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Atomoxetine hydrochloride 4 mg/mL Solution — NDC 72888-0456-01 package photo
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Atomoxetine hydrochloride 4 mg/mL Solution — NDC 72888-456-01 (Billing 72888-0456-01)

by Advagen Pharma Ltd. · 1 BOTTLE, GLASS in 1 CARTON / 100 mL in 1 BOTTLE, GLASS

This is a package of Atomoxetine hydrochloride 4 mg/mL Solution from Advagen Pharma Ltd., marketed since Mar 2026 and currently FDA-listed. It is this product's only package size.

NDC 72888-0456-01
🏷️ FDA NDC (as labeled) 72888-456-01 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 72888-456-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
72888 labeler · 456 product · 01 package
Package marketed since
Mar 20, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0372888456010
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72888-456-01
Product NDC 72888-456
11-digit billing NDC 72888045601
NCPDP billing unit ML — per mL (volume)
RxCUI 2739831
UNII 57WVB6I2W0
UPC 0372888456010
Application # NDA220320
SPL Set ID 16096e9c-2dcd-4c84-a1a8-1c85d6d6898c
Established class (EPC) Norepinephrine Reuptake Inhibitor
Mechanism of action Norepinephrine Uptake Inhibitors
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-03-20
Route ORAL
Dosage form SOLUTION
Substance ATOMOXETINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 2739831
Why two NDCs? The FDA registers this code as 72888-456-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 72888-0456-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Norepinephrine Reuptake Inhibitor class.

Pharmacologic class Norepinephrine Reuptake Inhibitor
Drug family (ATC) Centrally acting sympathomimetics
How it works Norepinephrine Uptake Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • It treats ADHD in adults and in children 6 and older. It's not a stimulant, and it works best as part of a full plan that can include behavioral, educational and social support.
  • Take it by mouth once a day in the morning, or split into two doses in the morning and late afternoon or early evening, as your prescriber directs. Food doesn't matter. Swallow cap...
  • In children, the most common are nausea, vomiting, tiredness, stomach pain, sleepiness and lower appetite. Adults more often notice dry mouth, constipation, dizziness, lower appeti...
  • Atomoxetine carries a boxed warning for suicidal thoughts in children and teens, mostly early in treatment. Watch daily for agitation, irritability, anxiety, aggression, panic or u...
📖 Read our full Atomoxetine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
72888-0456-01 You're viewing this Main listing 1 BOTTLE, GLASS in 1 CARTON / 100 mL in 1 BOTTLE, GLASS 2026-03-20 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Atoncy 4 mg/mL 30698-0456-02 Validus 1 bottle — — FDA listed —
Atomoxetine hydrochloride 4 mg/mLthis 72888-0456-01 Advagen 1 bottle — — FDA listed —
About this product: this is an authorized generic — the brand-name product marketed without its brand name. Other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2026
On the market since
Mar 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color white
FlavorGrape
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII D65DG142WK
    Maltitol is a sugar alcohol made by hydrogenating maltose. It's used as a sweetener and filler in medicines to improve taste and add bulk to tablets and capsules.
  • UNII E4GA8884NN
    Phosphoric acid is a weak mineral acid used in medicines as a buffer and pH adjuster. It helps stabilize the product and control its acidity level.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 3980JIH2SW
    A salt form of phosphoric acid that acts as a buffer and pH adjuster in medicines. It helps keep the product at the correct acidity level for stability and effectiveness.
  • UNII 8KW3E207O2
    A liquid sweetener made from sorbitol, a sugar alcohol derived from glucose. It sweetens the medicine and also acts as a humectant to help retain moisture and improve texture in liquid formulations.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII VCQ006KQ1E
    Xylitol is a naturally occurring sugar alcohol derived from plants. It's used in medicines as a sweetener, bulking agent, and to improve taste, especially in liquid formulations and chewable tablets.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAdvagen Pharma Ltd.
Application holderMAP77 LLC
FDA applicationNDA220320 (NDA AUTHORIZED GENERIC)
Labeler code72888
First marketedMar 2026
Product typeHuman Prescription Drug
Portfolio25 products on file

More NDCs from Advagen Pharma Ltd. labeler code 72888

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🧪 Nonclinical Toxicology 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER All pediatric patients 6 years of age or older treated with atomoxetine oral solution should be monitored and observed closely for suicidal thoughts and behaviors, clinical worsening, or unusual changes in behavior, especially during the initial months of therapy or at times of dosage changes. Families and caregivers should be advised of the need for close observation and communication with the health care provider. Consider stopping atomoxetine oral solution in patients who experience emergent suicidal thoughts and behavior [see Warnings and Precautions (5.1) ] .

Atomoxetine increased the risk of suicidal ideation in pediatric patients 6 years of age and older with attention-deficit/hyperactivity disorder (ADHD) in short-term studies [see Warnings and Precautions (5.1) ] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER See full prescribing information for complete boxed warning. All pediatric patients 6 years of age and older treated with atomoxetine oral solution should be monitored and observed closely for suicidal thoughts and behavior, clinical worsening, or unusual changes in behavior, especially during the initial months of therapy or at times of dosage changes.

