What is sulindac used for. How does sulindac work. What are the common side effects of sulindac. Is sulindac a narcotic drug. What are the FDA warnings for sulindac. How does sulindac interact with other medications.

What Is Sulindac and How Does It Work?

Sulindac is a nonsteroidal anti-inflammatory drug (NSAID) used to treat various types of arthritis, ankylosing spondylitis, and acute shoulder pain. It’s available as a generic oral tablet and works by reducing levels of prostaglandin, a hormone-like substance that causes inflammation. This mechanism helps decrease pain, swelling, and fever.

Sulindac is primarily prescribed for:

• Osteoarthritis
• Rheumatoid arthritis
• Ankylosing spondylitis
• Acute gout symptoms
• Acute shoulder pain

Is sulindac a narcotic?

No, sulindac is not a narcotic. It belongs to the NSAID class of medications, which are non-addictive and do not produce the euphoric effects associated with narcotics. Sulindac works differently from narcotic pain relievers and is primarily used for its anti-inflammatory properties.

Important FDA Warnings for Sulindac

The Food and Drug Administration (FDA) has issued black box warnings for sulindac, which are the most serious type of warning. These alerts inform healthcare providers and patients about potentially dangerous drug effects.

Cardiovascular Risk Warning

Sulindac may increase the risk of serious cardiovascular events, including:

• Blood clots
• Heart attack
• Stroke

These risks are higher for individuals with existing heart disease or risk factors such as high blood pressure. The danger may also increase with higher doses or prolonged use of sulindac.

Gastrointestinal Risk Warning

Taking sulindac can increase the risk of severe gastrointestinal problems, including:

• Stomach bleeding
• Ulcers
• Perforations in the lining of the digestive system

These complications can occur at any time during treatment and may be fatal. Patients over 65 years of age are at higher risk for these adverse effects.

Common Side Effects of Sulindac

While sulindac can be effective in treating various inflammatory conditions, it may cause several side effects. The most common side effects include:

• Stomach pain
• Heartburn
• Nausea
• Diarrhea
• Constipation
• Rash
• Dizziness
• Headache

These side effects are often mild and may resolve on their own within a few days or weeks. However, if they persist or worsen, it’s important to consult with a healthcare provider.

Serious Side Effects and When to Seek Medical Attention

While less common, sulindac can cause serious side effects that require immediate medical attention. These include:

Symptoms of Heart Attack or Stroke

• Chest pain or tightness
• Shortness of breath
• Arm pain
• Weakness on one side of the body
• Slurred speech

Signs of Gastrointestinal Bleeding

• Vomiting blood
• Bloody stools
• Black, tarry stools

Other Serious Side Effects

• Severe skin reactions (rash, blistering)
• Signs of liver problems (yellowing of skin or eyes)
• Asthma attacks
• Allergic reactions

If you experience any of these symptoms, seek medical help immediately or call emergency services.

Drug Interactions with Sulindac

Sulindac can interact with various medications, potentially altering their effectiveness or increasing the risk of side effects. It’s crucial to inform your healthcare provider about all medications, vitamins, and herbal supplements you’re taking.

Interactions with Other NSAIDs

Combining sulindac with other NSAIDs can significantly increase the risk of gastrointestinal bleeding and ulcers. Examples of other NSAIDs include:

• Ibuprofen
• Naproxen
• Aspirin
• Celecoxib

Other Potential Drug Interactions

Sulindac may also interact with:

• Blood thinners (e.g., warfarin)
• Certain antidepressants (e.g., SSRIs)
• Diuretics
• ACE inhibitors
• Beta-blockers

Always consult with your healthcare provider or pharmacist about potential drug interactions before starting sulindac or any new medication.

Proper Usage and Dosage Guidelines for Sulindac

Sulindac is available as an oral tablet and should be taken exactly as prescribed by your healthcare provider. The dosage and duration of treatment will vary depending on the condition being treated and individual factors.

General Dosage Information

• Typical starting dose: 150 mg twice daily
• Maximum daily dose: 400 mg
• Take with food or milk to reduce stomach upset
• Swallow tablets whole; do not crush, chew, or break them

It’s important to use the lowest effective dose for the shortest duration possible to minimize the risk of side effects. Your healthcare provider may adjust your dosage based on your response to treatment and any side effects you experience.

