Strattera - Instructions For Use Of The Drug, Reviews, Analogues, Price

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Stratter

Strattera: instructions for use and reviews

1. Release form and composition
2. Pharmacodynamics and pharmacokinetics
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Drug interactions
10. Analogs
11. Terms and conditions of storage
12. Terms of dispensing from pharmacies
13. Reviews
14. Price in pharmacies

Latin name: Strattera

ATX code: N06BA09

Active substance: Atomoxetine

Manufacturer: Lilly del Caribe Inc. (Puerto Rico)

Description and photo update: 2019-05-08

Prices in pharmacies: from 1099 rubles.

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Strattera is a centrally acting sympathomimetic drug that improves brain metabolism.

Release form and composition

Dosage form - capsules: opaque, hard gelatinous, size 3 with indication of dosage and identification code: on white - "10 mg" and "Lilly 3227", on yellow-white - "18 mg" and "Lilly 3238", on blue -white - "25 mg" and "Lilly 3228", on blue - "40 mg" and "Lilly 3229", size No. 2 - blue-yellow, with applied dosage "60 mg" and identification code "Lilly 3239"; the contents of the capsules are almost white to white powder (in blisters: 7 pcs., 1 blister in a cardboard box; 14 pcs., 1 or 2 blisters in a cardboard box).

1 capsule contains:

active substance: atomoxetine (in the form of hydrochloride) - 10 mg, 18 mg, 25 mg, 40 mg or 60 mg;
auxiliary components: pregelatinized starch, dimethicone;
shell composition: sodium lauryl sulfate, titanium dioxide, gelatin.

Additionally, as part of the capsule shell with dosage:

18 mg - iron dye yellow oxide;
25 mg - indigo carmine dye;
40 mg - indigo carmine dye;
60 mg - iron oxide yellow oxide, indigo carmine dye.

Pharmacodynamics and pharmacokinetics

Strattera is a centrally acting sympathomimetic containing the highly selective active ingredient atomoxetine. It belongs to the group of inhibitors of presynaptic norepinephrine transporters. The affinity of the drug for other receptors of the noradrenergic system or other transporters or neurotransmitter receptors is minimal.

Strattera does not belong to psychostimulants and amphetamine derivatives. Conducted clinical studies have not confirmed the severity of symptoms of the disease or other negative effects due to the withdrawal syndrome after the completion of the course of treatment.

When taken orally, atomoxetine is almost completely and at a fairly high rate absorbed into the gastrointestinal tract. At the same time, the time of a meal does not in any way affect its effect on the body. The maximum concentration of this substance in plasma is recorded within 60–120 minutes. Atomoxetine quickly begins to circulate throughout the body and binds well to plasma proteins, especially albumin.

At the first stage, atomoxetine is metabolized in the liver by means of the isoenzyme CYP2D6, and the actively glucuronizing compound 4-hydroxyatomoxetine is released as the main metabolite. This substance is similar in pharmacological action to atomoxetine, but in plasma it is contained in a lower concentration.

In patients with low CYP2D6 activity, 4-hydroxyatomoxetine is synthesized with the participation of other cytochrome P ₄₅₀ enzymes, but this process is longer.

Atomoxetine does not increase the cycle and is not a CYP2D6 inhibitor. When taken orally, the approximate half-life of this substance in patients with an intensive metabolism is 3.6 hours, and in patients with a slow metabolism - 21 hours. Atomoxetine in the form of 4-hydroxyatomoxetine-O-glucuronide is predominantly excreted through the kidneys.

In children over 6 years of age, the pharmacokinetics of the drug is identical to the pharmacokinetics in adult patients.

Indications for use

The use of Strattera is indicated for attention deficit hyperactivity disorder (ADHD) in patients over 6 years of age.

Contraindications

severe heart disease;
simultaneous administration of monoamine oxidase inhibitors (MAO);
angle-closure glaucoma;
hypersensitivity to the components of the drug.

It is recommended to use capsules with caution during breastfeeding, patients with diseases of the cardiovascular system, tachycardia, arterial hypertension, impaired cerebral circulation, with severe physical overload, concomitant use of psychostimulants, a history of seizures, sudden cardiac death in a family history, which can cause arterial hypotension.

The use of the drug during pregnancy is possible if, according to the conclusion of the attending physician, the expected effect of therapy for the mother is higher than the potential threat to the fetus.

Instructions for use of Strattera: method and dosage

Capsules are taken orally in the morning 1 time per day during or after meals. Since atomoxetine is irritating in contact with the eyes, the capsules should be swallowed without breaking the shell.

If undesirable effects occur with a single dose of the drug, the patient can be transferred to the prescribed dose 2 times a day, dividing it into reception in the morning and early in the evening.

