PAEDIATRIC HOSPITAL LEVEL ESSENTIAL MEDICINES LIST CHAPTER 5: DERMATOLOGY NEMLC 30 JUNE 2016

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1 PAEDIATRIC HOSPITAL LEVEL ESSENTIAL MEDICINES LIST CHAPTER 5: DERMATOLOGY NEMLC 30 JUNE 2016 PICTURES OF CONDITIONS: The Paediatric Expert Review Committee (ERC) recommended that the Dermatology Chapter include photographs of various dermatological conditions. New Standard Treatment Guideline - Cutaneous Haemangiomas The Paediatric ERC recommended the addition of a section on cutaneous haemangiomas in the Dermatology Chapter. The following section was added: CUTANEOUS HAEMANGIOMAS D18.0 DESCRIPTION Benign tumours of the vascular endothelium that may be classified as either infantile or congenital.» Infantile haemangiomas: vascular neoplasms characterised by abnormal proliferation of endothelial cells and abnormal blood vessel architecture. Usually appear before 4 weeks of age and continue to grow, with most completing their growth by 5 months.» Congenital haemangiomas: fully grown at birth, and are either rapidly involuting or non-involuting. DIAGNOSTIC CRITERIA» Physical examination.» Most haemangiomas can be diagnosed clinically. GENERAL AND SUPPORTIVE MEASURES» Counseling to assist patient in dealing with the condition. MEDICINE TREATMENT Treatment with propranolol recommended for:» Life-threatening haemangiomas (airways),» Function-threatening haemangiomas,» Ulcerating lesions. Pre-treatment evaluation: Ensure no cardiac or pulmonary abnormalities.» Minimum baseline assessment: o Full clinical history and examination. o Baseline heart rate, blood pressure and oxygen saturation. o ECG (Only in patients where there are concerns of cardiovascular disease).» Propranolol, oral: o Initial dose: 0.5 mg/kg/dose, 12 hourly for 7 days; o Then: 1 mg/kg/dose, 12 hourly for 7 days; o Then: 1.5 mg/kg/dose, 12 hourly for 6 months.

2 o Discontinue over 2 weeks as for initiation. REFERRAL Diagnostic uncertainty. Failure to respond to therapy. Peri-ocular haemangioma. Suspected airway haemangioma. Large segmental haemangioma on face or neck for echocardiogram MEDICINE AMENDMENTS SECTION MEDICINE ADDED/DELETED/NOT ADDED Staphalococcal scalded skin syndrome Oral medicine treatment Flucloxacillin Dose amended Medicine treatment Pain management Referral added to the Pain Control and Palliative Care in Paediatrics Chapter Erythema Multiform/Stevens-Johnson Syndrome Dressings Dressings guidance Added Antibiotic therapy Flucloxacillin Added Drug Reactions Antihistamines Cetirizine Dose amended Chlorphenamine Age specification added Maximum dose added Promethazine Maximum dose added Acne Topical retinoids Class Cellulitis and Erysipelas Peri-orbital cellulitis Ceftriaxone/ cefotaxime Moved to eye chapter Non-severe disease Flucloxacillin Added Penicillin allergy Erythromycin Deleted Azithromycin Added Eczema Antihistamine Cetirizine Dose amended Chlorphenamine Age specification added Maximum dose added Urticaria Severe chronic urticaria Cetirizine Dose amended Cutaneous Haemangiomas Medicine treatment Propranolol Added

3 5.1.2 Stapholococcal scalded skin syndrome Flucloxacillin - dose amended Pain management - referral added The Paediatric ERC recommended that the lower range dose be removed and the dose recommendation be 25 mg/kg/dose, in line with the British National Formulary for Children. 1» Flucloxacillin, oral, mg/kg/dose 6 hourly for 7 days. The Paediatric ERC recommended that pain management would be important to include in the staphylococcal scalded skin syndrome section. It was recommended that a referral to the Pain Control and Palliative Care in Paediatrics Chapter be added. The following text was added: For Pain Management: Refer to Chapter 20: Pain Control and Palliative Care in Paediatrics Erythema Multiform/Stevens-Johnson Syndrome Dressings: added Flucloxacillin: added The Paediatric ERC agreed that it would be beneficial to add recommendations on use of dressings that were aligned with the Adult Hospital Level STGs and EML. 2 The following text was added: Dressings Skin hygiene, daily cleansing and bland, non-adherent dressings as needed. Do not use silver sulfadiazine if Stevens Johnsons Syndrome is thought to be due to cotrimoxazole or other sulphonamide Cephalexin was the only recommended oral agent for use in Erythema multiform/stevens-johnson Syndrome. During previous review of the Paediatric Standard Treatment Guidelines (STGs) and Essential Medicines List (EML), cephalexin was included in place of flucloxacillin as a result of previous medicine availability problems with flucloxacillin. The Paediatric ERC recommended that flucloxacillin should be included as the oral alternative to cloxacillin. 1 The British National Formulary for Children BMJ Group, Pharmaceutical Press, RCPCH Publication Ltd. 2 National Department of Health. Adult Hospital Level Standard Treatment Guidelines and Essential Medicines List

