Strattera capsules 25mg №7

Packaging

7 pieces

Indications and usage

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

Contraindications

• Hypersensitivity to the drug
• Concurrent use with monoamine oxidase inhibitors (IMAO)
• Angle-closure glaucoma
• Severe heart damage

Carefully 
In patients with hypertension, tachycardia, cardiovascular diseases, severe physical overload, simultaneous taking of psychostimulants, sudden cardiac death in the family history, cerebral circulation disturbance, convulsive seizures in history, as well as in conditions that can lead to hypotension

Pregnancy and Breastfeeding

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.

Dosage and Administration

The drug should be taken 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. In the absence of improvement, the daily dose may be increased to a maximum of 1.8 mg / kg (or 120 mg) no earlier than 2-4 weeks after the start of 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.

Adverse reactions

Very often (more than 10%), often (1-10%), not often (0.1-1%) Children and adolescents: most often - abdominal pain, loss of appetite (18% and 16%, respectively). In connection with a decrease in appetite, a decrease in body weight was observed at the beginning of treatment (on average about 0.5 kg and increased at higher doses). After the initial weight loss, there was a slight increase in body weight during prolonged therapy. Growth rates (weight and height) after 2 years of treatment are close to normal. Nausea and vomiting (9% and 11%, respectively), especially during the first month of treatment. The increase in heart rate at 6 / min, systolic and diastolic blood pressure by 2 mm Hg. On the part of the nervous system: often - dizziness, drowsiness, early morning awakening, irritability, emotional lability. From the senses: often - mydriasis. From the CCC: not often - palpitations, sinus tachycardia. On the part of the digestive system: very often - abdominal pain, vomiting; often - dyspepsia (including constipation, nausea). For the skin: often - dermatitis, itching, rash. On the part of metabolism: very often - loss of appetite; often - anorexia, weight loss. Allergic reactions: skin rash, angioedema, urticaria. Other: often - fatigue, flu. The following side effects were observed in 2% of patients with low cytochrome CYP2D6 activity and were 2 times more often or statistically significantly more often in patients with reduced metabolism, compared with patients with high CYP2D6 activity: decreased appetite (24.1% and 17%, respectively), insomnia (10.5% and 6.8% respectively), impaired quality of sleep (3.8% and 1.5% respectively),enuresis (3% and 1.2% respectively), low mood (3% and 1% respectively), tremor (5.1% and 1.1% respectively), early morning awakening (3% and 1.1% respectively), conjunctivitis (3% and 1.5% respectively), syncope (2.1% and 0.7% respectively), mydriasis (2.5% and 0.7% respectively). In adults: an increase in heart rate at 6 / min, systolic blood pressure at 3 mm Hg. and diastolic at 1 mm Hg; orthostatic hypotension (0.2%), syncope (0.8%). The most common side effects are observed on the part of the digestive and urinary systems. On the part of the nervous system: very often - insomnia; often - dizziness, sleep disturbance, headache, early morning awakening, decrease in libido, sleep disturbance, drowsiness, general weakness. From the CCC: often - blood, heartbeat, tachycardia; not often - feeling cold in the lower limbs. On the part of the digestive system: very often - dryness of the oral mucosa, nausea; often - abdominal pain, dyspepsia (including constipation, flatulence). On the part of metabolism: very often - loss of appetite; often - weight loss. On the part of the skin: often - dermatitis, excessive sweating. On the part of the urogenital system: often - difficulty urinating, urinary retention, dysmenorrhea, impaired ejaculation and erection, impaired orgasm, prostatitis. Allergic reactions: skin rash, angioedema, urticaria.

Treatment should be carried out under the supervision of a physician who has experience working with patients with attention deficit hyperactivity disorder. Removal of the drug does not require a gradual reduction in dose.While taking the drug in clinical studies in children and adolescents, the likelihood of developing suicidal thoughts increased. A single suicide attempt was reported during these clinical trials; completed suicides were not. In many patients during the treatment period, an increase in heart rate (less than 10 / min) and / or an increase in blood pressure (less than 5 mm Hg) was noted, which in most cases had no clinical significance. Cases of the development of orthostatic hypotension have been noted, so care should be taken when prescribing the drug for conditions and diseases leading to hypotension. In the case of jaundice or changes in laboratory parameters, indicating impaired liver function, treatment with atomoxetine should be canceled. Rare cases of hepatotoxicity, manifested by increased activity of enzymes, hyperbilirubinemia and jaundice. Efficacy and safety in children under 6 years of age and in elderly patients has not been established. The effectiveness of treatment for more than 1.5 years, as well as safety with the duration of therapy over 2 years has not been studied. 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 evaluated. In children and adolescents weighing up to 70 kg, the safety of a single and total daily dose exceeding 1.8 mg / kg is not known. Aggressive behavior or hostility is often observed in children and adolescents with attention deficit hyperactivity disorder.The relationship of aggressive behavior or hostility with atomoxetine has not been established (they were observed on the background of taking the drug without statistically significant differences compared with the placebo group). During the period of treatment, patients should be observed in order to identify signs of aggressive behavior or hostility. During pregnancy, the drug is prescribed only if the potential benefit to the mother outweighs the potential risk to the fetus. It is not known whether atomoxetine is secreted in breast milk. It is necessary to refuse the appointment of the drug during breastfeeding. The drug may be accompanied by drowsiness. In this regard, during the period of treatment, care should be taken when engaging in potentially hazardous activities that require increased concentration of attention and psychomotor speed (including driving).

Atomoksetin should not be used for at least 2 weeks after discontinuation of MAO inhibitors . Treatment with MAO inhibitors should not begin within 2 weeks after discontinuation of atomoxetine. Beta2-adrenostimulyatory - the risk of side effects from the cardiovascular system (increase in heart rate and blood pressure). Does not cause clinically significant inhibition or induction of isoenzymes СYP1A2, CYP3A, CYP2D6 and CYP2C9. In patients with a pronounced activity of the CYP2D6 isoenzyme, the inhibitors of this enzyme increase the plasma concentration of atomoxetine to a value similar to that in patients with a reduced activity of the CYP2D6 isoenzyme.Inhibitors of cytochrome P450 in patients with reduced activity of the isoenzyme CYP2D6 do not increase the concentration of atomoxetine in plasma, however, a gradual increase in its dose is recommended. Vasoconstrictive drugs - the risk of increasing blood pressure. Drugs that increase the pH of gastric juice (magnesium hydrochloride / aluminum hydroxide, omeprazole) do not affect the bioavailability of atomoxetine. Drugs affecting the secretion of norepinephrine - may increase or synergism of action. Atomoksetin does not affect the connection with proteins of Warfarin , ASA, phenytoin and diazepam.

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 severity. 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 resulted in convulsions. It was also reported about cases of acute overdose with a fatal outcome 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.

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

3 years.