Special Dosage Considerations

Certain groups may require dosage adjustments:

• Elderly patients: May need lower doses due to increased risk of side effects
• Patients with kidney or liver problems: May require dose reduction
• Individuals with a history of stomach ulcers: May need additional medications to protect the stomach

Always follow your healthcare provider’s instructions and never adjust your dosage without consulting them first.

Precautions and Contraindications for Sulindac Use

While sulindac can be an effective treatment for various inflammatory conditions, it’s not suitable for everyone. Certain precautions and contraindications should be considered before starting treatment.

Who should not take sulindac?

Sulindac is contraindicated in the following situations:

• Individuals with a known allergy to sulindac or other NSAIDs
• Patients who have experienced asthma, urticaria, or allergic reactions after taking aspirin or other NSAIDs
• People scheduled for coronary artery bypass graft (CABG) surgery
• Individuals with active gastrointestinal bleeding

Precautions for specific groups

Certain groups should use sulindac with caution and under close medical supervision:

• Elderly patients: Higher risk of adverse effects
• Individuals with a history of gastrointestinal problems
• Patients with cardiovascular disease or risk factors
• People with kidney or liver disease
• Individuals with asthma
• Pregnant women, especially in the third trimester
• Breastfeeding mothers

Always inform your healthcare provider about your complete medical history and any medications you’re taking before starting sulindac treatment.

Alternatives to Sulindac for Pain and Inflammation Management

While sulindac can be effective for many patients, some individuals may need to consider alternatives due to side effects, contraindications, or personal preferences. There are several other options available for managing pain and inflammation.

Other NSAIDs

Different NSAIDs may have varying levels of effectiveness and side effects for different individuals:

• Ibuprofen
• Naproxen
• Celecoxib
• Meloxicam

Non-NSAID Pain Relievers

For those who cannot take NSAIDs, other pain relief options include:

• Acetaminophen (Tylenol)
• Topical pain relievers (e.g., capsaicin, lidocaine)
• Certain antidepressants (for chronic pain)
• Gabapentin or pregabalin (for neuropathic pain)

Disease-Modifying Antirheumatic Drugs (DMARDs)

For conditions like rheumatoid arthritis, DMARDs may be prescribed:

• Methotrexate
• Hydroxychloroquine
• Sulfasalazine
• Biologic agents (e.g., TNF inhibitors)

Non-Pharmacological Approaches

Complementary therapies can be used alongside or instead of medication:

• Physical therapy
• Exercise and weight management
• Hot and cold therapy
• Acupuncture
• Massage
• Cognitive behavioral therapy for pain management

The choice of alternative treatment should be made in consultation with a healthcare provider, taking into account the specific condition, individual health status, and potential risks and benefits of each option.

Monitoring and Follow-Up Care While Taking Sulindac

Regular monitoring and follow-up care are essential when taking sulindac to ensure its effectiveness and minimize the risk of complications. Your healthcare provider will likely establish a monitoring plan tailored to your individual needs and risk factors.

Regular Check-ups

Periodic appointments with your healthcare provider may include:

• Assessment of pain relief and overall symptom management
• Evaluation of any side effects
• Blood pressure checks
• Cardiovascular risk assessment

Laboratory Tests

Your doctor may order certain tests to monitor your health while on sulindac:

• Complete blood count (CBC) to check for anemia or bleeding problems
• Liver function tests
• Kidney function tests
• Stool tests if gastrointestinal bleeding is suspected

Self-Monitoring

Patients should be aware of and report any of the following to their healthcare provider:

• Unexplained weight gain or swelling
• Changes in urine output
• Signs of gastrointestinal bleeding
• New or worsening cardiovascular symptoms
• Skin reactions or rashes

Maintaining open communication with your healthcare provider and adhering to the recommended monitoring schedule is crucial for safe and effective use of sulindac.

Side Effects, Dosage, Uses, and More

Highlights for sulindac

1. Sulindac oral tablet is available as a generic drug. It doesn’t have a brand-name version.
2. Sulindac only comes as a tablet you take by mouth.
3. Sulindac is used to treat different types of arthritis, shoulder pain, and ankylosing spondylitis.

