Atomoxetine (Atomoxetine)

Trade Name : Atomoxetine

Teva Pharmaceuticals USA, Inc.

CAPSULE

Strength 10 mg/1

Storage and handling for Atomoxetine

ATOMOXETINE HYDROCHLORIDE Norepinephrine Reuptake Inhibitor [EPC],Norepinephrine Uptake Inhibitors [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Atomoxetine (Atomoxetine) which is also known as Atomoxetine and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 10 mg/1 per ml. Read more

Atomoxetine (Atomoxetine) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

About GNH

No data

Atomoxetine hydrochloride 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 hydrochloride 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 hydrochloride is approved for ADHD in pediatric and adult patients. Atomoxetine hydrochloride is not approved for major depressive disorder.
Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of atomoxetine hydrochloride 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 hydrochloride compared to placebo. The average risk of suicidal ideation in patients receiving atomoxetine hydrochloride was 0.4% (5/1357 patients), compared to none in placebo-treated patients (851 patients). No suicides occurred in these trials [].
WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS
See full prescribing information for complete boxed warning.

Increased risk of suicidal ideation in children or adolescents ()
No suicides occurred in clinical trials ()
Patients started on therapy should be monitored closely ()

Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). ()

Initial, Target and Maximum Daily Dose ()
(Acute and Maintenance/Extended Treatment)
Dosing adjustment u2013 Hepatic Impairment, Strong CYP2D6 Inhibitor, and in patients known to be CYP2D6 poor metabolizers (PMs). (, )

Each capsule contains atomoxetine HCl, USP equivalent to 10 mg (white opaque, white opaque), 18 mg (yellow opaque, white opaque), 25 mg (aqua blue opaque, white opaque), 40 mg (aqua blue opaque, aqua blue opaque), 60 mg (aqua blue opaque, yellow opaque), 80 mg (brownish-yellow opaque, white opaque), or 100 mg (brownish-yellow opaque, brownish-yellow opaque) of atomoxetine.
Each capsule contains atomoxetine HCl, USP equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. (, , )

No data

Hypersensitivity to atomoxetine or other constituents of product. ()
Atomoxetine capsule use within 2 weeks after discontinuing MAOI or other drugs that affect brain monoamine concentrations. (, )
Narrow Angle Glaucoma. ()
Pheochromocytoma or history of pheochromocytoma. ()
Severe Cardiovascular Disorders that might deteriorate with clinically important increases in HR and BP. ()

No data

Suicidal Ideation - Monitor for suicidality, clinical worsening, and unusual changes in behavior. ()
Severe Liver Injury - Should be discontinued and not restarted in patients with jaundice or laboratory evidence of liver injury. ()
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 hydrochloride 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 hydrochloride in adults with clinically significant cardiac abnormalities. ()
Emergent Cardiovascular Symptoms - Patients should undergo prompt cardiac evaluation. ()
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. ()
Emergent Psychotic or Manic Symptoms - Consider discontinuing treatment if such new symptoms occur. ()
Bipolar Disorder - Screen patients to avoid possible induction of a mixed/manic episode. ()
Aggressive behavior or hostility should be monitored. ()
Possible allergic reactions, including anaphylactic reactions, angioneurotic edema, urticaria, and rash. ()
Effects on Urine Outflow - Urinary hesitancy and retention may occur. ()
Priapism - Prompt medical attention is required in the event of suspected priapism. (, )
Growth - Height and weight should be monitored in pediatric patients. ()
Concomitant Use of Potent CYP2D6 Inhibitors or Use in patients known to be CYP2D6 PMs - Dose adjustment of atomoxetine hydrochloride may be necessary. ()

Most common adverse reactions (u2265 5% and at least twice the incidence of placebo patients)
To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Child and Adolescent Clinical Trials - Nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence. ()
Adult Clinical Trials - Constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction, and urinary hesitation. ()

No data

Monoamine Oxidase Inhibitors. (, )
CYP2D6 Inhibitors - Concomitant use may increase atomoxetine steady-state plasma concentrations in EMs. ()
Antihypertensive Drugs and Pressor Agents - Possible effects on blood pressure. ()
Albuterol (or other beta agonists) - Action of albuterol on cardiovascular system can be potentiated. ()

No data

Pregnancy/Lactation u2013 Pregnant or nursing women should not use unless potential benefit justifies potential risk to fetus or infant. (, )
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). ()
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. ()
Patients with Concomitant Illness - Does not worsen tics in patients with ADHD and comorbid Touretteu2019s Disorder. ()
Patients with Concomitant Illness u2013 Does not worsen anxiety in patients with ADHD and comorbid Anxiety Disorders. ()

No data

No data

Atomoxetine HCl is a selective norepinephrine reuptake inhibitor. Atomoxetine HCl is the (-) isomer as determined by x-ray diffraction. The chemical designation is (-)--methyl-3-phenyl-3-(-tolyoxy)-propylamine hydrochloride.The chemical structure is:
CHNOu2022HCl M.W. 291.82
Atomoxetine HCl is a white to practically white powder, which has a solubility of 27.8 mg/mL in water.
Atomoxetine capsules USP are intended for oral administration only.
Each capsule contains atomoxetine HCl, USP equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. The capsules also contain black iron oxide, gelatin, potassium hydroxide, pregelatinized corn starch, propylene glycol, shellac, sodium lauryl sulfate, strong ammonia solution, and titanium dioxide. Additionally the 18 mg and 60 mg capsules contain D&C yellow #10; the 25 mg, 40 mg, and 60 mg capsules contain FD&C blue #1; and the 80 mg and 100 mg capsules contain red iron oxide and yellow iron oxide.

