atoncy
Atoncy (Atomoxetine Hydrochloride) is a norepinephrine reuptake inhibitor used to treat Attention Deficit Disorder with Hyperactivity.
Atomoxetine Hydrochloride · by Map77
Available as a generic: Atomoxetine Hydrochloride
Key facts
- Active ingredient
- Atomoxetine Hydrochloride
- Drug class
- Norepinephrine Reuptake Inhibitor
- Form
- Solution
- Strength
- Atomoxetine Hydrochloride EQ 4MG BASE/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Map77
- What the pharmacy pays
- ~$14.50 for 30 — not your price
- FDA application
- NDA220320
- FDA boxed warning
- Yes — see the boxed warning
What is Atoncy?
From the FDA label: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"
How to use
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 ) 2.1 Recommendations 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…
Side effects
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 . 6.1 Clinical 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…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
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 )
Warnings
Important safety information
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 ) 5.1 Suicidal 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. Although a causal link between the emergence of such symptoms and the emergence of suicidal impulses has not been established, there is a concern that such symptoms may represent precursors to emerging suicidality. 5.2 Severe Liver Injury Atomoxetine oral solution should be discontinued and not restarted in patients with jaundice or laboratory evidence of liver injury. Liver enzyme and function tests should be obtained upon the first symptom or sign of liver dysfunction (e.g., pruritus, dark urine, jaundice, right upper quadrant tenderness, or unexplained “flu like” symptoms). Postmarketing reports indicate that atomoxetine can cause severe liver injury. Although no evidence of liver injury was detected in clinical trials of about 6,000 patients, there have been rare cases of clinically significant liver injury that were considered probably or possibly related to atomoxetine use during postmarketing use. Rare cases of liver failure have been reported during postmarketing use, including a case that resulted in a liver transplant. Reported cases of liver injury occurred within 120 days of initiation of atomoxetine in most cases and some patients presented with markedly elevated liver enzymes (>20 times upper limit of normal (ULN)), and jaundice with significantly elevated bilirubin levels (>2 times ULN), followed by recovery upon atomoxetine discontinuation. In one patient, liver injury, manifested by elevated hepatic enzymes up to 40 times ULN and jaundice with bilirubin up to 12 times ULN, recurred upon rechallenge, and was followed by recovery upon atomoxetine discontinuation, providing evidence that atomoxetine likely caused the liver injury. Such reactions may occur several months after atomoxetine oral solution is started, but laboratory abnormalities may continue to worsen for several weeks after atomoxetine oral solution is stopped. 5.3 Serious Cardiovascular Reactions Risk Management Recommendations for Serious Cardiovascular Reactions Prior to atomoxetine oral solution treatment, adults or pediatric patients 6 years of age or older should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiovascular disease and should receive further cardiac evaluation if findings suggest such disease (e.g., electrocardiogram, echocardiogram). Although some serious heart problems alone carry an increased risk of sudden death, atomoxetine oral solution generally should not be used in pediatric patients with known serious structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, or other serious cardiac problems. Consideration should be given to not treating adults with atomoxetine oral solution with clinically significant cardiac abnormalities. Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during atomoxetine treatment should stop atomoxetine oral solution and undergo a prompt cardiac evaluation. Sudden Death and Pre-existing Structural Cardiac Abnormalities or Other Serious Heart Problems Pediatric Patients 6 Years of Age and Older: Sudden death has been reported in association with atomoxetine treatment at the recommended dosage in pediatric patients 6 years of age and older with structural cardiac abnormalities or other serious heart problems. Adults: Sudden deaths, stroke, and myocardial infarction have been reported in atomoxetine-treated adults at the recommended ADHD dosage. Although the role of atomoxetine in these adult cases is also unknown, adults have a greater likelihood than pediatric patients of having serious structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, or other serious cardiac problems. 5.4 Increases in Blood Pressure and Heart Rate Atomoxetine oral solution is contraindicated in patients with severe cardiac or vascular disorders whose condition would be expected to deteriorate if…
Who should not take Atoncy
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.
Overdose — what happens if you take too much
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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
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 )
Drug class
May treat (source: NIH RxClass)
Dosage forms
Solution
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Atoncy treat?
- Atoncy (Atomoxetine Hydrochloride) may be used to treat attention deficit disorder with hyperactivity, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How much does Atoncy cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $14.50 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Atoncy?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Atoncy. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Atoncy?
- Atoncy is marketed by Map77. You can see Map77's full profile, rating, and other products on pharmaranks.
- Is Atoncy a brand-name or generic drug?
- Atoncy is a brand-name product with the active ingredient Atomoxetine Hydrochloride. Lower-cost generic equivalents containing Atomoxetine Hydrochloride are available — ask your pharmacist.
- Is Atoncy available over the counter?
- No. Atoncy is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Atoncy come in?
- Atoncy is currently marketed as solution, per the FDA's National Drug Code Directory.
- What class of drug is Atoncy?
- Atoncy is classified as norepinephrine reuptake inhibitor, per the FDA's Established Pharmacologic Class.
- Is Atoncy FDA-registered?
- Atoncy is on record with the U.S. FDA under application number NDA220320. You can verify this on its official FDA label.
- Is Atoncy safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Atoncy. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Atoncy?
- Atoncy's side effects are taken directly from its FDA label. From the label: 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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