What are the common side effects of duloxetine. How can you manage duloxetine side effects. When should you seek medical help for duloxetine side effects. What are the serious side effects of duloxetine to watch out for.

Understanding Duloxetine and Its Common Side Effects

Duloxetine, also known by the brand name Cymbalta, is a medication used to treat various conditions, including depression, anxiety, and certain types of chronic pain. Like all medications, it can cause side effects in some people. However, it’s important to note that most individuals either experience no side effects or only minor ones that tend to improve as the body adjusts to the medication.

Common side effects of duloxetine can affect up to 1 in 10 people. These include:

• Difficulty sleeping
• Headaches
• Dizziness
• Blurred vision
• Constipation
• Diarrhea
• Nausea or vomiting
• Dry mouth
• Excessive sweating
• Fatigue
• Decreased appetite and weight loss
• Sexual side effects

Managing Sleep Disturbances and Fatigue from Duloxetine

Difficulty sleeping and fatigue are common side effects that can significantly impact daily life. How can you manage these symptoms?

• Take duloxetine in the morning to minimize sleep disturbances
• Establish a consistent sleep schedule
• Avoid driving or operating machinery if experiencing excessive fatigue
• Limit alcohol consumption, as it can exacerbate tiredness
• If fatigue persists for more than two weeks, consult your doctor

Can changing the time of day you take duloxetine help with sleep issues? Many patients find that taking the medication in the morning rather than at night can improve sleep quality. However, always consult your healthcare provider before making changes to your medication regimen.

Coping with Gastrointestinal Side Effects of Duloxetine

Gastrointestinal issues such as nausea, vomiting, constipation, and diarrhea are common when starting duloxetine. Here are some strategies to manage these side effects:

For Nausea and Vomiting:

• Take duloxetine with food in the morning
• Stick to simple, bland meals
• Stay hydrated with small, frequent sips of water

For Constipation:

• Increase fiber intake through fruits, vegetables, and whole grains
• Drink plenty of water
• Engage in regular physical activity

For Diarrhea:

• Stay well-hydrated to prevent dehydration
• Avoid rich or spicy foods
• Consult a healthcare professional before using anti-diarrheal medications

Is it normal for gastrointestinal side effects to persist? While these side effects are common initially, they often improve as your body adjusts to the medication. If symptoms persist or worsen, it’s important to discuss this with your healthcare provider.

Addressing Duloxetine’s Impact on Sexual Function

Sexual side effects, such as decreased libido or difficulty achieving orgasm, can be particularly distressing for some patients. How can these issues be addressed?

• Open communication with your partner about the side effects
• Explore non-sexual forms of intimacy
• Discuss potential dosage adjustments or alternative medications with your doctor
• Consider seeing a sex therapist for additional strategies

Are sexual side effects permanent? In most cases, sexual side effects are not permanent and may improve over time. However, if they persist and significantly impact your quality of life, it’s crucial to discuss this with your healthcare provider. They may suggest alternative treatments or strategies to manage these effects.

Managing Weight Changes and Appetite Fluctuations

Duloxetine can affect appetite and weight in some individuals. How can you maintain a healthy weight while on this medication?

• Monitor your weight regularly
• Focus on nutrient-dense foods to ensure proper nutrition
• Eat smaller, more frequent meals if experiencing decreased appetite
• Engage in regular physical activity
• Consult a dietitian for personalized advice

Will weight changes stabilize over time? Many patients find that weight fluctuations tend to stabilize as their body adjusts to the medication. However, if significant weight loss or gain occurs, it’s important to discuss this with your healthcare provider.

Recognizing and Responding to Serious Side Effects of Duloxetine

While rare, serious side effects can occur with duloxetine use. It’s crucial to be aware of these potential reactions and seek immediate medical attention if they occur. Serious side effects may include:

• Hallucinations or aggressive behavior
• Extreme mood changes or restlessness
• Signs of low sodium levels (constant headaches, confusion, muscle cramps)
• Liver problems (yellowing of skin or eyes)
• Eye pain or persistent blurred vision
• Signs of internal bleeding
• Unexplained bruising or bleeding

When should you seek emergency medical care? Call emergency services immediately if you experience chest tightness, shortness of breath, or signs of a severe allergic reaction while taking duloxetine.

Interacting with Healthcare Providers About Duloxetine Side Effects

Open communication with your healthcare provider is crucial when managing duloxetine side effects. How can you effectively discuss your concerns?

• Keep a detailed log of side effects, including onset and duration
• Be honest about the impact of side effects on your daily life
• Ask about potential strategies to manage side effects
• Discuss the possibility of dosage adjustments or alternative treatments
• Report any new or worsening symptoms promptly

Should you stop taking duloxetine if you experience side effects? Never discontinue duloxetine abruptly without consulting your healthcare provider. Sudden cessation can lead to withdrawal symptoms and may worsen your underlying condition. Your doctor can guide you on how to safely adjust or discontinue the medication if necessary.

