Imipramine Hydrochloride (Page 4 of 4)

HOW SUPPLIED

Imipramine Hydrochloride Tablets, USP are available as follows:

10 mg are yellow, triangular, film coated tablets debossed “par” on one side and “54” on the other side and supplied in bottles of 100 (NDC 60429-095-01) and 1000 (NDC 60429-095-10) tablets.

25 mg are brown, round, film coated tablets debossed “par” on one side and “55” on the other side and supplied in bottles of 100 (NDC 60429-096-01) and 1000 (NDC 60429-096-10) tablets.

50 mg are green, round, film coated tablets debossed “par” on one side and “56” on the other side and supplied in bottles of 100 (NDC 60429-097-01) and 1000 (NDC 60429-097-10) tablets.

Storage

Store between 15°-25°C (59°-77°F).

ANIMAL PHARMACOLOGY AND/OR TOXICOLOGY

Acute: Oral LD 50 ranges are as follows:

Rat-355 to 682 mg/kg

Dog-100 to 215 mg/kg

Depending on the dosage in both species, toxic signs proceeded progressively from depression, irregular respiration and ataxia to convulsions and death.

Reproduction/Teratogenic:

The overall evaluation may be summed up in the following manner:

Oral: Independent studies in three species (rat, mouse, and rabbit) revealed that when imipramine hydrochloride is administered orally in doses up to approximately 2 1/2 times the maximum human dose in the first 2 species and up to 25 times the maximum human dose in the third species, the drug is essentially free from teratogenic potential. In the three species studied, only one instance of fetal abnormality occurred (in the rabbit) and in that study there was likewise an abnormality in the control group. However, evidence does exist from the rat studies that some systemic and embryotoxic potential is demonstrable. This is manifested by reduced litter size, a slight increase in the stillborn rate and a reduction in the mean birth weight.

MEDICATION GUIDE

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

Read the Medication Guide that comes with your 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 family member’s, or your 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 by: PAR PHARMACEUTICAL CO, INC. , Spring Valley, NY 10977

Marketed/Packaged by: GSMS Inc. Camarillo, CA 93012

Revised: 11/09 OS054-01-1-20

PRINCIPAL DISPLAY PANEL 10 MG TABLETS 100’S

Label Graphic -- 10 mg 100s
(click image for full-size original)

PRINCIPAL DISPLAY PANEL 25 MG TABLETS 100’S

Label Graphic -- 25 mg 100s
(click image for full-size original)

PRINCIPAL DISPLAY PANEL 50 MG TABLETS 100’S

Label Graphic -- 50 mg 100s
(click image for full-size original)
IMIPRAMINE HYDROCHLORIDE
imipramine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-095(NDC:49884-054)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IMIPRAMINE HYDROCHLORIDE (IMIPRAMINE) IMIPRAMINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6
HYDROXYPROPYL CELLULOSE
HYPROMELLOSES
ANHYDROUS LACTOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE B POTATO
STEARIC ACID
TITANIUM DIOXIDE
TRIACETIN
D&C YELLOW NO. 10
Product Characteristics
Color YELLOW (film-coated) Score no score
Shape TRIANGLE (debossed) Size 5mm
Flavor Imprint Code par;54
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-095-01 100 TABLET in 1 BOTTLE None
2 NDC:60429-095-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088292 08/27/1999
IMIPRAMINE HYDROCHLORIDE
imipramine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-096(NDC:49884-055)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IMIPRAMINE HYDROCHLORIDE (IMIPRAMINE) IMIPRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6
HYDROXYPROPYL CELLULOSE
HYPROMELLOSES
ANHYDROUS LACTOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE B POTATO
STEARIC ACID
TITANIUM DIOXIDE
TRIACETIN
FD&C RED NO. 40
FD&C BLUE NO. 2
Product Characteristics
Color BROWN (film-coated) Score no score
Shape ROUND (debossed) Size 5mm
Flavor Imprint Code Par;55
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-096-01 100 TABLET in 1 BOTTLE None
2 NDC:60429-096-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088262 08/27/1999
IMIPRAMINE HYDROCHLORIDE
imipramine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60429-097(NDC:49884-056)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IMIPRAMINE HYDROCHLORIDE (IMIPRAMINE) IMIPRAMINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 6
HYDROXYPROPYL CELLULOSE
HYPROMELLOSES
ANHYDROUS LACTOSE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE B POTATO
STEARIC ACID
TITANIUM DIOXIDE
TRIACETIN
D&C YELLOW NO. 10
FD&C BLUE NO. 1
Product Characteristics
Color GREEN (film-coated) Score no score
Shape ROUND (debossed) Size 7mm
Flavor Imprint Code Par;56
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60429-097-01 100 TABLET in 1 BOTTLE None
2 NDC:60429-097-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088276 08/27/1999
Labeler — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply, Inc. 603184490 REPACK (60429-095), REPACK (60429-096), REPACK (60429-097), RELABEL (60429-095), RELABEL (60429-096), RELABEL (60429-097)

Revised: 01/2012 Golden State Medical Supply, Inc.

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