JAPROLOX Patch Ref.[49536] Active ingredients: Loxoprofen

Careful Administration

Loxoprofen sodium patch should be administered with caution in the following patients: Patients with bronchial asthma (as the disease state may be exacerbated.)

Clinically Significant Adverse Reactions

Shock, anaphylaxis: Shock or anaphylaxis (decreased blood pressure, urticaria, laryngeal oedema, dyspnoea, etc.) may occur. Patients should be carefully monitored. If any abnormalities are observed, use of this drug should be discontinued immediately and appropriate measures should be taken."

Important Precautions

• It is important to note that treatment with anti-inflammatory- analgesic agents is a symptomatic treatment, not a causal treatment.
• For treatment of skin inflammation caused by infectious disease, Loxoprofen sodium patch may cause a risk of masking the signs and symptoms of the infectious disease, therefore, the appropriate antibacterial and/or antifungal drugs must be administered in combination with Loxoprofen sodium patch to the affected part of the skin, under careful observation and caution.
• Therapies other than drug treatment must also be considered in using Loxoprofen sodium patch in the management of chronic diseases (osteoarthritis and others). The patient’s clinical condition should be closely monitored with caution against the development of adverse reactions.
• Avoid using this drug in people with bleeding in the stomach, intestines or ulcers. Since this drug increases the risk of developing these symptoms.
• Avoid using in people with liver disease or kidney disease or abnormal liver function or kidney function.
• This drug, if used continuously for a long time, may produce adverse reactions, such as oral medication, such as the risk of platelet abnormalities or disorders of the cardiovascular system.

Use in the Elderly

Loxoprofen sodium patch should be used with careful monitoring of dermal condition of application area, in the elderly patients.

Pediatric Use

The safety of Loxoprofen sodium patch in low birth weight infants, newborn infants, infants and toddlers, children and adolescents has not been established (because there has been little experience of its use in pediatric patients).

Precautions Concerning Use

Site of application:

• Do not apply Loxoprofen sodium patch onto area of damaged or non-intact skin or mucosal membrane.
• Do not apply Loxoprofen sodium patch onto area of eczema and rash.

Not applicable to both contraindications and precautions for coadministration.

Loxoprofen sodium patch 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 Loxoprofen sodium patch in these populations has not been established.]

It has been reported that constriction of the fetal ductus arteriosus is observed when woman in the late stage of pregnancy received other nonsteroidal anti-inflammatory analgesic drugs for external use.

There is no data available on effects on ability to drive and use machines.

No applicable data is available.