Daktarin 20mg / 1g Oral Gel

DAKTARIN oral gel is indicated for the treatment of fungal infections of the mouth (e.g. thrush in babies four months and older and oral candidiasis in other age groups) and for fungal stomatitis occurring in association with dentures

Full term infants: 4 u2013 24 months: 1.25 m l (1/4 measuring spoon) of gel, applied four times a day after meals. Each dose is to be divided into smaller portions and the gel applied to the affected area(s) with a clean finger. The gel is not to be swallowed immediately, but kept in the mouth as long as possible.

Adults and children 2 years of age and older: 2.5 m l (1/2 measuring spoon) of gel, applied four times a day after meals. The gel is not to be swallowed immediately, but kept in the mouth as long as possible.

DAKTARIN 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. The application of DAKTARIN oral gel must be repeated three to four times daily depending upon the severity of the infection. Apply the gel regularly until all signs of the infection have disappeared. Continue using for another two days after the infection has cleared. Application of the gel is preferably done after meals. 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.

Instructions for use and handling: To open the tube, unscrew the cap. Then pierce the seal of the tube by means of the pin on the top of the cap.

DAKTARIN oral gel is contraindicated in the following situations:

• In patients with hypersensitivity to miconazole, another ingredient of the formulation, or other imidazole derivatives of DAKTARIN oral gel
• In infants less than 4 months of age or in those with swallowing reflex not yet fully developed and prematurely born infants less than six months of age.
• In patients with impaired liver function
• Use in combination with the following medicine that are subject to metabolism by CYP3A4 :
• Substrates known to prolong QT-interval for example astemizole, bepridil, cisapride, dofetilide, halofantrine, mizolastine, pimozide, quinidine and sertindole
• Ergot alkaloids
• HMG-CoA reductase inhibitors such as simvastatin and lovastatin
• Triazolam and midazolam
• Use of DAKTARIN oral gel in combination with Warfarin (metabolized by CYP2C9)

Avoid contact with the eyes. 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 6 months of age for infants who are pre-term, or infants exhibiting slow neuromuscular development. Particularly in infants and young children (aged 4 months u2013 2 years), caution is required, to ensure that the gel does not obstruct the throat. Hence, the gel is not to be applied to the back of the throat. Each dose is to 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.

Miconazole is systemically absorbed and is known to inhibit CYP2C9 and CYP3A4 (see section 5.2) which can lead to prolonged effects of warfarin. Bleeding events, some with fatal outcomes, have been reported with concurrent use of miconazole oral gel and warfarin (see section 4.3). It is advisable to monitor with DAKTARIN oral gel and phenytoin levels, if used concomitantly. In patients using certain oral hypoglycemics such as sulfonylureas, an enhanced therapeutic effect leading to hypoglycaemia may occur during concomitant treatment with DAKTARIN oral gel and appropriate measures must be considered. (See section 4.5).

Severe hypersensitivity reactions including anaphylaxis and angioedema have been reported during treatment with DAKTARIN ORAL GEL. (see If a reaction suggesting hypersensitivity should occur, the treatment should be discontinued. Serious skin reactions (e.g., Toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS)) have been reported in patients receiving DAKTARIN ORAL GEL (see section 4.8). It is recommended that patients be informed about the signs of serious skin reactions, and that the use of DAKTARIN ORAL GEL be discontinued at the first appearance of skin rash.

When using any concomitant medication, consult the corresponding product information for information on the route of metabolism. Miconazole can inhibit the metabolism of medicines metabolised by the CYP3A4 and CYP2C9 enzyme systems. This can result in an increase and/or prolongation of their effects, including adverse effects. Refer to the CONTRAINDICATIONS section for coadministration of certain medicines that are subject to metabolism by CYP3A4.

When co-administered with DAKTARIN oral gel, the following medicines must be used with caution because of a possible increase or prolongation of the therapeutic outcome and/or adverse effects. If necessary, reduce their dosage and, where appropriate, monitor plasma levels:

• Medicines subject to metabolism by CYP2C9 Oral anticoagulants such as Warfarin (See section 4.3)
• Oral hypoglycemics such as sulfonylureas
• Phenytoin
• Other medicines subject to metabolism by CYP3A4:
• HIV Protease Inhibitors such as ritonavir and saquinavir
• Certain antineoplastic medicines such as vinca alkaloids, busulfan and docetaxel
• Certain Calcium Channel Blockers such as dihydropyridines and verapamil
• Certain immunosuppressive medicines: cyclosporin, tacrolimus, sirolimus (= rapamycin)
• Others: alfentanil, alprazolam, brotizolam, buspirone, carbamazepine cilostasol, disopyramide, ebastine, methylprednisolone, midazolam IV, reboxetine, rifabutin and sildenafil

DAKTARIN oral gel should not be used during pregnancy as safety has not been demonstrated.

There are no data available on the excretion of miconazole in human milk; therefore, DAKTARIN oral gel should not be used in patients who are breastfeeding their infants.

DAKTARIN oral gel does not affect alertness or driving ability.

Clinical trial data

Nervous system disorders

• Frequent: Dysgeusia

Gastrointestinal disorders

• Frequent: Dry mouth, nausea, oral discomfort and vomiting

General disorders and administration site conditions

• Frequent: Abnormal taste

Infants

Gastrointestinal disorders

• Frequent: Nausea, regurgitation and vomiting

Post - marketing experience

Adverse drug reactions first identified during post-marketing experience with DAKTARIN oral gel are listed below.

Post marketing reports of adverse drug reactions

System Organ Class Adverse drug reaction

• Immune System Disorders Anaphylatic reaction, angioedema, hypersensitivity
• Respiratory, Thoracic and Mediastinal Disorders Choking (see section 4.3)
• Gastrointestinal Disorders Diarrhoea, stomatitis, tongue discolouration
• Hepatobiliary Disorders Hepatitis
• Skin and Subcutaneous Tissue Disorders Toxic epidermal necrolysis, Stevens - Johnson syndrome, urticaria, rash, acute generalized exanthemous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine product is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via u201c6.04 Adverse Drug Reaction Reporting Formu201d found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/index/8

Alternatively, suspected adverse reactions may be reported directly to Janssen Pharmaceutica (see section 7 for contact details or visit www.janssen.com).

Symptoms

In the event of accidental overdose, vomiting and diarrhoea may occur.

Treatment

Treatment is symptomatic and supportive. A specific antidote is not available.