DULOXETINE- duloxetine capsule, delayed release
Delayed-release Capsules, USP
Read this Medication Guide before you start taking duloxetine delayed-release capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
Talk to your healthcare provider about:
What is the most important information I should know about antidepressant medicines, depression, other serious mental illnesses, and suicidal thoughts or actions?
Call your healthcare provider right away if you have any of the following symptoms or feelings, especially if they are new, worse, or worry you. In an emergency, call 911.
What else do I need to know about antidepressant medicines?
What are duloxetine delayed-release capsules?
Duloxetine delayed-release capsules are a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD). Duloxetine belongs to a class of medicines known as SNRIs (or serotonin-norepinephrine reuptake inhibitors).
Duloxetine delayed-release capsules are also used to treat or manage:
Who should not take duloxetine delayed-release capsules?
Do Not take duloxetine delayed-release capsules if you:
• Do not take an MAOI within 5 days of stopping duloxetine unless directed to do so by your healthcare provider.
• Do not start duloxetine if you stopped taking an MAOI in the last 14 days unless directed to do so by your healthcare provider.
People who take duloxetine delayed-release capsules close in time to an MAOI may have a serious problem called Serotonin Syndrome (see "What are the possible side effects of duloxetine delayed-release capsules?").
What should I tell my healthcare provider before taking duloxetine delayed-release capsules?
Before starting duloxetine delayed-release capsules, tell your healthcare provider if you:
● have heart problems or high blood pressure
● have diabetes (Duloxetine treatment makes it harder for some people with diabetes to control their blood sugar)
● have liver problems
● have kidney problems
● have glaucoma
● have or had seizures or convulsions
● have bipolar disorder or mania
● have low sodium levels in your blood
● have delayed stomach emptying
● have or had bleeding problems
● are pregnant or plan to become pregnant. It is not known if duloxetine will harm your unborn baby.Talk to your healthcare provider about the benefits and risks of treating depression or other conditions with duloxetine delayed-release capsules during pregnancy.
Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Duloxetine delayed-release capsules and some medicines may interact with each other, may not work as well, or may cause serious side effects.
Especially tell your healthcare provider if you take:
Ask your healthcare provider for a list of these medicines if you are not sure.
Do not take duloxetine delayed-release capsules with any other medicine that contain duloxetine.
How should I take duloxetine delayed-release capsules?
What should I avoid while taking duloxetine delayed-release capsules?
What are the possible side effects of duloxetine delayed-release capsules?
Duloxetine delayed-release capsules may cause serious side effects, including: See "What is the most important information I should know about duloxetine delayed-release capsules?"
Common possible side effects in people who take duloxetine delayed-release capsules include:
1. liver damage. Symptoms may include:
● right upper abdominal pain
● dark urine
● yellow skin or eyes
● enlarged liver
● increased liver enzymes
2. changes in blood pressure and falls. Monitor your blood pressure before starting and throughout treatment. Duloxetine delayed-release capsules may:
• increase your blood pressure.
• decrease your blood pressure when standing and cause dizziness or fainting, mostly when first starting duloxetine delayed-release capsules or when increasing the dose.
• increase risk of falls, especially in elderly.
3. Serotonin Syndrome: This condition can be life-threatening and symptoms may include:
● agitation, hallucinations, coma or other changes in mental status
● coordination problems or muscle twitching (overactive reflexes)
● racing heartbeat, high or low blood pressure
● sweating or fever
● nausea, vomiting, or diarrhea
● muscle rigidity
4. abnormal bleeding: Duloxetine delayed-release capsules and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin*, Jantoven*), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.
5. severe skin reactions: Duloxetine delayed-release capsules may cause serious skin reactions that may require stopping its use. This may need to be treated in a hospital and may be life-threatening. Call your healthcare provider right away or get emergency help if you have skin blisters, peeling rash, sores in the mouth, hives or any other allergic reactions.
6. discontinuation symptoms: Do not stop duloxetine delayed-release capsules without first talking to your healthcare provider. Stopping duloxetine delayed-release capsules too quickly or changing from another antidepressant too quickly may result in serious symptoms including:
• feeling tired or problems sleeping
• electric shock-like sensations
• vomiting or nausea
7. manic episodes:
• greatly increased energy
• severe trouble sleeping
• racing thoughts
• reckless behavior
• unusually grand ideas
• excessive happiness or irritability
• talking more or faster than usual
8. 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.
9. seizures or convulsions
10. low salt (sodium) levels in the blood. Elderly people may be at greater risk for this.
Symptoms may include:
• weakness or feeling unsteady
• confusion, problems concentrating or thinking or memory problems
11. problems with urination. Symptoms may include:
The most common side effects of duloxetine delayed-release capsules include:
Common possible side effects in children and adolescents who take duloxetine delayed-release capsules include:
Side effects in adults may also occur in children and adolescents who take duloxetine delayed-release capsules. Children and adolescents should have height and weight monitored during treatment.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of duloxetine delayed-release capsules. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to 1-800-FDA-1088.
How should I store duloxetine delayed-release capsules?
Store duloxetine delayed-release capsules at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Dispense in a tight container.
Keep duloxetine delayed-release capsules and all medicines out of the reach of children.
General information about the safe and effective use of duloxetine delayed-release capsules.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use duloxetine delayed-release capsules for a condition for which it was not prescribed. Do not give duloxetine delayed-release capsules to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about duloxetine delayed-release capsules. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about duloxetine delayed-release capsules that is written for healthcare professionals.
Please address medical inquiries to, (MedicalAffairs@zydususa.com) Tel.: 1-877-993-8779.
What are the ingredients in duloxetine delayed-release capsules?
Active ingredient: duloxetine hydrochloride, USP
Inactive ingredients: FD&C blue # 1, gelatin, hypromellose, hypromellose phthalate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide and triethyl citrate. Sugar spheres contain corn starch and sucrose. Additionally each 20 mg capsule shell contains D&C yellow # 10 and FD&C yellow # 6, each 30 mg capsule shell contains D&C yellow # 10, FD&C red # 40 and FD&C yellow # 6 and each 60 mg capsule shell contains FD&C red # 40. Each capsule shell is printed with golden pharmaceutical ink which contains the following inactive ingredients: butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, shellac, strong ammonia solution and yellow iron oxide.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
*The brands listed are trademarks of their respective owners.
This product’s package insert may have been updated. For current package insert, please visit www.zydususa.com