (> 10%>): decreased appetite

Disturbances from the nervous system

Very often (> 10%): headache

Often (1-10%): dizziness, change in taste, paresthesia, drowsiness⁴, tremor

Disorders of the psyche

Very often (> 10%>): insomnia¹

Often (1-10%): agitation, decreased libido, sleep disturbance¹

Infrequently (0,1-1,0%): violation of orgasm, anxiety, suicidal thoughts and behavior, aggressive behavior, hostility, emotional instability

Disturbances on the part of the organ of sight

Infrequently (0.1-1.0%): blurred vision

Violations from the heart and blood vessels

Very often (> 10%): increased blood pressure², an increase in heart rate²

Often (1-10%): palpitations, tachycardia, "hot flashes" (blood), redness of the skin

Infrequent (0.1-1.0%): sensation of cold in the lower limbs

Disorders from the gastrointestinal tract

Very often (> 10%): dry mouth, nausea

Often (1-10%): abdominal pain³, constipation, indigestion, flatulence, vomiting

Disturbances from the skin and subcutaneous tissues

Often (1-10%): rash, hyperhidrosis

Infrequently: (0,1-1,0%): itching, urticaria

Musculoskeletal system disorders

Infrequently (0.1-1.0%): muscle spasms

Disorders from the kidneys and urinary tract

Often (1-10%): dysuria, urinary retention, difficulty in starting urination⁵, frequent urination

Infrequently: (0,1-1,0%): a painful urge to urinate

Violations of the genitals and mammary gland

Often (1-10%): dysmenorrhea⁶, ejaculation disorder⁷, erectile disfunction⁷, prostatitis⁷, pain in the testicles⁷

Infrequently (0.1-1%): lack of ejaculation, violation of the menstrual cycle⁶

General disorders

Often (1-10%): fatigue, chills, weight loss, asthenia, anxiety, irritability, thirst

Infrequently (0.1-1%): sensation of cold

¹Includes the difficulties of falling asleep, restless sleep and early awakening.

²The data are based on measurements of heart rate and blood pressure.

³Includes the phenomena of discomfort in the abdomen, pain and discomfort in the epigastric abdomen, discomfort in the stomach.

⁴Includes sedative effect

⁵Includes jet reduction

⁶The frequency is based on the data of female patients

⁷The frequency is based on the data of male patients

The following side effects were observed in at least 2% of adult patients with a low activity of the isoenzyme CYP2D6 statistically significantly more likely than in patients with high isozyme activity CYP2D6: blurred vision (3.9% and 1.3%, respectively), dry mouth (34.5% and 17.4%, respectively), constipation (11.3% and 6.7%, respectively), a sense of anxiety (4.9% and 1.9% respectively), a decrease in appetite (23.2% and 14.7%, respectively), tremor (5.4% and 1.2%, respectively), insomnia (19.2% and 11.3%, respectively), sleep disorders (6.9% and 3.4% respectively), restless sleep (5.4% and 2.7% respectively), early awakening (3.0% and 0.9%, respectively), urinary retention (5.9% and 1.2%, respectively), erectile dysfunction (20.9% and 8.9%, respectively),violation of ejaculation (6.1% and 2.2%, respectively), increased sweating (14.8% and 6.8%, respectively), cold extremities (3.0% and 0.5%, respectively).

Spontaneous (post-marketing) messages

Violations from the heart and blood vessels

Infrequently (0.1-1%): prolongation of the QT interval

Rarely (> 0.01% and <0.1%): increase blood pressure

Very rarely (<0.01%): peripheral vascular reactions and / or Raynaud's syndrome and risk of exacerbation of Raynaud's syndrome

Disorders from the liver and bile ducts

Infrequently (0.1-1%): increase concentration of bilirubin in children and teenagers

Rarely (> 0.01% and <0.1%): a violation of the liver function, jaundice, hepatitis, liver damage, acute liver failure; increasing the concentration of bilirubin in adults.

