Indomethacin Dosage

Overview Side Effects Dosage Interactions For Professionals More...

This dosage information may not include all the information needed to use Indomethacin safely and effectively. See additional information for Indomethacin.

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

Usual Adult Dose for Ankylosing Spondylitis

Immediate-release: 25 mg orally every 8 to 12 hours. Dosage may be increased by 25 or 50 mg increments every week to a maximum daily dose of 150 to 200 mg. Give with food, immediately after meals, or with antacids to reduce gastric irritation.

Extended-release: 75 mg orally once a day. Dosage may be increased to 75 mg orally twice a day.

Rectal: 50 mg rectally every 8 to 12 hours.

Usual Adult Dose for Osteoarthritis

Immediate-release: 25 mg orally every 8 to 12 hours. Dosage may be increased by 25 or 50 mg increments every week to a maximum daily dose of 150 to 200 mg. Give with food, immediately after meals, or with antacids to reduce gastric irritation.

Extended-release: 75 mg orally once a day. Dosage may be increased to 75 mg orally twice a day.

Rectal: 50 mg rectally every 8 to 12 hours.

Usual Adult Dose for Rheumatoid Arthritis

Immediate-release: 25 mg orally every 8 to 12 hours. Dosage may be increased by 25 or 50 mg increments every week to a maximum daily dose of 150 to 200 mg. Give with food, immediately after meals, or with antacids to reduce gastric irritation.

Extended-release: 75 mg orally once a day. Dosage may be increased to 75 mg orally twice a day.

Rectal: 50 mg rectally every 8 to 12 hours.

Usual Adult Dose for Acute Gout

50 mg orally or rectally 3 times a day until the gouty attack has resolved, usually 2 to 3 days. Indomethacin should be given with food, immediately after meals, or with antacids to reduce gastric irritation.

Usual Adult Dose for Bursitis

75 to 150 mg daily in 3 to 4 divided doses. Give with food, immediately after meals, or with antacids to reduce gastric irritation. The usual course of therapy is 7 to 14 days.

Usual Adult Dose for Tendonitis

75 to 150 mg daily in 3 to 4 divided doses. Give with food, immediately after meals, or with antacids to reduce gastric irritation. The usual course of therapy is 7 to 14 days.

Usual Adult Dose for Cluster Headache

Immediate-release: 25 to 50 mg orally 3 times a day. Give with food, immediately after meals, or with antacids to reduce gastric irritation.

Extended-release: 75 mg orally once or twice a day.

Rectal: 50 mg rectally 2 to 3 times a day.

Usual Pediatric Dose for Patent Ductus Arteriosus

Indomethacin IV:

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.
Doses are given at 12 to 24 hour intervals.

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.
Doses are given at 12 to 24 hour intervals.

Greater than 7 days:
First dose: 0.2 mg/kg IV.
Second dose: 0.25 mg/kg IV.
Third dose: 0.25 mg/kg IV.
Doses are given at 12 to 24 hour intervals.

Usual Pediatric Dose for Rheumatoid Arthritis

2 to 14 years: 2 mg/kg/day given in divided doses. Titrate dose upward to a maximum of 4 mg/kg/day or 200 mg per day. Give with food, immediately after meals, or with antacids to reduce gastric irritation.

Usual Pediatric Dose for Pain

1 to 2 mg/kg/day in 2 to 4 divided doses. Maximum daily dose 4 mg/kg. Give with food, immediately after meals, or with antacids to reduce gastric irritation.

Usual Pediatric Dose for Bartter Syndrome

0.5 to 2 mg/kg/day in divided doses, given with food, immediately after meals, or with antacids to reduce gastric irritation.

Usual Pediatric Dose for Gitelman Syndrome

Case Report (n=3): 1 to 2 mg/kg/day given in three divided doses. Maximum doses of 4 mg/kg/day have been used if poor growth observed.

Usual Pediatric Dose for Langerhans' Cell Histiocytosis

Study (n=10)
Greater than 2 years: 1 to 2.5 mg/kg/day given in 2 to 3 divided doses for an average time of 6 weeks (range: 2 to 16 weeks).

Renal Dose Adjustments

A lower daily dosage should be anticipated to avoid excessive drug accumulation in patients with significantly impaired renal function.

