Indocin (Indomethacin) - Indications and Dosage

INDICATIONS

Indomethacin has been found effective in active stages of the following:

1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease.
2. Moderate to severe ankylosing spondylitis.
3. Moderate to severe osteoarthritis.
4. Acute painful shoulder (bursitis and/or tendinitis).
5. Acute gouty arthritis.

INDOCIN may enable the reduction of steroid dosage in patients receiving steroids for the more severe forms of rheumatoid arthritis. In such instances the steroid dosage should be reduced slowly and the patients followed very closely for any possible adverse effects.

The use of INDOCIN in conjunction with aspirin or other salicylates is not recommended. Controlled clinical studies have shown that the combined use of INDOCIN and aspirin does not produce any greater therapeutic effect than the use of INDOCIN alone. Furthermore, in one of these clinical studies, the incidence of gastrointestinal side effects was significantly increased with combined therapy (see DRUG INTERACTIONS).

DOSAGE AND ADMINISTRATION

INDOCIN is available as 25 and 50 mg Capsules INDOCIN, Oral Suspension INDOCIN, containing 25 mg of indomethacin per 5 mL, and 50 mg Suppositories INDOCIN for rectal use.

Adverse reactions appear to correlate with the size of the dose of INDOCIN in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.

Always give Capsules INDOCIN or Oral Suspension INDOCIN with food, immediately after meals, or with antacids to reduce gastric irritation.

Pediatric Use

INDOCIN ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).

Adult Use

Dosage Recommendations for Active Stages of the Following:

1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
   Suggested Dosage:
   Capsules INDOCIN 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150-200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
   In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
   If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
   If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
   Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
   As advancing years appear to increase the possibility of adverse reactions, INDOCIN should be used with greater care in the elderly (see PRECAUTIONS, Geriatric Use).
2. Acute painful shoulder (bursitis and/or tendinitis).
   Initial Dose:
   75-150 mg daily in 3 or 4 divided doses.
   The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7-14 days.
3. Acute gouty arthritis.
   Suggested Dosage:
   Capsules INDOCIN 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.

HOW SUPPLIED

No. 3316--Capsules INDOCIN, 25 mg are opaque blue and white capsules, coded INDOCIN and MSD 25. They are supplied as follows:

NDC 0006-0025-68 bottles of 100

NDC 0006-0025-82 bottles of 1000

No. 3317--Capsules INDOCIN, 50 mg are opaque blue and white capsules, coded INDOCIN and MSD 50. They are supplied as follows:

NDC 0006-0050-68 bottles of 100

No. 3376--Oral Suspension INDOCIN, 25 mg per 5 mL, is an off-white suspension with a pineapple coconut mint flavor. It is supplied as follows:

NDC 0006-3376-66 in bottles of 237 mL.

No. 3354--Suppositories INDOCIN, 50 mg each, are white, opaque, rectal suppositories and are supplied as follows:

NDC 0006-0150-30, boxes of 30

Storage

Store Oral Suspension INDOCIN below 30°C (86°F). Avoid temperatures above 50°C (122°F). Protect from freezing.

Store Suppositories INDOCIN below 30°C (86°F). Avoid transient temperatures above 40°C (104°F).

Suppositories INDOCIN are distributed by:

MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Manufactured by:

MERCK SHARP & DOHME

(Italia) S.p.A.

27100--Pavia, Italy

Capsules and Oral Suspension INDOCIN® are distributed and manufactured by:

MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

7873328 Issued February 2002

COPYRIGHT © MERCK & CO., INC., 1988

All rights reserved