Disorders from the kidneys and urinary tract

Very rarely (<0.01%): painful or prolonged erections, pain in the genital area of men, difficulty urinating in children and adolescents, delayed urination in children and adolescents

Disturbances from the nervous system

Infrequently (0.1-1%): migraine, convulsive seizures in children and adolescents

Very rarely (<0.01%): syncope, paresthesia in children and adolescents, hypoesthesia, tics Disorders of the psyche

Rarely (> 0.01% and <0.1%): depression and decreased mood, anxiety

Very rarely (<0.01%) perceptual disturbances, including hallucinations

Disturbances from the skin and subcutaneous tissues

Infrequently (0.1-1%): allergic reactions

Very rarely (<0.01%): hyperhidrosis

General disorders

Very rarely (<0.01%): lethargy

Overdose:

Signs and symptoms. The most frequent symptoms in acute and chronic overdose with atomoxetine were symptoms from the digestive system, drowsiness, dizziness, tremors and behavioral disorders. Also reported on the increase in hyperactivity and the development of excitation. There were signs and symptoms of mild or moderate enhancement of the activity of the sympathetic nervous system (such as tachycardia, increased blood pressure, mydriasis, dry mouth). The severity of most manifestations ranged from mild to moderate. In some cases, with an overdose of several drugs, including atomoxetine, there were convulsions and very rarely - lengthening the interval QT. There have also been reports of deaths of acute overdose with atomoxetine, when it was taken in combination with at least one other drug.

Treatment for overdose. It is recommended to provide ventilation lungs, monitor cardiac activity and vital signs, and symptomatic and supportive treatment. A gastric lavage may be indicated if a little time passes after taking the drug. May be appropriate application of activated carbon to limit absorption. As atomoxetine has a high affinity for plasma proteins, the treatment of an overdose by dialysis will rather be impractical.

Interaction:

Beta2-adrenomimetics. Atomoxetine should be used with caution in patients taking beta2-adrenomimetics, since their effects on the cardiovascular system may increase. In adults, healthy volunteers, the effect of the drug salbutamol in the standard Inhaled dose of 200 μg per hemodynamic parameters was insignificant in comparison with the effect of this dose of salbutamol on intravenous administration. Simultaneous use of Atomoxetine at a dose of 80 mg / day for 5 days did not lead to an increase in these effects of salbutamol. The heart rate after repeated inhalations of salbutamol at a dose of 800 μg was characterized by similar values under conditions of both monotherapy and in combination with atomoxetine.Simultaneous use of atomoxetine with drugs that cause lengthening of the interval QT (neuroleptics, antiarrhythmics, moxifloxacin, erythromycin, tricyclic antidepressants, lithium carbonate), as well as with drugs that cause electrolyte imbalance (diuretics) and inhibitors of isoenzyme CYP2D6 increases the risk of lengthening the interval QT.

Isozymes of cytochrome P450. Atomoxetine does not cause clinically significant inhibition or induction of cytochrome P450 isoenzymes, including isoenzymes CYP1A2, CYP3A, CYP2D6 and CYP2C9. In patients with high isoenzyme activity CYP2D6 its inhibitors increase the equilibrium content of atomoxetine in the blood plasma to a value similar to that of patients with low isoenzyme activity CYP2D6.

Methylphenidate. The concomitant use of methylphenidate with atomoxetine did not increase the effect on the cardiovascular system beyond what was observed with the use of methylphenidate alone.

Drugs affecting blood pressure. Because of the possible effects on blood pressure atomoxetine should be used with caution in combination with antihypertensive or vasopressor agents, as well as other drugs that can increase blood pressure.

Drugs affecting the acidity of gastric juice. Preparations, increasing the pH of gastric juice (antacids containing magnesium or aluminum, omeprazole) do not affect the bioavailability of atomoxetine.

Drugs affecting the secretion of norepinephrine. Drugs that affect the secretion of norepinephrine, should be carefully administered together with atomoxetine because of the possibility of enhancing or weakening its pharmacological effect.

Drugs with high affinity for plasma proteins. Atomoxetine does not affect the binding of warfarin, acetylsalicylic acid, phenytoin and diazepam to human albumin.

Drugs that reduce the threshold of convulsive readiness (antidepressants, antipsychotics, mefloquine, tramadol). Care must be exercised when they are used simultaneously.

Special instructions:

Symptoms of ADHD in the form of impaired attention and hyperactivity (identified in more than one social environment, for example, at home and at school) can manifest as insufficiency concentration, attention, distraction, excessive impatience, impulsivity, disorganization, restlessness and other similar behavioral disorders.The diagnosis of ADHD should be consistent with the accepted diagnostic criteria.

