Atomoxetine 18 mg Capsule, 30-count
Other active recalls for Atomoxetine (different manufacturers) — 6 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Norepinephrine Reuptake Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Atomoxetine is used as part of a total treatment program to increase the ability to pay attention and decrease impulsiveness and hyperactivity in children and adults with ADHD. Atomoxetine is in a class of medications called selective norepinephrine reuptake inhibitors. It works by increasing the levels of norepinephrine, a natural substance in the brain that is needed to control behavior.
Read the full MedlinePlus article ↗- No — atomoxetine is not a stimulant. It works differently from medications like amphetamines or methylphenidate. Instead of stimulating the brain directly, it blocks the reuptake o...
- Is atomoxetine a stimulant like other ADHD medications?
- Atomoxetine typically takes several weeks to reach its full effect — it's not something you'll feel on the first day. Your prescriber will usually start you on a lower dose and gra...
- How long does it take before I notice atomoxetine working?
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
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UNII 767IP0Y5NH
A synthetic red colorant used to give medicines their color. It helps patients identify their medication and makes the product visually appealing.
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A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
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FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
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Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
15 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.409 | $12.26 / 30 capsules |
| Medicaid paysCMS SDUD · 12 mo | $0.8252 | $24.76 / 30 capsules |
| Medicare drug plans payPart D · Q2 2026 | $0.8079 | $24.24 / 30 capsules |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Atomoxetine 18 mg 00093-3543-56 | Teva | 30 capsules | $0.409 | AB | Availability likely | — |
| atomoxetine 18 mg 16714-0756-01 | Northstar | 30 capsules | $0.409 | AB | Availability likely | — |
| Atomoxetine 18 mg 31722-0715-30 | Camber | 30 capsules | $0.409 | AB | Availability likely | — |
| Atomoxetine Hydrochloride 18 mg 60505-2831-03 | Apotex | 30 capsules | $0.409 | AB | Availability likely | — |
| Atomoxetine 18 mgthis 64380-0473-01 | Strides | 30 capsules | $0.409 | AB | Availability likely | — |
| Atomoxetine 18 mg 64980-0374-03 | Rising | 30 capsules | $0.409 | AB | Availability likely | — |
| Atomoxetine 18 mg 72603-0436-01 | NorthStar | 30 capsules | $0.409 | AB | Availability likely | — |
| Strattera 18 mg 00002-3238-30 | Eli | 30 capsules | $12.642 | — | Availability likely | +2994% |
| Atomoxetine 18 mg 42291-0065-30 | AvKARE | 30 capsules | — | AB | FDA listed | — |
| Atomoxetine Hydrochloride 18 mg 51407-0101-30 | Golden | 30 capsules | — | AB | FDA listed | — |
| Atomoxetine 18 mg 55111-0520-05 | Dr. | 500 capsules | — | AB | FDA listed | — |
| Atomoxetine 18 mg 65862-0239-22 | Aurobindo | 2000 capsules | — | AB | FDA listed | — |
| atomoxetine 18 mg 68462-0266-23 | Glenmark | 2000 capsules | — | AB | FDA listed | — |
| Atomoxetine 18 mg 72162-2542-03 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Atomoxetine 18 mg 82619-0116-01 | Creekwood | 30 capsules | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
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🔬 Reported adverse events (FAERS)
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Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 64380-0473-01 You're viewing this | 30 CAPSULE in 1 BOTTLE, PLASTIC (64380-473-01) | $0.4086 / ea | $12.26 | 2025-07-01 | Active |
| 64380-0473-02 | 500 CAPSULE in 1 BOTTLE, PLASTIC (64380-473-02) | — | — | 2025-07-01 | Active |
You're viewing the smallest of 2 pack sizes for this product.
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 64380-0473-01?
What is the difference between NDC 64380-0473-01 and NDC 64380-0473-02?
What NDC number is used to bill for this package of Atomoxetine 18 mg Capsule?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
BOXED WARNING WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS 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 atomoxetine 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. Atomoxetine is approved for ADHD in pediatric and adult patients.
Atomoxetine is not approved for major depressive disorder. Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of atomoxetine 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 atomoxetine compared to placebo. The average risk of suicidal ideation in patients receiving atomoxetine was 0.4% (5/1357 patients), compared to none in placebo-treated patients (851 patients).
No suicides occurred in these trials [see Warnings and Precautions (5.1)] . WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS See full prescribing information for complete boxed warning. ● Increased risk of suicidal ideation in children or adolescents (5.1) ● No suicides occurred in clinical trials (5.1) ● Patients started on therapy should be monitored closely (5.1)
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Atomoxetine is selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1)
1.1Attention-Deficit/Hyperactivity Disorder (ADHD) Atomoxetine is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). The efficacy of atomoxetine is 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)].
1.2Diagnostic 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 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.
1.3Need for Comprehensive Treatment Program Atomoxetine is 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.
