What are the primary uses of Cymbalta. How does duloxetine work in the body. What are the recommended dosages for different conditions. What potential side effects and interactions should patients be aware of. How has Cymbalta’s market presence evolved over time. What are the cost considerations for Cymbalta and its generic alternatives.

Understanding Cymbalta: An Overview of Duloxetine

Cymbalta, with its active ingredient duloxetine, is a widely prescribed antidepressant that has gained prominence in treating various mood and pain disorders. As a serotonin and norepinephrine reuptake inhibitor (SNRI), it offers a unique approach to managing mental health and chronic pain conditions. This comprehensive guide delves into the multifaceted aspects of Cymbalta, from its mechanisms of action to its diverse applications in modern medicine.

What is Cymbalta and How Does It Work?

Cymbalta functions by inhibiting the reabsorption of two crucial neurotransmitters: serotonin and norepinephrine. This mechanism increases the levels of these neurotransmitters in the brain, which is believed to alleviate symptoms of depression and anxiety. The drug’s ability to modulate pain perception also makes it effective in treating various chronic pain conditions.

The Therapeutic Spectrum of Cymbalta

Initially approved by the FDA in 2004 for major depressive disorder and generalized anxiety disorder, Cymbalta’s therapeutic scope has expanded significantly over the years. Its efficacy in managing pain has led to additional approvals for conditions such as:

• Diabetic peripheral neuropathic pain
• Fibromyalgia
• Chronic musculoskeletal pain

This versatility has positioned Cymbalta as a valuable treatment option for patients experiencing comorbid mood and pain disorders.

Exploring Off-Label Uses

While not FDA-approved, some healthcare providers may prescribe Cymbalta for off-label uses. These might include stress urinary incontinence, a condition for which Eli Lilly initially sought approval but later withdrew its application. It’s crucial for patients to discuss any off-label use with their healthcare provider to weigh potential benefits against risks.

Dosage Guidelines and Administration

Cymbalta is available in delayed-release capsules of 20 mg, 30 mg, and 60 mg strengths. The dosage varies depending on the condition being treated and the patient’s age and overall health status.

Recommended Dosages for Various Conditions

1. Major Depressive Disorder: 40-60 mg daily, with a maximum of 120 mg/day
2. Generalized Anxiety Disorder: 60 mg daily, with a maximum of 120 mg/day
3. Diabetic Peripheral Neuropathic Pain: 60 mg daily
4. Fibromyalgia: Starting at 30 mg daily, with a maximum of 60 mg/day
5. Chronic Musculoskeletal Pain: Starting at 30 mg daily, with a maximum of 60 mg/day

Patients should adhere strictly to their prescribed dosage and consult their healthcare provider before making any adjustments. Cymbalta capsules should be swallowed whole, with or without food, and patients should avoid crushing or chewing them to maintain the delayed-release properties.

Side Effects and Safety Considerations

As with any medication, Cymbalta can cause side effects. Common adverse reactions include:

• Nausea
• Dry mouth
• Constipation
• Fatigue
• Decreased appetite
• Increased sweating

More serious side effects, though less common, can include liver damage, serotonin syndrome, and increased risk of suicidal thoughts, particularly in young adults and adolescents. Patients should be monitored closely, especially during the initial stages of treatment or when dosages are adjusted.

Withdrawal Symptoms and Discontinuation

Abrupt discontinuation of Cymbalta can lead to withdrawal symptoms, which may include dizziness, nausea, headaches, and paresthesia. To minimize these effects, doctors typically recommend a gradual tapering of the dose when discontinuing the medication.

Drug Interactions and Precautions

Cymbalta has a significant number of potential drug interactions. It’s crucial for patients to inform their healthcare providers about all medications, supplements, and herbal products they are taking. Some notable interactions include:

• Monoamine Oxidase Inhibitors (MAOIs): Concurrent use can lead to potentially life-threatening serotonin syndrome
• NSAIDs and Aspirin: May increase the risk of bleeding
• Warfarin: Can affect blood clotting
• Certain Antidepressants: May increase the risk of serotonin syndrome

Additionally, alcohol consumption should be limited or avoided while taking Cymbalta, as it can increase the risk of liver damage.

The Economic Impact and Market Presence of Cymbalta

Since its introduction, Cymbalta has been a significant revenue generator for Eli Lilly. At its peak in 2012, the drug’s annual sales reached an impressive $4.99 billion. Even after patent expiration in 2013, which paved the way for generic alternatives, Cymbalta continued to generate substantial revenue. In the first nine months of 2018 alone, it brought in $523.5 million worldwide for Eli Lilly.

Cost Considerations and Generic Alternatives

The cost of Cymbalta can vary significantly depending on factors such as dosage strength and whether a patient opts for the brand-name or generic version. Brand-name Cymbalta can cost between $242.73 and $472.66 for a 30-day supply. In contrast, generic duloxetine offers a more affordable option, with some formulations costing as little as $12 for chemotherapy-induced peripheral neuropathy treatment.

