Indocid

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell 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 indomethacin rectal suppositories in children up to 14 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of indomethacin rectal suppositories in the elderly. However, elderly patients may be more sensitive to the effects of indomethacin than younger adults, and are more likely to have unwanted effects (eg, stomach ulcers, confusion, psychosis) and age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving indomethacin rectal suppositories.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

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 taking any of the medicines 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 recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ketorolac

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often 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
• 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
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Deflazacort
• Desipramine
• Desirudin
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexibuprofen
• Dexketoprofen
• Diazoxide
• Dibenzepin
• Diflunisal
• Digoxin
• Dipyridamole
• Dipyrone
• Dothiepin
• Doxepin
• Droxicam
• Duloxetine
• Edoxaban
• Enoxaparin
• Eplerenone
• Epoprostenol
• Eptifibatide
• Escitalopram
• Ethacrynic Acid
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Feverfew
• Floctafenine
• Flufenamic Acid
• Fluocortolone
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Furosemide
• Ginkgo
• Gossypol
• Heparin
• Hydrochlorothiazide
• Hydrocortisone
• Hydroflumethiazide
• Ibuprofen
• Iloprost
• Imipramine
• Indapamide
• Ketoprofen
• Lepirudin
• Levomilnacipran
• Lithium
• Lofepramine
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Magnesium Salicylate
• Meadowsweet
• Meclofenamate
• Mefenamic Acid
• Melitracen
• Meloxicam
• 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
• Piroxicam
• Polythiazide
• Potassium
• Pralatrexate
• Prasugrel
• Prednisolone
• Prednisone
• Probenecid
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Protriptyline
• Reboxetine
• Reviparin
• Rivaroxaban
• Rofecoxib
• Salicylamide
• Salicylic Acid
• Salsalate
• Sertraline
• Sibutramine
• Sodium Salicylate
• Spironolactone
• Sulfasalazine
• Sulindac
• Tacrolimus
• Tenoxicam
• Tianeptine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Torsemide
• Treprostinil
• Triamterene
• Trichlormethiazide
• Trimipramine
• Trolamine Salicylate
• Valdecoxib
• Vasopressin
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin
• Xipamide

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

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

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 Problems

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

• Anemia or
• Bleeding problems or
• Blood clots or
• Depression or other mental changes or
• Edema (fluid retention or body swelling) or
• Heart attack, recent or history of or
• Heart disease (eg, congestive heart failure) or
• Hepatitis or jaundice, history of or
• Hyperkalemia (high potassium in the blood) or
• Hypertension (high blood pressure) or
• Kidney disease or
• Liver disease or
• Parkinsonism or
• Seizures or epilepsy, history of or
• Stomach ulcers or bleeding, history of or
• Stroke, history of—Use with caution. May make these conditions worse.

• Aspirin-sensitive asthma, history of or
• Aspirin sensitivity, history of or
• Proctitis (inflammation of the rectum), history of or
• Rectal bleeding, recent—Should not be used in patients with these conditions.

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

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Acid or sour stomach
• belching
• diarrhea
• heartburn
• indigestion
• nausea
• stomach discomfort, upset, or pain
• vomiting

