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Indocin

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Indocin

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Indications
Dosage
How Supplied

INDICATIONS

Carefully consider the potential benefits and risks of INDOCIN (indomethacin) and other treatment options before deciding to use INDOCIN (indomethacin) . Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

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.

DOSAGE AND ADMINISTRATION

Carefully consider the potential benefits and risks of INDOCIN (indomethacin) and other treatment options before deciding to use INDOCIN (indomethacin) . Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

After observing the response to initial therapy with INDOCIN (indomethacin) , the dose and frequency should be adjusted to suit an individual patient's needs.

INDOCIN (indomethacin) 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 (indomethacin) for rectal use.

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

Pediatric Use

INDOCIN (indomethacin) ordinarily should not be prescribed for pediatric patients 14 years of age and under (see PRECAUTIONS, Pediatric Use).

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 (indomethacin) 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 (indomethacin) 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 (indomethacin) 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 (indomethacin) , 25 mg are opaque blue and white capsules, coded INDOCIN (indomethacin) 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 (indomethacin) , 50 mg are opaque blue and white capsules, coded INDOCIN (indomethacin) and MSD 50. They are supplied as follows:

NDC 0006-0050-68 bottles of 100.

No. 3376 - Oral Suspension INDOCIN (indomethacin) , 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 (indomethacin) , 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 (indomethacin) below 30°C (86°F). Avoid temperatures above 50°C (122°F). Protect from freezing.

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

Suppositories INDOCIN® (indomethacin) are distributed by: MERCK & CO., INC., Whitehouse Station, N J 08889, USA
Manufactured by: MERCK SHARP & DOHME., (Italia) S.p.A. 27100 = Pavia, Italy
Capsules and Oral Suspension INDOCIN® (indomethacin) are distributed and manufactured by: MERCK & CO., INC., Whitehouse Station, N J 08889, USA
FDA rev date: 1/30/2007

Last reviewed on RxList: 7/11/2007
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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