DRUGS & SUPPLEMENTS
Dermolin usesDermolin consists of Camphor, Menthol, Methyl Salicylate, Mustard Oil.
Dermolin (Camphor) 0.70%
Uses : For the temporarily relief of pain and itching associated with:
- minor burn, sunburn - minor cuts, scrapes, insect bites
- minor skin problems.
|n (%) of patients with AEs||n (%) of patients with AEs|
|Burning sensation skin||65 (50.0%)||9 (14.8%)|
|Erythema||60 (46.2%)||12 (19.7%)|
|Skin pain||27 (20.8%)||6 (9.8%)|
|Stinging skin||25 (19.2%)||2 (3.3%)|
|Crusting||20 (15.4%)||6 (9.8%)|
|Edema skin||20 (15.4%)||1 (1.6%)|
|Skin peeling||14 (10.8%)||2 (3.3%)|
|Blisters||14 (10.8%)||2 (3.3%)|
|Bleeding skin||11 (8.5%)||2 (3.3%)|
|Pruritus/Itching||17 (13.1%)||2 (3.3%)|
|Skin ulceration||7 (5.4%)||0 (0%)|
|Skin infection||3 (2.3%)||1 (1.6%)|
|Skin hyper-pigmentation||1 (0.8%)||0 (0%)|
The majority of patients in all the clinical trials had local pain or discomfort upon illumination. There were 4 (1.0%) withdrawals/discontinuations among 383 patients treated with Dermolin (Methyl Salicylate) Cream in all the clinical trials of actinic keratosis, all of which were due to the adverse event of local pain on illumination.
There have been reported instances of patients treated with Dermolin (Methyl Salicylate) Cream (2 out of 130) who have developed squamous cell and basal cell carcinoma at the site of treatment. The relationship to treatment with Dermolin (Methyl Salicylate) Cream is unknown. Serious erythema and facial edema have been described in European post-marketing reports.
Dermolin (Methyl Salicylate) Cream overdose has not been reported. If the patient for any reason cannot have the red light treatment during the prescribed period after application (the 3 hour timespan), the cream should be rinsed off, and the patient should protect the exposed area from sunlight, prolonged or intense light for two days.
There is no information on overdose of red light following Dermolin (Methyl Salicylate) Cream application.
Photodynamic therapy for non-hyperkeratotic actinic keratoses with Dermolin (Methyl Salicylate) Cream is a multi-stage process as described below: Two treatment sessions 7 days apart should be conducted. Not more than one gram (half a tube) of Dermolin (Methyl Salicylate) Cream should be applied per treatment session.
One Dermolin (Methyl Salicylate) -PDT session consists of: 1) Lesion debriding –
Before applying Dermolin (Methyl Salicylate) Cream, the surface of the lesions should be prepared with a small dermal curette to remove scales and crusts and roughen the surface of the lesion. This is to facilitate access of the cream and light to all parts of the lesion.
Figure 1 A Lesion debriding Only nitrile gloves should be worn during this and subsequent steps and Universal Precautions should be taken. Vinyl and latex gloves do not provide adequate protection when using this product.
Figure 1B Lesion debriding2) Application of Dermolin (Methyl Salicylate) Cream –
Using a spatula, apply a layer of Dermolin (Methyl Salicylate) Cream about 1 mm thick to the lesion and the surrounding 5 mm of normal skin. Do not apply more than one gram of Dermolin (Methyl Salicylate) Cream for each patient per treatment session.
Figure 2: Cream applicationThe area to which the cream has been applied should then be covered with an occlusive, non-absorbent dressing for 3 hours. Multiple lesions may be treated during the same treatment session. Each treatment field is limited to a diameter of 55 mm. Only nitrile gloves should be worn by the qualified healthcare provider in order to avoid skin contact with the cream. This product is not intended for application by patients or unqualified medical personnel.
Figure 3: Occlusive dressing application3) Wait for 3 hours - (at least 2.5 hours, but no more than 4 hours).
