Strattera capsules 18mg, No. 7

Attention deficit hyperactivity disorder (ADHD) in children 6 years of age and older, adolescents and adults.

For oral administration.

StratteraЃ can be administered as a single daily dose in the morning. In the event of adverse events occurring when taking the drug as a single daily dose, patients can be advised to take the drug twice a day, dividing the dose into a morning dose and a late afternoon or early evening dose.

Children and adolescents weighing up to 70 kg. The recommended initial daily dose is approximately 0.5 mg / kg and is increased to a therapeutic daily dose of approximately 1.2 mg / kg no earlier than 3 days later. If there is no improvement in the patient's condition, the total daily dose can be increased to a maximum dose of 1.8 mg / kg no earlier than 2-4 weeks after starting 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 is increased to a therapeutic daily dose of about 80 mg no earlier than 3 days later. If there is no improvement in the patient's condition, the total daily dose can 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.

Treatment should be supervised by a physician experienced in ADHD patients. StratteraЃ can be taken with or without food. Cancellation of the drug does not require a gradual dose reduction.

StratteraЃ capsules are not intended to be opened. Atomoxetine 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.

Each capsule contains:
active substance: atomoxetine hydrochloride, equivalent to 18 mg of atomoxetine;
excipients:
capsule contents - dimethicone, pregelatinized starch;
capsule shell - titanium dioxide, sodium lauryl sulfate, gelatin, iron dye yellow oxide (only for capsules 18 mg and 60 mg)

? Hypersensitivity to the drug

? Concomitant use with monoamine oxidase inhibitors (MAOIs) (see section 'Special instructions')

? Closed-angle glaucoma

? Severe heart damage

With caution
In patients with hypertension, tachycardia, cardiovascular diseases, severe physical overload, concomitant use of psychostimulants, family history of sudden cardiac death, cerebrovascular accident, seizures in history, as well as conditions that can lead to hypotension (see . section 'Special instructions').

Trade name of the drug: StratteraЃ

International Non-Proprietary Name (INN): Atomoxetine

Chemical name: (-) - N-Methyl-3-phenyl-3- (o-tolyloxy) -propylamine hydrochloride

Dosage form
Capsules

Composition
Each capsule contains:
active substance: atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg or 60 mg of atomoxetine;
excipients:
capsule contents - dimethicone, pregelatinized starch;
capsule shell - titanium dioxide, sodium lauryl sulfate, gelatin, iron oxide yellow dye (only for 18 mg and 60 mg capsules), indigo carmine dye (only for 25 mg, 40 mg and 60 mg capsules).

Description
Capsules 10 mg: opaque, white / white, hard gelatin capsules (size 3) with a dosage of '10 mg' applied and the identification code 'Lilly 3227';
Capsules 18 mg: opaque, yellow / white, hard gelatin capsules (size 3) with a dosage of '18 mg' applied and the identification code 'Lilly 3238';
25 mg capsules: opaque, blue / white, hard gelatin capsules (size 3) with a 25 mg dosage and an identification code Lilly 3228;
Capsules 40 mg: opaque, blue / blue, hard gelatin capsules (size 3) coated with a dosage of '40 mg' and identification code 'Lilly 3229';
60 mg capsules: opaque, blue / yellow, hard gelatin capsules (size 2), coated with a 60 mg dosage and the identification code Lilly 3239.

Contents of all capsules: powder from white to almost white.

Pharmacotherapeutic group
Centrally acting sympathomimetic agent.

Pharmacological properties
Pharmacodynamics
Atomoxetine is a highly selective potent inhibitor of presynaptic norepinephrine transporters. Atomoxetine has minimal affinity for other noradrenergic receptors or other neurotransmitter transporters or receptors.

Atomoxetine is not a psychostimulant and is not an amphetamine derivative. In clinical studies, when the drug was discontinued, there was no increase in the symptoms of the disease or any adverse events associated with the withdrawal syndrome.

Pharmacokinetics
Pharmacokinetics in children and adolescents are similar to those in adults. The pharmacokinetics of atomoxetine in children under 6 years of age has not been studied.

Suction. Atomoxetine is rapidly and almost completely absorbed after oral administration, reaching a maximum plasma concentration (Cmax) after about 1 to 2 hours. Atomoxetine is prescribed with or without food.

