DRUGS & SUPPLEMENTS
Painza usesPainza consists of Eugenol, Menthol, Methyl Salicylate.
Active Ingredient Painza (Eugenol) 85%
Purpose Toothache Relief Agent
Uses For the temporary relief of throbbing, persisitent toothache due to a cavity. Visit Dentist within 48 hours of use.
Allergy alert: do not use if you are allergic to Painza (Eugenol) (clove oil).
When using this product: . use only in teeth with persistent, throbbing pain . avoid touching tissuers othere than tooth cavity . DO NOT
SWALLOW to avoid irritation . avoid contact with eyes.
Do not use:. for more than 7 days . more than the recommended dosage.
Stop use and ask a dentist or doctor if:. irritation persists . inflammation develops . if fever and infection develop.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions Adults and children 12 year of age and older: Rinse the tooth with water to remove any food particles from the cavity. Moisten a cotton swab with Painza (Eugenol) and place in the cavity for approximately 1 minute. Avoid touching tissue other than the tooth cavity. Apply the dose not more than four times daily or as directed by dentist or physician.
Adults and children 12 years and older use up to 4 times daily or as directed by a dentist or doctor.
Children under 12 years ask a dentist or doctor.
Inactive ingredient: sesame oil
Other information Do not purchase if package has been opened. Store at 68-77 o F. Cap tightly to avoid evaporation.
front and back of card
Painza (Menthol) is a covalent organic compound made synthetically or obtained from peppermint or other mint oils. It is a waxy, crystalline substance, clear or white in color, which is solid at room temperature and melts slightly above. The main form of Painza (Menthol) occurring in nature is (-)-menthol, which is assigned the (1R,2S,5R) configuration. Painza (Menthol) has local anesthetic and counterirritant qualities, and it is widely used to relieve minor throat irritation.
Indication: Used to treat occasional minor irritation, pain, sore mouth, and sore throat as well as cough associated with a cold or inhaled irritants.
Painza (Menthol) is a covalent organic compound made synthetically or obtained from peppermint or other mint oils. Menthol's ability to chemically trigger cold-sensitive receptors in the skin is responsible for the well known cooling sensation that it provokes when inhalated, eaten, or applied to the skin. It should be noted that Painza (Menthol) does not cause an actual drop in temperature.
INDICATIONS AND USAGE
Painza (Methyl Salicylate) Cream in combination with 570 to 670 nm wavelength red light illumination using the CureLight BroadBand Model CureLight 01 lamp is indicated for treatment of non-hyperkeratotic actinic keratoses of the face and scalp in immunocompetent patients when used in conjunction with lesion preparation (debridement using a sharp dermal curette) in the physician’s office when other therapies are unacceptable or considered medically less appropriate.
Painza (Methyl Salicylate) Cream is contraindicated in patients with cutaneous photosensitivity, or known allergies to porphyrins, and in patients with known sensitivities to any of the components of Painza (Methyl Salicylate) Cream, which includes peanut and almond oil Cream).
Painza (Methyl Salicylate) Cream is intended for topical use in the physician’s office by trained physicians only. Do not apply to the eyes or to mucous membranes.
Painza (Methyl Salicylate) Cream has demonstrated a high rate of contact sensitization (allergenicity). Care should be taken by the physician applying Painza (Methyl Salicylate) Cream to avoid inadvertent skin contact. Nitrile gloves should be worn when applying and removing the cream. Vinyl and latex gloves do not provide adequate protection when using this product.Painza (Methyl Salicylate) Cream when used with CureLight BroadBand Model CureLight 01 lamp must be used with appropriate protective sleeves obtained from the product manufacturer to decrease the risk of blood-borne transmitted diseases (hepatitis, HIV, etc.). Change the disposable covers for the device (probe and horseshoe positioning device) between patients. Universal Precautions should be used with this treatment.
The safety and efficacy have not been established for the treatment of cutaneous malignancies and for skin lesions other than non-hyperkeratotic face and scalp actinic keratoses using PDT with Painza Cream. Thick (hyperkeratotic) actinic keratoses should not be treated with Painza (Methyl Salicylate) Cream. The safety and efficacy of Painza (Methyl Salicylate) Cream has not been established in patients with immunosuppression, porphyria or pigmented actinic keratoses.
