GROUP 15 TOPICAL PREPARATIONS

Similar documents
Core Safety Profile. Pharmaceutical form(s)/strength: solution 1%, spray 1%, cream 1%, gel 1% SK/H/PSUR/0005/001 Date of FAR:

Your health is our priority

50 microgram/g Calcipotriol and 500 microgram/g betamethasone (as dipropionate).

Prescribing Information

PRODUCT INFORMATION ELEUPHRAT CREAM, OINTMENT AND LOTION. Betamethasone dipropionate equivalent to betamethasone 0.5 mg/g (0.

SUMMARY OF PRODUCT CHARACTERISTICS. Excipient with known effect Cetyl alcohol For the full list of excipients, see section 6.1.

PACKAGE LEAFLET: INFORMATION FOR THE USER. Flutarzole 0,05% w/w cream, Fluticasone propionate

Prescribing Information. Taro-Clobetasol. Taro-Clobetasol

TOPCORT Cream/Ointment (Mometasone furoate 0.1%)

SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT

Pediatric Dermatology. Wingfield Rehmus, MD MPH BC Children s Hospital

Cordran Cream and Cordran Ointment Flurandrenolide, USP

PRODUCT MONOGRAPH DIPROSONE. Betamethasone Dipropionate Cream, Merck Standard, 0.05% W/W betamethasone (as dipropionate)

PRESCRIBING INFORMATION. ratio-topisone. Betamethasone dipropionate USP. 0.5 mg Cream, Ointment and Lotion. Topical corticosteroid

DATA SHEET. Betamethasone dipropionate equivalent to betamethasone 0.5mg/g (0.05% w/w).

The skin is the largest organ of the human body. Functions: protection sensation maintain temperature vitamin synthesis

PRODUCT MONOGRAPH. Betamethasone dipropionate USP. 0.5 mg Cream, Ointment and Lotion. Topical corticosteroid

NEW ZEALAND DATA SHEET

CORTISPORIN Cream (neomycin and polymyxin B sulfates and hydrocortisone acetate cream, USP)

Summary of Product Characteristics

DIPROSONE OV Cream and Ointment do not contain preservatives, parabens or lanolin.

AUSTRALIAN PRODUCT INFORMATION RESOLVE PLUS 1.0 (MICONAZOLE NITRATE, HYDROCORTISONE) CREAM

PRESCRIBING INFORMATION. Cream 0.025% Topical Corticosteroid

Common Superficial Fungal Infections

For topical use only. Not for oral, ophthalmic, or intravaginal use.

Rashes Not To Be Missed In Children

Fluocinolone Acetonide 0.01% Topical Oil (Scalp Oil)

NOVASONE CREAM, OINTMENT AND LOTION PRODUCT INFORMATION

SUMMARY OF PRODUCT CHARACTERISTICS

HYDROCORTISONE OINTMENT USP,

Each gram of the ointment contains 0.25 mg Fluocinolone Acetonide in a base containing White Petrolatum.

CORTISPORIN Ointment (neomycin and polymyxin B sulfates, bacitracin zinc, and. hydrocortisone ointment, USP)

Diagnosis and Management of Common and Infective Skin Diseases in Children at primary care level

1. NAME OF THE MEDICINAL PRODUCT. Lamisil 1% cutaneous solution. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION

See 17 for PATIENT COUNSELING INFORMATION. Revised: 03/2018

Subspecialty Rotation: Dermatology

Students. Exhibit - Reporting and Exclusion Requirements for Common Communicable Disease. Reporting Mandated to Local Health Authority

0BCore Safety Profile. Pharmaceutical form(s)/strength: Cream 1% DK/H/PSUR/0009/005 Date of FAR:

LUMACIP PLUS Cream (Fluocinolone acetonide 0.01% + Hydroquinone 4% + Tretinoin 0.05%)

Drugs dermatological conditions II

(5). (1, 5) Table 1:Appearance and location of dandruff, psoriasis and seborrhoeic dermatitis

Package leaflet: Information for the user. Fluticrem 0.05% cream Fluticasone propionate

forniture parafarmaceutiche

Kelly H. Tyler, MD, FACOG, FAAD S052 Gender Dermatology: Diagnosis and Treatment of Genital Skin Disorders Vulvar Dermatitis

Diagnosis And Treatment Of Seborrheic Dermatitis

Ultravate (halobetasol propionate) Cream, 0.05% (halobetasol propionate) Ointment, 0.05% For Dermatological Use Only. Not for Ophthalmic Use.

