Attentin40 mg

Attentin is a non-stimulant medicine approved for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).

• FDA-approved / established use: Treatment of ADHD in children aged 6 years and older, adolescents, and adults, as part of a comprehensive treatment programme that may also include psychological, educational and social measures.
• Maintenance therapy: Attentin has demonstrated benefit in maintaining response with continued use in children and adolescents who initially responded to treatment.
• Not established: Safety and efficacy have not been established in children younger than 6 years, and Attentin is not indicated for this age group.

Attentin is not a controlled substance and does not carry the abuse potential associated with stimulant ADHD medicines, making it a preferred option in some patients, such as those with a personal or family history of substance misuse.

Each capsule contains Atomoxetine Hydrochloride equivalent to atomoxetine base. Atomoxetine Hydrochloride is commonly available in capsule strengths such as 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg (strengths marketed may vary by manufacturer and country).

Attentin is a selective norepinephrine (noradrenaline) reuptake inhibitor (SNRI/NRI) used as a non-stimulant treatment for Attention-Deficit/Hyperactivity Disorder (ADHD). Unlike stimulant medicines such as methylphenidate or amphetamines, Attentin does not act on the dopamine transporter to a significant degree and is not classified as a controlled substance.

Attentin works over several weeks to improve attention, reduce hyperactivity and impulsivity, and is taken once or twice daily depending on individual response and tolerability.

Attentin belongs to the therapeutic class of Selective Norepinephrine Reuptake Inhibitors (non-stimulant agents for ADHD).

Atomoxetine Hydrochloride selectively inhibits the presynaptic norepinephrine transporter (NET), increasing the availability of norepinephrine in the synaptic cleft. In the prefrontal cortex, where dopamine is cleared largely by the norepinephrine transporter, this action also secondarily increases dopamine levels, which is thought to underlie its benefit in attention and impulse control.

Pharmacokinetics

• Absorption: Well absorbed orally; food has minimal effect on absorption. Peak plasma concentration is reached in about 1–2 hours.
• Distribution: Approximately 98% bound to plasma protein (mainly albumin).
• Metabolism: Primarily metabolised by the hepatic enzyme CYP2D6 to 4-hydroxyatomoxetine, which is further glucuronidated.
• Elimination half-life: Approximately 5 hours in normal (extensive) CYP2D6 metabolisers and up to 24 hours in poor metabolisers (about 7% of people), who achieve substantially higher drug exposure.

Attentin capsules should be swallowed whole with water and should not be opened, chewed, or crushed, as the contents can be irritating to the eyes. It may be taken once daily in the morning, or the total daily dose may be split into two doses (morning and late afternoon/early evening) if a single daily dose is not well tolerated. Attentin may be taken with or without food. Doses should not be doubled to make up for a missed dose.

The following interactions with Attentin are clinically significant and well established:

• Monoamine oxidase inhibitors (MAOIs): Concomitant use, or use within 14 days of stopping an MAOI, is contraindicated because of the risk of serious, sometimes fatal reactions including hyperthermia, muscle rigidity, autonomic instability and altered mental status.
• Strong CYP2D6 inhibitors (e.g. paroxetine, fluoxetine, quinidine): These can increase Attentin plasma exposure several-fold, raising the risk of dose-related side effects; a slower dose titration and/or lower target dose is recommended.
• Systemic beta-2 agonists (e.g. albuterol/salbutamol): Concurrent use may potentiate cardiovascular effects such as increased heart rate and blood pressure.
• Antihypertensive drugs and pressor agents: Attentin may affect blood pressure; use with caution as it may reduce the effect of antihypertensives or add to the effect of pressor agents.

Side effects of Attentin differ somewhat between children/adolescents and adults.

Less common but clinically important effects include increased heart rate and blood pressure, weight/growth changes in children (see Precautions and Warnings), and rare but serious reactions such as liver injury, priapism and allergic reactions (see Precautions and Warnings for full detail).

Pregnancy: Data on the use of Attentin in pregnant women are limited and insufficient to establish a drug-associated risk of major birth defects. Attentin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus; a physician should be consulted before use in pregnancy.

Lactation: There is no adequate information on whether Attentin passes into human breast milk or its effects on a breastfed infant. The developmental and health benefits of breastfeeding should be weighed against the mother's clinical need for Attentin and any potential adverse effects on the breastfed child; consult a physician before use while breastfeeding.

Boxed Warning: Suicidal Ideation

Attentin increases the risk of suicidal thoughts in children and adolescents with ADHD. In pooled clinical trials, this risk was seen more often in patients aged 12 years or younger, particularly during the first month of treatment. Patients of all ages started on Attentin should be monitored closely for worsening mood, agitation, unusual behaviour changes, or suicidal thinking, especially during the first few months of treatment and after dose changes.

