CHAPTER 1: DENTAL AND ORAL CONDITIONS 12/7/2018 CHAPTER 1: DENTAL AND ORAL CONDITIONS NATIONAL DEPARTMENT OF HEALTH AFFORDABLE MEDICINES ESSENTIAL MEDICINES PROGRAMME DISCLAIMER This slide set is an implementation tool and should be used alongside the published STG. This information does not supersede or replace the STG itself. PRIMARY HEALTHCARE 2014 Updates to the 2008 PHC STG & EML

1.2 CANDIDIASIS, ORAL (THRUSH) Amphotericin B lozenges: deleted Currently not available on the market. Gentian violet: deleted Safety: WHO Children Medicines Formulary 2010 1: Carcinogenic in animal studies. Contra-indications: excoriated or ulcerated lesions, broken skin, mucous membranes, porphyria. Common adverse effects: irritation and ulceration of mucous membranes; Uncommon adverse effects: severe irritation. Stigma: Discolouration on the oral mucosa may be unacceptable to the patient. Nystatin suspension: retained Directions for use amended. Level of evidence: III Expert opinion Ref 1 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: DENTAL AND ORAL CONDITIONS

Level of evidence: III Expert opinion 1.3 GINGIVITIS AND PERIODONTITIS: 1.3.1 GINGIVITIS, UNCOMPLICATED; 1.3.2 PERIODONTITIS; 1.3.3 NECROTISING PERIODONTITIS Chlorhexidine 0.2%, 15 mL as a mouthwash: directions for use amended Gargling is inadequate for dental problems; the solution should be swirled through the mouth area and not the throat. Level of evidence: III Expert opinion Ref 2 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: DENTAL AND ORAL CONDITIONS

1.4 HERPES SIMPLEX INFECTIONS OF THE MOUTH AND LIPS Tetracaine 0.5%, oral, topical: amended Indicated for adults & children > 6 years of age. Strength & the dosing interval was aligned to the package insert’s recommendation of 5-7 hourly. Safety: Paucity of data - surface anaesthetic in the mouth. Martindale, 37th edition (April 2011): Rapid absorption of tetracaine hydrochloride from the mucous membranes, with high risk of systemic toxicity. Local manufacturer: No clinical data or documented evidence to confirm safety in infants and children. Use in infants and children not recommended by the company. Ref 3 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: DENTAL AND ORAL CONDITIONS

1.4 HERPES SIMPLEX INFECTIONS OF THE MOUTH AND LIPS Aciclovir: Prescriber level and directions for use, amended ; Dosing interval of 8 hourly retained. Non severe herpes stomatatis: prescribed by nurse practitioners – refer severe conditions with complications. Children with extensive lesions on the lips & mouth: anti-viral therapy within 72 hours of onset of symptoms; Child presents > 1 week of the onset of symptoms: omit aciclovir therapy (lesions heal spontaneously within 7 days). Dosing interval: Double-blind, placebo-controlled trial of 5-day aciclovir (400 mg 3 times daily) RCT (n=615) where men with genital ulcers, received syndromic management. Outcomes assessed over a month suggested that aciclovir, at an 8 hourly dose, improved ulcer healing: 61% of those receiving aciclovir healed by D 7, vs. 42% receiving placebo (adjusted RR, 1.4 [95% CI, 1.1 to 1.8]; P=0.003). Aciclovir also improved healing by a median of 3 days (P=0.002) and; Reduced HIV-1 ulcer shedding on day 7 (24% for acyclovir vs 37% for placebo; P=0.05 Level of evidence: III Extrapolated RCT, Expert opinion Ref 4 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: DENTAL AND ORAL CONDITIONS

1.5 APHTHOUS ULCERS Choline salicylate/cetalkonium chloride 8.7/0.01% oral gel: deleted Safety : The MHRA issued a safety warning regarding topical oral salicylate gels, not be used in those < 16 years. Triggered by a report of a suspected case of Reye’s syndrome associated with oral salicylate gel in a 20 month old child. Availability: Not available on the local South African market. Tetracaine 0.5%, oral, topical: added Product already recommended for extensive oral herpes. Refer to section 1.4 Herpes simplex infections of the mouth and lips. Ref 5 PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: DENTAL AND ORAL CONDITIONS

1.5 APHTHOUS ULCERS Paracetamol, oral: added No topical product available on the market, for children to manage pain. Triamcinalone 1mg/g paste: not added Not available on the South African market. Benzydamine hydrochloride 10mg/g: not added More expensive than tetracaine 0.5%,oral, topical. PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: DENTAL AND ORAL CONDITIONS

1.6 TEETHING, INFANT New STG: No medicine added. A common complaint at primary level of care. To deter unnecessary use of medication and other local oral anaesthetic preparations that are not safe for use in the teething infant. No medicine added. PRIMARY HEALTHCARE IMPLEMENTATION SLIDES 2014: DENTAL AND ORAL CONDITIONS

Slide Ref # Reference 1.2 CANDIDIASIS, ORAL (THRUSH) 3 1 GENTIAN VIOLET WHO model formulary for children, 2010. Available at: http://www.who.int/selection_medicines/list/WMFc_2010.pdf Hill SR, Kouimtzi M, Stuart MC, eds. WHO model formulary. Geneva, World Health Organization, 2008. McEvoy GK, ed. AHFS drug information. Bethesda, American Society of Health-System Pharmacists, 2009. Sweetman SC, ed. Martindale: the complete drug reference. 34th ed. London, Pharmaceutical Press, 2005. WHO expert committee on the selection and use of essential medicines. The selection and use of essential medicines: report of the WHO expert committee October 2007 (including the model list of essential medicines for children). WHO Technical Report Series, 2008, 950 http://www.who.int/medicines/publications/essentialmeds_committeereports/TRS_950.pdf 1.3 GINGIVITIS AND PERIODONTITIS 4 2 CHLORHEXIDINE. (2009). In DRUGDEX® Drug Point. 1.4 HERPES SIMPLEX INFECTIONS OF THE MOUTH AND LIPS 5 TETRACAINE HYDROCHLORIDE. Adcock Ingram Pharmaceuticals. MCC registered Dynexan® ointment package insert. Sweetman SC, ed. Martindale: the complete drug reference. 37th ed. London, Pharmaceutical Press, 2011. 6 ACICLOVIR Paz-Bailey G et al. Improvement in healing and reduction in HIV shedding with episodic acyclovir therapy as part of syndromic management among men: a randomized, controlled trial. J Infect Dis. 2009 Oct 1;200(7):1039-49. 1.5 APHTHOUS ULCERS 7 CHOLINE SALICYLATE/CETALKONIUM CHLORIDE 8.7/0.01% ORAL GEL Osman TK, et al. BMJ 2008;336:1376. MHRA Drug safety update. June 2009, Volume 2, Issue 11.