Suicidal thoughts and behavior. Against the background of taking the drug in clinical studies in children and adolescents the likelihood of developing suicidal thoughts. During the course of 12 clinical studies in 2,200 patients (including 1,357 patients, who received atomoxetine and 851 patients receiving a placebo), of them in the group of atomoxetine in 0.37% of cases, development of suicidal thoughts (5 of the 1,357 patients), in the placebo group, suicidal ideation was not detected. In the course of these clinical trials, one suicide attempt was reported, there were no completed suicides. All reactions were observed in children 12 years of age during the first month after the start of treatment. It is not known whether the risk of developing suicidal thoughts persists for a longer period of treatment. In similar studies in adult patients, there was no increase in the risk of suicidal ideation.

Parents and close relatives of children and adolescents treated with Stratter® should carefully monitor the occurrence of unusual behavioral changes, worsening of clinical manifestations,the appearance of suicidal thoughts, especially in the first months of treatment, as well as during the change (both increase and decrease) of the dose of the drug.

When using Stratter ®, the following symptoms were noted: anxiety, agitation, panic attacks, insomnia, irritability, aggressiveness, impulsivity, akathisia, hypomania, mania. Despite the fact that the relationship between the onset of these symptoms and the appearance of suicidal phenomena is not revealed, there is an assumption that such symptoms may be harbingers of the development of suicidal thoughts. If these symptoms appear, you may need to change the dosage regimen, including the possible withdrawal of the drug, especially if they suddenly occur and are significant.

Parents and caregivers should be warned about the need to monitor daily the appearance of excitement, irritability, unusual behavioral changes and other symptoms described above, as well as the occurrence of suicidal thoughts and immediately report such symptoms to the treating physician.

Allergic reactions. In rare cases, patients receiving atomoxetine, there were allergic reactions in the form of rash, angioedema, urticaria.

Inhibitors of monoamine oxidase (MAOI). Atomoxetine should not be used for at least 2 weeks after the abolition of MAOI. Treatment of MAOI should not begin within 2 weeks after the withdrawal of atomoxetine.

Influence on the cardiovascular system. Atomoxetine can affect the heart rate (heart rate) and blood pressure (BP). It is recommended to measure heart rate and blood pressure before starting treatment and then periodically repeat measurements during treatment to identify a clinically significant increase in these indicators. Most patients receiving atomoxetine, there was a slight increase in heart rate (an average of less than 10 beats per minute) and / or an increase in blood pressure (an average of less than 5 mm Hg), which were not clinically significant. Nevertheless, data from clinical studies of ADHD indicate that in some patients (about 5-10% of children and adults) there are clinically significant changes in heart rate (by 20 beats / min and more) and blood pressure (by 15-20 mm Hg. Articles and more). Atomoxetine should be used with caution in patients with concomitant pathology,such as hypertension, tachycardia, other cardiovascular and cerebrovascular disorders, in which the patient's condition may worsen in the event of an increase in blood pressure or heart rate. This drug should not be used in patients with severe cardiovascular disease.

Besides, atomoxetine should be used with caution in patients with congenital or acquired lengthening interval QT (including because of the concomitant drug), or hereditary burden of lengthening the interval QT. Orthostatic hypotension was also reported, so atomoxetine should be used with caution in patients with those diseases in which there may be an arterial hypotension, or sudden changes in blood pressure or heart rate.

Impaired liver or kidney function. Very rarely reported spontaneous observations of liver damage, which was manifested by an increase in the activity of liver enzymes and an increase in the concentration of bilirubin in the blood with the development of jaundice. Also in very rare cases, severe liver damage was reported until the development of acute liver failure.Reception of atomoxetine should be discontinued and not resumed in patients with jaundice or laboratory signs of liver damage.

In clinical studies in adult patients with ADHD, taking atomoxetine, the number of cases of urinary retention was higher in comparison with the placebo group. Complaints about urinary retention can potentially be regarded as the result of the use of atomoxetine.

Convulsive seizures. Use with caution in patients with seizures in the anamnesis. It is necessary to stop receiving atomoxetine in the case of seizures that can not be explained by reasons other than the use of atomoxetine.

Use in children. Insufficient data on the safety and efficacy of atomoxetine in children under 6 years of age. The efficacy of treatment with atomoxetine for more than 18 months and the safety of treatment for more than 2 years have not been systematically evaluated. Application in the elderly. The safety and efficacy of Atomoxetine in elderly patients have not been studied.

Aggressive behavior or hostility. Aggressive behavior or hostility often observed in patients with ADHD. Unambiguous evidence that atomoxetine can cause aggressive behavior or hostility does not exist. However, in clinical trials, aggressive behavior or hostility was more common in children, adolescents and adults taking atomoxetine (without statistically significant differences compared to the placebo group). Patients receiving treatment for ADHD should be observed with regard to their appearance of aggressive behavior or hostility.

