Topicazole

Indications

Topicazole Oral Gel is prescribed for:

• Treating oral and gastrointestinal candidiasis.
• Eradicating fungal colonization in the oral cavity and gastrointestinal tract.
• Managing superinfections caused by gram-positive bacteria.

Topicazole Cream is indicated for various dermatomycoses, including:

• Tinea pedis (Athlete’s foot)
• Tinea corporis (ringworm)
• Tinea manuum
• Tinea cruris caused by Trichophyton mentagrophytes, Trichophyton rubrum, Microsporum audouinii, and Epidermophyton floccosum
• Candidiasis
• Tinea versicolor
• Skin infections (e.g., intertrigo)
• Perianal infections
• Angular stomatitis (cheilitis)
• Balanoposthitis
• Otitis externa

Additionally, Miconazole cream provides rapid relief from the itching commonly associated with infections.
Consult a registered healthcare professional before using any medication.

Pharmacology

Pharmacodynamics: Miconazole exhibits antifungal properties against common dermatophytes and yeasts and possesses antibacterial activity against select gram-positive bacteria. Its mechanism involves inhibiting a demethylation step in ergosterol biosynthesis. Ergosterol, the primary sterol in yeast and fungi, is crucial for maintaining the integrity of the fungal cell membrane. Disruption in ergosterol production leads to cell membrane damage, causing leakage of essential cellular components and ultimately resulting in fungal cell death.

Pharmacokinetics: Miconazole has low oral bioavailability (25-30%) due to minimal absorption in the gastrointestinal tract. When administered as an oral gel, Miconazole is absorbed systemically, with approximately 88.2% bound to plasma proteins, mainly serum albumin and red blood cells. Less than 1% of the administered dose is excreted unchanged in urine, with a terminal plasma half-life ranging from 20 to 25 hours. This half-life remains consistent in patients with renal impairment.

Dosage

Miconazole Oral Gel
For Oropharyngeal candidiasis:

• Infants (4-24 months): 1.25 ml (1/4 measuring spoon) of gel, applied four times a day after meals.
• Adults and children (2 years and older): 2.5 ml (1/2 measuring spoon) of gel, applied four times a day after meals.

For Gastrointestinal candidiasis:

• Infants (4 months and older): For children and adults who have difficulty swallowing tablets: 20 mg per kg body weight per day, divided into four doses. The daily dose should not exceed 250 mg (10 ml of gel) four times daily.

Missed Dose: If a dose is missed, apply it as soon as you remember. If it’s close to the next scheduled dose, skip the missed dose and resume your regular dosing schedule.

Miconazole Cream: Apply enough cream to cover the affected areas twice daily (morning and evening) for conditions such as tinea pedis, tinea cruris, tinea corporis, and cutaneous candidiasis. For tinea versicolor, apply once daily. In intertriginous areas, use sparingly to prevent maceration.

Patients usually experience early relief of symptoms (within 2 to 3 days), with clinical improvement observed soon after treatment initiation. Most lesions resolve within 2 to 5 weeks. It’s advisable to extend treatment for an additional 10 days to prevent relapse. However, Candida infections and tinea cruris and corporis should be treated for two weeks, while tinea pedis requires treatment for one month to minimize recurrence risks.
Consult a registered healthcare professional before using any medication.

Administration

For localized lesions in the mouth, apply a small amount of gel directly to the affected area 2 to 4 times a day using a clean finger. For optimal results, keep the gel in contact with the affected area for as long as possible. Continue treatment for at least one week after symptoms have resolved. For oral candidiasis, dental prostheses should be removed at night and brushed with the gel.
Consult a registered healthcare professional before using any medication.

Interactions

Avoid concurrent use with Terfenadine, Astemizole, and Cisapride, as in vitro studies suggest that Topicazole may inhibit their metabolism, potentially leading to adverse effects. Additionally, Topicazole may delay the metabolism of Phenytoin and Cyclosporine, which could lead to toxicity.

Contraindications

Miconazole is contraindicated in patients with known hypersensitivity to the active ingredient.

Side Effects

Possible side effects include nausea, vomiting, diarrhea with prolonged use, and, rarely, allergic reactions.

Pregnancy & Lactation

There is limited information on the safety of Miconazole oral gel during pregnancy. Therefore, it should be avoided if possible, or the potential risks should be carefully weighed against the benefits. Since many drugs are excreted in breast milk, caution is advised when administering Miconazole to nursing mothers.

Precautions & Warnings

When considering the combined use of Topicazole with anticoagulants, monitor the anticoagulant effect closely and adjust dosage as necessary. The plasma levels of Topicazole and phenytoin should also be monitored during concurrent use. In infants and young children, ensure that the gel does not obstruct the throat.

Overdose Effects

Accidental overdose may lead to symptoms such as vomiting and diarrhea. Treatment should be symptomatic and supportive, as no specific antidote exists.

Therapeutic Class

Aural antifungal preparations.

Storage Conditions

Store in a dry place, away from light and heat. Keep out of reach of children.