⏱️ Dosage and 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)
2.1Acute 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 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.
2.2Maintenance/Extended Treatment It is generally agreed that pharmacological treatment of ADHD may be needed for extended periods. The benefit of maintaining pediatric patients (ages 6-15 years) with ADHD on atomoxetine after achieving a response in a dose range of 1.2 to 1.8 mg/kg/day was demonstrated in a controlled trial. Patients assigned to atomoxetine in the maintenance phase were generally continued on the same dose used to achieve a response in the open label phase.
The physician who elects to use atomoxetine for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient [see Clinical Studies (14.1)] .
2.3General Dosing Information Atomoxetine may be taken with or without food. Atomoxetine can be discontinued without being tapered. Atomoxetine capsules are not intended to be opened, they should be taken whole [see Patient Counseling Information (17)] . The safety of single doses over 120 mg and total daily doses above 150 mg have not been systematically evaluated.
2.4Screen for Bipolar Disorder Prior to Starting Atomoxetine Prior to initiating treatment with atomoxetine, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.6)].
2.5Dosing 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 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 th…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Atomoxetine Capsules, USP are available containing atomoxetine hydrochloride, USP equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg of atomoxetine. A size "3", red opaque cap and light yellow opaque body, hard gelatin capsule filled with white to off-white powder. The cap imprinted with "Strides logo" and body imprinted with "010" axially in black ink.
A size "3", orange opaque cap and light yellow opaque body, hard gelatin capsule filled with white to off-white powder. The cap imprinted with "Strides logo" and body imprinted with "018" axially in black ink. A size "3", light blue opaque cap and white opaque body, hard gelatin capsule filled with white to off-white powder.
The cap imprinted with "Strides logo" and body imprinted with "025" axially in black ink. A size "2", blue opaque cap and light blue opaque body, hard gelatin capsule filled with white to off-white powder. The cap imprinted with "Strides logo" and body imprinted with "040" axially in black ink.
A size "1", violet opaque cap and light yellow opaque body, hard gelatin capsule filled with white to off-white powder. The cap imprinted with "Strides logo" and body imprinted with "060" axially in black ink. A size "0", light orange opaque cap and light yellow opaque body, hard gelatin capsule filled with white to off-white powder.
The cap imprinted with "Strides logo" and body imprinted with "080" axially in black ink. A size "0EL", light pink opaque cap and light yellow opaque body, hard gelatin capsule filled with white to off-white powder. The cap imprinted with "Strides logo" and body imprinted with "100" axially in black ink.
Each capsule contains atomoxetine hydrochloride equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. (3, 11, 16)
⛔ 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)
4.1Hypersensitivity Atomoxetine is contraindicated in patients known to be hypersensitive to atomoxetine or other constituents of the product [see Warnings and Precautions (5.8)] .
4.2Monoamine 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 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 Drug Interactions (7.1)] .
4.3Narrow Angle Glaucoma In clinical trials, atomoxetine use was associated with an increased risk of mydriasis and therefore its use is not recommended in patients with narrow angle glaucoma.
4.4Pheochromocytoma Serious reactions, including elevated blood pressure and tachyarrhythmia, have been reported in patients with pheochromocytoma or a history of pheochromocytoma who received atomoxetine. Therefore, atomoxetine should not be taken by patients with pheochromocytoma or a history of pheochromocytoma.
4.5Severe Cardiovascular Disorders Atomoxetine capsules should not be used in patients with severe cardiac or vascular disorders whose condition would be expected to deteriorate if they experience increases in blood pressure or heart rate that could be clinically important (for example, 15 to 20 mm Hg in blood pressure or 20 beats per minute in heart rate) [see Warnings and Precautions (5.4)] .
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Suicidal Ideation – Monitor for suicidality, clinical worsening and unusual changes in behavior. (5.1) Severe Liver Injury – Should be discontinued and not restarted in patients with jaundice or laboratory evidence of liver injury. (5.2) 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. Atomoxetine 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 atomoxetine in adults with clinically significant cardiac abnormalities.
(5.3) Emergent Cardiovascular Symptoms – Patients should undergo prompt cardiac evaluation. (5.3) Effects on Blood Pressure and Heart Rate – Increase in blood pressure and heart rate; orthostasis and syncope may occur. Use with caution in patients with hypertension, tachycardia, or cardiovascular or cerebrovascular disease.
(5.4) Psychotic or Manic Symptoms – Consider discontinuing atomoxetine if such new symptoms occur. (5.5) Bipolar Disorder – Screen patients for bipolar disorder. (5.6) Aggressive behavior or hostility – Monitor for the appearance or worsening of aggressive behavior or hostility.
(5.7) Possible allergic reactions, including anaphylactic reactions, angioneurotic edema, urticaria, and rash. (5.8) Effects on Urine Outflow – Urinary hesitancy and retention may occur. (5.9) Priapism – Prompt medical attention is required in the event of suspected priapism.
