Drugplain

Strattera 25 mg/1

Atomoxetine hydrochloride · CAPSULE · Eli Lilly and Company

No Recall History
Plain English

Strattera is a capsule containing atomoxetine hydrochloride at 25 mg/1, taken oral. Manufactured by Eli Lilly and Company.

Key Facts

Brand Name
Strattera
Generic Name
Atomoxetine hydrochloride
NDC Code (Product)
0002-3228
Manufacturer
Eli Lilly and Company
Strength
25 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
NDA021411
Marketing Start
11/26/2002

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective2,358 reports
nausea1,837 reports
fatigue1,827 reports
vomiting1,463 reports
headache1,433 reports
somnolence1,356 reports
dizziness1,355 reports
insomnia1,242 reports
off label use1,224 reports
feeling abnormal1,181 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE STRATTERA ® is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). ( 1.1 ) 1.1 Attention-Deficit/Hyperactivity Disorder (ADHD) 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) [see Clinical Studies ( 14 )] . 1.2 Diagnostic Considerations 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…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Initial, Target and Maximum Daily Dose ( 2.1 ) (Acute and Maintenance/Extended Treatment) Body Weight Initial Daily Dose Target Total Daily Dose Maximum Total Daily Dose Children and adolescents up to 70 kg 0.5 mg/kg 1.2 mg/kg 1.4 mg/kg Children and adolescents over 70 kg and adults 40 mg 80 mg 100 mg Dosing adjustment — Hepatic Impairment, Strong CYP2D6 Inhibitor, and in patients known to be CYP2D6 poor metabolizers (PMs). ( 2.5 , 12.3 ) 2.1 Acute Treatment Dosing of children and adolescents up to 70 kg body weight — STRATTERA 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 — STRATTERA should be initiated at a total daily do…

Contraindications

4 CONTRAINDICATIONS Hypersensitivity to atomoxetine or other constituents of product. ( 4.1 ) STRATTERA use within 2 weeks after discontinuing MAOI or other drugs that affect brain monoamine concentrations. ( 4.2 , 7.1 ) Narrow Angle Glaucoma. ( 4.3 ) Pheochromocytoma or history of pheochromocytoma. ( 4.4 ) Severe Cardiovascular Disorders that might deteriorate with clinically important increases in HR and BP. ( 4.5 ) 4.1 Hypersensitivity STRATTERA is contraindicated in patients known to be hypersensitive to atomoxetine or other constituents of the product [see Warnings and Precautions ( 5.8 )] . 4.2 Monoamine Oxidase Inhibitors (MAOI) STRATTERA should not be taken with an MAOI, or within 2 weeks after discontinuing an MAOI. Treatment with an MAOI should not be initiated within 2 weeks after discontinuing STRATTERA. With other drugs that affect brain monoamine concentrations, there have been reports of serious, sometimes fatal reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma) when taken in combination with an MAOI. S…

Drug Interactions

7 DRUG INTERACTIONS Monoamine Oxidase Inhibitors. ( 4.2 , 7.1 ) CYP2D6 Inhibitors - Concomitant use may increase atomoxetine steady-state plasma concentrations in EMs. ( 7.2 ) Antihypertensive Drugs and Pressor Agents - Possible effects on blood pressure. ( 7.3 ) Albuterol (or other beta 2 agonists) - Action of albuterol on cardiovascular system can be potentiated. ( 7.4 ) 7.1 Monoamine Oxidase Inhibitors With other drugs that affect brain monoamine concentrations, there have been reports of serious, sometimes fatal reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma) when taken in combination with an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Such reactions may occur when these drugs are given concurrently or in close proximity [see Contraindications ( 4.2 )] . 7.2 Effect of CYP2D6 Inhibitors on Atomoxetine In extensive metabolizers (EMs), inhibitors of CYP2D6 (e.g., paroxetine, fluoxetine, and quinidine) increase atomoxetine steady-state plasma concentrations to exposures simil…

Adverse Reactions

6 ADVERSE REACTIONS Most common adverse reactions (≥5% and at least twice the incidence of placebo patients) Child and Adolescent Clinical Trials – Nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence. ( 6.1 ) Adult Clinical Trials – Constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction, and urinary hesitation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience STRATTERA was administered to 5382 children or adolescent patients with ADHD and 1007 adults with ADHD in clinical studies. During the ADHD clinical trials, 1625 children and adolescent patients were treated for longer than 1 year and 2529 children and adolescent patients were treated for over 6 months. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Child and Adolescent Clinical Trials Reasons for discontinuation of tr…

Frequently Asked Questions

What is Strattera used for?

Strattera contains Atomoxetine hydrochloride. It is a capsule taken oral. Consult your doctor for specific uses.

Is Strattera a controlled substance?

Strattera is not classified as a controlled substance by the DEA.

What is the generic name for Strattera?

The generic name for Strattera is Atomoxetine hydrochloride. There are 10 other brand versions of Atomoxetine hydrochloride.

What is the NDC code for Strattera 25 mg/1?

The NDC (National Drug Code) for Strattera 25 mg/1 is 0002-3228, listed by Eli Lilly and Company.

Product NDC

0002-3228

Package NDC

0002-3228-30

Other Atomoxetine Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)