The availability of generic alternatives has made the treatment more accessible to a broader patient population, while still allowing Eli Lilly to maintain a significant market presence with the brand-name product.

Research and Future Directions

Ongoing research continues to explore new potential applications for duloxetine. One notable area of investigation has been its use in pediatric populations, particularly for conditions like juvenile fibromyalgia. However, a Phase III clinical trial presented at the 2018 World Congress on Pain suggested that duloxetine may not be significantly more effective than a placebo in treating juvenile primary fibromyalgia syndrome.

Emerging Areas of Study

Researchers are also examining the potential of duloxetine in treating other conditions, such as:

• Chemotherapy-induced peripheral neuropathy
• Chronic low back pain
• Post-traumatic stress disorder (PTSD)
• Irritable bowel syndrome (IBS)

These ongoing studies may further expand the therapeutic applications of duloxetine in the future, potentially offering new treatment options for patients with diverse medical needs.

Patient Education and Informed Decision-Making

Given the complex nature of Cymbalta’s effects and potential interactions, patient education plays a crucial role in ensuring safe and effective use of the medication. Healthcare providers should engage in thorough discussions with patients about the benefits and risks of Cymbalta, as well as potential alternatives.

Key Points for Patient Awareness

• The importance of adhering to prescribed dosages and schedules
• Potential side effects and when to seek medical attention
• The need for gradual discontinuation to avoid withdrawal symptoms
• Interactions with other medications and substances, including alcohol
• The availability of generic alternatives and their cost implications

By fostering open communication and providing comprehensive information, healthcare providers can empower patients to make informed decisions about their treatment and actively participate in their care.

Navigating the Complexities of Long-Term Cymbalta Use

For many patients, Cymbalta becomes a long-term treatment option, particularly for chronic conditions like major depressive disorder or fibromyalgia. Understanding the implications of extended use is crucial for both patients and healthcare providers.

Long-Term Efficacy and Tolerance

While Cymbalta can be effective in managing symptoms over extended periods, some patients may develop tolerance over time. This could necessitate dosage adjustments or consideration of alternative treatments. Regular follow-ups with healthcare providers are essential to monitor the drug’s continued efficacy and address any emerging concerns.

Managing Side Effects Over Time

Some side effects of Cymbalta may persist or evolve with long-term use. For instance, sexual side effects or weight changes might become more pronounced over time. Patients should be encouraged to report any persistent or new side effects to their healthcare providers, who can then consider strategies to mitigate these issues while maintaining the therapeutic benefits of the medication.

The Role of Cymbalta in Comprehensive Treatment Plans

While Cymbalta can be a powerful tool in managing various conditions, it’s often most effective when used as part of a comprehensive treatment plan. This may include other therapeutic approaches such as:

• Psychotherapy or counseling
• Lifestyle modifications (e.g., diet, exercise, stress management)
• Complementary therapies (e.g., acupuncture, mindfulness practices)
• Other medications for symptom management

Integrating Cymbalta into a holistic treatment approach can enhance its effectiveness and provide patients with a more robust support system for managing their conditions.

Collaborative Care and Interdisciplinary Approaches

Given Cymbalta’s diverse applications, patients taking this medication may benefit from collaborative care involving multiple healthcare specialists. For instance, a patient with depression and chronic pain might work with both a psychiatrist and a pain management specialist to optimize their treatment plan.

Addressing Special Populations and Considerations

While Cymbalta is not approved for use in children and adolescents, special considerations apply to other populations, including:

Elderly Patients

Older adults may be more sensitive to the effects of Cymbalta and may require lower starting doses. They should be monitored closely for side effects, particularly those affecting balance or cognitive function.

Pregnant and Breastfeeding Women

The use of Cymbalta during pregnancy and breastfeeding requires careful consideration of risks and benefits. Some studies have suggested potential risks to fetal development, particularly when used in the third trimester. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss their options thoroughly with their healthcare providers.

Patients with Liver or Kidney Impairment

Cymbalta is primarily metabolized by the liver and excreted by the kidneys. Patients with liver or kidney dysfunction may require dosage adjustments or alternative treatments. Regular monitoring of liver and kidney function may be necessary for these patients.

The Future of Duloxetine and SNRIs in Medicine

As research continues to uncover the intricate relationships between neurotransmitters, mood disorders, and chronic pain conditions, the role of SNRIs like duloxetine is likely to evolve. Future developments may include:

• More targeted formulations to enhance efficacy and reduce side effects
• Expanded applications for treating other neurological or pain disorders
• Combination therapies that leverage the synergistic effects of duloxetine with other medications
• Advanced genetic testing to predict individual responses to SNRIs, enabling more personalized treatment approaches

These advancements could further cement Cymbalta’s position as a versatile and valuable tool in the treatment of various mental health and chronic pain conditions.

In conclusion, Cymbalta (duloxetine) represents a significant advancement in the treatment of mood disorders and chronic pain conditions. Its unique mechanism of action, coupled with its diverse applications, has made it a valuable option for many patients. However, like all medications, it requires careful consideration, monitoring, and individualized approach to treatment. As research continues and our understanding of neurobiology advances, the role of Cymbalta in medical practice is likely to evolve, potentially offering new hope and improved outcomes for patients facing complex health challenges.

