Flurbiprofen Information
Flurbiprofen () Description
Flurbiprofen () is a member of the phenylalkanoic acid derivative group of non-steroidal anti-inflammatory drugs. Flurbiprofen () tablets USP are round, blue, film-coated tablets for oral administration. Flurbiprofen () is a racemic mixture of (+)S- and (-)R- enantiomers. Flurbiprofen () is a white or slightly yellow crystalline powder. It is slightly soluble in water at pH 7.0 and readily soluble in most polar solvents. The chemical name is [1,1’-biphenyl]-4-acetic acid,2-fluoro-α-methyl-, (±)-. It has the following structural formula:
CHFO M.W. 244.26
Each tablet, for oral administration, contains 100 mg Flurbiprofen () . In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide, and FD&C Blue #1 aluminum lake.
Flurbiprofen () Clinical Pharmacology
(see also PRECAUTIONS
Drug Interactions)
Flurbiprofen () Indications And Usage
Carefully consider the potential benefits and risks of Flurbiprofen () tablets and other treatment options before deciding to use Flurbiprofen () tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).
Flurbiprofen () tablets are indicated:
Flurbiprofen () Contraindications
Flurbiprofen () tablets are contraindicated in patients with known hypersensitivity to Flurbiprofen () .
Flurbiprofen () tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs. Severe, rarely fatal, anaphylactic-like reactions to non-steroidal anti-inflammatory drugs have been reported in such patients (see , and ,).
Flurbiprofen () tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see ).
Flurbiprofen () Warnings
NSAIDs, including Flurbiprofen () tablets, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3 to 6 months, and in about 2 to 4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk. NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a who use NSAIDs have a greater than 10 fold increased risk for developing a GI bleed compared to patients treated with neither of these risk factors. Other factors that increase the risk of 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. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population.
To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulcerations and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high-risk patients, alternate therapies that do not involve NSAIDs should be considered.
Flurbiprofen () Precautions
Flurbiprofen () tablets cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.
The pharmacological activity of Flurbiprofen () tablets in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.
Borderline elevations of one or more liver tests may occur in up to 15% of patients taking non-steroidal anti-inflammatory drugs, including Flurbiprofen () tablets. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy. Notable elevations of ALT or AST (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials with non-steroidal anti-inflammatory drugs. In addition, rare cases of severe hepatic reactions, including jaundice, fulminant hepatitis, liver necrosis, and hepatic failure, some of them with fatal outcomes have been reported.
A patient with symptoms and/or signs suggesting liver dysfunction, or with abnormal liver test values, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with Flurbiprofen () tablets. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), Flurbiprofen () tablets should be discontinued.
Anemia is sometimes seen in patients receiving non-steroidal anti-inflammatory drugs, including Flurbiprofen () tablets. This may be due to fluid retention, GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with non-steroidal anti-inflammatory drugs, including Flurbiprofen () tablets, should have their hemoglobin or hematocrit checked periodically even if they do not exhibit any signs or symptoms of anemia.
Non-steroidal anti-inflammatory drugs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible. Flurbiprofen () tablets do not generally affect platelet counts, prothrombin time (PT), or partial thromboplastin time (PTT). Patients receiving Flurbiprofen () tablets who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.
As with any NSAID, caution should be exercised in treating the elderly (65 years and older).
Clinical experience with Flurbiprofen () suggests that elderly patients may have a higher incidence of gastrointestinal complaints than younger patients, including ulceration, bleeding, flatulence, bloating, and abdominal pain. (see , ). Likewise, elderly patients are at greater risk of developing renal decompensation (see , ).
The pharmacokinetics of Flurbiprofen () do not seem to differ in elderly patients from those in younger individuals (see , ). The rate of absorption of Flurbiprofen () was reduced in elderly patients who also received antacids, although the extent of absorption was not affected (see , ).
Flurbiprofen () Overdosage
Symptoms following acute overdoses with non-steroidal anti-inflammatory drugs are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of non-steroidal anti-inflammatory drugs, and may occur following an overdose.
Patients should be managed by symptomatic and supportive care following overdose with a non-steroidal anti-inflammatory drug. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms, or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
Flurbiprofen () Dosage And Administration
Carefully consider the potential benefits and risks of Flurbiprofen () tablets USP and other treatment options before deciding to use Flurbiprofen () tablets USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).
After observing the response to initial therapy with Flurbiprofen () tablets USP, the dose and frequency should be adjusted to suit an individual patient's needs.
For relief of the signs and symptoms of rheumatoid arthritis or osteoarthritis, the recommended starting dose of Flurbiprofen () tablets USP is 200 to 300 mg per day, divided for administration two, three, or four times a day. The largest recommended single dose in a multiple-dose daily regimen is 100 mg.
Flurbiprofen () How Supplied
Flurbiprofen () tablets USP, 100 mg are round, blue, film-coated tablets debossed “93”-“711” available in bottles of 100 and 500.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Sellersville, PA 18960
Rev. I 9/2010
Flurbiprofen ()
Flurbiprofen ()
