Protriptyline Hydrochloride (Page 4 of 4)
HOW SUPPLIED
Protriptyline Hydrochloride Tablets USP
5 mg tablets are supplied as a round, white, biconvex tablet debossed with product identification “54” over “306” on one side and plain on the other.
NDC 0054-0210-25: Bottle of 100 Tablets
10 mg tablets are supplied as a round, white, biconvex tablet debossed with product identification “54” over “694” on one side and plain on the other.
NDC 0054-0211-25: Bottle of 100 Tablets
Storage
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, child-resistant container as defined in the USP/NF.
METABOLISM
Metabolic studies indicate that protriptyline is well absorbed from the gastrointestinal tract and is rapidly sequestered in tissues. Relatively low plasma levels are found after administration, and only a small amount of unchanged drug is excreted in the urine of dogs and rabbits. Preliminary studies indicate that demethylation of the secondary amine moiety occurs to a significant extent, and that metabolic transformation probably takes place in the liver. It penetrates the brain rapidly in mice and rats, and moreover that which is present in the brain is almost all unchanged drug.
Studies on the disposition of radioactive protriptyline in human test subjects showed significant plasma levels within 2 hours, peaking at 8 to 12 hours, then declining gradually.
Urinary excretion studies in the same subjects showed significant amounts of radioactivity in 2 hours. The rate of excretion was slow. Cumulative urinary excretion during 16 days accounted for approximately 50% of the drug. The fecal route of excretion did not seem to be important.
REFERENCES
ULTRAM is a registered trademark of Ortho-McNeil Pharmaceutical Inc.
Distr. by: West-Ward
Pharmaceuticals Corp.
Eatontown, NJ 07724
10004773/05
Revised March 2016
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
- •
- visual problems: eye pain, changes in vision, swelling or redness in or around the eye
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.
- •
- Visual problems: 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.
- •
- 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 with 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.
Distr. by: West-Ward
Pharmaceuticals Corp.
Eatontown, NJ 07724
10004773/05
Revised March 2016
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
| PROTRIPTYLINE HYDROCHLORIDE protriptyline hydrochloride tablet | ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| PROTRIPTYLINE HYDROCHLORIDE protriptyline hydrochloride tablet | ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| ||||||||||||||||||
| Labeler — West-Ward Pharmaceuticals Corp. (080189610) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| West-Ward Columbus Inc. | 058839929 | MANUFACTURE (0054-0210), MANUFACTURE (0054-0211) | |
Revised: 04/2016 West-Ward Pharmaceuticals Corp.
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.
https://medlibrary.org/lib/rx/meds/protriptyline-hydrochloride/page/4/