Strattera (capsule form) corresponds to the psychoanaleptic group. The instructions for use highlight the following features:
- Sold by prescription only
- During pregnancy: with caution
- When breastfeeding: with caution
- In childhood: with caution
- For violations of liver function: with caution
- In case of impaired renal function: you can
- In old age: contraindicated
Composition
1 capsule may contain 10; 18; 25; 40; or 60 mg of atomoxetine (in the form of hydrochloride) – the active ingredient.
Additional ingredients: pregelatinized starch, dimethicone, titanium dioxide, gelatin, sodium lauryl sulfate, dyes: yellow iron oxide (capsules 18 and 60 mg), indigo carmine (capsules 25, 40 and 60 mg).
Release form
The https://stop-adhd-meds.com/ is available in the form of capsules of various colors depending on the mass content of the active ingredient, 7 each; 14 or 28 pieces per pack.
Pharmachologic effect
Sympathomimetic.
Pharmacodynamics and pharmacokinetics
Strattera belongs to the group of centrally acting sympathomimetics with a powerful highly selective active ingredient – atomoxetine, which is an inhibitor of presynaptic norepinephrine transporters. The drug has a minimal affinity for other receptors of the noradrenergic system or for other receptors or transporters of neurotransmitters. Strattera is not a psychostimulant drug and is not an amphetamine derivative. In clinical trials, withdrawal of therapy did not lead to any intensification of the manifestations of the disease or to negative symptoms associated with a withdrawal syndrome.
When taken orally, atomoxetine is almost completely and rapidly absorbed in the gastrointestinal tract (regardless of the meal time). Plasma Cmax is observed after 60-120 minutes. The distribution in the body is quite extensive. It binds well to plasma proteins, especially albumin.
The primary metabolism of atomoxetine occurs in the liver using the isoenzyme CYP2D6 and with the release of the main rapidly glucuronizing metabolic product, 4-hydroxyatomoxetine. 4-hydroxyatomoxetine in its pharmacological activity is equivalent to atomoxetine, but exhibits lower plasma concentrations.
In people with low CYP2D6 activity, the function of 4-hydroxyatomoxetine formation is taken over by some other isozymes of cytochrome P450, but this takes longer. Atomoxetine does not increase the cycle and does not inhibit CYP2D6.
When taken orally, the average T1 / 2 of atomoxetine in patients with a fast metabolism is 3.6 hours, and in patients with a slower metabolism – 21 hours. The main route of elimination of atomoxetine in the form of 4-hydroxyatomoxetine-O-glucuronide is via the kidneys.
The pharmacokinetics of the drug in childhood after 6 years is similar to the pharmacokinetics of adult patients.
Indications for use
The drug Strattera is indicated for ADHD (attention deficit hyperactivity disorder) observed in adult patients, as well as in children after 6 years of age.
Contraindications
Reception of Strattera is absolutely contraindicated for:
- heart lesions of a serious nature;
- hypersensitivity to atomoxetine or other drug ingredients;
- angle-closure glaucoma;
- concurrent treatment with MAO inhibitors;
- under the age of 6.
The drug should be prescribed with caution when:
- conditions that can cause arterial hypotension;
- tachycardia;
- arterial hypertension;
- cardiovascular disease;
- activities associated with heavy physical exertion;
- a family history of seizures or sudden cardiac death;
- joint treatment with psychostimulants;
- circulatory disorders of the brain.
Side effects
Children over 6 years old:
When taking atomoxetine, the most often observed decrease in appetite (16%) and abdominal pain (18%), which, as a rule, were temporary and did not require discontinuation of treatment.
Due to a decrease in appetite, at the beginning of therapy, some patients had a slight weight loss (on average 0.5 kg), which increased with increasing dosages of the drug. However, after initial weight loss and with further prolonged therapy, a slight increase was recorded. After 2 years of taking Strattera, the growth and weight of the patients were not far from normal.
Vomiting and nausea, especially during the first month of therapy, were observed in 11% and 9% of patients, respectively. As in the previous case, these symptoms were most often temporary, mild and did not affect the continuation of treatment.
In a randomized study among children taking atomoxetine, compared with patients receiving placebo, there was an average increase in heart rate of 6 beats / min, and an average increase in diastolic and systolic pressure by 2 mm Hg. Art.
The study also revealed the occurrence of syncope (0.8%, N = 26) and orthostatic hypotension (0.2%, N = 7) in patients in the atomoxetine group, due to its effect on noradrenergic tone.
In this regard, the appointment of all drugs containing atomoxetine, in any conditions of increased risk of hypotension, should be carried out with special precautions.
Below, in percentage of occurrence (%), are the side effects that were observed in patients of this age category.
