Atomoxetine Hydrochloride (Strattera)

Trade Name : Strattera

Eli Lilly and Company

CAPSULE

Strength 10 mg/1

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

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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 Hydrochloride (Strattera) which is also known as Strattera and Manufactured by Eli Lilly and Company. It is available in strength of 10 mg/1 per ml. Read more

Atomoxetine Hydrochloride (Strattera) 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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About GNH

No data

STRATTERA (atomoxetine) increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of STRATTERA 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. STRATTERA is approved for ADHD in pediatric and adult patients. STRATTERA is not approved for major depressive disorder.
Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of STRATTERA 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 STRATTERA compared to placebo. The average risk of suicidal ideation in patients receiving STRATTERA 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 adolescentsnn- ()
No suicides occurred in clinical trialsnn- ()
Patients started on therapy should be monitored closelynn- ()

STRATTERA is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). ()n

Initial, Target and Maximum Daily Dose ()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 HCl equivalent to 10u00a0mg (Opaque White, Opaque White), 18u00a0mg (Gold, Opaque White), 25u00a0mg (Opaque Blue, Opaque White), 40u00a0mg (Opaque Blue, Opaque Blue), 60u00a0mg (Opaque Blue, Gold), 80u00a0mg (Opaque Brown, Opaque White), or 100u00a0mg (Opaque Brown, Opaque Brown) of atomoxetine.n
Each capsule contains atomoxetine HCl equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine. (, , )n

No data

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

No data

Suicidal Ideation u2013 Monitor for suicidality, clinical worsening, and unusual changes in behavior. ()n
Severe Liver Injury u2013 Should be discontinued and not restarted in patients with jaundice or laboratory evidence of liver injury. ()n
Serious Cardiovascular Events u2013 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. STRATTERA 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 STRATTERA in adults with clinically significant cardiac abnormalities. ()n
Emergent Cardiovascular Symptoms u2013 Patients should undergo prompt cardiac evaluation. ()n
Effects on Blood Pressure and Heart Rate u2013 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 u2013 Consider discontinuing treatment if such new symptoms occur. ()n
Bipolar Disorder u2013 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 u2013 Urinary hesitancy and retention may occur. ()n
Priapism u2013 Prompt medical attention is required in the event of suspected priapism. (, )n
Growth u2013 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 u2013 Dose adjustment of STRATTERA may be necessary. ()n

Most common adverse reactions (u22655% and at least twice the incidence of placebo patients)
To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Child and Adolescent Clinical Trials u2013 Nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence. ()n
Adult Clinical Trials u2013 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 Agents - Possible effects on blood pressure. ()n
Albuterol (or other beta agonists) - Action of albuterol on cardiovascular system can be potentiated. ()n

No data

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). ()n
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 Tourette's Disorder. ()n
Patients with Concomitant Illness u2013 Does not worsen anxiety in patients with ADHD and comorbid Anxiety Disorders. ()n

No data

No data

STRATTERA (atomoxetine) is a selective norepinephrine reuptake inhibitor. Atomoxetineu00a0HCl 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 weightu00a0ofu00a0291.82. The chemical structure is:n
Atomoxetineu00a0HCl is a white to practically white solid, which has a solubility of 27.8u00a0mg/mL in water.n
STRATTERA capsules are intended for oral administration only.n
Each capsule contains atomoxetineu00a0HCl equivalent tou00a010, 18, 25, 40, 60, 80, or 100u00a0mg of atomoxetine. The capsules also contain pregelatinized starch and dimethicone. The capsule shells contain gelatin, sodium lauryl sulfate, and other inactive ingredients. The capsule shells also contain one or more of the following:n
FD&C Blue No.u00a02, synthetic yellow iron oxide, titanium dioxide, red iron oxide. The capsules are imprinted with edible black ink.n

