General: A thorough health interview should be performed to predict hypersensitivity reactions.
For long term use, periodic laboratory tests (urine analysis, blood test, liver function test, etc.) should be performed. If any abnormality is observed, appropriate measures such as dose interruption should be taken.
Patients should be monitored closely for adverse reactions. Symptoms such as an excessive decrease in body temperature, collapse and coldness of limbs may occur and hence, this drug should be administered with great care while monitoring their condition in the elderly with hyperthermia or patients with debilitating diseases.
LOCOA must not be used with enoxacin hydrate, lomefloxacin, norfloxacin or prulifloxacin since convulsions have been reported in a few patients after receiving flurbiprofen axetil with these new quinolone antibiotics. The use of LOCOA with other new quinolone antibiotics should be avoided wherever possible.
If cutaneous symptoms are observed with the use of LOCOA, appropriate measures such as drug interruption or discontinuation should be taken according to symptoms.
Temporary infertility has been reported in women after long term use of nonsteroidal anti-inflammatory analgesics.
Careful administration: LOCOA should be administered with care in the following patients.
Patients with peptic ulcer induced by long term use of nonsteroidal anti-inflammatory analgesics who need long term use of LOCOA and are being treated with agents such as misoprostol: Since some patients may have peptic ulcer resistant to agents such as misoprostol, adequate monitoring and careful administration is required, when the use of LOCOA is continued.
Patients with a history of peptic ulcer: Gastric mucosal barrier decreased by inhibition of prostaglandin synthesis may cause a relapse of peptic ulcer.
Patients with current or previous blood abnormality: Blood abnormality may be aggravated or recur by development of blood disorder.
Patients with bleeding tendency: Platelet function may decrease, increasing bleeding tendency.
Patients with current or previous liver disorder: Liver disorder may be aggravated or recur by hepatic function abnormality.
Patients with current or previous renal disorder, or reduced renal blood flow: Renal disorder may be aggravated or recur, or may be induced by reduced renal blood flow via inhibition of prostaglandin synthesis.
Patients with abnormal cardiac function: Water and sodium retention induced by inhibition of prostaglandin synthesis may aggravate cardiac dysfunction.
Patients with hypertension: Water and sodium retention induced by inhibition of prostaglandin synthesis may further increase blood pressure.
Patients with a history of hypersensitivity to esflurbiprofen or flurbiprofen, or any of the other excipients: For the full list of excipients, see Description.
Patients with bronchial asthma: Some patients with bronchial asthma may actually have aspirin-induced asthma, with which asthmatic attacks may be induced.
Patients with ulcerative colitis: Symptoms aggravated by other nonsteroidal anti-inflammatory analgesics have been reported.
Patients with Crohn's disease: Symptoms aggravated by other nonsteroidal anti-inflammatory analgesics have been reported.
Risk of GI ulceration, bleeding and perforation with NSAID: Serious GI toxicity such as bleeding, ulceration and perforation can occur at any time, with or without warning symptoms, in patients treated with NSAID therapy. Although minor upper GI problems (e.g. dyspepsia) are common, usually developing early in therapy, prescribers should remain alert for ulceration and bleeding in patients treated with NSAIDs even in the absence of previous GI tract symptoms.
Studies to date have not identified any subset of patients not at risk of developing peptic ulceration and bleeding. Patients with prior history of serious GI events and other risk factors associated with peptic ulcer disease (e.g. alcoholism, smoking, and corticosteroid therapy) are at increased risk. Elderly or debilitated patients seem to tolerate ulceration or bleeding less than other individuals and account for most spontaneous reports for fatal GI events.
Use this medication by prescription only.
Effects on ability to drive and use machines: It is considered that application of LOCOA at recommended doses has no influence on the ability to drive and use machines.
Use in the elderly: Elderly patients are more susceptible to adverse reactions. Care should be taken in administering LOCOA to elderly patients, for example, limiting the use to a minimal level, while special attention should be paid to possible adverse reactions.
Use in Children: Safety has not been established in low birth weight babies, neonates, babies, infants and children. [There is no experience in the use for the previously mentioned patients.]