( 5.1 ) Consider stopping atomoxetine oral solution in patients who experience emergent suicidal thoughts and behavior. ( 5.1 ) Atomoxetine oral solution increased the risk of suicidal ideation in pediatric patients 6 years of age and older with attention deficit/ hyperactivity disorder (ADHD) in short-term studies. ( 5.1 )

🎯 Indications and Usage 85 words ▾

1 INDICATIONS AND USAGE Atomoxetine oral solution is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adult and pediatric patients 6 years of age and older. Atomoxetine oral solution is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with ADHD. Atomoxetine oral solution is a selective norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of ADHD in adults and pediatric patients 6 years of age and older.

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Prior to initiating treatment with atomoxetine oral solution: Screen patients for a personal or family history of bipolar disorder, mania, or hypomania. ( 2.1 , 5.6 ) Consider genetic testing to determine the patient’s CYP2D6 metabolizer status prior to dosing. ( 2.1 , 2.5 ) See table below for the recommended atomoxetine oral solution dosage.

( 2.3 ) Age and Body Weight Starting Dosage Target Dosage 1 Maximum Total Daily Dose 1 Pediatrics who weigh less than 70 kg 0.5 mg/kg/day 1.2 mg/kg/day 1.4 mg/kg/day or 100 mg/day (whichever is less) Pediatrics who weigh 70 kg or more and adults 40 mg/day 80 mg/day 100 mg/day 1 Administer either as once daily dosage in the morning or as evenly divided twice daily dosage in the morning and late afternoon/early evening For the recommended dosage in patients with hepatic impairment, see Full Prescribing Information. ( 2.4 ) For the recommended dosage with concomitant use of a strong CYP2D6 inhibitor or in CYP2D6 poor metabolizers, see Full Prescribing Information.

( 2.5 )

2.1Recommendations Prior to Initiating Atomoxetine Oral Solution Treatment Prior to initiating treatment with atomoxetine oral solution: Screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.6) ] . Consider genetic testing to determine the patient’s CYP2D6 metabolizer status [see Dosage and Administration (2.5) ] .

2.2Administration Instructions Atomoxetine oral solution may be taken with or without food. Instruct patients to only use the supplied syringe and bottle adapter to measure and take atomoxetine oral solution [see Instructions for Use ] .

2.3Recommended Dosage Table 1 includes the recommended dosage of atomoxetine oral solution in adult patients and pediatric patients 6 years of age and older for treatment of ADHD. Table 1: Recommended Dosage of Atomoxetine Oral Solution for the Treatment of ADHD​​​​​​​ Age and Body Weight Starting Dosage Titration Interval Target Dosage Maximum Dosage Pediatric patients who weigh less than 70 kg 0.5 mg/kg/day Minimum of 3 days 1.2 mg/kg/day a,b 1.4 mg/kg/day or 100 mg/day, whichever is less a Pediatric patients who weigh 70 kg or more and adult patients 40 mg/day Minimum of 3 days 80 mg/day a 100 mg/day a,c a Administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening. b No additional benefit has been demonstrated with atomoxetine dosages higher than 1.2 mg/kg/day [see Clinical Studies (14) ] . c If a patient has not achieved an optimal response at 80 mg/day after 2 to 4 additional weeks, may increase dosage to a maximum of 100 mg/day.

There are no data that support increased effectiveness at a dosage higher than 100 mg/day [see Clinical Studies (14) ] . The health care provider who elects to use atomoxetine oral solution for extended periods should periodically reevaluate the long-term usefulness of atomoxetine oral solution for the individual patient.

2.4Recommended Dosage in Patients with Hepatic Impairment For patients 6 years of age or older with: Severe hepatic impairment (HI) (Child-Pugh Class C), the recommended initial and target dosage is 25% of recommended dosage in patients with normal hepatic function [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ] . Moderate HI (Child-Pugh Class B), the recommended initial and target dosage is 50% of the recommended dosage in patients with normal hepatic function [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ] .

Mild HI (Child-Pugh Class A) the recommended initial and target dosage is the same as those with normal hepatic function.

2.5Recommended Dosage with Concomitant Use of Strong CYP2D6 Inhibitors or in CYP2D6 Poor Metabolizers Table 2 includes the recommended atomoxetine oral solution dosage in adult patients and pediatric patients aged 6 years of age or older with concomitant use of a strong CYP2D6 inhi… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 58 words ▾

3 DOSAGE FORMS AND STRENGTHS Oral Solution: Each mL contains 4 mg of atomoxetine (equivalent to 4.57 mg of atomoxetine hydrochloride), clear colorless solution, free from any visible foreign and particulate matter, free of precipitation and hazy mass. Supplied with a 10 mL oral syringe and a bottle adapter. Oral solution: Each mL contains 4 mg of atomoxetine

⛔ Contraindications ~1 min read ▾

4 CONTRAINDICATIONS Atomoxetine oral solution is contraindicated in patients: With known hypersensitivity reaction to atomoxetine oral solution or other components of atomoxetine oral solution. Hypersensitivity reactions that occurred with atomoxetine oral solution use included anaphylaxis, angioneurotic edema, urticaria, and rash [see Warnings and Precautions (5.8) ] . Taking, or within 14 days of stopping, a monoamine oxidase inhibitor (MAOI) [see Drug Interactions (7) ] .

With narrow angle glaucoma. In clinical trials, atomoxetine oral solution use was associated with an increased risk of mydriasis. With pheochromocytoma or a history of pheochromocytoma.

