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Cymbalta (Generic Duloxetine)

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WARNING

A tiny number of youngsters, teenagers, and young adults (up to 24 years old) who took mood-elevating antidepressants like duloxetine during clinical research developed suicide thoughts (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental diseases may have a higher risk of committing suicide than those who do not take these medications. However, experts disagree on how significant this risk is and how much it has to be taken into account when determining whether or not a kid or adolescent should take an antidepressant. Duloxetine is typically not recommended for use in people under the age of 18, however in some circumstances, a doctor may determine that it is the best treatment option for a child’s illness.

Even if you are an adult above the age of 24, you should be aware that taking duloxetine or other antidepressants may cause your mental health to change in unexpected ways. Even if you don’t have a mental disorder and are taking duloxetine to treat anything else, these changes could still happen. Suicidal thoughts may come to mind, especially at the start of treatment and whenever your dose is changed. If you have any of the following symptoms, you should call your doctor right once. This goes for you, your family, or your carer. A new or worsening depression, thoughts of self-harm or suicide, plans or attempts to carry them out, excessive worry, agitation, panic attacks, trouble falling or staying asleep, hostile or aggressive behaviour, irritability, acting without thinking, extreme restlessness, frenzied abnormal excitement, or any other unusual changes in behaviour should be reported. Make sure your family or carer keeps an eye on you every day and is aware of any symptoms that might be dangerous so they can call the doctor if you are unable to call for help yourself.

While you are taking duloxetine, your doctor will want to visit you frequently, especially at the start of your treatment. Be sure to show up for all of your doctor’s appointment times.

When you start your duloxetine treatment, your doctor or pharmacist will give you the patient information sheet (Medication Guide) from the manufacturer. If you have any questions, carefully read the material and contact your doctor or pharmacist. The FDA website also offers the Medication Guide.

No of your age, you, your parent, or your carer should discuss the advantages and disadvantages of treating your disease with an antidepressant or with alternative treatments with your doctor before starting an antidepressant. The dangers and advantages of not treating your ailment should also be discussed. You should be aware that your chance of committing suicide is significantly increased if you suffer from depression or any mental disorder. This risk is increased if you or anybody in your family currently has, or previously had, depression, mania (a frenetic, overly exuberant mood), bipolar disorder, or has had suicidal thoughts or attempts. Discuss your ailment, symptoms, and personal and family medical history with your doctor. The best course of therapy for you will be decided by you and your doctor.

Why is this medication prescribed?

Adults with depression and children seven years of age and older who have generalised anxiety disorder (GAD; excessive worry and tension that interferes with daily living and lasts for six months or more) are both treated with duloxetine. Duloxetine is also used to treat adults with fibromyalgia, a chronic condition that can cause pain, muscle stiffness and tenderness, fatigue, and problems falling or staying asleep, as well as children 13 years of age and older who have pain and tingling brought on by diabetic neuropathy (nerve damage that can develop in people with diabetes). It is also used to treat chronic bone or muscle pain in individuals with osteoarthritis (joint pain or stiffness that may get worse with time), lower back pain, or both. A group of drugs known as selective serotonin and norepinephrine reuptake inhibitors includes duloxetine (SNRIs). It functions by raising levels of serotonin and norepinephrine, two naturally occurring chemicals in the brain that support mental equilibrium and slow the transmission of pain impulses.

How should this medicine be used?

Duloxetine is available as a delayed-release capsule that must be swallowed. This prevents the medication from being broken down by stomach acids. Duloxetine is often used once or twice day, with or without food, to treat depression. Duloxetine is often given once day with or without food to treat generalised anxiety disorder, the discomfort of diabetic neuropathy, fibromyalgia, or persistent bone or muscular pain. Every day, take duloxetine around the same time(s). Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Administer duloxetine as prescribed. Never take it in larger or less amounts, more frequently, or for a longer period of time than your doctor has instructed.

