Japrolox Special Precautions

Careful administration (JAPROLOX TABLETS should be administered with care in the following patients): Patients with a history of peptic ulcers [since the use of this product may cause recurrence of ulceration].
Patients with peptic ulcer associated with chronic use of nonsteroidal anti-inflammatory-analgesic agents whose clinical condition required long-term administration of this product and who are currently on misoprostol therapy. [This drug must be administered with care while closely monitoring the clinical condition of patients receiving this drug continuously, because peptic ulcer maybe refractory to treatment with misoprostol, which is indicated for nonsteroidal anti-inflammatory-analgesic drug-induced peptic ulceration.]
Patients with or with a history of blood disorders [since adverse reactions such as hemolytic anemia are prone to occur].
Patients with or with a history of hepatic function disorder [because exacerbation or recurrence of the hepatic function disorder have been reported with the use of JAPROLOX TABLETS].
Patients with or with a history of renal impairment [since adverse reactions such as edema, proteinuria, serum creatinine elevation or hyperkalemia have been reported with the use of JAPROLOX TABLETS].
Patients with cardiac dysfunction [see "Contraindications"].
Patients with a history of hypersensitivity.
Patients with bronchial asthma [as the disease state may be exacerbated].
Patients with colitis ulcerative [as the disease state may be exacerbated].
Patients with Crohn's disease [as the disease state may be exacerbated].
Elderly subjects [see Use in the Elderly as follows].
Important Precautions: It is important to note that treatment with anti-inflammatory-analgesic agents is a symptomatic treatment, not a causal treatment.
The following should be considered when using this product in the management of chronic disease (rheumatoid arthritis, osteoarthritis): Patients receiving long-term medication should be followed by periodic laboratory examinations (e.g., urinalysis, hematological examination, liver function tests). If any abnormality is noted, appropriate measures such as dosage reduction or withdrawal should be taken; Therapies other than drug treatment must also be considered.
The following should be considered in using this product in the management of acute diseases: The proper dosage regimen, depending on the degree of acute inflammation, pain and fever, should be determined; Long-term use of the same drug(s) must be avoided in principle; If any causal treatment is available, should be undertaken preferentially. Aimless treatment with JAPROLOX TABLETS should be avoided.
The patient's clinical condition should be closely observed with caution against the development of adverse reactions. As an excessive decrease in body temperature, collapse, coldness of limbs, etc. may be manifested in patients using this product; the clinical status must be carefully observed after administration of the drug especially in elderly patients with a high-grade fever or patients with a debilitating disease.
JAPROLOX TABLETS may mask the signs and symptoms of infections. Therefore, an appropriate antibiotic should be used in combination with JAPROLOX TABLETS as necessary to treat inflammation due to infection, and the patient should be closely observed and JAPROLOX TABLETS administered with care.
It is recommended to avoid the concomitant use of other anti-inflammatory-analgesic agents with JAPROLOX TABLETS.
Other Precautions: It has been reported that temporary sterility is observed in women receiving long-term NSAID therapy.
Use in Children: The safety of this drug in low-birth-weight infants, newborn infants, infants and toddlers, children and adolescents have not been established.
Use in the Elderly: In elderly patients, pay special attention to adverse reactions. Careful administration is necessary; for example, care should be taken to administer the individual minimum effective dose.
In as much as adverse reactions are likely to occur in elderly patients, this product should be used with caution, e.g., starting at a low dose, while closely observation of the patient's condition (see "Important Precautions" as previously mentioned).