Only for the use of medical professionals

Micoral®oralgel

Miconazole Description

Micoral®oralgelisthepreparationofMiconazole.Itisasyntheticimidazolewhichexhibits broadspectrumactivityagainstpathogenicdermatophytes,includingTrichophytonspecies andyeastsincludingCandidaspecies,Cryptococcus neoformans,Coccidioidesimmitisand Paracoccidioides brasiliensisaswellasrangeofgram-positivecocciandbacilli.Itactsby inhibitingmembranesterol synthesisandinterferingwiththepermeabilityofthefungalcell membranes. Indications Micoral®oral gel is indicated in the treatment and prevention of fungal infections of the oropharynx and gastrointestinal tract and of superinfections due to gram positive bacteria, including oral candidosis and denture stomatitis. Also indicated in prophylactic management of patients at high risk from opportunistic fungal infection. Dosage and administration For oral administration:Dosage is based on 15 mg/ kg/ day. Infants under 2 years:Half spoonful (2.5 ml) of gel twice daily. Children aged 2-6 years:One spoonful (5 ml) of gel twice daily. Children aged 6 years and over:One spoonful (5 ml) of gel four times daily. Adult patients:One or two spoonfuls (5-10 ml) of gel four times daily. In case of localized lessions of the mouth, a small amount of gel may be applied directly to the affected area with a clean finger, 2-4 times a day. For best resultsMicoral®oral gel should be kept in contact with the affected area as long as possible. The treatment should be continued for up to two days after symptoms have cleared. For oral candidiasis, dental prosthesis should be removed at night and brushed with the gel. Elderly patients:Same as adult dose. Use in pregnancy and lactation There is no information concerning the safety of Miconazole oral gel during pregnancy. So Miconazole oral gel should be avoided in pregnant women if possible. The potential hazards should be balanced against the possible benefits. As many drugs are excreted in human milk, caution should be exercised when Miconazole is administered to a nursing woman. Side effects Occasionally, nausea and vomiting, diarrhoea with long term use, rarely allergic reactions, isolated reports of hepatitis. Contraindications Miconazole is contraindicated in patients with known hypersensitivity to theactive ingredient. Precautions If the concomitant use of Miconazole and Anticoagulant is considered, the anti-coagulant effect should be monitored and titrated. Miconazole and Phenytoin level should also bemonitored when used concomitantly. In infants a nd young children, caution must be taken to ensure that the gel does not obstruct the throat. Hence, the gel should not applied to the back of the throat and the full dose should be divided into smaller portions. Drug Interactions Miconazole can inhibit th and2C9 families e metabolism of drugs metabolized by the Cytochrome P4503A . Miconazole oral gel should not be used during treatment with cisapride, trizolam, oral midazolam, mizolastine, quinidine, simvastatin and lovastatin. Overdosage s In general Mic diarrhoea. onazole is not highly toxic. Accidental overdosage may cause vomiting and Pharmaceutical precautions Store in a cool and dry place. Presentation Micoral ® oral gel: Each gm contains Miconazole Base USP 20 mg. Package quantities Micoral ® ® oral gel: Tube of 15 gm Registered Trade Mark ACI Limited Narayanganj, Bangladesh