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ATOMOXETINE- atomoxetine hydrochloride capsule


  1. 1. Suicidal Thoughts And Actions In Children And Teenagers:
  2. The Chance For Suicidal Thoughts And Actions May Be Higher:
  3. Prevent Suicidal Thoughts And Action In Your Child Or Teenager By:
  4. Watch For The Following Signs In Your Child Or Teenager During Atomoxetine Capsule Treatment:
  5. 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:
  6. 3. Heart-related Problems:
  7. 4. New Mental (psychiatric) Problems In Children And Teenagers:
  8. What Is Atomoxetine?
  9. Atomoxetine Capsules Should Not Be Taken If You Or Your Child:
  10. Especially Tell Your Doctor If You Or Your Child Takes:
  11. How Should Atomoxetine Capsules Be Taken?
  12. What Are Possible Side Effects Of Atomoxetine Capsules?
  13. Active Ingredient:
  14. Inactive Ingredients:
  15. Revised: 6/2017document Id:

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 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.Although no suicides occurred in these studies, 4 out of every 1000 patients developed suicidal thoughts. Tell your child or teenager's doctor if your child or teenager (or there is a family history of):

  • has bipolar illness (manic-depressive illness)
  • had suicide thoughts or actions before starting atomoxetine capsules

The Chance For Suicidal Thoughts And Actions May Be Higher: 

  • early during atomoxetine capsule treatment
  • during dose adjustments

Prevent Suicidal Thoughts And Action In Your Child Or Teenager By: 

  • paying close attention to your child or teenager's moods, behaviors, thoughts, and feelings during atomoxetine capsule treatment
  • keeping all follow-up visits with your child or teenager's doctor as scheduled

Watch For The Following Signs In Your Child Or Teenager During Atomoxetine Capsule Treatment: 

  • anxiety
  • agitation
  • panic attacks
  • trouble sleeping
  • irritability
  • hostility
  • aggressiveness
  • impulsivity
  • restlessness
  • mania
  • depression
  • suicide thoughts

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.Your child or teenager may need to be closely watched for suicidal thoughts and actions or need a change in medicine.

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: 

  • itching
  • right upper belly pain
  • dark urine
  • yellow skin or eyes
  • unexplained flu-like symptoms

3. Heart-related Problems: 

  • sudden death in patients who have heart problems or heart defects
  • stroke and heart attack in adults
  • increased blood pressure and heart rate

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 child's 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.

4. New Mental (psychiatric) Problems In Children And Teenagers: 

  • new psychotic symptoms (such as hearing voices, believing things that are not true, being suspicious) or new manic symptoms

Call your child or teenager's doctor right away about any new mental symptomsbecause adjusting or stopping atomoxetine capsule treatment may need to be considered.

What Is Atomoxetine? 

Atomoxetine is a selective norepinephrine reuptake inhibitor medicine. It is used for the treatment of attention deficit and hyperactivity disorder (ADHD). Atomoxetine 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.

Atomoxetine Capsules Should Not Be Taken If You Or Your Child: 

  • are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI. Some names of MAOI medicines are Nardil(phenelzine sulfate), Parnate(tranylcypromine sulfate) and Emsam(selegiline transdermal system).
  • have an eye problem called narrow angle glaucoma
  • are allergic to anything in atomoxetine capsules.

    Tell your doctor about all the medicines that you or your child takes including prescription and nonprescription medicines, vitamins, and herbal supplements.Atomoxetine and some medicines may interact with each other and cause serious side effects. Your doctor will decide whether atomoxetine capsules can be taken with other medicines.

Especially Tell Your Doctor If You Or Your Child Takes: 

  • asthma medicines
  • anti-depression medicines including MAOIs
  • blood pressure medicines
  • cold or allergy medicines that contain decongestants

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? 

  • Take atomoxetine capsules exactly as prescribed. Atomoxetine capsules come in different dose strengths.Your doctor may adjust the dose until it is right for you or your child.
  • Do not chew, crush, or open the capsules.Swallow atomoxetine capsules whole with water or other liquids. Tell your doctor if you or your child cannot swallow atomoxetine capsules whole. A different medicine may need to be prescribed.
  • Avoid touching a broken atomoxetine capsule. Wash hands and surfaces that touched an open atomoxetine capsule. If any of the powder gets in your eyes or your child's eyes, rinse them with water right away and call your doctor.
  • Atomoxetine capsules can be taken with or without food.
  • Atomoxetine capsules are usually taken once or twice a day. Take atomoxetine at the same time each day to help you remember. If you miss a dose of atomoxetine, take it as soon as you remember that day. If you miss a day of atomoxetine, do not double your dose the next day. Just skip the day you missed.
  • From time to time, your doctor may stop atomoxetine capsule treatment for a while to check ADHD symptoms.
  • Your doctor may do regular checks of the blood, heart, and blood pressure while taking atomoxetine capsules. Children should have their height and weight checked often while taking atomoxetine capsules. Atomoxetine capsule treatment may be stopped if a problem is found during these check-ups.
  • If you or your child takes too much atomoxetine or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What Are Possible Side Effects Of Atomoxetine Capsules? 