(5.10, 17.5) Growth – Height and weight should be monitored in pediatric patients. (5.11) Concomitant Use of Potent CYP2D6 Inhibitors or Use in patients known to be CYP2D6 PMs – Dose adjustment of atomoxetine may be necessary. (5.13)
5.1Suicidal Ideation Atomoxetine increased the risk of suicidal ideation in short-term studies in children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of atomoxetine in children and adolescents have revealed a greater risk of suicidal ideation early during treatment in those receiving atomoxetine. There were a total of 12 trials (11 in ADHD and 1 in enuresis) involving over 2200 patients (including 1357 patients receiving atomoxetine and 851 receiving placebo).
The average risk of suicidal ideation in patients receiving atomoxetine was 0.4% (5/1357 patients), compared to none in placebo-treated patients. There was 1 suicide attempt among these approximately 2200 patients, occurring in a patient treated with atomoxetine. No suicides occurred in these trials.
All reactions occurred in children 12 years of age or younger. All reactions occurred during the first month of treatment. It is unknown whether the risk of suicidal ideation in pediatric patients extends to longer-term use.
A similar analysis in adult patients treated with atomoxetine for either ADHD or major depressive disorder (MDD) did not reveal an increased risk of suicidal ideation or behavior in association with the use of atomoxetine. All pediatric patients being treated with atomoxetine should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
The following symptoms have been reported with atomoxetine: anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania and mania. Although a causal link between the emergence of such symptoms and the emergence of suicidal impulses has not been established, t…
🤒 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 Strides Pharma Inc. at 1-877-244-9825 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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 Reactions in Child and Adolescent Clinical Trials - In acute child and adolescent placebo-controlled trials, 3.0% (48/1613) of atomoxetine subjects and 1.4% (13/945) placebo subjects discontinued for adverse reactions. For all studies, (including open-label and long-term studies), 6.3% of extensive metabolizer (EM) patients and 11.2% of poor metabolizer (PM) patients discontinued because of an adverse reaction. Among atomoxetine-treated patients, irritability (0.3%, N = 5); somnolence (0.3%, N = 5); aggression (0.2%, N = 4); nausea (0.2%, N = 4); vomiting (0.2%, N = 4); abdominal pain (0.2%, N = 4); constipation (0.1%, N = 2); fatigue (0.1%, N = 2); feeling abnormal (0.1%, N = 2); and headache (0.1%, N = 2) were the reasons for discontinuation reported by more than 1 patient.
Seizures - Atomoxetine has not been systematically evaluated in pediatric patients with seizure disorder as these patients were excluded from clinical studies during the product's premarket testing. In the clinical development program, seizures were reported in 0.2% (12/5073) of children whose average age was 10 years (range 6 to 16 years). In these clinical trials, the seizure risk among poor metabolizers was 0.3% (1/293) compared to 0.2% (11/4741) for extensive metabolizers.
Commonly Observed Adverse Reactions in Acute Child and Adolescent, Placebo-Controlled Trials - Commonly observed adverse reactions associated with the use of atomoxetine (incidence of 2% or greater) and not observed at an equivalent incidence among placebo-treated patients (atomoxetine incidence greater than placebo) are listed in Table 2. Results were similar in the BID and the QD trial except as shown in Table 3, which shows both BID and QD results for selected adverse reactions based on statistically significant Breslow-Day tests.
The most commonly observed adverse reactions in patients treated with atomoxetine (incidence of 5% or greater and at least twice the incidence in placebo patients, for either BID or QD dosing) were: nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence ( see Tables 2 and 3). Additional data from ADHD clinical trials (controlled and uncontrolled) has shown that approximately 5 to 10% of pediatric patients experienced potentially clinically important changes in heart rate (≥ 20 beats per min) or blood pressure (≥ 15 to 20 mm Hg) [see Contraindications (4) and Warnings and Precautions (5)] .
Table 2: Common Treatment-Emergent Adverse Reactions Associated with the Use of Atomoxetine in Acute (up to 18 weeks) Child and Adolescent Trials Adverse Reaction Reactions reported by at least 2% of patients treated with atomoxetine, and greater than placebo. The following reactions did not meet this criterion but were reported by more atomoxetine-treated patient…
🔄 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)
7.1Monoamine 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)].
7.2Effect 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 those observed in poor metabolizers (PMs). In EM individuals treated with paroxetine or fluoxetine, the AUC of atomoxetine is approximately 6- to 8-fold and C ss,max is about 3- to 4-fold greater than atomoxetine alone. In vitro studies suggest that coadministration of cytochrome P450 inhibitors to PMs will not increase the plasma concentrations of atomoxetine.
7.3Antihypertensive Drugs and Pressor Agents Because of possible effects on blood pressure, atomoxetine should be used cautiously with antihypertensive drugs and pressor agents (e.g., dopamine, dobutamine) or other drugs that increase blood pressure.