• Abdominal or stomach cramping, burning, or tenderness
• back or leg pains
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloody or black, tarry stools
• blue lips and fingernails
• blurred vision
• breast enlargement and tenderness
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• burning upper abdominal or stomach pain
• canker sores
• change in consciousness
• change in hearing
• chest pain, discomfort, or burning
• clay colored stools
• cloudy or bloody urine
• confusion
• continuing diarrhea
• cough or hoarseness
• coughing that sometimes produces a pink frothy sputum
• cracks in the skin
• dark urine
• decreased appetite
• decreased vision or any change in vision
• depression
• difficult or labored breathing
• difficulty with swallowing
• dilated neck veins
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• double vision
• dry mouth
• extreme fatigue
• false sense of well-being
• feeling of unreality
• feeling of warmth
• fever with or without chills
• flushed, dry skin
• fruit-like breath odor
• general body swelling
• greatly decreased frequency of urination or amount of urine
• hair loss
• headache
• heavier menstrual periods
• hives or welts, itching skin, or rash
• increased hunger
• increased sweating
• increased thirst
• increased urination
• irregular breathing
• irritation and swelling of the eye
• jerky movements of the head, face, mouth, and neck
• joint 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
• loss of balance control
• loss of bladder control
• loss of consciousness
• loss of hearing
• loss of heat from the body
• lower back or side pain
• mask-like face
• mental confusion
• mood swings
• muscle aches, pains, or weakness
• muscle spasm or jerking of all extremities
• nervousness
• noisy, rattling breathing
• nosebleeds
• numbness or tingling in the hands, feet, or lips
• pain in the ankles or knees
• pain or discomfort in the upper stomach or throat
• pain with swallowing
• painful or difficult urination
• painful, red lumps under the skin, mostly on the legs
• pale skin
• persistent bleeding or oozing from puncture sites, mouth, or nose
• personality changes
• 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
• red, swollen skin
• redness of the face, neck, arms and occasionally, upper chest
• scaly skin
• seeing double
• seeing, hearing, or feeling things that are not there
• seizures
• sense of detachment from self or body
• severe constipation
• severe mental changes
• severe or continuing stomach pain
• shuffling walk
• slow, fast, irregular, pounding, or racing heartbeat or pulse
• slowed movements
• slurred speech
• small red or purple spots on the skin
• sore throat
• sores, ulcers, or white spots on the lips or tongue or inside the mouth
• stiffness of the arms and legs
• sudden loss of consciousness
• swelling in the legs and ankles
• swelling of the face, fingers, feet, or lower legs
• swelling of the breasts or breast soreness in both females and males
• swollen or painful glands
• tightness in the chest
• trembling and shaking of the fingers and hands
• troubled breathing at rest
• troubled breathing with exertion
• unexplained weight loss
• unpleasant breath odor
• unsteadiness or awkwardness
• unusual bleeding or bruising
• unusual tiredness or weakness
• vaginal bleeding
• vomiting of blood or material that looks like coffee grounds
• weakness in the arms, hands, legs, or feet
• weight gain
• yellow eyes or skin

• Frequent urge to defecate
• rectal bleeding, burning, dryness, itching, or pain
• straining while passing stool

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

• Confusion about identity, place, and time
• severe headache
• unusual drowsiness, dullness, or feeling of sluggishness

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

• Mild headache

• Continuing ringing or buzzing or other unexplained noise in the ears
• difficulty having a bowel movement (stool)
• discouragement
• feeling sad or empty
• general feeling of discomfort or illness
• hearing loss
• irritability
• loss of interest or pleasure
• sleepiness
• trouble with concentrating

• Anxiety
• bloated full feeling
• changes in patterns and rhythms of speech
• excess air or gas in the stomach or intestines
• feeling of constant movement of self or surroundings
• involuntary muscle movements
• lightheadedness
• passing gas
• sensation of spinning
• tiredness
• trouble with speaking
• trouble sleeping

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.

Applies to indomethacin: compounding powder, intravenous powder for injection, oral capsule, oral capsule extended release, oral suspension, rectal suppository

Gastrointestinal

Very common (10% or more): Nausea (up to 34%), vomiting (up to 12%)
Common (1% to 10%): Constipation, diarrhea, dyspepsia, upper abdominal pain, abdominal pain/distress, indigestion, heartburn, epigastric pain, gastrointestinal (GI) bleeding, gastrointestinal perforation, necrotizing enterocolitis
Uncommon (0.1% to 1%): Anorexia, bloating/distention, flatulence, peptic ulcer, gastroenteritis, rectal bleeding, proctitis, ulcerations/perforations/hemorrhage of the esophagus, stomach, duodenum, or small and large intestines, intestinal ulceration, stenosis, obstruction, development of ulcerative colitis, development of regional ileitis, ulcerative stomatitis, intestinal strictures
Frequency not reported: Gastric perforation, gastritis, bleeding from sigmoid colon, perforation of existing sigmoid lesions, tenesmus, irritation of rectal mucosa, rectal burning/pain, rectal itching/discomfort, glossitis, esophageal lesions, tenesmus

