DRUGS & SUPPLEMENTS

Intragesic Gel

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Intragesic Gel uses

Intragesic Gel consists of Benzyl Alcohol, Diclofenac Diethylamine, Linseed Oil, Menthol, Methyl Salicylate.

Benzyl Alcohol:


Active Ingredients

Intragesic Gel Alcohol 10%

Camphor 0.6%

Menthol 0.4%

Purpose

External Analgesic

Uses

for the temporary relief of itching associated with insect bites and minor skin irritations.

Warnings

For external use only.

Do not use

  • face or genital areas
  • on a reas of blistered or broken skin
  • with a compress after application

When using this product

do not get into eyes if contact occurs, flush eyes with water

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days.

If pregnant or breastfeeding

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

Directions

  • Apply to affected area not more than 3 times daily.
  • Children under 2 years of age: do not use, ask a doctor.
  • Severe reactions to Urushiol (the chemical released by the plant, which causes the irritation) can look like chemical burns and have a thick leathery appearance. Additional applications may be necessary.

  • Test product on small patch of skin before applying to the entire body.
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Other information

  • Store at room temperature.
  • You may report a serious adverse reaction to Report Reaction, LLC. PO Box 22, Plainsboro, NJ 08536-0222.

Inactive Ingredients

Water, Structure XL, Cutina GMS, Phenoxol T, Cremaphor CO 40, Butylene Glycol, Zinc Acetate, Steareth-2,

Steareth-20, Steareth 100, Proaqua ISL, Pelemol IPM, Estol 1543, Glydant Plus, Dimethicone, VE Acetate, Allantoin.

Made in the U.S.A. for:

IVY-DRY, INC.

299-B Fairfield Ave.

Fairfield, NJ 07070

©2012 Ivy-Dry, Inc.

Questions or Comments

www.ivydry.com

If you get Poison Ivy,

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Intragesic Gel (Benzyl Alcohol) Products

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TEMPORARY

RELIEF

OF PAIN

AND ITCHING

Associated with Minor Skin

Irritations and Insect Bites

External Analgesic

Intragesic Gel (Benzyl Alcohol) Cream Intragesic Gel (Benzyl Alcohol) Cream

Diclofenac Diethylamine:


Pharmacological action

NSAIDs, a derivative of phenylacetic acid, diclofenac has a pronounced anti-inflammatory, analgesic and mild antipyretic effect. The mechanism of action is associated with inhibition of COX activity - the main enzyme metabolism of arachidonic acid, which is a precursor of prostaglandins, which play a major role in the pathogenesis of inflammation, pain and fever. Analgesic effect is due to two mechanisms: peripheral and central (due to inhibition of prostaglandin synthesis in the central and peripheral nervous system).

Inhibits synthesis of proteoglycan in cartilage.

In rheumatic diseases, diclofenac reduces joint pain at rest and in motion, as well as morning stiffness and swelling of the joints, helps to increase range of motion; reduces post-traumatic and postoperative pain, and inflammatory edema.

Inhibits platelet aggregation. With prolonged use has a desensitizing effect.

When used topically in ophthalmology reduces swelling and pain in inflammatory processes non-infectious etiology.

Pharmacokinetics

After intake is absorbed from the gastrointestinal tract. Eating slows down the rate of absorption, extent of absorption is not changed. About 50% of the active substance is metabolized in the "first passage" through the liver. When used rectally absorption is slower. Time to reach Cmax in plasma after oral administration is 2-4 hours depending on the used dosage form, after rectal - 1 h, I.M. administration - 20 min. The concentration of active substance in plasma is a linear function of the applied dose.

Not cumulative. Plasma protein binding is 99.7% (predominantly albumin). Penetrates into synovial fluid, Cmax is achieved in 2-4 hours later than in plasma.

To a large extent metabolized to form several metabolites, among which two pharmacologically active, but to a lesser extent than diclofenac.

