Adult: As 20 mg/g gel: Apply 2.5 mL directly to the affected area 4 times daily after meals. Retain the gel in the mouth for as long as possible before swallowing. Continue treatment for at least 1 week even after symptoms have resolved. As buccal tab: 50 mg once daily applied to the upper gum region for 7-14 days according to clinical response. Child: 4 months-2 years As 20 mg/g gel: Apply 1.25 mL directly to the affected area 4 times daily after meals, in divided smaller doses. Retain the gel in the mouth for as long as possible before swallowing. ≥2 years As 20 mg/g gel: Same as adult dose. Continue treatment for at least 1 week even after symptoms have resolved.
Topical/Cutaneous Nail fungal infections
Adult: As 2% tincture: Apply a thick layer to the affected nail(s) and surrounding area bid until a new nail started to grow. As 2% cream: Apply to the affected area 1-2 times daily. Continue treatment for 10 days even after all lesions have disappeared. Child: Same as adult dose.
Topical/Cutaneous Skin fungal infections
Adult: As 2% cream or powder: Apply to the affected area(s) bid for 2-6 weeks depending on the localisation and severity of the lesion. Continue treatment for at least 1 week even after symptoms have resolved. Tinea pedis: As spray powder: Apply to the affected area bid until lesions disappear. Child: Same as adult dose.
Vaginal Vulvitis
Adult: As 2% vaginal cream: Apply to anogenital area bid. Continue treatment even after pruritus and leukorrhoea have disappeared or menstruation begins.
Vaginal Vulvovaginal candidiasis
Adult: As vaginal supp: Insert 100 mg once daily for 7 days, or 200 mg once daily for 3 days, or 1,200 mg as a single dose. All doses are given at bedtime. As 2% vaginal cream: Insert 1 applicatorful once daily at bedtime for 7 days. As 4% vaginal cream: Insert 1 applicatorful once daily at bedtime for 3 days. Continue treatment even after pruritus and leukorrhoea have disappeared or menstruation begins.
Contraindications
Hypersensitivity. Oral gel: Infants <4 months, or with underdeveloped swallowing reflex. Concomitant use with drugs that prolong QT-interval (e.g. astemizole, cisapride, dofetilide, mizolastine, pimozide, quinidine, sertindole, terfenadine); ergot alkaloid, HMG-CoA reductase inhibitors, triazolam, and oral midazolam.
Special Precautions
Hepatic impairment. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Hypersensitivity reactions (e.g. anaphylactic reactions, angioedema), serious skin reactions (e.g. Steven-Johnson syndrome, toxic epidermal necrolysis), skin irritation. Gastrointestinal disorders: Nausea, dry mouth, vomiting, oral discomfort, regurgitation, diarrhoea, upper abdominal pain. General disorders and administration site conditions: Application site reactions (e.g. irritation, burning, warmth, pruritus). Nervous system disorders: Headache, dysgeusia. Reproductive system and breast disorders: Dysmenorrhoea, vaginal burning sensation, genital pruritus, vulvovaginal discomfort. Skin and subcutaneous tissue disorders: Rash, pruritus, skin burning sensation, inflammation, hypopigmentation.
Avoid contact of topical preparations with the mucosa of the eyes. Avoid inhalation of spray powder. Vaginal preparations may decrease the effectiveness of latex contraceptive agents (e.g. condoms and diaphragms).
Overdosage
Symptoms: Oral gel, buccal tab, vaginal cream or supp: Vomiting and diarrhoea. Cream, tincture: Skin irritation. Spray powder: Impaction blockage of airways. Management: Symptomatic and supportive treatment. If respiration is compromised, consider endotracheal intubation, removal of impacted material and assisted breathing.