Recommended daily dosage:

children and adolescents with a body weight of up to 70 kg: the initial dose is at the rate of 0.5 mg per 1 kg of weight, within three days it is gradually increased to a therapeutic dose of 1.2 mg per 1 kg. In the absence of the desired clinical effect after 2-4 weeks of therapy, the dose can be increased to a maximum daily dose of 1.8 mg per 1 kg. The maintenance daily dose is 1.2 mg per 1 kg. The daily dose should not exceed 120 mg;
patients with a body weight of more than 70 kg: the initial daily dose is 40 mg, within three days it is brought to a therapeutic dose of 80 mg. If there is no improvement in the patient's condition after 2-4 weeks of using the drug, the dose can be increased to the maximum daily dose of 120 mg. The maintenance daily dose is 80 mg.

For moderate hepatic impairment (Child-Pugh class B), the initial and maintenance doses are ½ of the usual dose.

For severe liver dysfunction (Child-Pugh class C), the initial and maintenance doses should be no more than ¼ of the usual dose.

For chronic renal failure, including end-stage renal disease, the usual dosage regimen is used.

There is no systematic assessment of the safety of taking a single and total daily dose of more than 1.8 mg per 1 kg of body weight in children weighing up to 70 kg. The safety of using a single dose of more than 120 mg and a total daily dose of more than 150 mg in patients weighing more than 70 kg has not been established.

Side effects

Undesirable effects that may develop in children and adolescents:

digestive system: very often - vomiting, loss of appetite, abdominal pain (including discomfort in the abdomen and stomach area, discomfort and pain in the epigastrium); often - nausea, constipation, dyspepsia, anorexia (adverse reactions are largely temporary in nature and usually do not require discontinuation of therapy);
nervous system: very often - drowsiness (including sedation); often - dizziness, mood swings, irritability; sometimes - early morning awakening;
cardiovascular system: sometimes - sinus tachycardia, palpitations;
dermatological reactions: often - rash, dermatitis; sometimes itchy skin;
on the part of the organ of vision: often - mydriasis;
others: often - fatigue, flu, weight loss; sometimes weakness.

Side effects of the drug in adults:

digestive system: very often - dry mouth, decreased appetite, nausea; often - constipation, abdominal pain (including discomfort in the abdomen and stomach area, pain and discomfort in the epigastrium), flatulence, dyspepsia;
cardiovascular system: often - tachycardia, palpitations, flushing; infrequently - a feeling of coldness in the lower extremities; very rarely - Raynaud's syndrome, peripheral vascular reactions, the risk of recurrence of Raynaud's syndrome;
nervous system: very often - difficulty falling asleep, insomnia, sleep disturbances in the middle of the night; often - dizziness, decreased libido, sinus headache, poor sleep quality; sometimes - early morning awakening; very rarely syncope;
reproductive system: often - menstrual irregularities, ejaculation disorders, dysmenorrhea, lack of ejaculation, prostatitis, erectile dysfunction, erectile dysfunction; very rarely - prolonged or painful erection, in men - pain in the external genital area;
urinary system: often - urinary retention, dysuria;
dermatological reactions: often - increased sweating, dermatitis;
others: often - chills, fatigue, weight loss.

Overdose

Strattera overdose is characterized by the following symptoms:

excitation;
convulsions (rarely);
behavior disorders;
drowsiness;
activation of the sympathetic nervous system (it is accompanied by dry mouth, mydriasis, tachycardia and other side effects);
hyperactivity;
dyspeptic phenomena.

Usually such manifestations are of mild to moderate severity and quickly regress.

There are isolated cases of acute overdose, which, when using Strattera as an element of combination therapy, were fatal.

As a treatment, the administration of sorbents (activated carbon, etc.), gastric lavage, ventilation of the lungs, as well as further supportive and symptomatic therapy are prescribed. During this period, it is imperative to carry out regular monitoring of cardiac activity and the most important vital signs.

special instructions

It is recommended to prescribe the drug with caution to patients with congenital, hereditary or acquired prolongation of the QT interval.

Diagnosis of ADHD should be carried out in accordance with the criteria of the International Classification of Diseases, 10th revision (ICD-10). Symptoms of the disease in the form of hyperactivity and impaired attention, manifested in more than one social environment (for example, at school and at home) can be expressed as impulsivity, excessive impatience, lack of concentration, distraction, restlessness, disorganization, and other similar behavioral disorders.

If it is necessary to cancel the drug, a gradual decrease in its dose is not required.

Taking the drug in children and adolescents may increase the risk of developing suicidal thoughts.

In rare cases, allergic reactions such as rash, urticaria, angioedema may occur.

In patients with end-stage renal disease, the drug can cause arterial hypertension.

Caution should be exercised when prescribing atomoxetine to patients using MAO inhibitors. You can start taking each of the drugs only after a two-week break after canceling one of them.

A slight increase (up to 10 beats per minute) in heart rate and / or an increase in blood pressure (BP) (up to 5 mm Hg) usually have no clinically significant effect. Development of orthostatic hypotension is possible.

