Egyptian Non-prescription Medicinal Products (OTC) List PDF

Guideline The Egyptian Non-prescription Medicinal Products (OTC) List No. Generic name Dosage form or Route Notes 1...

Guideline The Egyptian Non-prescription Medicinal Products (OTC) List No. Generic name Dosage form or Route Notes 1 Aceclofenac Topical 2 Minerals Oral,topical Accepted within daily dietary intake in multi- vitamins products, 3 Vitamin A Oral, topical in case single product with high doses and for specific indication it should be POM Accepted within daily dietary intake in multi- vitamins products, 4 Vitamin D Oral, topical in case single product with high doses and for specific indication it should be POM Accepted within daily dietary intake in multi- vitamins products, 5 Vitamin E Oral, topical in case single product with high doses and for specific indication it should be POM Accepted within daily dietary intake in multi- vitamins products, 6 Vitamin K Oral, topical in case single product with high doses and for specific indication it should be POM 7 Vitamin B Oral, topical 8 Vitamin C Oral, topical Adequately labeling mentioning impaired renal 9 Aluminium Hydroxide Oral function precautions 10 Ambroxol Oral 11 Antazoline Topical Aspirin 12 (75,81,100,150,162,250, Oral Concantrations above 325mg POM 300,320,325) 13 Benproperine Oral May cause dizziness Guideline title The Egyptian Non-prescription Medicinal Products (OTC) List 1 Code EDREX:GL.CAP.Care.007 Version /year 1/2021  Guideline No. Generic name Dosage form or Route Notes Adequate labeling mentioning Methemoglobinemia warning. Used only in the following age groups: Topical spray, Oral spray - Dental gel: From 2 years, only with medical 14 Benzocaine & gel & lozenges supervisio - Oral solution: From 6 years - Dental spray: From 6 years - Lozenges: From 12 years 15 Bisacodyl Oral, rectal 16 Bromhexine Oral Use of this drug is completely prohibited in children less than 2 years. 17 Brompheniramine Oral Use of this drug is prohibited in children less than 6 years without medical supervision. 18 Butenafine Topical 19 Caffeine Oral In combination products only. 20 Calamine Topical Calcium carbonate, Caution should be generally exercised in the case of 21 Oral Magnesium carbonate patient with impaired renal function. 22 Camphor Topical Contraindicated in patients less than 2 years. 23 Carbinoxamine Oral Antihistamines may cause drowsiness. Use caution when driving or using machine. 24 Carboxymethylcellulose Eye drops Guideline title The Egyptian Non-prescription Medicinal Products (OTC) List 2 Code EDREX:GL.CAP.Care.007 Version /year 1/2021  Guideline No. Generic name Dosage form or Route Notes Contraindicated in infants less than 6 month. In chronic conditions, it should be used under 25 Cetirizine Oral medical supervision. May cause drowsiness; Use caution when driving a motor vehicle or operating machinery Chlorhexidine 26 Topical Gluconate Use of this drug is completely prohibited in children less than 2 years. Use of this drug is prohibited in children less than 6 years without Chlorpheniramine medical supervision. 27 Oral Maleate May cause drowsiness; caution when driving a motor vehicle or operating machinery. In chronic cases, it must be used under medical supervision. 28 Cinchocaine Topical 29 Citric Acid Oral Sedation side effects should be clearly labeled. 30 Clemastine Oral In chronic conditions, it must be used under medical supervision. 31 Clotrimazole Topical 32 Cromoglicic acid Nasal Must not be used in children under 2 years unless 33 Cromolyn sodium Nasal directed by a doctor. (to include or to not include age limits) 34 Crotamiton Topical Sedation side effects should be clearly labeled 35 Cyproheptadine Oral Take care in geriatric because of atropine like effects. Antihistamines may cause drowsiness. Use caution 36 Desloratadine Oral when driving or using machine. Guideline title The Egyptian Non-prescription Medicinal Products (OTC) List 3 Code EDREX:GL.CAP.Care.007 Version /year 1/2021  Guideline No. Generic name Dosage form or Route Notes Antihistamines may cause drowsiness. Use caution when driving or using machine. 37 Dexbrompheniramine Oral In case of chronic cases, it must be used under medical supervision. Sedation side effects should be clearly labeled (daily med) 38 Dexchlorpheniramine Oral In case of chronic cases, it should be used under medical supervision. 