7.4Albuterol Atomoxetine should be administered with caution to patients being treated with systemically-administered (oral or intravenous) albuterol (or other beta 2 agonists) because the action of albuterol on the cardiovascular system can be potentiated resulting in increases in heart rate and blood pressure. Albuterol (600 mcg iv over 2 hours) induced increases in heart rate and blood pressure. These effects were potentiated by atomoxetine (60 mg BID for 5 days) and were most marked after the initial coadministration of albuterol and atomoxetine.
However, these effects on heart rate and blood pressure were not seen in another study after the coadministration with inhaled dose of albuterol (200-800 mcg) and atomoxetine (80 mg QD for 5 days) in 21 healthy Asian subjects who were excluded for poor metabolizer status.
7.5Effect of Atomoxetine on P450 Enzymes Atomoxetine did not cause clinically important inhibition or induction of cytochrome P450 enzymes, including CYP1A2, CYP3A, CYP2D6, and CYP2C9. CYP3A Substrate (e.g., Midazolam) - Coadministration of atomoxetine (60 mg BID for 12 days) with midazolam, a model compound for CYP3A4 metabolized drugs (single dose of 5 mg), resulted in 15% increase in AUC of midazolam. No dose adjustment is recommended for drugs metabolized by CYP3A.
CYP2D6 Substrate (e.g., Desipramine) - Coadministration of atomoxetine (40 or 60 mg BID for 13 days) with desipramine, a model compound for CYP2D6 metabolized drugs (single dose of 50 mg), did not alter the pharmacokinetics of desipramine. No dose adjustment is recommended for drugs metabolized by CYP2D6.
7.6Alcohol Consumption of ethanol with atomoxetine did not change the intoxicating effects of ethanol.
7.7Methylphenidate Coadministration of methylphenidate with atomoxetine did not increase cardiovascular effects beyond those seen with methylphenidate alone.
7.8Drugs Highly Bound to Plasma Protein In vitro drug-displacement studies were conducted with atomoxetine and other highly-bound drugs at therapeutic concentrations. Atomoxetine did not affect the binding of warfarin, acetylsalicylic acid, phenytoin, or diazepam to human albumin. Similarly, these compounds did…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Hepatic Insufficiency – Increased exposure (AUC) to atomoxetine than with normal subjects in EM subjects with moderate (Child-Pugh Class B) (2-fold increase) and severe (Child-Pugh Class C) (4-fold increase). (8.6) Renal Insufficiency – Higher systemic exposure to atomoxetine than healthy subjects for EM subjects with end stage renal disease – no difference when exposure corrected for mg/kg dose. (8.7) Patients with Concomitant Illness – Does not worsen tics in patients with ADHD and comorbid Tourette's Disorder.
(8.10) Patients with Concomitant Illness – Does not worsen anxiety in patients with ADHD and comorbid Anxiety Disorders. (8.10)
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including atomoxetine, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/. Risk Summary Available published studies with atomoxetine use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
Some animal reproduction studies of atomoxetine had adverse developmental outcomes. One of 3 studies in pregnant rabbits dosed during organogenesis resulted in decreased live fetuses and an increase in early resorptions, as well as slight increases in the incidences of atypical origin of carotid artery and absent subclavian artery. These effects were observed at plasma levels (AUC) 3 times and 0.4 times the human plasma levels in extensive and poor metabolizers receiving the maximum recommended human dose (MRHD), respectively.
In rats dosed prior to mating and during organogenesis a decrease in fetal weight (female only) and an increase in the incidence of incomplete ossification of the vertebral arch in fetuses were observed at a dose approximately 5 times the MRHD on a mg/m 2 basis. In one of 2 studies in which rats were dosed prior to mating through the periods of organogenesis and lactation, decreased pup weight and decreased pup survival were observed at doses corresponding to 5-6 times the MRHD on a mg/m 2 basis. No adverse fetal effects were seen in pregnant rats dosed during the organogenesis period (see Data) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Data Animal Data Pregnant rabbits were treated with up to 100 mg/kg/day of atomoxetine by gavage throughout the period of organogenesis. At this dose, in 1 of 3 studies, a decrease in live fetuses and an increase in early resorptions was observed. Slight increases in the incidences of atypical origin of carotid artery and absent subclavian artery were observed.
These findings were observed at doses that caused slight maternal toxicity. The no-effect dose for these findings was 30 mg/kg/day. The 100 mg/kg dose is approximately 23 times the MRHD on a mg/m 2 basis; plasma levels (AUC) of atomoxetine at this dose in rabbits are estimated to be 3.3 times (extensive metabolizers) or 0.4 times (poor metabolizers) those in humans receiving the MRHD.