Balancing the Benefits and Risks of Duloxetine Treatment

While side effects can be challenging, it’s important to consider the potential benefits of duloxetine in managing your condition. How can you determine if the benefits outweigh the risks?

• Assess the improvement in your symptoms since starting duloxetine
• Consider the impact of side effects on your quality of life
• Discuss your concerns and treatment goals with your healthcare provider
• Explore potential alternatives or adjunct therapies
• Remember that many side effects may improve over time

Is duloxetine the right choice for everyone? The effectiveness and tolerability of duloxetine can vary from person to person. Your healthcare provider will consider your individual medical history, symptoms, and response to treatment when determining if duloxetine is the best option for you.

Understanding and managing the side effects of duloxetine is an important aspect of treatment. By staying informed, communicating openly with your healthcare provider, and implementing appropriate management strategies, you can optimize your treatment experience and potentially improve your overall quality of life. Remember, your healthcare team is there to support you throughout your treatment journey, so don’t hesitate to reach out with any concerns or questions about duloxetine or its side effects.

Side effects of duloxetine – NHS

Like all medicines, duloxetine can cause side effects in some people. But most people have no side effects or only minor ones.

Some of the common side effects of duloxetine will gradually improve as your body gets used to it.

Common side effects

These common side effects of duloxetine can happen in up to 1 in 10 people. There are things you can do to help cope with them:

Difficulty sleeping

Try taking duloxetine first thing in the morning.

Headaches

Make sure you rest and drink plenty of fluids. Try not to drink too much alcohol. Ask your pharmacist to recommend a painkiller. Talk to your doctor if the headaches last longer than a week or are severe.

Feeling dizzy

If duloxetine makes you feel dizzy when you stand up, try getting up very slowly or stay sitting down until you feel better. If you begin to feel dizzy, lie down so you do not faint, then sit until you feel better. Do not drive, cycle or use tools or machinery if you feel dizzy.

Blurred vision

Avoid driving, cycling or using tools or machinery while this is happening. If it lasts for more than a day or two, your doctor may need to change your treatment.

Constipation

Try to get more fibre into your diet, such as fresh fruit and vegetables and cereals, and drink plenty of water. Try to exercise more regularly, for example by going for a daily walk or run.

Diarrhoea

Drink lots of fluids, such as water or squash, to avoid dehydration. Signs of dehydration include peeing less than usual or having dark, strong-smelling pee.

Do not take any other medicines to treat diarrhoea without speaking to a pharmacist or doctor.

If you take contraceptive pills and you have severe diarrhoea for more than 24 hours, your contraception may not protect you from pregnancy. Check the pill packet for advice.

Feeling or being sick (nausea or vomiting)

Stick to simple meals and do not eat rich or spicy food. Make sure you take duloxetine in the morning with some food. Try small, frequent sips of water if you’re being sick to avoid dehydration. Signs of dehydration include peeing less than usual or having dark, strong-smelling pee.

If you take contraceptive pills and you’re being sick, your contraception may not protect you from pregnancy. Check the pill packet for advice.

Dry mouth

Chew sugar-free gum or suck sugar-free sweets.

Sweating

Try wearing loose clothing, use a strong anti-perspirant, and keep cool using a fan if possible. If this does not help, you may need to try a different type of antidepressant.

Tiredness

Do not drive, cycle or use tools or machinery if you’re feeling this way. Try taking duloxetine 1 hour before bedtime. Cut down the amount of alcohol you drink as alcohol will make you feel more tired.

If the tiredness does not go away after 2 weeks, ask your doctor for advice.

Less appetite than usual and weight loss

This side effect should get better as your body gets used to the medicine. It may also help to eat smaller meals more often and eat foods you really enjoy. If your appetite does not improve or you lose a lot of weight, ask your doctor for advice.

Feeling less interested in sex, or having problems keeping an erection or reaching orgasm

Speak to your doctor if you get this side effect and it does not go away.

Speak to a doctor or pharmacist if the advice on how to cope does not help and a side effect is still bothering you or does not go away.

Serious side effects

Serious side effects are rare and happen in less than 1 in 100 people.

Book an appointment with your doctor if you get changes in your periods, such as heavy bleeding, spotting or bleeding between periods.

