Atomoxetine Hydrochloride
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Uses
Atomoxetine hydrochloride capsules are indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).
The efficacy of atomoxetine hydrochloride capsules was established in six clinical trials in outpatients with ADHD: four 6 to 9-week trials in pediatric patients (ages 6 to 18), and two 10-week trial in adults [see Clinical Studies (14)].
A diagnosis of ADHD (DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that cause impairment and that were present before age 7 years. The symptoms must be persistent, must be more severe than is typically observed in individuals at a comparable level of development, must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and must be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder.
The specific etiology of ADHD is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but also of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV characteristics.
For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes, lack of sustained attention, poor listener, failure to follow through on tasks, poor organization, avoids tasks requiring sustained mental effort, loses things, easily distracted, forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming, leaving seat, inappropriate running/climbing, difficulty with quiet activities, “on the go,” excessive talking, blurting answers, can’t wait turn, intrusive. For a Combined Type diagnosis, both inattentive and hyperactive-impulsive criteria must be met.
Atomoxetine hydrochloride capsules are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Drug treatment is not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential in children and adolescents with this diagnosis and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe drug treatment medication will depend upon the physician’s assessment of the chronicity and severity of the patient’s symptoms.
History
There is currently no drug history available for this drug.
Other Information
Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor. Atomoxetine HCl is the
R(-) isomer as determined by x-ray diffraction. The chemical designation is (-)-
N-Methyl-3-phenyl-3-(
o-tolyloxy)-propylamine hydrochloride. The molecular formula is C
17H
21NO•HCl, which corresponds to a molecular weight of 291.82. The chemical structure is:
Atomoxetine HCl is a white to practically white solid, which has a solubility of 27.8 mg/mL in water.
Atomoxetine hydrochloride capsules are intended for oral administration only.
Each capsule contains atomoxetine HCl equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. The capsules also contain pregelatinized starch and colloidal silicon dioxide. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide, FD&C Blue No. 2 (25 mg, 40 mg, 60 mg), iron oxide yellow (18 mg, 60 mg, 80 mg, 100 mg), and iron oxide red (80 mg, 100 mg). The imprinting edible black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water.
Sources
Atomoxetine Hydrochloride Manufacturers
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Sun Pharma Global Fze
![Atomoxetine Hydrochloride Capsule [Sun Pharma Global Fze]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Atomoxetine Hydrochloride | Sun Pharma Global Fze
2.1 Acute Treatment
Dosing of children and adolescents up to 70 kg body weight — Atomoxetine hydrochloride capsules should be initiated 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. No additional benefit has been demonstrated for doses higher than 1.2 mg/kg/day [see Clinical Studies (14)].
The total daily dose in children and adolescents should not exceed 1.4 mg/kg or 100 mg, whichever is less.
Dosing of children and adolescents over 70 kg body weight and adults — Atomoxetine hydrochloride capsules should be initiated 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. After 2 to 4 additional weeks, the dose may be increased to a maximum of 100 mg in patients who have not achieved an optimal response. There are no data that support increased effectiveness at higher doses [see Clinical Studies (14)].
The maximum recommended total daily dose in children and adolescents over 70 kg and adults is 100 mg. 2.2 Maintenance/Extended Treatment
It is generally agreed that pharmacological treatment of ADHD may be needed for extended periods. The physician who elects to use atomoxetine for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient. 2.3 General Dosing Information
Atomoxetine hydrochloride capsules may be taken with or without food.
Atomoxetine hydrochloride capsules can be discontinued without being tapered.
Atomoxetine hydrochloride capsules are not intended to be opened, they should be taken whole [see Patient Counseling Information (17.6)].
The safety of single doses over 120 mg and total daily doses above 150 mg have not been systematically evaluated. 2.4 Dosing in Specific Populations
Dosing adjustment for hepatically impaired patients — For those ADHD patients who have hepatic insufficiency (HI), dosage adjustment is recommended as follows: For patients with moderate HI (Child-Pugh Class B), initial and target doses should be reduced to 50% of the normal dose (for patients without HI). For patients with severe HI (Child-Pugh Class C), initial dose and target doses should be reduced to 25% of normal [see Use In Specific Populations (8.6)].