DERMATOP Ointment (prednicarbate ointment) 0.1% FOR DERMATOLOGIC USE ONLY. NOT FOR USE IN EYES.

SUMMARY OF PRODUCT CHARACTERISTICS

Revised: 03/2018. *Sections or subsections omitted from the full prescribing information are not listed.

For the use only of Registered Medical Practitioners or a Hospital or a Laboratory BETNOVATE - S

Tinea: Head to Toe A dermatophyte tour of human skin. Tour de Tinea Head to Toe. Tips for Tinea Head to Toe. Psoriasis. Non-inflammatory Tinea Capitis

SUMMARY OF PRODUCT CHARACTERISTICS

Provide relief with Topicort 0.05% 1,2. For your patients with corticosteroid-responsive dermatoses... IMPORTANT SAFETY INFORMATION

BETNOVATE SKIN CREAM. Betamethasone Valerate Cream IP QUALITATIVE AND QUANTITATIVE COMPOSITION

WR SKIN. DERMATOLOGY

6.1 CARDIAC DRUGS AGENT FOR CONGESTIVE HEART FAILURE

For the use only of Registered Medical Practitioners or a Hospital or a Laboratory ZODERM E CREAM. Oxiconazole Nitrate Cream

Atopic dermatitis Usually starts t in early infancy Xerosis (dry skin) Pruritus Eczematous lesions

KEY MESSAGES. Psoriasis patients are more prone to cardiovascular diseases, stroke, lymphoma and non-melanoma skin cancers, and increased mortality.

Contents. QAaptm-2. CAaptei-3. CAaptm-4. Cftapte%-5. Qfiaptvt-6. QhapteK-7. Qkaptefc-8 Clinical Immunology and Allergy 71

Elocon (mometasone furoate) Cream, Ointment, and Lotion Formulations : Core Safety Profile

ZOFLUT Cream (Fluticasone propionate)

Core Safety Profile. AT/H/PSUR/0013/002 Date of FAR:

NEW ZEALAND DATA SHEET

Identifying and managing dermatologic toxicities associated with EGFR-inhibitor therapy. An educational resource for healthcare professionals

Antifungal drugs Dr. Raz Muhammed

Atopic Eczema with detail on how to apply wet wraps

NIZORAL (KETOCONAZOLE) 2% SHAMPOO DESCRIPTION

FLUOCINOLONE ACETONIDE-

EMILOK Global. (omeprazole) Composition: Each capsule contains 20 mg omeprazole as enteric-coated

FLUCAND HIKMA PHARMACEUTICALS

CONDITIONS OF THE SKIN

Useful Medications for Oral Conditions *

BETNOVATE Betamethasone 17-valerate

miconazole and zinc oxide topical

Ketoconazole pills for toenail fungus

Core Safety Profile. Pharmaceutical form(s)/strength: Dry Powder Inhaler, Nebuliser Suspension, pressurised Metered Dose Inhaler (pmdi)

SUMMARY OF PRODUCT CHARACTERISTICS

COMMON SKIN CONDITIONS IN PRIMARY CARE. Ibrahim M. Zayneh, MD Dermatology Private Practice, Portsmouth, Ohio

Fungi are eukaryotic With rigid cell walls composed largely of chitin rather than peptidoglycan (a characteristic component of most bacterial cell

DIPROLENE AF (augmented betamethasone dipropionate) Cream, 0.05% for topical use Initial U.S. Approval: 1983

Eczema. By:- Dr. Naif Al-Shahrani Salman bin Abdazziz University

Chemically, clobetasol propionate is 21-chloro-9-fluoro,11β,17-dihydroxy-16βmethylpregna-1,4-diene-3,20-dione

Summary of Product Characteristics

New Medicine Report. Pimecrolimus. RED- Hospital only Date of Last Revision 6 th March 2003

Elements for a Public Summary

Report ADDITIONS: Product Brand Agents: Indication. Subcategory. Generic Agents: Gastrointestinal/ Antiemetics

METHYLPREDNISOLONE ACEPONATE (MPA)

