Mohrus Patch慕拉適貼藥

Mohrus Patch

ketoprofen

Manufacturer:

Hisamitsu Pharmaceutical

Distributor:

The Glory Medicina
/
DKSH
Full Prescribing Info
Contents
Ketoprofen.
Description
Each one gram of adhesive mass of this product contains 20 mg ketoprofen, which is listed in the Japanese Pharmacopoeia. This product also contains l-menthol, dibutylhydroxytoluene, hydrogenated rosin glycerol ester, styrene-isoprene-styrene black copolymer, 4-tert-butyl-4'-methoxydibenzoylmethane, polyisobutylene, liquid paraffin, and five other ingredients.
This product is a patch in which the adhesive mass is coated onto the pale brown-to brown-colored base material and the surface of the adhesive mass is covered with a plastic film. When the plastic film is removed, the surface of the adhesive mass is pale brown-to brown-colored and is semi-transparent, and has a distinctive odor.
Indications/Uses
Relief of pain and inflammation in the following disorders and symptoms: Lumbago (muscular and fascial lumbago, spondylosis deformans, discopathy, and sprain of lumber spine), osteoarthritis, humeroscapular periarthritis, tendinitis/tendovaginitis, peritendinitis, humeral epicondylitis (e.g. tennis elbow), myalgia and post-traumatic swelling/pain.
Relief of local joint pain in rheumatoid arthritis.
Dosage/Direction for Use
Apply this product to the affected site once a day. For external use only.
Contraindications
(This product should not be used in the following patients): Patients with a history of hypersensitivity to this product or its ingredients. (See Precautions.)
Patients with aspirin-induced asthma (induction of the attacks of asthma by drugs, e.g. nonsteroidal anti-inflammatory analgesic drugs) or a history thereof. (There is a risk of inducing attacks of bronchial asthma.)
Patients with a history of hypersensitivity to tiaprofenic acid, suprofen, fenofibrate, or products containing oxybenzone or octocrylene (sunscreen, fragrance, etc.). In the case of patients with a history of hypersensitivity to these ingredients, there is a risk of developing hypersensitivity to this product.
Patients with a history of photosensitivity reactions. (There is a risk of inducing photosensitivity reactions.)
Women in the late stage of pregnancy. (See Use in Pregnancy & Lactation.)
Special Precautions
Careful Administration (This product should be used with caution in the following patients): Patients with bronchial asthma (There is a risk of patients having possible latent aspirin-induced asthma). (See Adverse Reactions.)
Important Precautions: Do not use this product in patients with a history of hypersensitivity (including erythema, rash/reddening, swelling, irritation, itching, etc.) to this product or its ingredients.
As contact dermatitis and photosensitive reactions may develop after administration of this product and some cases have progressed to severe systemic rash, give the following instructions to patients prior to use. (See Adverse Reactions): 1) As contact dermatitis may develop irrespective of the presence or absence of exposure to ultraviolet light, stop using this product immediately, protect the site from sunlight and seek medical advice when any skin symptoms such as rash/reddening, itching, irritation, etc. develop. It should be noted that such symptoms may develop a few days after starting using this product.
2) As photosensitive reactions may develop, avoid outside activity irrespective of the weather while using this product, and cover the application site with clothes or a supporter, etc. to avoid sunlight when going out. As ultraviolet light may possibly penetrate white materials and thin clothes, wear colored clothes to prevent this. As the reactions may develop from a few days to a few months after stopping using this product, continue to take the above precautions for some time even after stopping using this product.
Stop using this product immediately when any abnormal findings are observed, cover the affected site from sunlight and treat it appropriately.
Because of the risk of masking underlying skin infections, it is advised to use appropriate antibiotics or antifungal agents concomitantly when this product is used to treat inflammation with infection. Apply this product with caution while carefully observing the patient's condition.
When this product is used for treating lumbago, osteoarthritis, humeroscapular periarthritis, tendinitis/tendovaginitis, peritendinitis, humeral epicodylitis, myalgia, and post-traumatic swelling/pain, pay attention to the following: As this product treats only symptoms, it is advised to consider using other therapies and other drug therapies depending on the symptoms.
Observe the patient's condition carefully and pay particular attention to the possible development of adverse reactions during long-term treatment.
When this product is used to relieve local joint pain in rheumatoid arthritis, pay attention to the following: 1) As this product treats only symptoms in rheumatoid arthritis, it should be used only for patients who have been treated appropriately with drugs such as anti-rheumatic agents yet who will still have joint pain.
2) Observe the condition of joint pain during use and avoid unnecessary long-term continuous applications. Keep the use of this product to a minimum.