Liver Dose Adjustments

Pediatric patients on indomethacin should be monitored closely and periodic assessment of liver function is recommended. Keep dose at the lowest level to control symptoms.

Dose Adjustments

If the ductus arteriosus closes or is significantly reduced in size after an interval of 48 hours or more from completion of the first course of indomethacin IV, no further doses are necessary. If the ductus arteriosus reopens, a second course of 1 to 3 doses may be given, each dose separated by a 12 to 24 hour interval.

In patients diagnosed with rheumatoid arthritis who have pain at night or morning stiffness, 100 mg of the total daily dose, orally or rectally, may be given at bedtime for relief. In acute flares it may be necessary to increase dose by 25 or 50 mg daily.

A 22-year study of 442 neonates treated with indomethacin for patent ductus arteriosus (PDA) who were also being treated with synthetic or natural surfactant for respiratory distress syndrome (RDS) has shown an increased total dosing requirement for indomethacin of about 0.1 mg/kg when using a synthetic surfactant and about 0.3 mg/kg when using a natural surfactant. Dosing guidelines established prior to the availability of surfactant would be expected to result in relatively poor response rates for PDA closure. The authors caution that only a controlled study of indomethacin dosing requirements in neonates with RDS, with or without surfactant treatment, which can adequately account for all other variables, can provide conclusive answers about the need to change dosing strategies.

Precautions

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 administration. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with NSAIDs, the lowest effective dose should be used for the shortest duration possible. Prescribers and patients should remain vigilant for the development of such events, even in the absence of previous CV symptoms. Patients should be advised about the signs and/or symptoms of serious CV events and the steps to take if they occur. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use.

Serious gastrointestinal (GI) toxicity, such as bleeding, ulceration, and perforation, can occur at any time with or without warning symptoms, in patients receiving NSAID therapy chronically. It has been shown that the incidence of symptomatic upper GI ulcers, gross bleeding, or perforation, caused by NSAIDs, increases with duration of use. However, even short-term therapy is not without risk. Only 1 in 5 patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Caution should be exercised when using NSAIDs in the elderly and debilitated, because most of the spontaneous reports of fatal GI adverse events are in this population. To minimize the potential risk for an adverse GI event, the lowest effective dose should be used for the shortest possible duration. Patients with a prior history of peptic ulcer disease and/or GI bleeding and who use NSAIDs have a greater than 10-fold risk of developing a GI bleeding than patients with neither of these risk factors. In addition, other comorbid conditions may increase the risk of GI bleeding, such as treatment with longer duration of NSAID therapy, smoking, alcoholism, older age, and poor general health status. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high-risk patients, alternate therapies that do not involve NSAIDs should be considered. NSAIDs should be administered with care to patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn's disease) as their condition may be exacerbated.

Indomethacin is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. Patients with a hypersensitivity (angioedema, bronchospasm, urticaria, or rhinitis) to aspirin or other nonsteroidal anti-inflammatory agents (NSAIDs) may be cross sensitive to indomethacin. Patients with the "triad" of asthma, nasal polyps, and aspirin or other NSAID hypersensitivity are at particular risk. The use of indomethacin is considered contraindicated in these patients. The use of indomethacin suppositories in patients with a history of proctitis or recent rectal bleeding is considered contraindicated.

NSAIDs, including indomethacin, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. NSAIDs, including indomethacin, should be used with caution in patients with hypertension. Blood pressure should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.

Fluid retention and edema have been reported in some patients taking NSAIDs. Indomethacin should be used with caution in patients with fluid retention or heart failure.

Long-term NSAIDs use has resulted in renal papillary necrosis and other renal injury. Renal function may be further compromised by the use of indomethacin in patients with renal dysfunction, heart failure, hypovolemia, cirrhosis, nephrotic syndrome, or hypoalbuminemia. Renal blood flow in patients with renal dysfunction, edematous disorders, or hypovolemic states is dependent upon renal prostaglandin synthesis. If indomethacin must be used, periodic monitoring of renal function is recommended. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state. No information is available from controlled clinical trials regarding the use of indomethacin in patients with advanced renal disease. If indomethacin must be initiated, close monitoring of the patient's renal function is advisable.