With a frequency of more than 10%: feeling of nausea; decreased appetite; vomiting; stomach ache.
With a frequency of 1-10%: influenza; anorexia; early awakening in the morning; increased irritability; mood disorders; dizziness; mydriasis; drowsiness; changes in cardiac activity; constipation; dermatitis; dyspepsia; itching; fatigue; rash; decrease in body weight.
With a frequency of 0.1-1%: sinus tachycardia; heartbeat.
Adult patients:
In the treatment of adult patients, side effects associated with the gastrointestinal tract and the urogenital tract were most often observed. No severe negative manifestations were observed during therapy with atomoxetine at any time interval.
In a randomized study among adults taking atomoxetine, compared with patients receiving placebo, there was an average increase in heart rate of 6 beats / min, and an average increase in diastolic and systolic pressure by 1 and 3 mm Hg. Art. respectively.
Below, in percentage of occurrence (%), are the side effects that were observed in patients of this age category.
With a frequency of more than 10%: decreased appetite; insomnia; nausea; dryness in the mouth.
With a frequency of 1-10%: decreased libido; weight loss; early awakening in the morning; violation of both the sleep itself and its quality; dizziness; tachycardia; sinus headaches; palpitations; hot flashes (blood); weakness; chills; drowsiness; abdominal pain, dermatitis; constipation, hyperhidrosis; dyspepsia, urinary retention; flatulence; Difficulty urinating violation or absence of ejaculation and erection; dysmenorrhea; shift in the menstrual cycle; prostatitis; violation of orgasm.
With a frequency of 0.1-1.0%: a feeling of coldness in the lower extremities.
With a frequency of less than 0.01%: peripheral vascular reactions and / or Raynaud’s syndrome, as well as an increased risk of its recurrence; prolonged or painful erection.
In any age group, in 2% of patients with insufficient metabolism of CYP2D6, side effects were observed 2 times more often.
Strattera, instructions for use
Capsules of the drug Strattera are intended for oral (inside) administration (without opening), once every 24 hours.
Therapy should only be carried out under the supervision of an experienced physician who specializes in treating ADHD patients.
If negative reactions occur in the case of a single daily intake of capsules, it is possible to divide the dosage by 2 times every 24 hours (preferably after 12 hours). In this case, it may be necessary to select capsules with a different dosage of the active ingredient.
Cancellation of treatment with Strattera does not lead to a withdrawal syndrome and therefore does not require a phased dose reduction.
The average recommended initial daily dosage for children weighing less than 70 kilograms is 500 mcg / kg and is increased to a therapeutic dose of 1.2 mg / kg (maintenance dose) no earlier than 72 hours later. In the absence of significant efficacy, it is possible to increase the dosage to 1.8 mg / kg (maximum dose), but not earlier than 14-28 days after the start of treatment. The effect of a dose over 1.8 mg / kg on patients in this age group has not been evaluated.
The average recommended initial daily dosage for children weighing more than 70 kilograms and adult patients is 40 mg and is increased to a therapeutic dose of 80 mg (maintenance dose) no earlier than 72 hours later. In the absence of significant efficacy, it is possible to increase the dosage to 120 mg (maximum dose), but not earlier than 14-28 days after the start of treatment. The effect of a single dose over 120 mg and a daily dose over 150 mg on patients in this age group has not been evaluated.
In case of moderate liver pathologies (class B according to Child-Pugh), all dosages of Strattera are halved, and in the case of severe manifestations of pathology (class C according to Child-Pugh) – four times.
In severe renal pathologies, the elimination of atomoxetine occurs more slowly, however, adjusting the dosage of Strattera did not lead to significant differences in pharmacokinetics. In this regard, in chronic renal failure, including the terminal stage of pathology, the usual dosage regimen can be used, but with an increased risk of arterial hypertension.
Overdose
In case of an overdose with Strattera, signs of drowsiness, behavioral disturbances, agitation, dyspeptic symptoms, hyperactivity, activation of the sympathetic nervous system (tachycardia, mydriasis, dry mouth, etc.), and sometimes convulsions were observed. Typically, these manifestations were mild or moderate and regressed.
There are also reports of episodes of acute overdose, which were fatal when taking Strattera in combination treatment.
The prescribed treatment consists of gastric lavage, intake of sorbents, ventilation of the lungs and further supportive and symptomatic therapy. All procedures are carried out against the background of monitoring cardiac activity and the most important vital signs.
Interaction
Concomitant use with MAO inhibitors should be excluded.
Parallel administration with β2-adrenergic receptor agonists can lead to an increase in their effect on the cardiovascular system, which requires caution in joint use.
