Clinoril (Oral)

Sulindac is a nonsteroidal anti-inflammatory drug (NSAID) that helps treat mild to moderate pain and relieve symptoms of arthritis, like osteoarthritis and rheumatoid arthritis, or acute gout. It can reduce inflammation, swelling, stiffness, and joint pain. This medicine does not cure arthritis and will only help you as long as you keep taking it.

Sulindac is also used to treat ankylosing spondylitis, a type of arthritis that affects the spine joints. It may also be used for painful shoulder conditions, such as bursitis or tendinitis.

You can only get this medicine with your doctor's prescription.

It is very important for your doctor to check your progress at regular visits to ensure that the medicine is working properly. Blood and urine tests may be needed to look for unwanted effects.

This medicine may increase your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time may also have a higher risk.

This medicine may cause bleeding in your stomach or intestines. These issues can occur without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years old, are in poor health, or if you are taking certain other medicines (such as a steroid medicine or a blood thinner).

Serious skin reactions can happen during treatment with this medicine. Contact your doctor immediately if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, or white spots in the mouth or on the lips; or unusual tiredness or weakness.

Some possible warning signs of serious side effects that can happen during treatment with this medicine may include black, tarry stools; decreased urination; severe stomach pain; skin rash; swelling of the face, fingers, feet, or lower legs; unusual bleeding or bruising; unusual weight gain; vomiting blood or material that looks like coffee grounds; or yellow skin or eyes. Also, signs of serious heart problems could occur, such as chest pain, fast or irregular heartbeat, tightness in the chest, unusual flushing or warmth of skin, weakness, or slurring of speech. Stop taking this medicine and contact your doctor right away if you notice any of these warning signs.

This medicine may cause a serious allergic reaction called anaphylaxis. Although this is rare, it may happen more often in patients who are allergic to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs). Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include a change in the color of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swelling of the eyelids or around the eyes. If these effects occur, seek emergency help immediately.

Using this medicine during late pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, inform your doctor right away.

This medicine may cause issues with your pancreas. Contact your doctor immediately if you have any of the following symptoms while taking this medicine: bloating; chills; constipation; darkened urine; fast heartbeat; fever; indigestion; loss of appetite; nausea; pain in the stomach, side, or abdomen, possibly radiating to the back; vomiting; or yellow eyes or skin.

Contact your doctor immediately if you experience blurred vision, difficulty reading, or any other change in vision during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Call your doctor right away if you have confusion, drowsiness, a fever, a general feeling of illness, a headache, loss of appetite, nausea, a stiff neck or back, or vomiting. These could be symptoms of meningitis.

Before having any kind of surgery or medical tests, inform your doctor that you are taking this medicine. It may be necessary for you to stop treatment for a while or to switch to a different nonsteroidal anti-inflammatory drug before your procedure.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of using the drug must be weighed against the good it will do. This is a decision you and your doctor will make. For this medication, the following should be considered:

Allergies

Tell your clinician if you have ever had any unusual or allergic reaction to this medicine or any other drugs. Also inform your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of sulindac in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues that would limit the usefulness of sulindac in the elderly. However, elderly patients may be more sensitive to the effects of sulindac than younger adults, and are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving sulindac.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medicine during breastfeeding. Weigh the potential benefits against the potential chances prior to taking this medicine while breastfeeding.

Interactions with Drugs

Although certain medications should not be used together at all, in other cases two different medications may be used together even if an interaction might occur. In these cases, your clinician may want to change the dose, or other precautions may be necessary. When you are using this drug, it is especially important that your healthcare professional know if you are taking any of the drugs listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not advised. Your doctor may decide not to treat you with this medicine or change some of the other drugs you take.

• Ketorolac

Using this medicine with any of the following medicines is typically not recommended, but may be required in some cases. If both medications are prescribed together, your doctor may change the dose or how frequently you use one or both of the medications.