Systemic clearance of the active substance is about 263 ml / min. T1/2 from plasma is 1-2 h, from synovial fluid - 3-6 h. Approximately 60% of the dose was excreted as metabolites by the kidneys, less than 1% excreted in the urine as unchanged, while the rest is displayed in the form of metabolites with bile.

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Why is Intragesic Gel prescribed?

Articular syndrome (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout), degenerative and chronic inflammatory diseases of musculoskeletal system (osteochondrosis, osteoarthritis, periartropatii), post-traumatic inflammation of soft tissue and musculoskeletal system (sprains, bruises). Pain in the spine, neuralgia, myalgia, arthralgia, pain and inflammation after surgery or injury, pain in gout, migraine, algomenorrhea, pain with Bursitis, proctitis, colic (biliary and renal), pain in infectious and inflammatory diseases of ENT organs.

For local use: the inhibition of miosis during surgery for cataract prevention of cystoid macular edema associated with removal and lens implantation, inflammatory eye non-infectious nature, post-traumatic inflammation in penetrating and nonpenetrating wound of the eyeball.

Dosage and administration

For oral use for adult single dose is 25-50 mg 2-3 times / 24 h. Frequency of admission depends on the dosage form employed, the severity of the disease and is 1-3 times / 24 h, rectally - 1 times / 24 h, for the treatment of acute conditions or the exacerbation of chronic edema use intramuscular in dose of 75 mg.

For children older than 6 years and adolescents daily dose is 2 mg / kg.

Topical applied at a dose of 2-4 g on the affected area 3-4 times / 24 h.

When used in ophthalmology frequency and duration of administration are determined individually.

The maximum oral daily dose for adults is 150 mg.

Intragesic Gel (Diclofenac Diethylamine) side effects

Digestive system: nausea, vomiting, anorexia, abdominal pain and discomfort in the epigastrium, flatulence, constipation, diarrhea, and in some cases - erosive-ulcerative lesions, gastrointestinal bleeding and perforation; rarely - abnormal liver function. When rectal administration - in isolated cases were observed inflammation of the colon bleeding, exacerbation of ulcerative colitis.

From the side of the central nervous system and peripheral nervous system: dizziness, headache, agitation, insomnia, irritability, fatigue, rarely - paresthesia, visual disturbances (blurred, double vision), tinnitus, insomnia, cramps, irritability, tremors, mental disorders, depression.

Hemopoietic system: rarely - anemia, leukopenia, thrombocytopenia, agranulocytosis.

Urinary system: rarely - renal failure; in predisposed patients may be swelling.

Dermatological reactions: rarely - hair loss.

Allergic reactions: skin rash, itching, when used in the form of eye drops - itching, redness, photosensitivity.

Local reactions: in the place of I.M. introducing possible burning, in some cases - the formation of infiltration, abscess, necrosis of adipose tissue in the rectal administration may be local irritation, the appearance of mucous discharge mixed with blood, painful defecation, when used externally, in rare cases - itching, redness, rash, burning sensation, when applied topically in ophthalmology may be a transient burning sensation and / or temporary blurred vision immediately after instillation.

With long-term topical use and / or drawing on a vast surface of body are possible systemic side effects due to resorptive action of diclofenac.

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Contraindications

known hypersensitivity to diclofenac sodium or to any accessory ingredient that is part of the drug diclofenac;

anamnestic information about the attacks of bronchial asthma, urticaria, acute rhinitis associated with the use of aspirin or other NSAIDs;

hemodyscrasia unknown origin;

children under 6 years

pregnancy ;

lactation

increased sensitivity to sulfite (for injection solution).

children under age 15 - tablets of 50 mg to 18 years - injection.

Using during pregnancy and breastfeeding

Use during pregnancy and lactation is possible in cases where the potential benefits for the mother exceeds than the potential risk to the fetus or newborn.

Special instructions

With extreme caution is used in diseases of liver, kidney, gastrointestinal history, dyspepsia, asthma, hypertension, heart failure, after major surgery, as well as elderly patients.

