- 105 - TOPICAL PREPARATIONS GROUP 15 TOPICAL PREPARATIONS 15.1 DERMATOLOGICAL PREPARATIONS 15.1.1 TOPICAL ANTIFUNGALS • CLOTRIMAZOLE Indication: Treatment of susceptible fungal infections, dermatophytoses, superficial mycoses, and cutaneous candidiasis Unlabeled/investigation indication: N/A Usual Dose: Apply twice daily Adverse Reaction: Mild burning, irritation, stinging to skin or vaginal area Pregnancy risk factor: B Lactation: Excretion in breast milk unknown Preparations: Cream15 g ED(%) (1% Clotrimazole) • KETOCONAZOLE Indication: Treatment of tinea corporis , tinea cruris , tinea versicolor , cutaneous candidiasis, seborrheic dermatitis. Unlabeled/investigation indication: N/A 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 Pregnancy risk factor: C Lactation: Enters breast milk/not recommended Preparations: Cream 5 g ED(%) ( 2% Ketoconazole) • SODIUM THIOSULFATE Indication: Treatment of tinea versicolor . Unlabeled/investigation indication: N/A Usual Dose: Apply a thin layer to affected areas twice daily. Adverse Reaction: Contact dermatitis, local irritation. Pregnancy risk factor: C Lactation: N/A Preparations: Solution 60 mL ED(%) ( 20% Sodium thiosulfate ) .!. 2553 %&' %' ()* +,)'& - 106 - TOPICAL PREPARATIONS 15.1.2 TOPICAL ANTIVIRALS • ACYCLOVIR Indication: Treatment of herpes simplex infection of the skin including recurrent genital herpes or herpes labialis. Unlabeled/investigation indication: N/A Usual Dose: Apply 5 times/day. Adverse Reaction: Transient burning, stinging, flaking and dry skin, erythema, itch. Pregnancy risk factor: B 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. Unlabeled/investigation indication: N/A 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 Pregnancy risk factor: C Lactation: Excretion in breast milk unknown/use caution Preparations: Cream 15 g ED(R) (0.1% Acyclovir) • PREDNISOLONE Indication: Treatment of inflammatory dermatoses such as atopic dermatitis, neurodermatitis, pruritis, contact dermatitis and non specific pruritis. Unlabeled/investigation indication: N/A Usual Dose: Apply 1-2 times/day. Adverse Reaction: Local atrophic changes(prolonged and intensive treatment), itching,hypertrichosis, acneform eruption Pregnancy risk factor: C Lactation: Enters breast milk/use caution Preparations: Cream 15 g ED(%) (0.5% Prednisolone) .!. 2553 %&' %' ()* +,)'& - 107 - TOPICAL PREPARATIONS • TRIAMCINOLONE ACETONIDE Indication: Treatment of Inflammatory dermatoses responsive to steroids. Unlabeled/investigation indication: N/A Usual Dose: Apply thin film to affected areas 2-4 times/day. Adverse Reaction: Itching, allergic contact dermatitis, dryness , burning, irritation Pregnancy risk factor: C Lactation: Excretion in breast milk unknown/use caution Preparations: Cream 15 g ED(%) (0.1% Triamcinolone acetonide) 15.1.4 ANALGESIC AND ANTI-INFLAMATORY • DICLOFENAC Indication: Treatment of traumatic inflammation of the tendons, ligament, muscle and joints . Unlabeled/investigation indication: N/A Usual Dose: Apply gel to lesion area twice daily. Adverse Reaction: Edema at site reactions Pregnancy risk factor: N/A Lactation: 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. Unlabeled/investigation indication: N/A 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 .!. 2553 %&' %' ()* +,)'& - 108 - TOPICAL PREPARATIONS - Local: Burning and stinging - Neuromuscular & skeletal: Paresthesias - Renal: Hematuria - Respiratory: Pulmonary edema Pregnancy risk factor: C Lactation: Enters breast milk/contraindicated Preparations: Cream 20 g ED(R) (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. Unlabeled/investigation indication: N/A Usual Dose: Apply to the affected area 1-4 times/day Adverse Reaction: Dermatitis, folliculitis, irritation, photosensitivity Pregnancy risk factor: C Lactation: N/A Preparations: Cream 100 g ED(%) (5% LCD cream) • COAL TAR SOLUTION (POLYTAR LIQUID) Indication: Topically for controlling seborrheic dermatitis, or psoriasis. Unlabeled/investigation indication: N/A Usual Dose: Rub shampoo onto wet hair and scalp leave on 5 minutes. Adverse Reaction: Dermatitis, folliculitis, irritation, photosensitivity Pregnancy risk factor: C Lactation: N/A 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 Unlabeled/investigation indication: N/A Usual Dose: Insert 100 mg/day for 6-7 days or 500 mg single dose Adverse Reaction: Vulvar/vaginal burning Pregnancy risk factor: B .!. 2553 %&' %' ()* +,)'& - 109 - TOPICAL PREPARATIONS Lactation: Excretion in breast milk unknown Preparations: Vaginal Tablets 100 mg ED(%) • NYSTATIN+DIIODOHYDROQUIN+BENZALKONIUM CHLORIDE Indication: Treatment of susceptible cutaneous, mucocutaneous fungal infections normally caused by the Candida species . Unlabeled/investigation indication: N/A Usual Dose: Insert 1 tablet/day at bedtime for 2 weeks. Adverse Reaction: Contact dermatitis, Stevens-Johnson syndrome Pregnancy risk factor: B 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. Unlabeled/investigation indication: N/A Usual Dose: Individualised dosage. Adverse Reaction: Local irritation in patients allergic to iodine Pregnancy risk factor: N/A Lactation: N/A Preparations: Solution 15 mL ED (10% Betadine) • CALAMINE+ZINC OXIDE (CALAMINE) Indication: Relief of itching, summer prurigo, rash and minor skin affections. Unlabeled/investigation indication: N/A Usual Dose: Apply 3-4 times/day. Pregnancy risk factor: N/A Lactation: N/A Preparations: Lotion (8% Calamine+8% Zinc oxide) ED(%) • CITRONELLA LOTION Indication: Protect insect and mosquito bite . Preparations: Lotion 60 mL NED .!. 2553 %&' %' ()* +,)'& - 110 - TOPICAL PREPARATIONS • 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 .!. 2553 %&' %' ()* +,)'& .