Serious reactions, including elevated blood pressure and tachyarrhythmia, have been reported in patients with pheochromocytoma or a history of pheochromocytoma who received atomoxetine oral solution. With severe cardiac or vascular disorders whose condition would be expected to deteriorate if they had clinically important increase in blood pressure or heart rate (e.g., 15 to 20 mm Hg in blood pressure or 20 beats per minute in heart rate) [see Warnings and Precautions (5.4) ] . Contraindicated in patients ( 4 ): With known hypersensitivity to atomoxetine oral solution or other components of atomoxetine oral solution Taking or within 14 days of stopping, a monoamine oxidase inhibitor (MAOI) With narrow angle glaucoma.

With pheochromocytoma or history of pheochromocytoma. With severe cardiac or vascular disorders whose condition would be expected to deteriorate with clinically important increases in blood pressure or heart rate.

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Severe Liver Injury: Atomoxetine oral solution should be discontinued and not restarted in patients with jaundice or laboratory evidence of liver injury. ( 5.2 ) Serious Cardiovascular Reactions: Prior to atomoxetine oral solution treatment, patients should have a careful history and physical exam to assess for presence of cardiovascular (CV) disease. Atomoxetine oral solution generally should not be used in pediatric patients with known serious cardiac abnormalities, cardiomyopathy, serious arrhythmias.

Consideration should be given to not using atomoxetine oral solution in adults with clinically significant cardiac abnormalities. Patients who develop symptoms suggestive of cardiac disease during atomoxetine oral solution treatment should stop atomoxetine oral solution and undergo a prompt cardiac evaluation. ( 5.3 ) Increase in Blood Pressure and Heart Rate: Heart rate and blood pressure should be measured at baseline, following atomoxetine oral solution dosage increases, and periodically while on therapy.

( 5.4 ) New Psychotic or Manic Symptoms and Activation of Mania: If psychotic or manic symptoms occur, consider discontinuing atomoxetine oral solution. ( 5.5 ) Aggressive Behavior or Hostility: Monitor for the appearance or worsening of aggressive behavior or hostility. ( 5.7 ) Effects on Urine Outflow: Urinary retention or hesitancy may occur.

( 5.8 ) Priapism: Prompt medical attention is required in the event of suspected priapism. ( 5.9 ) Effect on Growth in Pediatric Patients: Closely monitor growth (e.g., weight, height) in pediatric patients. ( 5.11 )

5.1Suicidal Thoughts and Behaviors in Pediatric Patients 6 Years of Age and Older All pediatric patients 6 years of age and older treated with atomoxetine oral solution should be monitored observed closely for clinical worsening, suicidal thoughts and behavior, and unusual changes in behavior, especially during the initial few months of atomoxetine oral solution therapy, or at times of dose changes, either increases or decreases. Families and caregivers of pediatric patients 6 years of age and older treated with atomoxetine oral solution should be alerted about the need to monitor patients daily for the emergence of agitation, irritability, unusual changes in behavior, and mental health-related symptoms, as well as the emergence of suicidal thoughts and behavior, and to report such symptoms immediately to a health care provider.

Consider changing the therapeutic regimen, including stopping atomoxetine oral solution, in patients who experience emergent suicidality or symptoms that might be precursors to emerging suicidal thoughts and behavior, especially if these symptoms are severe or abrupt in onset, or were not part of the patient’s presenting symptoms. Atomoxetine increased the risk of suicidal ideation in pediatric patients 6 years of age and older with ADHD in pooled placebo-controlled short-term studies (6 to 18 weeks). In 12 studies (11 studies in patients with ADHD and 1 in another clinical study ) with over 2,200 pediatric patients, the mean incidence of suicidal ideation in pediatric patients treated with another atomoxetine product was 0.4% (5/1357) (including one patient with a suicide attempt) compared to 0% (0/851) in placebo-treated pediatric patients.

No suicides occurred in these studies. All the suicidal ideations occurred in pediatric patients 6 to 12 years of age, and all occurred during the first month of treatment with the other atomoxetine product. 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 ADHD did not reveal an increased risk of suicidal ideation or behavior. The following psychiatric symptoms have been reported with the use of atomoxetine: anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania and mania… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions (≥5% and at least twice the incidence of placebo patients): Pediatric Clinical Studies: Nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence. ( 6.1 ) Adult Clinical Studies: Constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction, and urinary hesitation. ( 6.1 ) Patients should be instructed to use caution when driving a car or operating hazardous machinery (because of somnolence) until they are reasonably certain that their performance is not affected by atomoxetine oral solution ( 6.1 ).

To report SUSPECTED ADVERSE REACTIONS, contact Advagen Pharma Ltd, at 1-866-488-0312 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience 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. The safety of atomoxetine oral solution has been established from adequate and well-controlled studies of atomoxetine capsules (also referred to as another atomoxetine product) in patients 6 years of age and older with ADHD [see Clinical Studies (14) ] .

Below is a display of the adverse reactions of [atomoxetine capsules in these adequate and well-controlled studies. Atomoxetine capsules were administered to 5,382 pediatric patients 6 years of age and older in clinical ADHD studies (Studies 1, 2, 3, 4, and 5) [see Clinical Studies (14.1) ] and 1,007 adults in clinical ADHD studies (Studies 6 and 7) [see Clinical Studies (14.2) ] . In the ADHD clinical trials, 2,529 pediatric patients were treated for over 6 months, which included 1,625 pediatric patients who were treated for longer than 1 year.