FDA warnings

• This drug has black box warnings. These are the most serious warnings from the Food and Drug Administration (FDA). Black box warnings alert doctors and patients about drug effects that may be dangerous.
• Dangerous heart events warning: Sulindac isn’t recommended if you have heart disease or risks for heart disease, such as high blood pressure. It may increase your risk of blood clots, heart attack, and stroke, which may be fatal (cause death). Your risk may be higher if you take sulindac at high doses or for a long time. This drug can cause heart problems even if you don’t have risks factors for heart disease. You shouldn’t take sulindac if you’ll be having coronary artery bypass graft surgery. Your risk of heart attack or stroke may increase if you take sulindac to treat pain before or after your surgery. Also, avoid taking sulindac after a recent heart attack unless your healthcare provider tells you to.
• Dangerous stomach problems warning: Taking sulindac increases your risk of stomach bleeding, ulcers, or small holes in the lining of your digestive system, which can be fatal. These events may occur at any time and without any symptoms. You’re at a higher risk if you’re over the age of 65 years.

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Other warnings

Sulindac is a prescription drug. It comes as an oral tablet.

Sulindac is only available as a generic drug. Generic drugs usually cost less than brand-name versions.

Why it’s used

Sulindac is used to treat pain and redness, swelling, and inflammation from different types of arthritis, ankylosing spondylitis, and short-term shoulder pain. Sulindac is used to treat:

• osteoarthritis
• rheumatoid arthritis
• ankylosing spondylitis
• acute gout symptoms
• acute shoulder pain

How it works

Sulindac belongs to a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs help reduce pain, inflammation, and fever.

It isn’t known how sulindac works to decrease pain. It may help reduce swelling by lowering levels of prostaglandin, a hormone-like substance that usually causes inflammation.

Sulindac oral tablet doesn’t cause drowsiness, but it can cause other side effects.

More common side effects

The more common side effects that can occur with sulindac include:

• stomach pain
• heartburn
• nausea
• diarrhea
• constipation
• rash
• dizziness
• headache

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Chest pain or heart attack. Symptoms of heart attack can include:
  • chest pain
  • chest tightness
  • sweating
  • shortness of breath
  • heartburn/indigestion
  • arm pain
  • fatigue
  • Stroke. Symptoms can include:
    • weakness in one part or side of your body
    • slurred speech
  • High blood pressure
  • Swelling in your arms and legs, hands and feet, face, or throat
  • Stomach bleeding and ulcers. Symptoms can include:
    • vomiting blood
    • bloody stools
    • black and sticky stools
  • Skin reactions. Symptoms can include:
    • rash
    • blisters
  • Allergic reactions, such as itching
  • Liver problems. Symptoms can include:
    • yellowing of your skin or the whites of your eyes
  • Asthma attacks. Symptoms can include:
    • shortness of breath
    • trouble breathing

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.

Sulindac oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Examples of drugs that can cause interactions with sulindac are listed below.

Nonsteroidal anti-inflammatory drugs (NSAIDs)

Sulindac is an NSAID. Combining it with other NSAIDs increases your risk of stomach bleeding and ulcers. Examples of other NSAIDs include:

• aspirin
• ibuprofen
• naproxen
• diclofenac
• indomethacin
• meloxicam
• ketorolac
• ketoprofen

Blood pressure drugs

Taking sulindac with these drugs may reduce their blood pressure-lowering effects. Examples of these drugs include:

• angiotensin-converting enzyme (ACE) inhibitors such as:
  • enalapril
  • captopril
  • lisinopril
  • angiotensin receptor blockers such as:
    • valsartan
    • losartan
    • candesartan
  • diuretics such as:
    • furosemide
    • hydrochlorothiazide

Anticoagulants

Taking sulindac with anticoagulants increases your risk of bleeding. Examples of these drugs include:

• warfarin
• dabigatran
• rivaroxaban
• edoxaban

Bipolar disorder drug

Taking lithium with sulindac may increase the levels of lithium in your body. This can cause dangerous effects. Your doctor may monitor your lithium levels if you take these medications together.

Transplant drug

Taking cyclosporine with sulindac may increase the levels of cyclosporine in your body. This can cause dangerous effects. Your doctor may monitor your cyclosporine levels if you take these medications together.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

This drug comes with several warnings.

Allergy warning

Sulindac can cause a severe allergic reaction. Symptoms may include:

• trouble breathing
• swelling of your face or throat

If you develop these symptoms, call 911 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

Alcohol interaction warning

Drinking alcohol while taking sulindac increases your risk of stomach bleeding or ulcer.