Precautions Concerning Use: Application site: Since this product may cause skin irritation, it should not be used on the following sites: Damaged skin and mucous membrane.
A site with eczema or rash.
Pediatric Use: The safety of this product has not been established for low birth weight infants, neonates, babies, infants or children (limited clinical experience of use).
Use in the Elderly: The post-marketing surveillance study for the analogous drug (0.3% ketoprofen gel-patch) showed that the incidence of adverse reactions (contact dermatitis) was significantly higher in the elderly. Therefore, this product should be used with caution in the elderly while carefully observing the skin condition at the application site.
Use In Pregnancy & Lactation
When ketoprofen for external use is used in women at the late stage of pregnancy, it may cause fetal ductus arteriosus systole. Therefore, do not use this product in women at the late stage of pregnancy.
The safety of this product during pregnancy (other than women at the late stage of pregnancy), delivery or lactation has not been established.
Therefore, this product should be used only when the therapeutic benefit for these patients is considered to outweigh the risk.
When ketoprofen for external use was used at the mid stage of pregnancy, oligohydramnios was reported. Therefore, keep the use of this product to a minimum and use with caution.
Adverse Reactions
Lumbago, osteoarthritis, humeroscapular periarthritis, tendinitis/tendovaginitis, peritendinitis, humeral epicondylitis, myalgia and post-traumatic swelling/pain: Of a total number of 1,156 cases, 57 cases (4.93%) reported adverse reactions.
The major adverse reactions included the following: 54 events of contact dermatitis (4.67%), i.e., 11 events of rash, 9 events of reddening, 18 events of itching, and 5 events of irritation; 1 event (0.09%) of blister at the application site; 1 event (0.09%) of heart throbbing; and 1 event (0.09%) of edema of the face and hands.
Rheumatoid arthritis: Of a total number of 525 cases, 45 cases (8.57%) reported adverse reactions. The major adverse reactions included the following: 17 events of contact dermatitis, 12 events of application site itching, 6 events of application site erythema, 6 events of application site rash, and 3 events of application site dermatitis.
In addition to the previously-mentioned adverse reactions, spontaneous reports made by physicians and other health care professionals have described shock, anaphylaxis, induction of an asthmatic attack (aspirin-induced asthma), and the onset of photosensitive reactions.
Severe adverse reactions: Shock (incidence unknown), Anaphylaxis (less than 0.1%): As shock and anaphylaxis (e.g., urticaria, dyspnea and facial edema) may develop, carefully observe the patient's condition and stop using when any abnormal finding is observed and treat it appropriately.
Induction of attacks of asthma (aspirin-induced asthma) (less than 0.1%): This product may induce attacks of asthma. Stop using when initial symptoms, including dry rales, wheezing and dyspnea, develop. Caution should be exercised as about 10% of patients with bronchial asthma may latently have aspirin-induced asthma. Furthermore, an asthmatic attack induced by this product has developed several hours after application. (See Contraindications.)
Contact dermatitis (less than 5%, the incidence is unknown for serious cases): Itching, irritation, erythema, rash/reddening which have developed on the application sites may worsen and result in severe skin symptoms such as swelling, edema, and blister/erosion, and pigmentation and depigmentation, and dermatitis may become serious extending to the whole body, and therefore immediately stop use when any abnormal finding is observed, cover the affected site from sunlight and treat it appropriately. Such symptoms may occur a few days after the discontinuation of use.
Photosensitive reactions (incidence unknown): Exposure of the application site to ultraviolet light may induce severe dermatitis such as erythema with accompanying extreme itching, rash, irritation, swelling, edema and blister/erosion, as well as pigmentation and depigmentation. Some dermatitis may extend to the whole body and become serious and therefore immediately stop use when any abnormal finding is observed, cover the affected site from sunlight and treat it appropriately. Such symptoms may develop from a few days to a few months after the discontinuation of use.
Other adverse reactions: Other adverse reactions were reported with this product including local rash, reddening, swelling, itching, irritation, blister/erosion, pigmentation etc. (0.1% to less than 5%), subcutaneous bleeding (less than 0.1%), skin exfoliation (incidence unknown) and hypersensitivity such as urticaria, eyelid edema and facial edema (incidence unknown). Discontinue the use immediately when such a symptom occurred.
Storage
Store below 25°C (light-resistant tight container).
Shelf-Life: 24 months.
ATC Classification
M02AA10 - ketoprofen ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
Presentation/Packing
Patch 2% x 7's.
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