CLOMIPRAMINE HYDROCHLORIDE (Page 9 of 9)

ANIMAL TOXICOLOGY

Phospholipidosis and testicular changes commonly associated with tricyclic compounds, have been observed with clomipramine. In chronic rat studies, changes related to clomipramine consisted of systemic phospholipidosis, alteration 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.

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Dist. by: Taro Pharmaceuticals U.S.A., Inc. , Hawthorne, NY 10532

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MAJOR® PHARMACEUTICALS

17177 N Laurel Park Dr., Suite 233

Livonia, MI 48152

71009-0719-10
Revised: July 2019

Medication Guide

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

Do not take clomipramine 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 unless directed to do so by your physician.
Do not start clomipramine 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.

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

Revised: July 2019
71009-0719-10

Package/Label Display Panel

Clomipramine Hydrochloride Capsules USP

25 mg

30 Capsules

carton label
(click image for full-size original)

Package/Label Display Panel

Clomipramine Hydrochloride Capsules USP

50 mg

30 Capsules

carton label
(click image for full-size original)
CLOMIPRAMINE HYDROCHLORIDE
clomipramine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-7038(NDC:51672-4011)
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
Ferrosoferric Oxide
D&C Yellow No. 10
FD&C Blue No. 2
FD&C Red No. 3
GELATIN, UNSPECIFIED
Magnesium Stearate
Silicon Dioxide
Titanium Dioxide
Starch, Corn
Product Characteristics
Color BLUE (Dark blue/light blue) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code CLOM25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-7038-07 30 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (0904-7038-07)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074694 12/31/1996
CLOMIPRAMINE HYDROCHLORIDE
clomipramine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-7039(NDC:51672-4012)
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
GELATIN, UNSPECIFIED
Magnesium Stearate
Silicon Dioxide
Titanium Dioxide
Ferric Oxide Yellow
Starch, Corn
Product Characteristics
Color YELLOW (opaque) Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code CLOM50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0904-7039-07 30 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (0904-7039-07)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074694 12/31/1996
Labeler — Major Pharmaceuticals (191427277)

Revised: 12/2021 Major Pharmaceuticals

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