No data

No data

No data

No data

ntttttttAdvise the patient to read the FDA-approved patient labeling (Medication Guide).ntttttt
General Information
Physicians should instruct their patients to read the Medication Guide before starting therapy with STRATTERA and to reread it each time the prescription is renewed.n
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with STRATTERA and should counsel them in its appropriate use. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have.n
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking STRATTERA.n
Suicide Risk
Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, depression, and suicidal ideation, especially early during STRATTERA treatment and when the dose is adjusted. Families and caregivers of patients should be advised to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.n
Severe Liver Injury
Patients initiating STRATTERA should be cautioned that severe liver injury may develop. Patients should be instructed to contact their physician immediately should they develop pruritus, dark urine, jaundice, right upper quadrant tenderness, or unexplained u201cflu-likeu201d symptoms .n
Aggression or Hostility
Patients should be instructed to call their doctor as soon as possible should they notice an increase in aggression or hostility.n
Priapism
Rare postmarketing cases of priapism, defined as painful and nonpainful penile erection lasting more than 4 hours, have been reported for pediatric and adult patients treated with STRATTERA. The parents or guardians of pediatric patients taking STRATTERA and adult patients taking STRATTERA should be instructed that priapism requires prompt medical attention.n
Ocular Irritant
STRATTERA is an ocular irritant. STRATTERA capsules are not intended to be opened. In the event of capsule content coming in contact with the eye, the affected eye should be flushed immediately with water, and medical advice obtained. Hands and any potentially contaminated surfaces should be washed as soon as possible.n
Drug-Drug Interaction
Patients should be instructed to consult a physician if they are taking or plan to take any prescription or over-the-counter medicines, dietary supplements, or herbal remedies.n
Pregnancy Registry
Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to atomoxetine during pregnancy .n
Food
Patients may take STRATTERA with or without food.n
Missed Dose
If patients miss a dose, they should be instructed to take it as soon as possible, but should not take more than the prescribed total daily amount of STRATTERA in any 24-hour period.n
Interference with Psychomotor Performance
Patients should be instructed to use caution when driving a car or operating hazardous machinery until they are reasonably certain that their performance is not affected by atomoxetine.n
Marketed by: Lilly USA, LLCIndianapolis, IN 46285, USA
Copyright u00a9 2002, 2020, Eli Lilly and Company. All rights reserved.n
STR-0004-USPI-20200225n

MEDICATION GUIDE STRATTERAn n- (Stra-TAIR-a) n- (atomoxetine) Capsules
Read the Medication Guide that comes with STRATTERA before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your treatment or your child's treatment with STRATTERA.n
What is the most important information I should know about STRATTERA?
The following have been reported with use of STRATTERA:
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 STRATTERA 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 STRATTERA treatment:
Call your child or teenager's doctor right away if they have any of the above signs, especially if they are new, sudden, or severe.
2. Severe liver damage:
STRATTERA can cause liver injury in some patients. Call your doctor right away if you or your child has the following signs of liver problems:
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 STRATTERA.n
Your doctor should check your blood pressure or your child's blood pressure and heart rate regularly during treatment with STRATTERA.n
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 STRATTERA.
4. New mental (psychiatric) problems in children and teenagers:
Call your child or teenager's doctor right away about any new mental symptoms
What Is STRATTERA?
STRATTERA is a selective norepinephrine reuptake inhibitor medicine. It is used for the treatment of attention deficit and hyperactivity disorder (ADHD). STRATTERA may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.n
STRATTERA should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.n
STRATTERA has not been studied in children less than 6 years old.n
Who should not take STRATTERA?
STRATTERA should not be taken if you or your child:
STRATTERA may not be right for you or your child. Before starting STRATTERA tell your doctor or your child's doctor about all health conditions (or a family history of) including:
Can STRATTERA 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.n
Do not start any new medicine while taking STRATTERA without talking to your doctor first.
How should STRATTERA be taken?
What are possible side effects of STRATTERA?
See for information on reported suicidal thoughts and actions, other mental problems, severe liver damage, and heart problems.n
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.n
How should I store STRATTERA?
General information about STRATTERA
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use STRATTERA for a condition for which it was not prescribed. Do not give STRATTERA to other people, even if they have the same condition. It may harm them.n
This Medication Guide summarizes the most important information about STRATTERA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about STRATTERA that was written for healthcare professionals. For more information about STRATTERA call 1-800-Lilly-Rx (1-800-545-5979) or visit www.strattera.com.n
What are the ingredients in STRATTERA?
Active ingredient:
Inactive ingredients:
Nardil is a registered trademark of Pfizer Inc.n
Parnate is a registered trademark of GlaxoSmithKline.n
Emsam is a registered trademark of Somerset Pharmaceuticals Inc.n
This Medication Guide has been approved by the US Food and Drug Administration.
Revised: 2/2020n
Marketed by: Lilly USA, LLCIndianapolis, IN 46285, USA
Copyright u00a9 2003, 2020, Eli Lilly and Company. All rights reserved.n
STR-0001-MG-20200225n

