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Atomoxetine is a highly selective potent inhibitor of presynaptic noradrenaline carriers. Atomoxetine has a minimal affinity for other noradrenergic receptors or for 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 symptoms of the disease or any adverse events associated with withdrawal syndrome.
Pharmacokinetics in children and adolescents is similar to adult pharmacokinetics. 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 the maximum concentration (Cmax) in plasma after about 1 to 2 hours. Atomoxetine is prescribed 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 enzyme cycle of cytochrome P450 2D6 (CYP2D6). The main oxidized metabolite formed, 4-hydroxyatomsoxetine, is rapidly glucuronic. 4-hydroxyatomoxetine is equivalent to atomoxetine, but circulates in plasma at much lower concentrations.
Although 4-hydroxyatomsoxetin is primarily formed by CYP2D6, in people with insufficient CYP2D6 activity, 4-hydroxyatomoxetine may be formed by some other enzymes of cytochrome P450, but more slowly.
Atomoxetine does not inhibit and does not enhance the cycle of CYP2D6.
The average half-life of atomoxetine after oral administration is 3.6 hours in patients with a pronounced metabolism and 21 hours in patients with a reduced metabolism. Atomoxetine is mainly excreted in the urine in the form of 4-hydroxyatomoxetine-O-glucuronide.
Attention deficit hyperactivity disorder (ADHD) in children 6 years and older, adolescents and adults.
Each capsule contains:
active ingredient: atomoxetine hydrochloride, equivalent to 10 mg of atomoxetine;
the contents of the capsule are dimethicone, pregelatinized starch;
capsule shell - titanium dioxide, sodium lauryl sulfate, gelatin.
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Dosage and Administration
Orally, regardless of the meal (or during meals), 1 time a day in the morning or, if side effects occur, 2 times a day (in the morning and late afternoon or early evening). Children and adolescents weighing up to 70 kg: the recommended initial daily dose is 0.5 mg / kg, which is increased to 1.2 mg / kg no earlier than after 3 days. If there is no improvement in the condition, the daily dose may be increased to a maximum of 1.8 mg / kg (or 120 mg) not earlier than 2-4 weeks after starting the drug. The recommended maintenance dose is 1.2 mg / kg / day. Children and adolescents weighing more than 70 kg and adults: the recommended initial daily dose is 40 mg, which is increased to 80 mg no earlier than after 3 days. If there is no improvement in the state, the daily dose may be increased to a maximum of 120 mg no earlier than 2-4 weeks after starting the drug. The recommended maintenance dose is 80 mg. In patients with moderate hepatic impairment (Child-Pyuga class B), the initial and maintenance dose is reduced by 50%. In patients with severely impaired liver function (Child-Pyuga class C), the initial and maintenance dose is reduced to 25% of the usual dose.
Kids and teens
From 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. Due to 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: (0.1–1%) - palpitations, sinus tachycardia.
In placebo-controlled studies in children treated with stratter, there was an average increase in heart rate of 6 beats / min, and an average increase in blood pressure and dad - by 2 mm Hg. compared to placebo.
Patients who received atomoxetine had orthostatic hypotension (0.2%, n = 7) and syncope (0.8%, n = 26), due to its effect on noradrenergic tone.
From the side of the central nervous system: 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%) - flu, 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 2 times more often, and also statistically significantly more often than in patients with fast metabolism of substrates of CYP2D6: tremor (5.1 and 1.1%, respectively) , fainting (2.1 and 0.7%, respectively), conjunctivitis (3 and 1.5%, respectively), early morning awakening (3 and 1.1%, respectively), mydriasis (2.5 and 0.7%, respectively) .
In adults, the most frequent side effects associated with taking atomoxetine were noted on the part of the gastrointestinal tract and urogenital tract. No serious adverse events were observed during short or long-term treatment with atomoxetine.
From 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.
From the side of the central nervous system: very often (> 10%) - insomnia (includes difficulty in falling asleep and sleep disorders 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.
Since the cardiovascular system:often (1–10%) - flushing, palpitations, tachycardia; sometimes (0.1–1%) - feeling cold in the lower limbs; very rarely (
In placebo-controlled studies in adults who received stratter, there was an average increase in heart rate of 6 beats / min, an average increase in blood pressure (about 3 mm Hg) and DAD (about 1 mm Hg) compared with placebo.
From the urinary system: often (1–10%) - dysuria, difficulty urinating.
From the reproductive system:often (1–10%) - dysmenorrhea, impaired ejaculation, lack of ejaculation, erectile dysfunction, erectile dysfunction, menstrual disorder, orgasm disorder; very rarely (
On the part of the skin and subcutaneous tissue: often (1-10%) - dermatitis, increased sweating.
