Generic

Indications

• Miconazole Nitrate Oral Gel is used to treat candidiasis in the mouth and gastrointestinal tract.
• For fungal colonization in the mouth and gastrointestinal tract elimination.
• For the treatment of gram-positive bacterial superinfections.

Pharmacology

Miconazole has antifungal and antibacterial properties against common dermatophytes and yeasts. It also has antifungal and antibacterial properties against specific gram-positive bacilli and cocci. Its action is dependent on the suppression of an ergosterol biosynthesis demethylation step. Ergosterol is the major sterol in yeast and fungus and is produced as a byproduct of the metabolic process. The ergosterol production is disrupted, causing holes to form in the fungal cell membrane. These pores allow the fungal cells' critical elements to flow out, causing the cells to perish.

Miconazole has a limited oral bioavailability (25-30%) due to intestinal absorption. Miconazole is absorbed systemically after being given as an oral gel. Miconazole is linked to plasma proteins (88.2%), predominantly serum albumin and red blood cells, after absorption (10.6 percent ). Miconazole oral gel is processed to a great extent; less than 1% of the administered dose is excreted unaltered in the urine. In most people, the terminal plasma half-life is 20-25 hours. Miconazole has a comparable elimination half-life in all renally compromised patients.

Dosage & Administration

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.

Interaction

• Concurrent treatment with Terfenadine, Astemizole, and Cisapride should be avoided because
• Miconazole may inhibit their metabolism, causing these products to precipitate, according to in vitro studies.
• Miconazole may cause a delay in the metabolism of phenytoin and cyclosporine, which could lead to phenytoin and cyclosporine toxicity, respectively.

Contraindications

Miconazole should not be used in patients who have a history of hypersensitivity to the active component.

Side Effects

Long-term use may cause nausea and vomiting, as well as diarrhea and allergic responses.

Pregnancy & Lactation

There is no information about Miconazole oral gel's safety during pregnancy. Miconazole oral gel should be avoided during pregnancy if at all possible, or the risks should be weighed against the benefits. Miconazole should be provided with caution to a nursing mother because many medications are excreted in human milk.

Precautions & Warnings

If Miconazole and an anticoagulant are used together, the anticoagulant impact should be monitored and titrated. When taking miconazole and phenytoin at the same time, blood levels should be checked. In newborns and young children, care must be taken to avoid obstructing the throat with the gel.

Therapeutic Class

Aural Anti-fungal preparations

Storage Conditions

Pharmaceutical Name