Priapism. During post-marketing surveillance in adults and children, rare cases of priapism (persistent painful or painless erections, lasting more than 4 hours) were noted. In cases of suspected priapism, medical attention should be provided immediately.

Influence on height and body weight. In general, the growth and the corresponding increase in the body weight of children taking atomoxetine, occurred more slowly than in the norm, during the first 9-12 months from the beginning of treatment. Anthropometric indicators (body weight and height) after two years of treatment were close to normal. It is necessary to monitor growth rates in patients taking atomoxetine.

Psychotic or manic episodes. In children and adolescents without anamnestic information about the psychotic or manic episodes suffered atomoxetine when taken in usual doses can cause the development of symptoms of these conditions, including hallucinations, delusions and manic mood disorder. In the case of the described symptoms, it is necessary to evaluate the possible role of taking atomoxetine in their development and to decide whether to abolish therapy. Similar symptoms were observed in approximately 0.2% of cases (in 4 patients from 1939 who received atomoxetine for several weeks in usual doses) of therapy with atomoxetine for compared with the absence of such cases among the 1056 patients who received placebo, according to a combined analysis of multiple short-term placebo-controlled trials.

Bipolar disorder. In general, patients receiving therapy for ADHD with concomitant bipolar disorder should pay special attention to the possibility of induction of mixed / manic episodes under the influence of this therapy. Certainly it can not be stated whether the symptoms described above can be caused by such induction.In this regard, patients with existing symptoms of depression should be carefully examined to determine whether there is a risk of developing bipolar disorder before therapy with atomoxetine. Such a survey should include a detailed history of the disease, including a family history of suicide, bipolar disorder and depression.

Delayed urination. In adult patients with ADHD who participated in controlled studies, the frequency of urinary retention (1.7%, 9/540) and difficulty urinating (5.6%, 30/540) was higher in patients taking atomoxetine, compared with patients receiving placebo (0%, 0/402, 0.5%, 2/402, respectively). Two adult patients taking atomoxetine, prematurely dropped out of the study due to a delay in urine, while among those receiving placebo, no such cases were noted. Complaints about urinary retention or difficulty urinating should be considered as potentially associated with taking atomoxetine.

Special populations - in controlled trials in children with ADHD and comorbid chronic motor tics or Tourette's syndrome, in those taking atomoxetine patients showed no worsening of tics compared with placebo-treated patients. AT controlled studies of adolescents with ADHD and comorbid major depressive disorder in those who took atomoxetine patients showed no worsening of the symptoms of depression compared to placebo-treated patients. In two controlled trials (one in children and one in the adult population) of patients with ADHD and comorbid anxiety disorders in those taking atomoxetine patients showed no increase in anxiety compared with placebo-treated patients. During the post-marketing application, there were rare reports of anxiety and depression or worsened mood, and very rare reports of the occurrence of tics. The following symptoms were noted during the reception of atomoxetine: anxiety, agitation, panic attacks, insomnia, irritability, impulsivity, akathisia, hypomania and mania.

Parents and relatives should carefully monitor the occurrence of all of the above symptoms and suicidal thoughts in children and adolescents who receive atomoxetine, and immediately report this to the treating doctor.

Effect on the ability to drive transp. cf.and fur:

Taking the drug may be accompanied by drowsiness. In this regard, patients receiving atomoxetine, care must be taken when managing dangerous mechanical means, including a car, until they are sure that atomoxetine does not cause any violations.

Form release / dosage:

Capsules 10 mg, 18 mg, 25 mg, 40 mg and 60 mg.

Packaging:

7 capsules per blister; 1 blister with instructions for use in a pack of cardboard. 14 capsules per blister; 1 or 2 blisters together with instructions for use in a pack of cardboard.

Storage conditions:

At a temperature of 15-25 ° C, in places inaccessible to children.

List B.

Shelf life:

3 years.

Do not use after the date shown on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-001011

Date of registration:12.10.2011

The owner of the registration certificate:Eli Lilly East SAEli Lilly East SA Switzerland

Manufacturer: & nbsp

LILLY DEL CARIBE, Inc. Puerto Rico

Representation: & nbspELI LILLY EAST SA ELI LILLY EAST SA Switzerland

Information update date: & nbsp03.02.2014

Illustrated instructions

Instructions

Stratter® (Strattera®)