Atomoxetine Hydrochloride Capsules (Attentrol)

Atomoxetine Hydrochloride Capsules

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Attentrol (Atomoxetine Hydrochloride Capsules) is a medicine that is prescribed for treating children, adolescents and adults with attention deficit hyperactivity disorder (ADHD).

Attentrol Capsules


Attentrol Capsules are manufactured by Sun Pharmaceutical Industries Ltd. in the strengths of 10 mg, 18 mg and 25 mg. (Website: www.sunpharma.com)

Atomoxetine Hydrochloride Capsules – Brand Names


Atomoxetine Hydrochloride Capsules are available as Strattera, Attentrol, Tomoxetin , Attentin and Axepta.

Active Ingredient


The active ingredient contained in Attentrol Capsules is Atomoxetine Hydrochloride. Each capsule of Atomoxetine (Attentrol) contains Atomoxetine HCl equivalent to 10 mg, 18 mg, or 25 mg of Atomoxetine.

Chemical Structure


The structure of Atomoxetine Hydrochloride is given below:

Uses of Atomoxetine Capsules


Atomoxetine Hydrochloride Capsules (Attentrol) is used as part of a total treatment program for treating children, adolescents and adults with attention deficit hyperactivity disorder (ADHD).The treatment aims to increase the ability to pay attention and decrease impulsiveness and hyperactivity in children, adolescents and adults with ADHD. Atomoxetine (Attentrol capsules) is in a class of medicines called selective norepinephrine reuptake inhibitors. This medicine works by increasing the levels of norepinephrine, a natural substance in the brain that is needed to control behavior.

Storage Instructions


Atomoxetine Hydrochloride Capsules (Attentrol) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets.

Atomoxetine Capsules Dosage


➢ Dosing of children and adolescents over 70 kg body weight and adults — Therapy with Atomoxetine capsules should be started 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.

Treatment must be started by a specialist in the treatment of ADHD, such as a paediatrician, child/adolescent psychiatrist, or psychiatrist. The dosage of Atomoxetine Capsules (Attentrol) is given below:

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Atomoxetine Capsules Dosage


➢ Dosing of children and adolescents up to 70 kg body weight — Therapy with Atomoxetine Capsules should be started 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.

The dosage of Atomoxetine Hydrochloride Capsules (Attentrol) is given below:

Warnings


Suicidal Ideation - Monitor patients for suicidality, clinical worsening, and unusual changes in behavior.Severe Liver Injury - Attentrol Capsules should be discontinued and not restarted in patients with jaundice or laboratory evidence of liver injury.Serious Cardiovascular Events - Sudden death, stroke and myocardial infarction have been reported in association with Atomoxetine therapy. Generic Strattera generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm bnormalities, or other serious cardiac problems. Consideration has be given to not using Attentrol capsules in adults with clinically significant cardiac abnormalities.Emergent Cardiovascular Symptoms - Patients should undergo prompt cardiac evaluation.

Warnings


Effects on Blood Pressure and Heart Rate - Attentrol can increase blood pressure as well as heart rate. There is a possibility that orthostasis, syncope and Raynaud's phenomenon may occur. Use with caution in patients with hypertension, tachycardia, or cardiovascular or cerebrovascular disease.Emergent Psychotic or Manic Symptoms - Discontinuing treatment with Attentrol Capsules should be considered if such new Psychotic or Manic Symptoms symptoms occur.Bipolar Disorder - Patients must be screened to avoid possible induction of a mixed/manic episode.Aggressive behavior - Aggressive behavior or hostility in patients undergoing treatment with this medicine should be monitored.

Warnings


Possible allergic reactions - Possible allergic reactions including anaphylactic reactions, angioneurotic edema, urticaria, and rash can occur in patients undergoing Attentrol therapy.Effects on Urine Outflow - Urinary hesitancy and retention may occur.Priapism - Prompt medical attention is necessary in the event of suspected priapism.Growth - Height and weight should be carefully monitored in pediatric patients. Use of Potent CYP2D6 Inhibitors along with Attentrol or use in patients known to be CYP2D6 poor metabolizers may require dose adjustment of Attentrol.

Attentrol Capsules


ContraindicationsAttentrol is contraindicated in patients with a hypersensitivity to Atomoxetine Hydrochloride or any other component of this medication. Use of Atomoxetine Capsules (Attentrol) within 2 weeks after discontinuing MAOI or other drugs that affect brain monoamine concentrations and is therefore contraindicated. Attentrol is contraindicated in patients with Narrow Angle Glaucoma, Pheochromocytoma or history of pheochromocytoma. This medicine is also contraindicated in cases of Severe Cardiovascular Disorders that might deteriorate with clinically important increases in HR and BP.

Atomoxetine Capsules Side Effects


➢ Child and Adolescent Clinical Trials – Nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence.➢Adult Clinical Trials – Constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction, and urinary hesitation

Most common Atomoxetine Capsules (Attentrol) side effects with an incidence rate of at least 5% and at least twice the incidence of placebo patients

Atomoxetine Capsules Overdose


The most commonly reported symptoms accompanying acute and chronic overdoses of Atomoxetine Capsules were gastrointestinal symptoms, somnolence, dizziness, tremor, and abnormal behavior. Hyperactivity and agitation have also been reported. In some cases of overdose involving Atomoxetine Capsules, seizures have been reported. Signs and symptoms consistent with mild to moderate sympathetic nervous system activation (e.g., tachycardia, blood pressure increased, mydriasis, dry mouth) have also been observed. Most symptoms reported were mild to moderate.

Atomoxetine Overdose


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

Atomoxetine Capsules During Pregnancy


Atomoxetine Hydrochloride (Attentrol Capsules) has been classified by the US FDA as Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there have been no adequate and well-controlled studies conducted in humans.Use of this medicine is not recommended during pregnancy unless the benefit justifies the risk to the fetus.

Attentrol Capsules (Atomoxetine Hydrochloride)

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Attentrol (Atomoxetine Hydrochloride capsules) by Sun Pharmaceutical Industries Ltd., India

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Atomoxetine Hydrochloride Capsules (Attentrol)

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