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ATOMXETINE HYROCHLORIDE

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Overview

What is STRATTERA?

STRATTERA (atomoxetine HCl) is a selective norepinephrine reuptake inhibitor. Atomoxetine HCl is the (-) isomer as determined by x–ray diffraction. The chemical designation is (-)--Methyl-3-phenyl-3-(-tolyloxy)-propylamine hydrochloride. The molecular formula is CHNO•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.

STRATTERA 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 dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and other inactive ingredients. The capsule shells also contain one or more of the following:

FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink.



What does STRATTERA look like?



What are the available doses of STRATTERA?

Each capsule contains atomoxetine HCl equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine.

What should I talk to my health care provider before I take STRATTERA?

How should I use STRATTERA?

STRATTERA is indicated for the treatment of Attention–Deficit/Hyperactivity Disorder (ADHD).

The efficacy of STRATTERA Capsules was established in seven clinical trials in outpatients with ADHD: four 6 to 9-week trials in pediatric patients (ages 6 to 18), two 10-week trial in adults, and one maintenance trial in pediatrics (ages 6 to 15)

Dosing of children and adolescents up to 70 kg body weight

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

The maximum recommended total daily dose in children and adolescents over 70 kg and adults is 100 mg.


What interacts with STRATTERA?

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What are the warnings of STRATTERA?

Sorry No Records found


What are the precautions of STRATTERA?

Sorry No Records found


What are the side effects of STRATTERA?

Sorry No records found


What should I look out for while using STRATTERA?

Hypersensitivity to atomoxetine or other constituents of product.

STRATTERA use within 2 weeks after discontinuing MAOI or other drugs that affect brain monoamine concentrations.

Narrow Angle Glaucoma.

STRATTERA (atomoxetine) increased the risk of suicidal ideation in short–term studies in children or adolescents with Attention–Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of STRATTERA in a child or adolescent must balance this risk with the clinical need. Co-morbidities occurring with ADHD may be associated with an increase in the risk of suicidal ideation and/or behavior. Patients who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. STRATTERA is approved for ADHD in pediatric and adult patients. STRATTERA is not approved for major depressive disorder.

Pooled analyses of short–term (6 to 18 weeks) placebo–controlled trials of STRATTERA in children and adolescents (a total of 12 trials involving over 2200 patients, including 11 trials in ADHD and 1 trial in enuresis) have revealed a greater risk of suicidal ideation early during treatment in those receiving STRATTERA compared to placebo. The average risk of suicidal ideation in patients receiving STRATTERA was 0.4% (5/1357 patients), compared to none in placebo–treated patients (851 patients). No suicides occurred in these trials


What might happen if I take too much STRATTERA?


How should I store and handle STRATTERA?

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Pravastatin sodium tablets 10 mg tablets: 20 mg tablets: 40 mg tablets: 80 mg tablets: They are supplied by as follows:Pravastatin sodium tablets 10 mg tablets: 20 mg tablets: 40 mg tablets: 80 mg tablets: They are supplied by as follows:Pravastatin sodium tablets 10 mg tablets: 20 mg tablets: 40 mg tablets: 80 mg tablets: They are supplied by as follows:Pravastatin sodium tablets 10 mg tablets: 20 mg tablets: 40 mg tablets: 80 mg tablets: They are supplied by as follows:Pravastatin sodium tablets 10 mg tablets: 20 mg tablets: 40 mg tablets: 80 mg tablets: They are supplied by as follows:Pravastatin sodium tablets 10 mg tablets: 20 mg tablets: 40 mg tablets: 80 mg tablets: They are supplied by as follows:


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Clinical Information

Chemical Structure

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Clinical Pharmacology

The precise mechanism by which atomoxetine produces its therapeutic effects in Attention–Deficit/Hyperactivity Disorder (ADHD) is unknown, but is thought to be related to selective inhibition of the pre–synaptic norepinephrine transporter, as determined in ex vivo uptake and neurotransmitter depletion studies.

Non-Clinical Toxicology
Hypersensitivity to atomoxetine or other constituents of product.

STRATTERA use within 2 weeks after discontinuing MAOI or other drugs that affect brain monoamine concentrations.

Narrow Angle Glaucoma.

STRATTERA (atomoxetine) increased the risk of suicidal ideation in short–term studies in children or adolescents with Attention–Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of STRATTERA in a child or adolescent must balance this risk with the clinical need. Co-morbidities occurring with ADHD may be associated with an increase in the risk of suicidal ideation and/or behavior. Patients who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. STRATTERA is approved for ADHD in pediatric and adult patients. STRATTERA is not approved for major depressive disorder.

Pooled analyses of short–term (6 to 18 weeks) placebo–controlled trials of STRATTERA in children and adolescents (a total of 12 trials involving over 2200 patients, including 11 trials in ADHD and 1 trial in enuresis) have revealed a greater risk of suicidal ideation early during treatment in those receiving STRATTERA compared to placebo. The average risk of suicidal ideation in patients receiving STRATTERA was 0.4% (5/1357 patients), compared to none in placebo–treated patients (851 patients). No suicides occurred in these trials









































Digoxin:









In interaction studies with (1 hour prior to pravastatin) or , no statistically significant differences in bioavailability were seen when pravastatin sodium was administered.

Suicidal Ideation - Monitor for suicidality, clinical worsening, and unusual changes in behavior.

Severe Liver Injury - 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 treatment. Patients should have a careful history and physical exam to assess for presence of cardiovascular disease. STRATTERA generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to its noradrenergic effects. Consideration should be given to not using STRATTERA in adults with clinically significant cardiac abnormalities.

Emergent Cardiovascular Symptoms - Patients should undergo prompt cardiac evaluation.

Effects on Blood Pressure and Heart Rate - Can increase blood pressure and heart rate; 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 - Consider discontinuing treatment if such new symptoms occur.

Bipolar Disorder - Screen patients to avoid possible induction of a mixed/manic episode.

Aggressive behavior or hostility should be monitored.

Possible allergic reactions, including angioneurotic edema, urticaria, and rash.

Effects on Urine Outflow - Urinary hesitancy and retention may occur.

Priapism - Prompt medical attention is required in the event of suspected priapism.

Growth - Height and weight should be monitored in pediatric patients.

Concomitant Use of Potent CYP2D6 Inhibitors or Use in patients known to be CYP2D6 PMs- Dose adjustment of STRATTERA may be necessary.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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