Miconazole

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications:

• Fungal infections of the mouth (e.g. thrush in babies and oral candidiasis in other age groups)
• Fungal stomatitis occurring in association with dentures

Contraindications

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Infants less than 6 months of age or in those with swallowing reflex not yet fully developed
• Impaired liver function
• Coadministration of the following medicine that are subject to metabolism by CYP3A4
  - Substrates known to prolong QT-interval e.g. astemizole, bepridil, cisapride, dofetilide, halofantrine, mizolastine, pimozide, quinidine, sertindole and terfenadine
  - Ergot alkaloids
  - HMG-CoA reductase inhibitors such as simvastatin and lovastatin
  - Triazolam and midazolam

Contraindications registered in other jurisdictions

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to other imidazole derivatives
• Infants less than 4 months of age or in those whose swallowing reflex is not yet sufficiently developed
• Liver dysfunction
• Coadministration of the following agents that are subject to metabolism by CYP3A4
  - Substrates known to prolong the QT-interval e.g., astemizole, cisapride, dofetilide, mizolastine, pimozide, quinidine, sertindole and terfenadine
  - Ergot alkaloids
  - HMG-CoA reductase inhibitors such as simvastatin and lovastatin
  - Triazolam and oral midazolam

Cautions

• Pregnancy
• Breastfeeding
• Infants and young children (See additional prescribing points)

Forms avail. in SA and covered in this monograph: gel

Dosages below include:

• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

Infections caused by: Common dermatophytes and yeasts, certain gram-positive bacilli and cocci

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

South African registered indications and dosages

Fungal infections of the mouth
- Oral candidiasis
Fungal stomatitis occurring in association with dentures 

• Topical (gel): Apply evenly to the affected areas, 6-8hrly, depending on the severity of the infection, after meals; Treatment duration: Continue treatment for 48hrs after the infection has cleared

---

Miconazole oral gel should be spread evenly over the affected areas of the oropharyngeal mucosa and tongue taking care to properly cover oral ulcerations and other lesions

---

Apply the gel regularly until all signs of the infection have disappeared

---

For best results in treatment of oral lesions, miconazole oral gel must be kept in contact with the affected areas as long as possible

---

This can be achieved by retaining the gel in the mouth for the maximum time possible

---

In fungal stomatitis, associated with dentures, apply the gel to the lesions in the evening and leave on overnight. For oral candidosis, dental prostheses should be removed at night and brushed with the gel

---

Indications and dosages registered in other jurisdictions

Oropharyngeal candidosis

• Topical (gel): Apply 2.5ml to the affected areas, 6hrly after meals; Treatment duration: Continue treatment for ≥7 days after infection has cleared

---

The gel should not be swallowed immediately but kept in the mouth for as long as possible

---

For oral candidosis, dental prostheses should be removed at night and brushed with the gel

Paed. forms avail. in SA and covered in this monograph: gel

Paed. dosages below include:

• South African Standard Treatment Guideline indications and dosages
• South African registered indications and dosages
• Indications and dosages registered in other jurisdictions

Infections caused by: Common dermatophytes and yeasts, certain gram-positive bacilli and cocci

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

South African Standard Treatment Guideline indications and dosages

Oral candidiasis
- If no response to nystatin suspension

• Topical (gel): Apply to the affected areas, 8hrly
  (STG, Paed. 2017)

---

South African registered indications and dosages

Fungal infections of the mouth
- Thrush (in babies)
- Oral candidiasis (in other age groups)
Fungal stomatitis occurring in association with dentures 

Younger than 6 months

• Contraindicated

Older than 6 months

• See adult dosage

---

No specific dosages provided for babies, infants and children in South African manufacturer recommendations

---

Caution is required to ensure that the gel does not obstruct the throat. Hence, the gel should not be applied to the back of the throat and each dose should be divided into smaller portions

---

Observe the patient for possible choking

---

Indications and dosages registered in other jurisdictions

Oropharyngeal candidosis

Younger than 4 months

• Contraindicated

Between 4-24 months

• Topical (gel): Apply 1.25ml to the affected areas, 6hrly after meals; Treatment duration: Continue treatment for ≥7 days after infection has cleared

---

Each dose should be divided into smaller portions and the gel should be applied to the affected area(s) with a clean finger

