Description
Generics: Atomoxetine Hydrochloride
Dosage Form: Capsule.
Indications:
Attention deficit hyperactivity disorder (ADHD).
Pharmacology:
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.
Dosage guideline:
Three times in daily.
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:Â 0.5 mg/kg/day for at least 7 days.
- Maintenance: 1.2 mg/kg/day.
- Max: 1.8 mg/kg/day.
Route of administration: Orally.
Interaction:
Albuterol, CYP2D6 inhibitors & antihypertensive agents interact with Atomoxetine.
Contraindications:
- Hypersensitivity to Atomoxetine
- Concomitant use with Monoamine oxidase inhibitors (MAOIs).
- Narrow-angle glaucoma.
- Severe cardiovascular or cerebrovascular disorders.
- History of pheochromocytoma.
Side Effects:
Decreased appetite; headache; nausea; increased BP & heart rate; Insomnia; dry mouth in adults; Somnolence; abdominal pain; vomiting in children.
Pregnancy & Lactation:
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.
Precautions & Warnings:
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.
Pediatric use: The pharmacokinetics of Atomoxetine have not been evaluated in children under 6 years of age.
Therapeutic Class:
CNS stimulant drugs
Storage Conditions:
Keep in a cool and dry place, away from light and heat. Keep out of the reach of children.
Manufactured by: UniMed UniHealth Pharmaceuticals Ltd.
