Candoral® (Miconazole 2% w/w) 20mg Oral Gel (15 g)

Generic

Miconazole Nitrate

 

Indications

Miconazole Nitrate 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.

 

Pharmacology

Miconazole has a low oral bioavailability (25-30%) due to intestinal absorption. Miconazole is absorbed systemically after being given as an oral gel. Miconazole is bound to plasma proteins (88.2%), primarily serum albumin and red blood cells, after absorption (10.6 percent ). Miconazole oral gel is mostly metabolized after it is absorbed.

 

Administration & Dosage

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 ingredient.

 

Side Effect

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

 

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 administered with caution to a nursing woman because many drugs are excreted in human milk.

 

Precautions & Warnings

On the off chance that the concomitant utilize of Miconazole and anticoagulant is considered, the anti-coagulant impact ought to be observed and titrated. Miconazole and phenytoin plasma level ought to too be checked when utilized concomitantly. In newborn children and youthful children, caution must be taken to guarantee that the gel does not deter the throat.

 

Therapeutic Class

Aural Anti-fungal arrangements

 

Storage Conditions

Protect from light and moisture by storing below 30°C. Keep the medicine out of children's reach.