Call a doctor or call 111 straight away if you have:

• hallucinations (seeing or hearing things that are not real), or you become aggressive and angry
• feelings of euphoria, excessive enthusiasm or excitement, or feeling restless so that you cannot sit or stand still
• constant headaches, long-lasting confusion or weakness, or frequent muscle cramps – these can be signs of low sodium levels in your blood
• yellowing of the whites of your eyes, or your skin although this may be less obvious on brown or black skin – these can be signs of a liver problem
• eye pain or blurred vision
• black or red poo or blood in your vomit – these can be signs of bleeding from your gut
• coughed up blood or have blood in your pee
• bleeding from your gums, or bruises that appear without a reason or get bigger

Immediate action required: Call 999 or go to A&E now if you get:

• tightness in your chest or shortness of breath
• any heavy bleeding that you cannot stop, such as cuts or nosebleeds that do not stop within 10 to 15 minutes
• painful erections that last longer than 2 hours – this may happen even when you’re not having sex
• thoughts about harming yourself or ending your life

Find your nearest A&E

Serious allergic reaction

In rare cases, it’s possible to have a serious allergic reaction (anaphylaxis) to duloxetine.

Immediate action required: Call 999 now if:

• your lips, mouth, throat or tongue suddenly become swollen
• you’re breathing very fast or struggling to breathe (you may become very wheezy or feel like you’re choking or gasping for air)
• your throat feels tight or you’re struggling to swallow
• your skin, tongue or lips turn blue, grey or pale (if you have black or brown skin, this may be easier to see on the palms of your hands or soles of your feet)
• you suddenly become very confused, drowsy or dizzy
• someone faints and cannot be woken up
• a child is limp, floppy or not responding like they normally do (their head may fall to the side, backwards or forwards, or they may find it difficult to lift their head or focus on your face)

You or the person who’s unwell may also have a rash that’s swollen, raised, itchy, blistered or peeling.

These can be signs of a serious allergic reaction and may need immediate treatment in hospital.

Other side effects

These are not all the side effects of duloxetine. For a full list, see the leaflet inside your medicines packet.

Information:

You can report any suspected side effect using the Yellow Card safety scheme.

Visit Yellow Card for further information.

Page last reviewed: 14 February 2022

Next review due: 14 February 2025

Cymbalta Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Warnings:

Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. It is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.

Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.

Warnings:

Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. It is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.

Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.

… Show More

Uses

Duloxetine is used to treat depression and anxiety. In addition, duloxetine is used to help relieve nerve pain (peripheral neuropathy) in people with diabetes or ongoing pain due to medical conditions such as arthritis, chronic back pain, or fibromyalgia (a condition that causes widespread pain).Duloxetine may improve your mood, sleep, appetite, and energy level, and decrease nervousness. It can also decrease pain due to certain medical conditions. Duloxetine is known as a serotonin-norepinephrine reuptake inhibitor (SNRI). This medication works by helping to restore the balance of certain natural substances (serotonin and norepinephrine) in the brain.

How to use Cymbalta

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using duloxetine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually 1 or 2 times a day with or without food. If you have nausea, it may help to take this drug with food. Swallow the capsule whole. Do not crush or chew the capsule or mix the contents with food or liquid. Doing so can release all of the drug at once, increasing the risk of side effects.

The dosage is based on your age, medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor’s instructions carefully. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

Keep taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Also, you may experience symptoms such as dizziness, confusion, mood swings, headache, tiredness, diarrhea, sleep changes, and brief feelings similar to electric shock. Your dose may need to be gradually decreased to reduce side effects. Report any new or worsening symptoms right away.

Tell your doctor if your condition lasts or gets worse.

Side Effects

See also Warning section.

Nausea, dry mouth, constipation, loss of appetite, tiredness, drowsiness, or increased sweating may occur. If any of these effects last or get worse, tell your doctor promptly.

Dizziness or lightheadedness may occur, especially when you first start or increase your dose of this drug. To reduce the risk of dizziness, lightheadedness, or falling, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: confusion, easy bleeding/bruising, decreased interest in sex, changes in sexual ability, muscle cramps/weakness, shaking (tremor), difficulty urinating, signs of liver problems (such as nausea that doesn’t stop, stomach/abdominal pain, vomiting, yellowing eyes/skin, dark urine).

Get medical help right away if you have any very serious side effects, including: black stools, vomit that looks like coffee grounds, seizure, eye pain/swelling/redness, widened pupils, vision changes (such as seeing rainbows around lights at night, blurred vision).

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, skin blisters, mouth sores.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking duloxetine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of psychiatric disorders (such as bipolar/manic-depressive disorder), personal or family history of suicide attempts, bleeding problems, personal or family history of glaucoma (angle-closure type), high blood pressure, kidney disease, liver disease, seizure disorder, stomach problems (such as slow emptying of the stomach), use/abuse of alcohol.

