Miconazole

Miconazole is a prescription medication used to treat fungal yeast infections of the mouth or the throat. Miconazole belongs to a group of drugs called azole antifungals which work by killing fungi by interfering with their cell membranes.

This medication comes in buccal tablet form which is a tablet that dissolves when held between the cheek and gum. Miconazole is taken once daily and should be applied between the cheek and upper gum.

Common side effects of miconazole include diarrhea, change in taste, and headache.

Miconazole is part of the drug class:

• Imidazole and triazole derivatives

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Miconazole may affect the way other medicines work, and other medicines may affect how miconazole works.

Especially tell your doctor if you take:

• a diabetes medicine
• phenytoin (Dilantin, Phenytek)
• an ergot medicine. Ask your doctor or pharmacist if you are not sure if your medicine is an ergot medicine.
• the blood thinner medicine warfarin sodium (Coumadin, Jantoven)

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

Do not use miconazole if you:

• are allergic to miconazole (M-Zole, Monistat, Vusion)
• are allergic to milk protein concentrate
• are allergic to any of the ingredients in miconazole

Before taking miconazole, tell your doctor if you:

• have liver problems
• have any other medical conditions
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

The recommended dosing schedule for miconazole is the application of one 50 mg buccal tablet to the upper gum region once daily for 14 consecutive days.

• Store miconazole between 68 to 77 °F (20 to 25°C)
• Keep miconazole dry
• Keep miconazole and all medicine out of the reach of children

Miconazole Nitrate Vaginal Suppositories USP, 200 mg are white to off-white suppositories, each containing the antifungal agent, Miconazole nitrate, 1-[2,4-Dichloro-β-[(2,4- dichlorobenzyl)oxy] phenethyl]-imidazole mononitrate, 200 mg, in a hydrogenated vegetable oil base. The molecular formula is C18H14Cl4N2O•HNO3; the molecular weight is 479.14 and the structural formula may be represented as follows:

Miconazole nitrate exhibits fungicidal activity in vitro against species of the genus Candida. The pharmacologic mode of action is unknown. Following intravaginal administration of Miconazole nitrate, small amounts are absorbed. Administration of a single dose of Miconazole nitrate vaginal suppositories (100 mg) to healthy subjects resulted in total recovery from the urine and feces of 0.85% (±0.43%) of the administered dose.

Animal studies indicate that the drug crossed the placenta and doses above those used in humans result in embryo and fetotoxicity (80 mg/kg, orally), although this has not been reported in human subjects (See PRECAUTIONS).

In multi-center clinical trials in 440 women with vulvovaginal candidiasis, the efficacy of treatment with the Miconazole Nitrate Vaginal Suppositories USP, 200 mg for 3 days was compared with treatment for 7 days with Miconazole Nitrate Vaginal Cream 2%. The clinical cure rates (free of microbiological evidence and clinical signs and symptoms of candidiasis at 8 to 10 days and 30 to 35 days post therapy) were numerically lower, although not statistically different, with the 3-Day Suppository when compared with the 7-Day Cream.

Miconazole Nitrate Vaginal Suppositories USP, 200 mg: One suppository (Miconazole nitrate, 200 mg) is inserted intravaginally once daily at bedtime for three consecutive days. Before prescribing another course of therapy, the diagnosis should be reconfirmed by smears and/or cultures to rule out other pathogens.