Types of Skin Infections

Zatamil. Mometasone furoate PRODUCT INFORMATION

The chemical name of acyclovir, USP is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6Hpurin-6-one; it has the following structural formula:

Scabies. Scabies 10/22/2012. What s Bugging You? Common Cutaneous Infections and Infestations in Kids

Children s Hospital Of Wisconsin

Levocetirizine dihydrochloride

The Itch That Rashes. Sarah D. Cipriano, MD, MPH, MS Resident, Dermatology University of Utah

FULL PRESCRIBING INFORMATION

NEW ZEALAND DATA SHEET

Lung Pathway Group Afatinib in Non-Small Cell Lung Cancer (NSCLC)

MUCOCUTANEOUS MANIFESTATIONS OF HIV/AIDS IN ADOLESCENTS

Staying A- Head in Pediatric Dermatology:

Transcription:

- 105 - GROUP 15 15.1 DERMATOLOGICAL PREPARATIONS 15.1.1 TOPICAL ANTIFUNGALS CLOTRIMAZOLE Indication: Treatment of susceptible fungal infections, dermatophytoses, superficial mycoses, and cutaneous candidiasis Usual Dose: Apply twice daily Adverse Reaction: Mild burning, irritation, stinging to skin or vaginal area Lactation: Excretion in breast milk unknown Preparations: Cream15 g ED(ก) (1% Clotrimazole) KETOCONAZOLE Indication: Treatment of tinea corporis, tinea cruris, tinea versicolor, cutaneous candidiasis, seborrheic dermatitis. Usual Dose : Rub gently into the affected area once daily Adverse Reaction: Allergic reaction, contact dermatitis, facial swelling, headache, impetigo, local burning, ocular irritation, paresthesia, pruritus, severe irritation, stinging Lactation: Enters breast milk/not recommended Preparations: Cream 5 g ED(ก) ( 2% Ketoconazole) SODIUM THIOSULFATE Indication: Treatment of tinea versicolor. Usual Dose: Apply a thin layer to affected areas twice daily. Adverse Reaction: Contact dermatitis, local irritation. Preparations: Solution 60 ml ED(ก) ( 20% Sodium thiosulfate )

- 106-15.1.2 TOPICAL ANTIVIRALS ACYCLOVIR Indication: Treatment of herpes simplex infection of the skin including recurrent genital herpes or herpes labialis. Usual Dose: Apply 5 times/day. Adverse Reaction: Transient burning, stinging, flaking and dry skin, erythema, itch. Lactation: Enters breast milk/use with caution Preparations: Cream 1 g NED (5% Acyclovir) 15.1.3 TOPICAL ANTI-INFECTIVES WITH CORTICOSTEROIDS BETAMETHASONE VALERATE Indication: Treatment of inflammatory dermatoses such as seborrheic or atopic dermatitis,neurodermatitis, anogenital pruritus, psoriasis, inflammatory phase of xerosis. Usual Dose: Apply 1-2 times/day. Adverse Reaction: Acneiform eruptions, allergic dermatitis, burning, dry skin, erythema, folliculitis, hypertrichosis, irritation, miliaria, pruritus, skin atrophy, striae, vesiculation Lactation: Excretion in breast milk unknown/use caution Preparations: Cream 15 g ED( ) (0.1% Acyclovir) PREDNISOLONE Indication: Treatment of inflammatory dermatoses such as atopic dermatitis, neurodermatitis, pruritis, contact dermatitis and non specific pruritis. Usual Dose: Apply 1-2 times/day. Adverse Reaction: Local atrophic changes(prolonged and intensive treatment), itching,hypertrichosis, acneform eruption Lactation: Enters breast milk/use caution Preparations: Cream 15 g ED(ก) (0.5% Prednisolone)