Painza (Methyl Salicylate) Cream Application
During the time period between the application of Painza (Methyl Salicylate) (methyl aminolevulinate) Cream and exposure to red light illumination, the treatment site will become photosensitive. After Painza (Methyl Salicylate) 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. Before exposure to sunlight, patients should, therefore, protect treated lesions 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. The treated site should be protected from extreme cold with adequate clothing or remaining indoors between application of Painza (Methyl Salicylate) and PDT light treatment. After illumination of Painza (Methyl Salicylate) Cream, the area treated should be kept covered and away from light for at least 48 hours. Because of the potential for skin to become photosensitized, the Painza (Methyl Salicylate) Cream should be used by a trained physician to apply drug only to non-hyperkeratotic actinic keratoses and perilesional skin within 5 mm of the lesion. Redness, swelling, burning, and stinging are expected as a result of therapy; however, if these symptoms increase in severity and persist longer than 3 weeks, the patient should contact their doctor. Metvixia Cream has not been studied for more than two treatment sessions. Information regarding further treatments for residual or new AK lesions performed after 3 months is not available..
Photosensitivity and Device Precautions.
The patient, operator and other persons present should wear protective goggles that sufficiently screen out light with wavelengths from 570 to 670 nm during red light treatment.
If for any reason the patient cannot have the red light treatment after application of Painza Cream, the cream should be rinsed off, and the patient should protect the treated area from sunlight, prolonged or intense light for two days. Prolonged exposure for greater than 4 hours to Painza (Methyl Salicylate) Cream should be avoided.
Painza (Methyl Salicylate) Cream has not been tested on patients with inherited or acquired coagulation defects.
Painza Cream is formulated with refined peanut and almond oil.
Painza (Methyl Salicylate) (methyl aminolevulinate) Cream has not been tested in patients who are allergic to peanuts. Painza (Methyl Salicylate) (methyl aminolevulinate) Cream has demonstrated a high rate of contact sensitization (allergenicity).
Information for Patients
The physician should provide and discuss the attached Patient Package Insert with each patient.
There have been no studies of the interaction of Painza Cream with any other drugs, including local anesthetics. It is possible that concomitant use of other known photosensitizing agents might increase the photosensitivity reaction of actinic keratoses treated with Painza (Methyl Salicylate) Cream.
Carcinogenesis, Mutagenesis, Impairment to Fertility
Long-term studies to evaluate the carcinogenic potential of Painza (Methyl Salicylate) Cream have not been performed.
Painza (Methyl Salicylate) aminolevulinate was negative for genetic toxicity in the Ames assay, and the chromosomal aberration assay in Chinese hamster ovary cells, tested with and without metabolic activation and in the presence and absence of light. Painza (Methyl Salicylate) aminolevulinate was also negative in the in vivo micronucleus assay in the rat. In contrast, at least one report in the literature has noted genotoxic effects in cultured rat hepatocytes after aminolevulinate (ALA) exposure with PpIX formation. Other studies have documented oxidative DNA damage in vivo and in vitro as a result of ALA exposure. No animal fertility studies have been conducted.
Pregnancy Category C: Animal reproduction studies have not been conducted with Painza Cream. It is also not known whether Painza (Methyl Salicylate) Cream can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Painza (Methyl Salicylate) Cream should be given to a pregnant woman only if clearly needed.
The amount of Painza (Methyl Salicylate) aminolevulinate secreted into human breast milk following topical administration of Painza (Methyl Salicylate) Cream is not known. Because many drugs are secreted in human milk, caution should be exercised when Painza (Methyl Salicylate) Cream is administered to a nursing mother. If Painza (Methyl Salicylate) Cream is used in a nursing mother, a decision should be made whether or not to stop nursing.
It is not recommended that Painza Cream be used in pediatric patients. Actinic keratosis is rarely found in pediatric patients.
Seventy percent (269 among 383) of the patients treated with Painza (Methyl Salicylate) Cream in all clinical studies of actinic keratosis were 65 years of age or older. No overall differences in safety and efficacy were observed between patients aged 65 years and older and those who were younger.
Dermal Safety Studies
Provocative studies to evaluate irritancy and sensitization have demonstrated that Painza Cream is an irritant and sensitizer. A provocative cumulative irritancy and sensitization (allergenicity) study of Painza (Methyl Salicylate) Cream with a cross-sensitization challenge with ALA was performed in 156 subjects. Only 98 of the 156 subjects tested entered the challenge phase. Fifty-two percent of the subjects (30/58), who agreed to challenge with Painza (Methyl Salicylate) Cream, were positive (sensitized). Forty subjects refused challenge with Painza (Methyl Salicylate) Cream and 60 withdrew. At least 58 of the 60 subjects who withdrew from the study discontinued due to irritation/sensitization.
