Dolobid

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

GENERIC AVAILABLE: Yes

Most patients benefit from diflunisal and other NSAIDs with few side effects. However, serious side effects can occur and generally tend to be seen at higher doses. Therefore, it is often desirable to use the lowest effective dose to minimize side effects. The most common side effects of diflunisal involve the gastrointestinal system. It can cause ulcerations, abdominal burning, pain, cramping, nausea, gastritis, and even serious gastrointestinal bleeding and liver toxicity. Sometimes, stomach ulceration and bleeding can occur without any abdominal pain. Black tarry stools, weakness, and dizziness upon standing may be the only signs of internal bleeding. Rash, kidney impairment, ringing in the ears, and lightheadedness also may occur.

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%

The most frequent types of adverse reactions occurring with DOLOBID (diflunisal) are gastrointestinal: these include nausea** , vomiting, dyspepsia**, gastrointestinal pain**, diarrhea**, constipation, and flatulence.

  Somnolence, insomnia.

  Dizziness.  

  Tinnitus.

  Rash**.

  Headache**, fatigue/tiredness.

Incidence Less Than 1 in 100

The following adverse reactions, occurring less frequently than 1 in 100, were reported in clinical trials or since the drug was marketed. The probability exists of a causal relationship between DOLOBID (diflunisal) and these adverse reactions.

Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria, pruritus, sweating, dry mucous membranes, stomatitis, photosensitivity.

Peptic ulcer, gastrointestinal bleeding, anorexia, eructation, gastrointestinal perforation, gastritis.
Liver function abnormalities; jaundice, sometimes with fever; cholestasis; hepatitis.

Thrombocytopenia; agranulocytosis; hemolytic anemia.

Dysuria; renal impairment, including renal failure; interstitial nephritis; hematuria; proteinuria.

Nervousness, depression, hallucinations, confusion, disorientation.

Vertigo; light-headedness; paresthesias.

Transient visual disturbances including blurred vision.

Acute anaphylactic reaction with bronchospasm; angioedema; flushing.

Hypersensitivity syndrome (see WARNINGS, Hypersensitivity Syndrome).

Asthenia, edema.

Causal Relationship Unknown

Other reactions have been reported in clinical trials or since the drug was marketed, but occurred under circumstances where a causal relationship could not be established. However, in these rarely reported events, that possibility cannot be excluded. Therefore, these observations are listed to serve as alerting information to physicians.

  Dyspnea.

  Palpitation, syncope.

  Muscle cramps.

  Nephrotic syndrome.

 Hearing loss.

  Chest pain.

A rare occurrence of fulminant necrotizing fasciitis, particularly in association with Group A α-hemolytic streptococcus, has been described in persons treated with non-steroidal anti-inflammatory agents, including diflunisal, sometimes with fatal outcome (see also PRECAUTIONS, General).

Potential Adverse Effects

In addition, a variety of adverse effects not observed with DOLOBID (diflunisal) in clinical trials or in marketing experience, but reported with other non-steroidal analgesic/anti-inflammatory agents, should be considered potential adverse effects of DOLOBID (diflunisal) .

**Incidence between 3% and 9%. Those reactions occurring in 1% to 3% are not marked with an asterisk.

Cases of overdosage have occurred and deaths have been reported. Most patients recovered without evidence of permanent sequelae. The most common signs and symptoms observed with overdosage were drowsiness, vomiting, nausea, diarrhea, hyperventilation, tachycardia, sweating, tinnitus, disorientation, stupor and coma. Diminished urine output and cardiorespiratory arrest have also been reported. The lowest dosage of DOLOBID (diflunisal) at which a death has been reported was 15 grams without the presence of other drugs. In a mixed drug overdose, ingestion of 7.5 grams of DOLOBID (diflunisal) resulted in death.

In the event of overdosage, the stomach should be emptied by inducing vomiting or by gastric lavage, and the patient carefully observed and given symptomatic and supportive treatment. Because of the high degree of protein binding, hemodialysis may not be effective.

The oral LD50 of the drug is 500 mg/kg and 826 mg/kg in female mice and female rats respectively.

Dolobid is a prescription medication used to treat mild to moderate pain. It is also used to treat the symptoms of arthritis (osteoarthritis and rheumatoid arthritis). Dolobid belongs to a group of drugs called NSAIDs. These work by blocking chemicals in the body that cause pain and inflammation. 

This medication comes in an oral (by mouth) tablet form and can be taken up to every 8 hours, with food or milk. 

Tablets should be swallowed whole, not crushed or chewed.

Common side effects of Dolobid include nausea, dyspepsia (indigestion), stomach pain, and diarrhea.

Dolobid is a prescription medication used to treat mild to moderate pain. It is also used to treat the symptoms of osteoarthritis and rheumatoid arthritis, conditions that cause pain, swelling, tenderness, and stiffness of the joints.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Diflunisal is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.

Diflunisal is used to treat mild to moderate pain, osteoarthritis, or rheumatoid arthritis.

Diflunisal may also be used for purposes not listed in this medication guide.

Since diflunisal is sometimes used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of this medicine may increase the chance of unwanted effects, especially in elderly patients .

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.

Swallow the tablet whole with a full glass of water. Do not crush or chew it .

To lessen stomach upset, you may take this medicine with food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For mild to moderate pain:
    • Adults and teenagers—1000 milligrams (mg) for the first dose, then 500 mg every eight to twelve hours as needed. Some people may need only 500 mg for the first dose, then 250 mg every eight to twelve hours as needed. Usually, no more than a total of 1500 mg a day should be taken.
    • Children below 12 years of age—Use and dose must be determined by your doctor .
  • For osteoarthritis and rheumatoid arthritis:
    • Adults and teenagers—At first, 250 or 500 mg twice a day. Your doctor may increase or decrease your dose as needed. However, the dose usually is not more than 1500 mg once a day.
    • Children below 12 years of age—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.