Do not break, chew, or crush the delayed-release capsules; instead, swallow them whole. The contents of the delayed-release capsules should not be mixed with beverages or sprinkled on food.

After a week, your doctor may raise the medicine dose that you are taking.

Duloxetine may help you manage your symptoms, but it won’t make you better. Before you experience all of duloxetine’s benefits, it could take 1 to 4 weeks or longer. Even if you feel good, keep taking the duloxetine. Never stop taking duloxetine without consulting your doctor first. Most likely, your dosage will be gradually reduced by your doctor. Duloxetine withdrawal symptoms include nausea, vomiting, diarrhoea, anxiety, fatigue, headache, dizziness, and sweating. Other symptoms include pain, burning, numbness, or tingling in the hands or feet, irritability, difficulty going asleep or staying asleep, and nightmares. If you suffer any of these side effects after your duloxetine dosage is lowered, let your doctor know.

Other uses for this medicine

In addition, duloxetine is occasionally prescribed to women who experience stress incontinence, which is the loss of urine while laughing, sneezing, coughing, or exercising. Discuss using this medication to treat your condition with your doctor.

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking duloxetine,

  • If you have any allergies, including to drugs, foods, or any of the substances in duloxetine delayed-release capsules, notify your doctor right away. For a list of the ingredients, ask your doctor or pharmacist.
  • Inform your physician if you’re using thioridazine, an MAO inhibitor (such as isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Emsam, Zelapar), or tranylcypromine (Parnate), or if you’ve just discontinued taking an MAO inhibitor. Most likely, your doctor will advise against using duloxetine. You should wait at least 5 days after stopping duloxetine before starting an MAO inhibitor.
  • Inform your doctor and pharmacist about any additional prescription drugs, over-the-counter remedies, and vitamins you are now taking or intend to use. Incorporate any of the following: amphetamines such as methamphetamine (Desoxyn), dextroamphetamine (Dexedrine), and amphetamine (in Adderall, among others); warfarin (Coumadin, Jantoven), an anticoagulant (also known as “blood thinner”); antidepressants such amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), and trimipramine (Surmontil); Buspirone, cimetidine (Tagamet), ciprofloxacin (Cipro), diuretics (‘water pills’), fentanyl (Abstral, Actiq, Fentora, Onsolis, among others), nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), and flecainide (Tambocor); almotriptan, eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, Onzetra, Tosmyra, in Treximet), and zolmitriptan (Zomig) are drugs for migraine headaches; medications for anxiety, high blood pressure, mental disease, pain, and nausea; proton pump inhibitors, including lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), and rabeprazole (Aciphex); sedatives; some selective serotonin reuptake inhibitors (SSRIs), including fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), and paroxetine (Paxil); sleeping pills. Duloxetine may interact with a variety of different drugs, so be sure to let your doctor know about everything you’re taking, even anything not on this list. Your doctor might need to adjust your medication doses or keep a close eye out for any negative side effects.
  • Inform your doctor about any dietary supplements and herbal remedies you are using, especially if they contain tryptophan or St. John’s wort.
  • Inform your doctor if you regularly consume excessive amounts of alcohol, have ever used street drugs, or have ever taken prescription medications in excess. Tell your doctor if you have glaucoma, high blood pressure, seizures, coronary artery disease, bleeding issues, slow stomach emptying, heart, liver, or kidney disease, as well as any of the following: low sodium levels in your blood, glaucoma (increased eye pressure that may result in blindness), recent heart attack, high blood pressure, or any of the following: seizures, coronary artery disease, bleeding issues, bleeding problems. If you have diabetes, be careful to discuss the severity of your illness with your doctor so they can determine whether duloxetine is a good fit for you.
  • Inform your doctor if you are expecting, particularly if you are in the last few months of your pregnancy, if you intend to get pregnant, or if you are breastfeeding. Call your doctor if you become pregnant while taking duloxetine. If duloxetine is taken in the final months of pregnancy, it may have negative effects on babies after birth.
  • You should let your doctor or dentist know if you are taking duloxetine if you are having surgery, including dental surgery.
  • Duloxetine may cause you to feel sleepy, lightheaded, or impact your judgement, thinking, or coordination. Prior to understanding how this drug affects you, avoid using machinery or driving a car.
  • Inquire with your doctor if drinking alcohol is okay for you to do while taking duloxetine. Duloxetine’s potentially harmful side effects can be made more likely by alcohol.
  • You should be aware that if you stand up too rapidly from a laying position while taking duloxetine, you could have dizziness, lightheadedness, and fainting. When you initially start taking duloxetine or when the amount is increased, this happens more frequently. Get out of bed gradually, resting your feet on the floor for a few minutes before standing up, to avoid this issue.
  • You need to be aware that duloxetine might raise blood pressure. Before commencing treatment and on a frequent basis going forward, get your blood pressure tested.
  • Duloxetine may cause angle-closure glaucoma, as you should be aware (a condition where the fluid is suddenly blocked and unable to flow out of the eye causing a quick, severe increase in eye pressure which may lead to a loss of vision). Ask your doctor if you should get your eyes checked before beginning this medicine. Call your doctor or get emergency medical attention right away if you are experiencing nausea, eye pain, changes in your vision, such as seeing coloured rings around lights, or swelling or redness in or around your eyes.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Side effects from duloxetine are possible. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Nausea
  • Vomiting
  • Constipation
  • Diarrhea
  • Changes in weight
  • Heartburn
  • Abdominal pain
  • Less appetite
  • Mouth ache
  • More frequent urination
  • Sweating or nocturnal sweats
  • Dizziness
  • Headache
  • Weight changes
  • Tiredness
  • Drowsiness
  • Cramping or aching muscles
  • Male sexual dysfunction includes reduced sex desire, difficulty getting or maintaining an erection, and delayed or nonexistent ejaculation
  • Issues with sex; lack of orgasm, delayed orgasm, or diminished sex drive in women
  • Body part shaking that is uncontrollable

