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Strattera online in Australia

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Strattera

Payment methods: VISA, Mastercard, American Express, Jcb card

Availability: In stock

Prescription required for Generic Strattera?: No Prescription

Active ingredient: Atomoxetine

Medical form: Pills

Delivery time: EMS Trackable (5-9 days), Airmail (10 - 21 days)

Use

Therapeutic indications

STRATTERA is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children 6 years of age and older and in adolescents as part of comprehensive therapeutic treatment. Treatment should be started by a doctor who specializes in treating ADHD. The diagnosis must be established according to the criteria of the DSM-IV or the recommendations of the ICD-10.

Additional information for the proper use of this medicine.

Comprehensive therapeutic treatment generally includes psychological, educational, and social measures and aims to stabilize children with conduct disorders characterized by the following symptoms: chronic lack of sustained attention, distraction, emotional lability, impulsiveness, moderate to severe hyperactivity, neurological signs minor and abnormal EEG. Learning skills may be affected.

Medication therapy is not indicated in all children with this disorder, and the decision to seek medication should be based on a thorough assessment of the severity of the child's symptoms, taking into account the child's age and persistence of symptoms. symptom

Dosage and method of administration

Oral use. STRATTERA can be administered as a single daily dose in the morning, with or without food. For patients who do not have a satisfactory clinical response (in terms of tolerance or efficacy) when taking a single daily dose of STRATTERA, it may be preferable to divide the treatment into two equivalent doses, one in the morning and one at the end of the day. sooner or later.

Dose in children / adolescents weighing 70 kg or less

STRATTERA should be started with a total daily dose of approximately 0.5 mg / kg. The starting dose should be maintained for at least 7 days before increasing, depending on clinical response and tolerance. The recommended maintenance dose is approximately 1.2 mg / kg / day (depending on the patient's weight and available doses of atomoxetine). No additional benefit has been demonstrated at doses above 1.2 mg / kg / day. The safety of a single dose greater than 1.8 mg / kg / day and total daily doses greater than 1.8 mg / kg have not been systematically evaluated. In some cases, treatment can be continued into adulthood.

Dosage in children / adolescents weighing more than 70 kg.

STRATTERA should be started with a total daily dose of 40 mg. The starting dose should be maintained for a minimum of 7 days before increasing, depending on clinical response and tolerance. The recommended maintenance dose is 80 mg.

No additional benefit has been demonstrated at doses above 80 mg (see section Pharmacodynamic properties). The maximum recommended total daily dose is 100 mg. The safety of a single dose greater than 120 mg and total daily doses greater than 150 mg have not been systematically evaluated. In some cases, treatment can be continued into adulthood.

Additional information for the proper use of this medicine.

Atomoxetine should be used in accordance with national recommendations for clinical practice in the treatment of ADHD when they exist.

In drug development studies, no symptoms suggestive of withdrawal have been identified. At the time of significant adverse events, atomoxetine can be stopped immediately; It can also be gradually reduced over time.

When patients continue treatment beyond one year, a reevaluation of the need for treatment by a physician specializing in the treatment of ADHD is recommended.

In adolescents whose symptoms persist into adulthood and for whom a benefit under treatment has been clearly demonstrated, treatment may continue into adulthood. However, initiation of STRATTERA therapy in adults is not indicated.

Special populations

Hepatic impairment: In patients with moderate hepatic impairment (Child-Pugh, Class B), the starting and maintenance doses should be reduced to 50% of the usual dose. In patients with severe hepatic impairment (Child-Pugh, Class C), the starting and maintenance doses should be reduced to 25% of the usual dose (see section Pharmacokinetic properties).

Patients with renal impairment: Systemic exposure to atomoxetine in patients with end-stage renal disease was greater than in healthy subjects (approximately 65% increase), but no differences were found when exposure was corrected for a dose in mg / kg STRATTERA, therefore, can be administered to ADHD patients with end-stage renal disease or less severe renal impairment, using the usual dosing schedule. Atomoxetine may worsen hypertension in patients with end-stage renal disease (see section 5.2).