Warnings for people with certain health conditions

For people with high blood pressure: Sulindac may cause you to develop high blood pressure or make existing high blood pressure worse. Check your blood pressure before you start and while you take sulindac.

For people with ulcers or stomach bleeding: This medication increases your risk of stomach bleeding if you have a history of ulcers or stomach bleeding.

For people with heart disease: This medication may cause fluid retention, which is a problem with heart disease. Watch for symptoms of fluid retention while you take sulindac if you tend to retain water or you have heart failure.

For people with asthma: You shouldn’t take sulindac if you have a history of asthma, hives, or allergic reaction after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs). You may experience a similar reaction to this drug, which may be deadly.

Warnings for other groups

For pregnant women: Sulindac is a category C pregnancy drug. That means two things:

1. Research in animals has shown adverse effects to the fetus when the mother takes the drug.
2. There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.

Talk to your doctor if you’re pregnant or planning to become pregnant. Sulindac should be used during pregnancy only if the potential benefit justifies the potential risk.

If you become pregnant while taking this drug, call your doctor right away.

For women who are breastfeeding: It isn’t known if sulindac is passes through breast milk. If it does and you breastfeed, your child may be at risk of side effects from this drug. You and your doctor may decide whether you’ll take sulindac or breastfeed.

For seniors: If you’re older than 65 years, your body may process this drug more slowly. Your doctor may start you on a lowered dosage so that too much of this drug doesn’t build up in your body. Too much of the drug in your body can be dangerous.

For children: It hasn’t been established that sulindac is safe and effective for use in children younger than 18 years.

This dosage information is for sulindac oral tablet. All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:

• your age
• the condition being treated
• how severe your condition is
• other medical conditions you have
• how you react to the first dose

Drug form and strengths

Generic: Sulindac

• Form: oral tablet
• Strengths: 150 mg, 200 mg

Dosage for osteoarthritis

Adult dosage (ages 18–64 years)

Typical dosage: 150 mg taken twice per day in evenly spaced doses (for a total of 300 mg per day).

Child dosage (ages 0–17 years)

A dosage for children younger than 18 years hasn’t been established.

Senior dosage (ages 65 years and older)

Older adults may process drugs more slowly. A normal adult dose may cause levels of the drug to be higher than normal. If you’re a senior, you may need a lower dosage or you may need a different treatment schedule.

Dosage for rheumatoid arthritis

Adult dosage (ages 18–64 years)

Typical dosage: 150 mg taken twice per day in evenly spaced doses (for a total of 300 mg per day).

Child dosage (ages 0–17 years)

Dosage for children younger than 18 years hasn’t been established.

Senior dosage (ages 65 years and older)

Older adults may process drugs more slowly. A normal adult dose may cause levels of the drug to be higher than normal. If you’re a senior, you may need a lower dosage or you may need a different treatment schedule.

Dosage for ankylosing spondylitis

Adult dosage (ages 18–64 years)

Typical dosage: 150 mg taken twice per day in evenly spaced doses (for a total of 300 mg per day).

Child dosage (ages 0–17 years)

Dosage for children younger than 18 years hasn’t been established.

Senior dosage (ages 65 years and older)

Older adults may process drugs more slowly. A normal adult dose may cause levels of the drug to be higher than normal. If you’re a senior, you may need a lower dosage or you may need a different treatment schedule.

Dosage for acute shoulder pain

Adult dosage (ages 18–64 years)

Typical dosage: 200 mg taken twice per day in evenly spaced doses (for a total of 400 mg per day). Therapy usually lasts 7 to14 days.

Child dosage (ages 0–17 years)

Dosage for children younger than 18 years hasn’t been established.

Senior dosage (ages 65 years and older)

Older adults may process drugs more slowly. A normal adult dose may cause levels of the drug to be higher than normal. If you’re a senior, you may need a lower dosage or you may need a different treatment schedule.

Dosage for acute gouty arthritis

Adult dosage (ages 18–64 years)

Typical dosage: 200 mg taken twice per day in evenly spaced doses (for a total of 400 mg per day). Therapy usually lasts seven days.

Child dosage (ages 0–17 years)

Dosage for children younger than 18 years hasn’t been established.