  • Store atomoxetine in a safe place at room temperature, 59 to 86 F (15 to 30 C).
  • Keep atomoxetine capsules and all medicines out of the reach of children.

General information about Atomoxetine

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use atomoxetine for a condition for which it was not prescribed. Do not give atomoxetine to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about atomoxetine. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about atomoxetine that was written for healthcare professionals. For more information about atomoxetine call 1-800-545-5979.

Active Ingredient: 

atomoxetine hydrochloride.

Inactive Ingredients: 

pregelatinized starch, dimethicone, gelatin, sodium lauryl sulfate, FD&C Blue No. 2, synthetic yellow iron oxide, titanium dioxide, red iron oxide, and edible black ink.

Nardilis a registered trademark of Pfizer Inc.

Parnateis a registered trademark of GlaxoSmithKline.

Emsamis a registered trademark of Somerset Pharmaceuticals Inc.

This Medication Guide has been approved by the US Food and Drug Administration.

Patient Information issued February 1, 2017

Manufactured for: Prasco Laboratories, Mason, OH 45040, USA

Manufactured by: Eli Lilly and Company, Indianapolis, IN 46285, USA

Copyright 2003, 2014, Eli Lilly and Company. All rights reserved.

ATX-0001-MG-20170201

PACKAGE LABEL - Atomoxetine 10 mg bottle of 30

NDC 66993-040-30

PRASCO

Atomoxetine Capsules

Each capsule equivalent to 10 mg atomoxetine

10 mg

30 Capsules

Rx only

PACKAGE LABEL - Atomoxetine 10 mg bottle of 30

PACKAGE LABEL - Atomoxetine 18 mg bottle of 30

NDC 66993-041-30

PRASCO

Atomoxetine Capsules

Each capsule equivalent to 18 mg atomoxetine

18 mg

30 Capsules

Rx only

PACKAGE LABEL - Atomoxetine 18 mg bottle of 30

PACKAGE LABEL - Atomoxetine 25 mg bottle of 30

NDC 66993-042-30

PRASCO

Atomoxetine Capsules

Each capsule equivalent to 25 mg atomoxetine

25 mg

30 Capsules

Rx only

PACKAGE LABEL - Atomoxetine  25 mg bottle of 30

PACKAGE LABEL - Atomoxetine 40 mg bottle of 30

NDC 66993-043-30

PRASCO

Atomoxetine Capsules

Each capsule equivalent to 40 mg atomoxetine

40 mg

30 Capsules

Rx only

PACKAGE LABEL - Atomoxetine 40 mg bottle of 30

PACKAGE LABEL - Atomoxetine 60 mg bottle of 30

NDC 66993-044-30

PRASCO

Atomoxetine Capsules

Each capsule equivalent to 60 mg atomoxetine

60 mg

30 Capsules

Rx only

PACKAGE LABEL - Atomoxetine 60 mg bottle of 30

PACKAGE LABEL - Atomoxetine 80 mg bottle of 30

NDC 66993-045-30

PRASCO

Atomoxetine Capsules

Each capsule equivalent to 80 mg atomoxetine

80 mg

30 Capsules

Rx only

PACKAGE LABEL - Atomoxetine 80 mg bottle of 30

PACKAGE LABEL - Atomoxetine 100 mg bottle of 30

NDC 66993-046-30

PRASCO

Atomoxetine Capsules

Each capsule equivalent to 100 mg atomoxetine

100 mg

30 Capsules

Rx only

PACKAGE LABEL - Atomoxetine 100 mg bottle of 30
ATOMOXETINE
atomoxetine hydrochloride capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66993-040
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Atomoxetine hydrochloride(UNII: 57WVB6I2W0) (Atomoxetine - UNII:ASW034S0B8)Atomoxetine10 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, Corn(UNII: O8232NY3SJ)
DIMETHICONE(UNII: 92RU3N3Y1O)
Gelatin(UNII: 2G86QN327L)
sodium lauryl sulfate(UNII: 368GB5141J)
titanium dioxide(UNII: 15FIX9V2JP)
Product Characteristics
Colorwhite (opaque white)Scoreno score
ShapeCAPSULESize16mm
FlavorImprint CodeLILLY;3227;10;mg
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66993-040-3030 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02141105/30/2017
ATOMOXETINE
atomoxetine hydrochloride capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66993-041
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Atomoxetine hydrochloride(UNII: 57WVB6I2W0) (Atomoxetine - UNII:ASW034S0B8)Atomoxetine18 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, Corn(UNII: O8232NY3SJ)
DIMETHICONE(UNII: 92RU3N3Y1O)
Gelatin(UNII: 2G86QN327L)
sodium lauryl sulfate(UNII: 368GB5141J)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
titanium dioxide(UNII: 15FIX9V2JP)
Product Characteristics
Colorwhite (opaque white) , yellow (gold)Scoreno score
ShapeCAPSULESize16mm
FlavorImprint CodeLILLY;3238;18;mg
