INIR Capsule Ref.[51183] Active ingredients: Atomoxetine

Do not exceed the recommended daily dose and subsequent increases, as potentially serious side effects could result with overdosing.

INIR capsules should not be opened. In the event of the capsule contents coming into contact with the eye, the eyes should be immediately flushed with water and medical advice obtained. Hands and any contaminated surfaces should be washed as soon as possible.

Dosing of children and adolescents up to 70 kg body weight: INIR should be initiated at a total dose of approximately 0,5 mg/kg. The initial dose should be maintained for a minimum of 7 days prior to upward dose titration according to clinical response and tolerability. The recommended maintenance dose is approximately 1,2 mg/kg/day (depending on the patient’s weight and available dosage strengths of INIR). No additional benefit has been demonstrated for doses higher than 1,2 mg/kg/day.

Treatment must be initiated by or under the supervision of a medical practitioner with appropriate knowledge and experience of childhood and/or adolescent behavioural disorders (for example, paediatrician or child/adolescent psychiatrist).

Dosing of children and adolescents over 70 kg body weight and adults: INIR should be initiated at a total daily dose of 40 mg. The initial dose should be maintained for a minimum of 7 days prior to upward dose titration according to clinical response and tolerability. The recommended maintenance dose is 80 mg. No additional benefit has been demonstrated for doses higher than 80 mg.

Treatment must be initiated by or under the supervision of a medical practitioner with appropriate knowledge and experience of adult ADHD, e.g. a psychiatrist.

General dosing information

INIR may be taken with or without food.

For those ADHD patients who have hepatic insufficiency or end-stage renal disease, cautious titration of INIR to the desired clinical response is recommended. Atomoxetine clearance may be reduced in patients with hepatic insufficiency. INIR may exacerbate hypertension in patients with end-stage renal disease. INIR may be discontinued without tapering the dose.

Long-term use

No fixed dose-response studies have been conducted in adults. The recommended daily dose of 80 mg reflects the optimal daily dose of 1,2 mg/kg/day demonstrated in children and adolescents. No controlled long-term studies have been conducted in adults.

Missing a dose

If patients miss a dose, they should take it as soon as possible; however, they should not take more than the prescribed total daily amount of INIR in a 24-hour period.

Human experience

The most commonly reported symptoms accompanying acute and chronic overdoses were somnolence, agitation, hyperactivity, abnormal behaviour and gastrointestinal symptoms. Signs and symptoms consistent with mild to moderate sympathetic nervous system activation (e.g. mydriasis, tachycardia, dry mouth) have also been observed. In some cases of overdose, seizures have been reported. There have also been reports of fatal acute overdose involving a mixed ingestion of INIR and at least one other medicine.

Management of overdose

An airway should be established. Monitoring of cardiac and vital signs is recommended, along with appropriate symptomatic and supportive measures. Gastric lavage may be indicated if performed soon after ingestion. Activated charcoal may be useful in limiting absorption. Because INIR is highly protein-bound, dialysis is not likely to be useful in the treatment of overdose.

Store at or below 25ºC. Store in the original blister packs.

Keep the blisters in the carton until required for use. Store protected from light and moisture.

Keep the HDPE containers tightly closed.

KEEP OUT OF REACH OF CHILDREN.

HDPE containers: The capsules will be packaged in white plastic containers with white plastic caps containing 30 or 500 capsules.

PVC-PVdC/Alu pack: The capsules are packed in blister strips of clear transparent PVC film coated with PVdC on one side and paper backed aluminium foil with heat seal coating on the other side. The blister strips will be packaged in a cardboard box containing 7, 10, or 14 capsules.