Atomox Apex 10 mg 30 capsules

Trade Name:

AtomoxApex 10 mg 30 capsules

Compositions:

Each AtomoxApex 10 mg capsule contains: 10 mg atomoxetine.

Description:

Atomox Apex is used to treat attention-deficit hyperactivity disorder (ADHD) in children,
teenagers, and adults. It belongs to the group of medicines called selective norepinephrine
reuptake inhibitors.
Mechanism of Action: The precise mechanism by which Atomoxetine produces its
therapeutic effects in attention-deficit/hyperactivity disorder
(ADHD) is unknown, but is thought to be related to selective inhibition of the pre-synaptic
norepinephrine transporter, as determined in ex vivo
uptake and neurotransmitter depletion studies.

Indictaion:

AtomoxApex is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD)

Dosage:

Dosing for children and adolescents up to 70 kg body weight:
AtomoxApex should be initiated at a total daily dose of approximately 0.5 mg/kg and
increased after a minimum of 3 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.
Dosing for children and adolescents over 70 kg body weight and adults:
AtomoxApex should be initiated at a total daily dose of 40 mg and increased after a
minimum of 3 days to a target total daily dose of approximately
80 mg administered either as a single daily dose in the morning or as evenly divided doses
in the morning and late afternoon/early evening. After
2 to 4 additional weeks, the dose may be increased to a maximum of 100 mg in patients who
have not achieved an optimal response.

Dosing in Specific Populations:

For patients with moderate HI (Child-Pugh Class B), initial and target doses should be
reduced to 50% of the normal dose
(for patients without HI). For patients with severe HI (Child-Pugh Class C), initial dose and
target doses should be reduced to 25% of normal.
Pregnancy and Loctation:
Pregnant or nursing women should not use unless potential benefit justifies potential risk to
fetus or infant.

Precautions:

• Suicidal Ideation – Monitor for suicidality, clinical worsening, and unusual changes in
behavior.
• Severe Liver Injury – Should be discontinued and not restarted in patients with jaundice or
laboratory evidence of liver injury.
• Patients should have a careful history and physical exam to assess for presence of
cardiovascular disease. Atomoxetine generally should not be
used in children or adolescents with known serious structural cardiac abnormalities,
cardiomyopathy, serious heart rhythm abnormalities, or other
serious cardiac problems that may place them at increased vulnerability to its noradrenergic
effects. Consideration should be given to not using
atomoxetine in adults with clinically significant cardiac abnormalities.
• Use with caution in patients with hypertension, tachycardia, or cardiovascular or
cerebrovascular disease.
• Aggressive behavior or hostility should be monitored.
• Possible allergic reactions, including angioneurotic edema, urticaria, and rash.
• Urinary hesitancy and retention may occur.
• Concomitant use of potent CYP2D6 Inhibitors or use in patients known to be CYP2D6 PMs
– Dose adjustment of atomoxetine may be necessary

Contraindications:

• Hypersensitivity to atomoxetine or other constituents of product.
• Atomoxetine use within 2 weeks after discontinuing MAOI or other drugs that affect brain
monoamine concentrations.
• Narrow Angle Glaucoma.

Side Effects:

Nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence.

Storage Method:

Store in a dry place at temperature below 25 °C
Keep Out of reach of children

Package:

A carton box contains 30 hard gelatin capsules and leaflet.