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

Metabolism. Atomoxetine is primarily biotransformed through the cytochrome P450 2D6 (CYP2D6) enzyme cycle. The main oxidized metabolite formed, 4-hydroxyatomoxetine, is rapidly glucuronized. 4-hydroxyatomoxetine is equivalent in action to atomoxetine, but circulates in plasma at much lower concentrations.

Although 4-hydroxyatomoxetine is produced primarily by CYP2D6, in people with insufficient CYP2D6 activity, 4-hydroxyatomoxetine can be produced by some other cytochrome P450 enzymes, but more slowly.

Atomoxetine does not inhibit or enhance the CYP2D6 cycle.

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

Indications for use
Attention deficit hyperactivity disorder (ADHD) in children 6 years of age and older, adolescents and adults.

Contraindications

? Hypersensitivity to the drug

? Concomitant use with monoamine oxidase inhibitors (MAOIs) (see section 'Special instructions')

? Closed-angle glaucoma

? Severe heart damage

With caution
In patients with hypertension, tachycardia, cardiovascular diseases, severe physical overload, concomitant use of psychostimulants, family history of sudden cardiac death, cerebrovascular accident, seizures in history, as well as conditions that can lead to hypotension (see . section 'Special instructions').

Application during pregnancy and breastfeeding
Due to insufficient experience with atomoxetine during pregnancy, the drug should be prescribed during pregnancy only if the potential benefit to the patient significantly outweighs the potential risk to the fetus.

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

Method of administration and dosage
For oral administration.

StratteraЃ can be administered as a single daily dose in the morning. In the event of adverse events occurring when taking the drug as a single daily dose, patients can be advised to take the drug twice a day, dividing the dose into a morning dose and a late afternoon or early evening dose.

Children and adolescents weighing up to 70 kg. The recommended initial daily dose is approximately 0.5 mg / kg and is increased to a therapeutic daily dose of approximately 1.2 mg / kg no earlier than 3 days later. If there is no improvement in the patient's condition, the total daily dose can be increased to a maximum dose of 1.8 mg / kg no earlier than 2-4 weeks after starting 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 is increased to a therapeutic daily dose of about 80 mg no earlier than 3 days later. If there is no improvement in the patient's condition, the total daily dose can 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.

Treatment should be supervised by a physician experienced in ADHD patients. StratteraЃ can be taken with or without food. Cancellation of the drug does not require a gradual dose reduction.

StratteraЃ capsules are not intended to be opened. Atomoxetine 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.

Special groups of patients
Liver failure. 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.

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

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

Side effect
Children and adolescents

Abdominal pain and decreased appetite are the side effects most often associated with atomoxetine (18% and 16% of patients, respectively), but they usually do not require discontinuation of the drug. These side effects are usually temporary.

Due to decreased appetite, some patients lost weight at the beginning of treatment (average of about 0.5 kg), and weight loss was greater at higher doses. After initial weight loss in patients taking atomoxetine, there was a slight increase in weight with prolonged therapy. Growth indicators (weight and height) after two years of treatment were close to normal.

Nausea and vomiting may occur in approximately 9% and 11% of patients, respectively, especially during the first month of treatment. However, these episodes were usually mild to moderate, were temporary, and did not cause treatment withdrawal in a significant number of cases.

In placebo-controlled studies in children treated with atomoxetine, there was an average increase in heart rate of 6, an average increase in systolic and diastolic pressure of 2 mm Hg. Art. compared to placebo. In placebo-controlled studies in adults who received atomoxetine, there was an average increase in heart rate of 6 beats / min, and an average increase in systolic (about 3 mmHg) and diastolic (about 1 mmHg) pressure compared with placebo ...

Patients receiving atomoxetine had orthostatic hypotension (0.2%, N = 7) and syncope (0.8%, N = 26) due to its effect on noradrenergic tone. Atomoxetine should be used with caution in any condition that could lead to hypotension.

Adults

In adults, the most frequent side effects associated with taking atomoxetine were from the gastrointestinal and urogenital tract. No serious adverse events were observed during short or long term treatment with atomoxetine.

Overdose
Signs and symptoms. The most common symptoms in acute and chronic overdose with atomoxetine monotherapy were drowsiness, agitation, hyperactivity, behavioral disturbances, and gastrointestinal symptoms. Most of the manifestations were mild to moderate. Signs and symptoms of mild to moderate sympathetic nervous system activation (eg, mydriasis, tachycardia, dry mouth) have also been reported. All patients showed regression of this kind of symptomatology. In some cases, convulsions have been reported with atomoxetine overdose. Cases of acute fatal overdose have also been reported when atomoxetine was taken in combination with at least one other drug.

