"The U.S. Food and Drug Administration today approved the first generic versions of Celebrex (celecoxib) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term (acute) pain, and other conditions.
Teva Pharmaceutical Indus"...
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DOSAGE AND ADMINISTRATION
General Dosing Instructions
Carefully consider the potential benefits and risks of INDOCIN and other treatment options before deciding to use INDOCIN. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS AND PRECAUTIONS].
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient's needs.
Adverse reactions generally appear to correlate with the dose of indomethacin. Therefore, every effort should be made to determine the lowest effective dosage for the individual patient.
Dosage recommendations for active stages of the following:
Moderate To Severe Rheumatoid Arthritis Including Acute Flares Of Chronic Disease; Moderate To Severe Ankylosing Spondylitis ; And Moderate To Severe Osteoarthritis
INDOCIN 25 mg (5 mL) twice a day or three times a day. If this is well tolerated, increase the daily dosage by 25 mg (5 mL) or by 50 mg (10 mL), if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150- 200 mg (30 - 40 mL) 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 (20 mL), of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg (40 mL). In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg (5 mL) or, if required, by 50 mg (10 mL) 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 Use In Specific Populations].
Acute Painful Shoulder (Bursitis And/Or Tendinitis )
INDOCIN 75-150 mg (15-30 mL) 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.
Acute Gouty Arthritis
INDOCIN 50 mg (10 mL) three times a day 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.
Dosage Forms And Strengths
INDOCIN (indomethacin) Oral Suspension 25 mg per 5 mL, is an off-white suspension with a pineapple coconut mint flavor.
Storage And Handling
INDOCIN (indomethacin) Oral Suspension, 25 mg per 5 mL, is an off-white suspension with a pineapple coconut mint flavor. It is supplied as follows:
NDC 42211-101-11 in bottles of 237 mL
Store below 30°C (86°F). Avoid temperatures above 50°C (122°F). Do not freeze.
Manufactured by: Patheon Inc. 111 Consumers Dr. Whitby ON L1N 5Z5 Canada. Distributed by: Iroko Pharmaceuticals, LLC, One Kew Place150 Rouse Boulevard, Philadelphia, PA 19112. Revised: May 2016This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 11/28/2016
Additional Indocin Information
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