Concise Prescribing Info
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 daily. 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.
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.
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.
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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