Nortriptyline Hydrochloride (Page 5 of 5)

HOW SUPPLIED

Nortriptyline Hydrochloride Oral Solution USP

Nortriptyline Hydrochloride Oral Solution USP, 10 g/5 mL, is a clear, cherry-flavored solution. Alcohol content is 4%.

It is available as follows:

NDC 0121-0678-16: 16 fl oz (473 mL) bottle

Store and Dispense

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

Preserve in tight, light-resistant containers as defined in the USP.

MANUFACTURED BY

Pharmaceutical Associates, Inc.
Greenville, SC 29605
www.paipharma.com

R03/23

Medication Guide

Nortriptyline Hydrochloride Oral Solution USP
(nor trip te len)

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. 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

Heart problem (Brugada Syndrome)

• If you have unexplained fainting or have a family history of sudden unexplained death before 45 years of age, you may have Brugada Syndrome and not know it. • Talk to your healthcare provider right away if you faint or feel abnormal heartbeats.

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 nortriptyline hydrochloride?

Do not take nortriptyline hydrochloride 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 nortriptyline hydrochloride unless directed to do so by your physician.
  • Do not start nortriptyline hydrochloride 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.

Pharmaceutical Associates, Inc.
Greenville, SC 29605
www.paipharma.com

MG067840323

R03/23

PRINCIPAL DISPLAY PANEL — 473 mL Bottle Label

NDC 0121-0678-16

Nortriptyline
Hydrochloride
Oral Solution USP

10 mg/5 mL
base

Each 5 mL contains:
Nortriptyline hydrochloride
equivalent to 10 mg of base.
Alcohol 4%

PHARMACIST: Provide one attached
Medication Guide to each patient or caregiver
at the time of dispensing.

Rx ONLY

16 fl oz (473 mL)

pai
Pharmaceutical
Associates, Inc. Greenville, SC 29605

NORTRIPTYLINE HYDROCHLORIDE nortriptyline hydrochloride solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0121-0678 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NORTRIPTYLINE HYDROCHLORIDE (NORTRIPTYLINE) NORTRIPTYLINE 10 mg in 5 mL

Inactive Ingredients Ingredient Name Strength ALCOHOL ANHYDROUS CITRIC ACID WATER SODIUM BENZOATE SORBITOL

Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0121-0678-16 473 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075606 08/23/2000

Labeler — PAI Holdings, LLC (044940096)

Establishment
Name	Address	ID/FEI	Operations
PAI Holdings, LLC dba Pharmaceutical Associates, Inc.		097630693	manufacture (0121-0678)

Revised: 03/2023 PAI Holdings, LLC