AMITRIPTYLINE HYDROCHLORIDE (Page 5 of 5)

MEDICATION GUIDE

Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions

Read the Medication Guide that comes with you or your family member’s antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member’s, healthcare provider about:

  • all risks and benefits of treatment with antidepressant medicines
  • all treatment choices for depression or other serious mental illness

What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

  1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
  2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.
  3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
    • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
    • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
    • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling very agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood

What else do I need to know about antidepressant medicines?

  • Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
  • Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
  • Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
  • Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
  • Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.

Manufactured For:
Accord Healthcare, Inc.,
1009, Slater Road,
Suite 210-B,
Durham, NC 27703,
USA.

Manufactured By:
Intas Pharmaceuticals Limited, Ahmedabad- 380 009, India.

10 0374 1 667968

Issued August 2016

PRINCIPAL DISPLAY PANEL

10 mg Tablets

1000 Tablets

Amitriptyline Hydrochloride Tablets
(click image for full-size original)

25 mg Tablets

1000 Tablets

Amitriptyline Hydrochloride Tablets
(click image for full-size original)

50 mg Tablets

1000 Tablets

Amitriptyline Hydrochloride Tablets
(click image for full-size original)

75 mg Tablets

1000 Tablets

Amitriptyline Hydrochloride Tablets
(click image for full-size original)

100 mg Tablets

1000 Tablets

Amitriptyline Hydrochloride Tablets
(click image for full-size original)

150 mg Tablets

1000 Tablets

Amitriptyline Hydrochloride Tablets
(click image for full-size original)
AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-171
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE) AMITRIPTYLINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
LECITHIN, SOYBEAN
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYVINYL ALCOHOL
FERRIC OXIDE RED
TALC
TITANIUM DIOXIDE
XANTHAN GUM
Product Characteristics
Color brown Score no score
Shape ROUND Size 5mm
Flavor Imprint Code I1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-171-10 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:16729-171-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:16729-171-17 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202446 12/05/2014
AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-172
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE) AMITRIPTYLINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
XANTHAN GUM
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
LECITHIN, SOYBEAN
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYVINYL ALCOHOL
FERRIC OXIDE RED
TALC
TITANIUM DIOXIDE
Product Characteristics
Color brown Score no score
Shape ROUND Size 7mm
Flavor Imprint Code I2
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-172-10 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:16729-172-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:16729-172-17 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202446 12/05/2014
AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-173
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE) AMITRIPTYLINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
XANTHAN GUM
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
LECITHIN, SOYBEAN
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYVINYL ALCOHOL
FERRIC OXIDE RED
TALC
TITANIUM DIOXIDE
Product Characteristics
Color brown Score no score
Shape ROUND Size 9mm
Flavor Imprint Code I3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-173-10 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:16729-173-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:16729-173-17 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202446 12/05/2014
AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-174
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE) AMITRIPTYLINE HYDROCHLORIDE 75 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
LECITHIN, SOYBEAN
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYVINYL ALCOHOL
FERRIC OXIDE RED
TALC
TITANIUM DIOXIDE
XANTHAN GUM
Product Characteristics
Color brown Score no score
Shape ROUND Size 10mm
Flavor Imprint Code I4
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-174-10 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:16729-174-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:16729-174-17 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202446 12/26/2014
AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-175
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE) AMITRIPTYLINE HYDROCHLORIDE 100 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
LECITHIN, SOYBEAN
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYVINYL ALCOHOL
FERRIC OXIDE RED
TALC
TITANIUM DIOXIDE
XANTHAN GUM
Product Characteristics
Color brown Score no score
Shape ROUND Size 11mm
Flavor Imprint Code I5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-175-10 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:16729-175-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:16729-175-17 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202446 12/05/2014
AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-176
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE) AMITRIPTYLINE HYDROCHLORIDE 150 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
LACTOSE MONOHYDRATE
LECITHIN, SOYBEAN
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYVINYL ALCOHOL
FERRIC OXIDE RED
TALC
TITANIUM DIOXIDE
XANTHAN GUM
Product Characteristics
Color brown Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code I6
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-176-10 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:16729-176-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:16729-176-17 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202446 12/26/2014
Labeler — Accord Healthcare Inc. (604222237)
Establishment
Name Address ID/FEI Operations
Intas Pharmaceuticals Limited. 725927649 manufacture (16729-171), manufacture (16729-172), manufacture (16729-173), manufacture (16729-174), manufacture (16729-175), manufacture (16729-176), analysis (16729-171), analysis (16729-172), analysis (16729-173), analysis (16729-174), analysis (16729-175), analysis (16729-176)
Establishment
Name Address ID/FEI Operations
Intas Pharmaceuticals Limited 915837971 manufacture (16729-171), manufacture (16729-172), manufacture (16729-173), manufacture (16729-174), manufacture (16729-175), manufacture (16729-176)

Revised: 10/2019 Accord Healthcare Inc.

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