Senior dosage (ages 65 years and older)

Older adults may process drugs more slowly. A normal adult dosage may cause levels of the drug to be higher than normal. If you’re a senior, you may need a lower dosage or you may need a different treatment schedule.

Special dosage considerations

For people with liver disease: Liver disease may make it harder to clear this drug from your body. This could cause drug levels to get too high. If you have liver disease, your daily dosage may be lowered.

For people with kidney disease: Kidney disease may make it harder to clear this drug from your body. If you have kidney disease, your daily dosage may be lowered.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.

Sulindac oral tablet is used for short-term treatment when used for shoulder pain or gouty arthritis. It may be a long-term treatment when used for osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis.

This drug comes with risks if you don’t take it as prescribed by your doctor.

If you stop taking the drug or don’t take it at all: You may experience more pain caused by your condition.

If you miss doses or don’t take the drug on schedule: Your medication may not work as well or may stop working completely. For this drug to work well, a certain amount needs to be in your body at all times.

If you take too much: You could have dangerous levels of the drug in your body. Symptoms of an overdose of this drug can include:

• nausea
• vomiting
• dizziness
• black or bloody stools
• coughing up blood

In rare cases, taking too much of this drug can result in death. If you think you’ve taken too much of this drug, call your doctor or seek guidance from the American Association of Poison Control Centers at 1-800-222-1222 or through their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

What to do if you miss a dose: If you miss a dose and it’s more than a few hours until your next dose, take it as soon as you can. If it’s just a few hours until your next dose, skip the dose and take the next one at the usual time.

Never try to catch up by taking two doses at once. This could result in dangerous side effects.

How to tell if the drug is working: You should have less pain from your condition.

Keep these considerations in mind if your doctor prescribes sulindac for you.

General

• Take this medication with food to reduce stomach irritation and damage.
• You can cut or crush the oral tablets.

Storage

• Store this medication at room temperature between 68°F and 77°F (20°C and 25°C).
• Don’t freeze this drug.
• Keep this drug away from light.
• Don’t store this medication in moist or damp areas, such as bathrooms.

Refills

A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

• Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
• Don’t worry about airport X-ray machines. They can’t harm your medication.
• You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled container with you.
• Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Clinical monitoring

If you take sulindac for a long period of time, your doctor may take blood tests periodically to monitor your kidneys and liver.

Your doctor may also monitor you for signs of stomach bleeding, such as:

• vomiting blood
• bloody stools
• black and sticky stools

Availability

Not every pharmacy stocks this drug. When filling your prescription, be sure to call ahead to make sure your pharmacy carries it.

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other drug options that may work for you.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Sulindac – StatPearls – NCBI Bookshelf

Continuing Education Activity

Sulindac is a medication used as an anti-inflammatory and analgesic agent. It is in the class of non-steroidal anti-inflammatory drugs (NSAIDs). It is administered for the acute treatment of musculoskeletal shoulder pain,  acute gouty arthritis, wear and tear osteoarthritis, and inflammatory arthritic conditions, including both rheumatoid arthritis and ankylosing spondylarthritis. For the individual patient, the lowest effective dose and shortest duration are recommended for initial treatment. This activity reviews the indications, contraindications, mechanism of action, adverse events, and other key elements of sulindac therapy in the clinical setting, which is helpful for clinicians. It also highlights the role of the interprofessional team in managing diseases when using sulindac.

Objectives:

• Identify the mechanism of action of sulindac.

• Describe the adverse effects of sulindac.

• Review the appropriate monitoring for sulindac.

• Summarize interprofessional team strategies for improving care coordination and communication to advance sulindac and improve outcomes.

Access free multiple choice questions on this topic.

Indications

Sulindac is a non-steroidal anti-inflammatory drug (NSAID). Like other NSAIDs, sulindac is used primarily to treat conditions characterized by acute or chronic inflammation. However, as per the manufacturer, the indications are broad.

• Sulindac is indicated for a short duration for acute treatment of musculoskeletal shoulder pain (acute subacromial bursitis/supraspinatus tendinitis).