Patent Ductus Arteriosus:
Common (1% to 10%): GI bleeding, GI perforation, necrotizing enterocolitis
Frequency not reported: Gross/microscopic bleeding into gastrointestinal tract, vomiting, abdominal distention, transient ileus, gastric perforation, localized perforations of small/large intestines, melena[Ref]

Hepatic

Borderline elevations of 1 or more liver function tests can occur in up to 15% of patients taking NSAIDs, including this drug. These elevations may progress, remain unchanged, or may be transient with continued treatment. Elevations of ALT or AST of 3 or more times the upper limit of normal have been reported in about 1% of patients in clinical trials with NSAIDs. Rare cases of severe hepatic reactions, including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure, some with fatal outcomes, have been reported.

Pediatric patients: There have been cases of hepatotoxicity, including fatalities, in pediatric patients with juvenile rheumatoid arthritis.[Ref]

Uncommon (0.1% to 1%): Toxic hepatitis, jaundice, elevated ALT/AST
Frequency not reported: Cholestasis, abnormal liver function[Ref]

Renal

In controlled clinical trials, renal dysfunction occurred statistically significantly more frequently during IV use in neonates than in those treated with placebo. Renal dysfunction has been reported in 41% of neonates and included at least 1 of the following: reduced urinary output, reduced urine sodium, chloride, or potassium; reduced urine osmolality, free water clearance, or GFR; elevated serum creatinine or BUN; or uremia.[Ref]

Uncommon (0.1% to 1%): Nephrotic syndrome, interstitial nephritis, elevated BUN, renal insufficiency, renal failure

Patent Ductus Arteriosus:
Very common (10% or more): Renal dysfunction (41%)
Frequency not reported: Elevated serum creatinine, renal failure, elevated BUN[Ref]

Metabolic

Common (1% to 10%): Decreased appetite
Uncommon (0.1% to 1%): Hyperglycemia, hyperkalemia, glycosuria, weight gain, fluid retention

Patent Ductus Arteriosus:
Common (1% to 10%): Hyponatremia, elevated serum potassium
Frequency not reported: Reduction in blood sugar/hypoglycemia, weight gain/fluid retention, metabolic acidosis, metabolic alkalosis[Ref]

Hematologic

Uncommon (0.1% to 1%): Leukopenia, bone marrow depression, anemia secondary to obvious or occult GI bleeding, aplastic anemia, hemolytic anemia, agranulocytosis, thrombocytopenic purpura, disseminated intravascular coagulation
Frequency not reported: Leukemia, blood dyscrasias/hematopoietic disorders, neutropenia

Patent Ductus Arteriosus:
Common (1% to 10%): Bleeding
Frequency not reported: Disseminated intravascular coagulation, decreased platelet aggregation, thrombocytopenia[Ref]

In a double blind placebo controlled trial of 405 premature infants weighing less than or equal to 1750 g with evidence of large ductal shunting, there was statistically significant greater incidence of bleeding problems, including gross or microscopic bleeding in GI tract, oozing from skin after needle stick, pulmonary hemorrhage, and disseminated intravascular coagulopathy in infants treated with this drug (n=206). There was no statistically significant difference between treatment groups of intracranial hemorrhage.[Ref]

Nervous system

Very common (10% or more): Headache (up to 16%), dizziness (up to 15%)
Common (1% to 10%): Presyncope, somnolence, syncope, intracranial bleeding, fainting
Uncommon (0.1% to 1%): Drowsiness, lightheadedness, paresthesia, aggravation of epilepsy and Parkinsonism, coma, peripheral neuropathy, convulsion, dysarthria, aseptic meningitis, optic neuritis

Patent Ductus Arteriosus:
Very common (10% or more): Intraventricular hemorrhage (up to 14.3%), intracranial hemorrhage (up to 10.5%)
Common (1% to 10%): Intracranial bleeding, periventricular leukomalacia[Ref]

Psychiatric

Common (1% to 10%): Depression, listlessness
Uncommon (0.1% to 1%): Anxiety, nervousness, insomnia, muzziness, psychic disturbances, psychotic episodes, mental confusion, depersonalization
Frequency not reported: Hallucinations[Ref]