Adverse Reactions in the Clinical Trials of Pediatric Patients 6 Years of Age and Older with ADHD Discontinuation of Treatment Due to Adverse Reactions in the Clinical Studies of Pediatric Patients 6 Years of Age and Older: In the acute placebo-controlled studies of pediatric patients 6 years of age and older with ADHD, 3% (48/1,613) of atomoxetine capsules-treated pediatric patients and 1.4% (13/945) of placebo-treated pediatric patients discontinued due to an adverse reaction. Among atomoxetine capsules-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 one patient.

For all studies, (including open-label and long-term studies), 6% of atomoxetine capsules-treated pediatric patients who were other CYP2D6 metabolizer types (ultrarapid, normal, and intermediate) and 11% of those who were CYP2D6 poor metabolizers discontinued due to an adverse reaction. Common Adverse Reactions in the Clinical Studies of Pediatric Patients 6 Years of Age and Older: Common adverse reactions (incidence of 2% or greater in atomoxetine capsules-treated patients and with a higher incidence in atomoxetine capsules-treated patients compared to placebo-treated patients) in pediatric patients 6 years of age and older with ADHD are listed in Table 3.

The most commonly observed adverse reactions in atomoxetine capsules-treated patients (incidence of ≥5% and ≥twice the incidence in placebo-treated patients), for either twice daily or once daily dosing were: nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence (see Tables 3 and 4). Table 3: Common Adverse Reactions a in Acute Studies (up to 18 weeks) in Pediatric Patients 6 Years and Older with ADHD Atomoxetine Capsules (N=1,597) Placebo (N=934) Headache 19% 15% Abdominal pain b 18% 10% Decreased appetite 16% 4% Somnolence c 11% 4% Vomiting 11% 6% Nausea 10% 5% Fatigue 8% 3% Irritability 6% 3% Dizziness 5% 2% Decreas… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS See Table 9 for clinically significant drug interactions with atomoxetine oral solution and other drugs. Table 9: Clinically Significant Drug Interactions with Atomoxetine Oral Solution and Other Drugs​​​​​​​ Monoamine Oxidase Inhibitors (MAOIs) Prevention or Management Atomoxetine oral solution is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue, or in patients who stopped an MAOI within 14 days. Mechanism and Clinical Effect(s) As with other drugs affecting brain monoamine concentrations, there have been reports of serious, sometimes fatal reactions (hyperthermia, rigidity, myoclonus, autonomic instability with fluctuations of vital signs, extreme agitation progressing to delirium/coma) with concomitant use of atomoxetine oral solution and an MAOI.

Some cases presented with features resembling neuroleptic malignant syndrome. Strong CYP2D6 Inhibitors Prevention or Management With concomitant use of atomoxetine oral solution and a strong CYP2D6 inhibitor 1 , increase the titration interval [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) ] . Mechanism and Clinical Effect(s) Atomoxetine is a CYP2D6 substrate.

Concomitant use of atomoxetine oral solution and a strong CYP2D6 inhibitor increases atomoxetine exposure [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) ] . Antihypertensive Drugs Prevention or Management Increase the frequency of monitoring blood pressure and adjust atomoxetine oral solution dosage as clinically appropriate. Mechanism and Clinical Effect(s) Because of increased risk of increased blood pressure, atomoxetine oral solution should be used cautiously with antihypertensive drugs, other drugs that increase blood pressure or pressor drugs (e.g., dopamine, dobutamine).

Albuterol or Other Beta 2 (β2) Agonists Prevention or Management Increase the frequency of monitoring blood pressure and heart rate and adjust atomoxetine oral solution dosage as clinically appropriate. Mechanism and Clinical Effect(s) Systemically administered albuterol (e.g., oral) can be potentiated by atomoxetine oral solution, resulting in increases in heart rate and blood pressure [see Clinical Pharmacology (12.3) ] . 1 See www.fda.gov/CYPandTransporterInteractingDrugs for examples of strong CYP2D6 inhibitors.

Monoamine Oxidase Inhibitors: Concomitant use contraindicated. ( 4 , 7 ) Strong CYP2D6 Inhibitors: With concomitant of atomoxetine oral solution and strong CYP2D6 inhibitors, increase the titration intervals. ( 7 ) Antihypertensives: Increase the frequency of monitoring blood pressure and adjust atomoxetine oral solution dosage as clinically appropriate.

( 7 ) Albuterol (or other beta 2 agonists): Increase the frequency of monitoring blood pressure and heart rate. ( 7 )

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Hepatic Impairment: Increased exposure (AUC) to atomoxetine in subjects with moderate (Child-Pugh Class B) (2-fold increase) and severe (Child-Pugh Class C) (4-fold increase) compared to subjects with normal liver function. ( 8.6 and 12.3 ) Use in Genomic Subgroups: CYP2D6 poor metabolizers may have a greater risk of atomoxetine-related adverse reactions compared to other CYP2D6 metabolizer types (ultrarapid, normal, and intermediate) ( 8.7 )

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD drugs, including atomoxetine oral solution, 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 other CYP2D6 metabolizer types (ultrarapid, normal, and intermediate) 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 (other CYP2D6 metabolizer types) or 0.4 times (CYP2D6 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 de… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 182 words ▾

10 OVERDOSAGE During postmarketing use, 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 1,400 mg (14 times the maximum recommended dosage). The most commonly reported symptoms with 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.

