Oragel-M 2% Oral Gel 15gm

Indications:

Oragel-M is indicated for:

• The treatment of oral and gastrointestinal candidiasis.
• The eradication of fungal colonization in the mouth and gastrointestinal tract.
• The treatment of superinfections caused by gram-positive bacteria.

Pharmacology:

Pharmacodynamics: Miconazole exhibits antifungal activity against common dermatophytes and yeasts, and antibacterial activity against certain gram-positive bacilli and cocci. It inhibits a demethylation step in ergosterol biosynthesis, disrupting the production of ergosterol, a key component of fungal cell membranes. This disruption causes holes in the fungal cell membrane, leading to leakage of essential cell constituents and ultimately cell death.

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

Dosage:

Oropharyngeal candidosis:

• 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 candidosis:

• Infants (4 months and 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.

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 your regular schedule. Do not double the dose.

Administration:

For localized lesions of the mouth, apply a small amount of gel 2-4 times a day directly to the affected area with a clean finger. For best results, keep the gel in contact with the affected area as long as possible. Continue treatment for at least a week after symptoms have disappeared. For oral candidosis, remove dental prostheses at night and brush them with the gel.

Interaction:

• Concomitant use with terfenadine, astemizole, and cisapride should be avoided as in vitro studies suggest that miconazole may inhibit their metabolism, potentially leading to adverse effects.
• Miconazole may 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.

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. It should be avoided in pregnant women if possible, or the potential risks should be weighed against the possible benefits. Caution should be exercised when miconazole is administered to a nursing woman as many drugs are excreted in human milk.

Precautions & Warnings:

• If the concomitant use of miconazole and an anticoagulant is considered, the anticoagulant effect should be monitored and titrated. Miconazole and phenytoin plasma levels should also be monitored when used concomitantly. In infants and young children, caution must be taken to ensure 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.

Storage Conditions:

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