Cardiovascular

Common (1% to 10%): Hot flush
Uncommon (0.1% to 1%): Congestive heart failure, hypertension, hypotension, tachycardia, chest pain, arrhythmia, palpitations, angiitis
Frequency not reported: Thrombophlebitis, rapid fall in blood pressure resembling shock, cardiac failure, thrombotic events

Patent Ductus Arteriosus:
Frequency not reported: Bradycardia, hypertension, cardiac failure[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash, sweating/hyperhidrosis, flushing, urticaria
Uncommon (0.1% to 1%): Petechiae, ecchymosis, exfoliative dermatitis, erythema nodosum, loss of hair/alopecia, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, angioedema, purpura
Very rare (less than 0.01%): Eczema
Frequency not reported: Fulminant necrotizing fasciitis, photosensitivity[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Acute anaphylaxis
Very rare (less than 0.01%): Allergy-induced vasculitis
Frequency not reported: Hypersensitivity reactions

Patent Ductus Arteriosus:
Frequency not reported: Hypersensitivity reactions[Ref]

Ocular

Uncommon (0.1% to 1%): Corneal deposits, retinal disturbances, blurred vision, diplopia
Frequency not reported: Orbital/periorbital pain, double vision

Patent Ductus Arteriosus:
Very common (10% or more): Retinopathy of prematurity (up to 21.1%)
Common (1% to 10%): Retrolental fibroplasia
Uncommon (0.1% to 1%): Blindness[Ref]

Other

Very common (10% or more): Post-procedural edema (up to 26%), post-procedural hemorrhage (up to 11%)
Common (1% to 10%): Post-procedural swelling, vertigo, fatigue, malaise, tinnitus, asthenia, exhaustion
Uncommon (0.1% to 1%): Hearing disturbances, deafness, edema, fever
Postmarketing reports: Exacerbation of infection

Patent Ductus Arteriosus:
Frequency not reported: Exacerbation of infection, edema[Ref]

General

The most frequently reported adverse effects were nausea, headache, dizziness, vomiting, constipation, pruritus, diarrhea, dyspepsia, presyncope, rash, upper abdominal pain, somnolence, pruritus, hyperhidrosis, decreased appetite, hot flush, and syncope.

Patent Ductus Arteriosus: The most frequently reported adverse effects were bleeding problems, transient oliguria, and elevated serum creatinine.[Ref]

Genitourinary

Uncommon (0.1% to 1%): Hematuria, vaginal bleeding, proteinuria, breast enlargement/tenderness, gynecomastia
Frequency not reported: Urinary frequency

Patent Ductus Arteriosus:
Very common (10% or more): Oliguria (44%)
Frequency not reported: Transient oliguria[Ref]

Information from various medical literature states that 44% of infants treated with this drug had oliguria. Renal dysfunction appears to be dose related; renal function usually returns to normal 24 hours following discontinuation.[Ref]

Local

Patent Ductus Arteriosus:
Frequency not reported: Bleeding/oozing from skin following needle puncture[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Muscle weakness, involuntary muscle movements
Frequency not reported: Hypercreatininemia, acceleration of cartilage degeneration[Ref]

Respiratory

Uncommon (0.1% to 1%): Dyspnea, acute respiratory distress, asthma, pulmonary edema, epistaxis
Frequency not reported: Bronchospasm, pulmonary eosinophilia, alveolitis

Patent Ductus Arteriosus:
Frequency not reported: Pulmonary hemorrhage, pneumothorax, pulmonary hypertension, apnea, exacerbation of preexisting pulmonary infection[Ref]

Some side effects of indomethacin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Immediate-release capsules and suspension:
75 to 150 mg orally per day in 3 or 4 divided doses

Suppository:
50 mg rectally up to 3 times a day

Extended Release:
75 mg orally once or twice a day

Comments:
-The lowest effective dose for the shortest duration possible should be used based on individual patient treatment goals.
-Therapy should continue until signs/symptoms of inflammation have been controlled for several days; usually 7 to 14 days

Use: For the treatment of acute painful shoulder (e.g. bursitis, tendonitis).

