Diflunisal
Generic Name: diflunisal
Brand Names:
Dolobid
DESCRIPTION Diflunisal, USP is [1, 1’-Biphenyl]-3-carboxylic acid, 2’, 4’-difluoro-4-hydroxy. Its structural formula is: Molecular Formula: C 13 H 8 F 2 O 3 Molecular Weight: 250.20 g/mol 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.
Overview
DESCRIPTION Diflunisal, USP is [1, 1’-Biphenyl]-3-carboxylic acid, 2’, 4’-difluoro-4-hydroxy. Its structural formula is: Molecular Formula: C 13 H 8 F 2 O 3 Molecular Weight: 250.20 g/mol 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.
Uses
INDICATIONS AND USAGE 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 WARNINGS ). Dolobid is indicated for acute or long-term use for symptomatic treatment of the following: Mild to moderate pain Osteoarthritis Rheumatoid arthritis
Dosage
DOSAGE AND ADMINISTRATION 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 WARNINGS ). 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.
Side Effects
ADVERSE REACTIONS 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.
Warnings
Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNINGS and PRECAUTIONS ). Dolobid is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATION and WARNINGS ). WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. CONTRAINDICATIONS Dolobid is contraindicated in patients with known hypersensitivity to diflunisal or the excipients (see DESCRIPTION ). Dolobid tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
Storage
HOW SUPPLIED 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.
Frequently Asked Questions
What is Diflunisal used for?▼
INDICATIONS AND USAGE 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 WARNINGS ). Dolobid is indicated for acute or long-term use for symptomatic treatment of the following: Mild to moderate pain Osteoarthritis Rheumatoid arthritis
What are the side effects of Diflunisal?▼
ADVERSE REACTIONS 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.
What are the important warnings for Diflunisal?▼
Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNINGS and PRECAUTIONS ). Dolobid is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATION and WARNINGS ). WARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. CONTRAINDICATIONS Dolobid is contraindicated in patients with known hypersensitivity to diflunisal or the excipients (see DESCRIPTION ). Dolobid tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.