Finished product reference
Diflunisal
Tablet · Oral · 500 mg
- List code
- 52514
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
Cardiovascular Risk • 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 ).
What it is and how it works
Mechanism class: Cyclooxygenase Inhibitors
Indications
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of diflunisal tablets and other treatment options before deciding to use diflunisal tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Diflunisal tablets are indicated for acute or long-term use for symptomatic treatment of the following: 1. Mild to moderate pain 2. Osteoarthritis 3. Rheumatoid arthritis
Dosage and administration (summary)
DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of diflunisal tablets and other treatment options before deciding to use diflunisal 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 diflunisal tablets, the dose and frequency should be adjusted to suit an individual patient's needs. Concentration-dependent pharmacokinetics prevail when diflunisal is administered; a doubling of dosage produces a greater than doubling of drug accumulation. The effect becomes more apparent with repetitive doses.
Contraindications
CONTRAINDICATIONS Diflunisal tablets are contraindicated in patients with known hypersensitivity to diflunisal or the excipients (see DESCRIPTION ). Diflunisal tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
Warnings and precautions
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.
Pregnancy
Fetal Toxicity Premature Closure of Fetal Ductus Arteriosus: Avoid use of NSAIDs, including diflunisal tablets, in pregnant women at about 30 weeks gestation and later. NSAIDs including diflunisal tablets, increase the risk of premature closure of the fetal ductus arteriosus at approximately this gestational age.
Storage and supply
HOW SUPPLIED Diflunisal Tablets USP, 500 mg are light blue to blue color, capsule shaped, biconvex, coated tablets, debossed with "530" on one side and plain on the other side and are supplied as follows: NDC 68382-530-06 in bottle of 30 tablets NDC 68382-530-14 in bottle of 60 tablets NDC 68382-530-16 in bottle of 90 tablets NDC 68382-530-01 in bo…
Source: Diflunisal (Diflunisal) — US FDA prescribing information, 2024-08-05, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
Tell us the quantity, the market and the timing.
Send the molecule or ingredient, the specification and the destination. We reply from Tehran with the questions, the documents and the next step.