GROUP 15 TOPICAL PREPARATIONS

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1 GROUP DERMATOLOGICAL PREPARATIONS 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 )

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) 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)

3 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) 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 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

4 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) 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

5 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

6 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

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

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