Approximately 7% of Caucasian subjects have a genotype corresponding to a non-functional CYP2D6 enzyme (called slow CYP2D6 metabolizers). Patients with this genotype have exposure to atomoxetine many times greater than that of patients with a functional enzyme. Therefore, slow metabolizers are at increased risk of experiencing adverse effects (see sections 4.8 and 5.1). For patients known to have a slow metabolizing genotype, a lower starting dose and a slower dose adjustment may be considered.

Elderly patients: not applicable.

Children under 6 years of age: The safety and efficacy of STRATTERA in children under 6 years of age have not been established. Therefore STRATTERA should not be used in children below the age of 6 years (see section 4.4).

Prescription and delivery conditions

List I.

Initial biannual hospital prescription reserved for specialists and / or specialized services in neurology, psychiatry or pediatrics.

Duration and special precautions for conservation

Shelf life: 3 years.

Special precautions for storage: There are no special precautions for storage.

Preclinical safety data

Non-clinical data from conventional studies of safety pharmacology, repeated-dose toxicology, genotoxicity, carcinogenesis, and reproductive functions did not reveal any particular risk to humans. Due to an dose limited by an exaggerated clinical (or pharmacological) response to the drug in animals, and due to differences in metabolism between species, the maximum tolerated doses used in animals in non-clinical trials have produced exposures to atomoxetine similarly or even slightly higher than those obtained in slow CYP2D6 metabolizers at the maximum recommended daily dose.

A study was conducted in young rats to assess the effects of atomoxetine on neurobehavioral and sexual growth and development. Slight delays in the appearance of the vaginal cleft (at all doses) and detachment of the foreskin (≥ 10 mg / kg / day) and a slight decrease in the weight of the epididymis and the number of sperm (≥ 10 mg / kg / day ) Have been observed; however, there was no effect on fertility or reproductive performance. The relevance of these observations in humans is unknown.

Pregnant rabbits received atomoxetine doses of up to 100 mg / kg / day per tube during the organogenesis period. At this dose, in one in three studies, there was a decrease in the number of live fetuses, an increase in early resorptions and a slight increase in the incidence of carotid arteries of atypical origin and absence of subclavian artery. These results have been observed at doses that cause mild maternal toxicity. The impact of these observations is among the observed control values. The no effect dose for these observations was 30 mg / kg / day. Exposure (AUC) to non-plasma protein-related atomoxetine in rabbits treated at 100 mg / kg / day was approximately 3.3 times (CYP2D6 fast metabolizers) and 0.4 times (CYP2D6 slow metabolizers) that was measured in humans treated with the maximum dose of 1.4 mg / kg / day. The observations in one of the three rabbit studies are equivocal and their relevance to humans is unknown.

Incompatibilities

Aimlessly.

Employment precautions

Contraindications

  • Hypersensitivity to atomoxetine or to any of the excipients.
  • Atomoxetine should not be used in combination with monoamine oxidase inhibitors (MAOIs). Atomoxetine should not be used for at least two weeks after stopping MAOI treatment. MAOI therapy should not be started within two weeks of stopping atomoxetine.
  • Atomoxetine should not be used in patients with angle-closure glaucoma because the use of atomoxetine has been associated with an increased incidence of mydriasis in clinical studies.

Pregnancy and lactation

There are no clinical data on exposure to atomoxetine in pregnant women.

Animal studies generally have not shown any direct adverse effects on pregnancy, embryonic / fetal development, delivery or postnatal development (see section Preclinical safety data). Atomoxetine should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus.

Atomoxetine and / or its metabolites were excreted in the milk of rats. It is not known whether atomoxetine is excreted in human milk in women. In the absence of data, atomoxetine should be avoided in breastfeeding women.

Warnings and precautions for use

Possible allergic reactions.

Although rare, allergic reactions, such as skin rash, angioneurotic edema, and urticaria, have been reported in patients taking atomoxetine.

Sudden death and pre-existing structural heart defects or other serious heart problems

Sudden death has been reported in children and adolescents with structural heart defects at the usual doses of atomoxetine. While certain serious structural cardiac abnormalities may increase the risk of sudden death alone, atomoxetine should be used with caution in children and adolescents with such known serious structural cardiac abnormalities and in consultation with a cardiologist.