Rats were treated with up to approximately 50 mg/kg/day of atomoxetine (approximately 6 times the MRHD on a mg/m 2 basis) in the diet from 2 weeks (females) or 10 weeks (males) prior to mating through the periods of organogenesis and lactation. In 1 of 2 studies, decreases in pup weight and pup survival were observed. The decreased pup survival was also seen at 25 mg/kg (but not at 13 mg/kg).
In a study in which rats were treated with atomoxetine in the di…
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including atomoxetine, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/adhd-medications/. Risk Summary Available published studies with atomoxetine use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
Some animal reproduction studies of atomoxetine had adverse developmental outcomes. One of 3 studies in pregnant rabbits dosed during organogenesis resulted in decreased live fetuses and an increase in early resorptions, as well as slight increases in the incidences of atypical origin of carotid artery and absent subclavian artery. These effects were observed at plasma levels (AUC) 3 times and 0.4 times the human plasma levels in extensive and poor metabolizers receiving the maximum recommended human dose (MRHD), respectively.
In rats dosed prior to mating and during organogenesis a decrease in fetal weight (female only) and an increase in the incidence of incomplete ossification of the vertebral arch in fetuses were observed at a dose approximately 5 times the MRHD on a mg/m 2 basis. In one of 2 studies in which rats were dosed prior to mating through the periods of organogenesis and lactation, decreased pup weight and decreased pup survival were observed at doses corresponding to 5-6 times the MRHD on a mg/m 2 basis. No adverse fetal effects were seen in pregnant rats dosed during the organogenesis period (see Data) .
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Data Animal Data Pregnant rabbits were treated with up to 100 mg/kg/day of atomoxetine by gavage throughout the period of organogenesis. At this dose, in 1 of 3 studies, a decrease in live fetuses and an increase in early resorptions was observed. Slight increases in the incidences of atypical origin of carotid artery and absent subclavian artery were observed.
These findings were observed at doses that caused slight maternal toxicity. The no-effect dose for these findings was 30 mg/kg/day. The 100 mg/kg dose is approximately 23 times the MRHD on a mg/m 2 basis; plasma levels (AUC) of atomoxetine at this dose in rabbits are estimated to be 3.3 times (extensive metabolizers) or 0.4 times (poor metabolizers) those in humans receiving the MRHD.
Rats were treated with up to approximately 50 mg/kg/day of atomoxetine (approximately 6 times the MRHD on a mg/m 2 basis) in the diet from 2 weeks (females) or 10 weeks (males) prior to mating through the periods of organogenesis and lactation. In 1 of 2 studies, decreases in pup weight and pup survival were observed. The decreased pup survival was also seen at 25 mg/kg (but not at 13 mg/kg).
In a study in which rats were treated with atomoxetine in the diet from 2 weeks (females) or 10 weeks (males) prior to mating throughout the period of organogenesis, a decrease in fetal weight (female only) and an increase in the incidence of incomplete ossification of the vertebral arch in fetuses were observed at 40 mg/kg/day (approximately 5 times the MRHD on a mg/m 2 basis) but not at 20 mg/kg/day. No adverse fetal effects were seen when pregnant rats were treated with up to 150 mg/kg/day (approximately 17 times the MRHD on a mg/m 2 basis) by gavage throughout the period of organogenesis.
🧒 Pediatric Use ▾
8.4Pediatric Use Anyone considering the use of atomoxetine in a child or adolescent must balance the potential risks with the clinical need [see Boxed Warning and Warnings and Precautions (5.1)]. The pharmacokinetics of atomoxetine in children and adolescents are similar to those in adults. The safety, efficacy, and pharmacokinetics of atomoxetine in pediatric patients less than 6 years of age have not been evaluated.
A study was conducted in young rats to evaluate the effects of atomoxetine on growth and neurobehavioral and sexual development. Rats were treated with 1, 10, or 50 mg/kg/day (approximately 0.2, 2, and 8 times, respectively, the maximum human dose on a mg/m 2 basis) of atomoxetine given by gavage from the early postnatal period (Day 10 of age) through adulthood. Slight delays in onset of vaginal patency (all doses) and preputial separation (10 and 50 mg/kg), slight decreases in epididymal weight and sperm number (10 and 50 mg/kg), and a slight decrease in corpora lutea (50 mg/kg) were seen, but there were no effects on fertility or reproductive performance.
A slight delay in onset of incisor eruption was seen at 50 mg/kg. A slight increase in motor activity was seen on Day 15 (males at 10 and 50 mg/kg and females at 50 mg/kg) and on Day 30 (females at 50 mg/kg) but not on Day 60 of age. There were no effects on learning and memory tests.
The significance of these findings to humans is unknown.
🧓 Geriatric Use ▾
8.5Geriatric Use The safety, efficacy and pharmacokinetics of atomoxetine in geriatric patients have not been evaluated.