---

The gel should not be applied to the back of the throat due to possible choking

---

The gel should not be swallowed immediately but kept in the mouth as long as possible

---

2 years and older

• See adult dosage

---

The gel should not be swallowed immediately but kept in the mouth as long as possible

---

For oral candidosis, dental prostheses should be removed at night and brushed with the gel

Pregnancy

• Caution; not recommended
• In animals, miconazole has shown no teratogenic effects but is foetotoxic at high oral doses. The significance of this to man is unknown. However, as with other imidazoles, miconazole oral gel should be avoided in pregnant women if possible. The potential hazards should be balanced against the possible benefits

Breastfeeding

• Caution
• It is not known whether miconazole is excreted in human milk. Caution should be exercised when considering administering miconazole oral gel to breastfeeding mothers

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• Contraindicated

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Respiratory Disorders

• Choking

Gastrointestinal Disorders

• Dry mouth
• Nausea and vomiting
• Oral discomfort
• Regurgitation
• Diarrhoea
• Stomatitis
• Tongue discolouration
• Abnormal product taste

Hepatobiliary Disorders

• Hepatitis

Skin and Subcutaneous Tissue Disorders

• Angioedema
• Toxic epidermal necrolysis
• Stevens-Johnson syndrome
• Urticaria
• Rash
• Acute generalised exanthematous pustulosis
• Drug reaction with eosinophilia and systemic symptoms

Immune, Blood and Lymphatic System Disorders

• Anaphylactic reaction
• Hypersensitivity
• Increased International Normalised Ratio (coadministration with anticoagulants, such as warfarin)
• Bleeding events (coadministration with anticoagulants, such as warfarin)
  - Epistaxis
  - Contusion
  - Haematuria
  - Melaena
  - Haematemesis
  - Haematoma
  - Haemorrhages

Sensory Disorders

• Dysgeusia

• CYP3A4 substrates
• QT-interval prolonging agents
• Astemizole
• Cisapride
• Dofetilide
• Mizolastine
• Pimozide
• Quinidine
• Sertindole
• Terfenadine
• Ergot alkaloids
• HMG-CoA reductase inhibitors
• Lovastatin
• Simvastatin
• Triazolam
• Midazolam (oral)
• Bepridil
• CYP2C9 substrates
• Oral anticoagulants
• Warfarin
• Oral hypoglycaemics
• Sulfonylureas
• Phenytoin
• Protease inhibitors (Human Immunodeficiency Virus)
• Saquinavir
• Antineoplastic agents
• Vinca alkaloids
• Busulfan
• Docetaxel
• Calcium channel blockers
• Dihydropyridines
• Verapamil
• Certain immunosuppressive agents
• Cyclosporin
• Tacrolimus
• Sirolimus (= rapamycin)
• Carbamazepine
• Cilostazol
• Disopyramide
• Buspirone
• Alfentanil
• Sildenafil
• Alprazolam
• Brotizolam
• Midazolam (IV)
• Rifabutin
• Methylprednisolone
• Trimetrexate
• Ebastine
• Reboxetine

None routine

Use in infants and young children

• Particularly in infants and young children (aged 4 months-2 years), caution is required, to ensure that the gel does not obstruct the throat. Hence, the gel should not be applied to the back of the throat. Each dose should be divided into smaller portions and applied into the mouth with a clean finger. Observe the patient for possible choking. Also due to the risk of choking, the gel must not be applied to the nipple of a breastfeeding woman for administration to an infant
• It is important to take into consideration the variability of the maturation of the swallowing function in infants, especially when giving miconazole gel to infants between the ages of 4-6 months. The lower age limit should be increased to 5-6 months of age for infants who are pre-term, or infants exhibiting slow neuromuscular development

Miconazole possesses an antifungal activity based on the inhibition of the ergosterol biosynthesis in fungi and the change in the composition of the lipid components in the membrane, resulting in fungal cell necrosis.

Spectrum of activity: Common dermatophytes and yeasts, certain gram-positive bacilli and cocci

Gel (per g) 20mg

• Daktarin oral (Janssen) originator
• Vari Miconazole (Barrs)

Also available in the following forms: Cream (topical), vaginal cream and vaginal tablet.

COMBINATION PREPARATIONS

Hydrocortisone/ Miconazole

Cream (per g) 10mg/20mg

• Daktacort (Specpharm)
• Elozart (LeBasi)