Atomoxetine Hydrochloride

Attention deficit hyperactivity disorder (ADHD).

The precise mechanism by which Atomoxetine produces its therapeutic effects in Attention Deficit Hyperactivity Disorder (ADHD) is unknown. But, it is thought to be related to selective inhibition of the pre-synaptic nor-epinephrine transporter. Atomoxetine is well-absorbed after oral administration and is minimally affected by food. It is eliminated primarily by oxidative metabolism through the cytochrome P450 2D6 (CYP2D6) enzymatic pathway.

Adult & adolescents-
>70 kg:

• Initially: 40 mg/day for at least 7 days.
• Maintenance: 80 mg/day.
• Max: 100 mg/day.

Children & adolescents-
Up to 70 kg:

• Initially: 0.5 mg/kg/day for at least 7 days.
• Maintenance: 1.2 mg/kg/day.
• Max: 1.8 mg/kg/day.

Albuterol, CYP2D6 inhibitors & antihypertensive agents interact with Atomoxetine.

• Hypersensitivity to Atomoxetine
• Concomitant use with Monoamine oxidase inhibitors (MAOIs).
• Narrow-angle glaucoma.
• Severe cardiovascular or cerebrovascular disorders.
• History of pheochromocytoma.

Decreased appetite; headache; nausea; increased BP & heart rate; Insomnia; dry mouth in adults; Somnolence; abdominal pain; vomiting in children.

Pregnancy Category C. Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.

Atomoxetine should be used with caution in patients with a history of seizures. Atomoxetine can affect 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 Atomoxetine experience a modest increase in heart rate

The most commonly reported gastrointestinal symptoms including somnolence, dizziness, tremor, and abnormal behaviour. Hyperactivity and agitation have also been reported. Signs and symptoms consistent with mild to moderate sympatheticnervous system activation (e.g. tachycardia, blood pressure increased, mydriasis, dry mouth) were also observed. Most events were mild to moderate. In some cases of overdose involving Atomoxetine, seizures and very rarely QT prolongation have been reported. There is limited clinical trial experience with Atomoxetine overdose. No fatal overdoses occurred in clinical trials.

CNS stimulant drugs

Pediatric use: The pharmacokinetics of Atomoxetine have not been evaluated in children under 6 years of age.

Store in a cool and dry place, protected from light and moisture.