Duloxetine Uses, Doses and Drug Interactions

Cymbalta is an antidepressant approved to treat mood and pain disorders. It was one of Eli Lilly’s most profitable drugs. It works by preventing the body from reabsorbing two neurotransmitters: serotonin and norepinephrine. The drug has a long list of interactions, and possible side effects include nausea, increased sweating and withdrawal symptoms.

Cymbalta comes in delayed-release capsules and is a part of a drug class called serotonin and norepinephrine reuptake inhibitors, or SNRIs. Eli Lilly and Company manufactures the medication. Duloxetine is the drug’s active ingredient.

The U.S. Food and Drug Administration first approved the antidepressant in 2004. The drug quickly grew in popularity. In 2009 alone, doctors wrote 14.6 million prescriptions, according to The New York Times.

At its peak in 2012, the drug had annual sales of $4.99 billion, according to Indy Star. The drug’s patent ran out in 2013, opening the door to several generic manufacturers.

A Sept. 30, 2018 quarterly filing with the Securities and Exchange Commission reported Cymbalta had brought in $523.5 million worldwide in nine months for the drug maker in 2018, including $39.3 million in the United States.

Depending on the dose strength, the medication can cost anywhere between $242.73 and $472.66 for a 30-day supply, according to Drugs.com. One 2022 research report noted that, for chemotherapy-induced peripheral neuropathy, costs of duloxetine varied from $12 (generic) to $529 (brand name).

Uses, Dosages and Strengths

The FDA originally approved Cymbalta for major depressive disorder and generalized anxiety disorder. The agency has since approved the medication for diabetic peripheral neuropathic pain, fibromyalgia and chronic musculoskeletal pain in adults. The drug is not approved for use in children and teens.

Eli Lilly had tried to get the drug approved for stress urinary incontinence as well. But the FDA suggested it could not grant approval based on the data the company had provided, so the drug maker withdrew its application in 2005, according to a company press release.

Then, the company began investigating duloxetine to treat children with fibromyalgia. It updated its Phase III clinical trial progress on Aug. 14, 2018 on ClinicalTrials.gov. Eli Lilly researcher Dr. Himanshu P. Upadhyaya and colleagues presented the study results at the 2018 World Congress on Pain in Boston. They concluded duloxetine may not be effective in treating juvenile primary fibromyalgia syndrome compared to a placebo.

Depending on the treatment indication and the patient’s age, doctors may prescribe different strengths. The medication comes in 20 mg, 30 mg and 60 mg delayed-release capsules.

Cymbalta 20mg capsule

Cymbalta 30mg capsule

Cymbalta 60mg capsule

Major Depressive Disorder:

40 mg to 60 mg a day. The maximum dose is 120 mg a day.

Generalized Anxiety Disorder:

60 mg a day. The maximum dose is 120 mg a day.

Diabetic Peripheral Neuropathic Pain:

60 mg a day. The maximum dose is 60 mg a day.

Fibromyalgia:

30 mg a day. The maximum dose is 60 mg a day.

Chronic Musculoskeletal Pain:

30 mg a day. The maximum dose is 60mg a day.

Patients should swallow capsules whole with or without food. If patients miss a dose, they should take the missed dose as soon as possible, but they should not take two doses at the same time.

Advertisement

Professional Therapy, Done Online

A licensed therapist with BetterHelp can provide professional support and guidance, on your schedule. Sign up and get matched in as little as 48 hours.

Get Started

How Duloxetine Works

Researchers believe duloxetine works by increasing the activity of serotonin and norepinephrine in the central nervous system, according to the drug’s label.

The National Institutes of Health says duloxetine increases the levels of the neurotransmitters in the brain by preventing the body from reabsorbing them, and this contributes to its antidepressant effects.

Researchers believe blocking the reabsorption of neurotransmitters can reduce symptoms of depression.

Depression, chronic pain and anxiety have inter-related symptoms, according to researcher Cheryl L. Wright and fellow researchers at the Oregon Health and Science University School of Nursing. Researchers believe duloxetine treats general pain disorder, diabetic peripheral neuropathic pain and fibromyalgia in the same way it treats depression and anxiety.

Researchers know the drug does not repair the nerve damage that leads to diabetic peripheral neuropathy, but clinical trials have shown the drug can relieve the pain and other sensations associated with the condition, according to an Eli Lilly statement.

“While additional nonindustry-sponsored investigation is warranted, the evidence to date suggests that in those with [fibromyalgia], duloxetine has largely been a safe and, in some, a promising intervention to manage chronic pain. ”

Adjusting the levels of neurotransmitters can also relieve fibromyalgia pain without affecting mood, Wright and colleagues wrote in Expert Review of Clinical Immunology.

“While additional nonindustry-sponsored investigation is warranted, the evidence to date suggests that in those with [fibromyalgia], duloxetine has largely been a safe and, in some, a promising intervention to manage chronic pain,” the researchers wrote. “As with the introduction of any new pharmacologic agent, each patient deserves close monitoring to assess the drug’s effectiveness as well as adverse effects.”

