Atomoxetine (Atomoxetine)

Trade Name : Atomoxetine

Burel Pharma

CAPSULE

Strength 10 mg/1

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

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You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

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 Burel Pharma. 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

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.

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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.

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About GNH

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.

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.

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  • WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS
  • Arrayn- Array
  • u00a0
  • Increased risk of suicidal ideation in children or adolescentsu00a0n
  • No suicides occurred in clinical trials n
  • Patients started on therapy should be monitored closelyu00a0n
  • Atomoxetine capsules are a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). n
  • Initial, Target and Maximum Daily Dose n n (Acute and Maintenance/Extended Treatment)
  • Dosing adjustment u2014 Hepatic Impairment, Strong CYP2D6 Inhibitor, and in patients known to be CYP2D6 poor metabolizers (PMs). , n
  • Each capsule contains atomoxetine hydrochloride USP equivalent to 10 mg (off-white opaque/off-white opaque), 18 mg (golden opaque/off-white opaque), 25 mg (blue opaque/off-white opaque), 40 mg (blue opaque/blue opaque), 60 mg (blue opaque/golden opaque), 80 mg (brown opaque/off-white opaque), or 100 mg (brown opaque/brown opaque) of atomoxetine.
  • Each capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine. , , n
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  • Hypersensitivity to atomoxetine or other constituents of product. n
  • Atomoxetine capsules use within 2 weeks after discontinuing MAOI or other drugs that affect brain monoamine concentrations. , n
  • Narrow Angle Glaucoma. n
  • Pheochromocytoma or history of pheochromocytoma. n
  • Severe Cardiovascular Disorders that might deteriorate with clinically important increases in HR and BP.u00a0u00a0
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  • Suicidal Ideation Monitor for suicidality, clinical worsening, and unusual changes in behavior. n
  • Severe Liver Injury Should be discontinued and not restarted in patients with jaundice or laboratory evidence of liver injury.u00a0n
  • Serious Cardiovascular Events Sudden death, stroke and myocardial infarction have been reported in association with atomoxetine treatment. Patients should have a careful history and physical exam to assess for presence of cardiovascular disease. Atomoxetine generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to its noradrenergic effects. Consideration should be given to not using atomoxetine in adults with clinically significant cardiac abnormalities. n
  • Emergent Cardiovascular Symptoms Patients should undergo prompt cardiac evaluation. n
  • 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. n
  • Emergent Psychotic or Manic Symptoms Consider discontinuing treatment if such new symptoms occur. n
  • Bipolar Disorder Screen patients to avoid possible induction of a mixed/manic episode. n
  • Aggressive behavior or hostility should be monitored. n
  • Possible allergic reactions, including anaphylactic reactions, angioneurotic edema, urticaria, and rash. n
  • Effects on Urine Outflow Urinary hesitancy and retention may occur. n
  • Priapism Prompt medical attention is required in the event of suspected priapism. , n
  • Growth Height and weight should be monitored in pediatric patients. n
  • Concomitant Use of Potent CYP2D6 Inhibitors or Use in patients known to be CYP2D6 PMs Dose adjustment of atomoxetine may be necessary. n
  • Most common adverse reactions (u22655% and at least twice the incidence of placebo patients)
  • To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 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. n
  • Adult Clinical Trials Constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction, and urinary hesitation. n
  • No data
  • Monoamine Oxidase Inhibitors. , n
  • CYP2D6 Inhibitors Concomitant use may increase atomoxetine steady-state plasma concentrations in EMs. n
  • Antihypertensive Drugs and Pressor Agentsu00a0 Possible effects on blood pressure. n
  • Albuterol (or other beta agonists) Action of albuterol on cardiovascular system can be potentiated. n
  • No data
  • Pregnancy/Lactation Pregnant or nursing women should not use unless potential benefit justifies potential risk to fetus or infant. , n
  • 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).u00a0n
  • 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. n
  • Patients with Concomitant Illness - Does not worsen tics in patients with ADHD and comorbid Touretteu2019s Disorder. n
  • Patients with Concomitant Illness u2013 Does not worsen anxiety in patients with ADHD and comorbid Anxiety Disorders. n
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  • Atomoxetine is a selective norepinephrine reuptake inhibitor. Atomoxetine hydrochloride is the (-) isomer as determined by x-ray diffraction. The chemical designation is (-)--Methyl-3-phenyl-3-(-tolyloxy)-propylamine hydrochloride. The molecular formula is CHNOu2022HCl, which corresponds to a molecular weight of 291.82. The chemical structure is:n n Atomoxetine hydrochloride USP is a white to practically white solid, which has a solubility of 27.8 mg/mL in water.n Atomoxetine capsules USP are intended for oral administration only.n Each capsule contains atomoxetine hydrochloride USP equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, or 100 mg of atomoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch and simethicone emulsion. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulfate. In addition, the 18 mg contains iron oxide yellow, 25 mg and 40 mg contains FD&C Blue No 2, 60 mg contains FD&C Blue No 2 and iron oxide yellow, 80 mg and 100 mg contain iron oxide red and iron oxide yellow. The capsules are printed with edible ink containing black iron oxide and shellac.
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  • See .
  • Atomoxetine n- Capsules, USP
  • (a'' toe mox' e teen)n
  • Arrayn- Array
  • u00a0
  • The following have been reported with use of n- 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 n- atomoxetine capsules 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 n- atomoxetine capsules 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- Arrayn- 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 n- 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 n- atomoxetine capsules?
  • Atomoxetine capsules are 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 n- atomoxetine capsules?
  • Atomoxetine capsules n- should not be taken if you or your child:
  • Atomoxetine capsules may not be right for you or your child. Before starting atomoxetine capsules n- 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 n- 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. n- Array
  • 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 n- atomoxetine capsules without talking to your doctor first.
  • How should n- atomoxetine capsules be taken?
  • What are possible side effects of n- atomoxetine capsules?
  • See n 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 n- atomoxetine capsules?
  • General information about n- 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 it was 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 1-866-850-2876 (toll-free).
  • What are the ingredients in n- atomoxetine capsules?
  • Active ingredient:
  • Inactive ingredients:
  • Nardil is a registered trademark of Pfizer Inc.
  • Parnate is a registered trademark of GlaxoSmithKline.
  • Emsam is a registered trademark of Somerset Pharmaceuticals Inc.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.n n- Arrayn- Array
  • Burel Pharmaceuticals, Inc.n n- Aurobindo Pharma Limitedn
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  • NDC 35573-421-30
  • burelpharma
  • Atomoxetine
  • Capsules, USP 100 mg
  • PHARMACIST: PLEASE DISPENSE WITH
  • MEDICATION GUIDE PROVIDED SEPARATELY
  • 30 Capsules u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Rx Onlyn- Array

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