In some cases of overdose involving atomoxetine, seizures have been reported. Less commonly, there have been reports of QT prolongation and mental changes, including disorientation and hallucinations [see Clinical Pharmacology (12.2) ] . If an overdose occurs, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

Because atomoxetine is highly protein-bound, dialysis is not likely to be useful in the treatment of overdose of atomoxetine oral solution.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The precise mechanism by which atomoxetine oral solution produces its therapeutic effects in the treatment of ADHD in adults and pediatric patients 6 years of age and older 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 of atomoxetine (0.5, 1.2 or 1.8 mg/kg/day) or placebo demonstrated atomoxetine exposure correlates with the treatment of the signs and symptoms of ADHD as measured by the ADHD Rating Scale (ADHDRS)-IV-Parent Version (investigator administered and scored). At the observed median area under the plasma-concentration curve (AUC) after administration of atomoxetine 0.5 mg/kg/day, 1.2 mg/kg/day, and 1.8 mg/kg/day, 62%, 78% and 85%, respectively, of the maximum improvement over baseline for the ADHDRS scores are expected.

Cardiac Electrophysiology The effect of atomoxetine on QTc interval 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 another atomoxetine product (i.e., atomoxetine capsules) (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 this study, because the study failed to demonstrate assay sensitivity. There was a slight increase in QTc interval with increased atomoxetine concentration. Pharmacodynamic Drug Interaction Studies Consumption of ethanol with the other atomoxetine product did not change the intoxicating effects of ethanol.

Concomitant use of the other atomoxetine product with methylphenidate did not increase cardiovascular effects beyond those seen with methylphenidate alone. Albuterol 600 mcg given intravenously over 2 hours (albuterol is not approved for intravenous use) induced heart rate and blood pressure increases; these effects were potentiated when co-administered with the other atomoxetine product (60 mg twice daily for 5 days), particularly initially [see Drug Interactions (7) ].

12.3Pharmacokinetics No clinically significant differences in pharmacokinetics of atomoxetine were observed after administration of atomoxetine oral solution and immediate-release atomoxetine capsules under fasted conditions. Pharmacokinetic parameters for atomoxetine and its metabolites in CYP2D6 poor metabolizers and other CYP2D6 metabolizer types (ultrarapid, normal, and intermediate) from studies of another atomoxetine product (i.e., atomoxetine capsules) are presented in Table 11. Table 11: Atomoxetine and Metabolite Pharmacokinetics in Adult CYP2D6 Poor Metabolizers and Other CYP2D6 Metabolizer Types Parameter Other CYP2D6 Metabolizer Types a CYP2D6 Poor Metabolizers b Absorption Dose proportionality 10-120 mg Accumulation 1.1-fold 3.3-fold Absolute bioavailability 63% 94% T max 1 hour - Effect of Food AUC: Unchanged; C max : Decreased 21% T max : Delayed 1 hour Distribution Protein Binding 98% Volume of distribution

0.85L/kg Elimination Atomoxetine half-life 5.2 hours 21.6 hours Atomoxetine apparent oral clearance

0.35 L/hr/kg

0.03L/hr/kg 4-Hydroxyatomoxetine half-life 6 to 8 hours - N-Desmethylatomoxetine half-life 6 to 8 hours 34 to 40 hours Metabolism Primary metabolic pathways CYP2D6 Other CYP enzymes 4-Hydroxyatomoxetine c concentration 1% of atomoxetine 0.1% of atomoxetine d N-Desmethylatomoxetine e concentration 5% of atomoxetine 45% of atomoxetine Excretion Urine Greater than 80% of the administered dose excreted as 4- hydroxyatomoxetine-O-glucuronide; Less than 3% as unchanged drug Feces Less than 17% of the administered dose Values shown in the table are average values; T max is represented as median values.… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 122 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Atomoxetine oral solution is supplied in a 100 mL, amber glass bottles with child-resistant cap, and is co-packaged with a 10 mL calibrated oral dosing syringe and bottle adapter: NDC 72888-456-01. Each mL contains 4.57 mg of atomoxetine hydrochloride, USP (equivalent to 4 mg atomoxetine), clear colorless solution, free from any visible foreign and particulate matter, free of precipitation and hazy mass. Supplied with a 10 mL syringe and a bottle adapter.

16.2Storage and Handling Store at 20°C to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [see USP Controlled Room Temperature]. Discard unused atomoxetine oral solution remaining in the bottle, 45 days after first opening the bottle.

📋 Description 149 words ▾

11 DESCRIPTION Atomoxetine oral solution is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the R (-) isomer as determined by x-ray diffraction and its chemical designation is (-)- N -Methyl-3-phenyl-3-( o -tolyloxy)-propylamine hydrochloride and its molecular formula is C 17 H 21 NO•HCl, which corresponds to a molecular weight of 291.82. The chemical structure is: Atomoxetine hydrochloride is a white to almost white powder, which has a solubility of 27.8 mg/mL in water.

