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TOPICORT is a brand name for Desoximetasone, supplied as a cream. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 05/2022 1 INDICATIONS, 1.1 Pediatrics 05/2022 1 INDICATIONS, 1.2 Geriatrics 05/2022 4 DOSAGE AND ADMINISTRATION 05/2022 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 05/2022 7 WARNINGS AND PRECAUTIONS 05/2022 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism 05/2022 7 WARNINGS AND PRECAUTIONS, 7.1.3…
Verbatim from this product's HC label. Tap a section to expand.
3 Pediatrics 05/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ...................................................................................
2 TABLE OF CONTENTS ......................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION.............................................................. 4 1 INDICATIONS.............................................................................................................
1 Pediatrics .......................................................................................................... 2 Geriatrics...........................................................................................................
4 2 CONTRAINDICATIONS .............................................................................................. 4 4 DOSAGE AND ADMINISTRATION ............................................................................. 1 Dosing Considerations.......................................................................................
2 Recommended Dose and Dosage Adjustment ................................................... 5 5 OVERDOSAGE .......................................................................................................... 5
1 Adverse Reaction Overview The following adverse skin reactions have been reported with the use of topical steroids and are listed in an approximately decreasing order of occurrence: itching, folliculitis, striae, hypertrichosis, change in pigmentation, secondary infection, perioral dermatitis, a llergic contact dermatitis, maceration of the skin, acneiform eruptions and miliaria.
Adrenal suppression has also been reported following topical corticosteroid therapy. Posterior subcapsular cataracts have been reported following systemic use of corticosteroids. Systemic adverse reactions, such as vision blurred, have also been reported with the use of topical corticosteroids.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful for identifying and approxima ting rates of adverse drug reactions in real-world use. 3 Less Common Clinical Trial Adverse Reactions TOPICORT is well tolerated; side effects have been rare.
Similar to other topical corticosteroid preparations, they may cause burning sensation, dryness, itching, erythema, change in skin pigmentation, folliculitis, pyoderma, striae, telangiectasia and skin atrophy. The following reactions are reported when corticosteroid preparations are used extensively on intertriginous areas or under occlusive dressings: maceration of the skin, secondary infection, striae, miliaria, hypertrichosis and localized skin atrophy.
5 Post-Market Adverse Reactions The following local adverse reactions have been reported infrequently with topical corticosteroids but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of frequency: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, miliaria, glucocorticosteroid insufficiency.
3 Pediatrics 05/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ...................................................................................
2 TABLE OF CONTENTS ......................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION.............................................................. 4 1 INDICATIONS.............................................................................................................
1 Pediatrics .......................................................................................................... 2 Geriatrics...........................................................................................................
4 2 CONTRAINDICATIONS .............................................................................................. 4 4 DOSAGE AND ADMINISTRATION ............................................................................. 1 Dosing Considerations.......................................................................................
2 Recommended Dose and Dosage Adjustment ................................................... 5 5 OVERDOSAGE .......................................................................................................... 5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .......................
6 7 WARNINGS AND PRECAUTIONS ............................................................................. 1 Special Populations ........................................................................................... 1 Pregnant Women ...............................................................................................
2 Breast-feeding.................................................................................................... 3 Pediatrics ...........................................................................................................
Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see the 6 DOSAGE FORMS, COMPOSITION AND PACKAGING section of the Product Monograph. Topical corticosteroids are contraindicated in untreated bacterial, tubercular, fungal and most viral lesions of the skin (including herpes simplex, vaccinia and varicella) and in those patients with a history of hypersensitivity to any of the components of the preparation.
TOPICORT is not for ophthalmic use. Topical corticosteroids when used over large areas, at high doses for prolonge d period or under an airtight dressing are more likely to be absorbed into the bloodstream and cause side effects.
Apply only enough to cover the affected areas. TOPICORT should not be applied over large areas unless advised by your doctor. 1 Dosing Considerations Topical corticosteroids when used over large areas, at high doses for prolonged period or under an airtight dressing are more likely to be absorbed into the bloodstream and cause side effects.
Apply only enough to cover the affected areas. TOPICORT should not be applied over large areas unless advised by the healthcare professional. There are risks associated with sudden discontinuation after prolonged use of corticosteroids such as exacerbation or recurrence of the underlying disease, adrenocortical insufficiency or steroid withdrawal syndrome.
TOPICORT should not be suddenly discontinued unless advised by the healthcare professional (see 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism). TOPICORT has been shown to be safe and effective in children and is indicated in this PrTOPICORT ® Desoximetasone Cream, Gel and Ointment Product Monograph Page 5 of 23 population.
However, children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Desoximetasone in Canada.
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In addition, there are reports of the development of pustular psoriasis from chronic plaque psoriasis following reduction of discontinuation of potent topical steroid products. Hypothalamic-pituitary-adrenal [HPA] axis suppression, Cushing’s syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids.
Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches and bilateral papilledema.
Endocrine disorders: symptoms like erythema, burning pain, desquamation of the skin, pruritus (steroid withdrawal syndrome). Hyperglycemia has been reported as a systemic adverse effects of desoximetasone administration. Adrenal suppression has been shown to occur with prolonged use of large doses of topical corticosteroids, particularly under occlusion due to increased percutaneous absorption.
Eye disorders: blurred vision and chorioretinopathy have been reported. Posterior subcapsular cataracts have been reported following systemic use of corticosteroids .
