Strattera 10mg. 18mg. 25mg. 40mg. 60mg. 80mg Capsule

STRATTERA is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children 6 years of age or older, adolescents and adults.

Treatment must be initiated by or under the supervision of a medical practitioner with appropriate knowledge and experience of childhood and/or adolescent behavioural disorders (for example, paediatrician or child/adolescent psychiatrist) (See WARNINGS AND SPECIAL PRECAUTIONS).

The recommended initial dose and subsequent dosage escalations of STRATTERA should not be exceeded because of potential side effects (See SIDE EFFECTS).

STRATTERA capsules are not intended to be opened. STRATTERA is an ocular irritant. In the event of capsule content coming into contact with the eye, the affected eye should be flushed immediately with water, and medical advice obtained. Hands and any potentially contaminated surfaces should be washed as soon as possible.

Dosing of children and adolescents up to 70 kg body weight: STRATTERA should be initiated at a total daily dose of approximately 0,5 mg/kg. The initial dose should be maintained for a minimum of 7 days prior to upward dose titration according to clinical response and tolerability. The recommended maintenance dose is approximately 1,2 mg/kg/day (depending on the patientu2019s weight and available dosage strengths of STRATTERA). No additional benefit has been demonstrated for doses higher than 1,2 mg/kg/day.

Dosing of children and adolescents over 70 kg body weight and adults: STRATTERA should be initiated at a total daily dose of 40 mg. The initial dose should be maintained for a minimum of 7 days prior to upward dose titration according to clinical response and tolerability. The recommended maintenance dose is 80 mg. No additional benefit has been demonstrated for doses higher than 80 mg. The maximum recommended total daily dose for adults is 80 mg.

General dosing information: STRATTERA may be taken with or without food. For those ADHD patients who have hepatic insufficiency or end-stage renal disease, cautious titration of STRATTERA to the desired clinical response is recommended. STRATTERA clearance may be reduced in patients with hepatic insufficiency. STRATTERA may exacerbate hypertension in patients with end-stage renal disease. STRATTERA may be discontinued without tapering the dose.

STRATTERA should not be used in patients with hypersensitivity to atomoxetine or to any of its excipients.

STRATTERA should not be used in patients with uncontrolled hypertension or impairment of liver function.

Monoamine oxidase inhibitors: STRATTERA should not be used in combination with monoamine oxidase inhibitors (MAOIs), including linezolid. STRATTERA should not be used within a minimum of 2 weeks after discontinuing therapy with MAOIs. Treatment with MAOIs should not be initiated within 2 weeks after discontinuing STRATTERA.

Severe Cardiovascular Disorders: STRATTERA should not be used in patients with severe cardiovascular disorders whose condition would be expected to deteriorate if they experienced increases in blood pressure or in heart rate that could be clinically important (for example 15 to 20 mm Hg in blood pressure or 20 beats per minute in heart rate) (see WARNINGS AND SPECIAL PRECAUTIONS u2013 Cardiovascular Effects).

Phaeochromocytoma: STRATTERA should not be used in patients with phaeochromocytoma or a history of phaeochromocytoma (see WARNINGS AND SPECIAL PRECAUTIONS u2013 Cardiovascular Effects).

Narrow angle glaucoma: In clinical studies, the use of STRATTERA was associated with an increased risk of mydriasis and therefore its use is not recommended in patients with narrow angle glaucoma.

Treatment must only be initiated by or under the supervision of a medical practitioner with appropriate knowledge and experience of childhood and adolescent behaviour disorders (e.g. paediatrician or child/adolescent psychiatrist).

Possible allergic events: Allergic reactions including anaphylactic reactions, rash, angioedema and urticarial have been reported in patients taking STRATTERA.

Suicidal behavior, hostility: Suicidal behaviour, suicidal ideation, hostility (predominantly aggression, oppositional behaviour and anger) and emotional lability were more frequently observed in clinical trials among patients treated with STRATTERA compared to those treated with placebo but the differences were not statistically significant. Patients beginning treatment for ADHD should be carefully monitored for the appearance or worsening of suicide-related behaviour, hostility and emotional lability. The possibility of serious psychiatric adverse effects cannot be excluded. There is evidence that the risk of psychiatric adverse events is increased in children with a personal history of mood disorders, or who have a family history of mood disorders.

Hepatic effects: STRATTERA should be discontinued in patients with jaundice or laboratory evidence of liver injury and should never be restarted. Spontaneous reports of liver injury manifested by elevated hepatic enzymes and bilirubin with jaundice, have been reported, in some cases associated with, severe liver injury and acute liver failure. Signs and symptoms likely to indicate liver involvement include pruritus, dark urine, jaundice, right upper quadrant tenderness or unexplained u201cflu-likeu201d symptoms. Laboratory testing to determine liver enzyme levels and bilirubin should be done upon the first sign or symptom of possible liver involvement. Due to the seemingly idiosyncratic nature of the liver injury, routine monitoring of liver function is unlikely to be helpful in minimising the risk of such reactions.

Depression: STRATTERA lacks efficacy as treatment modality in depression and should not be used for the treatment of depression.