NSAIDs, including indomethacin, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Corneal deposits and retinal disturbances, including those of the macula, have been reported in some patients who had received prolonged therapy with indomethacin. Physicians should be alert to the possible association between the changes noted and indomethacin. It is advisable to discontinue therapy if such changes are reported. Blurred vision may be a significant effect and warrants a thorough ophthalmological examination. Since these changes may be asymptomatic, ophthalmologic examination is desirable at periodic intervals in patients where therapy is prolonged.

Indomethacin may aggravate depression or other psychiatric disturbances, epilepsy, and parkinsonism and should be used with extreme caution in patients with these conditions. If severe CNS adverse reactions are observed, indomethacin should be discontinued. Indomethacin may cause drowsiness; therefore, patients should be cautioned about engaging in activities that require mental alertness and motor coordination, such as driving a car. Indomethacin may also cause headache. Headache which persists despite dosage reduction requires discontinuation of therapy with indomethacin.

Severe hepatic reactions, including jaundice and cases of fatal hepatitis have been reported with indomethacin as with other NSAIDs. Borderline elevations of one or more liver tests have been reported. These abnormalities may progress, may remain essentially unchanged, or may be transient with continued therapy. The SGPT (ALT) test is probably the most sensitive indicator of liver dysfunction. Meaningful (3 times the upper limit of normal) elevations of SGPT or SGOT (AST) have been reported in controlled clinical trials. Patients with symptoms and/or signs suggesting liver dysfunction, or abnormal liver tests, should be evaluated for evidence of the development of more severe hepatic reactions while on indomethacin. Although such reactions are rare, if abnormal liver tests persist or worsen, if clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), the drug should be discontinued.

Anemia has been reported in patients receiving NSAIDs, including indomethacin. This may be due to fluid retention, GI blood loss, or an effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including indomethacin, should have their hemoglobin and hematocrit checked if they exhibit any signs or symptoms of anemia.

NSAIDs inhibit platelet aggregation and there are reports of prolonged bleeding time in some patients. Patients receiving indomethacin who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.

Intravenous injections of indomethacin should be administered with caution to avoid extravasation or leakage because it may be irritating to tissue.

Patients on long-term treatment with NSAIDs should have their CBC and a chemistry profile checked periodically.

If anuria or marked oliguria (urinary output less than 0.6 mL/kg/hr) is evident at the scheduled time of the second or third dose of indomethacin IV, no additional doses should be given until laboratory studies indicate that renal function has returned to normal. If the infant remains unresponsive to therapy after 2 courses, surgery may be necessary for closure of the ductus arteriosus. If severe adverse reactions occur, stop the drug.

The manufacturer strongly recommends the following actions regarding the use of indomethacin due to its potential to cause adverse reactions:
1. Dosage prescribed should be the lowest effective dose for the patient's condition. Higher dosages are associated with increased adverse events, without increase in clinical benefits.
2. Closely monitor patient for adverse events and instruct patient to report any side effect. Use indomethacin with great care in the elderly.
3. Indomethacin should not be prescribed to patients younger than 14 years of age unless benefits outweigh the risks. Effectiveness of indomethacin in pediatric patients has not been established. If drug must be used in patients two years of age or older, these patients should be closely monitored, and periodic assessment of liver function is recommended. There have been fatalities reported in children who developed hepatotoxicity after taking indomethacin for juvenile rheumatoid arthritis.

A greater incidence of bleeding problems, including gross or microscopic bleeding into the GI tract, oozing from the skin after needle stick, pulmonary hemorrhage, and disseminated intravascular coagulopathy have been reported in premature infants treated with indomethacin (n equals 206), weighing less than or equal to 1750 g, with evidence of large ductal shunting. Renal dysfunction has been reported the most frequently in the collaborative study. Other side effects from the collaborative study have included hyponatremia, hyperkalemia, gastrointestinal bleeding, intracranial bleeding, pulmonary hypertension, decreased platelet aggregation, hypoglycemia, fluid retention, vomiting, abdominal distention, transient ileus, gastric perforation, and necrotizing enterocolitis.

Intravenous injections of indomethacin should be administered with caution to avoid extravasation or leakage because it may be irritating to tissue.