Drug: Ansaid

ANSAID Tablets contain flurbiprofen, which is a member of the phenylalkanoic acid derivative group of nonsteroidal anti-inflammatory drugs. ANSAID (flurbiprofen) Tablets are white, oval, 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-alphamethyl-, (±)-. The molecular weight is 244.26. Its molecular formula is C15H13FO2 and it has the following structural formula: The inactive ingredients in ANSAID (flurbiprofen) (both strengths) include carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, propylene glycol, and titanium dioxide. In addition, the 100 mg tablet contains FD&C Blue No. 2.

Source: http://www.rxlist.com

TABLE 2: Reported adverse events in patients receiving ANSAID (flurbiprofen) or other nonsteroidal anti-inflammatory drugs
Reported in patients treated with ANSAID Reported in patients treated with other products but not ANSAID Incidence of 1% or greater † Incidence < 1% - Causal Relationship Probable ‡ Incidence < 1% - Causal Relationship Unknown ‡ BODY AS A WHOLE
  edema anaphylactic reaction
chills
fever   < 1%:
  death
  infection
  sepsis CARDIOVASCULAR SYSTEM congestive heart failure
hypertension
vascular diseases
vasodilation angina pectoris
arrhythmias
myocardial infarction < 1%:
  hypotension
  palpitations
  syncope
  tachycardia
  vasculitis DIGESTIVE SYSTEM
  abdominal pain
  constipation
  diarrhea
  dyspepsia/heartburn
  elevated liver enzymes
  flatulence
  GI bleeding
  nausea
  vomiting bloody diarrhea
esophageal disease
gastric/peptic ulcer
  disease
gastritis
jaundice (cholestatic and
noncholestatic)
hematemesis
hepatitis
stomatitis/glossitis appetite changes
cholecystitis
colitis
dry mouth
exacerbation of
  inflammatory
bowel disease
periodontal abscess
small intestine
  inflammation with loss of
  blood and protein > 1%:
  GI perforation
  GI ulcers
  (gastric/duodenal)
< 1%:
  eructation
  liver failure
  pancreatitis HEMIC AND LYMPHATIC SYSTEM aplastic anemia
  (including
agranulocytosis or
pancytopenia)
decrease in hemoglobin
  and hematocrit
ecchymosis/purpura
eosinophilia
hemolytic anemia
iron deficiency anemia
leukopenia
thrombocytopenia lymphadenopathy > 1%:
  anemia
  increased bleeding time
< 1%:
  melena
  rectal bleeding METABOLIC AND NUTRITIONAL SYSTEM
  body weight changes hyperuricemia hyperkalemia < 1%:
  hyperglycemia NERVOUS SYSTEM
  headache
  nervousness and other  manifestations of entral nervous system   (CNS) stimulation (eg, anxiety, insomnia, increased reflexes,  tremor)
  symptoms associated   with CNS inhibition (eg, amnesia, asthenia, depression,
malaise, somnolence) ataxia
cerebrovascular
  ischemia
confusion
paresthesia
twitching convulsion
cerebrovascular accident
emotional lability
hypertonia
meningitis
myasthenia
subarachnoid hemorrhage < 1%:
  coma
  dream abnormalities
  drowsiness
  hallucinations RESPIRATORY SYSTEM
  rhinitis asthma
epistaxis bronchitis
dyspnea
hyperventilation
laryngitis
pulmonary embolism
pulmonary infarct < 1%:
  pneumonia
  respiratory depression SKIN AND APPENDAGES
  rash angioedema
eczema
exfoliative dermatitis
photosensitivity
pruritus
toxic epidermal
necrolysis
urticaria alopecia
dry skin
herpes simplex/zoster
nail disorder
sweating < 1%:
  erythema multiforme
  Stevens Johnson
  syndrome SPECIAL SENSES
  changes in vision
  dizziness/vertigo
  tinnitus conjunctivitis
parosmia changes in taste
corneal opacity
ear disease
glaucoma
retinal hemorrhage
retrobulbar neuritis
transient hearing loss > 1%:
  pruritus
< 1%:
  hearing impairment UROGENITAL SYSTEM
  signs and symptoms
  suggesting urinary tract infection hematuria
interstitial nephritis
renal failure menstrual disturbances
prostate disease
vaginal and uterine
  hemorrhage
vulvovaginitis > 1%:
  abnormal renal function
< 1%:
  dysuria
  oliguria
  polyuria
  proteinuria † from clinical trials
‡ from clinical trials, post-marketing surveillance, or literature Read the Ansaid (flurbiprofen) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

Carefully consider the potential benefits and risks of ANSAID (flurbiprofen) and other treatment options before deciding to use ANSAID (flurbiprofen) . 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 ANSAID (flurbiprofen) , 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 ANSAID (flurbiprofen) 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.

Source: http://www.rxlist.com

ACE-inhibitors Reports suggest that nonsteroidal anti-inflammatory drugs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking nonsteroidal antiinflammatory drugs concomitantly with ACE-inhibitors. Anticoagulants The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone. The physician should be cautious when administering ANSAID (flurbiprofen) to patients taking warfarin or other anticoagulants. Aspirin Concurrent administration of aspirin lowers serum flurbiprofen concentrations (see CLINICAL PHARMACOLOGY, Drug-Drug Interactions). The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of flurbiprofen and aspirin is not generally recommended because of the potential for increased adverse effects. Beta-adrenergic blocking agents Flurbiprofen attenuated the hypotensive effect of propranolol but not atenolol (see CLINICAL PHARMACOLOGY, Drug-Drug Interactions). The mechanism underlying this interference is unknown. Patients taking both flurbiprofen and a beta-blocker should be monitored to ensure that a satisfactory hypotensive effect is achieved. Diuretics Clinical studies, as well as post marketing observations, have shown that ANSAID (flurbiprofen) can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see WARNINGS, Renal Effects), as well as diuretic efficacy. Lithium NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the nonsteroidal anti-inflammatory drug. Thus, when nonsteroidal anti-inflammatory drugs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. Methotrexate Nonsteroidal anti-inflammatory drugs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when nonsteroidal anti-inflammatory drugs are administered concomitantly with methotrexate.Read the Ansaid Drug Interactions Center for a complete guide to possible interactions Learn More »

Source: http://www.rxlist.com

Carefully consider the potential benefits and risks of ANSAID (flurbiprofen) and other treatment options before deciding to use ANSAID (flurbiprofen) . Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). ANSAID (flurbiprofen) is indicated:
  • For relief of the signs and symptoms of rheumatoid arthritis.
  • For relief of the signs and symptoms of osteoarthritis.

