Atomoxetine Hydrochloride capsule is used for the treatment of attention deficit hyperactivity disorder (ADHD), as defined by DSM-IV criteria, in children aged 6 years and above, as well as in adolescents and adults.

The exact mechanism by which Atomoxetine exerts its therapeutic effect in Attention Deficit Hyperactivity Disorder is not fully known. It is believed to act through selective inhibition of the presynaptic norepinephrine transporter, leading to increased levels of norepinephrine in the brain. Atomoxetine is well absorbed after oral administration, and its absorption is only minimally influenced by food intake. It is primarily eliminated through oxidative metabolism via the Cytochrome P450 2D6 enzymatic pathway.

Children and Adolescents up to 70 kg Body Weight: Atomoxetine should be initiated at a total daily dose of approximately 0.5 mg/kg and increased after a minimum of three days to a target total daily dose of approximately 1.2 mg/kg administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening. After an additional two to four weeks, the total daily dose may be increased to a maximum of 1.4 mg/kg in patients who have not achieved an optimal response. The maximum recommended total daily dose in children and adolescents is 1.4 mg/kg or 100mg, whichever is less.

Children and Adolescents over 70 kg Body Weight and Adults: Atomoxetine should be initiated at a total daily dose of 40mg and increased after a minimum of three days to a target total daily dose of approximately 80mg administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening. After an additional two to four weeks, the dose may be increased to a maximum of 100mg in patients who have not achieved an optimal response. The maximum recommended total daily dose in children and adolescents over 70 kg is 100mg.

Maintenance/Extended Treatment: There is no evidence available from controlled trials to indicate how long the patient with ADHD should be treated with Atomoxetine. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. Nevertheless, the physician who elects to use Atomoxetine for extended periods should periodically re-evaluate the long-term usefulness of the medicine for the individual patient.

• Caution is required when using Atomoxetine Hydrochloride with other medicines
• Slower dose titration may be needed in patients taking CYP2D6 inhibitors
• Should not be used with Monoamine Oxidase Inhibitors (MAOIs) or within 2 weeks after stopping them
• MAOIs should not be started within 2 weeks after discontinuing Atomoxetine
• Use cautiously with antihypertensive drugs, vasopressor agents, or other medicines that increase blood pressure
• Concomitant use with Tricyclic Antidepressants may increase cardiovascular side effects

Hypersensitivity: Atomoxetine Hydrochloride is contraindicated in patients with known hypersensitivity to the drug.

Monoamine Oxidase Inhibitors (MAOIs): Atomoxetine must not be used with Monoamine Oxidase Inhibitors, or within two weeks of stopping them. Likewise, MAOIs should not be started within two weeks after discontinuing Atomoxetine. Serious and sometimes fatal reactions have been reported when MAOIs are combined with drugs that affect brain monoamine levels. These may include hyperthermia, muscle rigidity, myoclonus, autonomic instability with rapid vital sign fluctuations, and severe mental status changes such as agitation, delirium, or coma. Some cases resemble neuroleptic malignant syndrome, and reactions may occur when the drugs are given together or in close sequence.

Narrow Angle Glaucoma: Use is not recommended in patients with narrow-angle glaucoma due to an increased risk of mydriasis observed in clinical studies.

Other Contraindications: Atomoxetine is also contraindicated in patients with severe cardiovascular disorders, symptomatic cardiovascular disease, uncontrolled hyperthyroidism, and pheochromocytoma.

• Very common: increased blood pressure, increased heart rate
• Common: abdominal pain, rash, dyspepsia, early morning awakening, ejaculation disorder, ejaculation failure, fatigue, lethargy, tachycardia, paraesthesia, chills
• Uncommon: peripheral coldness

Atomoxetine Hydrochloride is classified as Pregnancy Category B3. There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In animal studies, atomoxetine and/or its metabolites have been excreted in the milk of rats. It is not known whether atomoxetine is excreted in human breast milk. Therefore, caution should be taken when administering atomoxetine to a breastfeeding mother.

Suicidal Ideation & Behaviour:In clinical trials, suicidal thoughts were observed more frequently in children and adolescents treated with Atomoxetine Hydrochloride (5/1357; 0.37%) compared to placebo (0/851; 0%). One case of suicidal behaviour was also reported in the atomoxetine group, while none were reported with placebo.

Aggressive Behaviour or Hostility:There is no conclusive evidence that atomoxetine causes aggression or hostility. However, during clinical trials, these events were reported more often in children and adolescents receiving atomoxetine compared to placebo, although the difference was not statistically significant.

Seizures:Preclinical and clinical data do not indicate that atomoxetine is pro-convulsive. However, very rare cases of seizures have been reported after marketing. It should be used cautiously in patients with a history of seizures.

Cardiovascular Effects:Atomoxetine may increase heart rate and blood pressure. It is recommended to check blood pressure and heart rate before starting treatment and monitor them periodically during therapy to detect any clinically significant changes.

Atomoxetine Hydrochloride overdose has been associated with a range of symptoms. The most commonly reported effects include gastrointestinal symptoms along with somnolence, dizziness, tremor, and abnormal behaviour. Hyperactivity and agitation have also been observed. Signs consistent with mild to moderate sympathetic nervous system activation, such as tachycardia, increased blood pressure, mydriasis, and dry mouth, may occur. Most reported events are mild to moderate in severity. In some overdose cases, seizures have been reported, and very rarely QT prolongation has been observed. Clinical trial experience with atomoxetine overdose is limited, and no fatal overdoses were reported in clinical studies.

CNS stimulant drugs

Atomoxetine Hydrochloride should be stored in a cool, dry place and protected from light.