🆘 Overdosage ▾
10 OVERDOSAGE
10.1Human Experience There is limited clinical trial experience with atomoxetine overdose. During postmarketing, there have been fatalities reported involving a mixed ingestion overdose of atomoxetine and at least one other drug. There have been no reports of death involving overdose of atomoxetine alone, including intentional overdoses at amounts up to 1400 mg.
In some cases of overdose involving atomoxetine, seizures have been reported. The most commonly reported symptoms accompanying acute and chronic overdoses of atomoxetine were gastrointestinal symptoms, somnolence, dizziness, tremor, and abnormal behavior. Hyperactivity and agitation have also 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 events were mild to moderate. Less commonly, there have been reports of QT prolongation and mental changes, including disorientation and hallucinations [see Clinical Pharmacology (12.2)] .
10.2Management of Overdose Consult with a Certified Poison Control Center for up to date guidance and advice. Because atomoxetine is highly protein-bound, dialysis is not likely to be useful in the treatment of overdose.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action 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.
12.2Pharmacodynamics An exposure-response analysis encompassing doses of atomoxetine (0.5, 1.2 or 1.8 mg/kg/day) or placebo demonstrated atomoxetine exposure correlates with efficacy as measured by the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator administered and scored. The exposure-efficacy relationship was similar to that observed between dose and efficacy with median exposures at the two highest doses resulting in near maximal changes from baseline [see Clinical Studies (14.2)] .
Cardiac Electrophysiology - The effect of atomoxetine on QTc prolongation was evaluated in a randomized, double-blinded, positive-(moxifloxacin 400 mg) and placebo-controlled, cross-over study in healthy male CYP2D6 poor metabolizers. A total of 120 healthy subjects were administered atomoxetine (20 mg and 60 mg) twice daily for 7 days. No large changes in QTc interval (i.e., increases > 60 msec from baseline, absolute QTc > 480 msec) were observed in the study.
However, small changes in QTc interval cannot be excluded from the current study, because the study failed to demonstrate assay sensitivity. There was a slight increase in QTc interval with increased atomoxetine concentration.
12.3Pharmacokinetics Atomoxetine is well-absorbed after oral administration and is minimally affected by food. It is eliminated primarily by oxidative metabolism through the cytochrome P450 2D6 (CYP2D6) enzymatic pathway and subsequent glucuronidation. Atomoxetine has a half-life of about 5 hours.
A fraction of the population (about 7% of Caucasians and 2% of African Americans) are poor metabolizers (PMs) of CYP2D6 metabolized drugs. These individuals have reduced activity in this pathway resulting in 10-fold higher AUCs, 5-fold higher peak plasma concentrations, and slower elimination (plasma half-life of about 24 hours) of atomoxetine compared with people with normal activity [extensive metabolizers (Ems)]. Drugs that inhibit CYP2D6, such as fluoxetine, paroxetine, and quinidine, cause similar increases in exposure.
The pharmacokinetics of atomoxetine have been evaluated in more than 400 children and adolescents in selected clinical trials, primarily using population pharmacokinetic studies. Single-dose and steady-state individual pharmacokinetic data were also obtained in children, adolescents, and adults. When doses were normalized to a mg/kg basis, similar half-life, C max , and AUC values were observed in children, adolescents, and adults.
Clearance and volume of distribution after adjustment for body weight were also similar. Absorption and Distribution - Atomoxetine is rapidly absorbed after oral administration, with absolute bioavailability of about 63% in Ems and 94% in PMs. Maximal plasma concentrations (C max ) are reached approximately 1 to 2 hours after dosing.
Atomoxetine can be administered with or without food. Administration of atomoxetine with a standard high-fat meal in adults did not affect the extent of oral absorption of atomoxetine (AUC), but did decrease the rate of absorption, resulting in a 37% lower C max , and delayed T max by 3 hours. In clinical trials with children and adolescents, administration of atomoxetine with food resulted in a 9% lower C max .
The steady-state volume of distribution after intravenous administration is
0.85L/kg indicating that atomoxetine distributes primarily into total body water. Volume of distribution is similar across the patient weight range after normalizing for body weight. At therapeutic concentrations, 98% of atomoxetine in plasma is bound to protein, primarily albumin. Metabolism and Elimination - Atomo…
🧬 Mechanism of Action ▾
12.1Mechanism of Action 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied Atomoxetine Capsules, USP are available containing atomoxetine hydrochloride, USP equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 of atomoxetine. A size "3", red opaque cap and light yellow opaque body, hard gelatin capsule filled with white to off-white powder. The cap imprinted with "Strides logo" and body imprinted with "010" axially in black ink.
They are available as follows: NDC 64380-472-01 bottles of 30 capsules NDC 64380-472-02 bottles of 500 capsules A size "3", orange opaque cap and light yellow opaque body, hard gelatin capsule filled with white to off-white powder. The cap imprinted with "Strides logo" and body imprinted with "018" axially in black ink. They are available as follows: NDC 64380-473-01 bottles of 30 capsules NDC 64380-473-02 bottles of 500 capsules A size "3", light blue opaque cap and white opaque body, hard gelatin capsule filled with white to off-white powder.