• Sulindac also has FDA approval for other forms of arthritis, including wear and tear osteoarthritis and inflammatory arthritic conditions, including rheumatoid arthritis and ankylosing spondylarthritis.[1]

• Sulindac also has approval for use in the treatment of acute gouty arthritis.[1]

• Familial adenomatous polyposis (FAP) is a condition characterized by pediatric adenomas in the lower gastrointestinal tract and frequently results in colonic adenocarcinomas. Several chemopreventive strategies have been the object of research in an attempt to delay the development of colonic adenomas and subsequent adenocarcinomas. Sulindac has been one of the most extensively studied drugs used in this chemopreventative strategy.[2]

Mechanism of Action

Sulindac is a non-selective COX (cyclooxygenase) inhibitor that reversibly inhibits both COX-1 and COX-2 enzymes. The COX pathways are one of the two main pathways involved in arachidonic acid metabolism (the other involves leukotriene synthesis). The COX pathway results in the synthesis of both prostaglandins and thromboxanes. These are both critical mediators of inflammation and platelet aggregation.[3]

Prostaglandin E2 (PGE2) is often a trigger of the cardinal signs of inflammation: rubor (erythema), calor (warmth), tumor (swelling), and dolor (pain)- this is accomplished through increased blood flow and vascular permeability. PGE2 also triggers systemic fever through a hypothalamic-mediated reaction. Sulindac and other NSAIDs are responsible for inhibiting the synthesis of this prostaglandin and others. Sulindac exists as a pro-drug that activates upon initial metabolism. Its metabolism forms both sulfide and sulfone derivatives; the sulfide derivative is the one that is responsible for inhibiting prostaglandin synthesis.[4][5]

Pharmacokinetics

Absorption: Sulindac tablets have a similar extent of absorption compared to sulindac solution. There is no information regarding food’s effect on sulindac absorption. Antacids containing aluminum hydroxide 225 mg and magnesium hydroxide 200 mg per 5 mL do not change absorption extent.

Distribution: Sulindac, sulfone, and sulfide metabolites are highly protein bound (more than 90%), mainly to albumin.

Metabolism: Sulindac goes through two major biotransformations of its sulfoxide moiety: reduction to the pharmacologically active sulfide metabolite and oxidation to the inactive sulfone metabolite.

Elimination: Approximately half of the administered dose of sulindac is eliminated through urine with the conjugated sulfone metabolite. Approximately 25% of the administered dose of sulindac is excreted in the feces, the majority as the sulfone or sulfide metabolites. The mean plasma effective half-life for sulindac and its active sulfide metabolite is 7.8 hours and 16.4 hours, respectively.

Administration

For the individual patient, the lowest effective dose and shortest duration are recommended for initial treatment. Sulindac is available as 150 mg and 200 mg oral tablets. The maximum recommended daily dose is 400 mg. Sulindac is recommended to take with food or milk to decrease GI side effects in adults and pediatric patients. Healthcare providers should carefully consider the potential risk to the benefit of sulindac and other relevant treatment options before determining to use the sulindac therapy option. 

Osteoarthritis, Rheumatoid Arthritis, and Ankylosing Spondylitis

The initial recommended dose of sulindac is 150 mg twice a day. This dose can be increased or decreased based on the individual patient’s response. The dose can be increased up to 400 mg daily. Half of the patient population may expect a prompt response within one week of treatment; other patients may require prolonged treatment. [6][7]

Acute Supraspinatus Tendinitis/ Subacromial Bursitis (Acute Painful Shoulder)

The initial recommended dose of sulindac is 200 mg twice a day. This dose can be increased or decreased based on the individual patient’s response. The dose can be increased up to 400 mg daily. An adequate response may be achieved from 7 to 14 days of therapy.[8]

Acute Gouty Arthritis

The initial recommended dose of sulindac is 200 mg twice a day. This dose can be increased or decreased based on the individual patient’s response. The dose can be increased up to 400 mg daily. An adequate response may be achieved within seven days of therapy.[9] 

Specific Patient Population

Pregnancy Considerations

NSAID treatment during pregnancy can lead to lower amniotic fluid and may cause complications like impaired lung maturation and limb contractures in newly born babies. However, if a healthcare provider likes to use NSAIDs during the 20 and 28 weeks of pregnancy, they should consider using the lowest effective dose for the shortest duration possible. Using sulindac can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction, and, in some cases, neonatal renal impairment. Therefore, FDA recommends avoiding sulindac use at about 30 weeks of gestation and later in pregnancy.

