Dolobid 250 mg/1
Diflunisal · TABLET, FILM COATED · INA Pharmaceutics Inc
Dolobid is a tablet, film coated containing diflunisal at 250 mg/1, taken oral. Manufactured by INA Pharmaceutics Inc.
Key Facts
- Brand Name
- Dolobid
- Generic Name
- Diflunisal
- NDC Code (Product)
74157-009- Manufacturer
- INA Pharmaceutics Inc
- Strength
- 250 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA202845
- Drug Class
- Nonsteroidal Anti-inflammatory Drug [EPC]
- Marketing Start
- 08/19/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 & Administration
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. 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 accordin…
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. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the devel…
Contraindications
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. Severe, rarely fatal, anaphylactic/analphylactoid reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactic/Anaphylactoid Reactions and PRECAUTIONS, Preexisting Asthma ). In the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).
Adverse Reactions
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. Incidence Greater Than 1% Gastrointestinal The most frequent types of adverse reactions occurring with diflunisal are gastrointestinal: these include nausea*, vomiting, dyspepsia*, gastrointestinal pain*, diarrhea*, constipation, and flatulence. Psychiatric Somnolence, insomnia. Central Nervous System Dizziness. Special Senses Tinnitus. Dermatologic Rash*. Miscellaneous Headache*, fatigue/tiredness. * Incidence between 3% and 9%. Those reactions occurring in 1% to 3% are not marked with an asterisk. Skin and Appendages: Exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and …
Frequently Asked Questions
What is Dolobid used for?
Dolobid contains Diflunisal. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Dolobid a controlled substance?
Dolobid is not classified as a controlled substance by the DEA.
What is the generic name for Dolobid?
The generic name for Dolobid is Diflunisal. There are 5 other brand versions of Diflunisal.
What is the NDC code for Dolobid 250 mg/1?
The NDC (National Drug Code) for Dolobid 250 mg/1 is 74157-009, listed by INA Pharmaceutics Inc.