miconazole oral

Action and Spectrum

Actions and Spectrum: 

Action: 

The functioning mechanism involves the suppression of fungal growth and the disruption of ergosterol synthesis, a vital element found in the membranes of fungi cells. 

By disrupting the integrity of the fungal cell membrane, miconazole effectively kills or inhibits the growth of various types of fungi, including yeasts and dermatophytes. 

Spectrum: miconazole has a broad spectrum of activity against various fungi, including: 

Candida species: miconazole is effective against Candida albicans, which is a common cause of oral thrush and vaginal yeast infections. It may also be active against other Candida species, such as Candida glabrata and Candida tropicalis. 

Dermatophytes: miconazole can treat fungal infections caused by dermatophytes, such as Trichophyton, Microsporum, and Epidermophyton species. These fungi commonly cause skin infections like ringworm (tinea corporis), athlete’s foot (tinea pedis), and jock itch (tinea cruris). 

Drug Interaction

Adverse Reaction

Frequency defined  

1-10% 

Headache (5%) 

Vomiting (2.5%) 

Dysgeusia (2.9%) 

Nausea (4.6%) 

Diarrhea (6%) 

Upper abdominal pain (2.5%) 

Black Box Warning

Black Box Warning: 

None

Contraindication / Caution

Contraindication/Caution:  

• Milk protein allergy 
• Hypersensitivity to miconazole or other components 

Cautions: 

• The simultaneous use of miconazole (applied topically, intravaginally, or taken orally) with warfarin has been found to increase the anticoagulant activity. It is important to closely observe for signs of bleeding, monitor prothrombin time, and assess the (INR). 

• It is important to closely observe patients who have a previous history of allergic reactions to other azole antifungal medications. If any signs of hypersensitivity arise, it is necessary to discontinue the medication promptly.

• Recognized as a CYP2C9 and CYP3A4 inhibitor, this substance exhibits minimal systemic absorption and significantly lower plasma concentrations compared to intravenous administration. However, caution must be exercised regarding potential interactions with drugs metabolized by CYP2C9 and CYP3A4, such as oral hypoglycemics, phenytoin, and ergot alkaloids, as the possibility cannot be disregarded. 

Pregnancy / Lactation

Pregnancy warnings:     

Pregnancy category: AU TGA pregnancy category: A
US FDA pregnancy category: C 

Lactation: Excreted into human milk is unknown 

Pregnancy Categories:         

Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester. 

Category B: There were a lack of studies on pregnant women and no evidence of risk to the fetus in animal experiments.   

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.   

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    

Category N: There is no data available for the drug under this category

Pharmacology

Pharmacology: miconazole is an antifungal medication It belongs to the imidazole class of antifungals and is used to treat various fungal infections. 

Pharmacodynamics:  

The azole antifungal agent functions by impeding the activity of cytochrome P450 14-alpha-demethylase, an enzyme involved in the synthesis of ergosterol, thereby inhibiting its production. 

Pharmacokinetics: 

Absorption 

miconazole oral tablets are generally well-absorbed from the gastrointestinal tract, but absorption can be variable.  

Distribution 

miconazole is extensively distributed throughout the body. It is highly protein-bound (approximately 90%) and has a large volume of distribution. The drug crosses the blood-brain barrier and can be found in cerebrospinal fluid (CSF) at low concentrations. 

Metabolism 

miconazole undergoes extensive hepatic metabolism, primarily via cytochrome P450 enzymes, particularly CYP3A4. The main metabolite formed is hydroxymiconazole.  

Excretion and Elimination 

The elimination half-life of miconazole is variable and can range from several hours to days. The drug and its metabolites are primarily excreted in the feces, with a small proportion being excreted in the urine. 

Adminstartion

Administration:  

Do not crush, masticate, or ingest the tablet. While the buccal tablet is in position, you may consume food and beverages normally, but it is advisable to avoid chewing gum. 

If the buccal tablet becomes falls off or is swallowed after being in place for at least 6 hours, a new tablet should be applied until the next scheduled dose. 

Patient Information Leaflet

Patient information leaflet

Generic Name: miconazole oral

Why do we use miconazole oral?

Oral miconazole is indeed an antifungal medication used to treat infections caused by fungus, particularly candida (yeast) infections inside the mouth. The use of oral miconazole is typically prescribed for conditions like oral thrush (oral candidiasis) or other fungal infections in the mouth. It is essential to follow the recommended dosage and treatment duration provided by a healthcare professional when using oral miconazole or any other medication.