Clomipramine Hydrochloride (Page 7 of 7)

HOW SUPPLIED

Clomipramine Hydrochloride Capsules USP, 25 mg are white to off white powder filled in size “2” capsule with opaque pink cap printed with ‘1065’ in black ink and opaque light pink body and are supplied as:

NDC 70710-1065-3 in bottle of 30 capsules with child-resistant closure

NDC 70710-1065-9 in bottle of 90 capsules with child-resistant closure

NDC 70710-1065-1 in bottle of 100 capsules

Clomipramine Hydrochloride Capsules USP, 50 mg are white to off white powder filled in size “1” capsule with opaque yellow cap printed with ‘1066’ in black ink and opaque light pink body and are supplied as:

NDC 70710-1066-3 in bottle of 30 capsules with child-resistant closure

NDC 70710-1066-9 in bottle of 90 capsules with child-resistant closure

NDC 70710-1066-1 in bottle of 100 capsules

Clomipramine Hydrochloride Capsules USP, 75 mg are white to off white powder filled in size “1” capsule with opaque dark pink cap printed with ‘1067’ in black ink and opaque light pink body and are supplied as:

NDC 70710-1067-3 in bottle of 30 capsules with child-resistant closure

NDC 70710-1067-9 in bottle of 90 capsules with child-resistant closure

NDC 70710-1067-1 in bottle of 100 capsules

Storage

Store at 20ºC to 25ºC (68°F to 77°F) [see USP Controlled Room Temperature].

Dispense in tight, light-resistant containers with a child-resistant closure. Protect from moisture.

ANIMAL TOXICOLOGY

Phospholipidosis and testicular changes, commonly associated with tricyclic compounds, have been observed with clomipramine hydrochloride. In chronic rat studies, changes related to clomipramine hydrochloride consisted of systemic phospholipidosis, alterations in the testes (atrophy, mineralization) and secondary changes in other tissues. In addition cardiac thrombosis and dermatitis/keratitis were observed in rats treated for 2 years at doses which were 24 and 10 times the maximum recommended human daily dose (MRHD), respectively, on a mg/kg basis, and 4 and 1.5 times the MRHD, respectively, on a mg/m² basis.

Medication Guide available at www.zydususa.com/medguides or call 1-877-993-8779.

Manufactured by:

Cadila Healthcare Limited

Ahmedabad, India.

Distributed by:

Zydus Pharmaceuticals (USA) Inc.

Pennington, NJ 08534

Rev.:06/21

Medication Guide

Clomipramine Hydrochloride (kloe mip’ ra meen hye” droe klor’ ide) Capsules, USP

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

Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:

• headache
• weakness or feeling unsteady
• confusion, problems concentrating or thinking or memory problems

Visual problems

• eye pain
• changes in vision
• swelling or redness in or around the eye

Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

Who should not take clomipramine hydrochloride capsules?

Do not take clomipramine hydrochloride capsules if you:

• take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
  • Do not take an MAOI within 2 weeks of stopping clomipramine hydrochloride capsules unless directed to do so by your physician.
  • Do not start clomipramine hydrochloride capsules if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

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.

Please address medical inquiries to, MedicalAffairs@zydususa.com or Tel.: 1-877-993-8779.

Medication Guide available at www.zydususa.com/medguides or call 1-877-993-8779.

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

Manufactured by:

Cadila Healthcare Limited

Ahmedabad, India.

Distributed by:

Zydus Pharmaceuticals (USA) Inc.

Pennington, NJ 08534

Rev.: 06/21

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70710-1065-1

Clomipramine Hydrochloride Capsules USP, 25 mg

R_x only

100 Capsules

Zydus

NDC 70710-1066-1

Clomipramine Hydrochloride Capsules USP, 50 mg

R_x only

100 Capsules

Zydus

NDC 70710-1067-1

Clomipramine Hydrochloride Capsules USP, 75 mg

R_x only

100 Capsules

Zydus

CLOMIPRAMINE HYDROCHLORIDE clomipramine hydrochloride capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70710-1065 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE) CLOMIPRAMINE HYDROCHLORIDE 25 mg

Inactive Ingredients Ingredient Name Strength ALCOHOL AMMONIA BUTYL ALCOHOL CELLULOSE, MICROCRYSTALLINE D&C RED NO. 28 D&C RED NO. 33 D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C RED NO. 40 FERROSOFERRIC OXIDE GELATIN ISOPROPYL ALCOHOL MAGNESIUM STEARATE POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE WATER

Product Characteristics Color PINK (OPAQUE PINK CAP) , PINK (OPAQUE LIGHT PINK BODY) Score no score Shape CAPSULE (CAPSULE) Size 18mm Flavor Imprint Code 1065 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70710-1065-9 90 CAPSULE in 1 BOTTLE None 2 NDC:70710-1065-3 30 CAPSULE in 1 BOTTLE None 3 NDC:70710-1065-1 100 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208961 05/03/2018

CLOMIPRAMINE HYDROCHLORIDE clomipramine hydrochloride capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70710-1066 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE) CLOMIPRAMINE HYDROCHLORIDE 50 mg

Inactive Ingredients Ingredient Name Strength ALCOHOL AMMONIA BUTYL ALCOHOL CELLULOSE, MICROCRYSTALLINE D&C RED NO. 33 FD&C RED NO. 40 FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE GELATIN ISOPROPYL ALCOHOL MAGNESIUM STEARATE POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE WATER

Product Characteristics Color YELLOW (OPAQUE YELLOW CAP) , PINK (OPAQUE LIGHT PINK BODY) Score no score Shape CAPSULE (CAPSULE) Size 19mm Flavor Imprint Code 1066 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70710-1066-3 30 CAPSULE in 1 BOTTLE None 2 NDC:70710-1066-1 100 CAPSULE in 1 BOTTLE None 3 NDC:70710-1066-9 90 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208961 05/03/2018

CLOMIPRAMINE HYDROCHLORIDE clomipramine hydrochloride capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70710-1067 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE) CLOMIPRAMINE HYDROCHLORIDE 75 mg

Inactive Ingredients Ingredient Name Strength ALCOHOL AMMONIA BUTYL ALCOHOL CELLULOSE, MICROCRYSTALLINE D&C RED NO. 28 D&C RED NO. 33 FD&C BLUE NO. 1 FD&C RED NO. 40 FERROSOFERRIC OXIDE GELATIN ISOPROPYL ALCOHOL MAGNESIUM STEARATE POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE SODIUM LAURYL SULFATE STARCH, CORN TITANIUM DIOXIDE WATER

Product Characteristics Color PINK (OPAQUE DARK PINK CAP) , PINK (OPAQUE LIGHT PINK BODY) Score no score Shape CAPSULE (CAPSULE) Size 19mm Flavor Imprint Code 1067 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70710-1067-3 30 CAPSULE in 1 BOTTLE None 2 NDC:70710-1067-1 100 CAPSULE in 1 BOTTLE None 3 NDC:70710-1067-9 90 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208961 05/03/2018

Labeler — Zydus Pharmaceuticals USA Inc. (156861945)

Registrant — Zydus Pharmaceuticals USA Inc. (156861945)

Establishment
Name	Address	ID/FEI	Operations
Zydus Lifesciences Limited		863362789	ANALYSIS (70710-1065), ANALYSIS (70710-1066), ANALYSIS (70710-1067), MANUFACTURE (70710-1065), MANUFACTURE (70710-1066), MANUFACTURE (70710-1067)

Revised: 11/2022 Zydus Pharmaceuticals USA Inc.