Drugplain

Atomoxetine Hydrochloride 40 mg/1

atomoxetine hydrochloride · CAPSULE · AvPAK

No Recall History
Plain English

Atomoxetine Hydrochloride is a capsule containing atomoxetine hydrochloride at 40 mg/1, taken oral. Manufactured by AvPAK.

Key Facts

Brand Name
Atomoxetine Hydrochloride
Generic Name
atomoxetine hydrochloride
NDC Code (Product)
50268-058
Manufacturer
AvPAK
Strength
40 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
ANDA078983
Marketing Start
02/13/2020

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Atomoxetine 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) Atomoxetine capsules are indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). The efficacy of atomoxetine 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 spe…

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 — Atomoxetine 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 should be initiated at a total daily d…

Contraindications

4 CONTRAINDICATIONS Hypersensitivity to atomoxetine or other constituents of product. ( 4.1 ) Atomoxetine 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 Atomoxetine capsules are 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) Atomoxetine 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 atomoxetine. 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 combinati…

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 similar to tho…

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 Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Atomoxetine 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 treatment due to adverse reac…

Frequently Asked Questions

What is Atomoxetine Hydrochloride used for?

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

Is Atomoxetine Hydrochloride a controlled substance?

Atomoxetine Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Atomoxetine Hydrochloride?

The generic name for Atomoxetine Hydrochloride is atomoxetine hydrochloride. There are 2 other brand versions of atomoxetine hydrochloride.

What is the NDC code for Atomoxetine Hydrochloride 40 mg/1?

The NDC (National Drug Code) for Atomoxetine Hydrochloride 40 mg/1 is 50268-058, listed by AvPAK.

Product NDC

50268-058

Package NDC

50268-058-13

Other Atomoxetine Brands

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

Data from openFDA · Public domain (CC0 1.0)