Breastfeeding Women

It is unknown if sulindac is present in breast milk. Some NSAID agents with established safety data and short half-lives are considered compatible with lactating patients to treat rheumatic and musculoskeletal diseases. Due to some potential side effects of sulindac in the breastfeeding infant, the manufacturer recommends discontinuing treatment or breastfeeding based on risk-benefit assessments.[10][11]

Hepatic Impairment

Use sulindac with caution and monitor treatment closely in patients with hepatic impairment. Reduction of dose may be needed due to extensive metabolism in the liver.[12]

Renal Impairment

Patients with impaired renal function should be used medication with caution and monitor treatment closely. Reduction of dose may be needed in patients with advanced renal disease.

• eGFR 30-60 mL/minute/1.73m: Discontinue the treatment temporarily in patients with acute kidney diseases.

• eGFR LT 30 mL/minute/1.73m: Avoid treatment.

Adverse Effects

Prostaglandins and thromboxanes have critical functions throughout the body. Unfortunately, the wide range of functions results in a host of side effects for NSAIDs like sulindac. Blood vessels, the gastrointestinal (GI) tract, and kidneys are a few examples of critical organ systems impacted by sulindac.

• Sulindac is commonly associated with nausea and vomiting, stomach pain, indigestion, diarrhea, constipation, gas, anxiety, dizziness, tinnitus, and urticaria.

• The most common and severe side effect of NSAID use involves ulceration of the GI tract, as GI mucosa appears to be protected by various prostaglandins. Sulindac is commonly thought to have associations with lower rates of GI-related complications when compared to other non-selective NSAIDs; however, this has come into question, and the GI side effects related to NSAID use appear to be primarily mediated through COX-1, as COX-2 selective NSAIDs are associated with lower risks of GI complications. These side effects become exacerbated by the simultaneous use of alcohol and or steroids.[13]

• Sulindac also correlates with renal side effects. Certain prostaglandins are involved in dilating the afferent arteriole- inhibition of this prostaglandin-mediated mechanism may result in a reduced GFR, thus, the risk of acute kidney injury. Sulindac and other NSAIDs may also be nephrotoxic and may induce renal papillary necrosis and interstitial nephritis. This condition may become exacerbated with the simultaneous use of other nephrotoxic agents.[14][15]

• Sulindac is associated with various critical adverse effects, including changes in vision, hepatoxicity, pancreatitis, anemia, and steven-johnson syndrome.[16]

Contraindications

• Per the manufacturer, there are few absolute contraindications to the use of sulindac. The first is a previous hypersensitivity reaction to sulindac or other NSAIDs. NSAID hypersensitivity can present in a variety of ways. [15]

  • It can result in chronic respiratory disease because of the formation of nasal polyps.

  • Cutaneously it can present with urticaria and angioedema, and in severe instances, it can even result in generalized anaphylaxis.

• The other absolute contraindication is in patients in status post coronary artery bypass graft (CABG) operations.

Box Warnings

• NSAIDs increase the risk of serious and fatal cardiovascular thrombotic events, including stroke and myocardial infarction. This risk can occur in an early phase of treatment and may increase with the duration of administration.

• NSAIDs increase the risk of serious and fatal gastrointestinal bleeding, ulceration, and perforation of the stomach or intestines. These adverse events may occur at any time while using and without warning symptoms. Senior adults are at higher risk of serious gastrointestinal events.

Cautions/Warnings

• Sulindac can increase the risk of hypertension or exacerbate existing hypertension. [17]

• It increases the risk of hospitalizations for patients with heart failure.[18]

• Cholestatic hepatitis cases are reported in some patients. Therefore, if abnormal liver tests persist or worsen, clinical signs and symptoms consistent with liver disease develop, or systemic manifestations occur (e.g., eosinophilia, rash, etc.), sulindac should be discontinued.[19]

• Chronic use of NSAIDs is linked with renal papillary necrosis and other renal injuries. Therefore, caution must be exercised in patients with heart failure, impaired renal function, liver dysfunction, volume-depleted patients, those taking diuretics and ACE inhibitors, and the elderly.[17][20]

• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been observed in patients taking sulindac, so discontinue the use if any signs or symptoms of DRESS develops.[21]

Monitoring

Sulindac use, as is the case with other NSAIDs, does not involve any routine monitoring. No regular blood work is necessary; however, it is essential to note that sulindac is not free from toxic side effects. Adhering to the dosing regimen is critical in preventing some of the side effects discussed above.[22]

• If a patient develops signs of anemia, have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.[23]

• If pancreatitis develops while taking sulindac, monitor closely with appropriate laboratory studies (e.g., serum and urine amylase, amylase/creatinine clearance ratio, electrolytes, serum calcium, glucose, lipase, etc.[24]

• Patients with hepatic insufficiency need to be monitored closely.