When referring to a history of allergic reactions to NSAIDs diclofenac and sulfites are used only in urgent cases. In the course of treatment requires systematic monitoring of liver function and kidney picture of peripheral blood.

Do not recommended the use for rectal patients with diseases of anorectal region or anorectal bleeding in history. Topical should be applied only to intact skin areas.

Avoid contact with diclofenac in the eye, or on mucous membranes. Patients who use contact lenses, eye drops should be applied no earlier than 5 minutes after removing the lenses.

Not recommended for children under 6 years.

During the period of treatment drugs for systemic use is not recommended alcohol consumption.

During the period of treatment may decrease the speed of psychomotor reactions. With worsening blurred vision after application of eye drops should not be driving and doing other potentially danger activities.

Intragesic Gel (Diclofenac Diethylamine) drug interactions

At simultaneous application with diclofenac antihypertensive drugs may be weakening their actions.

There are few reports on the occurrence of seizures in patients taking both NSAIDs and antibacterial drugs quinolic series.

At simultaneous application with GCS and increased risk of side effects from the digestive system.

With simultaneous use of diuretics may decrease diuretic effect. With the simultaneous use of potassium-sparing diuretics may increase the concentration of potassium in the blood.

With simultaneous use with other NSAIDs may increase the risk of side effects.

There are reports of hypoglycemia or hyperglycemia in patients with diabetes who engaged in diclofenac together with hypoglycemic drugs.

When applied simultaneously with acetylsalicylic acid may decrease the concentration of diclofenac in plasma.

Although clinical studies have not found the influence of diclofenac on the action of anticoagulants, describes the individual cases of bleeding when used with diclofenac and warfarin.

With simultaneous use may increase digoxin, lithium, and phenytoin in blood plasma.

The absorption of diclofenac from the gastrointestinal tract is reduced by simultaneous application with kolestiraminom, to a lesser extent - with colestipol.

With simultaneous use may increase the concentration of methotrexate in plasma and increased its toxicity.

With simultaneous application of diclofenac could not affect the bioavailability of morphine, but the concentration of the active metabolite of morphine may be enhanced in the presence of diclofenac, which increases the risk of side effects metabolites of morphine, including respiratory depression.

When applied simultaneously with pentazocine described a case of great convulsions, and rifampicin - may decrease the concentration of diclofenac in plasma, with ceftriaxone - increases excretion of ceftriaxone in bile; with cyclosporine - may increase cyclosporine nephrotoxicity.

Intragesic Gel in case of emergency / overdose

Symptoms: may cause hypotension, renal failure, convulsions, gastrointestinal irritation or respiratory depression. Treatment: There is no specific antidote. In acute poisoning as soon as possible to stop drug absorption from the gastrointestinal tract. There is indicated gastric lavage, activated charcoal appointment and conduct of other symptomatic and supportive therapy. The use of forced diuresis, dialysis or blood transfusion is not justified because NSAIDs largely associated with serum proteins and possess extensive metabolism.

Storage conditions

In a dry, protected from light place, at temperature not above 25°C.Common expiration date for diclofenac tablets: 3 years.

Menthol:


Intragesic Gel (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 Intragesic Gel (Menthol) occurring in nature is (-)-menthol, which is assigned the (1R,2S,5R) configuration. Intragesic Gel (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.

Intragesic Gel (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 Intragesic Gel (Menthol) does not cause an actual drop in temperature.

Methyl Salicylate:


INDICATIONS AND USAGE

Intragesic Gel (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.

CONTRAINDICATIONS

Intragesic Gel (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 Intragesic Gel (Methyl Salicylate) Cream, which includes peanut and almond oil Cream).

This product contains refined peanut oil.

WARNINGS

Intragesic Gel (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.

Intragesic Gel (Methyl Salicylate) Cream has demonstrated a high rate of contact sensitization (allergenicity). Care should be taken by the physician applying Intragesic Gel (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.Intragesic Gel (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.

