JAPROLOX Tablet

This drug has anti-inflammatory and analgesic effects on the following diseases and symptoms: Chronic articular rheumatism, osteoarthritis, Lumbago, periarthritis of the shoulder and Shoulder-arm-neck syndrome.

This drug relieves pain and inflammation after operation, trauma and tooth extraction.

Dosage

For general use, 60mg are orally administered to adults 3 times a day.

For single administration, 60-120mg are orally given. The dosages should be adjusted according to age and symptoms.

1. Patients with peptic ulcers

2. Patients with severe hematological abnormalities

3. Patients with severe hepatic dysfunction

4. Patients with severe renal dysfunction

5. Patients with severe cardiac function failure

6. Patients with a history of hypersensitivity to any of the components of this product

7. Patients with a history of aspirin-induced asthma

8. Women in the late stages of pregnancy

1) This product should be administered to women who are or are possibly only when the anticipated therapeutic benefits are considered to outweigh any potential risk. (The safety of this product in pregnant women has not been established.)

2) This drug should not be used in women in the late stages of pregnancy. (Delayed parturition has been reported in an animal study (in rats).)

3) Fetal arterial vasoconstriction has been reported in a study on rats receiving the drug in the late stages of gestation.

4) Administration of this drug to nursing mothers should be avoided. If administration of this drug is judged to be essential, nursing should be discontinued. (Animal studies (in rats) have demonstrated that loxoprofen is secreted in breast milk.)

1. Patients with a history of peptic ulcers (since the use of this product may cause recurrence of ulceration).

2. Patients with peptic ulcer associated with chronic use of NSAIDs 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 ulcers may be refractory to treatment with misoprostol, which is indicated for NSAIDs-induced peptic ulceration).

3. Patients with or with a history of blood abnormalities (since adverse reaction such as hemolytic anemia are prone to occur).

4. Patients with or with a history of hepatic dysfunction (because exacerbation or recurrence of the liver dysfunction may occur).

5. Patients with or with a history a renal dysfunction (since adverse reactions such as edema, proteinuria, serum creatinine elevation or hyperkalemia may occur).

6. Patients with cardiac dysfunction (see “CONTRAINDICATIONS”).

7. Patients with a history of hypersensitivity.

8. Patients with bronchial asthma (as the disease state may be exacerbated).

9. Patients with colitis ulcerative (as the disease state may be exacerbated).

10. Elderly subjects (see section on “Use in the Elderly”).

11. Patients with Crohn’s disease (as the disease state may be exacerbated).

relatively lower toxicity to the gastrointestinal tract than other non-steroidal analgesic and anti-inflammatory drugs because it is the prodrug showing the effect after absorption from the gastrointestinal tract and active metabolites.

The mode of action of this drug is prostaglandin biosynthesis inhibition and its side of action is cyclooxygenase.

After oral administration, this tablet is rapidly absorbed from the digestive tract in the unchanged from causing weak irritation to the stomach mucosa, and then rapidly converted to an active metabolite, the trans-alcohol from (in SRS configuration) which potently inhibit prostaglandin biosynthesis.