The cap imprinted with "Strides logo" and body imprinted with "025" axially in black ink. They are available as follows: NDC 64380-474-01 bottles of 30 capsules NDC 64380-474-02 bottles of 500 capsules A size "2", blue opaque cap and light blue opaque body, hard gelatin capsule filled with white to off-white powder. The cap imprinted with "Strides logo" and body imprinted with "040" axially in black ink.
They are available as follows: NDC 64380-475-01 bottles of 30 capsules NDC 64380-475-02 bottles of 500 capsules A size "1", violet opaque cap and light yellow opaque body, hard gelatin capsule filled with white to off-white powder. The cap imprinted with "Strides logo" and body imprinted with "060" axially in black ink. They are available as follows: NDC 64380-476-01 bottles of 30 capsules NDC 64380-476-02 bottles of 500 capsules A size "0", light orange opaque cap and light yellow opaque body, hard gelatin capsule filled with white to off-white powder.
The cap imprinted with "Strides logo" and body imprinted with "080" axially in black ink. They are available as follows: NDC 64380-477-01 bottles of 30 capsules NDC 64380-477-02 bottles of 500 capsules A size "0EL", light pink opaque cap and light yellow opaque body, hard gelatin capsule filled with white to off-white powder. The cap imprinted with "Strides logo" and body imprinted with "100" axially in black ink.
They are available as follows: NDC 64380-478-01 bottles of 30 capsules NDC 64380-478-02 bottles of 500 capsules
16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
16.1How Supplied Atomoxetine Capsules, USP are available containing atomoxetine hydrochloride, USP equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 of atomoxetine. A size "3", red opaque cap and light yellow opaque body, hard gelatin capsule filled with white to off-white powder. The cap imprinted with "Strides logo" and body imprinted with "010" axially in black ink.
They are available as follows: NDC 64380-472-01 bottles of 30 capsules NDC 64380-472-02 bottles of 500 capsules A size "3", orange opaque cap and light yellow opaque body, hard gelatin capsule filled with white to off-white powder. The cap imprinted with "Strides logo" and body imprinted with "018" axially in black ink. They are available as follows: NDC 64380-473-01 bottles of 30 capsules NDC 64380-473-02 bottles of 500 capsules A size "3", light blue opaque cap and white opaque body, hard gelatin capsule filled with white to off-white powder.
The cap imprinted with "Strides logo" and body imprinted with "025" axially in black ink. They are available as follows: NDC 64380-474-01 bottles of 30 capsules NDC 64380-474-02 bottles of 500 capsules A size "2", blue opaque cap and light blue opaque body, hard gelatin capsule filled with white to off-white powder. The cap impr…
📦 Storage and Handling ▾
16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
📋 Description ▾
11 DESCRIPTION Atomoxetine capsules, USP are a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride 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 17 H 21 NO•HCl, which corresponds to a molecular weight of 291.82. The chemical structure is: Atomoxetine hydrochloride, USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water. Atomoxetine capsules are intended for oral administration only.
Each capsule contains atomoxetine hydrochloride equivalent to 10, 18, 25, 40, 60, 80 or 100 mg of atomoxetine. The capsules also contain colloidal silicon dioxide, gelatin, magnesium stearate, pregelatinized starch (corn), sodium lauryl sulfate and titanium dioxide. The 10 mg capsules also contain D&C Yellow No.
10, D&C Red No. 28, D&C Red No. 33, FD&C Red No.
40 and FD&C Yellow No. 6; the 18 mg capsules also contain D&C Red No. 28, D&C Yellow No.
10, FD&C Red No. 40 and FD&C Yellow No. 6; the 25 mg capsules also contain FD&C Blue No.
1 and FD&C Red No. 3; the 40 mg capsules also contain D&C Red No. 28 and FD&C Blue No.
1; the 60 mg capsules also contain D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No.
1 and FD&C Yellow No. 6; the 80 mg capsules also contain D&C Red No. 28, D&C Yellow No.
10 and FD&C Yellow No. 6; the 100 mg capsules also contain D&C Yellow No. 10, FD&C Red No.
3, FD&C Yellow No. 6 and red iron oxide. In addition, the imprinting ink contains the following: black iron oxide, FD&C Blue No.
1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, D&C Yellow No.
10 Aluminum Lake, propylene glycol and shellac glaze. Image
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Suicide Risk Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, depression, and suicidal ideation, especially early during atomoxetine treatment and when the dose is adjusted.
Families and caregivers of patients should be advised to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication [see Warnings and Precautions (5.1)] .