• Abciximab
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Amiloride
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amtolmetin Guacil
• Anagrelide
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Balsalazide
• Bemetizide
• Bemiparin
• Bendroflumethiazide
• Benzthiazide
• Betamethasone
• Betrixaban
• Bismuth Subsalicylate
• Bivalirudin
• Bromfenac
• Budesonide
• Bufexamac
• Bumetanide
• Cangrelor
• Celecoxib
• Certoparin
• Chlorothiazide
• Chlorthalidone
• Choline Magnesium Trisalicylate
• Choline Salicylate
• Cilostazol
• Citalopram
• Clomipramine
• Clonixin
• Clopamide
• Clopidogrel
• Cortisone
• Cyclopenthiazide
• Cyclosporine
• Cyclothiazide
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Deflazacort
• Desipramine
• Desirudin
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexibuprofen
• Dexketoprofen
• Diazoxide
• Dibenzepin
• Diclofenac
• Diflunisal
• Digoxin
• Dipyridamole
• Dipyrone
• Dothiepin
• Doxepin
• Droxicam
• Duloxetine
• Edoxaban
• Emtricitabine
• Enoxaparin
• Eplerenone
• Epoprostenol
• Eptifibatide
• Escitalopram
• Ethacrynic Acid
• Etodolac
• Etofenamate
• Etoricoxib
• Etozolin
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Feverfew
• Floctafenine
• Flufenamic Acid
• Fluocortolone
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Furosemide
• Ginkgo
• Gossypol
• Heparin
• Hydrochlorothiazide
• Hydrocortisone
• Hydroflumethiazide
• Ibuprofen
• Iloprost
• Imipramine
• Indapamide
• Indomethacin
• Inotersen
• Ketoprofen
• Lepirudin
• Levoketoconazole
• Levomilnacipran
• Lithium
• Lofepramine
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Magnesium Salicylate
• Meadowsweet
• Meclofenamate
• Mefenamic Acid
• Melitracen
• Meloxicam
• Melphalan
• Mesalamine
• Methotrexate
• Methyclothiazide
• Methylprednisolone
• Metolazone
• Milnacipran
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nefazodone
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nortriptyline
• Olsalazine
• Opipramol
• Oxaprozin
• Oxyphenbutazone
• Paramethasone
• Parecoxib
• Parnaparin
• Paroxetine
• Pemetrexed
• Pentosan Polysulfate Sodium
• Pentoxifylline
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Phenyl Salicylate
• Piketoprofen
• Piretanide
• Piroxicam
• Polythiazide
• Potassium Citrate
• Prasugrel
• Prednisolone
• Prednisone
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Protriptyline
• Quinethazone
• Reviparin
• Rivaroxaban
• Rofecoxib
• Salicylamide
• Salicylic Acid
• Salsalate
• Selexipag
• Sertraline
• Sibutramine
• Sodium Salicylate
• Spironolactone
• Sulfasalazine
• Sulfinpyrazone
• Sulodexide
• Tacrolimus
• Tenofovir Alafenamide
• Tenofovir Disoproxil Fumarate
• Tenoxicam
• Tianeptine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Torsemide
• Trazodone
• Treprostinil
• Triamterene
• Trichlormethiazide
• Trimipramine
• Trolamine Salicylate
• Valdecoxib
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin
• Xipamide

Using this medicine with any of the following drugs may cause an increased chance of certain adverse effects, but using both drugs may be the best therapy for you. If both drugs are prescribed together, your physician may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Atenolol
• Azilsartan
• Azilsartan Medoxomil
• Benazepril
• Betaxolol
• Bisoprolol
• Candesartan
• Captopril
• Carteolol
• Carvedilol
• Celiprolol
• Dicumarol
• Enalapril
• Enalaprilat
• Eprosartan
• Esmolol
• Fosinopril
• Irbesartan
• Labetalol
• Levobunolol
• Lisinopril
• Losartan
• Metipranolol
• Metoprolol
• Moexipril
• Nadolol
• Nebivolol
• Olmesartan
• Oxprenolol
• Penbutolol
• Perindopril
• Pindolol
• Propranolol
• Quinapril
• Ramipril
• Sotalol
• Spirapril
• Telmisartan
• Timolol
• Trandolapril
• Valsartan

Interactions with Food/Tobacco/Alcohol

Certain medications should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain drugs may additionally cause interactions to occur. Discuss with your healthcare professional the use of your drug with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical issues may affect the use of this medicine. Make sure you inform your clinician if you have any other medical problems, especially:

• Anemia or
• Bleeding problems or
• Blood clots or
• Edema (fluid retention or body swelling) or
• Heart attack, history of or
• Heart disease (e.g., congestive heart failure) or
• Hypertension (high blood pressure) or
• Kidney disease (e.g., kidney stones), history of or
• Liver disease (e.g., hepatitis) or
• Pancreatitis (inflammation of the pancreas) or
• Stomach ulcers or intestinal bleeding, history of or
• Stroke, history of—Use with caution. May make these conditions worse.

