Oriham(Atomoxetine)

Therapeutic Group: Antidepressants

Presentation

Orihamâ„¢ 10: Each capsule contains Atomoxetine Hydrochloride USP equivalent to Atomoxetine 10 mg.

Description

Atomoxetine is a selective norepinephrine reuptake inhibitor. The precise mechanism of action of Atomoxetine is unknown, but is thought to be related to selective inhibition of the pre-synaptic norepinephrine transporter.

Indications

Atomoxetine is indicated for treatment of Attention Deficit/Hyperactivity Disorder (ADHD)

Dosage & Administration

Children and adolescents up to 70 kg;
Initial dose: 0.5 mg/kg
Recommended dose: 1.2 mg/kg
Maximum dose: 1.4 mg/kg

Children and adolescents over 70 kg and adults;
Initial dose: 40 mg
Recommended dose: 80 mg
Maximum dose: 100 mg

For patients with moderate hepatic insufficiency (Child-Pugh Class B), initial and target doses should be reduced to 50% of the normal dose. For patients with severe hepatic insufficiency (Child-Pugh Class C), initial dose and target doses should be reduced to 25% of normal.

Side Effects

The most common adverse reactions of Atomoxetine are nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence, constipation, dry mouth, dizziness, erectile dysfunction, and urinary hesitation and retention.

Precautions

Caution should be exercised when Atomoxetine is prescribed in patients with known Cardiovascular diseases, suicidal ideation, severe liver injury, hypertension, tachycardia, psychotic or manic symptoms, bipolar disorder, aggressive behavior or hostility, possible allergic reactions, including anaphylactic reactions, angioneurotic edema, urticaria, and rash.

Use in Pregnancy & Lactation

There are no adequate and well-controlled studies in pregnant women. Lactation studies have not been conducted to assess the presence of Atomoxetine in human milk, the effects of Atomoxetine on the breastfed infant, or the effects of Atomoxetine on milk production.

Drug Interaction

Atomoxetine should be used with caution in combination with:
• Monoamine Oxidase Inhibitors
• Antihypertensive drugs-possible effects on blood pressure
• CYP2D6 Inhibitors-concomitant use may increase Atomoxetine steady-state plasma concentrations

Over Dose

There have been no reports of death involving overdose of Atomoxetine alone, including intentional overdoses at amounts up to 1400 mg. The most commonly reported symptoms accompanying overdoses of Atomoxetine were seizures, gastrointestinal symptoms, somnolence, dizziness, tremor, abnormal behavior, hyperactivity, tachycardia, blood pressure increased, mydriasis and dry mouth. Most events were mild to moderate.

Storage

Do not store above 30°C. Keep away from light and out of the reach of children.

Commercial Pack

Orihamâ„¢ 10: Each box contains 3 blister strips of 10 capsules.