Due to the risk of sudden cardiac death, caution should be exercised with the concomitant use of psychostimulants and severe physical overload should be avoided during the period of atomoxetine use. Atomoxetine should not be prescribed to patients with gross cardiac pathology.

If symptoms of jaundice or laboratory parameters appear that indicate liver dysfunction, treatment should be canceled.

You can not continue taking the drug with the development of seizures that have arisen during therapy with Strattera.

During treatment for ADHD, patients, especially children and adolescents, should be monitored for hostility and aggressive behavior.

In the event of manic and psychotic symptoms such as abnormal mood elevation, hallucinations and / or delusions, it is recommended to see a doctor.

While taking atomoxetine, patients may experience feelings of anxiety, insomnia, agitation, panic attacks, impulsivity, irritability, akathisia. For the timely detection of the development of undesirable effects, patients should be provided with regular monitoring of their behavior by relatives and parents.

In case the powder contained in the capsule gets into the eyes, immediately rinse thoroughly with water, eyes, hands and contact surfaces and consult a doctor.

The effectiveness of atomoxetine use for more than 18 months and the safety of its intake for more than 2 years have not been systematically evaluated.

The safety and efficacy of the drug in children under 6 years of age and elderly patients have not been established.

It is recommended to be careful when driving vehicles and mechanisms, since the effect of the drug may cause drowsiness.

Drug interactions

When combining Strattera with beta ₂ -adrenoreceptor agonists, caution should be exercised, since their effect on the cardiovascular system may be enhanced.

CYP2D6 inhibitors, drugs that cause prolongation of the QT interval (antiarrhythmics, antipsychotics, erythromycin, moxifloxacin, lithium carbonate, tricyclic antidepressants) and disturb the electrolyte balance (diuretics) - increase the risk of an increase in the duration of the QT interval.

Atomoxetine does not have a clinically significant effect on inhibition or induction of isoenzymes of the cytochrome P _{450 system}, including CYP3A, CYP1A2, CYP2D6, CYP2C9.

In patients with slow metabolism of CYP2D6 substrates, concomitant therapy with inhibitors of cytochrome P ₄₅₀ does not affect the concentration of atomoxetine in blood plasma. When treating with CYP2D6 inhibitors, patients are advised to gradually titrate atomoxetine.

Drugs that affect blood pressure should be taken with caution.

Magnesium hydrochloride, omeprazole, aluminum hydroxide, increasing the pH of gastric juice, do not affect the bioavailability of atomoxetine.

With simultaneous use with agents acting on the secretion of norepinephrine, synergism or an increase in the pharmacological effect is possible.

According to the instructions, Strattera does not interfere with the binding of acetylsalicylic acid, warfarin, phenytoin, diazepam to plasma albumin.

Caution should be exercised when atomoxetine is used in combination with antidepressants, neuroleptics, mefloquine, tramadol and other drugs that lower the threshold of seizure activity.

Analogs

The analogues of the Strattera are Fenamin and Concert.

Terms and conditions of storage

Store at 15-25 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Stratter reviews

Reviews of Stratter are represented by completely opposite opinions. Mostly the drug is prescribed for children suffering from attention deficit disorder. According to some parents, this drug played an important role in the adaptation of their child to society and a normal life. At the same time, there are also extremely negative reviews, in which moms and dads are afraid of serious side effects of the drug, which are indeed observed quite often, especially at the beginning of therapy. This may be due to both increased sensitivity of the child to the components of the Strattera, and not quite correctly selected treatment regimen or non-compliance.

Many parents claim that at a certain stage in the life of a child diagnosed with ADHD, they underwent a full course of therapy and were satisfied with its result and the effectiveness of the drug. However, only a specialist should prescribe Stratter, since the success of treatment and its safety have not yet been finally proven.

Stratter price in pharmacies

The price of Strattera in pharmacies varies widely depending on the content of the active ingredient and is:

for 10 mg capsules (7 pcs in a package) - from 1400 to 1650 rubles;
for capsules 18 mg (7 pcs in a package) - from 1,700 to 1950 rubles;
for 25 mg capsules (7 pcs in a package) - from 1,500 to 1,750 rubles;
for 40 mg capsules (7 pcs in a package) - from 1,500 to 1,670 rubles;
for 60 mg capsules (7 pcs in a package) - from 1,500 to 1,700 rubles.

Strattera: prices in online pharmacies

Drug name

Price

Pharmacy

Strattera 10 mg capsule 7 pcs.

1099 RUB

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Strattera 40 mg capsules 7 pcs.

1409 RUB

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Strattera 18 mg capsule 7 pcs.

1412 RUB

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Strattera 25 mg capsules 7 pcs.

1429 RUB

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Strattera 60 mg capsule 7 pcs.

1433 RUB

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Strattera capsules 10mg 7 pcs.

1448 RUB

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Strattera capsules 40mg 7 pcs.

1452 RUB

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Strattera capsules 18mg 7 pcs.

1522 RUB

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Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!