Indocin label

Indocin

Indocin Recall

Get an alert when a recall is issued.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Carefully consider the potential benefits and risks of INDOCIN and other treatment options before deciding to use INDOCIN. 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.

History

There is currently no drug history available for this drug.

Other Information

Suspension INDOCIN1 for oral use contains 25 mg of indomethacin per 5 mL, alcohol 1%, and sorbic acid 0.1% added as a preservative and the following inactive ingredients: antifoam AF emulsion, flavors, purified water, sodium hydroxide or hydrochloric acid to adjust pH, sorbitol solution, and tragacanth. 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 suspension has a pH of 4.0-5.0. The structural formula is:

Chemical Structure
1
Registered trademark of MERCK & CO., Inc., Whitehouse Station, NJ U.S.A. and licensed to Iroko Pharmaceuticals, LLC, Philadelphia, PA, U.S.A.

All rights reserved

Indocin Manufacturers

  • Iroko Pharmaceuticals, Llc
    Indocin | Iroko Pharmaceuticals, Llc
    No Recall

    Indocin | Iroko Pharmaceuticals, Llc

    Indocin | Iroko Pharmaceuticals, Llc

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

    Oral Suspension INDOCIN contains 25 mg of indomethacin per 5 mL.

    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.

  • Iroko Pharmaceuticals, Llc
    Indocin | Clinical Solutions Wholesale, Llc
    No Recall

    Indocin | Clinical Solutions Wholesale, Llc

    Indocin | Clinical Solutions Wholesale, Llc

    Rifampin can be administered by the oral route (see INDICATIONS AND USAGE).

    See CLINICAL PHARMACOLOGY for dosing information in patients with renal failure.

    Tuberculosis

    Adults: 10 mg/kg, in a single daily administration, not to exceed 600 mg/day, oral

    Pediatric Patients: 10-20 mg/kg, not to exceed 600 mg/day, oral

    It is recommended that oral rifampin be administered once daily, either 1 hour before or 2 hours after a meal with a full glass of water.

    Rifampin is indicated in the treatment of all forms of tuberculosis. A three-drug regimen consisting of rifampin, isoniazid, and pyrazinamide (e.g., RIFATER® 1) is recommended in the initial phase of short-course therapy which is usually continued for 2 months. The Advisory Council for the Elimination of Tuberculosis, the American Thoracic Society, and the Centers for Disease Control and Prevention recommend that either streptomycin or ethambutol be added as a fourth drug in a regimen containing isoniazid (INH), rifampin and pyrazinamide for initial treatment of tuberculosis unless the likelihood of INH resistance is very low. The need for a fourth drug should be reassessed when the results of susceptibility testing are known. If community rates of INH resistance are currently less than 4%, an initial treatment regimen with less than four drugs may be considered.

    Following the initial phase, treatment should be continued with rifampin and isoniazid (e.g., RIFAMATE® 2) for at least 4 months. Treatment should be continued for longer if the patient is still sputum or culture positive, if resistant organisms are present, or if the patient is HIV positive.

    Meningococcal Carriers

    Adults: For adults, it is recommended that 600 mg rifampin be administered twice daily for two days.

    Pediatric Patients: Pediatric patients 1 month of age or older: 10 mg/kg (not to exceed 600 mg per dose) every 12 hours for two days.

    Pediatric patients under 1 month of age: 5 mg/kg every 12 hours for two days.