• Aspirin-sensitive asthma or
• Aspirin sensitivity, history of—Should not be used in patients with these conditions.

• Heart surgery (e.g., coronary artery bypass graft [CABG])—Should not be used to relieve pain right prior to or after the surgery.

• Systemic lupus erythematosus (SLE)—May cause adverse effects to become worse.

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor right away if any of the following side effects happen:

More common

• Acid or sour stomach
• belching
• constipation
• headache
• heartburn
• nausea or vomiting
• skin rash
• stomach pain

Less common

• Excess air or gas in the stomach or intestines
• itching skin
• passing gas
• stomach cramps
• swelling
• weight loss

Rare

• Back or leg pains
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloating
• bloody or black, tarry stools
• bloody or cloudy urine
• blurred or loss of vision
• burning feeling in the chest or stomach
• burning while urinating
• chest pain
• chills
• clay-colored stools
• confusion
• cough or hoarseness
• cracks in the skin
• dark urine
• decreased urine output
• diarrhea
• difficult or labored breathing
• difficult or painful urination
• difficulty with swallowing
• dilated neck veins
• discoloration of urine
• disturbed color perception
• dizziness
• double vision
• extreme fatigue
• eye pain
• fainting
• feeling of warmth
• fever
• flu-like symptoms
• general body swelling
• general feeling of discomfort or illness
• groin pain
• halos around lights
• hives
• increased sensitivity of the skin to sunlight
• increased sweating
• increased thirst
• indigestion
• irregular breathing
• joint or muscle pain
• large, flat, blue, or purplish patches in the skin
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• loss of appetite
• loss of heat from the body
• lower back or side pain
• muscle aches, pains, or weakness
• nervousness
• night blindness
• noisy breathing
• nosebleeds
• numbness or tingling in the hands, feet, or lips
• overbright appearance of lights
• painful or difficult urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• persistent bleeding or oozing from puncture sites, mouth, or nose
• pinpoint red or purple spots on the skin
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• redness of the face, neck, arms and occasionally, upper chest
• redness or other discoloration of the skin
• redness, swelling, or soreness of the tongue
• scaly skin
• seizures
• severe or continuing stomach pain
• severe sunburn
• shortness of breath
• slow or fast, irregular, pounding, or racing heartbeat or pulse
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stiff neck or back
• stomach upset
• swelling of the face, fingers, feet, or lower legs
• swelling or inflammation of the mouth
• swollen or painful glands
• tenderness in the stomach area
• tightness in the chest
• troubled breathing
• tunnel vision
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• upper right abdominal pain
• vomiting of blood or material that looks like coffee grounds
• watery or bloody diarrhea
• weakness or heaviness of the legs
• weight gain
• wheezing
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Change in consciousness
• decreased awareness or responsiveness
• loss of consciousness
• severe sleepiness

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your healthcare professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your healthcare professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Continuing ringing or buzzing or other unexplained noise in the ears
• hearing loss

Rare

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• burning, dry, or itching eyes
• decreased hearing
• difficulty with moving
• discharge, excessive tearing
• discouragement
• false sense of well-being
• feeling of constant movement of self or surroundings
• feeling sad or empty
• hair loss or thinning of the hair
• hallucinations
• irritability
• loss of interest or pleasure
• metallic or bitter taste
• mood swings
• muscle cramping or stiffness
• personality changes
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• restlessness
• sensation of spinning
• sleepiness or unusual drowsiness
• sleeplessness
• sore or dry mucous membranes
• swelling or redness in the joints
• trouble with concentrating
• trouble with sleeping
• unable to sleep
• vaginal bleeding

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Clinoril

Available Dosage Forms:

• Tablet

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Acetic Acid (class)

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.

It is best to take this medicine with food. Also drink extra fluids so you will pass more urine while you are using this medicine. This will keep your kidneys working well and help prevent kidney problems.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis: Adults—At first, 150 milligrams (mg) two times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 400 mg per day. Children—Use and dose must be determined by your doctor. For acute gout, bursitis, or tendinitis: Adults—At first, 200 milligrams (mg) two times a day. After the pain is relieved, your doctor may direct you to take a lower dose for a while before treatment is stopped completely. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.