TRIAMCINOLONE ACETONIDE Indication: Treatment of Inflammatory dermatoses responsive to steroids. Usual Dose: Apply thin film to affected areas 2-4 times/day. Adverse Reaction: Itching, allergic contact dermatitis, dryness, burning, irritation Lactation: Excretion in breast milk unknown/use caution Preparations: Cream 15 g ED(ก) (0.1% Triamcinolone acetonide) - 107-15.1.4 ANALGESIC AND ANTI-INFLAMATORY DICLOFENAC Indication: Treatment of traumatic inflammation of the tendons, ligament, muscle and joints. Usual Dose: Apply gel to lesion area twice daily. Adverse Reaction: Edema at site reactions Pregnancy risk factor: N/A Preparations: Gel 30 gm NED 15.1.5 SCABICIDES AND PEDICULICIDES GAMMA BENZENE HEXACHLORIDE (LINDANE) Indication: Treatment of scabies,head lice, and crab lice. Usual Dose: Scabies: Apply and massage it on skin from the neck to the toes, after 8-12 hours, bathe and remove the drug. Head lice, crab lice: Apply to dry hair and massage into hair for 4 minutes add small quantities of water to hair until lather forms, then rinse hair thoroughly and comb with a fine tooth comb to remove nits. Adverse Reaction: - Cardiovascular: Cardiac arrhythmia - Central nervous system: Ataxia, dizziness, headache, restlessness, seizure, pain - Dermatologic: Alopecia, contact dermatitis, skin and adipose tissue may act as repositories, eczematous eruptions, pruritus, urticaria - Gastrointestinal: Nausea, vomiting - Hematologic: Aplastic anemia - Hepatic: Hepatitis

- 108 - - Local: Burning and stinging - Neuromuscular & skeletal: Paresthesias - Renal: Hematuria - Respiratory: Pulmonary edema Lactation: Enters breast milk/contraindicated Preparations: Cream 20 g ED( ) (1% Gamma benzene hexachloride) 15.1.6 PSORIASIS, SEBORRHEA AND ICHTHYOSIS PREPARATIONS COAL TAR SOLUTION IN HYDROPHICLIC OINTMENT Indication: Topically for controlling seborrheic dermatitis, or psoriasis. Usual Dose: Apply to the affected area 1-4 times/day Adverse Reaction: Dermatitis, folliculitis, irritation, photosensitivity Preparations: Cream 100 g ED(ก) (5% LCD cream) COAL TAR SOLUTION (POLYTAR LIQUID) Indication: Topically for controlling seborrheic dermatitis, or psoriasis. Usual Dose: Rub shampoo onto wet hair and scalp leave on 5 minutes. Adverse Reaction: Dermatitis, folliculitis, irritation, photosensitivity Preparations: Shampoo 120 ml NED (1% Coal Tar Solution) 15.2 VAGINAL PREPARATIONS CLOTRIMAZOLE Indication: Treatment of susceptible fungal infections including vulvovaginal candidiasis oropharyngeal candidiasis Usual Dose: Insert 100 mg/day for 6-7 days or 500 mg single dose Adverse Reaction: Vulvar/vaginal burning

- 109 - Lactation: Excretion in breast milk unknown Preparations: Vaginal Tablets 100 mg ED(ก) NYSTATIN+DIIODOHYDROQUIN+BENZALKONIUM CHLORIDE Indication: Treatment of susceptible cutaneous, mucocutaneous fungal infections normally caused by the Candida species. Usual Dose: Insert 1 tablet/day at bedtime for 2 weeks. Adverse Reaction: Contact dermatitis, Stevens-Johnson syndrome Lactation: Does not enter breast milk/compatible (not absorbed orally) Preparations:Vaginal tablets NED (Nystatin 100,000U+Diiodohydroquin 100mg+Benzalkonium Chloride 7 mg) 15.3 OTHER PREPARATIONS BETADINE Indication: Antiseptics, used in the treatment of dermatological diseases. Usual Dose: Individualised dosage. Adverse Reaction: Local irritation in patients allergic to iodine Pregnancy risk factor: N/A Preparations: Solution 15 ml ED (10% Betadine) CALAMINE+ZINC OXIDE (CALAMINE) Indication: Relief of itching, summer prurigo, rash and minor skin affections. Usual Dose: Apply 3-4 times/day. Pregnancy risk factor: N/A Preparations: Lotion (8% Calamine+8% Zinc oxide) ED(ก) CITRONELLA LOTION Indication: Protect insect and mosquito bite. Preparations: Lotion 60 ml NED

- 110 - KY Jelly Indication: Lubricant for easy insertion of rectal thermonometers, enema, douche and similar type nozzles, in gynecology and surgery. Preparations: Gel 50 g NED