After Cream application, patients should avoid exposure of the photosensitive treatment sites to sunlight or bright indoor light (e.g., examination lamps, operating room lamps, tanning beds, or lights at close proximity) during the period prior to red light treatment. Exposure to light may result in a stinging and/or burning sensation and may cause erythema and/or edema of the lesions. Patients should protect treated areas from the sun by wearing a wide-brimmed hat or similar head covering of light-opaque material. Sunscreens will not protect against photosensitivity reactions caused by visible light. It has not been determined if perspiration can spread the Dermolin (Methyl Salicylate) Cream outside the treatment site to the eyes or surrounding skin. The treated site should be protected from extreme cold with adequate clothing or remaining indoors between application of Dermolin (Methyl Salicylate) Cream and PDT light treatment.4) Removal of Dressing and Rinse Off Excess Cream - Following removal of the occlusive dressing, clean the area with saline and gauze. Nitrile gloves should be worn at this step by the trained physician.
Figure 4: Cream removal5) Illumination of Dermolin (Methyl Salicylate) Treated Lesion - It is important to ensure that the correct light dose is administered. The light intensity at the lesion surface should not be higher than 200 mW/cm2. Patient and operator should adhere to safety instructions and Universal Precautions provided with the lamp. The patient and operator should wear protective goggles during illumination. Patients should be advised that transient stinging and/or burning at the target lesion sites may occur during the period of light exposure.
Figure 5: IlluminationThe CureLight BroadBand Model CureLight 01 lamp is approved for the use in Dermolin (Methyl Salicylate) -PDT. The lamp should be carefully calibrated so that dosing is accurate and immediately thereafter the lesion should be exposed to red light with a continuous spectrum of 570 to 670 nm and a total light dose of 75 J/cm2. To avoid direct contact between lamp parts and patient skin, always use disposable protective plastic sleeves on the positioning device and on the light measuring probe. Following each patient treatment, the disposable protective plastic sleeves should be removed from the positioning device and from the light measuring probe and discarded. If red light treatment is interrupted or stopped for any reason, it may be restarted. If the patient for any reason cannot have the red light treatment during the prescribed period after application (the 3 hour timespan), the cream should be rinsed off and the patient should protect the exposed area from sunlight, prolonged or intense light for two days. Dermolin (Methyl Salicylate) Cream is not intended for use with any device other than the approved lamp: CureLight BroadBand Model CureLight 01. Use of Dermolin (Methyl Salicylate) Cream without subsequent red light illumination is not recommended. No more than 1 gram (half a tube) of product should be used for each of the two weekly treatment sessions. Multiple lesions may be treated during the same treatment session using a total of 1 gram of Dermolin (Methyl Salicylate) Cream. Lesion response should be assessed 3 months after the last treatment session. This product is not intended for application by patients or unqualified medical personnel, therefore, this product is only dispensed to physicians.
Dermolin Cream, 16.8%, is available as the following:
NDC 63069-401-01, 2 gram aluminum tube, box of 1
Keep out of reach of children
For topical use only by physicians in the physician’s office. Rx Only
Store refrigerated, 2-8°C.
Use contents within one week after opening.
Should not be used after 24 hours out of refrigerator.
Metvixia Cream is a registered trade name of PhotoCure ASA.
PhotoCure ASA, Hoffsveien 48, N-0377 Oslo, Norway
USA Contact: Cato Research, Westpark Corporate Center, 4364 South Alston Avenue, Durham NC 27713
Revision: September 5, 2007
Dermolin (Methyl Salicylate)™ Cream 16.8% (phonetic)
Generic name: Dermolin (Methyl Salicylate) aminolevulinate hydrochloride
Read this Patient Information before you get treated with Dermolin (Methyl Salicylate) Cream and each time you get a treatment. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment. Ask your healthcare provider about anything you do not understand about Dermolin (Methyl Salicylate) Cream.
