Adult Dosing
Mild to moderate pain
- Initial dose 1000 mg PO, then 500 mg PO q8-12 hrs
- May start 500 mg PO, followed by 250 mg PO q8-12 hrs, depending on factors such as pain severity, patient response, weight, or advanced age
- Max: 1500 mg/day
Osteoarthritis and rheumatoid arthritis
- 500-1000 mg PO daily in 2 divided doses; adjust the dose as per the patient response
- Max: 1500 mg/day
Note:
- Use the lowest effective dose for shortest duration consistent with the patient treatment goals
- Do not crush or chew the tablet; swallow them whole
Pediatric Dosing
- Safety and effectiveness in pediatric patients <12 yrs of age have not been established
Mild to moderate pain
- Initial dose 1000 mg PO, then 500 mg PO q8-12 hrs
- May start 500 mg PO, followed by 250 mg PO q8-12 hrs, depending on factors such as pain severity, patient response, weight, or advanced age
- Max: 1500 mg/day
Osteoarthritis and rheumatoid arthritis
- 500-1000 mg PO daily in 2 divided doses; adjust the dose as per the patient response
- Max: 1500 mg/day
Note:
- Use the lowest effective dose for shortest duration consistent with the patient treatment goals
- Do not crush or chew the tablet; swallow them whole
[Outline]
Renal Dose Adjustment (Based on CrCL)
- Renal impairment (<50 mL/min): Decrease the dose to 50%
- Advanced renal disease: Contraindicated
Hepatic Dose Adjustment
- Hepatic impairment: Dose adjustment not defined; use with caution
- NSAIDs may increase the risk of serious and potentially fatal cardiovascular thrombotic events, MI, and stroke. This risk further increases with the duration of use, presence of cardiovascular disease/risk factors for CV disease [US Black Box Warning]
- Use the lowest effective dose for the shortest duration possible in patients with known CV disease or risk factors for CV disease to minimize the potential risk for an adverse CV event
- Diflunisal may cause severe inflammation, bleeding, ulceration, and perforation of the stomach, small intestine or large intestine, which can be fatal. Restrict use in patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding
- If a serious GI adverse event is suspected, discontinue the therapy and promptly institute an alternative therapy
- Factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status
- Carefully observe patients for signs and symptoms of GI ulceration and bleeding during therapy
- Severe hepatotoxicity can occur any time during treatment; closely monitor ALT and AST levels periodically in patients receiving prolonged therapy. Use the lowest effective dose for the shortest duration possible to minimize the potential risk of hepatotoxicity
- Avoid concomitant use of the drugs known to be potentially hepatotoxic
- May cause onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to increased risk of CV events
- Use with caution in patients taking thiazides or loop diuretics as it may impair the therapeutic response of thiazides or loop diuretics; closely monitor BP during the therapy
- Use cautiously in patients with fluid retention or heart failure because it may cause fluid retention and edema
- Monitor for renal toxicity in long-term treatment, including renal papillary necrosis and other renal injury. Patients at greater risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, patients who are volume depleted, and the elderly
- Contraindicated in advanced renal disease
- Restrict administration in patients with aspirin triad, which occurs typically in asthmatic patients who experience rhinitis with or without nasal polyps, or in patients who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs
- Discontinue the treatment at the first appearance of skin rash or any other signs of hypersensitivity such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis
- Potentially fatal, life-threatening hypersensitivity reactions which include constitutional symptoms and cutaneous findings, and involvement of major organs (changes in liver function, jaundice, leukopenia, thrombocytopenia, eosinophilia, disseminated intravascular coagulation, renal impairment, including renal failure) have been reported
- Do not administer in pregnant women after 30 weeks as it may cause premature closure of the ductus arteriosus in the fetus
- Check hematologic profile including hemoglobin or hematocrit at regular intervals in patients on long-term treatment with NSAIDs as it may cause anemia due to fluid retention, occult or gross GI blood loss
- Diflunisal may inhibit platelet aggregation and prolong bleeding time; closely monitor patients with coagulation disorders or those receiving anticoagulants
- Cautiously administer in patients with preexisting asthma/aspirin-sensitive asthma as it may exacerbate the symptoms
- Perform CBC and other blood chemistries, liver function test, and renal function test periodically
- Patients who develop eye complaints during treatment with diflunisal tablets should have ophthalmologic studies because of the potential for adverse eye reactions
- Reye's syndrome may develop during the therapy
- Use with caution in older age, poor general health status, and debilitated patients
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Corticosteroid use
- Preexisting kidney disease
- Dehydration
Pregnancy Category:C (caution in 3rd trimester)
Breastfeeding: Very small amounts of the drug have been found in milk which does not pose a serious risk to breastfeeding infants. Shorter-acting agents having more published information may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 22 March 2011). As per manufacturer's data, due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, analyzing the importance of the drug to the mother.
Pricing data from www.DrugStore.com in U.S.A.
- Diflunisal 500 MG TABS [Bottle] (TEVA PHARMACEUTICALS USA)
60 mg = $81.99
180 mg = $220.98
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
Drug Name: DIFLUNISAL 500 mg
Ingredient(s): N/A
Imprint: 755;93
Color(s): Blue
Shape: Oval
Size (mm): 19.00
Score: 1
Inactive Ingredient(s): croscarmellose sodium / fd&c blue no. 2 / hypromellose / cellulose, microcrystalline / starch, corn / propylene glycol / sodium stearyl fumarate / titanium dioxide
Drug Label Author:
TEVA Pharmaceuticals USA Inc
DEA Schedule:
Non-Scheduled
Drug Name: Diflunisal 500 MG Oral Tablet
Ingredient(s): Diflunisal
Imprint: 755;93
Color(s): Blue
Shape: Oval
Size (mm): 19.00
Score: 1
Inactive Ingredient(s): croscarmellose sodium / fd&c blue no. 2 / hypromellose / cellulose, microcrystalline / starch, corn / propylene glycol / sodium stearyl fumarate / titanium dioxide
Drug Label Author:
Physicians Total Care, Inc.
DEA Schedule:
Non-Scheduled