PACKAGE LABEL - STRATTERA 10 mg bottle of 30
30 Capsulesn
NDC 0002-3227-30n
PU 3227n
stratteran
atomoxetine capsulesn
Rx onlyn
10 mgn
Each capsule equivalent to 10 mg atomoxetinen
Do not use if Lilly inner seal is missing or broken.n
www.strattera.comn
Lillyn

PACKAGE LABEL - STRATTERA 18 mg bottle of 30
30 Capsulesn
NDC 0002-3238-30n
PU 3238n
stratteran
atomoxetine capsulesn
Rx onlyn
18 mgn
Each capsule equivalent to 18 mg atomoxetinen
Do not use if Lilly inner seal is missing or broken.n
www.strattera.comn
Lillyn

PACKAGE LABEL - STRATTERA 25 mg bottle of 30
30 Capsulesn
NDC 0002-3228-30n
PU 3228n
stratteran
atomoxetine capsulesn
Rx onlyn
25 mgn
Each capsule equivalent to 25 mg atomoxetinen
Do not use if Lilly inner seal is missing or broken.n
www.strattera.comn
Lillyn

PACKAGE LABEL - STRATTERA 40 mg bottle of 30
30 Capsulesn
NDC 0002-3229-30n
PU 3229n
stratteran
atomoxetine capsulesn
Rx onlyn
40 mgn
Each capsule equivalent to 40 mg atomoxetinen
Do not use if Lilly inner seal is missing or broken.n
www.strattera.comn
Lillyn

PACKAGE LABEL - STRATTERA 60 mg bottle of 30
30 Capsulesn
NDC 0002-3239-30n
PU 3239n
stratteran
atomoxetine capsulesn
Rx onlyn
60 mgn
Each capsule equivalent to 60 mg atomoxetinen
Do not use if Lilly inner seal is missing or broken.n
www.strattera.comn
Lillyn

PACKAGE LABEL - STRATTERA 80 mg bottle of 30
30 Capsulesn
NDC 0002-3250-30n
PU 3250n
stratteran
atomoxetine capsulesn
Rx onlyn
80 mgn
Each capsule equivalent to 80 mg atomoxetinen
Do not use if Lilly inner seal is missing or broken.n
www.strattera.comn
Lillyn

PACKAGE LABEL - STRATTERA 100 mg bottle of 30
30 Capsulesn
NDC 0002-3251-30n
PU 3251n
stratteran
atomoxetine capsulesn
Rx onlyn
100 mgn
Each capsule equivalent to 100 mg atomoxetinen
Do not use if Lilly inner seal is missing or broken.n
www.strattera.comn
Lillyn

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Atomoxetine Hydrochloride (Strattera)

Trade Name : Strattera

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Atomoxetine Hydrochloride (Strattera)

Trade Name : Strattera

CAPSULE

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

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Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

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