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

If you have diabetes, duloxetine may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially bleeding, dizziness, lightheadedness, or loss of coordination. Older adults may also be more likely to develop a type of salt imbalance (hyponatremia), especially if they are taking “water pills” (diuretics). Dizziness, lightheadedness, or loss of coordination can increase the risk of falling.

Children may be more sensitive to the side effects of this drug, especially loss of appetite and weight loss. Monitor weight and height in children who are taking this drug. See also Warning.

During pregnancy, this medication should be used only when clearly needed. When this medication is taken during the last 30 days of pregnancy, the mother may be at an increased risk of bleeding at birth. This medication may also harm an unborn baby. Babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop withdrawal symptoms such as feeding/breathing difficulties, seizures, muscle stiffness, or constant crying. If you notice any of these symptoms in your newborn, tell the doctor promptly.

Since untreated mental/mood problems (such as depression, anxiety) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss the benefits and risks of using this medication during pregnancy with your doctor.

This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Some products that may interact with this drug are: other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, “blood thinners” such as dabigatran/warfarin).

Other medications can affect the removal of duloxetine from your body, which may affect how duloxetine works. Examples include cimetidine, viloxazine, certain quinolone antibiotics (such as ciprofloxacin, enoxacin), among others.

This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include antiarrhythmic drugs (such as propafenone, flecainide, quinidine), antipsychotics (such as thioridazine), tricyclic antidepressants (such as desipramine, imipramine), among others.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and at least 5 days after treatment with this medication. Ask your doctor when to start or stop taking this medication.

The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/”ecstasy,” St. John’s wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, other SNRIs such as desvenlafaxine/venlafaxine), tryptophan, among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and opioid pain relievers (such as codeine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually 81-162 milligrams a day), you should continue taking it unless your doctor instructs you otherwise.

Does Cymbalta interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, fainting.

Do not share this medication with others.

Lab and/or medical tests (such as blood pressure, liver function) should be done while you are taking this medication. Keep all medical and lab appointments.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Images

Cymbalta 30 mg capsule,delayed release

Color: white,blueShape: oblongImprint: 30 mg LILLY 3240

This medicine is a white blue, oblong, capsule imprinted with “30 mg” and “LILLY 3240”.

Cymbalta 60 mg capsule,delayed release

Color: green,blueShape: oblongImprint: 60 mg LILLY 3237

This medicine is a white blue, oblong, capsule imprinted with “30 mg” and “LILLY 3240”.

Cymbalta 60 mg capsule,delayed release

Color: green,blueShape: oblongImprint: Lilly 3270 60mg

This medicine is a white blue, oblong, capsule imprinted with “30 mg” and “LILLY 3240”.

Cymbalta 20 mg capsule,delayed release

Color: greenShape: oblongImprint: 20 mg LILLY 3235

This medicine is a white blue, oblong, capsule imprinted with “30 mg” and “LILLY 3240”.

Next

Save up to 80% on your prescriptions.

Available coupons

Save up to 80% on your prescription with WebMDRx

Drug Survey

Are you currently using Cymbalta?

This survey is being conducted by the WebMD marketing sciences department.

Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Simbalta: instruction, price, analogues | hard capsules, enteric Lilly S.A.

• Pharmacological properties
• Simbalt’s testimony
• Application of Cymbalta
• Contraindications
• Side effects
• Special instructions
• Interactions
• Overdose
• Storage conditions
• Diagnosis
• Recommended alternatives
• Trade names

duloxetine ((S)-(+)-N-Methyl-g-(1-naphthalenyloxy)-2-thiophenepropanamine) is a serotonin and norepinephrine reuptake inhibitor. It slightly inhibits dopamine uptake, has no significant affinity for histamine and dopamine, cholinergic and adrenergic receptors. The mechanism of the therapeutic action of duloxetine in depression is due to inhibition of serotonin and norepinephrine reuptake and, as a result, increased serotonergic and noradrenergic neurotransmission in the CNS. Duloxetine also normalizes pain threshold in some experimental models of neuropathic and inflammatory pain and reduces pain in a model of chronic pain. The analgesic effect of duloxetine is probably due to a slowdown in the transmission of nociceptive impulses in the CNS.

Duloxetine is well absorbed after oral administration. The maximum plasma concentration is reached 6 hours after taking the drug. Simultaneous ingestion of food slows down absorption, while the period of reaching the maximum concentration in the blood is lengthened from 6 to 10 hours, and absorption decreases (approximately 11%).

Duloxetine is highly bound to plasma proteins (greater than 90%).

Duloxetine is extensively metabolized in the body, metabolites are excreted primarily in the urine. Isoenzymes CYP 2D6 and CYP 1A2 catalyze the formation of the two main metabolites of duloxetine (glucuronide coupled to 4-hydroxy duloxetine, sulfate coupled to 5-hydroxy, methoxy duloxetine). The resulting metabolites do not have pharmacological activity.

