Oriham

• Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients 6 years and older [citation:1][citation:2]

Atomoxetine is a selective norepinephrine transporter inhibitor (NET inhibitor) [citation:2][citation:9]. It inhibits the pre-synaptic norepinephrine transporter, increasing norepinephrine levels in the synaptic cleft [citation:9]. It has weak affinity for the dopamine transporter and no significant affinity for other neurotransmitter receptors or transporters [citation:1].

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 [citation:1][citation:9].

Children & Adolescents (6 years+) - ADHD:

• Body weight ≤70 kg: Initial dose 0.5 mg/kg/day (once daily or divided into 2 doses). After minimum 3 days, increase to target dose 1.2 mg/kg/day. After 2-4 weeks, may increase to maximum 1.4 mg/kg/day or 100 mg/day (whichever is less) [citation:2].
• Body weight >70 kg: Initial dose 40 mg/day (once daily or divided into 2 doses). After minimum 3 days, increase to target dose 80 mg/day. After 2-4 weeks, may increase to maximum 100 mg/day [citation:2].

Adults - ADHD:

• Initial dose: 40 mg/day (once daily or divided into 2 doses). After minimum 3 days, increase to target dose 80 mg/day. After 2-4 weeks, may increase to maximum 100 mg/day [citation:2].

Hepatic Impairment:

• Moderate impairment (Child-Pugh Class B): Reduce dose by 50% [citation:1][citation:2].
• Severe impairment (Child-Pugh Class C): Reduce dose by 75% [citation:1][citation:2].

Renal Impairment: Dose adjustment may be needed in ESRD patients [citation:1][citation:2].

Common Adverse Reactions in Children & Adolescents (≥5% and at least twice placebo):

• Nausea
• Vomiting
• Fatigue
• Decreased appetite
• Abdominal pain
• Somnolence

Common Adverse Reactions in Adults:

• Constipation
• Dry mouth
• Nausea
• Decreased appetite
• Dizziness
• Erectile dysfunction
• Urinary hesitation

Serious Adverse Reactions:

• Suicidal ideation in children and adolescents (0.4% of patients) [citation:1][citation:2]
• Severe liver damage (rare) [citation:10]
• Increased heart rate and blood pressure

[CONSULT YOUR DOCTOR] Insufficient safety data on atomoxetine use during pregnancy (Category B3) [citation:1][citation:2]. Animal studies have shown fetal risk. Use only if potential benefit justifies the risk [citation:1].

Serious Precautions:

• Suicide risk: Atomoxetine increases the risk of suicidal ideation in children and adolescents [citation:1][citation:2]. Close monitoring is required during initiation and dose changes [citation:10].
• Liver damage: Inform your doctor immediately if you experience signs of liver problems (itching, right upper abdominal pain, dark urine, yellow skin/eyes) [citation:10].
• Cardiac risk: Caution in patients with heart problems, heart defects, or high blood pressure [citation:1][citation:2].
• Driving and machinery: Do not drive or operate hazardous machinery until you know how atomoxetine affects you [citation:10].
• Growth and weight monitoring: Monitor height and weight in children during treatment [citation:1].
• Do not stop suddenly: Do not stop taking the medication without talking to your doctor first.

There is no specific antidote for atomoxetine overdose. Symptomatic and supportive treatment is recommended. Overdose may cause nausea, vomiting, somnolence, dizziness, tremor, abnormal behavior, tachycardia, and increased blood pressure [citation:1][citation:2].

Store below 30°C, in a cool and dry place, protected from light. Keep out of reach of children.