Miconazole

Mouth/Throat
Oropharyngeal candidiasis
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 to <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
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.

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(s) 1-2 times daily. Continue treatment for 10 days even after all lesions have disappeared.
Child: Same as adult dose.

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.

Vaginal
Vulvitis
Adult: As 2% vaginal cream: Apply to anogenital area bid. Continue treatment even after pruritus and leukorrhoea have disappeared or menstruation begins.

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.

Hepatic impairment. Neonates (when used for skin fungal infections) and children. Pregnancy and lactation. Patient Counselling 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).

Significant: Hypersensitivity reactions (e.g. anaphylactic reactions, angioedema), serious skin reactions (e.g. Stevens-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.

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.

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.

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.
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.

Mouth/Throat: Store between 20-25°C. Buccal tab: Protect from moisture. Storage recommendations may vary among countries or individual products (refer to detailed product guidelines). Topical/Cutaneous: Store between 20-25°C. 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). Vaginal: Store between 20-25°C. Storage recommendations may vary among countries or individual products (refer to detailed product guidelines).

Mouth/Throat Preparations / Preparations for Vaginal Conditions / Topical Antifungals & Antiparasites

D01AC02 - miconazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.
A01AB09 - miconazole ; Belongs to the class of local antiinfective and antiseptic preparations. Used in the treatment of diseases of the mouth.
A07AC01 - miconazole ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of intestinal infections.
S02AA13 - miconazole ; Belongs to the class of antiinfectives used in the treatment of ear infections.
G01AF04 - miconazole ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of gynecological infections.
J02AB01 - miconazole ; Belongs to the class of imidazole derivatives. Used in the systemic treatment of mycotic infections.