Indications

Gelora oral gel is indicated-

• For the treatment of oral and gastrointestinal candidiasis.
• For eradication of fungal colonization in the mouth and gastrointestinal tract.
• For the treatment of super infections due to gram-positive bacteria.

Gelora cream is indicated in dermatomycoses, e.g.:

• Tinea pedis (Athlete's foot)
• Tinea corporis (Tinea circinata)
• Tinea manuum
• Tinea cruris due to: Trichophyton mentagrophytes, Trichophyton rubrum, Microsporum audouinii, Epidermophyton floccosum
• Candidial infections
• Tinea versicolor.
• Infections of the skin (e.g. intertrigo)
• Perianal infections
• Stomatitis angularis (cheilitis)
• Balanoposthitis
• Otitis externa

In addition miconazole cream has a very rapid alleviating effect on the pruritis which frequently accompanies infection.

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Pharmacology

Pharmacodynamics: Miconazole possesses an antifungal activity against the common dermatophytes and yeasts as well as an antibacterial activity against certain gram-positive bacilli and cocci. Its activity is based on the inhibition of a demethylation step in the ergosterol biosynthesis. Ergosterol, the end-product of the biosynthetic pathway and the main sterol in yeast and fungi. The disruption in production of ergosterol disrupts the fungal cell membrane, causing holes to appear in it. These holes allow the essential constituents of the fungal cells to leak out and ultimately the fungal cells die.

Pharmacokinetics: The oral bioavailability of Miconazole is low (25-30%) because there is little absorption of Miconazole from the intestinal tract. Miconazole is systemically absorbed after administration as the oral gel. Absorbed Miconazole is bound to plasma proteins (88.2%), primarily to serum albumin and red blood cells (10.6%). The absorbed portion of Miconazole oral gel is largely metabolized; less than 1% of the administered dose is excreted unchanged in the urine. The terminal plasma half-life is 20-25 hours in most patients. The elimination half-life of Miconazole is similar in any renal impaired patient.

Dosage

Miconazole Oral Gel-
Oropharyngeal candidosis-

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

Gastrointestinal tract candidosis-

• Infants (4 months of age or above): 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.

Missed Dose: Apply the missed dose as soon as you remember. In case of next dosing time, omit the missed
dose and continue your usual course.

Miconazole Cream: Sufficient Miconazole Cream should be applied to cover affected areas twice daily (morning and evening) in patients with tinea pedis, tinea cruris, tinea corporis and cutaneous candidiasis and once daily in patients with tinea versicolor. If Miconazole Cream is used in intertriginous areas it should be applied sparingly and smoothed in well to avoid maceration effects.

Early relief of symptoms (2 to 3 days) is experienced by the majority of patients and clinical improvement may be seen fairly soon after treatment is begun.All lesions usually disappear after 2 to 5 weeks.Prolong treatment for 10 days to prevent relapse. However, Candida infections, tinea cruris and corporis should be treated for two weeks and tinea pedis for one month in order to reduce the possibility of recurrence.

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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. The treatment should be continued for at least a week after symptoms have disappeared. For oral candidosis, dental prosthesis should be removed at night and brushed with the gel.

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Interaction

• Concomitant treatment with Terfenadine, Astemizole and Cisapride should be avoided because in vitro studies suggest that Gelora may inhibit their metabolism, so these products miqht precipitated.
• Gelora may delay Phenytoin and Cyclosporine metabolism and this might precipitate Phenytoin and Cyclosporine toxicity, respectively.

Contraindications

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

Side Effects

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

Pregnancy & Lactation

There is no information regarding the safety of Miconazole oral gel during pregnancy. So Miconazole oral gel should be avoided in pregnant women if possible or the potential hazards should be balanced against the possible benefits. As many drugs are excreted in human milk, caution should be exercised when Miconazole is administered to a nursing woman.

Precautions & Warnings

If the concomitant use of Gelora and anticoagulant is considered, the anti-coagulant effect should be monitored and titrated. Gelora and phenytoin plasma level should also be monitored when used concomitantly. In infants and young children, caution must be taken to ensure that the gel does not obstruct the throat.

Overdose Effects

Accidental overdosage may cause vomiting and diarrhea. Treatment is symptomatic and supportive. A specific antidote is not available.

Therapeutic Class

Aural Anti-fungal preparations

Storage Conditions

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