Side Effects

Five percent or more of the people who had taken Cymbalta during clinical trials reported common side effects at least twice as often as those who had taken a placebo. According to the drug’s label, the most common side effects of Cymbalta were nausea, dry mouth, sleepiness, constipation, loss of appetite and increased sweating.

Though rare, serious side effects can include life-threatening conditions, and the FDA has released several warnings for side effects such as liver disease and low blood pressure. The medication carries a black box warning for suicidal thoughts and behaviors in children, adolescents and young adults.

Patients should talk to their doctor as soon as they notice any changes in their condition. Many side effects will simply work themselves out in time, but a doctor may need to adjust the medication dosage.

Never stop taking duloxetine suddenly or without first consulting a doctor, even if you experience side effects. Stopping the medication abruptly can trigger withdrawal symptoms, including dizziness, headache, nausea, diarrhea, tingling sensation, irritability, vomiting, insomnia, anxiety, increased sweating and fatigue.

The medication insert recommends doctors gradually reduce the dose rather than suddenly stopping treatment. Some people who say they suffered withdrawal side effects filed lawsuits against Eli Lilly.

Food, Alcohol and Drug Interactions

Medications that may interact with Cymbalta range from over-the-counter pain relievers to prescription blood pressure medicines, according to Everyday Health. The drug’s label has a long list of possible interactions.

Taking duloxetine with certain other drugs can affect serotonin levels, blood pressure and body temperature. It can lead to a life-threatening condition called serotonin syndrome.

Symptoms of serotonin syndrome can include agitation, confusion, diarrhea and dilated pupils. Other signs to look for are elevated blood pressure, heavy sweating and rapid heart rate. The condition can also cause muscles to be rigid or twitch.

Did You Know?

Smoking decreases Cymbalta’s concentration in the blood by 30 percent.

Source:

Clinical Pharmacokinetics

Mixing Cymbalta with grapefruit or grapefruit juice may increase the risk of side effects or overdose. The acidic fruit interferes with the metabolism of the drug and may allow it to build up in the patient.

Light drinking of alcohol does not appear to enhance duloxetine’s effects. But heavy alcohol drinking can contribute to liver stress or damage.

Drugs and substances that may interact with Cymbalta include:

• MAO Inhibitors (Nardil, Parnate, others)
• SSRIs (Celexa, Fluvoxamine, Lexapro, Prozac, Paxil, Symbyax, Zoloft)
• Triptans (Amerge, Axert, Frova, Imitrex, Masalt, Replax, Zomig)
• Other SNRIs (Pristiq, Fetzima, Ixel, Savella, Elamol, Tofacine, Effexor)
• Tricyclic antidepressants (Anafranil, Ascendin, Norpramin, Sinequan)
• Aminoketones (Wellbutrin)
• Fluoroquinolone antibiotics (Cipro, Levaquin, Avelox)
• St. John’s Wort
• NSAIDs such as ibuprofen
• Aspirin
• Warfarin
• Drugs that affect gastric acidity
• Caffeine

This is not a complete list of all food and drug interactions. Patients should talk with their doctors about any drugs or supplements they are taking as well as alcohol use and diet to make sure they are not exposed to a potential interaction.

Before You Take Cymbalta

Some complications can be prevented if patients have an honest discussion with their doctors before starting treatment. This will also ensure patients receive the most effective treatment the drug can deliver.

The National Alliance on Mental Illness recommends people discuss the following issues with their doctors:

• The most bothersome symptoms
• 
  Thoughts of harming themselves
• 
  Previous medicines taken for their condition
• 
  How effective other medicines were or if they caused any side effects
• 
  Other mental or physical health conditions including bipolar disorder, kidney or liver disease
• 
  Other medications the patient is taking including over-the-counter drugs and supplements
• 
  Allergies to any medications
• 
  Other mental health treatment such as talk or substance therapy
• 
  Current or planned pregnancy or breastfeeding
• 
  Alcohol or drug use

Misleading Ads

The FDA has repeatedly reprimanded Eli Lilly for running misleading ads that overstate the benefits of Cymbalta while downplaying the risks.

In 2005, the FDA said Eli Lilly had run ads in a medical journal that were misleading because they failed to disclose important risks and side effects, Pharma Times reported.

Then, in 2007, the FDA called out the company for using a professional mailer that “overstates the efficacy of Cymbalta and omits some of the most serious and important risk information associated with its use.”

Eli Lilly suggested patients with diabetic peripheral neuropathy “experienced significantly less pain interference with overall functioning” but there was no evidence the claim was true, the FDA said in letter to the company.

In an ad in the WebMD Little Blue Book of Rheumatology, the drug maker claimed patients with fibromyalgia could achieve a 30 percent improvement in pain after taking Cymbalta, MedCity News reported. The FDA said in 2010 that no data existed to support the claim.

In all these cases, the FDA ordered Eli Lilly to stop the ad campaigns.