The half-life of duloxetine is 12 hours. The mean plasma clearance of duloxetine is 101 l/h.

In patients with end-stage renal disease who are constantly on dialysis, there is a doubling of the concentration of duloxetine in the blood plasma and an increase in AUC compared with healthy individuals. Therefore, in patients with chronic renal failure, the drug is prescribed at a lower initial dose.

depression; diabetic neuropathy.

for depression and diabetic neuropathy is prescribed orally at a dose of 60 mg 1 time per day daily, regardless of food intake. Some patients may be recommended to prescribe the drug at a higher dose (up to a maximum of -120 mg / day in 2 divided doses). The possibility of prescribing at doses exceeding 120 mg / day has not been studied.

Initial dosage for patients with end-stage renal disease (creatinine clearance <30 mL/min) is 30 mg once daily.

Patients with cirrhosis of the liver are prescribed at a lower initial dose or with longer intervals between doses.

No dose adjustment is required in elderly or elderly patients. Duloxetine has not been studied in patients under 18 years of age.

hypersensitivity to duloxetine, concomitant therapy with MAO inhibitors.

during clinical trials, side effects such as constipation, nausea, dry mouth, dizziness, fatigue, insomnia and headache (≥10%) were observed. Less commonly (with a frequency of <10%, but ≥1%), tachycardia, dyspepsia, vomiting, decreased appetite, drowsiness, tremor, lethargy, sweating, feeling hot, yawning were observed. On the part of the reproductive system, ejaculation and erection disorders were observed (with a frequency of <10%, but ≥1%), decreased libido and anorgasmia. Rarely (<1%, but ≥0.1%), gastroenteritis, stomatitis, increased blood pressure, weight gain, muscle tension, taste and visual disturbances, agitation, urinary retention were observed.

Treatment with duloxetine in placebo-controlled clinical trials was associated with non-significant increases in ALT, AsAT, and CPK compared to placebo.

In clinical trials of duloxetine for the treatment of diabetic neuropathy, the mean duration of diabetes mellitus was approximately 11 years, mean initial fasting serum glucose was up to 163 mg/dl, and mean initial glycated hemoglobin was 7.80%. These studies noted a slight increase in initial fasting blood glucose after 12 weeks in patients treated with duloxetine, compared with placebo, at the usual regimen for 52 weeks. There were no changes in the rate of glycated hemoglobin, body weight of patients, lipid concentrations (Cholesterol, LDL, HDL, TG) or any side effects associated with diabetes mellitus.

The following side effects have been reported from post-marketing studies:

on the part of the organ of vision: very rarely (<0.01%) - glaucoma;

from the hepatobiliary system: very rarely (<0.01%) - hepatitis, jaundice;

from the immune system: very rarely (<0.01%) - anaphylactic reactions;

on the part of laboratory parameters: very rarely (<0. 01%) – increased activity of ALT, AST, alkaline phosphatase, bilirubin levels in the blood;

from the side of metabolism: very rarely (<0.01%) - hyponatremia;

on the part of the skin: rarely (0.01-0.1%) – rash; very rarely (<0.01%) - angioedema, Stevens-Johnson syndrome, urticaria;

from the side of the cardiovascular system: very rarely (<0.01%) - orthostatic hypotension and syncope (especially at the beginning of treatment).

patients at high risk of suicide during the treatment period should be under strict observation, since the possibility of suicidal attempts is not excluded before the onset of a pronounced remission.

Duloxetine hydrochloride has not been studied in patients under 18 years of age and should therefore not be used in this age group.

As with other CNS-active drugs, duloxetine should be used with caution in patients with a history of mania.

As with other CNS-active drugs, duloxetine should be used with caution in patients with a history of seizures.

Mydriasis has been reported in association with duloxetine, so duloxetine should be used with caution in patients with elevated intraocular pressure or at risk of developing acute narrow-angle glaucoma.

Increased plasma concentrations of duloxetine have been reported in patients with severe renal insufficiency (creatinine clearance <30 ml/min) or severe hepatic insufficiency. Such patients are advised to prescribe the drug at a lower initial dose.

In some patients, duloxetine leads to an increase in blood pressure. In patients with hypertension and / or other diseases of the cardiovascular system, monitoring of blood pressure is recommended.

In clinical studies, there was an increase in the activity of liver enzymes in the blood. In most patients treated with duloxetine, this increase was transient and resolved upon discontinuation of duloxetine treatment. A significant increase in liver enzyme activity (greater than 10 times normal) or liver damage with cholestasis, or a significant increase in enzyme activity in combination with liver damage, has rarely occurred, in some cases it has been associated with alcohol abuse.