Drug Interactions
May increase or prolong the therapeutic and adverse effects of warfarin, phenytoin, fosphenytoin, sulfonylureas, saquinavir, vinca alkaloids, busulfan, docetaxel, Ca channel blockers (e.g. dihydropyridines, verapamil), immunosuppressants (e.g. ciclosporin, tacrolimus, sirolimus), carbamazepine, cilostazol, buspirone, disopyramide, alfentanil, sildenafil, alprazolam, brotizolam, midazolam IV, rifabutin, methylprednisolone, trimetrexate, ebastine, reboxetine. Potentially Fatal: May increase and/or prolong the therapeutic and adverse effects of QT-prolonging drugs (e.g. astemizole, cisapride, dofetilide, mizolastine, pimozide, quinidine, sertindole, and terfenadine), ergot alkaloids (e.g. ergotamine, dihydroergotamine), HMG-CoA reductase inhibitors (e.g. simvastatin, lovastatin), triazolam and oral midazolam.
Action
Description: Miconazole is an imidazole derivative antifungal agent which inhibits the biosynthesis of ergosterol and changes the composition of other lipid components in the membrane, thereby resulting in fungal cell necrosis. Duration: Buccal adhesion: 15 hours. Pharmacokinetics: Absorption: Minimally absorbed from the gastrointestinal tract (oral); negligible absorption (topical); small amount absorbed systemically (vaginal). Bioavailability: Approx 25-30% (oral); approx 1-2% (vaginal). Time to peak plasma concentration: Approx 2 hours. Distribution: Distributed into body tissues, joints and fluids (topical). Plasma protein binding: 88.2%, mainly to serum albumin; 10.6% to RBC. Metabolism: Metabolised in the liver to its inactive metabolites. Excretion: Mainly via faeces (approx 50% as metabolites and unchanged drug); urine (<1% as unchanged drug). Terminal half-life: Approx 20-25 hours.
Chemical Structure
Miconazole Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 4189, Miconazole. https://pubchem.ncbi.nlm.nih.gov/compound/Miconazole. Accessed Sept. 26, 2022.
Storage
Store between 20-25°C. Buccal tab: Protect from moisture. Spray powder: Do not expose to temperature >50°C. Protect from light. Storage recommendations may vary among countries or individual products (refer to detailed product guidelines).
D01AC02 - miconazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection. G01AF04 - miconazole ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of gynecological infections. A01AB09 - miconazole ; Belongs to the class of local antiinfective and antiseptic preparations. Used in the treatment of diseases of the mouth.
References
Anon. Miconazole (Oral). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 06/06/2022.Anon. Miconazole (Topical). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 06/06/2022.Basic Care Miconazole 3 Cream (Amazon.com Services LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/07/2022.Buckingham R (ed). Miconazole. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/06/2022.Care One Miconazole 1 Kit (American Sales Company). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/07/2022.Careone Miconazole 3 Kit (American Sales Company). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 10/06/2022.Daktarin 2% Cream (McNeil Products Limited). MHRA. https://products.mhra.gov.uk. Accessed 09/06/2022.Daktarin Aktiv Cream (McNeil Products Limited). MHRA. https://products.mhra.gov.uk. Accessed 09/06/2022.Daktarin Aktiv Spray Powder (McNeil Products Limited). MHRA. https://products.mhra.gov.uk. Accessed 09/06/2022.Daktarin Cream, Tincture (Johnson & Johnson Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 10/06/2022.Daktarin Oral Gel (Janssen-Cilag Limited). MHRA. https://products.mhra.gov.uk. Accessed 09/06/2022.Daktarin Powder (McNeil Products Limited). MHRA. https://products.mhra.gov.uk. Accessed 09/06/2022.Gyno-Daktarin 20 mg/g Vaginal Cream (Janssen-Cilag Limited). MHRA. https://products.mhra.gov.uk. Accessed 09/06/2022.Joint Formulary Committee. Miconazole. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/06/2022.Miconazole 7 Suppository (Strategic Sourcing Services LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 07/07/2022.Oravig Tablet (Galt Pharmaceuticals, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 09/06/2022.
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