Advertisement

Professional Therapy, Done Online

A licensed therapist with BetterHelp can provide professional support and guidance, on your schedule. Sign up and get matched in as little as 48 hours.

Get Started

Cymbalta Facts

Please seek the advice of a medical professional before making health care decisions.

TELL US WHAT YOU THINK

Did You Find Drugwatch Helpful?

Yes

No

Thank you for your feedback. Do you have any thoughts you’d like to share about Drugwatch.com?

This article changed my life!

This article was informative

I have a question

How can we improve this page?

This article contains incorrect information

This article doesn’t have the information I’m looking for

I have a question

How can we improve this page?

Thank You for Your Feedback

We appreciate your feedback. One of our content team members will be in touch with you soon.

We appreciate your feedback. One of our content team members will be in touch with you soon.

Duloxetine (Cymbalta) for Treatment of Major Depressive Disorder

CARLA COBB, PHARM.D., B.C.P.P., AND RENEE CRICHLOW, M.D., Montana Family Medicine Residency, Deering Community Health Center, Billings, Montana

Am Fam Physician. 2005;72(6):1099-1101

Synopsis

Duloxetine (Cymbalta) is a serotonin and norepinephrine reuptake inhibitor in the same class as venlafaxine (Effexor). It is approved by the U. S. Food and Drug Administration (FDA) for use in the treatment of major depressive disorder and of diabetic peripheral neuropathic pain. In Europe it is marketed for the treatment of stress urinary incontinence; it is not approved for that indication in the United States.

Safety

Duloxetine is considered to be safe. In one open-label study¹ there were seven suicide attempts among 1,279 patients in one year (one suicide attempt per 115 patient-years of drug exposure) and no cases of fatal acute overdose. Duloxetine should not be used in patients taking a monoamine oxidase inhibitor (MAOI), including a period of five days before initiation of the MAOI and 14 days after its discontinuation.² Duloxetine is metabolized extensively by cytochrome P450 enzymes 1A2 and 2D6. Duloxetine plasma concentrations may be increased significantly by some antidepressants, quinidine, and quinolone antibiotics. Duloxetine may increase the plasma concentrations of other antidepressants, antipsychotics, and type 1C antiarrhythmics such as propafenone (Rythmol) and flecainide (Tambocor).

Serum alanine transaminase levels increased to more than three times the upper limit of normal in about 1 percent of patients taking duloxetine in placebo-controlled trials²; alcohol may increase this risk. However, there have been no reports of hepatic failure. Duloxetine is not recommended in patients with end-stage renal disease or severe renal impairment because of the increased plasma concentrations of the drug and its metabolites. Duloxetine is FDA pregnancy category C based on negative animal studies; there have been no trials assessing its use in pregnant women.

Tolerability

In clinical trials for depression, the discontinuation rate in patients receiving duloxetine was significantly higher than in patients receiving placebo (approximately 10 percent and 4 percent, respectively).² Nausea, somnolence, insomnia, and dizziness are the main side effects, reported by about 10 to 20 percent of patients.² Anticholinergic-type side effects can occur. Changes in heart rate, blood pressure, and weight are not clinically significant.³ In four studies of depression, there was a higher rate of sexual dysfunction in men receiving duloxetine compared with those receiving placebo, based on the Arizona Sexual Experience scale.² Men receiving duloxetine, 80 mg daily, found it more difficult to achieve orgasm than men receiving placebo.⁴ Rates of sexual dysfunction based on voluntary reporting range from 3 to 6 percent, although underreporting is likely. ² No effect on sexual function in women has been reported. There are no data comparing duloxetine with other anti-depressants in terms of their impacts on the rates of sexual dysfunction.

Effectiveness

Four studies involving a total of 1,059 patients with major depression have demonstrated the superiority of duloxetine over placebo based on the Hamilton Depression Rating Scale.² Three of these studies,^4–6 however, used duloxetine at higher-than-labeled dosages (80 to 120 mg daily). In an eight-week study⁴ of patients with mild to moderate depression, duloxetine, 40 mg daily, produced a response rate of 44 percent, compared with 31 percent for placebo (number needed to treat [NNT] = 8) and 40 percent for paroxetine (Paxil), 20 mg daily. In a study³ of patients given the maximum daily dose of 60 mg, the response rates were 45 percent for duloxetine and 23 percent for placebo (NNT = 5). There are no data regarding the effectiveness of duloxetine for preventing recurrence of symptoms.

Although duloxetine is marketed for the treatment of painful physical symptoms associated with depression, research results do not support its effectiveness for this use. In manufacturer-conducted studies, patients with low baseline pain scores had clinically insignificant changes in pain scores, with no significant improvement in overall pain or functional status.⁵ A study⁷ involving patients who had fibromyalgia with or without major depressive disorder showed a modest improvement (five-point difference on an 80-point scale) in those taking duloxetine compared with those taking placebo, which is unlikely to be clinically significant.