Other: often (1–10%) - weakness, drowsiness, chills, weight loss.
In patients with hypertension, tachycardia, cardiovascular diseases, severe physical overload, simultaneous taking of psychostimulants, sudden cardiac death in the family history, cerebrovascular accident, convulsive seizures in history, as well as in conditions that may lead to hypotension
Agonists of beta-adrenergic receptors.
Atomoxetine should be used with caution in patients taking beta2 agonists, since their effects on the cardiovascular system may increase. In adult healthy 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 when administered intravenously. 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 μg was characterized by similar values in terms of monotherapy and in combination with the use of atomoxetine. Simultaneous appointment 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 inhibitors of CYP2D6 increase the risk of prolonging the QT interval.
Enzymes of cytochrome P450. Atomoxetine does not cause clinically significant suppression or induction of cytochrome P450 enzymes, including CYP1A2, CYP3A, CYP2D6 and CYP2C9. In patients with a pronounced metabolism of CYP2D6, CYP2D6 inhibitors increase the constant content of atomoxetine in the blood plasma to a level similar to that in patients with a reduced metabolism of CYP2D6.
In vitro studies suggest that the administration of cytochrome P450 inhibitors to patients with reduced CYP2D6 metabolism does not increase plasma atomoxetine concentration. For patients using CYP2D6 inhibitors, gradual titration of atomoxetine is recommended.
Drugs that affect blood pressure. Because of the possible effects on blood pressure, atomicetine needs to be used with caution when combined with drugs that affect blood pressure.
Drugs that affect the acidity of gastric juice. 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. Drugs that affect the secretion of norepinephrine should be carefully prescribed together with atomoxetine because of the possibility of enhancing or synergizing the pharmacological effect.
Drugs with high affinity for plasma proteins. Atomoxetine does not affect the binding of warfarin, acetylsalicylic acid, phenytoin and diazepam with human albumin.
Preparations with a known effect of lowering the threshold of seizure activity
(antidepressants, antipsychotics, mefloquine, tramadol). Caution must be exercised when administered simultaneously.
Pregnancy and Lactation
Due to the lack of experience with atomoxetine during pregnancy, the drug should be prescribed during pregnancy only if the potential benefit to the patient greatly exceeds the potential risk to the fetus. It is not known whether atomoxetine is secreted in breast milk. Care must be taken when prescribing the drug to a nursing woman.
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) 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.
Suicidal thoughts and behavior. While taking the drug in clinical studies in children and adolescents, the likelihood of suicidal thoughts increased. In 12 clinical trials in 2,200 patients (including 1357 patients receiving atomoxetine and 851 patients receiving placebo), of them in the atomoxetine group in 0.37% of cases development of suicidal thoughts was detected (5 of 1357 patients), in the placebo group suicidal no thoughts were revealed. A single suicide attempt was reported during these clinical trials; there were no completed suicides.
Allergic reactions. In rare cases, patients taking atomoxetine, had allergic reactions in the form of a rash, angioedema, urticaria.
Monoamine oxidase inhibitors (IMA O).Atomoxetine should not be used for at least 2 weeks after the abolition of MAOI. Treatment of MAOIs should not begin within 2 weeks after discontinuation of atomoxetine. The cardiovascular system. Many patients taking atomoxetine showed a slight increase in pulse (on average,
acquired prolongation 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 rough heart disease that violates its structure, an increased risk of sudden cardiac death was detected. Atomoxetine does not belong to the class of psychostimulants, as it has an alternative mechanism of therapeutic action in the treatment of ADHD. Nevertheless, given the overall recorded indication of use (ADHD), caution should be exercised when using atomoxetine in patients with: (1) severe physical overload, (2) simultaneous use of psychostimulants, (3) a family history of sudden cardiac death. Atomoxetine should not be used in patients with gross heart disease.
Impaired liver or kidney function. Rare cases of serious liver damage have been reported with 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 with the placebo group. Complaints of urinary retention can potentially be regarded as the result of the use of atomoxetine.
Use with caution in patients with convulsive seizures in history.You must stop taking atomoxetine in the event of seizures that cannot be explained by other reasons.
Use in children. There is not enough data on the safety and efficacy of atomoxetine in children under 6 years of age.
The effectiveness of treatment with atomoxetine for more than 18 months and the safety of treatment for more than 2 years have not been systematically evaluated.
Use in the elderly. Safety and efficacy of atomoxetine in elderly patients has not been established.
Aggressive behavior or hostility. 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 should be monitored for aggressive behavior or hostility.
Psychotic and manic symptoms.
We are aware of the occurrence 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 withdrawing the drug.
The following symptoms were noted while taking atomoxetine: anxiety, agitation, panic attacks, insomnia, irritability, impulsivity, akathisia. Patients taking atomoxetine should be seen by a doctor regarding the development of these symptoms.