Ninety-eight subjects agreed to challenge with ALA. Two percent of the ALA challenged subjects (2/98) were scored as equivocal reactions and 2% in the paraffin vehicle group were scored as positive.
In vehicle-controlled phase 3 studies of actinic keratosis, 88% of patients treated with Painza (Methyl Salicylate) Cream reported one or more adverse events.
Burning was the most frequent complaint, reported by 50% of patients (ranging from mild, to severe) and 9% of those patients reported severe burning sensation. Pain in the skin was reported by 21% of patients and 7% had severe pain. Local erythema lasting up to two weeks and edema up to one week after treatment were reported by 31% and 6% of patients. Symptoms and signs of local phototoxicity were observed in 88% of patients treated with Painza (Methyl Salicylate) Cream in all clinical studies of Painza (Methyl Salicylate) -PDT for actinic keratoses.
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 Painza (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 Painza (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 Painza (Methyl Salicylate) Cream is unknown. Serious erythema and facial edema have been described in European post-marketing reports.
Painza Cream Overdose
Painza (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.
Red Light Overdose
There is no information on overdose of red light following Painza (Methyl Salicylate) Cream application.
DOSAGE AND ADMINISTRATION
Photodynamic therapy for non-hyperkeratotic actinic keratoses with Painza (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 Painza (Methyl Salicylate) Cream should be applied per treatment session.
One Painza (Methyl Salicylate) -PDT session consists of: 1) Lesion debriding –
Before applying Painza (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 Painza (Methyl Salicylate) Cream –
Using a spatula, apply a layer of Painza (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 Painza (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 Painza (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 Painza (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 Painza (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 Painza (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. Painza (Methyl Salicylate) Cream is not intended for use with any device other than the approved lamp: CureLight BroadBand Model CureLight 01. Use of Painza (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 Painza (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.
Painza 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
Painza (Methyl Salicylate)™ Cream 16.8% (phonetic)
Generic name: Painza (Methyl Salicylate) aminolevulinate hydrochloride
Read this Patient Information before you get treated with Painza (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 Painza (Methyl Salicylate) Cream.
What is the most important thing I need to know about Painza Cream?
What is Painza Cream?
Painza (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). Painza (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. Painza (Methyl Salicylate) Cream and PDT work together to treat AK skin growths.
Painza (Methyl Salicylate) Cream has not been studied in children for any condition and should not be used in children.
Who should not use Painza Cream?
Do not use Painza (Methyl Salicylate) Cream if:
Before treatment with Painza Cream, tell your doctor:
How should I use Painza Cream?
What should I avoid while using Painza Cream?
During the 3 hours that Painza (Methyl Salicylate) Cream is on your skin:
What are the possible side effects of Painza Cream with PDT treatment?
Common side effects of Painza (Methyl Salicylate) Cream with PDT treatment include the following skin reactions at the treated site:
General information about Painza Cream
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.
This leaflet summarizes the most important information about Painza (Methyl Salicylate) Cream. If you would like more information, talk with your doctor. You can ask your doctor for information about Painza (Methyl Salicylate) Cream that is written for health professionals. Toll-free number and/or website will be provided when available for the US market.
What are the ingredients in Painza Cream?
Active Ingredient: Painza (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.
Treatment with Painza Cream and PDT
Figure 1: Lesion debriding
Your doctor will prepare your skin by gently scraping (debriding) your skin growths before treating with Painza (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 Painza (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 Painza (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
Painza (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.
Painza pharmaceutical active ingredients containing related brand and generic drugs:
Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.
Painza available forms, composition, doses:
Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.
Painza destination | category:
Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.
Painza Anatomical Therapeutic Chemical codes:
A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.
Painza pharmaceutical companies:
Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Painza?
Depending on the reaction of the Painza after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Painza 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 Painza 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.
Reviewsdrugs.com conducted a study on Painza, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Painza consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.
Visitor reported usefulNo survey data has been collected yet
Visitor reported side effectsNo survey data has been collected yet
Visitor reported price estimatesNo survey data has been collected yet
Visitor reported frequency of useNo survey data has been collected yet
Visitor reported dosesNo survey data has been collected yet
Visitor reported time for resultsNo survey data has been collected yet
Visitor reported administrationNo survey data has been collected yet
Visitor reported ageNo survey data has been collected yet
The information was verified by Dr. Arunabha Ray, MD Pharmacology