In the treatment of painful diabetic neuropathic pain, studies involving 791 patients showed duloxetine, 60 mg once or twice daily, to be more effective than placebo.² The primary outcome measure—a reduction in the 24-hour average pain severity on the 11-point Brief Pain Inventory—decreased by about one point more with duloxetine than with placebo. A change in pain intensity of two points or more is considered clinically relevant. Functional outcomes were not assessed. There are no published studies, other than the trials mentioned above,² of duloxetine’s efficacy in the treatment of diabetic neuropathy. Duloxetine has not been compared with other treatments for diabetic neuropathy.

Although not labeled for the treatment of stress urinary incontinence, duloxetine has been compared with placebo for this use in four studies worldwide.⁸ Duloxetine, 40 to 80 mg daily for 12 weeks, was shown to decrease the median incontinence episode frequency in 2,188 women by 50 to 64 percent, significantly better than placebo (reduction of 27 to 41 percent). Duloxetine has not been compared with other drugs for incontinence.

A one-month supply of duloxetine, 60 mg daily, costs approximately $100. This is comparable to or lower than the price of extended-release venlafaxine (Effexor XR), depending on the dose, and more expensive than paroxetine and escitalopram (Lexapro). Generic fluoxetine is much less expensive at $9 to $25 per month.

Simplicity

The usual dosage of duloxetine is 40 to 60 mg once daily, without regard to food. It may be divided and given in a 20− to 30-mg dose twice daily to decrease nausea. The maximum daily dose is 60 mg.

Bottom Line

Duloxetine is safe and effective for the treatment of major depressive disorder. Because of its expense and the lack of data supporting its superiority over other antidepressants, it should be used as an alternative if other agents are ineffective or are not tolerated. The manufacturer has launched an aggressive marketing campaign targeting the use of duloxetine for the painful physical symptoms of depression, although there is insufficient evidence to support the choice of duloxetine for this indication over any other antidepressant. Duloxetine causes a modest reduction in pain in patients with diabetic neuropathy but is more expensive than amitriptyline (Elavil) and desipramine (Norpramin), and evidence showing benefit over these older agents is lacking.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

This series is coordinated by Allen F. Shaughnessy, PharmD, assistant medical editor.

A collection of STEPS published in AFP is available at https://www.aafp.org/afp/steps.

Duloxetine (Cymbalta) – instructions: indications, contraindications, side effects

It is used to treat major depressive disorder, generalized anxiety disorder, neuropathic pain, including diabetic neuropathy, neuralgia, fibromyalgia, and to reduce the pain of arthritis. A frequent indication for use, however, not approved by the instruction is stress urinary incontinence. Thus, not only a psychiatrist or a neurologist, but also a urologist with an endocrinologist can prescribe it.

Duloxetine (Duloxenta, Simbalta) is an antidepressant, belongs to serotonin and norepinephrine reuptake inhibitors (SNRIs). Its action on norepinephrine and serotonin transport is balanced, so the effect is noticeable both in the fight against depressive and anxiety disorders. It also has a small non-reuptake effect on the dopaminergic system, increasing the level of dopamine in the brain areas responsible for executive functions: comparison, prediction, control.

It was developed by Eli Lilly, which had previously created the most effective drug at that time, fluoxetine, one of the first SSRIs in the United States. However, other variants of drugs from this class soon filled the market, and the researchers decided to synthesize a substance that, simultaneously with serotonin, would act on norepinephrine, similar to the mechanism of the already existing venlafaxine.

The proposed mechanism for reducing pain is increased pain threshold : a nerve impulse perceived as pain reaches the brain with less intensity and can be tolerated much more easily. Few antidepressants have this property.

The dosage of 30 mg/day is the minimum and is used primarily for fibromyalgia and arthritis pain. Treatment of generalized anxiety disorder, depressive disorders, diabetic neuropathy requires maximum dose of 60 mg/day . If necessary, the dose can be increased to 90 or 120 mg per day, taking the medicine in two visits (morning and evening). Depending on tolerance, the doctor may either prescribe the full dose immediately or increase it over the course of a week. It is usually taken in the form of capsules, once a day, after breakfast. Taking on an empty stomach may cause nausea. Long-term therapy with duloxetine, as with other antidepressants
(from 6 months).

Like any antidepressant, it does not begin to act immediately, the first effect can be seen in two to three weeks.

At the beginning of treatment, in rare cases, dilated pupils can be observed. This effect is dangerous only
with glaucoma or a high risk of its development. The reverse side of high efficiency in urinary incontinence: in rare cases, already at the beginning of treatment, you can feel urinary retention.

Adverse reactions to the drug are quite similar to those of SSRIs:

• from the gastrointestinal tract – nausea, vomiting, loss of appetite, sometimes – diarrhea;
• decreased libido;
• increased blood pressure – rare (less than venlafaxine), but requires monitoring and control;
• urinary retention;
• weight gain is rare.