Parents and loved ones 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.
Driving a car and performing work requiring increased attention
The drug may be accompanied by drowsiness. In this regard, patients taking atomoxetine, should be careful when driving hazardous mechanical means, including the car, until they are sure that atomoxetine does not cause any disturbances.
Signs and symptoms. The most frequent symptoms in acute and chronic overdose with atomoxetine monotherapy were drowsiness, agitation, hyperactivity, behavioral disturbances and symptoms of the gastrointestinal tract. Most of the manifestations were mild and moderate. There were also signs and symptoms of mild to moderate sympathetic nervous system activation (for example, mydriasis, tachycardia, dry mouth). All patients had regression of this kind of symptoms. In some cases, overdose with atomoxetine caused convulsions. Cases of acute overdose with a fatal outcome have also been reported when taking atomoxetine in combination with at least one other drug.
Treatment with overdose.It is recommended to provide ventilation of the lungs, to monitor cardiac activity and basic 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 useful to limit absorption. Since atomoxetine has a high affinity for plasma proteins, treatment of overdose by dialysis is more likely to be impractical.
- Brand name: Strattera
- Active ingredient: Atomoxetine
- Dosage form: Capsules
- Manufacturer: Eli lilly
- Country of Origin: USA
- Synthesis and Biological Evaluation of the Major Metabolite (VI) of Atomoxetine: Elucidation of a Partial ϰ-Opioid Agonist Effect.
- Synthesis of the carbon-14 labeled isotopomers of (R)-N-methyl-3-[2-methylphenoxyl]-benzenepropanamine hydrochloride (atomoxetine hydrochloride, LY139603), and two of its metabolites
- Structural determination of the stable and meta-stable forms of atomoxetine HCl using single crystal and powder X-ray diffraction methods
- Atomoxetine for the treatment of executive dysfunction in Parkinson's disease: A pilot open-label study
- Population pharmacokinetic analysis of atomoxetine in pediatric patients
- Pharmacokinetics and tolerability of atomoxetine in adults of known CYP2D6 phenotype
- Sensitive quantification of atomoxetine in human plasma by HPLC with fluorescence detection using 4-(4,5-diphenyl-1H-imidazole-2-yl) benzoyl chloride derivatization
- A new high performance liquid chromatographic method for quantification of atomoxetine in human plasma and its application for pharmacokinetic study
- Determination of atomoxetine in human plasma by a high performance liquid chromatographic method with ultraviolet detection using liquid–liquid extraction
- Simultaneous quantification of atomoxetine as well as its primary oxidative and O-glucuronide metabolites in human plasma and urine using liquid chromatography tandem mass spectrometry (LC/MS/MS)
- Determination of the enantiomer and positional isomer impurities in atomoxetine hydrochloride with liquid chromatography using polysaccharide chiral stationary phases
- A quality by design approach to impurity method development for atomoxetine hydrochloride (LY139603)
- Biocatalytic synthesis towards both antipodes of 3-hydroxy-3-phenylpropanitrile a precursor to fluoxetine, atomoxetine and nisoxetine
- Comparative efficacy and acceptability of methylphenidate and atomoxetine in treatment of attention deficit hyperactivity disorder in children and adolescents: a meta-analysis
- A modelled economic evaluation comparing atomoxetine with methylphenidate in the treatment of children with attention-deficit/hyperactivity disorder in Spain
- A pilot study for augmenting atomoxetine with methylphenidate: safety of concomitant therapy in children with attention-deficit/hyperactivity disorder
- Emotional well-being in children and adolescents treated with atomoxetine for attention-deficit/hyperactivity disorder: Findings from a patient, parent and physician perspective using items from the pediatric adverse event rating scale (PAERS)
- Acute atomoxetine treatment of younger and older children with ADHD: A meta-analysis of tolerability and efficacy
- Atomoxetine treatment and ADHD-related difficulties as assessed by adolescent patients, their parents and physicians
- Atomoxetine for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children with ADHD and dyslexia
- Morning and evening behavior in children and adolescents treated with atomoxetine once daily for Attention-Deficit/Hyperactivity Disorder (ADHD): Findings from two 24-week, open-label studies
- Differences between children and adolescents in treatment response to atomoxetine and the correlation between health-related quality of life and Attention Deficit/Hyperactivity Disorder core symptoms: Meta-analysis of five atomoxetine trials
- Time courses of improvement and symptom remission in children treated with atomoxetine for attention-deficit/hyperactivity disorder: analysis of Canadian open-label studies
- Outcomes of OROS® methylphenidate compared with atomoxetine in children with ADHD: A multicenter, randomized prospective study