PRECAUTIONS

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 Intragesic Gel Cream. Thick (hyperkeratotic) actinic keratoses should not be treated with Intragesic Gel (Methyl Salicylate) Cream. The safety and efficacy of Intragesic Gel (Methyl Salicylate) Cream has not been established in patients with immunosuppression, porphyria or pigmented actinic keratoses.

General

Intragesic Gel (Methyl Salicylate) Cream Application

During the time period between the application of Intragesic Gel (Methyl Salicylate) (methyl aminolevulinate) Cream and exposure to red light illumination, the treatment site will become photosensitive. After Intragesic Gel (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 Intragesic Gel (Methyl Salicylate) and PDT light treatment. After illumination of Intragesic Gel (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 Intragesic Gel (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 Intragesic Gel 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 Intragesic Gel (Methyl Salicylate) Cream should be avoided.

Coagulation defects

Intragesic Gel (Methyl Salicylate) Cream has not been tested on patients with inherited or acquired coagulation defects.

Hypersensitivity

Intragesic Gel Cream is formulated with refined peanut and almond oil.

Intragesic Gel (Methyl Salicylate) (methyl aminolevulinate) Cream has not been tested in patients who are allergic to peanuts. Intragesic Gel (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.

Drug Interactions

There have been no studies of the interaction of Intragesic Gel 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 Intragesic Gel (Methyl Salicylate) Cream.

Carcinogenesis, Mutagenesis, Impairment to Fertility

Long-term studies to evaluate the carcinogenic potential of Intragesic Gel (Methyl Salicylate) Cream have not been performed. 

Intragesic Gel (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. Intragesic Gel (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

Teratogenic effects

Pregnancy Category C: Animal reproduction studies have not been conducted with Intragesic Gel Cream. It is also not known whether Intragesic Gel (Methyl Salicylate) Cream can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Intragesic Gel (Methyl Salicylate) Cream should be given to a pregnant woman only if clearly needed.

Nursing Mothers

The amount of Intragesic Gel (Methyl Salicylate) aminolevulinate secreted into human breast milk following topical administration of Intragesic Gel (Methyl Salicylate) Cream is not known. Because many drugs are secreted in human milk, caution should be exercised when Intragesic Gel (Methyl Salicylate) Cream is administered to a nursing mother. If Intragesic Gel (Methyl Salicylate) Cream is used in a nursing mother, a decision should be made whether or not to stop nursing.

Pediatric Use

It is not recommended that Intragesic Gel Cream be used in pediatric patients. Actinic keratosis is rarely found in pediatric patients. 

Geriatric Use

Seventy percent (269 among 383) of the patients treated with Intragesic Gel (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.

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ADVERSE REACTIONS

Dermal Safety Studies

Provocative studies to evaluate irritancy and sensitization have demonstrated that Intragesic Gel Cream is an irritant and sensitizer. A provocative cumulative irritancy and sensitization (allergenicity) study of Intragesic Gel (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 Intragesic Gel (Methyl Salicylate) Cream, were positive (sensitized). Forty subjects refused challenge with Intragesic Gel (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.

Adverse Events

In vehicle-controlled phase 3 studies of actinic keratosis, 88% of patients treated with Intragesic Gel (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 Intragesic Gel (Methyl Salicylate) Cream in all clinical studies of Intragesic Gel (Methyl Salicylate) -PDT for actinic keratoses.

EventsMetvixia-PDT

(n=130)

Vehicle PDT*

(n=61)

n (%) of patients with AEsn (%) of patients with AEs
Burning sensation skin65 (50.0%)9 (14.8%)
Erythema60 (46.2%)12 (19.7%)
Skin pain27 (20.8%)6 (9.8%)
Stinging skin25 (19.2%)2 (3.3%)
Crusting 20 (15.4%)6 (9.8%)
Edema skin20 (15.4%)1 (1.6%)
Skin peeling14 (10.8%)2 (3.3%)
Blisters14 (10.8%)2 (3.3%)
Bleeding skin11 (8.5%)2 (3.3%)
Pruritus/Itching17 (13.1%) 2 (3.3%)
Skin ulceration7 (5.4%)0 (0%)
Skin infection3 (2.3%)1 (1.6%)
Skin hyper-pigmentation1 (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 Intragesic Gel (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 Intragesic Gel (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 Intragesic Gel (Methyl Salicylate) Cream is unknown. Serious erythema and facial edema have been described in European post-marketing reports.