Atomoxetine oral solution is for oral administration only. Each mL contains 4 mg of atomoxetine (equivalent to 4.57 mg of atomoxetine hydrochloride) and the following inactive ingredients: grape flavor, maltitol solution, monobasic sodium phosphate, phosphoric acid, purified water, sodium benzoate, sodium hydroxide, sorbitol crystallizing solution, sucralose, and xylitol. Atomoxetine oral solution is a clear colorless solution, free from any visible foreign and particulate matter, free of precipitation and hazy mass with pH 3.0-5.0. "Image Description"

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Suicide Risk Patients, their families, and their caregivers should be alerted about the need to monitor patients daily for 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 oral solution treatment and when the dosage is adjusted.

Such symptoms should be reported to the patient’s health care provider immediately [see Warnings and Precautions (5.1) ] . Severe Liver Injury Patients initiating atomoxetine oral solution 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) ] .

Serious Cardiovascular Reactions Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during atomoxetine oral solution treatment should stop atomoxetine oral solution and contact a health care provider [see Warnings and Precautions (5.3) ] . Increased Blood Pressure or Heart Rate Atomoxetine can increase the blood pressure and heart rate [see Warnings and Precautions (5.4) ] . Emergence of New Psychotic or Manic Symptoms and Activation of Mania Instruct patients and their caregivers to look for signs of activation of mania/hypomania and psychosis [see Warnings and Precautions (5.5) ] .

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 The parents or guardians of pediatric patients taking atomoxetine oral solution 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.

In the event atomoxetine oral solution comes in contact with an 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 Interactions Patients should be instructed to consult a healthcare provider if they are taking or plan to take any prescription or over-the-counter drugs, dietary supplements, or herbal remedies [see Drug Interactions (7) ] .

Sexual Dysfunction Advise patients that atomoxetine oral solution may impair sexual function. Advise patients if they experience sexual dysfunction, they should contact their health care provider [see Adverse Reactions (6.1) ] . 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 oral solution with or without food. Missed Dose If patients miss an atomoxetine oral solution 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 oral solution in any 24-hour period. Somnolence The incidence of somnolence was higher in atomoxetine-treated patients than placebo-treated patients [see Adverse Reactions (6.1) ] .

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 oral solution. Manufactured by: Rubicon Research Ltd., Satara, 415004, India. Distributed by: Advagen Pharma Ltd., East Windsor, NJ 08520, USA Rev.

00, 03/2026

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE​​​​​​​ Atomoxetine (AT-oh-mox-e-teen) Oral Solution What is the most important information I should know about atomoxetine oral solution? Atomoxetine oral solution can cause serious side effects, including: Suicidal thoughts and actions in children 6 years of age and older. Atomoxetine oral solution increases the risk of suicidal thoughts and actions in children ages 6 and older with attention deficit hyperactivity disorder (ADHD), especially within the first few months of treatment or when the dose is changed.

How can I watch for and try to prevent suicidal thoughts and actions? Pay close attention to, and tell your healthcare provider right away about, any changes, especially sudden changes, in mood, behavior, actions, thoughts, or feelings, or suicidal thoughts or actions. This is very important when atomoxetine oral solution is started or when the dose is changed.

Keep all follow-up visits with the healthcare provider as scheduled. Tell your healthcare provider about symptoms between visits as needed, especially if you have concerns. Tell your healthcare provider right away if any of the following symptoms develop during treatment, especially if they are new, worse, or worry you: anxiety trouble sleeping acting aggressive extreme increase in activity or talking (mania) unusual decrease in activity (hypomania) feeling agitated or restless irritability impulsivity depression panic attacks restlessness or feeling like you have to move panic attacks hostility or being angry or violent suicide attempts thoughts about suicide or dying other unusual changes in mood or behavior See “What are the possible side effects of atomoxetine oral solution?” for more information about side effects.

What is atomoxetine oral solution? Atomoxetine oral solution is a prescription medicine used to treat ADHD in adults and children 6 years of age and older. Atomoxetine oral solution may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

Atomoxetine oral solution should be used as a part of a total treatment program for ADHD that may include counseling or other therapies. It is not known if atomoxetine oral solution is safe and effective in children less than 6 years old. Who should not take atomoxetine oral solution?

Do not take atomoxetine oral solution​​​​​​​ if you or your child: are allergic to atomoxetine or any of the ingredients in atomoxetine oral solution. See the end of this Medication Guide for a complete list of ingredients in atomoxetine oral solution. are taking or have stopped taking within the past 14 days a medicine called a monoamine oxidase inhibitor (MAOI). have an eye problem called narrow angle glaucoma. have or had a rare tumor called pheochromocytoma. have severe heart or blood vessel problems that could get worse if your blood pressure or heart rate increases.

Before taking atomoxetine oral solution​​​​​​​, tell your healthcare provider about all medical conditions, including if you or your child: have, or have a family history of, suicide thoughts or attempts, bipolar disorder, depression, mania, or hypomania. have liver problems. have, or have a family history of, heart problems, heart defects, irregular heartbeat, or sudden death. have high blood pressure or low blood pressure. have problems urinating such as trouble starting urination, weak stream, or not fully emptying the bladder. have glaucoma. are pregnant or plan to become pregnant.

