Indomethacin Suppository

Indomethacin suppositories, for rectal use, contain 50 mg of indomethacin and the following inactive ingredients: butylated hydroxyanisole, butylated hydroxytoluene, edetic acid, glycerin, polyethylene glycol 3350, polyethylene glycol 8000, purified water and sodium chloride. Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid. Indomethacin is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali.

The structural formula is:

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

Indomethacin is indicated 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 tendonitis).
5. Acute gouty arthritis.

Indomethacin is contraindicated in patients with known hypersensitivity to indomethacin or the excipients (see DESCRIPTION).

Indomethacin should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic like reactions to NSAIDs have been reported in such patients (see WARNINGS - Anaphylactoid Reactions, and PRECAUTIONS - Preexisting Asthma).

Indomethacin is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

Indomethacin suppositories are contraindicated in patients with a history of proctitis or recent rectal bleeding.

Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use Indomethacin Suppositories. 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 Indomethacin Suppositories, the dose and frequency should be adjusted to suit an individual patient’s needs.

Indomethacin is available as 50 mg suppositories for rectal use. THIS SECTION MAKES REFERENCE TO CAPSULE DOSAGE FOR GUIDANCE IN USING SUPPOSITORIES.

Adverse reactions appear to correlate with the size of the dose of 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
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:
Indomethacin capsules 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, indomethacin should be used with greater care in the elderly (see PRECAUTIONS, Geriatric Use).

2. Acute painful shoulder (bursitis and/or tendonitis).
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:
Indomethacin capsules 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.

Indomethacin Suppositories, 50 mg each, are white, opaque, rectal suppositories and are supplied in boxes of 30 (NDC 0713-0176-30)

G&W
NDC 0713-0176-30

INDOMETHACINSuppositories USP 50 mgFor Rectal Use

Rx Only

30 Suppositories

FOR RECTAL USE ONLY
Each suppository contains 50 mg indomethacin and the following inactive ingredients: butylated hydroxyanisole, butylated hydroxytoluene, edetic acid, glycerin, polyethylene glycol 3350, polyethylene glycol 8000, purified water, and sodium chloride.

Directions for Suppository Insertion:
1.) Remove foil wrapper. 2. Moisten suppository with water. 3. Insert pointed end first well into rectum. 4. If resistance to insertion is experienced, or suppository is expelled, the suppository may be inserted flat end first. 5. Prevention of expulsion may also necessitate holding the buttocks together. 6. If the suppository cannot be retained, discontinue use.

USUAL DOSAGE: See insert for detailed information regarding dosage and precautions for use.

Store refrigerated between 2° - 8°C (36° - 46°F).

Package not child resistant. Keep this and all drugs out of reach of children.

G&W Laboratories, Inc. South Plainfield, NJ 07080
www.gwlabs.com