Duloxetine was not mutagenic in experiments in vitro and in vivo .

In experiments, duloxetine at a dose of 45 mg/kg/day did not affect the reproductive function of male rats. In female rats, the use of duloxetine at a dose of 45 mg / kg / day was accompanied by such manifestations of reproductive toxicity as menstrual irregularities, a decrease in the birth rate index, survival rate, and slow growth of pups.

Adequate and well-controlled studies of the effect of the drug in pregnant women have not been conducted, so the use of the drug during pregnancy is not recommended.

Duloxetine is excreted in breast milk. The approximate daily dose in an infant is 0.14% of the dose for a nursing woman (in mg / kg). The safety of duloxetine use in a nursing infant has not been established, so breast-feeding while taking duloxetine is not recommended.

During the period of treatment with the drug, patients should refrain from potentially hazardous activities that require increased attention and speed of psychomotor reactions.

duloxetine should not be given concomitantly with MAO inhibitors or within at least 14 days after stopping treatment with MAO inhibitors. Due to the half-life of duloxetine, MAO inhibitors should also not be administered for at least 5 days after discontinuation of duloxetine treatment.

In clinical studies with the simultaneous administration of theophylline, a CYP1A2 substrate, with duloxetine at a dose of 60 mg 2 times a day, no significant changes in their pharmacokinetics were noted. These results indicate that duloxetine is unlikely to have a clinically significant effect on the metabolism of CYP1A2 substrates.

Since CYP1A2 is involved in the metabolism of duloxetine, concomitant use of duloxetine with active inhibitors of CYP1A2 may result in increased plasma concentrations of duloxetine. Fluvoxamine (at a dose of 100 mg 1 time per day), being an active inhibitor of CYP1A2, reduces the clearance of duloxetine from blood plasma by approximately 77%. In this regard, when prescribing duloxetine with CYP1A2 inhibitors (some quinolone antibacterial agents), it is advisable to prescribe duloxetine at a lower dose.

Duloxetine is a moderate inhibitor of CYP2D6. When prescribing duloxetine at a dose of 60 mg 2 times a day with a single dose of desipramine, which is a substrate of CYP2D6, the AUC of desipramine increases 3 times. Co-administration of duloxetine (at a dose of 40 mg 2 times a day) increases the stationary AUC of tolterodine (2 mg 2 times a day) by 71%, but does not affect the pharmacokinetics of the 5-hydroxyl metabolite. In this regard, when prescribing duloxetine with CYP2D6 inhibitors, which have a narrow therapeutic index, care must be taken.

Since CYP2D6 is involved in the metabolism of duloxetine, concomitant use of duloxetine with active inhibitors of CYP2D6 can lead to an increase in the concentration of duloxetine in the blood. Paroxetine (at a dose of 20 mg 1 time per day) reduces the clearance of duloxetine from blood plasma by approximately 37%. In this regard, caution should be exercised when prescribing duloxetine with CYP2D6 inhibitors.

When prescribing duloxetine in combination with other drugs that affect the central nervous system, especially with a similar mechanism of action, care should be taken.

Duloxetine binds to plasma proteins (>90%), so the administration of duloxetine to a patient who is taking other drugs that are highly bound to plasma proteins may lead to an increase in the free concentration of any of these drugs.

Clinical data on duloxetine overdose are limited. No cases of fatal overdose of duloxetine have been reported in pre-marketing clinical trials. There have been cases of overdose of the drug (up to 1400 mg), including in combination with other drugs, but they did not lead to death.

In animal experiments, the main manifestations of toxicity in case of overdose were noted from the side of the central nervous system and gastrointestinal tract. These included symptoms such as tremor, clonic convulsions, ataxia, vomiting, and anorexia.

No specific antidote known. Immediately after an overdose, gastric lavage and the appointment of activated charcoal are indicated. The airway should be secured. It is recommended to monitor the main vital signs, primarily cardiac activity, if necessary, symptomatic and supportive therapy. Duloxetine has a large volume of distribution, and therefore forced diuresis, hemoperfusion and exchange perfusion are ineffective in overdose.

at temperatures up to 30 °C in original packaging.

Cymbalta :: Instructions :: Price :: Description of the drug

Other ingredients, including hypromelose, sucrose, spherical sugar, ammonium hydroxide, talc, triethyl citrate, hypromelose acetate succinate, colors, titanium dioxide, sodium lauryl sulfate, gelatin.

1 capsule of Cymbalta 60 contains:
Duloxetine hydrochloride (converted to duloxetine) – 30 mg;
Other ingredients, including hypromelose, sucrose, spherical sugar, ammonium hydroxide, talc, triethyl citrate, hypromelose acetate succinate, colors, titanium dioxide, sodium lauryl sulfate, gelatin.

