Micosina 2% Oral Gel 15gm

Oral and Gastrointestinal Candidiasis:

Candidiasis is a fungal infection caused by Candida species, particularly Candida albicans. This gel is effective in treating candidiasis affecting the mouth (oral candidiasis) and the gastrointestinal tract.

Fungal Colonization:

A-Migel oral gel helps eliminate fungal colonization in both the mouth and the gastrointestinal tract. Fungal colonization refers to the presence and growth of fungi without causing infection. This gel helps in clearing such colonization and preventing potential infections.

Superinfections due to Gram-positive Bacteria:

Superinfections occur when a new infection develops on top of an existing one. A-Migel oral gel is effective in treating superinfections caused by gram-positive bacteria. Gram-positive bacteria include species like Staphylococcus aureus and Streptococcus pyogenes, which can cause various infections, including those of the mouth and gastrointestinal tract.

Pharmacology

Pharmacodynamics: Miconazole has antifungal properties effective against common dermatophytes and yeasts, and antibacterial properties against certain gram-positive bacilli and cocci. It functions by inhibiting a demethylation step in the biosynthesis of ergosterol, a key component of fungal cell membranes. This disruption creates holes in the membrane, causing essential components to leak out and ultimately resulting in the death of the fungal cells.

Pharmacokinetics: Miconazole has low oral bioavailability (25-30%) due to limited absorption from the intestinal tract. Once administered as an oral gel, it is systemically absorbed and primarily binds to plasma proteins (88.2%), especially serum albumin and red blood cells (10.6%). The absorbed portion is largely metabolized, with less than 1% excreted unchanged in the urine. The terminal plasma half-life is 20-25 hours in most patients and is similar in those with renal impairment.

Dosage

Oropharyngeal candidiasis:

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

Gastrointestinal tract candidiasis:

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

Side Effects

Occasionally, nausea and vomiting, diarrhea with long-term use, and rarely allergic reactions may occur.

Administration

In case of localized lesions of the mouth, a small amount of gel may be applied 2-4 times a day directly to the affected area with a clean finger. For best results, miconazole oral gel should be kept in contact with the affected area as long as possible. Treatment should be continued for at least a week after symptoms have disappeared. For oral candidosis, dental prostheses should be removed at night and brushed with the gel.

Missed Dose:

Apply the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and continue with your regular schedule. Do not double the dose.

Interaction

Avoid concomitant treatment with terfenadine, astemizole, and cisapride, as miconazole may inhibit their metabolism, potentially leading to adverse effects. Miconazole may also delay the metabolism of phenytoin and cyclosporine, increasing the risk of toxicity.

Contraindications

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

Pregnancy & Lactation

There is no safety information regarding the use of miconazole oral gel during pregnancy. It should be avoided in pregnant women if possible, or the potential risks should be weighed against the possible benefits. Caution is advised when administering miconazole to nursing women, as many drugs are excreted in human milk.

Precautions & Warnings

When using miconazole with anticoagulants, monitor and adjust the anticoagulant effect as necessary. Miconazole and phenytoin plasma levels should also be monitored when used together. In infants and young children, ensure the gel does not obstruct the throat.

Storage Conditions

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