Cardiovascular effects

Many patients taking atomoxetine have experienced a moderate increase in heart rate (mean minus 10 beats / min) and / or increase in blood pressure (mean minus 5 mmHg) (see section 4.8). For most patients, these changes are not clinically significant. Atomoxetine should be used with caution in patients with hypertension, tachycardia, or cardiovascular or cerebrovascular disease. Heart rate and blood pressure should be regularly monitored during treatment. Orthostatic hypotension has also been reported. Atomoxetine should be used with caution in all situations that may predispose patients to hypotension.

Atomoxetine should be used with caution in patients with congenital or acquired QT interval prolongation, or with a family history of QT interval prolongation (see Interactions with other medicinal products and other forms of 'interactions and adverse effects').

Liver effects

STRATTERA should be discontinued and should not be resumed in patients with jaundice or laboratory abnormalities showing liver damage. Hepatotoxicity resulting in elevated liver enzymes and bilirubin jaundice has been reported very rarely.

Growth and development

Growth and development should be monitored during treatment with atomoxetine. Patients who need long-term treatment should be monitored, and dose reduction or discontinuation should be considered in patients who are not experiencing satisfactory growth or weight gain.

Clinical data do not suggest an adverse effect of atomoxetine on cognitive functions or sexual maturation; However, the long-term data available is limited. Therefore, patients requiring long-term treatment should be carefully monitored.

Suicidal behavior

Suicidal behaviors (suicide attempts and suicidal thoughts) have been reported in patients treated with atomoxetine. In double-blind clinical trials, suicidal behaviors were observed infrequently in children and adolescents treated with atomoxetine, but more frequently than in those who received placebo, with whom this event was not observed. . ADHD-treated patients should be carefully monitored for the onset or worsening of suicidal behavior.

Psychotic or manic symptoms.

Manic or psychotic symptoms, eg, hallucinations, delirium, manic episode, or restlessness in children and adolescents with no history of psychotic illness or manic episode may be caused by taking atomoxetine at the usual doses. If such symptoms appear, a possible causal role of atomoxetine should be considered, as well as discontinuation of treatment. The possibility that STRATTERA may exacerbate pre-existing psychotic or manic symptoms cannot be excluded.

Aggressive behavior, hostility and emotional lability.

Hostility (mainly aggression, opposite behavior, and anger) and emotional lability were observed more frequently in clinical trials in children and adolescents treated with STRATTERA compared to those treated with placebo. Patients should be carefully monitored to detect the onset or worsening of aggressive behavior, hostility, or emotional lability.

Seizures

Atomoxetine presents a potential risk of seizures. Atomoxetine should be introduced with caution in patients with a history of epilepsy. Discontinuation of atomoxetine should be considered in any patient with a seizure or in an increase in seizure frequency with no other identified cause.

Children under 6 years

STRATTERA should not be used in children younger than 6 years, as efficacy and safety in this age group have not been established.

Other indications

STRATTERA is not indicated for the treatment of major depressive episodes and / or anxiety, as clinical trials in adults have shown no effect compared to placebo and are therefore considered negative.

Interaction with other medicinal products and other forms of interaction

Effects of other substances on atomoxetine

+ MAOI

Atomoxetine should not be used with MAOIs (see section 4.3).

+ CYP2D6 inhibitors (SSRIs (eg fluoxetine, paroxetine), quinidine, terbinafine)

Atomoxetine is metabolized primarily by the CYP2D6 pathway to 4-hydroxyatomoxetine. In patients with rapid CYP2D6 metabolizers, potent CYP2D6 inhibitors increase steady-state plasma concentrations of atomoxetine to levels similar to those observed in slow CYP2D6 metabolizers. In fast metabolizers treated with paroxetine or fluoxetine, the area under the curve (AUC) of atomoxetine is approximately 6 to 8 times greater and the maximum steady state concentration (Css max) is 3 4 times greater than with atomoxetine alone. A dose adjustment and a slower increase in the dose of atomoxetine may be necessary if a CYP2D6 inhibitor drug is used. If a CYP2D6 inhibitor is prescribed or discontinued after the atomoxetine dose has been adjusted to the optimal dose, clinical response and tolerance should be re-evaluated to determine if dose adjustment is necessary.

