Diflunisal

The recommended adult dose of diflunisal for the treatment of rheumatoid arthritis and osteoarthritis ranges from 500mg to 1,000mg daily, in two divided doses with food or milk.

For the relief of pain associated with other types of inflammation, the usual dose is an initial dose of 1000 mg, followed by 500mg every 12 hours. In some cases, such as for seniors or people with a low body weight, a smaller dose of 250mg every 12 hours may be used.

Diflunisal produces significant pain relief within one hour and maximum relief after 2 to 4 hours. Pain relief lasts for 8 to 12 hours. Do not crush or chew the tablets.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Diflunisal exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Diflunisal at room temperature, protect it from moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause diarrhea or constipation, depending on the person; it may cause indigestion; it may cause dizziness - use caution when getting up from a lying or sitting position and use caution if driving; it may increase your blood pressure. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

250 mg
Each light-orange, capsule-shaped, film-coated, biconvex tablet engraved "D250" on one side contains 250 mg of diflunisal. Nonmedicinal ingredients: hydroxypropyl methylcellulose, polyethylene glycol, titanium dioxide, D&C Yellow No. 10, FD&C Yellow No. 6, starch, magnesium stearate, colloidal silicon dioxide, microcrystalline cellulose, and croscarmellose sodium.

500 mg
Each orange, capsule-shaped, film-coated, biconvex tablet engraved "D500" on one side contains 500 mg of diflunisal. Nonmedicinal ingredients: hydroxypropyl methylcellulose, polyethylene glycol, titanium dioxide, FD&C Yellow No. 6, starch, magnesium stearate, colloidal silicon dioxide, microcrystalline cellulose, and croscarmellose sodium.

Do not take diflunisal if you:

• are allergic to diflunisal or any of the ingredients of the medication
• are currently taking an NSAID (e.g., Asa, Ibuprofen)
• have recently had heart bypass surgery are planning to have it
• currently have or recently had an inflammatory disease of the stomach or intestines such as stomach or intestinal ulcer or Ulcerative Colitis
• have had an allergic reaction to ASA or other anti-inflammatory medications
• have high levels of potassium in your blood
• have severely impaired or deteriorating kidney function
• have significant liver impairment or liver disease

There may be an interaction between diflunisal and any of the following:

• Acetaminophen
• alcohol
• angiotensin II receptor blockers (ARBs; e.g., Candesartan, Irbesartan)
• angiotensin converting enzyme (ACE) inhibitors (e.g., Ramipril)
• beta-blockers (e.g., Metoprolol, Atenolol)
• bisphosphonates (e.g., Alendronate, etidronate, Pamidronate, Risedronate, Zoledronic Acid)
• Celecoxib
• Cholestyramine
• Colestipol
• corticosteroids (e.g., Prednisone)
• Cyclosporine
• Desmopressin
• Desvenlafaxine
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, Spironolactone)
• Digoxin
• fluoroquinolone antibiotics (e.g., Ofloxacin, ciprofloxacin)
• Haloperidol
• herbal medications that affect blood clotting (e.g., ginkgo biloba, garlic, ginger, ginseng, glucosamine)
• lithium
• medications used to treat stomach or intestinal ulcers, reflux, or excessive acidity (e.g., Ranitidine, Omeprazole, Esomeprazole, Pantoprazole)
• medications that affect blood clotting, such as acetylsalicylic acid (ASA, Aspirin), Apixaban, Clopidogrel, Enoxaparin, Dalteparin, Heparin, lepirudin, Tinzaparin, or Warfarin
• Methotrexate
• other NSAIDs (e.g.,Naproxen, Indomethacin)
• Pentoxifylline
• potassium supplements
• probenecid
• Pemetrexed
• SSRIs (e.g., Paroxetine, Fluoxetine, Citalopram, Sertraline)
• Sulfinpyrazone
• Tacrolimus
• tenofovir
• tricyclic antidepressants (e.g., Amitriptyline, Doxepin, Imipramine)
• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Diflunisal. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Diflunisal.