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66993-041-3030 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02141105/30/2017
ATOMOXETINE
atomoxetine hydrochloride capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66993-042
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Atomoxetine hydrochloride(UNII: 57WVB6I2W0) (Atomoxetine - UNII:ASW034S0B8)Atomoxetine25 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, Corn(UNII: O8232NY3SJ)
DIMETHICONE(UNII: 92RU3N3Y1O)
Gelatin(UNII: 2G86QN327L)
sodium lauryl sulfate(UNII: 368GB5141J)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
titanium dioxide(UNII: 15FIX9V2JP)
Product Characteristics
Colorwhite (opaque white) , blue (opaque blue)Scoreno score
ShapeCAPSULESize16mm
FlavorImprint CodeLILLY;3228;25;mg
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66993-042-3030 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02141105/30/2017
ATOMOXETINE
atomoxetine hydrochloride capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66993-043
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Atomoxetine hydrochloride(UNII: 57WVB6I2W0) (Atomoxetine - UNII:ASW034S0B8)Atomoxetine40 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, Corn(UNII: O8232NY3SJ)
DIMETHICONE(UNII: 92RU3N3Y1O)
Gelatin(UNII: 2G86QN327L)
sodium lauryl sulfate(UNII: 368GB5141J)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
titanium dioxide(UNII: 15FIX9V2JP)
Product Characteristics
Colorblue (opaque blue)Scoreno score
ShapeCAPSULESize16mm
FlavorImprint CodeLILLY;3229;40;mg
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66993-043-3030 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02141105/30/2017
ATOMOXETINE
atomoxetine hydrochloride capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66993-044
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Atomoxetine hydrochloride(UNII: 57WVB6I2W0) (Atomoxetine - UNII:ASW034S0B8)Atomoxetine60 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, Corn(UNII: O8232NY3SJ)
DIMETHICONE(UNII: 92RU3N3Y1O)
Gelatin(UNII: 2G86QN327L)
sodium lauryl sulfate(UNII: 368GB5141J)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
titanium dioxide(UNII: 15FIX9V2JP)
Product Characteristics
Colorblue (opaque blue) , yellow (gold)Scoreno score
ShapeCAPSULESize18mm
FlavorImprint CodeLILLY;3239;60;mg
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66993-044-3030 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02141105/30/2017
ATOMOXETINE
atomoxetine hydrochloride capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66993-045
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Atomoxetine hydrochloride(UNII: 57WVB6I2W0) (Atomoxetine - UNII:ASW034S0B8)Atomoxetine80 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, Corn(UNII: O8232NY3SJ)
DIMETHICONE(UNII: 92RU3N3Y1O)
Gelatin(UNII: 2G86QN327L)
sodium lauryl sulfate(UNII: 368GB5141J)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
titanium dioxide(UNII: 15FIX9V2JP)
Product Characteristics
Colorwhite (opaque white) , brown (opaque brown)Scoreno score
ShapeCAPSULESize18mm
FlavorImprint CodeLILLY;3250;80;mg
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66993-045-3030 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02141105/30/2017
ATOMOXETINE
atomoxetine hydrochloride capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66993-046
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Atomoxetine hydrochloride(UNII: 57WVB6I2W0) (Atomoxetine - UNII:ASW034S0B8)Atomoxetine100 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, Corn(UNII: O8232NY3SJ)
DIMETHICONE(UNII: 92RU3N3Y1O)
Gelatin(UNII: 2G86QN327L)
sodium lauryl sulfate(UNII: 368GB5141J)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
titanium dioxide(UNII: 15FIX9V2JP)
Product Characteristics
Colorbrown (opaque brown)Scoreno score
ShapeCAPSULESize20mm
FlavorImprint CodeLILLY;3251;100;mg
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66993-046-3030 in 1 BOTTLE; Type 0: Not a Combination Product05/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02141105/30/2017
Labeler -Prasco Laboratories (065969375)

Revised: 6/2017document Id: 

d3eb9324-f3a5-4191-b4eb-413b4b770951Set id: 48980c85-2fa0-4c9e-b182-227b0d057f6bVersion: 3Effective Time: 20170608Prasco Laboratories



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