It is not known if atomoxetine oral solution will harm the unborn baby. Tell your healthcare provider right away if you or your child become pregnant or plan to become pregnant during treatment with atomoxetine oral solution. There is a pregnancy exposure registry for women who are exposed to ADHD medicines, including atomoxetine oral solution, during pregnancy.

The purpose of the registry is to collect information about the health of women exposed to atomoxetine oral solution and their baby. If you or your child become pregnant d… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1ADHD Studies in Pediatric Patients 6 Years of Age and Older The effectiveness of atomoxetine oral solution has been established for the treatment of ADHD in pediatric patients 6 years of age and older based on adequate and well-controlled studies of atomoxetine capsules in pediatric patients 6 years of age and older with ADHD. Below is a display of the efficacy results of the adequate and well-controlled studies of atomoxetine capsules in pediatric patients 6 years of age and older with ADHD. Acute Studies in Pediatric Patients 6 Years of Age and Older with ADHD In four randomized, double-blind, placebo-controlled studies of pediatric patients 6 to 18 years of age (Studies 1, 2, 3, and 4) with ADHD, approximately one-third of the patients met DSM-IV criteria for inattentive ADHD subtype and two-thirds met criteria for both inattentive and hyperactive/impulsive ADHD subtypes.

In these studies, signs and symptoms of ADHD were evaluated with the investigator administered and scored ADHD Rating Scale-IV-Parent Version (ADHDRS) total score including hyperactive/impulsive and inattentive subscales by comparing the mean change from baseline to endpoint in the atomoxetine and placebo groups using an intent-to-treat (ITT) analysis (the primary endpoint). Each item on the ADHDRS maps directly to one symptom criterion for ADHD in the DSM-IV. In Study 1, an 8-week randomized, double-blind, placebo-controlled, dose-response, acute treatment study, pediatric patients 8 to 18 years of age (N=297) received either a fixed dosage of atomoxetine capsules (0.25, 0.6, or 9 mg/kg twice daily (in the early morning and late afternoon/early evening) or placebo.

Improvements in ADHD symptoms were statistically significantly superior in patients treated with either of the two higher atomoxetine capsules dosages compared with patients treated with placebo as measured on the ADHDRS scale. The 0.9 mg/kg twice daily atomoxetine capsules dosage did not provide any additional benefit over that observed with the 0.6 mg/kg twice daily atomoxetine capsules dosage. The 0.25 mg/kg twice daily atomoxetine capsules dosage group was not superior to the placebo group.

In Study 2, a 6-week randomized, double-blind, placebo-controlled, acute treatment study, pediatric patients 6 to 16 years of age (N=171) received either atomoxetine capsules or placebo. Atomoxetine capsules was administered as a once daily dosage in the early morning and titrated on a weightadjusted basis according to clinical response, up to a maximum dosage of 1.5 mg/kg once daily. The mean final dosage of atomoxetine capsules was approximately 1.3 mg/kg once daily.

ADHD symptoms were statistically significantly improved in the atomoxetine capsules group compared to the placebo group, as measured on the ADHDRS scale. Study 2 showed that atomoxetine capsules was effective when administered once daily in the morning. In two identically designed, 9-week, acute, double-blind, placebo-controlled studies. pediatric patients 7 to 13 years of age (Study 3, N=147; Study 4, N=144) were randomized to receive atomoxetine capsules, methylphenidate, or placebo.

In Studies 3 and 4, atomoxetine capsules was administered twice daily in the early morning and late afternoon (after school) and titrated on a weight-adjusted basis according to clinical response up to a maximum recommended atomoxetine capsules dosage of 1 mg/kg twice daily. The mean final dosage of atomoxetine capsules in Studies 3 and 4 was approximately 0.8 mg/kg twice daily. In both Studies 3 and 4, ADHD symptoms statistically significantly improved more in the atomoxetine capsules group than in the placebo group, as measured on the ADHDRS scale.

Examination of population subsets based on sex and age (<12 and 12 to 17 years of age) in these studies did not reveal any differences in response. There were not sufficient numbers of patients in racial or ethnic groups to determine if there were differences in responses in these subgro… [Excerpted — this section continues on DailyMed.]

🔒 Drug Abuse and Dependence 124 words ▾

9 DRUG ABUSE AND DEPENDENCE

9.1Controlled Substance Atomoxetine oral solution contains atomoxetine which is not a controlled substance.

9.2Abuse In a randomized, double-blind, placebo-controlled, abuse-potential study in adults that compared effects of another atomoxetine product and placebo, the other atomoxetine product was not associated with stimulant or euphoriant properties. Clinical study data in over 2,000 adults and pediatric patients with ADHD and over 1,200 adults with depression (atomoxetine oral solution is not indicated for the treatment of depression) showed only isolated incidents of inappropriate atomoxetine self-administration. Drug discrimination studies in rats and monkeys showed inconsistent stimulus generalization between atomoxetine and cocaine.

9.3Dependence After atomoxetine discontinuation, there was no evidence of symptom rebound or adverse reactions suggesting an atomoxetine-discontinuation or withdrawal syndrome.