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you suffer any of the following adverse effects or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections:

  • Significant bruising or bleeding
  • Stomach ache in the top right corner
  • Abdomen-related edoema
  • Itching
  • Eyes or skin that have a yellow tint
  • Urine with a dark colour
  • Reduced appetite
  • Excessive fatigue or sluggishness
  • Confusion
  • Shaky gait that could lead to falling
  • Flu-like signs
  • Significant muscle stiffness or twitching, lack of coordination, fever, sweating, confusion, anxiety, nausea, vomiting, or diarrhoea
  • Seizures
  • Hallucinations (seeing objects or hearing voices that do not exist)
  • Fever
  • Flaking or blistering skin
  • Rash
  • Hives
  • Breathing or swallowing challenges
  • Edoema of the hands, feet, ankles, lower legs, cheeks, neck, tongue, lips, and eyes
  • Hoarseness
  • Having trouble urinating

Children who use duloxetine may experience decreased appetite and weight loss. The physician for your child will keep a close eye on their development. If you are worried about your child’s weight gain or growth while taking this medicine, talk to your child’s doctor. The hazards of providing your child duloxetine should be discussed with your child’s doctor.

Other negative effects of duloxetine could exist. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Store it away from excessive heat and moisture at room temperature (not in the bathroom).

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs could include the following:

  • Agitation
  • Hallucinating (seeing things or hearing voices that do not exist)
  • Rapid heart rate
  • Fever
  • Inability to coordinate
  • Nausea
  • Vomiting
  • Diarrhea
  • Drowsiness
  • Seizures
  • Dizziness
  • Lightheadedness
  • Fainting
  • Unresponsiveness

What other information should I know?

Keep all of your doctor’s appointments.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Cymbalta®
  • Drizalma Sprinkle®
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