However, side effects of duloxetine appear more often in the work of the cardiovascular system, gastrointestinal tract, and central nervous system. Sleep disturbances, sweating, headache, fatigue, nausea, erectile dysfunction, dizziness, abdominal pain, loss of appetite, constipation, diarrhea, tremors, and yawning occur with varying likelihood. Most side effects occurs in the first week and passes without a trace. Serious side effects include suicidal thoughts, fainting, mania, liver and kidney dysfunction. In these cases, the doctor may suggest a replacement drug.

Duloxetine is not used in angle-closure glaucoma, with simultaneous or recent therapy with MAO inhibitors, severe renal or hepatic insufficiency. Pregnant and lactating women may be treated with duloxetine , but its effect on the fetus and child has not been well studied. The doctor correlates the likelihood of risk and benefit for the mother, so it is necessary to inform him about planning or pregnancy during treatment.

Abrupt withdrawal of duloxetine, as with other SNRIs, often results in a “withdrawal syndrome” and should not be discontinued without consulting a physician. An overdose of duloxetine is extremely dangerous. Report any side effects, changes in sleep or behavior, or suicidal thoughts to your doctor.

As a result, duloxetine is an antidepressant that is very effective in the treatment of pathologies associated with pain syndrome (anxiety disorder or depressive state), somatotrophic pain syndrome. Also, along with other SNRIs, it is used as a replacement for SSRIs when they are ineffective or develop adverse side effects during administration.

Simbalta Enteric capsules 60 mg 28 pcs

{{if type === ‘partner-stocks’}}

{{/if}}

{{/if}}
{{each list}}

${this}
{{if isGorzdrav}}

Delete

{{/if}}

{{/each}}

{{/if}}
Search by drug, disease, substance:
Vitamins, Quit smoking, Voltaren, Nurofen, Lymphomyosot

Home

Medicines

Organs and systems

Nervous system

Antidepressants

Simbalta

{{each product}}
{{tmpl({prod:this. target, type: ”}) “#productGalleryItemTemplate”}}
{{/each}}

Attention! The price of the goods is valid only when placing an order on the site

Basic

Analogues

Availability in pharmacies

Instruction

The appearance of the product may differ from the image

Product code:
24917

Manufacturer:
Lilly France

Country of origin:
Spain

Release form:
Capsules

Active ingredients:
Duloxetine

Dispensing order:
Prescription

There are contraindications, consult a doctor

+37 bonuses

The price is valid only when ordering on the site

There are contraindications, consult a doctor

Manufacturer:
Lilly France

Country of origin:
Spain

Release form:
Capsules

Active ingredients:
Duloxetine

Dispensing order:
Prescription

Added to Your Shopping Cart

Buy in 1 click

See all analogues of Simbalt

Prices for Simbalta Enteric capsules 60 mg 28 pcs and availability of goods in pharmacies GORZDRAV in Moscow and the Moscow region0137

Listed

On the map

Featured
The closest

You can buy Simbalta enteric capsules 60 mg 28 pcs at the price of 3 723 ₽ in pharmacies of GORZDRAV in Moscow and the Moscow region

Features

Features

Minimum age from.	18 years old
Minimum storage temperature, °С	15 °C
Maximum allowable storage temperature, °С	30 °C
Expiration date	36 months
Storage conditions	Keep out of the reach of children
Release form	Capsules
Order of leave	Prescription
Active ingredient	Duloxetine
Application	Neurology
Pharmacological group	N06AA Non-selective monoamine reuptake inhibitors
Registered as	Medicine
Pack quantity	28 pcs

Information

Instructions for use

Active ingredients

Duloxetine

Presentation

Capsules 900 03

Composition

Active ingredient: Duloxetine (Duloxetine) Active ingredient concentration (mg): 60

Pharmacological effect

Antidepressant, serotonin and norepinephrine (norepinephrine) reuptake inhibitor. Weakly inhibits the capture of dopamine, does not have a significant affinity for histamine, dopamine, cholinergic and adrenergic receptors. The mechanism of action of duloxetine is to inhibit the reuptake of serotonin and norepinephrine (norepinephrine). Duloxetine has a central mechanism for suppressing pain, which is primarily manifested by an increase in the threshold of pain sensitivity in pain syndrome of neuropathic etiology.

Pharmacokinetics

After oral administration, duloxetine is well absorbed from the gastrointestinal tract, absorption begins 2 hours after administration, Cmax is reached 6 hours after administration. Reception simultaneously with food increases the time to reach Cmax up to 10 hours, which reduces the degree of absorption (by approximately 10%), but does not affect the value of Cmax. Plasma protein binding is high (more than 90%), mainly with albumin and α1-globulin. Liver or kidney disorders do not affect the degree of protein binding. Duloxetine is actively biotransformed with the participation of CYP2D6 and CYP1A2 isoenzymes, which catalyze the formation of two main metabolites (4-hydroxyduloxetine glucuronic conjugate, 5-hydroxy,6-methoxyduloxetine sulfate conjugate). Circulating metabolites do not have pharmacological activity. T1 / 2 is 12 hours. The average clearance of duloxetine is 101 l / h. It is excreted in the urine as metabolites. In patients with end-stage chronic renal failure on hemodialysis, the Cmax and AUC values ​​of duloxetine increased by 2 times. In this regard, the advisability of reducing the dose of the drug in patients with clinically pronounced impaired renal function should be considered. Patients with clinical signs of hepatic insufficiency may experience a slowdown in metabolism and excretion of duloxetine. After a single dose of duloxetine at a dose of 20 mg in 6 patients with cirrhosis of the liver and moderate hepatic impairment (Child-Pugh class B), duloxetine T1 / 2 was approximately 15% higher than in healthy people of the same sex and age with five times an increase in the mean AUC. Despite the fact that Cmax in patients with cirrhosis was the same as in healthy people, T1 / 2 is approximately 3 times greater.

