ROXONIN 3D BOX

Roxonin®

Loxoprofen Sodium 60mg

Tablets for oral use

Product leaflet summary

Therapeutic Indications

  1. For relief of inflammation and pain in the following disorders and symptoms:

Rheumatoid arthritis, osteoarthritis, lower back pain, per arthritis of the shoulder, and shoulder-arm-neck syndrome, toothache

  1. For relief of postoperative, post-traumatic or post-exodontia pain and inflammation
  2. An antipyretic and relief of pain in the following disorder:

Acute upper respiratory, tract inflammation, (including acute upper, airway inflammation, accompanying acute bronchitis).

 

Dosage and Administration

ROXONIN usual adult dosage is one tablet three times a day, yet such dosage can be modified accordingly.

 

Contraindications

  • Patients with peptic ulcers [Peptic ulcers may be aggravated due to reduced gastric blood flow resulting from inhibition of prostaglandin biosynthesis.]
  • Patients with severe blood disorders [Platelet dysfunction may occur and the abnormality may be worsened.
  • Patients with severe hepatic functions disorders [Hepatic function disorders have been reported with the use of ROXONIN, and the patient’s hepatic function disorder may be aggravated.]
  • Patients with severe renal impairment [Adverse reactions such as acute renal failure, nephritic syndrome, etc. have been reported with the use of ROXONIN.]
  • Patients with severe cardiac function failure [Cardiac symptoms may be exacerbated because inhibition of prostaglandin biosynthesis in the kidneys may cause edema and an increase in circulating body fluid volume, with a consequent increase in cardiac work.]
  • Patients with a history of hypersensitivity to any ingredients of ROXONIN.
  • Patients with or with a history of aspirin-induced asthma (induction of asthmatic attack with non-steroidal anti-inflammatory-analgesics, etc.) [May induce an aspirin-induced asthmatic attack.]
  • Women in the late stages of pregnancy.

 

Pregnancy and Lactation

 

Pregnancy:

  • ROXONIN should be administered to women who are or are possibly pregnant only when the anticipated therapeutic benefits are considered to outweigh any potential risk. [The safety of this ROXONIN in these populations has not been established.]
  • ROXONIN should not be used in women in the late stages of pregnancy. [Delayed parturition has been reported in an animal study (in rats).]
  • Fetal arterial vasoconstriction has been reported in a study on rats receiving the drug in the late stages of gestation.

 

Lactation:

  • Administration of this drug to nursing mothers should be avoided. If administration of this drug is judged to be essential, nursing should be discontinued.

 

Ability to drive and use machinery

Some undesirable effects of ROXONIN (e.g. dizziness or sleepiness), have been reported to be safe, should be careful when driving and using machines.

 

Package Presentation:

A box of 20 tablets each contains 60 mg loxoprofen sodium