4 Use IV antibiotics if the oral route cannot be used.» Cloxacillin, IV, 50 mg/kg/dose 6 hourly. OR» Flucloxacillin, oral, 25mg/kg/dose 6 hourly. OR (if flucloxacillin is unavailable)» Cephalexin, oral, mg/kg/dose 6 hourly Drug Reactions Cetirizine: dose amended Chloramphenicol: Age specifications added, maximum dose added Promethazine: Maximum dose added The cetirizine package insert 3 and the SAMF 4 recommend dosing cetirizine from 2 years of age. The Paediatric ERC recommended that the cetirizine dosing be aligned with both the SAMF and package insert. For children 3 2 years and older:» Cetirizine, oral, as a single dose at night. o Children years: 5 mg. o Children > years: 10 mg. The Paediatric ERC recommended that the use of chlorphenamine should be specified for use in children less than 2 years where cetirizine can not be used. For children less than 2 years Where the oral route can be used:» Chlorphenamine, oral, 0.1mg/kg/dose as a single dose at night. (Maximum 4mg). A maximum dose for promethazine was included. Where the oral route cannot be used:» Promethazine, IV, 0.1 mg/kg/dose 8 12 hourly. (Maximum 25mg) Acne Topical retinoids: Class added 3 Allecet Syrup package insert. Cipla Life Sciences (Pty)Ltd April South African Medicines Formulary. 11th Edition. Division of Clinical Pharmacology. University of Cape Town. 2014

5 During scoping, adapalene was investigated for the management of acne as an alternative to topical tretinoin. Topical adapalene has shown to be better tolerated than tretinoin (currently the recommended topical retinoid in the Paediatric STGs and EML), however these studies were based on older formulations of tretinoin. 5 The Paediatric ERC recommended that topical retinoids be declared a therapeutic class, with either tretinoin or adapalene included as members of this class. The text was amended to indicate the topical retinoid class: Topical retinoid, e.g.: Tretinoin cream/gel 0.05%, topical, applied sparingly once daily at bedtime until substantial improvement Cellulitis and Erysipelas Peri-orbital cellulitis Treatment: Moved to Eye Chapter Flucloxacillin: added Erythromycin: Deleted Azithromycin: Added The Paediatric ERC recommended that the management of peri-orbital cellulitis be moved to the Eye chapter. As previously discussed flucloxacillin was added as the oral alternative to cloxacillin in addition to cephalexin. In line with the National Essential Medicines List Committee (NEMLC) meeting January 2015, where it was recommended that the macrolide erythromycin be replaced with clarithymycin or azithromycin, erythromycin was deleted, and replaced with azithromycin, for penicillin allergy. Penicillin allergy Macrolide, e.g.: Erythromycin, oral, Azithromycin, oral 10 mg/kg/day, 6 hourly for 5 3 day Eczema Cetirizine: dose amended Chlorphenamine: age specifications added, maximum dose added 5 Zaenglein AI, et. al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016; 74:

6 As previously discussed, cetirizine dose was amended and recommended for age 2 years and above, while chlorphenamine was recommended for use in children under 2 years. For children 2 years and older:» Cetirizine, oral, as a single dose. o Children 2-6 years: 5 mg. o Children 6-12 years: 10 mg. For children less than 2 years:» Chlorphenamine, oral, 0.1mg/kg/dose as a single dose at night. (Maximum 4mg) Urticaria Cetirizine: dose amended Cetirizine dose amended as discussed above. For children 2 years and older:» Cetirizine, oral, as a single dose. o Children 2-6 years: 5 mg. o Children 6-12 years: 10 mg. Cetirizine, oral, as a single dose at night. o Child 3 12 years: 5 mg. o Child > 12 years: 10 mg Cutaneous Haemangiomas Propranolol: added A section on cutaneous haemangiomas was added to the Dermatology Chapter. Propranalol was added as the medication treatment for life-threatening haemangiomas (airways), function-threatening haemangiomas and ulcerating lesions. 6, 7, Propranolol has been demonstrated to be a safe and effective treatment for infantile haemangiomas. 8, 9 A randomised controlled trial including 40 children between the ages of 9 weeks and 5 years 6 Solman L, Murabit A, Gnarra M, Harper JI, Syed SB, Glover M. Propranolol for infantile haemangiomas: single centre experience of 250 cases and proposed therapeutic protocol. Arch Dis Child. 2014; 99: Zimmermann AP, Wiegand S, Werner JA, Eivazi. Propranolol therapy for infantile haemangiomas: Review of the literature. International Journal of Pediatric Otorhinolaryngology. 2010; 74:

7 randomly assigned patients to either propranolol or placebo. Infantile haemangioma growth stopped by week 4 in the propranalol group, with significant changes in volume seen between the groups at week 12 [difference (95% CI to -5.2), P = 0.03]. There were significant improvements in redness and elevation as based on investigator scores from clinical photographs at weeks 12 and 24 (P = 0.07 and P=0.01 respectively for redness, and P= and P= 0.01 for elevation. 9 The following text was added: Treatment with propranolol recommended for:» Life-threatening haemangiomas (airways),» Function-threatening haemangiomas,» Ulcerating lesions. Pre-treatment evaluation: Ensure no cardiac or pulmonary abnormalities.» Minimum baseline assessment: o Full clinical history and examination; o Baseline heart rate, blood pressure and oxygen saturation; o ECG (Only in patients where there are concerns of cardiovascular disease).» Propranolol, oral: o Initial dose: 0.5 mg/kg/dose, 12 hourly for 7 days; o Then: 1 mg/kg/dose, 12 hourly for 7 days; o Then: 1.5 mg/kg/dose, 12 hourly for 6 months. o Discontinue over 2 weeks as for initiation. 8 Chen TS, Eichenfield LF, Friedlander SF. Infantile hemangiomas: An update of pathogenesis and therapy. Pediatrics. 2013; 131: Hogeling M, Adams S, Wargon O. A Randomized Controlled Trial of Propranolol for Infantile Hemangiomas. Pediatrics. 2011; 128:e259-e266.