Dermolin (Methyl Salicylate) Cream is a prescription cream used with PDT (light treatment) to treat skin growths on the face and scalp called actinic keratosis (AK). Dermolin (Methyl Salicylate) Cream is only used for AK skin growths that are thin and not dark colored. AK skin growths are not cancer. AK skin growths are caused partly by too much sun exposure. Dermolin (Methyl Salicylate) Cream and PDT work together to treat AK skin growths.
Dermolin (Methyl Salicylate) Cream has not been studied in children for any condition and should not be used in children.
Do not use Dermolin (Methyl Salicylate) Cream if:
During the 3 hours that Dermolin (Methyl Salicylate) Cream is on your skin:
Common side effects of Dermolin (Methyl Salicylate) Cream with PDT treatment include the following skin reactions at the treated site:
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.
This leaflet summarizes the most important information about Dermolin (Methyl Salicylate) Cream. If you would like more information, talk with your doctor. You can ask your doctor for information about Dermolin (Methyl Salicylate) Cream that is written for health professionals. Toll-free number and/or website will be provided when available for the US market.
Active Ingredient: Dermolin (Methyl Salicylate) aminolevulinate hydrochloride
Other Ingredients: Glyceryl monostearate, cetostearyl alcohol, poloxyl stearate, cholesterol, oleyl alcohol glycerin, white petrolatum, isopropyl myristate, refined peanut oil, refined almond oil, edetate disodium, methylparaben and propylparaben. The color of the product is cream to pale yellow.
Figure 1: Lesion debriding
Your doctor will prepare your skin by gently scraping (debriding) your skin growths before treating with Dermolin (Methyl Salicylate) Cream and PDT. A small skin scraper is used to remove scales and crusts and to roughen the surface of any skin growths. This is to help Dermolin (Methyl Salicylate) Cream and PDT to reach all parts of the skin growths.
Figure 2: Cream application Metvixia Cream is applied to the actinic keratosis skin growths and to a small area of the skin around the growths.
Figure 3: Clear bandage application The treated skin areas will be covered with a special clear bandage for about 3 hours.
During these 3-hours you should avoid exposure of treated area to sunlight or bright indoor light. Exposure to light may make your treated skin area sting or burn. Your treated skin area may turn red or swell (photosensitive reactions). Wear a hat and protective clothes if you are exposed to sunlight during this time. Sunscreens will not help protect your treated skin during this time. In cold weather, your treated skin site should be protected from the cold with warm clothes or you should stay indoors for these 3 hours between the cream and light treatment.
Figure 4: Cream removal The clear bandage will be removed and the area will be rinsed with a saline solution before the PDT (light) treatment.
Figure 5: IlluminationThe skin growth will be treated with PDT. PDT lasts about 10 minutes for each area treated with the lamp. You will wear protective goggles to cover your eyes during this part of the treatment. More than 1 skin growth may be treated at a time. Your treated skin areas may burn, feel painful, sting, or tingle during light treatment. These symptoms may last for a few hours after the treatment. If you cannot have the light treatment 3 hours after Dermolin (Methyl Salicylate) Cream is applied, rinse the cream off your skin and you must protect your skin from sunlight and bright indoor light for 2 days. This product should only be stored in refrigerators in pharmacies and medical offices. Rx only
Dermolin (Methyl Salicylate) Cream is a registered trade name of PhotoCure ASA.
Sponsor: PhotoCure ASA, Hoffsveien 48, NO-0377 Oslo, Norway
U.S. Contact: Cato Research, Westpark Corporate Center, 4364 South Alston Avenue, Durham NC 27713
Manufacturer: Penn Pharmaceutical Services Ltd., Tafarnaubach Industrial Estate, Tredegar, Gwent, NP22 3AA, UK.
Depending on the reaction of the Dermolin after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Dermolin not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Dermolin addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Arunabha Ray, MD Pharmacology