Severe Liver Injury Patients initiating atomoxetine should be cautioned that severe liver injury may develop. Patients should be instructed to contact their healthcare provider immediately should they develop pruritus, dark urine, jaundice, right upper quadrant tenderness, or unexplained "flu-like" symptoms [see Warnings and Precautions (5.2)]. Screening Patients for Bipolar Disorder Instruct patients and their caregivers to look for signs of activation of mania/hypomania [see Warnings and Precautions (5.6)] .
Aggression or Hostility Instruct patients and their caregivers to contact their healthcare provider as soon as possible should they notice an increase in aggression or hostility [see Warnings and Precautions (5.7)] . Priapism Rare postmarketing cases of priapism, defined as painful and nonpainful penile erection lasting more than 4 hours, have been reported for pediatric and adult patients treated with atomoxetine. The parents or guardians of pediatric patients taking atomoxetine and adult patients taking atomoxetine should be instructed that priapism requires prompt medical attention [see Warnings and Precautions (5.10)] .
Ocular Irritant Atomoxetine is an ocular irritant. Atomoxetine is not intended to be opened. In the event of capsule content coming in contact with the eye, the affected eye should be flushed immediately with water, and medical advice obtained.
Hands and any potentially contaminated surfaces should be washed as soon as possible. Drug-Drug Interaction Patients should be instructed to consult a healthcare provider if they are taking or plan to take any prescription or over-the-counter medicines, dietary supplements, or herbal remedies. Pregnancy Registry Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to atomoxetine during pregnancy [see Use in Specific Populations (8.1)] .
Food Patients may take atomoxetine with or without food. Missed Dose If patients miss a dose, they should be instructed to take it as soon as possible, but should not take more than the prescribed total daily amount of atomoxetine in any 24-hour period. Interference with Psychomotor Performance Patients should be instructed to use caution when driving a car or operating hazardous machinery until they are reasonably certain that their performance is not affected by atomoxetine.
Distributed by: Strides Pharma Inc. Bridgewater, NJ 08807 Revised:08/2025
💬 Medication Guide ▾
SPL MEDGUIDE Medication Guide Atomoxetine Capsules, USP (a" toe mox' e teen) Read the Medication Guide that comes with atomoxetine before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your treatment or your child's treatment with atomoxetine.
What is the most important information I should know about atomoxetine? The following have been reported with use of atomoxetine: 1. Suicidal thoughts and actions in children and teenagers : Children and teenagers sometimes think about suicide, and many report trying to kill themselves.
Results from atomoxetine clinical studies with over 2200 child or teenage ADHD patients suggest that some children and teenagers may have a higher chance of having suicidal thoughts or actions. Although no suicides occurred in these studies, 4 out of every 1000 patients developed suicidal thoughts. Tell your child or teenager's doctor if your child or teenager (or there is a family history of): ● has bipolar illness (manic-depressive illness) ● had suicide thoughts or actions before starting atomoxetine The chance for suicidal thoughts and actions may be higher: ● early during atomoxetine treatment ● during dose adjustments Prevent suicidal thoughts and action in your child or teenager by: ● paying close attention to your child or teenager's moods, behaviors, thoughts, and feelings during atomoxetine treatment ● keeping all follow-up visits with your child or teenager's doctor as scheduled Watch for the following signs in your child or teenager during atomoxetine treatment: ● anxiety ● agitation ● panic attacks ● trouble sleeping ● irritability ● hostility ● aggressiveness ● impulsivity ● restlessness ● mania ● depression ● suicide thoughts Call your child or teenager's doctor right away if they have any of the above signs, especially if they are new, sudden, or severe.
Your child or teenager may need to be closely watched for suicidal thoughts and actions or need a change in medicine. 2. Severe liver damage : Atomoxetine can cause liver injury in some patients.
Call your doctor right away if you or your child has the following signs of liver problems: ● itching ● right upper belly pain ● dark urine ● yellow skin or eyes ● unexplained flu-like symptoms 3. Heart-related problems : ● sudden death in patients who have heart problems or heart defects ● stroke and heart attack in adults ● increased blood pressure and heart rate Tell your doctor if you or your child has any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting atomoxetine.
Your doctor should check your blood pressure or your child's blood pressure and heart rate regularly during treatment with atomoxetine. Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking atomoxetine. 4.
New mental (psychiatric) problems in children and teenagers : ● new psychotic symptoms (such as hearing voices, believing things that are not true, being suspicious) or new manic symptoms Call your child or teenager's doctor right away about any new mental symptoms because adjusting or stopping atomoxetine treatment may need to be considered. What is atomoxetine? Atomoxetine is a selective norepinephrine reuptake inhibitor medicine.
It is used for the treatment of attention deficit and hyperactivity disorder (ADHD). Atomoxetine may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD. Atomoxetine should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
Atomoxetine has not been studied in children less than 6 years old. Who should not take atomoxetine? Atomoxetine should not be taken if you or your child: ● are taking or have taken within the pa…