Diflunisal, USP is [1, 1’-Biphenyl]-3-carboxylic acid, 2’, 4’-difluoro-4-hydroxy. Its structural formula is:

Diflunisal, USP is a stable, white, crystalline compound with a melting point of 211° to 213°C. It is practically insoluble in water at neutral or acidic pH. Because it is an organic acid, it dissolves readily in dilute alkali to give a moderately stable solution at room temperature. It is soluble in most organic solvents including ethanol, methanol, and acetone. Each tablet, for oral administration, contains 250 mg and 375 mg diflunisal, USP. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, FD&C Blue No. 2, hypromellose, microcrystalline cellulose, pregelatinized starch, propylene glycol, sodium stearyl fumarate and titanium dioxide.

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

Dolobid is indicated for acute or long-term use for symptomatic treatment of the following:

Dolobid is contraindicated in patients with known hypersensitivity to diflunisal or the excipients (see

Dolobid tablets 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/analphylactoid reactions to NSAIDs have been reported in such patients (see

In the setting of coronary artery bypass graft (CABG) surgery (see

The adverse reactions observed in controlled clinical trials encompass observations in 2,427 patients.

Listed below are the adverse reactions reported in the 1,314 of these patients who received treatment in studies of two weeks or longer. Five hundred thirteen patients were treated for at least 24 weeks, 255 patients were treated for at least 48 weeks, and 46 patients were treated for 96 weeks. In general, the adverse reactions listed below were 2 to 14 times less frequent in the 1,113 patients who received short-term treatment for mild to moderate pain.

Cases of overdosage have occurred and deaths have been reported. Most patients recovered without evidence of permanent sequelae. The most common signs and symptoms observed with overdosage were drowsiness, vomiting, nausea, diarrhea, hyperventilation, tachycardia, sweating, tinnitus, disorientation, stupor, and coma. Diminished urine output and cardiorespiratory arrest have also been reported. The lowest dosage of diflunisal at which a death has been reported was 15 grams without the presence of other drugs. In a mixed drug overdose, ingestion of 7.5 grams of diflunisal resulted in death.

In the event of overdosage, the stomach should be emptied by inducing vomiting or by gastric lavage, and the patient carefully observed and given symptomatic and supportive treatment. Because of the high degree of protein binding, hemodialysis may not be effective.

The oral LD

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

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

Concentration-dependent pharmacokinetics prevail when Dolobid is administered; a doubling of dosage produces a greater than doubling of drug accumulation. The effect becomes more apparent with repetitive doses.

For mild to moderate pain, an initial dose of 1,000 mg followed by 500 mg every 12 hours is recommended for most patients. Following the initial dose, some patients may require 500 mg every 8 hours.

A lower dosage may be appropriate depending on such factors as pain severity, patient response, weight, or advanced age; for example, 500 mg initially, followed by 250 mg every 8 to 12 hours.

For osteoarthritis and rheumatoid arthritis, the suggested dosage range is 500 mg to 1,000 mg daily in two divided doses. The dosage of Dolobid may be increased or decreased according to patient response.

Maintenance doses higher than 1,500 mg a day are not recommended.

Tablets should be swallowed whole, not crushed or chewed.

Dolobid is supplied as follows:

250 mg tablets: Modified Capsule Shape, Blue Film Coated Tablets, Debossed “250” on One Side and Plain on the Reverse Side.

 Bottles of 60: NDC 74157-009-60

375 mg tablets: Modified Capsule Shape, Blue Film Coated Tablets, Debossed “375” on One Side and Plain on the Reverse Side

Bottles of 60: NDC 74157-101-60

Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required).

Keep tightly closed.

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Manufactured for:

Fairmont, WV 26554

ο with increasing doses of NSAIDs

o with longer use of NSAIDs

o anytime during use

o past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs

o taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”

o increasing doses of NSAIDs

o longer use of NSAIDs

o smoking

o drinking alcohol

o older age

o poor health

o advanced liver disease

o bleeding problems

o exactly as prescribed

o at the lowest dose possible for your treatment

o for the shortest time needed

NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain.

These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or to INA Pharmaceutics, Inc. at 866.835.0469.

Other information about NSAIDs

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them.

If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.

Manufactured for:

Fairmont, WV 26554

This Medication Guide has been approved by the U.S. Food and Drug Administration.

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