Miconazole


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : Mouth/Throat Oropharyngeal candidiasis As 20 mg/g (24 mg/mL) gel: Apply 2.5 mL directly to the affected area 4 times daily. As buccal tab: 50 mg once daily applied to the upper gum region for 1-2 weeks according to clinical response. Intestinal candidiasis As 20 mg/g (24 mg/mL) gel: 20 mg/kg daily given in 4 divided doses. Max: 1,000 mg (40 mL)/day. Topical Skin fungal infections As 2% cream or powder: Apply over affected area bid for 2-6 weeks. As 2% powder with 2% cream: Apply both formulations over affected area once daily for 2-6 weeks. Tinea pedis: As spray powder: Apply over affected area bid until lesions disappear. Nail fungal infections As 2% cream: Apply over affected area 1-2 times/day. Vag Vulvovaginal candidiasis As 2% cream (approx 5 g): Apply intravaginally at bedtime once daily for 10-14 days or bid for 7 days. 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.
Dosage Details
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.

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.

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.

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.
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.
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 admin 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.
Buccal/Topical/Vag: C
Patient Counseling Information
Vaginal preparations may decrease the effectiveness of latex contraceptive agents (e.g. condoms and diaphragms).
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
Description: 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).
Pharmacokinetics:
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.
Chemical Structure

Chemical Structure Image
Miconazole

Source: National Center for Biotechnology Information. PubChem Database. Miconazole, CID=4189, https://pubchem.ncbi.nlm.nih.gov/compound/Miconazole (accessed on Jan. 22, 2020)

Storage
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.
A07AC01 - miconazole ; Belongs to the class of imidazole derivative antiinfectives. Used in the treatment of intestinal infections.
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
AFT Pharmaceutical Ltd. Decozol 2% w/w Oral Gel data sheet February 2019. Medsafe. http://www.medsafe.govt.nz/. Accessed 08/05/2019.

Anon. Miconazole (Oral). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 08/05/2019.

Anon. Miconazole (Topical). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 08/05/2019.

Anon. Miconazole Nitrate (Topical). AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 08/05/2019.

Buckingham R (ed). Miconazole. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/05/2019.

Conazol Cream (Marcas USA LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 22/07/2014.

Daktarin 2% w/w Cream (Janssen-Cilag Limited). MHRA. https://products.mhra.gov.uk/. Accessed 08/05/2019.

Daktarin Powder (McNeil Products Limited). MHRA. https://products.mhra.gov.uk/. Accessed 08/05/2019.

Gyno-Daktarin 1200 mg Vaginal Capsule (Janssen-Cilag Limited). MHRA. https://products.mhra.gov.uk/. Accessed 08/05/2019.

Gyno-Daktarin 20 mg/g Vaginal Cream (Janssen-Cilag Limited). MHRA. https://products.mhra.gov.uk/. Accessed 08/05/2019.

Joint Formulary Committee. Miconazole. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/05/2019.

Loramyc 50 mg Muco-adhesive Buccal Tablets (Onxeo). MHRA. https://products.mhra.gov.uk/. Accessed 08/05/2019.

McEvoy GK, Snow EK, Miller J et al (eds). Miconazole Nitrate (Topical). AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 22/07/2014.

Miconazole Nitrate Suppository (Actavis Pharma, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 08/05/2019.

Monistat 3 Suppository (Ortho Pharmaceutical Corporation). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 08/05/2019.

Oravig Buccal Tablets. U.S. FDA. https://www.fda.gov/. Accessed 22/07/2014.

Preston CL (ed). Miconazole Interactions. Stockley’s Drug Interactions [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 22/07/2014.

Disclaimer: This information is independently developed by MIMS 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 MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS 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 MIMS. All rights reserved. Powered by MIMS.com
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