Caution is advised when atomoxetine is combined with potent cytochrome P450 inhibitors other than CYP2D6 in patients with slow CYP2D6 metabolizers as the risk of a clinically significant increase in atomoxetine exposure in vivo is not known.

+ Salbutamol

Due to the possible potentiation of the action of salbutamol in the cardiovascular system, atomoxetine should be administered with caution in patients treated with high doses of salbutamol (or other beta2-mimetics) in nebulization or systemically (oral or intravenous). Systemically administered salbutamol (600 µg IV over 2 hours) induced an acceleration of heart rate and an increase in blood pressure. These effects were potentiated by atomoxetine (60 mg, twice daily for 5 days) and were more marked after a concomitant initial administration of salbutamol and atomoxetine. In a study in healthy Asian-type adults, rapid atomoxetine metabolizers, the effects of an inhaled dose of salbutamol (200 µg) on heart rate and blood pressure were not clinically significant compared to intravenous administration and did not increase with concomitant short-term administration of atomoxetine (80 mg, once daily for 5 days). The heart rate after multiple inhalations of salbutamol (800 µg) was similar in the presence or absence of atomoxetine.

There is a potential risk of QT prolongation when atomoxetine is administered with other QT prolongation drugs (such as neuroleptics, class IA and III antiarrhythmics, moxifloxacin, erythromycin, methadone, mefloquine, tricyclic antidepressants, lithium, or cisapride), with medicinal products that They cause an electrolyte imbalance (such as thiazide diuretics) and with drugs that inhibit CYP2D6.

There is a potential risk of seizures with atomoxetine. Caution is advised in concomitant use of medicinal products known to lower the epileptogenic threshold (such as antidepressants, neuroleptics, mefloquine, buproprion, or tramadol) (see section Warnings and precautions for use).

+ Vasopressor agents

Due to the possible effects on blood pressure, atomoxetine should be used with caution with vasopressors.

+ Substances with noradrenergic effect

Substances with a noradrenergic effect should be used with caution when administered with atomoxetine, taking into account possible pharmacological, additive or synergistic effects. Examples: antidepressants like imipramine, venlafaxine and mirtazapine or decongestants like pseudoephedrine or phenylephrine.

+ Substances that have an effect on gastric pH

Substances that increase gastric pH (magnesium hydroxide / aluminum hydroxide, omeprazole) had no effect on the bioavailability of atomoxetine.

+ Substances strongly linked to plasma proteins.

In vitro competition studies have been carried out, at therapeutic concentrations, with atomoxetine and other substances strongly linked to plasma proteins. Warfarin, acetylsalicylic acid, phenytoin, or diazepam had no effect on the binding of atomoxetine to human albumin. Also, atomoxetine did not affect the binding of these substances to human albumin.

Effects of atomoxetine on other substances.

+ Enzymes of cytochrome P450

Atomoxetine did not cause a clinically significant inhibition or induction of cytochrome P450 enzymes, including CYP1A2, CYP3A, CYP2D6, and CYP2C9. In vitro studies indicate that atomoxetine does not cause a clinically significant induction of CYP1A2 and CYP3A.

Caution

Undesirable effects

Children and adolescents

In placebo-controlled pediatric studies, headache, abdominal pain1, and decreased appetite are the most commonly reported adverse reactions during treatment with atomoxetine in approximately 19%, 18%, and 16% of patients, respectively, but they rarely result in discontinuation (0.1% of patients for headache, 0.2% of patients for abdominal pain, and 0.0% loss of appetite). Abdominal pain and decreased appetite are usually transient.

Weight loss (on average 0.5 kg) associated with decreased appetite has been described in some cases at the start of treatment and more markedly at higher doses. After an initial weight loss, long-term patients treated with atomoxetine experienced an average weight gain. Growth of weight gain after 2 years of treatment is almost normal (see section 4.4).

Nausea, vomiting, and drowsiness2 may occur in approximately 10% to 11% of patients, especially during the first month of treatment. However, these episodes were generally low to moderate intensity, transient, and did not result in a significant number of treatment interruptions (interruption rate ≤ 0.5%).