Immediate-release capsules and suspension:
-Initial dose: 25 mg orally 2 or 3 times a day
-Maintenance dose: Adjust dose as needed and tolerated in increments of 25 mg or 50 mg weekly until satisfactory response or maximum dose is achieved
-Maximum single dose: 100 mg
-Maximum daily dose: 200 mg

Suppository:
-Initial dose: 50 mg rectally once a day
-Maintenance dose: 50 to 200 mg rectally per day in divided doses
-Maximum single dose: 100 mg
-Maximum daily dose: 200 mg per day

Comment: For patients who have persistent night pain or morning stiffness, a larger portion of the total daily dose (up to 100 mg) orally or rectally at bedtime may be helpful.

Extended-release:
-Initial dose: 75 mg orally once a day
For patients currently receiving immediate-release at 150 mg per day:
-Initial dose: 75 mg orally twice a day

Comments:
-Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient's treatment goals.
-During acute flares, it may be necessary to increase the dose by 25 mg or 50 mg daily.
-Doses above 150 mg to 200 mg once a day generally do not increase the effectiveness of this drug.

Use: For the treatment of active stages of moderate to severe ankylosing spondylitis.

2 to 14 years:
-Initial dose: 1 to 2 mg/kg/day orally in divided doses
-Maximum dose: 3 mg/kg/day or 150 to 200 mg/day, whichever is less; limited data supports a maximum of 4 mg/kg/day

Comments:
-Safety and efficacy have not been established in patients 14 years and younger; use should be limited to patients for whom toxicity or lack of efficacy with other drugs warrants the risk.
-As symptoms subside, the dose should be reduced or discontinued.
-Use in pediatric patients have been confined to the use of capsules.

Over 14 years:
Immediate-release capsules and suspension:
-Initial dose: 25 mg orally 2 or 3 times a day
-Maintenance dose: Adjust dose as needed and tolerated in increment of 25 mg or 50 mg weekly until satisfactory response or maximum dose is achieved
-Maximum single dose: 100 mg
-Maximum daily dose: 200 mg

Suppository:
-Initial dose: 50 mg rectally once a day
-Maintenance dose: 50 to 200 mg rectally per day in divided doses
-Maximum single dose: 100 mg
-Maximum daily dose: 200 mg per day

Comment:
-For patients who have persistent night pain or morning stiffness a larger portion of the total daily dose (up to 100 mg) orally or rectally at bedtime may be helpful.

Extended-release:
-Initial dose: 75 mg orally once a day
For patients currently receiving immediate-release at 150 mg per day:
-Initial dose: 75 mg orally twice a day

Comments:
-Once response to therapy is determined, dose and frequency should be adjusted to the lowest effective dose for the shortest duration possible to suit the individual patient's treatment goals.
-During acute flares, it may be necessary to increase the dose by 25 mg or 50 mg daily.
-Doses above 150 mg to 200 mg once a day generally do not increase the effectiveness of this drug.

Use: For the treatment of active stages of moderate to severe rheumatoid arthritis, including acute flares of chronic disease.

Advanced Renal Disease: Not recommended; if treatment is necessary, close monitoring of renal function is advised.

Neonates:
-Contraindicated in significant renal impairment.
-If anuria or marked oliguria (urinary output less than 0.6 mL/kg/hr) occurs after a dose of IV therapy, no additional doses should be given until renal function returns to normal.

US BOXED WARNINGS: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS:
-Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with CV disease or risk factors for CV disease may be at greater risk.
-This drug is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
-NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at a greater risk for serious GI events.

Oral and Rectal:
Safety and efficacy have not been established in patients 14 years of age and younger.

Tivorbex (R): Safety and efficacy have not been established in patients 17 years of age and younger.

Consult WARNINGS section for additional precautions.

• Indomethacin helps relieve pain and inflammation by blocking the effects of COX enzymes. This prevents prostaglandin synthesis (prostaglandins elevate body temperature and make nerve endings more sensitive to pain transmission).
• Indomethacin belongs to a group of medicines known as NSAIDs (nonsteroidal anti-inflammatory drugs).

Indomethacin relieves inflammation and pain associated with various types of arthritis. The risk of stomach-related side effects may be higher than that seen with other NSAIDs such as ibuprofen.