miconazole

Miconazole oral is an antifungal medication used to treat Candida yeast infection of the mouth and throat (oropharyngeal candidiasis).

Candida yeast is a type of fungus that normally lives on human skin and mucous membranes, but overgrowth of some of the common species such as Candida albicans can result in infection, and cause itching and burning. Miconazole oral is a tablet that is topically placed on the gum to slowly dissolve and kill the fungus over hours.

Miconazole works by inhibiting cytochrome P450 14-alpha-demethylase, an enzyme required for the synthesis of ergosterol, an essential component that maintains the integrity of the fungal cell membrane. In addition, miconazole also affects the synthesis of triglycerides and fatty acids and inhibits oxidative and peroxidative enzymes required for neutralizing free radicals (reactive oxygen species) that can damage the cell. These actions damage the fungal cell membrane, resulting in leakage of cell contents and cell death.

• Do not use miconazole oral in patients with hypersensitivity to miconazole, milk protein concentrates or any components of the formulation.
• There have been reports of hypersensitivity reactions including severe allergic reaction (anaphylaxis). Discontinue miconazole oral at the first sign of hypersensitivity reaction.
• It is not known if there is cross-hypersensitivity between miconazole and other azole antifungal agents. Monitor patients with a history of hypersensitivity to azoles and discontinue if there is a reaction.
• Although systemic absorption is minimal, use with caution in patients with liver function impairment.
• Concurrent use with blood-thinning medications such as warfarin can enhance their anticoagulant effects. Closely monitor the patient's blood clotting time, and watch for evidence of bleeding.

Common side effects of miconazole oral include:

• Application site reactions including:
  • Discomfort
  • Pain
  • Itching (pruritus)
  • Burning
  • Swelling (edema)
  • Tongue pain (glossalgia)
  • Oral ulcer
  • Toothache
• Hypersensitivity reactions
• Headache
• Fatigue
• Pain
• Diarrhea
• Nausea
• Vomiting
• Dry mouth (xerostomia)
• Upper abdominal pain
• Oral discomfort
• Taste perversion (dysgeusia)
• Loss of taste (ageusia)
• Gastroenteritis
• Upper respiratory tract infection
• Cough
• Sore throat
• Blood disorders including:
  • Low red blood cell count (anemia)
  • Low count of lymphocyte immune cells (lymphocytopenia)
  • Low count of neutrophil immune cells (neutropenia)
• Increase in gamma-glutamyl transferase (GGT) enzyme

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Buccal Tablet

• 50 mg

Adult and Pediatric

Oropharyngeal Candidiasis

• Children below 16 years: Safety and efficacy not established
• Adults and children above 16 years: Apply 50 mg buccal tablet to gum region once daily for 14 consecutive days

Buccal Administration

• Do not crush, chew, or swallow tablet
• Food and drink can be taken normally when buccal tablet is in place, but avoid chewing gum

Applying buccal tablet

• Apply buccal tablet in AM, after brushing the teeth
• The tablet should be applied with dry hands
• The rounded side surface of the tablet should be placed against the upper gum just above the incisor tooth (canine fossa) and held in place with slight pressure over the upper lip for 30 seconds to ensure adhesion
• Tablet is round on one side for comfort, but either side of the tablet can be applied to the gum
• Once applied, the tablet stays in position and gradually dissolves
• Subsequent applications should be made to alternate sides of the mouth
• Before applying the next tablet, the patient should clear away any remaining tablet material

Buccal tablet falls off or is swallowed

• Buccal tablet does not adhere or falls off within the first 6 hr: The same tablet should be repositioned immediately; if the tablet still does not adhere, a new tablet should be placed
• Buccal tablet is swallowed within the first 6 hr: The patient should drink a glass of water and a new tablet should be applied only once
• Buccal tablet falls off or is swallowed after it was in place for ≥6 hr: Apply a new tablet until the next regularly scheduled dose

Overdose

• There are no reports of miconazole oral overdose in humans. Systemic absorption of buccal administration of miconazole is minimal.
• Miconazole overdose may cause headache, skin irritation, diarrhea, nausea, vomiting, abdominal pain, and taste perversion (dysgeusia).
• Overdose may be treated with symptomatic and supportive care.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

Severe interactions of miconazole oral include:

• Saccharomyces boulardii
• Miconazole oral has no listed serious interactions with other drugs.
• Moderate interactions of miconazole oral include:
  • fosphenytoin
  • phenytoin
  • sulfonylureas
  • warfarin
• Miconazole oral has no listed mild interactions with other drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• There are no adequate and well-controlled studies on the use of miconazole oral in pregnant women, however, animal studies show miconazole can cause fetal harm. Miconazole should be used during pregnancy only if potential benefits to the mother outweigh the possible risks to the fetus.
• It is not known if miconazole oral is present in breast milk. Use with caution in nursing mothers, because many drugs are excreted in breast milk.

• Use miconazole oral exactly as instructed in the label.
• Report to your healthcare provider if you experience hypersensitivity reactions such as rash, hives or other symptoms.
• Store safely out of reach of children.
• In case of overdose, seek medical help or contact Poison Control.