Overdose treatment

It is recommended to provide ventilation of the lungs, monitor cardiac activity and vital signs, as well as symptomatic and supportive treatment. Gastric lavage may be indicated if not much time has passed after taking the drug. Activated carbon may be helpful to limit absorption. Since atomoxetine has a high affinity for plasma proteins, treatment of an overdose by dialysis is likely to be inappropriate.

Interaction with other medicinal products
Beta-adrenergic receptor agonists.

Atomoxetine should be used with caution in patients taking beta2 agonists, as their effects on the cardiovascular system may increase. In healthy adult volunteers, the effect of salbutamol in a standard inhaled dose of 200 ?g on hemodynamic parameters was insignificant compared to the effect of the indicated dose of this drug when administered intravenously. The simultaneous use of atomoxetine at a dose of 80 mg / day for 5 days did not lead to an increase in the indicated effects of albuterol. The heart rate after repeated inhalations of 800 ?g albuterol was characterized by similar values ??under the conditions of both monotherapy and in combination with the use of atomoxetine. Simultaneous administration of atomoxetine with drugs that cause prolongation of the QT interval (antipsychotics, antiarrhythmic drugs,moxifloxacin, erythromycin, tricyclic antidepressants, lithium carbonate), as well as drugs that cause electrolyte imbalance (diuretics) and CYP2D6 inhibitors increase the risk of QT prolongation.

Cytochrome P450 enzymes. Atomoxetine does not cause clinically significant suppression or induction of cytochrome P450 enzymes, including CYP1A2, CYP3A, CYP2D6, and CYP2C9. In patients with a pronounced CYP2D6 metabolism, CYP2D6 inhibitors increase the constant content of atomoxetine in the blood plasma to a level similar to that in patients with a reduced CYP2D6 metabolism.

In vitro studies suggest that administration of cytochrome P450 inhibitors to patients with reduced CYP2D6 metabolism does not increase the plasma concentration of atomoxetine. Gradual titration of atomoxetine is recommended for patients using CYP2D6 inhibitor drugs.

Drugs that affect blood pressure. Due to the possible effect on blood pressure, atomoxetine should be used with caution when combined with drugs that affect blood pressure.

Drugs that affect the acidity of gastric juice. Drugs 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. Drugs that affect the secretion of norepinephrine should be used with caution in conjunction with atomoxetine because of the possibility of an increase or synergy of the pharmacological effect.

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

Drugs with a known effect of lowering the seizure threshold

(antidepressants, antipsychotics, mefloquine, tramadol). Care must be taken with simultaneous administration.

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 lack of concentration, distraction, excessive impatience, impulsivity, disorganization, restlessness, and other similar behavioral disorders. A diagnosis of ADHD must meet the ICD-10 criteria.

Suicidal thoughts and behavior. While taking the drug in clinical studies in children and adolescents, the likelihood of developing suicidal thoughts increased. In 12 clinical studies in 2200 patients (including 1357 patients who received atomoxetine and 851 patients who received placebo), of which in the atomoxetine group, in 0.37% of cases, the development of suicidal thoughts was revealed (5 out of 1357 patients), in the placebo group, suicidal thoughts were not revealed. In the course of these clinical studies, one suicide attempt was reported, there were no completed suicides.

Allergic reactions. In rare cases, patients taking atomoxetine experienced allergic reactions such as rash, angioedema, urticaria.

Monoamine oxidase inhibitors (IMA O).Atomoxetine should not be used for at least 2 weeks after discontinuation of MAOIs. Treatment with MAOIs should not begin within 2 weeks after discontinuation of atomoxetine. The cardiovascular system. In many patients taking atomoxetine, there was a slight increase in heart rate (on average, <10 beats / min) and / or an increase in blood pressure (on average, <5 mm Hg). In most cases, these changes did not have a clinically significant effect. Atomoxetine should be used with caution in patients with hypertension, tachycardia, cardiovascular disease or cerebrovascular accident. Cases of orthostatic hypotension have also been reported. Use with caution in conditions that may lead to hypotension. Use with caution in patients with hereditary, congenital or

acquired lengthening of the QT interval.