Dosing adjustment for use with a strong CYP2D6 inhibitor or in patients who are known to be CYP2D6 PMs — In children and adolescents up to 70 kg body weight administered strong CYP2D6 inhibitors, e.g., paroxetine, fluoxetine, and quinidine, or in patients who are known to be CYP2D6 PMs, atomoxetine hydrochloride capsules should be initiated at 0.5 mg/kg/day and only increased to the usual target dose of 1.2 mg/kg/day if symptoms fail to improve after 4 weeks and the initial dose is well tolerated.
In children and adolescents over 70 kg body weight and adults administered strong CYP2D6 inhibitors, e.g., paroxetine, fluoxetine, and quinidine, atomoxetine hydrochloride capsules should be initiated at 40 mg/day and only increased to the usual target dose of 80 mg/day if symptoms fail to improve after 4 weeks and the initial dose is well tolerated. -
Sandoz Inc
Atomoxetine Hydrochloride | Sandoz Inc
2.1 Acute TreatmentDosing of children and adolescents up to 70 kg body weight
Atomoxetine hydrochloride capsules should be initiated 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. No additional benefit has been demonstrated for doses higher than 1.2 mg/kg/day [see CLINICAL STUDIES (14 )].
The total daily dose in children and adolescents should not exceed 1.4 mg/kg or 100 mg, whichever is less.
Dosing of children and adolescents over 70 kg body weight and adults
Atomoxetine hydrochloride capsules should be initiated 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. After 2 to 4 additional weeks, the dose may be increased to a maximum of 100 mg in patients who have not achieved an optimal response. There are no data that support increased effectiveness at higher doses [see CLINICAL STUDIES (14 )].
The maximum recommended total daily dose in children and adolescents over 70 kg and adults is 100 mg.
2.2 Maintenance/Extended TreatmentIt is generally agreed that pharmacological treatment of ADHD may be needed for extended periods. The physician who elects to use atomoxetine hydrochloride capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
2.3 General Dosing InformationAtomoxetine hydrochloride capsules may be taken with or without food.
Atomoxetine hydrochloride capsules can be discontinued without being tapered.
Atomoxetine hydrochloride capsules are not intended to be opened, they should be taken whole [see PATIENT COUNSELING INFORMATION (17.6 )].
The safety of single doses over 120 mg and total daily doses above 150 mg have not been systematically evaluated.
2.4 Dosing in Specific PopulationsDosing adjustment for hepatically impaired patients
For those ADHD patients who have hepatic insufficiency (HI), dosage adjustment is recommended as follows: For patients with moderate HI (Child-Pugh Class B), initial and target doses should be reduced to 50% of the normal dose (for patients without HI). For patients with severe HI (Child-Pugh Class C), initial dose and target doses should be reduced to 25% of normal [see USE IN SPECIFIC POPULATIONS (8.6 )].
Dosing adjustment for use with a strong CYP2D6 inhibitor or in patients who are known to be CYP2D6 PMs
In children and adolescents up to 70 kg body weight administered strong CYP2D6 inhibitors, e.g., paroxetine, fluoxetine, and quinidine, or in patients who are known to be CYP2D6 PMs, atomoxetine hydrochloride should be initiated at 0.5 mg/kg/day and only increased to the usual target dose of 1.2 mg/kg/day if symptoms fail to improve after 4 weeks and the initial dose is well tolerated.
In children and adolescents over 70 kg body weight and adults administered strong CYP2D6 inhibitors, e.g., paroxetine, fluoxetine, and quinidine, atomoxetine hydrochloride should be initiated at 40 mg/day and only increased to the usual target dose of 80 mg/day if symptoms fail to improve after 4 weeks and the initial dose is well tolerated.
![Atomoxetine Hydrochloride Capsule [Sandoz Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=47137273-b9c1-4cb4-99ca-2dab9690b560&name=6b194d5b-7326-4baf-9e5a-d9ada2f369ca-03.jpg)
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