In placebo-controlled pediatric studies, patients treated with atomoxetine experienced an average increase in heart rate of approximately 6 beats per minute and an average increase in systolic and diastolic blood pressure of approximately 2 mm Hg compared to the placebo group. . In placebo-controlled studies in adults, patients treated with atomoxetine experienced an average increase in heart rate of approximately 5 beats per minute and an average increase in systolic (approximately 2 mm Hg) and diastolic (approximately 1 mm Hg) blood pressure. compared to the placebo group.

Due to the effect of atomoxetine on the noradrenergic system, orthostatic hypotension (0.2%) and syncope (0.8%) have been reported in patients taking atomoxetine. Atomoxetine should be used with caution in all situations that may predispose patients to hypotension.

The following table of adverse reactions is based on the collection of adverse events and laboratory analysis in clinical studies in children and adolescents and on the collection of spontaneous post-marketing reports in children / adolescents and adults.

Table: undesirable effects

Frequency estimate: very common (≥1 / 10), common (≥1 / 100, 1/10), infrequent (≥1 / 1,000, minus 1/100), rare (≥1 / 10,000, minus 1 / 1,000 ), very rare (minus 1/10000), spontaneous reporting data (frequency not known - cannot be estimated from the available data).

Organ system

Very common

Frequent

Rare

Post-marketing experience

Spontaneous notifications *

Metabolism and nutrition disorders.

Decreased appetite.

Anorexia (loss of appetite).

Psychiatric disorders

Irritability, mood swings, insomnia 3.

Suicidal events, aggression, hostility, emotional lability **, waking up early in the morning.

Psychosis (including hallucinations) **, agitation **.

Nervous system disorders

Headache, drowsiness 2.

Dizzying sensations.

Syncope, tremors, migraine.

Seizures ***.

Eye conditions

Mydriasis

Heart conditions

Palpitations, sinus tachycardia.

QT interval extension ***.

Vascular disorders

Raynaud's phenomenon.

Gastrointestinal disorders.

Abdominal pain1, vomiting, nausea.

Constipation, dyspepsia.

Hepatobiliary disorders.

Liver function test abnormality, jaundice, hepatitis **.

Skin and subcutaneous tissue disorders.

Dermatitis, skin rash.

Itching, sweating, allergic reactions.

Kidney and urinary tract disorders.

Hesitant hesitation, urinary retention.

Reproductive system and breast disorders.

Priapism, genital pain in children.

General disorders and administration site conditions.

Fatigue, lethargy.

Asthenia

Research

Weight loss, increased blood pressure.

1 also includes upper abdominal pain, stomach discomfort, abdominal discomfort, and epigastric discomfort

2 also includes sedation

3 also includes insomnia for sleeping and insomnia at night

* These reports are the result of spontaneous notifications and their frequency cannot be accurately established

** see section Warnings and precautions for use

*** see sections Warnings and precautions for use and interactions with other medications and other forms of interaction.

CYP2D6 (ML) slow metabolizers

The following adverse events occurred in at least 2% of slow CYP2D6 (ML) metabolizers and were statistically significantly more frequent in these patients than in CYP2D6 fast metabolizers (MR): decreased appetite (24.1% ML, 17 0.0% MR); insomnia (including insomnia, nocturnal insomnia, and sleep insomnia 14.9% ML, 9.7% MR); depression (including depression, major depression, depressive symptoms, depressed mood and dysphoria, 6.5% of ML and 4.1% of MR), weight loss (7.3% of ML, 4.4% of MR), constipation (6.8% of ML , 4.3% of MR), tremors (4.5% of ML, 0.9% of MR), sedation (3.9% of ML, 2.1% of MR), skin excoriations (3.9% of ML, 1.7% of MR); enuresis (3.0% of ML, 1.2% of MR); conjunctivitis (2.5% ML, 1.2% MR); syncope (2.5% ML, 0.7% MR); waking up early in the morning (2.3% ML, 0.8% MR); mydriasis (2.0% ML, 0.6% MR). The following event does not meet the criteria mentioned above, but should be mentioned: generalized anxiety disorder (0.8% ML, 0.1% MR). Furthermore, in studies lasting up to 10 weeks, weight loss was greater in patients with ML (on average 0.6 kg in patients with MR and 1.1 kg in patients with ML).