Indications

Depression. Painful form of diabetic neuropathy. Generalized anxiety disorder.

Contraindications

Hypersensitivity to the drug. Simultaneous use with monoamine oxidase inhibitors (MAOIs). Uncompensated angle-closure glaucoma.

Precautions

Use with caution in patients with a history of manic episodes and a history of epileptic seizures; with exacerbation of a manic / hypomanic state, epileptic seizures, mydriasis, impaired liver or kidney function, in patients with a tendency to suicidal attempts.

Use during pregnancy and lactation clinical experience with the use of duloxetine during pregnancy is not enough. If it is necessary to use the drug during lactation, the issue of stopping breastfeeding (due to lack of experience with use) should be decided.

about it to your doctor.

Dosage and administration

Inside. Capsules should be swallowed whole, without chewing or crushing. Do not add the drug to food or mix it with liquids, as this can damage the enteric coating of the pellets. The recommended initial dose of duloxetine is 60 mg 1 time per day, regardless of food intake. In some patients, to achieve a good result, it is necessary to increase the dose from 60 mg 1 time per day to a maximum dose of 120 mg per day in two divided doses. A systematic evaluation of the drug at a dose of more than 120 mg was not carried out. In patients with renal insufficiency: the initial dose should be 30 mg 1 time per day in patients with severely impaired renal function (end-stage renal failure) (creatinine clearance < 30 ml / min). In patients with impaired liver function: the initial dose of the drug should be reduced or the frequency of administration should be reduced in patients with cirrhosis. Age: the use of the drug in patients ≥ 18 years is recommended. There is no clinical experience with the use of duloxetine in patients under 18 years of age.

Side effects

The most common (≥ 10%) reported in clinical studies were: dizziness (except vertigo), dry mouth, nausea, constipation, sleep disturbances (drowsiness or insomnia) and headache. Headache was less common than with placebo. Less common (≥ 1 to < 10%) were: diarrhea, vomiting, tremor, decreased appetite, weight loss, weakness, increased sweating, hot flashes, blurred vision, anorgasmia, decreased libido, delayed and impaired ejaculation and erectile dysfunction. Dizziness, nausea, headache were noted as frequent adverse effects when duloxetine was withdrawn. Effect on glucose concentration in patients with painful diabetic neuropathy: there may be a slight increase in fasting blood glucose while taking duloxetine.

Special instructions

When prescribing serotonin reuptake inhibitors in combination with MAO inhibitors, there have been cases of serious reactions, sometimes with a fatal outcome (hyperthermia, rigidity, myoclonus, various disorders with possible sharp fluctuations in vital signs of the body and changes in mental status, including pronounced excitement with the transition to delirium and coma). Such reactions are also possible in cases where the serotonin reuptake inhibitor was canceled shortly before the appointment of MAO inhibitors (possible development of symptoms, including those characteristic of neuroleptic malignant syndrome). The effects of the combined use of duloxetine and MAO inhibitors have not been evaluated in humans or in animals. The use of duloxetine simultaneously with MAO inhibitors or up to 14 days after their withdrawal is not recommended, because. Duloxetine is a serotonin and norepinephrine (norepinephrine) reuptake inhibitor. MAO inhibitors should not be prescribed for at least 5 days after discontinuation of duloxetine. Depressive states are accompanied by a high risk of suicidal behavior. As a result, patients with a diagnosis of depression taking duloxetine should inform the doctor about any disturbing thoughts and feelings. Against the background of the use of the drug, mydriasis may develop; in patients with arterial hypertension and / or other diseases of the cardiovascular system, it is recommended to control blood pressure. Influence on the ability to drive vehicles and control mechanisms Patients taking duloxetine should be careful when engaging in potentially hazardous activities (due to the possible occurrence of drowsiness).

Prescription

Yes

Certificates

Q&A

Can I unsubscribe from receiving your marketing emails?

Of course. Use the “Unsubscribe” function in the mail, or write to us.

Can I cancel an order?

Yes, at any time before receiving the goods.

I bought medicines from you, and when I got home I saw that instead of one of the medicines I was given another one. Who will answer for this?

All claims on the order are accepted until the moment of its payment. When receiving goods at the checkout, be sure to check their compliance with the reservation (name, expiration date, quantity, warranty card for products and other information).

Why does the pharmacy need my personal data?

Your data is needed by the pharmacy and related services (courier, logistics, postal) in order to fulfill your order efficiently.