ROXONIN TAPE is indicated for anti-inflammation and analgesia in the following diseases and
symptoms: Osteoarthritis, myalgia, post traumatic swelling and pain
 

Posology:
ROXONIN TAPE should be applied once daily to the affected area.
Use in the Elderly
Significant greater incidence of adverse reactions in the elderly patients age ≥ 65 (3.7%,
65/1,738 patients) compared to age < 65, (1.7%,22/1,300 patients) were observed in the post
marketing surveillance of and ROXONIN TAPE (50mg/100mg). Since the major adverse
reactions included dermal symptoms at the application area, ROXONIN TAPE should be used
with careful monitoring of dermal condition of application area, in the elderly patients age ≥ 65.
Pediatric Use
The safety of ROXONIN TAPE 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:
(1) Do not apply ROXONIN TAPE onto area of damaged or non-intact skin or mucosal membrane.
(2) Do not apply ROXONIN TAPE onto area of eczema and rash
 

1) Careful Administration (ROXONIN TAPE should be administered with
caution in the following patients.)
Patients with bronchial asthma (as the disease state may be exacerbated.)
2) Important Precautions
(1) It is important to note that treatment with anti-inflammatory-analgesic agents is a
symptomatic treatment, not a causal treatment.
(2) For treatment of skin inflammation caused by infectious disease, ROXONIN TAPE 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 ROXONIN TAPE
to the affected part of the skin, under careful observation and caution.
(3) Therapies other than drug treatment must also be considered in using ROXONIN TAPE 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
 

No drug-drug interaction occurs
 

Pregnancy category C
ROXONIN TAPE 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
ROXONIN TAPE 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 non steroidal anti-inflammatory-analgesic drugs for
external use.
 

Not applicable
 

There has been no clinical trial conducted for evaluating frequency of adverse event of ROXONIN
TAPE to date.
However, adverse reactions with use of ROXONIN TAPE 100mg were reported in 91 (8.5%) of
1,075 patients for safety evaluation before approval (based on their subjective/objective
symptoms and clinical laboratory data). The major adverse reactions included dermal
symptoms such as itching (2.1%), erythema (1.5%) and contact dermatitis (1.4%),
gastrointestinal symptoms such as stomach discomfort (0.6%), and abnormal clinical laboratory
values such as increased ALT (0.6%) and increased AST (0.5%). Adverse reactions with use of
ROXONIN TAPE 100mg and ROXONIN TAPE (50mg/100mg) were reported in 87 (2.9%) of
3,038 patients included in the post marketing surveillance. The major adverse reactions
included dermal symptoms such as contact dermatitis (1.4%), pruritus (0.5%) and erythema
(0.4%). [At the end of the re examination period.]
If use of ROXONIN TAPE results in development of any symptom listed below, stop using the
patch preparation or take other appropriate remedy depending on the severity of the symptom

Not applicable
 

CLINICAL STUDIES
The results from clinical studies of the product, including double blind controlled comparative
trials against ROXONIN TAPE 100mg conducted in Japan were as summarized below

Anti-inflammatory effect
ROXONIN TAPE 100mg has been demonstrated significant an anti-inflammatory effect on both
acute inflammations such as carrageenin-induced edema (rat) and chronic inflammations such
as adjuvant arthritis (rat).
Analgesic effect)
ROXONIN TAPE 100mg has been demonstrated to show the analgesic effect in the RandollSelitto test (inflamed paw pressuring method: rat), and in the chronic adjuvant arthritis pain test
(rat)
 

Absorption and Metabolism
Clinical studies to evaluate the bioequivalence between ROXONIN TAPE (50mg/100mg) and
ROXONIN TAPE 100mg in healthy male subjects by applying the patch preparation on the back
of each subject conformed that the concentration of loxoprofen in the horny layer of the skin in
the subjects treated with ROXONIN TAPE was equal to that in the subjects treated with
ROXONIN TAPE 100mg.
After being absorbed transdermally, loxoprofen sodium hydrate is biotransformed into an active
metabolite trans-OH form (SRS coordination) to exert its excellent anti-inflammatory and
analgesic effects in acute inflammations, chronic inflammations and pain
 

No safety information
 

Active Ingredient
Roxonin Tape 50 mg
Loxoprofen sodium hydrate (JP) 56.7mg (50mg as anhydride) in a sheet (1g of ointment)
Roxonin Tape 100 mg
Loxoprofen sodium hydrate (JP) 113.4mg (100mg as anhydride) in a sheet (2g of ointment)
Inactive Ingredients
Styrene-isoprene-styrene block copolymer, polyisobutylene, hydrated silicon dioxide, hydrogenated
rosin glycerol ester, dibutyl hydroxytoluene, l-menthol, liquid paraffin and Phosphoric acid
 

Not applicable
 

ROXONIN TAPE must be stored in light-proof tightly-sealed container below 25 °C
 

How supplied
ROXONIN TAPE is packaged in pouches, each containing seven (7) patches, for supply in a
package size: 1 pouch (7 patches) per package

No special requirements