Applies to the following strength(s): 50 mg; 10 mg/mL
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Oropharyngeal candidiasis: Apply 50 mg buccally to the upper gum region once a day for 14 consecutive days.
16 years or older: Apply 50 mg buccally to the upper gum region once a day for 14 consecutive days.
No adjustment recommended.
The manufacturer recommends caution when administering this drug to patients with liver dysfunction.
Miconazole buccal tablets are contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to milk protein concentrate.
Allergic reactions (including anaphylactic reactions and hypersensitivity) have been reported with the use of Miconazole products. Miconazole should be discontinued at once at the first sign of hypersensitivity.
There are no data regarding cross-hypersensitivity between Miconazole and other azole antifungal agents. Patients with a history of hypersensitivity to azoles should be monitored.
Safety and effectiveness have not been established in pediatric patients less than 16 years of age.
No adjustment recommended.
Miconazole buccal tablets should be applied with dry hands each morning after brushing teeth. The tablets should be placed against the upper gum, above the incisor tooth, and held in place with slight pressure over the upper lip for 30 seconds to ensure adhesion. Once in place, the buccal tablet stays in position and gradually dissolves. Subsequent applications should be made to alternate sides of the mouth. Any remaining tablet material should be cleared away before the next tablet is applied.
Miconazole buccal tablets should not be crushed, chewed, or swallowed. Food and drink can be taken normally when the buccal tablet is in place but chewing gum should be avoided.
If the Miconazole buccal tablet does not adhere or falls off within the first 6 hours, the same tablet should be repositioned at once; however, if the tablet still does not adhere, a new tablet should be used. If the buccal tablet is swallowed within the first 6 hours, the patient should drink a glass of water and a new tablet should be applied only once. If the buccal tablet falls off or is swallowed after it was in place for at least 6 hours, a new tablet should not be applied until the next scheduled dose.
It is not likely that other drugs you take orally or inject will have an effect on topically applied Miconazole. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.
Interaction with other medicinal products and other forms of interaction: When using any concomitant medication, the corresponding label should be consulted for information on the route of metabolism. Miconazole can inhibit the metabolism of drugs metabolized by the CYP3A4 and CYP2C9 enzyme systems. This can result in an increase and/or prolongation of their effects, including adverse effects.
Drugs which should not be used during treatment with Miconazole:
Oral Miconazole is contraindicated with the co-administration of the following drugs that are subject to metabolism by CYP3A4 : Substrates known to prolong QT-interval eg, astemizole, bepridil, cisapride, dofetilide, halofantrine, mizolastine, pimozide, quinidine, sertindole and terfenadine; ergot alkaloids; HMG-CoA reductase inhibitors eg, simvastatin and lovastatin; triazolam and oral midazolam.
When co-administered with oral Miconazole, the following drugs should be used with caution because of a possible increase or prolongation of the therapeutic outcome and/or adverse effects. If necessary, their dosage should be reduced and when appropriate, plasma levels monitored: Others:
Oral hypoglycemics (CYP2C9), phenytoin (CYP2C9), carbamazepine, buspirone, alfentanil, sildenafil, alprazolam, brotizolam, midazolam IV, rifabutin, methylprednisolone, trimetrexate, ebastine and reboxetine.
Drugs subject to metabolism by CYP2C9 :
Other drugs subject to metabolism by CYP3A4: HIV protease inhibitors eg, saquinavir; certain antineoplastic agents eg, vinca alkaloids, busulfan and docetaxel; certain calcium channel blockers eg, dihydropyridines and verapamil; certain immunosuppressive agents: cyclosporine, tacrolimus, sirolimus (rapamycin); others: alfentanil, alprazolam, brotizolam, buspirone, carbamazepine, cilostasol, disopyramide, ebastin, methylprednisolone, midazolam IV, reboxetine, rifabutin, sildenafil and trimetrexate.
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Information checked by Dr. Sachin Kumar, MD Pharmacology