OVERDOSAGE

Intragesic Gel Cream Overdose

Intragesic Gel (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 Intragesic Gel (Methyl Salicylate) Cream application.

In case of red light overexposure and skin burn occurs, the patient should be treated according to standard of practice guidelines for treatment of cutaneous burns.

DOSAGE AND ADMINISTRATION

Photodynamic therapy for non-hyperkeratotic actinic keratoses with Intragesic Gel (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 Intragesic Gel (Methyl Salicylate) Cream should be applied per treatment session.

One Intragesic Gel (Methyl Salicylate) -PDT session consists of: 1) Lesion debriding –

Before applying Intragesic Gel (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 Intragesic Gel (Methyl Salicylate) Cream

Using a spatula, apply a layer of Intragesic Gel (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 Intragesic Gel (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 Intragesic Gel (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 Intragesic Gel (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 Intragesic Gel (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 Intragesic Gel (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. Intragesic Gel (Methyl Salicylate) Cream is not intended for use with any device other than the approved lamp: CureLight BroadBand Model CureLight 01. Use of Intragesic Gel (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 Intragesic Gel (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.

HOW SUPPLIED

Intragesic Gel Cream, 16.8%, is available as the following:

NDC 63069-401-01, 2 gram aluminum tube, box of 1

Product Package

Keep out of reach of children

For topical use only by physicians in the physician’s office. Rx Only

Storage Conditions

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

PATIENT INFORMATION

Intragesic Gel (Methyl Salicylate) Cream 16.8% (phonetic)

Generic name: Intragesic Gel (Methyl Salicylate) aminolevulinate hydrochloride

Read this Patient Information before you get treated with Intragesic Gel (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 Intragesic Gel (Methyl Salicylate) Cream.

What is the most important thing I need to know about Intragesic Gel Cream?

  • Intragesic Gel (Methyl Salicylate) Cream with light treatment (Photodynamic therapy or PDT) is only done in medical offices by trained doctors.
  • Intragesic Gel (Methyl Salicylate) Cream is not applied by patients. Intragesic Gel (Methyl Salicylate) Cream should not be applied by doctors who have not been trained in its use.

What is Intragesic Gel Cream?

Intragesic Gel (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). Intragesic Gel (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. Intragesic Gel (Methyl Salicylate) Cream and PDT work together to treat AK skin growths.

Intragesic Gel (Methyl Salicylate) Cream has not been studied in children for any condition and should not be used in children.

Who should not use Intragesic Gel Cream?

Do not use Intragesic Gel (Methyl Salicylate) Cream if:

  • your skin over reacts to sun or light (photosensitivity)
  • you are allergic to porphyrins or to any of the ingredients in Intragesic Gel (Methyl Salicylate) Cream. The active ingredient is Intragesic Gel (Methyl Salicylate) aminolevulinate hydrochloride. Intragesic Gel (Methyl Salicylate) Cream also contains peanut and almond oil. See the end of this leaflet for a complete list of ingredients in Intragesic Gel (Methyl Salicylate) Cream.

Before treatment with Intragesic Gel Cream, tell your doctor:

  • about your medical conditions, including if you
    • are pregnant or planning to become pregnant. It is not known if Intragesic Gel (Methyl Salicylate) Cream can harm your unborn baby.
    • are breastfeeding. It is not known if Intragesic Gel (Methyl Salicylate) Cream passes into your milk and if it can harm your baby. You should decide whether or not to stop breastfeeding while getting treatment with Intragesic Gel (Methyl Salicylate) Cream. Talk to your doctor for help with this choice.
    • are allergic to nuts or peanuts
    • have or had skin cancer or other skin growths on your body
    • have bleeding problems.
  • about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. It is not known if Intragesic Gel (Methyl Salicylate) Cream and other medicines can affect each other.

