Miconazole


Full Prescribing Info
Dosage/Direction for Use

Mouth/Throat
Oropharyngeal candidiasis
Adult: As 20 mg/g (24 mg/mL) gel: Apply 2.5 mL directly to the affected area 4 times daily, retain the gel in the mouth 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 1-2 weeks according to clinical response.
Child: 4 months-2 years
As 20 mg/g (24 mg/mL) gel: Apply 1.25 mL directly to the affected area 4 times daily, in divided smaller doses. ≥2 years As 20 mg/g gel: Same as adult dose. Continue treatment for at least 1 week after symptoms have resolved.

Mouth/Throat
Intestinal candidiasis
Adult: As 20 mg/g (24 mg/mL) gel: 20 mg/kg daily given in 4 divided doses. Max: 1,000 mg (40 mL) daily. Continue treatment for at least 1 week even after symptoms have resolved.

Vaginal

Vulvovaginal candidiasis
Adult: As 2% cream (approx 5 g): Apply intravaginally at bedtime once daily for 10-14 days or bid for 7 days. Continue treatment even after pruritus and leukorrhoea have disappeared or menstruation begins. As pessary: 100 mg once daily preferably at bedtime for 7 or 14 days, 100 mg bid for 7 days, 200 mg or 400 mg daily for 3 days, or 1,200 mg as a single dose. As vaginal cap: 1,200 mg inserted intravaginally at bedtime as a single dose.

Topical/Cutaneous

Skin fungal infections
Adult: As 2% cream or powder: Apply over affected area bid for 2-6 weeks. As 2% powder along with 2% cream: Apply both formulations over affected area once daily for 2-6 weeks. Continue treatment for at least 1 week even after symptoms have resolved. Tinea pedis: As spray powder: Apply over affected area bid until lesions disappear.
Child: Same as adult dose.

Topical/Cutaneous

Nail fungal infections
Adult: As 2% cream: Apply over affected area 1-2 times daily. Continue treatment for 10 days even after all lesions have disappeared.
Child: Same as adult dose.
Contraindications
Hypersensitivity. Infants <4 months or with underdeveloped swallowing reflex. Oral: Concomitant use with drugs that prolong QT-interval (e.g. astemizole, cisapride, dofetilide, halofantrine, mizolastine, pimozide, quinidine, sertindole, terfenadine); ergot alkaloid, HMG-CoA reductase inhibitors, triazolam, and oral midazolam.
Special Precautions
Hepatic impairment. Children. Pregnancy and lactation. Patient Counselling Vaginal preparations may decrease the effectiveness of latex contraceptive agents (e.g. condoms and diaphragms).
Adverse Reactions
Significant: Contact dermatitis (topical), eyes and mucous membrane irritation (topical), airway irritation (spray powder), hypersensitivity reactions (including anaphylactic reactions). Blood and lymphatic system disorders: Anaemia, lymphocytopenia, neutropenia. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain, xerostomia, gingival pain. General disorders and administration site conditions: Application site reactions (e.g. irritation, burning, warmth, pain, pruritus), fatigue. Hepatobiliary disorders: Hepatitis. Nervous system disorders: Headache, dysgeusia. Reproductive system and breast disorders: Dysmenorrhoea, vulvovaginal burning sensation, itching, irritation. Respiratory, thoracic and mediastinal disorders: Upper respiratory tract infection. Skin and subcutaneous tissue disorders: Rash, pruritus, skin maceration, inflammation, hypopigmentation, urticaria, erythema.
Overdosage
Symptoms: Vomiting and diarrhoea (buccal tab, vaginal cream or pessary); skin irritation (topical); impaction blockage of airways (spray powder). Management: Symptomatic and supportive treatment. In case of accidental ingestion, consider appropriate methods of gastric emptying if necessary. Spray powder: If respiration is compromised, may consider endotracheal intubation, removal of impacted material and assisted breathing.
Drug Interactions
May increase anticoagulant effect of warfarin. May increase serum concentrations or enhance the effects of 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.
Potentially Fatal: Increases the risk of cardiac arrhythmia with drugs known to prolong QT interval or induce torsade de pointes such as astemizole, cisapride, dofetilide, halofantrine, mizolastine, pimozide, quinidine, sertindole, and terfenadine. May increase risk of ergotism with necrosis of extremities with ergot alkaloids (e.g. ergotamine, dihydroergotamine). May inhibit metabolism of triazolam, oral midazolam and HMG-CoA reductase inhibitors (e.g. simvastatin, lovastatin).
Action
Miconazole, an imidazole derivative antifungal agent, inhibits the ergosterol biosynthesis in fungi and changes the composition of other lipid components in the membrane, thereby resulting in fungal cell necrosis.
Duration: Intravaginal: 72 hours. Buccal adhesion: 15 hours (buccal tab).
Absorption: Minimally absorbed from the gastrointestinal tract. Bioavailability: Approx 25-30% (oral); Approx 1-2% (intravaginal). Time to peak plasma concentration: Approx 2 hours.
Distribution: Distributed into body tissues, joints and fluids (topical). Plasma protein binding: Approx 88% mainly to serum albumin; Approx 10% to RBC.
Metabolism: Metabolised in the liver to its inactive metabolites.
Excretion: Mainly via faeces (Oral: Approx 50% as metabolites and unchanged drug); urine (Oral: <1% as unchanged drug). Terminal half-life: Approx 20-25 hours.
Storage
Mouth/Throat: Store between 15-30°C. Protect from moisture, heat and light. Topical/Cutaneous: Store between 15-30°C. Protect from moisture, heat and light. Vaginal: Store between 15-30°C. Protect from moisture, heat and light.
ATC Classification
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.
Disclaimer: This information is independently developed by CIMS based on miconazole from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 CIMS. All rights reserved. Powered by CIMSAsia.com
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