8 PrTOPICORT ® Desoximetasone Cream, Gel and Ointment Product Monograph Page 3 of 23 8 ADVERSE REACTIONS ............................................................................................. 1 Adverse Reaction Overview...............................................................................
2 Clinical Trial Adverse Reactions ......................................................................... 3 Less Common Clinical Trial Adverse Reactions.................................................. 5 Post-Market Adverse Reactions .........................................................................
9 9 DRUG INTERACTIONS .............................................................................................. 4 Drug-drug interactions ....................................................................................... 5 Drug-food interactions........................................................................................
6 Drug-herb interactions ....................................................................................... 7 Drug-laboratory test interactions ...................................................................... 10 10 CLINICAL PHARMACOLOGY ..................................................................................
1 Mechanism of Action .................................................................................. 3 Pharmacodynamics.................................................................................... 10 11 STORAGE, STABILITY AND DISPOSAL .................................................................
11 12 SPECIAL HANDLING INSTRUCTIONS .................................................................... 11 PART II: SCIENTIFIC INFORMATION ................................................................................. 12 13 PHARMACEUTICAL INFORMATION .......................................................................
12 14 CLINICAL TRIALS ................................................................................................... 13 15 MICROBIOLOGY......................................................................................................
13 16 NON-CLINICAL TOXICOLOGY ................................................................................ 13 PATIENT MEDICATION INFORMATION ............................................................................. 16 PrTOPICORT ® Desoximetasone Cream, Gel and Ointment Product Monograph Page 4 of 23 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS TOPICORT is indicated for the relief of acute or chronic corticosteroid-responsive dermatoses.
3 Pediatrics). 2 Geriatrics (≤ 65 years old) Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness. 2 CONTRAINDICATIONS Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container.
For a complete listing, see the 6 DOSAGE FORMS, COMPOSITION AND PACKAGING section of the Product Monograph. Topical corticosteroids are contraindicated in untreated bacterial, tubercular, fungal and most viral lesions of the skin (including herpes simplex, vaccinia and varicella) and in those patients with a history of hypersensitivity to any of the components of the preparation.
TOPICORT is not for ophthalmic use. Topical corticosteroids when used over large areas, at high doses for prolonge d period or under an airtight dressing are more likely to be absorbed into the bloodstream and cause side effects.
Apply only enough to cover the affected areas. TOPICORT should […]
2 Recommended Dose and Dosage Adjustment Apply a thin film of TOPICORT to the affected skin areas twice daily. Rub in gently. 5 OVERDOSAGE Toxic effects due to prolonged percutaneous absorption of large amounts of corticosteroids may include: reversible suppression of adrenal function, skin striae, ecchymoses, discoloration or atrophy, acneiform eruptions, hirsutism, infection.
Prolonged systemic corticosteroid action may cause hypertension, peptic ulceration, hypokalemia, muscle weakness and wastage and subcapsular cataracts. Treatment should include symptomatic therapy and discontinuation of corticosteroid administration.
In chronically affected patients, a gradual discontinuatio n may prevent the development of steroid withdrawal symptoms. For management of a suspected drug overdose, contact your regional poison control centre. 25% w/w is available in tubes of 20 g, 60 g and 10 tubes of 2 g sample pack.
05% w/w is available in in tubes of 20 g and 60 g. 05% w/w is available in tubes of 60 g. 25% w/w is available in tubes of 60 g. 7 WARNINGS AND PRECAUTIONS General Patients should be advised to inform subsequent physicians of the prior use of corticosteroids.
Infection If local infection exists, suitable concomitant antimicrobial or antifungal therapy should be administered as primary therapy. If it is considered necessary, the topical corticosteroid may be used as an adjunct to control inflammation, erythema and itching.
If a favorable response does not occur promptly, application of the corticosteroid should be discontinued until the infection is adequately controlled. 25% w/w Isopropyl Myristate, Methylparaben, Propylparaben, Water, Wool Alcohols, and Wool Alcohols Ointment.
Edetate Disodium, Isopropyl Myristate, Lactic Acid, Methylparaben, Propylparaben, Water, Wool Alcohols, and Wool Alcohols Ointment. Alcohol, Carbomer Homopolymer Type C, Docusate Sodium, Edetate Disodium, Isopropyl Myristate, Trolamine and Water.
Aluminum Stearates, Beeswax, Dicocoyl Pentaerythrityl, Distearyl Citrate, Propylene Glycol, Sorbitan Sesquioleate, White Petrolatum, and Vitamin E. PrTOPICORT ® Desoximetasone Cream, Gel and Ointment Product Monograph Page 7 of 23 Endocrine and Metabolism Hyperglycemia has been reported as a systemic adverse effects of desoximetasone administration.
Adrenal suppression has been shown to occur with prolonged use of large doses of topical corticosteroids, particularly under occlusion due to increased percutaneous absorption. The use of occlusive dressings increases the percutaneous absorption of corticosteroids; their extensive use increases the possibility of systemic effects and is therefore not advisable.
For patients with extensive lesions, it may be preferable to use a sequential approach, treating one portion of the body at a time. The patient should be kept under close observation if treated with large amounts of topical corticosteroid or with the occlusive technique over a prolon ged period of time.
Occlusive dressings should not be applied if there is an elevation of body temperature. The product should be used with caution in patients with stasis dermatitis and other skin diseases associated with impaired circulation. The risks associated with sudden discontinuation after prolonged use of corticosteroids are exacerbation or recurrence of the underlying disease, adrenocortical insufficiency or steroid withdrawal syndrome.
The risk […]