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Indomethacin Dosage

Applies to the following strength(s): 25 mg ; 50 mg ; 75 mg ; 25 mg/5 mL ; 1 mg ; 20 mg ; 40 mg

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for Acute Gout

50 mg orally or rectally 3 times a day
Duration of therapy: Until gout attack has resolved

Comments:
-Relief of pain has been observed within 2 to 4 hours; tenderness and heat usually subside within 24 to 36 hours; swelling gradually disappears in 3 to 5 days.
-Extended release capsules are not recommended for the treatment of acute gouty arthritis.

Use: For the treatment of acute gouty arthritis.

Usual Adult Dose for Bursitis

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).

Usual Adult Dose for Tendonitis

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).

Usual Adult Dose for Pain

20 mg orally 3 times a day or 40 mg orally 2 to 3 times a day

Comment:
-The lowest effective dose for the shortest duration possible should be used based on individual patient treatment goals.

Use: For the treatment of mild to moderate acute pain

Usual Adult Dose for Rheumatoid Arthritis

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 rheumatoid arthritis, including acute flares of chronic disease.

Usual Adult Dose for Ankylosing Spondylitis

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.

Usual Adult Dose for Osteoarthritis

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 osteoarthritis.

Usual Pediatric Dose for Patent Ductus Arteriosus

Dosing depends on age of neonate at time of therapy; A course of therapy is defined as 3 IV doses given at 12 to 24 hour intervals.

Age at first dose: Less than 48 hours:
-First dose: 0.2 mg/kg IV
-Second dose: 0.1 mg/kg IV
-Third dose: 0.1 mg/kg IV

Age at first dose: 2 to 7 days:
-First dose: 0.2 mg/kg IV
-Second dose: 0.2 mg/kg IV
-Third dose: 0.2 mg/kg IV

Age at first dose: Over 7 days:
-First dose: 0.2 mg/kg IV
-Second dose: 0.25 mg/kg IV
-Third dose: 0.25 mg/kg IV

Comments:
-Monitor urinary output; if anuria or marked oliguria (urinary output less than 0.6 mL/kg/hr) is evident at time of the second or third dose, hold drug until laboratory studies indicate renal function has returned to normal.
-If ductus arteriosus closes or has significantly reduced in size 48 hours or more after completion of the first course, no further doses are needed.
-If ductus arteriosus re-opens, a second course of 1 to 3 doses may be given.
-If neonate is unresponsive after 2 courses of therapy, surgery may be necessary.

Use: For the closure of a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1750 g when 48 hours of usual medical management is ineffective; clear-cut clinical evidence of hemodynamically significant patent ductus arteriosus should be present (e.g., respiratory distress, continuous murmur, hyperactive precordium, cardiomegaly and pulmonary plethora on chest x-ray).

Usual Pediatric Dose for Rheumatoid Arthritis

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.

Usual Pediatric Dose for Ankylosing Spondylitis

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.

Usual Pediatric Dose for Osteoarthritis

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.

Usual Pediatric Dose for Bursitis

Over 14 years:
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).

Usual Pediatric Dose for Tendonitis

Over 14 years:
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).

Renal Dose Adjustments

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.

Liver Dose Adjustments

-Patients who have an abnormal liver test or who develop signs or symptoms of liver dysfunction should be evaluated for hepatic dysfunction.
-If liver disease develops or if systemic manifestations such as eosinophilia or rash occur, this drug should be discontinued.

-Pediatric: If the decision is made to use this drug in patients 2 years of age or older, close monitoring and periodic assessment of liver function is recommended; there have been reports of hepatotoxicity in pediatric patients with juvenile rheumatoid arthritis, including fatalities.

Dose Adjustments

Elderly:
-Careful dose selection is advised along with close monitoring of renal function.

Adverse events:
-If minor adverse effects develop during dose escalation, reduce dose rapidly to a tolerated dose and observe the patient closely; if severe adverse reactions develop, stop the drug.
-Once acute phase of disease is under control, an attempt to reduce daily dose should be made repeatedly until smallest effective dose is being given or drug is discontinued.

Precautions

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.

Dialysis

Data not available

Other Comments

Administration advice:
Take orally with food, milk, or antacid
-Oral Suspension: Shake well before use
-Rectal Suppositories: Wash hands before use; unwrap and insert rectally with pointed end first while laying on side with knees bent up; lie in place for at least 1 minute following insertion.
-IV: Slow IV infusion over 20 to 30 minutes

Neonatal use:
-Optimal rate of IV injection has not been established, however, published literature suggests an IV infusion rate of 20 to 30 minutes.
Reconstitution/preparation techniques:
-Refer to manufacturer product information
-Must be prepared with preservative-free sterile Sodium Chloride or Water for injection only; benzyl alcohol as a preservative has been associated with toxicity in neonates.

Storage requirements:
-Lyophilized vials: Protect from light; store in carton until ready for use.
-Suppositories: Store at 2C to 8C (36F to 46F).

General:
-Prior to initiating treatment, the potential benefits and risks should be weighed against other treatment options.
-The lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
-There is an increased risk of heart attack, heart failure, and stroke when taking nonsteroidal anti-inflammatory drugs (NSAIDs). These events may occur at any time during treatment and risk increases with long term use; a history of, or risk factors for cardiovascular disease; and higher doses.

Monitoring:
-Neonates: Monitor renal function and serum electrolytes during therapy.
-Cardiovascular: Monitor blood pressure closely during initiation and throughout course of therapy.
-Gastrointestinal: Monitor for signs/symptoms of gastrointestinal bleeding.
-Renal function: Monitor renal status, especially in patients with conditions where renal prostaglandins have a supportive role in the maintenance of renal perfusion.
-Monitor blood counts, renal, and hepatic function periodically for patients receiving long-term therapy.

Patient advice:
-Patients should seek medical advice for signs and symptoms of cardiovascular events, gastrointestinal events, adverse skin reactions, allergic reactions, hepatotoxicity, or unexplained weight gain or edema.
-Patients should seek medical attention immediately if signs/symptoms of cardiovascular events occur, including, shortness of breath, slurred speech, chest pain, or weakness on one side of the body.
-Patients should talk to their health care provider if they are pregnant, planning to become pregnant, or breastfeeding; this drug should not be used during pregnancy at 30 weeks gestation or later.
-Patients should be aware that there are a number of potential drug interactions with this drug and they should speak with a healthcare professional before starting any new medications including over the counter medications.
-Advise patients not to engage in activities requiring mental alertness or motor coordination, including driving, until the effects of this drug are realized.

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