Growth: Weight gain and longitudinal growth should be monitored during treatment with STRATTERA. Paediatric patients treated with STRATTERA in ADHD clinical trials had a mean initial decrease in weight and height gain. Subsequently, over the long-term period, patients recovered to the mean weight and height predicted by group baseline data.

Cardiovascular effects: STRATTERA can significantly increase heart rate and blood pressure. It is recommended that the heart rate and blood pressure be measured before treatment is started and periodically during treatment to detect possible clinically important increases. Most patients taking STRATTERA experience a modest increase in heart rate (mean <10 bpm) and/or increase in blood pressure (mean <5 mm Hg (see SIDE EFFECTS). However, data from ADHD clinical trials show that some patients (approximately 5 to 10 % of children and adults) do experience clinically important changes in heart rate (20 beats per minute or greater) or blood pressure (15 to 20 mm Hg or greater). STRATTERA should be used with caution in patients whose underlying medical conditions could be worsened by increases in blood pressure or heart rate, such as patients with hypertension, tachycardia or cardiovascular or cerebrovascular disease. It should not be used in patients with severe cardiovascular disorders whose condition would be expected to deteriorate if they experienced increases in blood pressure or heart rate that could be clinically important (see CONTRAINDICATIONS u2013 Severe Cardiovascular Disorders).

In addition, STRATTERA should be used with caution in patients with congenital long QT syndrome, acquired long QT syndrome (for example, due to concomitant use of a medicine that prolongs the QT), or a family history of QT prolongation. Because orthostatic hypotension has also been reported, STRATTERA should be used with caution in any condition that may predispose patients to hypotension, or conditions associated with abrupt heart rate or blood pressure changes.

STRATTERA should not be used in patients with Raynaudu2019s phenomenon.

Effects on micturition: In adult ADHD controlled trials, the rates of urinary retention and urinary hesitation were increased among the STRATTERA subjects compared with placebo subjects. A complaint of urinary retention or urinary hesitancy should be considered potentially related to STRATTERA.

Paediatric use: The safety and efficacy of STRATTERA in paediatric patients less than 6 years of age have not been established. The efficacy of STRATTERA beyond 18 months of treatment and safety of STRATTERA beyond 2 years of treatment has not been systematically evaluated.

Geriatric use: The safety and efficacy of STRATTERA in geriatric patients have not been established.

Special Populations: STRATTERA has been used in patients with ADHD without deterioration of conditions of motor tics, Tourette syndrome (children), co-morbid major depressive disorder (adolescents) and anxiety disorders (adults and children).

Interaction with other medicaments and other forms of interaction:

Beta-adrenergic receptor agonists: STRATTERA should be administered with caution to patients treated with high dose inhaled, nebulised or systemically administered salbutamol (or other beta2 agonists) because cardiovascular effects can be potentiated.

Cytochrome P450 enzyme: STRATTERA did not cause clinically significant inhibition or induction of cytochrome P450 enzymes, including CYP1A2, CYP3A, CYP2D6 and CYP2C9. STRATTERA is principally metabolised by the CYP2D6 pathway. In CYP2D6 extensive metabolisers, inhibitors of CYP2D6 increase STRATTERA steady-state plasma concentrations to exposures similar to those observed in CYP2D6 poor metabolisers. In vitro studies suggest that co-administration of cytochrome P450 inhibitors to CYP2D6 poor metabolisers will not increase the plasma concentrations of STRATTERA. Slower titration of STRATTERA may be necessary in those patients who are also taking CYP2D6 inhibitor medicines as the side effects are increased in frequency in patients who are poor CYP2D6 metabolisers (See SIDE EFFECTS).

Medicines that affect norepinephrine (noradrenaline): Medicines that affect norepinephrine (noradrenaline) should be used cautiously when co-administered with STRATTERA because of the potential for additive or synergistic pharmacological effects.

Pressor agents: Because of possible effects on blood pressure, STRATTERA should be used cautiously with anti-hypertensive medicines and pressor agents or other medicines that increase blood pressure.

Methylphenidate: Co-administration of methylphenidate with STRATTERA did not increase cardiovascular effects beyond those seen with methylphenidate administration alone.

Medicines that affect gastric pH: Medicines that elevate gastric pH (magnesium hydroxide/aluminium hydroxide, omeprazole) had no effect on STRATTERA bioavailability.

Alcohol: Consumption of ethanol with STRATTERA did not change the intoxicating effects of ethanol.

Midazolam: Co-administration of STRATTERA (60 mg twice daily for 12 days) with midazolam, a model compound for CYP3A4 metabolised medicines (single dose of 5 mg), resulted in 15 % increase in AUC of midazolam. No dose adjustment is recommended for medicines metabolised by CYP3A.

Medicines highly bound to plasma protein: In vitro drug-displacement studies were conducted with STRATTERA and other highly bound medicines at therapeutic concentrations. STRATTERA did not affect the binding of warfarin, aspirin, phenytoin or diazepam to human albumin. Similarly, these medicines did not affect the binding of STRATTERA to human albumin.