HEALTH CANADA ADVISORY

June 8, 2021

Health Canada has issued new information concerning the use of non-steroidal anti-inflammatory drugs (NSAIDs). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

A previous advisory on non-steroidal anti-inflammatory drugs (NSAIDs) was issued on October 30, 2020.

Drowsiness/reduced awareness: Headache, dizziness, lightheadedness, and confusion have been reported by some people using Diflunisal. Avoid operating machinery or motor vehicles or doing other potentially hazardous tasks until you determine how Diflunisal affects you.

Fluid and electrolyte balance: Fluid retention and edema have been reported with use of Diflunisal. People who have the following conditions should be monitored by their doctor while taking Diflunisal:

• certain heart conditions (e.g., Congestive Heart Failure)
• high blood pressure
• Kidney Disease or impaired kidney function
• liver disease
• recovering from surgical operations under general anesthesia
• other conditions that might lead to fluid retention

There is a risk of high blood potassium with treatment with diflunisal. People most at risk are seniors, those having conditions such as Diabetes or kidney failure, and those taking beta-adrenergic blockers, angiotensin converting enzyme (ACE) inhibitors, or some diuretics (water pills).

Heart problems: NSAID medications may increase the risk of heart attacks, strokes, and Blood Clots. The risk is greater with higher doses and long-term use. People at risk of heart problems, such as those with high blood pressure, High Cholesterol, diabetes, peripheral arterial disease, heart failure, or Coronary Artery Disease, should discuss with their doctor how Diflunisal may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Diflunisal, and whether any special monitoring is needed.

Infection: Diflunisal may mask the signs of an infection, such as a fever.

Kidney function: Long-term use of diflunisal may lead to a higher risk of reduced kidney function. This is most common for people who already have kidney disease, liver disease, or heart failure; for people who take diuretics (water pills); and for seniors.

Liver function: Diflunisal may cause liver problems. If you have a liver condition, you may need more frequent checkups with your doctor. If you develop signs of a liver problem (such as yellow skin or eyes, dark urine, pale stools, abdominal pain, or itchy skin), stop taking the medication and see your doctor as soon as possible.

Stomach problems: Stomach ulcers, perforation, and bleeding from the stomach have been known to occur while taking diflunisal. These complications can occur at any time, and are sometimes severe enough to require immediate medical attention. The risk of ulcers and bleeding are increased in people taking higher doses of diflunisal for longer periods of time.

Diflunisal should be taken under close medical supervision by people prone to irritation of the stomach and intestines, particularly those who have had a stomach ulcer, bloody stools, or diverticulosis or other inflammatory disease of the stomach or intestines (such as ulcerative colitis or Crohn's Disease). In these cases, your doctor must weigh the benefits of treatment against the possible risks.

Stop taking the medication and contact your doctor immediately if you experience symptoms or signs suggestive of stomach ulcers or bleeding in the stomach (black, tarry stools). These reactions can occur at any time during treatment without warning.

Pregnancy: Diflunisal should not be used during the third trimester (last 3 months) of pregnancy. Diflunisal should not be used during the first and second trimester (first 6 months) of pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Diflunisal, contact your doctor immediately.

Breast-feeding: Diflunisal passes into breast milk. If you are a breast-feeding mother and are taking Diflunisal, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children:. Diflunisal is not recommended for children under 12 years of age. The safety, effectiveness, and dosages of Diflunisal for this age group have not been established.

Seniors: Seniors appear to have a higher risk of side effects. They should use the lowest effective dosage under close medical supervision.

This medication is typically used twice a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Depending on the treated condition, it may be used regularly or only as needed. Follow the instructions provided by your health care professional. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. It is not advisable to split, chew or crush this medication since it may irritate your mouth and gastrointestinal tract. This medication may irritate the stomach, and should be taken with food. It is best to avoid coffee, spicy food or alcohol.