Miconazole Buccal mucosa

Miconazole buccal treats fungus (yeast) infections in the mouth and throat (oral thrush). It belongs to the group of medicines called antifungals and works by killing or preventing growth of the fungus or yeast.

miconazole is available only with your doctor's prescription.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to make sure the medicine is working properly and to check for any unwanted effects that may be caused by the medicine.

miconazole may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using miconazole.

If your symptoms do not improve, or if they become worse, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Body aches or pain
• cough
• difficulty with breathing
• ear congestion
• fever or chills
• headache
• loss of voice
• lower back or side pain
• nasal congestion
• painful or difficult urination
• pale skin
• runny nose
• sneezing
• sore throat
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness

• Black, tarry stools
• pale skin
• shortness of breath
• ulcers, sores, or white spots in the mouth

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Change in taste
• diarrhea
• dry mouth
• headache
• itching skin
• loss of taste
• nausea
• pain, redness, and swelling of the gums
• sores on the tongue
• toothache

• Abdominal or stomach pain
• loss of appetite
• pain
• upper abdominal or stomach pain
• weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Oropharyngeal candidiasis: Apply 50 mg buccally to the upper gum region once a day for 14 consecutive days.

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.