MICONAZ ORAL GEL 2%

Miconazole Nitrate 2%

Antifungal Oral Gel – 20 g

Medical Description

MICONAZ Oral Gel 2% contains miconazole nitrate 2%, a broad-spectrum imidazole antifungal formulated for the topical treatment of oral and oropharyngeal candidiasis (oral thrush).

Miconazole acts directly against susceptible Candida species responsible for fungal infections of the mouth and throat. Oral candidiasis commonly presents with white or creamy patches on the tongue or oral mucosa, soreness, redness, altered taste and discomfort during eating or swallowing.

The gel formulation allows the active ingredient to remain in contact with the affected oral mucosa, providing localized antifungal activity.

Active Ingredient

Miconazole nitrate 2% w/w

Equivalent to approximately 20 mg miconazole nitrate per gram of oral gel.

Dosage form: Oral gel
Pack size: 20 g
Pharmacological class: Imidazole antifungal

Indications

MICONAZ Oral Gel 2% is used for the treatment of oral and oropharyngeal candidiasis, including oral thrush caused by susceptible Candida species.

It may be used for candidal infection involving:

• Tongue
• Inner cheeks and buccal mucosa
• Gums
• Palate
• Other susceptible areas of the oral cavity

Common manifestations may include:

• Creamy-white or white patches in the mouth
• Oral redness and soreness
• Burning or discomfort
• Altered or unpleasant taste
• Difficulty or discomfort when eating
• Pain or difficulty swallowing when infection extends toward the throat.

Mechanism of Action

Miconazole is an imidazole antifungal agent that interferes with the synthesis of ergosterol, an essential component of the fungal cell membrane.

Disruption of ergosterol production alters fungal cell-membrane structure and permeability, inhibiting fungal growth and ultimately contributing to elimination of susceptible Candida organisms.

When administered as an oral gel, miconazole acts primarily at the site of infection within the oral cavity.

Clinical Benefits

MICONAZ Oral Gel 2% may:

• Treat susceptible oral Candida infections.
• Inhibit fungal growth within the oral cavity.
• Help reduce oral fungal overgrowth.
• Relieve symptoms associated with oral candidiasis, including soreness, irritation and burning.
• Help improve white plaques and associated oral discomfort.
• Provide localized antifungal treatment directly to affected oral tissues.

Dosage & Administration

Adults and Children Over 2 Years

A commonly recommended regimen is:

2.5 mL of 2% miconazole oral gel, 4 times daily, administered after meals.

The gel should be kept in the mouth for approximately 2–3 minutes before being swallowed, where appropriate.

Children 6 Months–2 Years

WHO-derived guidance recommends:

1.25 mL, 4 times daily, with the gel distributed carefully over the affected oral mucosa.

Important Administration Instructions

• Use the measuring device supplied with the product whenever available.
• Apply the gel directly to the affected areas of the mouth.
• Spread the gel over the oral mucosa and allow adequate contact time.
• Do not immediately rinse the mouth after application.
• Treatment is generally continued for approximately 7 days, although 14 days may be required depending on clinical response and the underlying infection.
• Continue treatment for the recommended duration even if symptoms improve earlier.

The exact dose and duration should follow the approved MICONAZ product leaflet and the prescribing healthcare professional's instructions.

Important Warnings & Precautions

• For oral use only.
• Do not use in patients with known hypersensitivity to miconazole or other imidazole antifungals.
• Do not administer to children under 6 months of age because of the risk associated with the oral-gel formulation.
• Use particular caution in young children because the gel may present a choking/suffocation risk.
• Do not give the gel to patients with significant swallowing difficulties.
• Patients with liver disease or hepatic impairment should consult a healthcare professional before use.
• Seek medical evaluation if symptoms are severe, recurrent or fail to improve.
• Painful or difficult swallowing may indicate extension of candidiasis into the esophagus and requires medical assessment.

Possible Side Effects

MICONAZ Oral Gel is generally well tolerated, but possible adverse effects may include:

• Nausea
• Altered or unpleasant taste
• Oral irritation
• Burning or discomfort in the mouth
• Vomiting or gastrointestinal discomfort
• Hypersensitivity or allergic reactions, rarely

If significant swelling, rash, breathing difficulty or other signs of a serious allergic reaction occur, discontinue treatment and seek immediate medical attention.

Important Drug Interactions

Miconazole oral gel can produce clinically important drug interactions because some of the administered miconazole may be absorbed and can inhibit drug-metabolizing enzymes.

Particular caution is required with:

Warfarin and Other Vitamin K Antagonists

Miconazole may increase the anticoagulant effect of warfarin, potentially increasing the risk of bleeding.

Patients receiving warfarin or another vitamin K antagonist should not use miconazole oral gel without medical supervision and may require closer INR monitoring.

Phenytoin

Miconazole may increase phenytoin plasma concentrations, potentially increasing the risk of phenytoin toxicity.

Sulfonylureas

Miconazole may enhance the hypoglycemic effect of certain sulfonylurea medicines, potentially increasing the risk of hypoglycemia.

Because of these interactions, patients should inform their healthcare professional of all prescription medicines, OTC medicines, vitamins and supplements they are taking before starting treatment. WHO guidance specifically highlights interactions with vitamin K antagonists, glibenclamide and phenytoin.

Pregnancy & Breastfeeding

Pregnancy and breastfeeding should be discussed with a healthcare professional before treatment.

Available WHO-derived guidance does not identify pregnancy or breastfeeding as absolute contraindications to miconazole oral gel; however, treatment should be used when clinically appropriate and according to the approved product information.

Oral Hygiene During Treatment

Good oral hygiene can support treatment and reduce the likelihood of persistent or recurrent oral candidiasis.

Patients should:

• Brush teeth regularly.
• Maintain appropriate oral hygiene.
• Clean dentures thoroughly if applicable.
• Remove dentures at night when appropriate.
• Follow healthcare-professional advice regarding denture hygiene.

In patients wearing dentures, the dentures should be cleaned appropriately because they can contribute to persistence or recurrence of oral candidiasis.

When to Seek Medical Advice

Medical evaluation is recommended if:

• Symptoms do not improve with treatment.
• Oral candidiasis repeatedly returns.
• There is significant pain or difficulty swallowing.
• Infection appears to extend toward the throat.
• The patient is immunocompromised.
• The patient is receiving chemotherapy or immunosuppressive treatment.
• There is poorly controlled diabetes.
• The diagnosis is uncertain.

Recurrent or persistent oral candidiasis can sometimes be associated with underlying conditions or medications that predispose to fungal overgrowth.

Storage

• Store according to the manufacturer's labeled storage conditions.
• WHO-derived guidance for miconazole oral gel specifies storage below 25°C.
• Keep the tube tightly closed when not in use.
• Protect from excessive heat and moisture.
• Keep out of reach of children.
• Do not use after the expiry date.

Key Product Advantages

MICONAZ Oral Gel 2% provides:

• 2% miconazole nitrate
• Targeted treatment for oral and oropharyngeal candidiasis
• Direct application to affected oral mucosa
• Local antifungal activity against susceptible Candida
• Convenient gel formulation
• Suitable for use in appropriate patients according to age, clinical condition and medical advice

Patient Disclaimer

This information is provided for educational purposes only and does not replace the advice of a qualified healthcare professional. MICONAZ Oral Gel 2% should be used according to the approved product information and/or as directed by a physician. This product is intended for the treatment of susceptible oral fungal infections and is not intended to diagnose, treat, cure, or prevent other causes of oral lesions or discomfort. Consult a healthcare professional if symptoms are severe, recurrent, associated with difficulty swallowing, or do not improve with treatment.