Severe Liver Injury

Attentin can rarely cause severe liver injury, including cases of liver failure. Most reported cases occurred within the first few months of treatment. Attentin should be discontinued and a physician consulted promptly if jaundice, dark urine, right-upper-quadrant pain/tenderness, unexplained "flu-like" symptoms, or itching develop; Attentin should not be restarted in patients who develop liver injury.

Cardiovascular Effects

Attentin can increase heart rate and blood pressure. It should be used with caution in patients whose underlying conditions might be worsened by such increases. Sudden death has been reported in children with structural cardiac abnormalities and in adults with underlying cardiac disease; a cardiac history and examination should be performed before starting treatment, with further cardiac evaluation if indicated. Report any exertional chest pain, unexplained fainting, or breathlessness on exertion promptly.

Psychiatric Symptoms

New psychotic or manic symptoms (e.g. hallucinations, delusions) and increased aggression or hostility can occur even in patients with no prior psychiatric history. Patients should be screened for personal or family history of bipolar disorder before starting Attentin, and monitored for these symptoms during treatment.

Growth Monitoring in Children

Some children treated with Attentin show a slower rate of weight and height gain during the first 9–12 months of treatment, generally normalising over time. Height and weight should be monitored periodically during treatment.

Priapism

Rare cases of priapism (a prolonged, painful erection unrelated to sexual activity) have been reported with Attentin. This is a medical emergency — prompt medical attention is required if an erection lasts more than 4 hours.

Allergic and Urinary Effects

Uncommon allergic reactions (including anaphylaxis, angioedema, urticaria/rash) and urinary retention or hesitation have been reported; seek medical advice if these occur.

Reported symptoms of Attentin overdose include gastrointestinal upset, drowsiness, dizziness, tremor, abnormal behaviour, agitation, and signs of sympathetic nervous system activation such as a fast heart rate, high blood pressure, dilated pupils and dry mouth. Rarely, prolongation of the QT interval on ECG, seizures or confusion/hallucinations have been reported, particularly when Attentin was taken together with other substances.

Suspected overdose of Attentin is a medical emergency. Seek immediate medical attention or contact emergency services/a poison control centre; do not attempt specific home treatment. Because Attentin is highly protein-bound, dialysis is not expected to be effective in removing the drug from the body.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

• Pediatric use: Attentin is approved for children aged 6 years and above; safety and efficacy have not been established below age 6. See Pediatric Uses and Precautions and Warnings (growth monitoring, suicidal ideation risk).
• Elderly: Safety, efficacy and pharmacokinetics of Attentin have not been specifically evaluated in geriatric patients; use with caution.
• Hepatic impairment: Dose reduction is required (see Dosage and Administration).
• Renal impairment: No dose adjustment is generally required.
• CYP2D6 poor metabolisers: Achieve substantially higher Attentin levels and may have a higher rate of dose-related side effects; slower titration is recommended.
• Pregnancy and breastfeeding: See Pregnancy and Lactation section.

The duration of treatment with Attentin is individualised based on clinical response and tolerability. There is no fixed treatment duration; many patients continue treatment over months to years under medical supervision. The prescribing physician should periodically reassess (for example, at least once a year) whether continued treatment with Attentin remains necessary and beneficial, taking into account symptom control, growth (in children), and any emerging side effects.

Atomoxetine Hydrochloride belongs to the drug class of Selective Norepinephrine Reuptake Inhibitors (NRIs), used specifically as a non-stimulant treatment for ADHD, distinct from stimulant classes such as methylphenidate derivatives and amphetamines.

Atomoxetine Hydrochloride works by selectively blocking the presynaptic norepinephrine transporter (NET), which reduces the reuptake of norepinephrine back into nerve cells. This increases norepinephrine levels at the synapse throughout the nervous system, and because the norepinephrine transporter also clears dopamine in the prefrontal cortex, Atomoxetine Hydrochloride secondarily raises dopamine levels in this brain region. These actions on noradrenergic and dopaminergic signalling in brain circuits governing attention, impulse control and executive function are believed to underlie the therapeutic effect of Atomoxetine Hydrochloride in ADHD.

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Attentin is approved for the treatment of ADHD in children aged 6 years and older and in adolescents, dosed by body weight up to 70 kg and using adult dosing above 70 kg (see Dosage and Administration). Safety and efficacy have not been established in children younger than 6 years, and Attentin should not be used in this age group.

Because the risk of suicidal ideation associated with Attentin appears to be greatest in patients 12 years of age or younger, close monitoring for mood changes, agitation, or suicidal thinking is essential, particularly during the first weeks of treatment and after dose adjustments. Height and weight should be monitored periodically, as Attentin can slow growth rate during the first 9–12 months of treatment in some children.