How should I use Intragesic Gel Cream?

  • Intragesic Gel (Methyl Salicylate) Cream and PDT treatment is only done by trained doctors.
  • You will receive 2 treatments with Intragesic Gel (Methyl Salicylate) Cream and PDT 7 days (1 week) apart. Your doctor will check you three months after treatment to see if the treatment worked for you. Cream and PDT.”)
  • Intragesic Gel (Methyl Salicylate) Cream is for skin use only. Do not get Intragesic Gel (Methyl Salicylate) Cream in your eyes, mouth, or nose. Tell your doctor right away if this happens.

What should I avoid while using Intragesic Gel Cream?

During the 3 hours that Intragesic Gel (Methyl Salicylate) Cream is on your skin:

  • Avoid exposure to sunlight or bright indoor light during the 3 hours that Intragesic Gel (Methyl Salicylate) Cream is on your skin. Wear a protective hat and clothing if you need to be outside in the sun.
  • Avoid exposure to cold temperatures during the 3 hours that Intragesic Gel (Methyl Salicylate) Cream is on your skin. Wear warm clothing and keep your treated skin site covered if you are in cold temperatures.
If for some unavoidable reason you are not treated with the lamp you should
  • Carefully rinse off the Cream.
  • Avoid exposure to sunlight, prolonged or intense light for two days after treatment.

What are the possible side effects of Intragesic Gel Cream with PDT treatment?

Common side effects of Intragesic Gel (Methyl Salicylate) Cream with PDT treatment include the following skin reactions at the treated site:

  • burning feeling
  • redness
  • pain
  • stinging
  • swelling
  • crusting, peeling, blisters, bleeding, itching, ulcers
  • infection
Tell your doctor if you get any of these side effects. Your healthcare provider should be able to treat these reactions according to standard treatments for such skin reactions. These reactions usually go away within 10 days of treatment. Redness may last for up to 1 month. If any of your skin reactions get worse and last longer than 3 weeks, call your doctor. These are not all the side effects of Intragesic Gel (Methyl Salicylate) Cream with PDT. Ask your doctor or pharmacist for more information.

General information about Intragesic Gel Cream

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.

This leaflet summarizes the most important information about Intragesic Gel (Methyl Salicylate) Cream. If you would like more information, talk with your doctor. You can ask your doctor for information about Intragesic Gel (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 Intragesic Gel Cream?

Active Ingredient: Intragesic Gel (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 Intragesic Gel Cream and PDT

Figure 1: Lesion debriding

Your doctor will prepare your skin by gently scraping (debriding) your skin growths before treating with Intragesic Gel (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 Intragesic Gel (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 Intragesic Gel (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

Intragesic Gel (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.

Intragesic Gel pharmaceutical active ingredients containing related brand and generic drugs:

infoActive 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.


Intragesic Gel available forms, composition, doses:

infoForm 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.


Intragesic Gel destination | category:

infoDestination 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.


Intragesic Gel Anatomical Therapeutic Chemical codes:

infoA 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.


Intragesic Gel pharmaceutical companies:

infoPharmaceutical 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.


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References

  1. Dailymed."MYOGESIC-CS (MENTHOL ) SPRAY [VETGENIX]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."PROTOCOXIL (BENZYL ALCOHOL) GEL [BIO EKUILIBER LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."IMADA RED FLOWER ANALGESIC (METHYL SALICYLATE) OIL [LUEN WAH HK MEDICINE LTD]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Intragesic Gel?

Depending on the reaction of the Intragesic Gel after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Intragesic Gel 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 Intragesic Gel 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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Review

sDrugs.com conducted a study on Intragesic Gel, 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 Intragesic Gel 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.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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