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Atomoxetine HCl was not carcinogenic in rats and mice when given in the diet for 2 years at time-weighted average doses up to 47 and 458 mg/kg/day, respectively. The highest dose used in rats is approximately 8 and 5 times the maximum recommended human dose (MRHD) in pediatrice patients and adults, respectively, on a mg/m 2 basis. Plasma levels (AUC) of atomoxetine at this dose in rats are estimated to be 1.8 times (other CYP2D6 metabolizer types) or 0.2 times (CYP2D6 poor metabolizers) those in humans receiving the maximum human dose.

The highest dose used in mice is approximately 39 and 26 times the MRHD in pediatrice patients and adults, respectively, on a mg/m 2 basis. Mutagenesis ​​​​​​​ Atomoxetine HCl was negative in a battery of genotoxicity studies that included a reverse point mutation assay (Ames Test), an in vitro mouse lymphoma assay, a chromosomal aberration test in Chinese hamster ovary cells, an unscheduled DNA synthesis test in rat hepatocytes, and an in vivo micronucleus test in mice. However, there was a slight increase in the percentage of Chinese hamster ovary cells with diplochromosomes, suggesting endoreduplication (numerical aberration).

The metabolite N-desmethylatomoxetine HCl was negative in the Ames Test, mouse lymphoma assay, and unscheduled DNA synthesis test. Impairment of fertility ​​​​​​​ Atomoxetine HCl did not impair fertility in rats when given in the diet at doses of up to 57 mg/kg/day, which is approximately 6 times the MRHD on a mg/m 2 basis.

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE Atomoxetine (AT-oh-mox-e-teen) Oral Solution This Instructions for Use contains information on how to take atomoxetine oral solution. Important Information You Need to Know Before Taking Atomoxetine Oral Solution: Read these instructions carefully to learn how to prepare and take atomoxetine oral solution the right way. Atomoxetine oral solution is for oral use only (taken by mouth).

Take atomoxetine oral solution with or without food. Use only the oral dosing syringe and bottle adapter that come with atomoxetine oral solution to measure and take a dose of the medicine. Do not get atomoxetine oral solution in or near the eyes.

If atomoxetine oral solution gets into the eyes, rinse them with water right away and tell the healthcare provider. Check the expiration date on the atomoxetine oral solution bottle and carton. Do not take atomoxetine oral solution after the expiration date has passed.

Throw away (discard) any unused atomoxetine oral solution 45 days after first opening the bottle. Write the discard date in the space provided on the bottle and carton. See “ Disposing of atomoxetine oral solution. ” Storing Atomoxetine Oral Solution Store atomoxetine oral solution at room temperature between 68°F to 77°F (20°C to 25°C).

Keep the child-resistant cap tightly closed. Keep atomoxetine oral solution and all medicines out of the reach of children. Supplies included in the Atomoxetine Oral Solution Carton A press-in bottle adapter that you push into the neck of the bottle.

After it is inserted, the bottle adapter must always stay in the bottle. A bottle containing medicine, with a child-resistant cap. Always put the child-resistant cap back on the bottle and close it tightly after use.

A 10 milliliter (mL) oral dosing syringe that fits into the bottle adapter to withdraw and measure the prescribed dose of medicine from the bottle. Hand Washing Wash and dry your hands. Remove the atomoxetine oral solution bottle and bottle adapter from the carton.

Tell your pharmacist right away if you are missing supplies from the carton. Step 1: Preparing the Bottle Remove the child-resistant cap by pushing it firmly down and turning it to the left (counterclockwise) as shown on the top of the child-resistant cap. Note: Save the child-resistant cap so you can close the bottle after each use.

Hold the open bottle upright on a table and push the bottle adapter firmly into the neck of the bottle as far as you can. Put the child-resistant cap back on the bottle and close it tightly by turning it to the right (clockwise) to make sure that the bottle adapter has been fully forced into the neck of the bottle. Note : You may not be able to push the bottle adapter fully down, but it will be forced into the bottle when you screw the child-resistant cap back on. ​​​​​​​Now the bottle is ready to use with the syringe.

The bottle adapter must always stay in the bottle. Do not remove the bottle adapter. The child-resistant cap should seal the bottle in between use.

Step 2: Measuring the Dose of Atomoxetine Oral Solution Push and turn the child-resistant cap counterclockwise to open the bottle. ​​​​​​​ Note: Always put the child-resistant cap tightly back on the bottle after use. Check that the plunger is pushed all the way down inside the barrel of the syringe. Keep the bottle upright and push the tip of the syringe firmly into the hole in the bottle adapter.

Step 3: Hold the syringe in place and carefully turn the bottle upside down. Check the oral dosing syringe to find the right dose in milliliters (mL) that has been prescribed by the healthcare provider. Slowly pull the plunger out to fill the oral dosing syringe so that the top edge of the plunger is slightly past the prescribed dose line to help remove any air bubbles.

Step 4: Tap the syringe barrel to move air bubbles to the top. Doing this helps set the correct dose. Push the plunger down slowly just far enough to completely push out any large or small air bubbles that may be tra… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 31 words ▾

PRINCIPAL DISPLAY PANEL Atomoxetine Oral Solution 4mg/mL - NDC 72888-456-01 - 100 mL Bottle Label Atomoxetine Oral Solution 4mg/mL - NDC 72888-456-01 - 100 mL Carton Label "Image Description" "Image Description"

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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← 72888-0271-01 · Advagen 72888-0457-01 · Advagen →
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