Against the background of the use of psychostimulants registered for the treatment of ADHD in the United States in children with a gross pathology of the heart that violates its structure, an increased risk of sudden cardiac death was revealed. Atomoxetine does not belong to the class of psychostimulants, as it has an alternative mechanism of therapeutic action in the treatment of ADHD. However, given the common reported indication for use (ADHD), caution should be exercised when using atomoxetine in patients with: (1) severe physical overload, (2) concomitant use of psychostimulants, (3) a family history of sudden cardiac death. Atomoxetine should not be used in patients with gross heart disease.

Ќарушение функции печени или почек. —ообщалось о редких случа¤х серьезных повреждений печени на фоне приема атомоксетина (описаны два случа¤ выраженного повышени¤ уровн¤ ферментов печени и билирубина на 2 миллиона пациентов). ” пациентов с про¤влени¤ми желтухи или вы¤вленными лабораторными показател¤ми, свидетельствующими о нарушении функции печени, лечение атомоксетином необходимо отменить.

¬ клинических исследовани¤х у взрослых пациентов с —?¬v, принимающих атомоксетин, количество случаев задержки мочеиспускани¤ было выше в сравнении с группой плацебо. ?алобы на задержку мочеиспускани¤ потенциально могут расцениватьс¤ как результат применени¤ атомоксетина.

ѕримен¤ть с осторожностью у пациентов с судорожными припадками в анамнезе. Ќеобходимо прекратить прием атомоксетина в случае развити¤ припадков, которые не могут быть объ¤снены иными причинами.

ѕрименение у детей. Ќет достаточно данных о безопасности и эффективности атомоксетина у детей до 6 лет.

Ёффективность лечени¤ атомоксетином более 18 мес¤цев и безопасность лечени¤ им более 2 лет не были оценены систематически.

ѕрименение у пожилых. Ѕезопасность и эффективность атомоксетина у пожилых больных не установлена.

јгрессивное поведение или враждебность. јгрессивное поведение или враждебность часто наблюдаютс¤ у детей и подростков с —?¬v. Ќеопровержимых доказательств того, что атомоксетин может вызывать агрессивное поведение или враждебность не существует. ќднако в ходе клинических исследований агрессивное поведение или враждебность наблюдались чаще у детей и подростков, принимающих атомоксетин (без статистически достоверных различий по сравнению с группой плацебо). ѕациенты, получающие лечение по поводу —?¬v, должны наблюдатьс¤ в отношении по¤влени¤ у них агрессивного поведени¤ или враждебности.

ѕсихотические и маниакальные симптомы.

»звестно о случа¤х возникновени¤ психотических и маниакальных симптомов, включа¤ галлюцинации, бред и патологический подъем настроени¤, на фоне применени¤ атомоксетина в терапевтических дозах у детей и подростков. ѕри возникновении указанных симптомов, рекомендуетс¤ оценить степень их св¤зи с приемом атомоксетина и при необходимости рассмотреть вопрос об отмене препарата.

—ледующие симптомы были отмечены на фоне приема атомоксетина: тревога, ажитаци¤, панические атаки, бессонница, раздражительность, импульсивность, акатизи¤. ѕациенты, принимающие атомоксетин, должны наблюдатьс¤ у врача в отношении развити¤ данных симптомов.

–одители и близкие должны тщательно отслеживать по¤вление всех вышеперечисленных симптомов и суицидальных мыслей у детей и подростков, принимающих атомоксетин и немедленно сообщать об этом лечащему врачу.

¬ождение автомобил¤ и выполнение работ, требующих повышенного внимани¤
ѕрием препарата может сопровождатьс¤ сонливостью. ¬ св¤зи с этим пациентам, принимающим атомоксетин, следует про¤вл¤ть осторожность при управлении опасными механическими средствами, в том числе автомобилем, до тех пор, пока они не будут уверены, что атомоксетин не вызывает никаких нарушений.

‘орма выпуска
 апсулы 10 мг, 18 мг, 25 мг, 40 мг и 60 мг.

”паковка:
ѕо 7 капсул в блистер; по 1 блистеру вместе с инструкцией по применению в пачке картонной.

ѕо 14 капсул в блистер; по 1 или 2 блистера вместе с инструкцией по применению в пачке картонной.

”слови¤ хранени¤
ѕри температуре 15-25?—, в местах недоступных дл¤ детей.

—писок Ѕ.

—рок годности
3 года.

Do not use after the date printed on the package.

Terms of dispensing from pharmacies
Prescription.