Simbalta is a drug with an antidepressant effect. Cymbalta contains duloxetine, a compound that is a combined norepinephrine and serotonin reuptake inhibitor.

Duloxetine slightly inhibits dopamine uptake, has practically no affinity for histamine, cholinergic, dopamine and adrenergic receptors. The effectiveness of the drug in the treatment of depression is due to the inhibition of the reuptake of norepinephrine and serotonin, resulting in increased noradrenergic and serotonergic neurotransmission in the central nervous system.
Cymbalta also has some analgesic effect, which, theoretically, is due to a decrease in the rate of transmission of pain impulses in the central nervous system.

After oral administration, duloxetine is well absorbed (with a time to peak serum concentrations of 6 hours). Food increases the time to reach peak concentrations (by 4 hours compared to fasting), and also reduces the plasma level of the drug (by 11%).
More than 90% of duloxetine in serum is bound.
The metabolism of duloxetine takes place with the participation of CYP1 A2 and CYP2 D6, the derivatives do not have therapeutic activity.
The half-life of the active ingredient is 12 hours with an average clearance of about 101 l / h.
In end-stage renal failure, duloxetine levels and exposures are doubled (compared to those in volunteers with normal kidney function).

Cymbalta is used to treat major depressive disorder and generalized anxiety disorder.
Cymbalta is also used in the treatment of peripheral diabetic neuropathy (with severe pain).

Cymbalta is taken orally, regardless of food, with the necessary amount of liquid. During administration, damage to the integrity of the capsule shell must be avoided.

The dosage of the drug is determined depending on the severity and nature of the disease:
Patients with major depressive disorder are prescribed 1 capsule of Cymbalt 60 per day. Some patients may require a larger dose, in which case 1 capsule of Simbalt 60 is prescribed twice a day.
The maximum dose recommended for patients is 120 mg duloxetine per day. The use of doses exceeding the maximum has not been studied.

Patients with diabetic neuropathic peripheral pain are recommended to take 1 capsule of Cymbalt 60 per day at the beginning of therapy. In some cases, the dose can be increased to 1 capsule of Simbalt 60 twice a day (under medical supervision).
The effect of the drug Simbalta develops over 2 months of therapy.
The maximum dose of duloxetine is 120 mg per day.

Patients with generalized anxiety disorders are usually recommended to take 1 capsule of Cymbalt 30 per day at the beginning of therapy. For patients in whom the effect of therapy is not sufficiently pronounced, the dose can be increased to 1 capsule of Simbalt 60 per day. Also, if necessary, the possibility of prescribing 90 or 120 mg of duloxetine per day can be considered.
The effect of the drug develops within 2-4 weeks after therapy has been started.

Withdrawal of Cymbalta should be carried out gradually, over a period of at least 2 weeks (with abrupt discontinuation of therapy, patients may develop a withdrawal syndrome).
Dosage adjustment of duloxetine is not required in mild to moderate renal impairment.
Do not use duloxetine in patients with end-stage renal disease.
Do not prescribe duloxetine to persons with hepatobiliary disease.

Patients treated with duloxetine may experience the following adverse effects:
Nervous system: agitation, sleep disturbances, anxiety, abnormal orgasms, visions, bruxism, disorientation, suicidal thoughts, apathy, aggression, hallucinations, mania. In addition, tremors, paresthesias, impaired attention and memory, taste changes, dyskinesia, lethargy, seizures, serotonin syndrome and extrapyramidal disorders may occur.
Sense organs: visual disturbances, mydriasis, dry eyes, glaucoma, pain and ringing in the ears.
Heart and blood vessels: tachycardia, atrial fibrillation, supraventricular arrhythmia, palpitations, hot flashes, loss of consciousness, as well as orthostatic hypotension, arterial pressure lability, cold extremities, hypertensive crisis.
Respiratory system: epistaxis, sore throat, yawning, tightness in the throat.
Digestive system: hyperglycemia, anorexia, stool disorders, vomiting, dyspepsia, abdominal pain, increased gas formation, bleeding of the gastrointestinal system, belching, gastritis, gastroenteritis, bad breath, stomatitis, blood in the stool.
Liver: acute liver injury, hepatitis, elevated liver enzymes, liver failure, jaundice.
Urinary system: urinary retention, dysuria, polyuria, nocturia, slow urine flow, change in urine odor.
Reproductive system: menstrual disorders, erectile dysfunction, delayed ejaculation, uterine bleeding, galactorrhea, signs of menopause, hyperprolactinemia.
Allergic reactions: rash, sweating, angioedema, contact dermatitis, urticaria, photosensitivity, Stevens-Johnson syndrome, anaphylactic shock.
Others: laryngitis, hypothyroidism, antidiuretic hormone deficiency, hyponatremia, increased risk of bruising, bone and muscle pain, muscle spasm and twitching, lockjaw.

