"July 8, 2010 -- The recall of Tylenol and other over-the-counter medicines has grown once again, with Tylenol maker McNeil PCC Inc. today announcing the recall of 21 lots of medicines as a precautionary measure.
Today's recall includes "...
Carefully consider the potential benefits and risks of MOTRIN (ibuprofen) tablets and other treatment options before deciding to use MOTRIN (ibuprofen) . Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
MOTRIN (ibuprofen) tablets are indicated for relief of mild to moderate pain.
MOTRIN (ibuprofen) tablets are also indicated for the treatment of primary dysmenorrhea.
Controlled clinical trials to establish the safety and effectiveness of MOTRIN (ibuprofen) tablets in children have not been conducted.
DOSAGE AND ADMINISTRATION
Carefully consider the potential benefits and risks of MOTRIN (ibuprofen) tablets and other treatment options before deciding to use MOTRIN (ibuprofen) tablets. 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 MOTRIN (ibuprofen) tablets, the dose and frequency should be adjusted to suit an individual patient's needs.
Do not exceed 3200 mg total daily dose. If gastrointestinal complaints occur, administer MOTRIN (ibuprofen) tablets with meals or milk.
Suggested Dosage: 1200 mg-3200 mg daily (300 mg qid; 400 mg, 600 mg or 800 mg tid or qid). Individual patients may show a better response to 3200 mg daily, as compared with 2400 mg, although in well-controlled clinical trials patients on 3200 mg did not show a better mean response in terms of efficacy. Therefore, when treating patients with 3200 mg/day, the physician should observe sufficient increased clinical benefits to offset potential increased risk.
The dose should be tailored to each patient, and may be lowered or raised depending on the severity of symptoms either at time of initiating drug therapy or as the patient responds or fails to respond.
In general, patients with rheumatoid arthritis seem to require higher doses of MOTRIN (ibuprofen) tablets than do patients with osteoarthritis.
The smallest dose of MOTRIN (ibuprofen) tablets that yields acceptable control should be employed. A linear blood level dose-response relationship exists with single doses up to 800 mg (See CLINICAL PHARMACOLOGY for effects of food on rate of absorption).
The availability of four tablet strengths facilitates dosage adjustment.
In chronic conditions, a therapeutic response to therapy with MOTRIN (ibuprofen) tablets is sometimes seen in a few days to a week but most often is observed by two weeks. After a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required.
Mild to moderate pain: 400 mg every 4 to 6 hours as necessary for relief of pain.
In controlled analgesic clinical trials, doses of MOTRIN (ibuprofen) tablets greater than 400 mg were no more effective than the 400 mg dose.
For the treatment of dysmenorrhea, beginning with the earliest onset of such pain, MOTRIN (ibuprofen) tablets should be given in a dose of 400 mg every 4 hours as necessary for the relief of pain.
MOTRIN (ibuprofen) tablets are available in the following strengths, colors and sizes:
|400 mg (white, round, imprinted with MOTRIN 400)|
|Bottles of 100 NDC 0009-7385-01|
|Bottles of 500 NDC 0009-7385-02|
|Unit dose blister of 100 NDC 0009-7385-04|
|600 mg (white, elliptical, imprinted with MOTRIN 600)|
|Bottles of 90 NDC 0009-7386-05|
|Bottles of 100 NDC 0009-7386-01|
|Bottles of 270 NDC 0009-7386-09|
|Bottles of 500 NDC 0009-7386-02|
|Unit dose blister of 100 NDC 0009-7386-04|
|800 mg (white, elliptical, imprinted with MOTRIN 800)|
|Bottles of 100 NDC 0009-7387-01|
|Bottles of 270 NDC 0009-7387-08|
|Bottles of 500 NDC 0009-7387-02|
|Unit dose blister of 100 NDC 0009-7387-04|
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
Distributed by: Pharmacia & Upjohn Company., Division of Pfizer Inc, NY, NY 10017. April 2007. FDA rev date: 9/10/2007
Last reviewed on RxList: 9/18/2007
This monograph has been modified to include the generic and brand name in many instances.
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