Adults

In adults, the most frequently reported adverse events during treatment with atomoxetine were gastrointestinal and insomnia. Urinary retention or vacillating hesitation in adults should be considered potentially related to atomoxetine. No serious safety concerns were observed during short or long term treatment.

The following table of adverse reactions is based on the collection of adverse events and laboratory analysis in clinical studies in adults and the collection of spontaneous post-marketing reports in children / adolescents and adults.

Table: undesirable effects

Frequency estimate: very common (≥1 / 10), common (≥1 / 100, minus 1/10), uncommon (≥1 / 1,000, minus 1/100), rare (≥1 / 10,000, minus 1 / 1,000), very rare (less than 1 / 10,000), spontaneous reporting data (frequency unknown - cannot be estimated from the available data).

Organ system

Very common

Frequent

Rare

Post-marketing experience Spontaneous notifications *

Metabolism and nutrition disorders.

Decreased appetite.

Psychiatric disorders

Insomnia 2.

Decreased libido, sleep disorders.

Wake up early in the morning.

Suicidal events, aggression, hostility and emotional lability **, psychosis (including hallucinations) **, agitation **.

Nervous system disorders

Dizziness, sinus headache, paraesthesia, tremors.

Syncope, migraine.

Seizures ***.

Heart conditions

Palpitations, tachycardia.

QT interval extension ***.

Vascular disorders

Redness

Coldness of the extremities.

Raynaud's phenomenon.

Gastrointestinal disorders.

Dry mouth, nausea

Abdominal pain1, constipation, dyspepsia, flatulence.

Hepatobiliary disorders.

Liver function test abnormality, jaundice, hepatitis **.

Skin and subcutaneous tissue disorders.

Dermatitis, sweating, skin rash.

Allergic reactions

Kidney and urinary tract disorders.

Dysuria

Hesitant hesitation, urinary retention.

Reproductive system and breast disorders.

Dysmenorrhea, ejaculation disorder, erectile dysfunction, menstrual irregularity, abnormal orgasm, prostatitis, genital pain in men.

Anejaculation

Priapism

General disorders and administration site conditions.

Fatigue, lethargy, chills.

Research

Weightloss.

Increased blood pressure.

1 also includes upper abdominal pain, stomach discomfort, abdominal discomfort, and epigastric discomfort.

2 also includes insomnia for sleeping and insomnia at night.

* These reports are the result of spontaneous notifications and their frequency cannot be precisely established.

** see section Warnings and precautions for use.

*** see sections Warnings and precautions for use and interactions with other medications and other forms of interaction.

Overdose

Signs and symptoms

In the post-marketing period, acute and chronic non-fatal overdoses of atomoxetine alone have been reported. The most commonly reported symptoms of acute and chronic overdoses were drowsiness, restlessness, hyperactivity, abnormal behavior, and gastrointestinal symptoms. Most were of low to moderate intensity. Signs and symptoms consistent with weak to moderate stimulation of the sympathetic nervous system (eg mydriasis, tachycardia, dry mouth) have also been observed and cases of pruritus and rash have been reported. These effects were reversible in all patients. In some cases of overdose with atomoxetine, seizures and very rarely cases of QT prolongation have been reported. Cases of acute and fatal overdose involving mixed ingestion of atomoxetine and at least one other drug have been reported.

In clinical trials, there is limited experience with overdose with atomoxetine. There was no fatal overdose during clinical studies.

Management of overdose

Clearing of the upper airway should be practiced. Activated charcoal can be helpful in limiting absorption if the patient arrives within 1 hour of ingestion. Cardiovascular monitoring and monitoring of vital functions are recommended in addition to symptomatic treatment and appropriate supportive care. The patient must be monitored for a minimum of 6 hours. Since atomoxetine is strongly bound to plasma proteins, dialysis is unlikely to be of benefit in case of overdose.

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