• Pregnant women who use sulindac for more than 48 hours between 2 and 30 weeks of gestation should be monitored for oligohydramnios.[25]

• Patients on long-term treatment should have their CBC and chemistry profile checked periodically since sulindac might cause unexpected severe GI bleeding and ulcerations.

Toxicity

It is essential to note that sulindac toxicity is rare; few cases are reported in the literature. It is also important to note that though sulindac is an NSAID, the toxicity does not present similarly to salicylate (aspirin) toxicity with metabolic acidosis, respiratory alkalosis, and tinnitus. Cases in the literature have demonstrated hepatic and renal toxicity associated with sulindac overdose; a case of granulocytosis has also been shown secondary to sulindac toxicity. One of the cases with hepatorenal toxicity further resulted in ischemic skin changes and ulceration.[26][27]

Since there have been exceedingly few cases of sulindac toxicity reported, many of the implications of overdose have not had a thorough investigation. Other research has demonstrated the utility of activated charcoal in the acute treatment of sulindac toxicity. Charcoal can help minimize absorption and some of the later sequelae associated with the drug’s toxicity. However, other studies have demonstrated that once the drug has been in the system, proper treatment protocol involves supportive care, which includes aggressive hydration, fluid replacement, and hemodialysis in some instances. [26]

Enhancing Healthcare Team Outcomes

NSAIDs like sulindac are a common therapy for patients with arthritis, spondylitis, and tendinitis. Clinicians should be vigilant while prescribing sulindac, as it has few long-term and toxic adverse effects. Nurses should understand the signs and symptoms of toxicities thoroughly and counsel the patients on the importance of adhering to scheduled dosing regimens. Pharmacists should check the dose, verify the appropriateness of the treatment with sulindac, and report to the clinicians any concerns. Nurses can counsel the patient and monitor for these adverse events, reporting to the prescriber if they note any concerns. All healthcare team members should be able to implement treatment protocols rapidly in the case of emergencies to improve patient care. Sulindac therapy needs an interprofessional healthcare team, including clinicians, specialists, specialty-trained nurses, and pharmacists, collaborating across disciplines to achieve optimal patient outcomes. [Level 5]

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References

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Disclosure: Akul Munjal declares no relevant financial relationships with ineligible companies.

Disclosure: Roopma Wadhwa declares no relevant financial relationships with ineligible companies.

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Call for a complete ban on diclofenac

Two clinical pharmacologists from the UK and Canada have called for the worldwide removal of the common pain reliever diclofenac from national lists of essential drugs. The analysis showed that, despite the dangerous side effects, the drug remains popular in most countries of the world.

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Two clinical pharmacologists from the UK and Canada have called for the widespread removal from sale and removal from national lists of essential drugs of the common pain reliever diclofenac, an analgesic from the group of non-steroidal anti-inflammatory drugs.

As pointed out in their work published in the journal PLOS Medicine , Patricia McGettigen (Patricia McGettigan) from the British School of Medicine and Dentistry Barts and The London and David Henry (David Henry) from the University of Toronto, back in 2006 it was proved that diclofenac , as well as the drug Vioxx, which was banned in 2004, increases the risk of heart attacks and other cardiovascular diseases by about 40 percent with long-term use.

However, the analysis carried out by the authors showed that diclofenac, despite the presence of a less dangerous analogue, naproxen, continues to be the most commonly prescribed non-steroidal anti-inflammatory drug in 15 countries of the world, and also remains included in the national lists of essential medicines in another 74 countries. . Moreover, diclofenac is used with the same frequency both in the most developed and in the poorest countries of the planet.

At the same time, naproxen is included in the national lists of vital drugs only in 27 countries, and, unlike diclofenac, which is in the top three most popular drugs, occupies only 10 percent of the market. The analysis showed that the level of sales and frequency of prescriptions of diclofenac (at least in the UK and Canada) is on average three times higher than that of naproxen.

The results of the study prove that information about the risks associated with diclofenac has not reached practicing clinicians, McGettigen and Henry conclude.