Lodine XL (Oral)

Etodolac is a nonsteroidal anti-inflammatory drug (NSAID) that is used to treat mild to moderate pain and to relieve symptoms of arthritis, such as osteoarthritis and rheumatoid arthritis. It helps with inflammation, swelling, stiffness, and joint pain. However, this medicine does not cure arthritis and will only help you as long as you keep taking it.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress during regular visits. This will help your doctor see if the medicine is working properly. Blood and urine tests may be needed to check for side effects.

Using this medicine during the later part of your pregnancy can harm your unborn baby. If you think you may be pregnant while using the medicine, tell your doctor immediately.

This medicine may increase your risk of having a heart attack or stroke. This risk is higher for people who already have heart disease or for those who use this medicine for a longer time.

This medicine may cause bleeding in your stomach or intestines. These issues can happen without warning signs. You are at greater risk if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years old, if you are in poor health, or if you are using certain other medicines (e.g., steroids or a blood thinner).

Contact your doctor immediately if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be signs of a serious liver issue.

Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), can occur while using this medicine. Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

Possible warning signs of serious side effects during treatment with this medicine may include swelling of the face, fingers, feet, or lower legs, severe stomach pain, black, tarry stools, vomiting of blood or material that looks like coffee grounds, unusual weight gain, yellow skin or eyes, decreased urination, unusual bleeding or bruising, or skin rash. Also, signs of serious heart problems could occur, including chest pain or tightness, fast or irregular heartbeat, unusual flushing or warmth of the skin, weakness, or slurred speech. Contact your doctor immediately if you notice any of these warning signs.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be signs of a serious kidney issue.

This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. This may happen more often in patients who are allergic to aspirin or to any nonsteroidal anti-inflammatory drugs. Call your doctor right away if you have a rash, itching, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while using this medicine.

Before having any type of surgery or medical tests, tell your doctor that you are using this medicine. You may need to stop treatment for a while or switch to a different NSAID before your procedure.

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

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

Allergies

Inform your physician if you have ever had any unusual or allergic reaction to this drug or any other medications. As well 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 etodolac capsules and tablets in the pediatric population and extended-release tablets in children younger than 6 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of etodolac in the elderly. Nevertheless, elderly patients are more sensitive to the effects of etodolac than younger adults, and are more likely to have age-related kidney issues, which may require adjustment of dosage in patients receiving etodolac.

Breast Feeding

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

Interactions with Medications

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are using any of the medications 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 drugs is not advised. Your physician may decide not to treat you with this drug or change some of the other medications you take.

• Ketorolac

Using this medication with any of the following medicines is typically not advised, 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 medicines.

• 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
• 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
• 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
• Sulindac
• 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 medication with any of the following medicines may cause an increased risk of certain side 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 frequently you use one or both of the drugs.

• 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 medicines 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 medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Issues

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

• Anemia or
• Asthma or
• Bleeding issues or
• Blood clots or
• Edema (fluid retention or body swelling) or
• Heart attack, recent or history of or
• Heart disease (eg, heart failure) or
• Hypertension (high blood pressure) or
• Kidney disease or
• Liver disease or
• Stomach ulcers or bleeding, history of or
• Stroke, history of—Use with caution. May make these conditions worse.

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

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

Along with its needed effects, Lodine XL (Oral) may 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 occur:

More common

• Belching
• bloody or black, tarry stools
• blurred vision
• body aches or pain
• chest pain
• cloudy urine
• constipation
• cough or hoarseness
• decrease in urine output or decrease in urine-concentrating ability
• diarrhea
• dizziness
• dryness or soreness of throat
• feeling of indigestion
• fever or chills
• headache
• increased bleeding time
• itching, skin rash
• loss of appetite
• lower back or side pain
• nausea and vomiting
• nervousness
• pain in the chest below the breastbone
• painful or difficult urination
• pale skin
• pounding in the ears
• runny nose
• slow or fast heartbeat
• stomach bloating, burning, cramping, or pain
• swelling
• tender, swollen glands in neck
• trouble swallowing
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• voice changes
• vomiting of blood or material that looks like coffee grounds
• weight loss

Symptoms of overdose

• Agitation
• change in consciousness
• confusion
• depression
• difficult or trouble breathing
• hives
• hostility
• irregular, fast or slow, or shallow breathing
• irritability
• loss of consciousness
• muscle twitching
• pain or discomfort in chest, upper stomach, or throat
• pale or blue lips, fingernails, or skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• seizures
• sleepiness
• stupor
• swelling of face, ankles, or hands
• tightness in chest
• trouble breathing
• unusual drowsiness, dullness, or feeling of sluggishness

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 Lodine XL (Oral). Your health care professional may also be able to tell you ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Bloated, full feeling
• continuing ringing or buzzing or other unexplained noise in ears
• excess air or gas in stomach or intestines
• hearing loss
• lack or loss of strength
• passing gas
• sneezing
• stuffy nose

Other side effects not listed may also occur 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.

• Lodine
• Lodine XL

Available Dosage Forms:

• Tablet, Extended Release
• Tablet
• Capsule

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. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Swallow the extended-release tablet whole. Do not crush, break, or chew it.

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 acute pain:For oral dosage form (capsules or tablets): Adults—200 to 400 milligrams (mg) every 6 to 8 hours. However, the dose usually is not more than 1000 mg per day. Children—Use and dose must be determined by your doctor.

• For osteoarthritis and rheumatoid arthritis:For oral dosage form (capsules or tablets): Adults—300 milligrams (mg) 2 to 3 times a day, or 400 or 500 mg 2 times a day. Your doctor may lower your dose to 600 mg once a day. The dose usually is not more than 1000 mg per day. Children—Use and dose must be determined by your doctor. For oral dosage form (extended-release tablets): Adults—400 to 1000 milligrams (mg) once a day. Children 6 to 16 years of age—Dose is based on body weight and must be determined by your doctor. Children younger than 6 years of age—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.

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.