No data

Carcinogenesis
Mutagenesis
in vitro
in vivo
The metabolite N-desmethylatomoxetine HCl was negative in the Ames Test, mouse lymphoma assay, and unscheduled DNA synthesis test.
Impairment of fertility

No data

No data

See FDA-approved Medication Guide.

ATOMOXETINE (AT oh mox e teen) CAPSULES USP
Read the Medication Guide that comes with atomoxetine capsules before you or your child starts taking them 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 childu2019s treatment with atomoxetine capsules.
Arrayn- What is the most important information I should know about atomoxetine capsules?
The following have been reported with use of atomoxetine capsules:
Arrayn- 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 capsule 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.
The chance for suicidal thoughts and actions may be higher:
Prevent suicidal thoughts and action in your child or teenager by:
Watch for the following signs in your child or teenager during atomoxetine capsule treatment:
Call your child or teenageru2019s doctor right away if they have any of the above signs, especially if they are new, sudden, or severe.
Arrayn- 2. Severe liver damage:
Atomoxetine capsules can cause liver injury in some patients. Call your doctor right away if you or your child has the following signs of liver problems:
Arrayn- 3. Heart-related problems:
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 capsules.
Your doctor should check your blood pressure or your childu2019s blood pressure and heart rate regularly during treatment with atomoxetine capsules.
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 capsules.
Arrayn- 4. New mental (psychiatric) problems in children and teenagers:
Call your child or teenageru2019s doctor right away about any new mental symptoms
What are atomoxetine capsules?
Atomoxetine capsules are a selective norepinephrine reuptake inhibitor medicine. They are used for the treatment of attention deficit and hyperactivity disorder (ADHD). Atomoxetine capsules may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
Atomoxetine capsules should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
Atomoxetine capsules have not been studied in children less than 6 years old.
Who should not take atomoxetine capsules?
Atomoxetine capsules should not be taken if you or your child:
Atomoxetine capsules may not be right for you or your child. Before starting atomoxetine capsules tell your doctor or your childu2019s doctor about all health conditions (or a family history of) including:
Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.
Can atomoxetine capsules be taken with other medicines?
Tell your doctor about all the medicines that you or your child takes including prescription and nonprescription medicines, vitamins, and herbal supplements.
Especially tell your doctor if you or your child takes:
Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.
Do not start any new medicine while taking atomoxetine capsules without talking to your doctor first.
How should atomoxetine capsules be taken?
What are possible side effects of atomoxetine capsules?
See for information on reported suicidal thoughts and actions, other mental problems, severe liver damage, and heart problems.
Other serious side effects include:
Common side effects in children and teenagers include:
Common side effects in adults include:
Other information for children, teenagers, and adults:
This is not a complete list of possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store atomoxetine capsules?
General information about atomoxetine capsules
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use atomoxetine capsules for a condition for which they were not prescribed. Do not give atomoxetine capsules to other people, even if they have the same condition. They may harm them.
This Medication Guide summarizes the most important information about atomoxetine capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about atomoxetine capsules that was written for healthcare professionals. For more information about atomoxetine capsules call 1-888-838-2872.
What are the ingredients in atomoxetine capsules USP?
Active ingredient:
Inactive ingredients:
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured In Croatia By:
Pliva Hrvatska d.o.o.
Zagreb, Croatia
Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454
Rev. E 11/2018

NDCn- 3542
Atomoxetine
Capsules USP
10 mg*
PHARMACIST: Dispense the
accompanying Medication Guide
to each patient.
Rx only
30 CAPSULES
TEVA

NDCn- 3543
Atomoxetine
Capsules USP
18 mg*
PHARMACIST: Dispense the
accompanying Medication Guide
to each patient.
Rx only
30 CAPSULES
TEVA

NDCn- 3544
Atomoxetine
Capsules USP
25 mg*
PHARMACIST: Dispense the
accompanying Medication Guide
to each patient.
Rx only
30 CAPSULES
TEVA

NDCn- 3545
Atomoxetine
Capsules USP
40 mg*
PHARMACIST: Dispense the
accompanying Medication Guide
to each patient.
Rx only
30 CAPSULES
TEVA

NDCn- 3546
Atomoxetine
Capsules USP
60 mg*
PHARMACIST: Dispense the
accompanying Medication Guide
to each patient.
Rx only
30 CAPSULES
TEVA
Arrayn- Array

NDCn- 3547
Atomoxetine
Capsules USP
80 mg*
PHARMACIST: Dispense the
accompanying Medication Guide
to each patient.
Rx only
30 CAPSULES
TEVA

NDCn- 3548
Atomoxetine
Capsules USP
100 mg*
PHARMACIST: Dispense the
accompanying Medication Guide
to each patient.
Rx only
30 CAPSULES
TEVA

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