Pregnancy: Safety and efficacy have not been demonstrated in pregnancy.

Lactation: STRATTERA and/or its metabolites were excreted in the milk of rats. It is not known if STRATTERA is excreted in human milk. Women using STRATTERA should not breastfeed their infants.

As STRATTERA may cause somnolence and dizziness, patients should be advised to use caution when driving a car or operating hazardous machinery until they are reasonably certain that their performance is not affected by STRATTERA.

Clinical Trial Data:

Child and Adolescent Patients

Frequency of Occurrence

System Organ Class/Adverse Event

Very common u2265 1:10 ( u2265 10 %)

Common u2265 1:100 and <1:10 ( u2265 1 % and <10 %)

Uncommon u2265 1:1000 and <1:100 ( u2265 0,1 % and <1 %)

Metabolism and Nutritional Disorders

Appetite decreased

Anorexia

Psychiatric Disorders

Insomnia

Depression

Mood swings

Nervous System Disorders

Headache

Somnolence

Dizziness

Syncope

Tremor

Eye disorders

Mydriasis

Conjunctivitis

Cardiac disorders

Palpitations

Sinus Tachycardia

Gastrointestinal Disorders

Abdominal pain

Nausea

Vomiting

Constipation

Dyspepsia

Skin and Subcutaneous Tissue Disorders

Pruritus

Rash

General Disorders and Administration Site Conditions

Fatigue

Irritability

Asthenia

Investigations

Blood pressure increased

Heart rate increased

Weight decreased

Adults

Frequency of Occurrence

System Organ Class/Adverse Event

Very common u2265 1:10 ( u2265 10 %)

Common u2265 1:100 and <1:10 ( u2265 1 % and <10 %)

Uncommon u2265 1:1000 and <1:100 ( u2265 0,1 % and <1 %)

Metabolism and Nutritional Disorders

Appetite decreased

Psychiatric disorders

Insomnia

Agitation

Libido decreased

Sleep disorder

Orgasm abnormal

Restlessness

Nervous System Disorders

Headache

Dizziness

Dysgeusia

Paraesthesia

Somnolence

Tremor

Eye Disorders

Vision blurred

Cardiac disorders

Palpitations

Tachycardia

Vascular disorders

Flushing

Hot flushes

Peripheral coldness

Gastrointestinal disorders

Dry mouth

Nausea

Abdominal pain

Constipation

Dyspepsia

Flatulence

Vomiting

Skin and subcutaneous disorders

Rash

Hyperhidrosis

Pruritus

Urticaria

Musculoskeletal and connective tissue disorders

Muscle spasms

Renal and urinary disorders

Dysuria

Pollakiuria

Urinary hesitation

Urinary retention

Micturition urgency

Reproductive System and Breast Disorders

Dysmenorrhoea

Ejaculation disorder

Ejaculation failure

Menstruation disorder

Erectile dysfunction

Prostatitis

Testicular pain

General Disorders and Administration Site Conditions

Asthenia

Fatigue

Chills

Feeling jittery

Irritability

Thirst

Feeling cold

Investigations

Blood pressure increased

Heart rate increased

Weight decreased

The following adverse events occurred in at least 2 % of child and adolescent CYP2D6 poor metaboliser (PM) patients and were statistically significantly more frequent in PM patients compared with CYP2D6 extensive metaboliser (EM) patients: weight decreased (7,3 % of PMs, 4,4 % of EMs), constipation (6,8 % of PMs, 4,3 % of EMs), insomnia (11 % of PMs, 6,1 % of EMs), depression (6,5 % of PMs, 4,1 % of EMs), tremor (4,5 % of PMs, 0,9 % of EMs); middle insomnia (2,8 % of PMs, 1,3 % of EMs); syncope (2,5 % of PMs, 0,7 % of EMs); conjunctivitis (2,5 % of PMs, 1,2 % of EMs); early morning awakening (2,3 % of PMs, 0,8 % of EMs); mydriasis (2,0 % of PMs, 0,6 % of EMs); sedation (3,9 % of PMs, 2,1 % of EMs).

Human experience: During post-marketing, there have been reports of non-fatal acute and chronic overdoses of STRATTERA alone. The most commonly reported symptoms accompanying acute and chronic overdoses were gastrointestinal symptoms, somnolence, dizziness, tremor, and abnormal behaviour. Hyperactivity and agitation have also been reported. Signs and symptoms consistent with mild to moderate sympathetic nervous system activation (e.g. tachycardia, blood pressure increased, mydriasis, dry mouth) were also observed. In some cases of overdose involving STRATTERA, seizures and very rarely QT prolongation have been reported (see Pharmacodynamic properties). There have also been reports of fatal, acute overdoses involving a mixed ingestion of STRATTERA and at least one other medicine. There is limited clinical trial experience with STRATTERA overdose. No fatal overdoses occurred in clinical trials.

Management of overdose: An airway should be established. Monitoring of cardiac and vital signs is recommended, along with appropriate symptomatic and supportive measures. Activated charcoal may be useful in limiting absorption. Because STRATTERA is highly protein-bound, dialysis is not likely to be useful in the treatment of overdose.