39 Dexpanthenol Topical 40 Diclofenac Sodium Topical 41 Dicyclomine Oral Adequately labeling mentioning impaired renal function precautions 42 Dihydroxy Aluminum Oral Used with extreme caution and only in necessary cases of ascites resulting from liver failure, hypertensive patients and heart diseases. 43 Dimethicon Oral & Topical Antihistamines may cause drowsiness. Use caution when driving or using machine. Sedation side effects should be clearly labeled 44 Dimetindene maleate Oral & Topical Not used in children less than 1 year. Topical anti-histaminic may cause hypersensitivity; avoid in eczema; photosensitivity Not recommended for longer than 3 days Sedation side effects should be clearly labeled. Topical anti-histaminic may cause hypersensitivity; avoid in eczema; Not recommended for longer than 3 days in photosensitivity 45 Diphenhydramine Oral & Topical Use of this drug is completely prohibited in children less than 2 years. Use of this drug is prohibited in children less than 6 years without medical supervision. 46 Docosanol Topical 47 Domiphen bromide Oral Guideline title The Egyptian Non-prescription Medicinal Products (OTC) List 4 Code EDREX:GL.CAP.Care.007 Version /year 1/2021  Guideline No. Generic name Dosage form or Route Notes In chronic cases, it should be used under medical supervision. May cause drowsiness. Use caution when driving or using machinery. Use of this drug is completely prohibited in 48 Doxylamine succinate Oral children less than 2 years. Use of this drug is prohibited in children less than 6 years without medical supervision Use of this drug in pregnancy is prohibited as it may cause birth defects. In chronic cases, it should be used under medical supervision. May cause drowsiness. Use caution when driving or using machinery. Doxylamine succinate, Use of Doxylamine is completely prohibited in 49 Oral Caffeine children less than 2 years. Use of this drug is prohibited in children less than 6 years without medical supervision Use of Doxylamine in pregnancy is prohibited as it may cause birth defects. 50 Etofenamate Topical 51 Fexofenadine Oral Not used in children less than 2 years. 52 Folic acid Oral (< 1 mg) Use of this drug is completely prohibited in children less than 2 years. Use of this drug is 53 Guaifenesin Oral & rectal prohibited in children less than 6 years without medical supervision. 54 Hexetidine Mouth Wash Prolonged use of corticosteroids may increase the 55 Hydrocortisone Topical incidence of secondary infection. 56 Hyoscine Oral 57 Ibuprofen Topical Topical (maximum 58 Indomet(h)acin strength 1 %) Guideline title The Egyptian Non-prescription Medicinal Products (OTC) List 5 Code EDREX:GL.CAP.Care.007 Version /year 1/2021  Guideline No. Generic name Dosage form or Route Notes In combinations only 59 Iron Oral ADR: Constipation, darkening of stools, Dental discoloration, Urine discoloration. 60 Lactulose Oral Lidocaine 2 % products are not approved to treat 61 Lidocaine Topical teething pain as use in infants and young children can cause serious harm, including death In chronic cases, it should be used under medical supervision. 62 Loratadine Oral May cause drowsiness. Use caution when driving or using machinery. lysosyme HCl , 63 Lozenges Dequalinium Chloride 64 Magaldrate Oral 65 Magnesium Hydroxide Oral 66 Magnesium Trisilicate Oral 67 Mebevirin Oral The use of this drug is contraindicated in children 68 Meclizine Oral & rectal under 2 years of age, and in children 2-12 years is allowed only under medical supervision. 69 Menthol Topical For the oral dosage forms: 1- In chronic cases, it should be used under medical 70 Mepyramine maleate Oral & Topical supervision. 2- May cause drowsiness. Use caution when driving or using machinery. 71 Methyl salicylate Topical Topical & Oral Gel 72 Miconazole (Maximum strength 2%) 73 Minoxidil sulphate Topical only except gel Maximum strength 5% for use as OTC Guideline title The Egyptian Non-prescription Medicinal Products (OTC) List 6 Code EDREX:GL.CAP.Care.007 Version /year 1/2021  Guideline No. Generic name Dosage form or Route Notes Treatment duration should not exceed 5 days; frequent or prolonged use may cause nasal Nasal (Maximum congestion to recur or worsen. strength 0.05%) & [FDA & technical committee decision] 74 Naphazoline Ophthalmic (Maximum As a single agent it should not be used in children strength 0.015%)