Loading…
DERMATOP EMOLLIENT is a brand name for Prednicarbate, supplied as a cream. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 04/2022 1 INDICATIONS, 1.1 Pediatrics 04/2022 1 INDICATIONS, 1.2 Geriatrics 04/2022 4 DOSAGE AND ADMINISTRATION 04/2022 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 04/2022 7 WARNINGS AND PRECAUTIONS 04/2022 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism 04/2022 TABLE OF CONTENTS Sections or…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations 04/2022 7 WARNINGS AND PRECAUTIONS 04/2022 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism 04/2022 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, allergic 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 approximating rates of adverse drug reactions in real-world use. 6%). 8%) was associated with the use of DERMATOP EMOLLIENT CREAM in controlled clinical trials with patients aged 12-86 years.
1%. 8%). 6%). In a controlled study in pediatric patients with atopic dermatitis, mild signs of atrophy were observed in 3 (3%) of the prednicarbate treated subjects (mild telangiectasia and thinness, mild loss of elasticity, mild shininess) and 1 (1%) of the hydrocortisone treated subjects (mild shininess).
In an uncontrolled study in a similar patient population, mild signs of atrophy developed in 5 patients (8%) with 2 patients exhibiting more than one sign. Two patients (3%) developed shininess, and 2 patients (3%) developed thinness.
Three patients were observed with mild telangiectasia. It is unknown whether prior use of topical corticosteroids was a contributing factor in the development of telangiectasia in two of the patients. 4%). 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.
04/2022 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism 04/2022 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. DERMATOP EMOLLIENT CREAM contains wool alcohols ointment and wool wax alcohols and is contraindicated in individuals hypersensitive to wool/lanolin.
DERMATOP OINTMENT and DERMATOP EMOLLIENT CREAM should not be used to treat bacterial/fungal skin infections, tuberculosis of the skin, syphilitic skin infections, chicken pox, eruptions following vaccinations and viral diseases of the skin in g eneral.
DERMATOP OINTMENT and DERMATOP EMOLLIENT CREAM are not for ophthalmic use.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Prednicarbate in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
These reactions are listed in an approximate decreasing order of frequency: burning, itchi ng, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, miliaria.
In addition, there are reports of the development of pustular psoriasis from chronic plaque psoriasis following reduction of discontinuation of potent topical steroid products. Skin atrophogenic effects (such as skin thinning, skin atrophy, skin discolouration, telangiectasia) may occur with use of DERMATOP OINTMENT and DERMATOP EMOLLIENT CREAM for more than three weeks.
Endocrine disorders: symptoms like erythema, burning pain, desquamation of the skin, pruritus (steroid withdrawal syndrome). Adrenal suppression has been reported following topical corticosteroid therapy. Posterior subcapsular cataracts have been reported following systemic use of corticosteroids.
Eye disorders: blurred vision and chorioretinopathy have been reported. PrDERMATOP ® OINTMENT and PrDERMATOP ® EMOLLIENT CREAM Prednicarbate Ointment and Prednicarbate Cream Product Monograph Page 11 of 28
8 8 ADVERSE REACTIONS ............................................................................................. 1 Adverse Reaction Overview............................................................................... 2 Clinical Trial Adverse Reactions .........................................................................
1 Clinical trial adverse reactions – pediatrics........................................................ 3 Less Common Clinical Trial Adverse Reactions................................................ 5 Post-Market Adverse Reactions .......................................................................
10 9 DRUG INTERACTIONS ............................................................................................ 4 Drug-drug interactions ..................................................................................... 5 Drug-food interactions......................................................................................
6 Drug-herb interactions ..................................................................................... 7 Drug-laboratory test interactions ...................................................................... 11 10 CLINICAL PHARMACOLOGY ..................................................................................
1 Mechanism of Action .................................................................................. 3 Pharmacodynamics.................................................................................... 11 11 STORAGE, STABILITY AND DISPOSAL .................................................................
13 12 SPECIAL HANDLING INSTRUCTIONS .................................................................... 13 PART II: SCIENTIFIC INFORMATION ................................................................................. 14 13 PHARMACEUTICAL INFORMATION .......................................................................
14 14 CLINICAL TRIALS ................................................................................................... 15 15 MICROBIOLOGY......................................................................................................
16 16 NON-CLINICAL TOXICOLOGY ................................................................................ 16 PATIENT MEDICATION INFORMATION ............................................................................. 1% w/w) are indicated for the relief of the inflammatory and pruritic manifestations of acute and chronic corticosteroid-responsive dermatoses.
1 Pediatrics DERMATOP EMOLLIENT CREAM has been shown to be safe and effective in children and infants and is indicated in this population. 3 Pediatrics). 2 Geriatrics Evidence from clinical studies in this population is limited. Therefore, use in geriatric patients may be associated with variations 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.
DERMATOP EMOLLIENT […]