Combined therapy with drugs that prolong the QT interval (antiarrhythmics, antipsychotics, Erythromycin, Moxifloxacin, tricyclic antidepressants, lithium carbonate), diuretics (diuretics) and CYP2D6 inhibitors) can lead to a prolongation of the QT interval.
When taking Strattera, no significant induction or inhibition of cytochrome P450 was noted. In patients with pronounced metabolism of CYP2D6, inhibitors of this substrate increased the plasma CSS of atomoxetine to the level observed in patients with slow metabolism.
According to in vitro studies, the use of cytochrome P450 inhibitors in patients with insufficient metabolism of CYP2D6 should not affect the plasma concentration of atomoxetine. Although when taking CYP2D6 inhibitors, gradual titration of Strattera dosages is advised.
Careful use of Stratters requires painful conditions associated with blood pressure disorders, as well as the parallel use of drugs that affect this indicator.
The bioavailability of atomoxetine does not depend on the intake of drugs that increase the pH of gastric juice (Omeprazole, aluminum hydroxide, magnesium hydrochloride).
Atomoxetine does not affect the relationship with albumin of drugs such as: Diazepam, Warfarin, phenytoin and acetylsalicylic acid.
Due to the possible increase in efficacy, care should be taken to jointly prescribe Strattera and drugs that affect the secretion of norepinephrine.
Combined treatment with drugs that reduce seizure activity (Tramadol, antidepressants, Mefloquine, antipsychotics) increases the risk of seizures.
Terms of sale
You can buy Strattera only upon presentation of a prescription.
Storage conditions
The temperature indicators for the storage of capsules should be within 15-25 ° C.
Shelf life
From the date of production – 3 years.
Special instructions
The substance atomoxetine can irritate the eyes, therefore, if it gets on the mucous membranes of the eyes, immediately rinse them with water and inform your doctor about it. Also, washing with water is required for all skin surfaces in contact with atomoxetine.
Caution in the use of Stratters is required by patients with prolonged QT-interval.
A diagnosis of ADHD must be made in accordance with all ICD-10 criteria. The symptoms of this syndrome, observed in more than one social group (school, home), can be manifested by distraction, lack of concentration, excessive impatience, disorganization, impulsivity, restlessness and other similar behavioral disorders.
Against the background of the use of Strattera in children and adolescents, a slight increase in suicidal thoughts was observed.
The time interval between taking Strattera and MAO inhibitors should be at least 14 days.
Allergic manifestations (rash, urticaria, Quincke’s edema) were occasionally noted when taking Strattera.
In many patients undergoing therapy with atomoxetine, there was a slight increase in blood pressure (about 5 mm Hg), an increase in heart rate (about 10 beats / min) or orthostatic hypotension. Most often, such cases did not affect the clinical effectiveness of the treatment.
There is information about the facts of serious complications of hepatic function when taking Strattera, and therefore any manifestations of deterioration in the condition of the kidneys require discontinuation of treatment.
According to the indications of the conducted clinical studies, adult patients with ADHD who took Strattera complained more often of urinary retention than patients from the placebo group, which indicates the effect of atomoxetine on this condition.
If you experience seizures that have no other explanation, you should stop taking Strattera. With caution, prescribe the drug if a patient has a history of convulsive seizures.
A systematic assessment of the effectiveness of atomoxetine therapy for more than one and a half years and the safety of its administration for more than 2 years has not been carried out.
Manifestations of hostility and aggressive behavior are common in children and adolescents with ADHD. There is no proven evidence of an increase in these behavioral disorders when taking atomoxetine. Nevertheless, according to the results of clinical studies, a slight increase in these conditions was observed precisely in the atomoxetine group, which requires increased attention from medical personnel.
Against the background of Strattera therapy, facts of the formation of manic and psychotic symptoms (delirium, hallucinations, pathological mood elevation, etc.) were noted, which, if the connection with the treatment is proven, may require its cancellation.
Patients with symptoms of anxiety, panic attacks, agitation, insomnia, impulsivity, irritability and akathisia require a special approach and careful observation.
During therapy, close people of children and adolescents are required to carefully monitor the possible occurrence of all of the above signs and suicidal tendencies, in order to inform the attending physician about this in time.
The effectiveness and safety of taking Strattera in old age have not been studied.
Adult patients need to exercise caution when performing hazardous or delicate work, or when driving.
Analogs
Analogs of Strattera are represented by the preparations Concert and Fenamin.
For children
The effectiveness of treatment and its safety before the age of 6 years have not been established.
During pregnancy (and lactation)
Due to the small clinical experience of using Strattera during pregnancy, its appointment during this period is possible only after a comprehensive assessment of the benefits / risks for the mother and the fetus.
Studies on the excretion of atomoxetine in breast milk have not been carried out, and therefore the appointment of Strattera during breastfeeding requires special care.