Source: http://www.rxlist.com

ANSAID (flurbiprofen) Tablets are contraindicated in patients with known hypersensitivity to flurbiprofen. ANSAID (flurbiprofen) should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs. Severe, rarely fatal, anaphylactic-like reactions to nonsteroidal anti-inflammatory drugs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions, and PRECAUTIONS, Preexisting Asthma). ANSAID (flurbiprofen) is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS). Last reviewed on RxList: 9/10/2010
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Symptoms following acute overdoses with nonsteroidal 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 nonsteroidal anti-inflammatory drugs, and may occur following an overdose. Patients should be managed by symptomatic and supportive care following overdose with a nonsteroidal 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.

Source: http://www.rxlist.com

ANSAID (flurbiprofen) Tablets are available as follows: 50 mg: white, oval, film-coated, imprinted ANSAID (flurbiprofen) 50 mg Bottles of 2000 NDC 0009-0170-24 100 mg: blue, oval, film-coated, imprinted ANSAID (flurbiprofen) 100 mg Bottles of 100 NDC 0009-0305-03
Bottles of 2000 NDC 0009-0305-30 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Distributed by: Pharmacia & Upjohn Company, Division of Pfizer Inc, NY, NY 10017. Revised July 2010 Last reviewed on RxList: 9/10/2010
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General ANSAID (flurbiprofen) 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 ANSAID (flurbiprofen) in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions. Hepatic effects Borderline elevations of one or more liver tests may occur in up to 15% of patients taking nonsteroidal anti-inflammatory drugs, including ANSAID (flurbiprofen) . 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 nonsteroidal 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 ANSAID (flurbiprofen) . If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (eg, eosinophilia, rash, etc.), ANSAID (flurbiprofen) should be discontinued. Hematological effects Anemia is sometimes seen in patients receiving nonsteroidal anti-inflammatory drugs, including ANSAID (flurbiprofen) . This may be due to fluid retention, GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with nonsteroidal anti-inflammatory drugs, including ANSAID (flurbiprofen) , should have their hemoglobin or hematocrit checked periodically even if they do not exhibit any signs or symptoms of anemia. Nonsteroidal 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. ANSAID (flurbiprofen) does not generally affect platelet counts, prothrombin time (PT), or partial thromboplastin time (PTT). Patients receiving ANSAID (flurbiprofen) who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored. Preexisting asthma Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm, which can be fatal. Since cross reactivity, including bronchospasm, between aspirin and other nonsteroidal anti-inflammatory drugs has been reported in such aspirin-sensitive patients, ANSAID (flurbiprofen) should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma. Vision changes Blurred and/or diminished vision has been reported with the use of ANSAID (flurbiprofen) and other nonsteroidal anti-inflammatory drugs. Patients experiencing eye complaints should have ophthalmologic examinations. Laboratory Tests Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs of symptoms of GI bleeding. Patients on long-term treatment with nonsteroidal anti-inflammatory drugs should have their CBC and chemistry profile checked periodically. If clinical signs and symptoms consistent with liver or renal disease develop, systemic manifestations occur (eg, eosinophilia, rash etc.), or abnormal liver tests persist or worsen, ANSAID (flurbiprofen) should be discontinued. Pregnancy Teratogenic effects: Pregnancy Category C Reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities. However, animal reproduction studies are not always predictive of human response. There are no adequate and well-controlled studies in pregnant women. ANSAID (flurbiprofen) should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic effects Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of ductus arteriosus), use during late pregnancy should be avoided. Labor and Delivery In rat studies with nonsteroidal anti-inflammatory drugs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred. The effects of ANSAID (flurbiprofen) on labor and delivery in pregnant women are unknown. Nursing Mothers Concentrations of flurbiprofen in breast milk and plasma of nursing mothers suggest that a nursing infant could receive approximately 0.10 mg flurbiprofen per day in the established milk of a woman taking ANSAID (flurbiprofen) 200 mg/day. Because of possible adverse effects of prostaglandin-inhibiting drugs on neonates, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use As with any NSAID, caution should be exercised in treating the elderly (65 years and older). Clinical experience with ANSAID (flurbiprofen) suggests that elderly patients may have a higher incidence of gastrointestinal complaints than younger patients, including ulceration, bleeding, flatulence, bloating, and abdominal pain. To minimize the potential risk for gastrointestinal events, the lowest effective dose should be used for the shortest possible duration (see WARNINGS, Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation). Likewise, elderly patients are at greater risk of developing renal decompensation (see WARNINGS, Renal Effects). The pharmacokinetics of flurbiprofen do not seem to differ in elderly patients from those in younger individuals (see CLINICAL PHARMACOLOGY, Special Populations). The rate of absorption of ANSAID (flurbiprofen) was reduced in elderly patients who also received antacids, although the extent of absorption was not affected (see CLINICAL PHARMACOLOGY, Drug-Drug Interactions). Last reviewed on RxList: 9/10/2010
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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