Chest pain, tingling, heat, thirst, weakness and gait disturbance may also develop.
Some patients have experienced weight lability, elevated cholesterol and creatinine phosphokinase levels during therapy.
Withdrawal of duloxetine (in case of abrupt discontinuation) may result in patients developing vomiting, nausea, headache and dizziness, as well as hyperhidrosis, irritability, stool disturbances, tremors, and sensory and sleep disturbances.

Cymbalta is not used in the treatment of patients who cannot tolerate the active or auxiliary components of the capsules.
Contraindications to the use of the drug Cymbalta are also:
– Unstable hypertension (taking into account the risk of a hypertensive crisis).
– Impaired kidney function (with filtration rates below 30 ml / min).
– Pathology of the liver.
The use of duloxetine is strictly contraindicated in patients receiving therapy with irreversible non-selective MAOIs (duloxetine is also prohibited for 2 weeks after completion of therapy with such drugs, therapy with monoamine oxidase inhibitors can be started no earlier than 5 days after duloxetine is completed).
In addition, duloxetine is contraindicated during therapy with fluvoxamine, enoxacin and ciprofloxacin (given the significant effect of these drugs on CYP1 A2).
Cymbalta is not used in pediatrics.

Caution should be exercised when prescribing duloxetine to suicidal patients (such patients should be monitored closely to prevent suicide attempts early in therapy).
In addition, the drug Cymbalta is prescribed with caution in:
– Epileptic seizures, bipolar disorders and mania (including history).
– Increased intraocular pressure and the danger of acute narrow-angle glaucoma.
– Arterial hypertension, heart pathologies and heart rhythm disturbances.
– Increased risk of hyponatremia.
– Taking drugs that have a hepatotoxic effect.
Potentially hazardous machinery should not be administered during duloxetine therapy.

Duloxetine has not been studied in pregnant women and therefore the use of Cymbalta during pregnancy is not recommended.
It is likely that when taking Cymbalta, as well as other serotonergic drugs, during pregnancy, neonates may develop withdrawal symptoms, including tremor, hypotension, increased neuro-reflex excitability, respiratory, swallowing and sucking disorders. In some cases, epileptic seizures may also occur in newborns whose mothers have received serotonergic drugs.

If you plan to become pregnant or become pregnant while taking duloxetine, consult your doctor.

The dose of duloxetine excreted in breast milk is about 0.14% of the mother’s dose. Cymbalta is not recommended for pregnant women.

Drugs metabolized by CYP1 A2 do not interfere with the efficacy of duloxetine, but strong inhibitors of CYP1 A2 may increase serum levels of duloxetine. Co-administration of duloxetine with CYP1 A2 inhibitors is not recommended.
Duloxetine moderately inhibits CYP2 D6. When prescribing drugs that are metabolized with the participation of CYP2 D6, care should be taken and the possibility of increasing their plasma levels should be taken into account.

Duloxetine should be used with caution with sedatives and other CNS depressants, including tricyclic antidepressants, peptidine, tryptophan and tramadol.
With drugs that inhibit MAO (including St. John’s wort), duloxetine is strictly prohibited from prescribing (including within 4 weeks after completion of therapy with MAO inhibitors).
Cymbalta may increase the risk of bleeding during therapy with antithrombotic and anticoagulant agents.

Data on duloxetine intoxication are limited, and there are reports of a few cases of duloxetine in a single dose up to 1400 mg (including cases of concomitant use with other drugs) with a favorable outcome. With an overdose of the drug Simbalta in patients, there is a risk of developing epileptic seizures, vomiting, serotonin syndrome, tachycardia and drowsiness.

No specific antidote for duloxetine is known. With the development of serotonin syndrome, specific therapy is recommended. In case of overdose, the airway patency, the patient’s body temperature, and heart function should be monitored.
Immediately after an overdose of duloxetine has been taken, gastric lavage may be effective. Enterosorbents reduce the absorption of duloxetine and reduce the risk of overdose when taking excessive doses.
Conducting forced diuresis and hemodialysis with an overdose of duloxetine is ineffective.

Cymbalta enteric capsules in blister packs. In a pack of cardboard 14 (1×14) or 28 (2×14) capsules.

Cymbalta should be kept out of the reach of children.
No specific temperature required.
Shelf life of Simbalta is 3 years.

duloxetine

N06A X21

The instruction was compiled by a team of authors and editors of the Piluli website. The list of authors of the drug reference book is presented on the site editorial page: Site editors.

Links to used sources of information.

Attention!
The description of the drug “ Simbalta ” on this page is a simplified and supplemented version of the official instructions for use.