DAKTARIN Miconazole 20mg / g Oral Gel 3.5g

Treatment of candidosis of the oropharyngeal cavity and the gastrointestinal tract in adult and pediatric patients 4 months and older (see Contraindications and Precautions).

 

To open the tube, unscrew the cap and pierce the seal of the tube using the pin on the top of the cap.
Oropharyngeal candidiasis: Infants: 4-24 months: 1.25 mL (1/4 teaspoon) 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 mL (1/2 teaspoon) 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. Continue the treatment for at least a week after the symptoms have disappeared. For oral candidosis, dental prostheses are to be removed at night and brushed with the gel.
Gastrointestinal tract candidosis: The gel may be used for infants (≥ 4 months of age), children, and adults who have difficulty swallowing tablets.
The dosage is 20 mg per kg body weight per day, administered in 4 divided doses. The daily dose should not exceed 250 mg (10 mL oral gel) four times a day. Continue the treatment for at least a week after the symptoms have disappeared.

 

Overdosage

Daktarin oral gel is contraindicated in the following situations: In patients with hypersensitivity to miconazole, another ingredient of the formulation, or other imidazole derivatives.
In infants less than 4 months of age or in those whose swallowing reflex is not yet sufficiently developed.
In patients with liver dysfunction.
Use in combination with the following drugs that are subject to metabolism by CYP3A4 (see Interactions): Substrates known to prolong the QT-interval for example, astemizole, bepridil, cisapride, dofetilide, halofantrine, mizolastine, pimozide, quinidine, sertindole and terfenadine; Ergot alkaloids; HMG-CoA reductase inhibitors such as simvastatin and lovastatin; Triazolam and oral midazolam.
Use of miconazole oral gel in combination with the following drug that is subject to metabolism by CYP2C9 (see Interactions): Warfarin.

Miconazole is systemically absorbed and is known to inhibit CYP2C9 and CYP3A4 (see Pharmacology: Pharmacokinetics under Actions ) 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 Interactions). If the concomitant use of Daktarin oral gel with coumarin anticoagulants such as warfarin is planned, caution should be exercised and the anticoagulant effect must be carefully monitored and titrated.
It is advisable to monitor miconazole and phenytoin levels, if these 2 drugs are used concomitantly. In patients using certain oral hypoglycemic such as sulfonylureas, an enhanced therapeutic effect leading to hypoglycemia may occur during concomitant treatment with miconazole and appropriate measures must be considered (see Interactions). It is important to take into consideration the variability of the maturation of the swallowing function in infants, especially when giving Daktarin 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. 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 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 breast-feeding woman for administration to an infant. Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with Daktarin oral gel (see Adverse Reactions). If a reaction suggesting sensitivity should occur, the treatment should be discontinued. Serious skin reactions (e.g. Toxic epidermal necrolysis and Stevens-Johnson syndrome) have been reported in patients receiving Daktarin oral gel (see Adverse Reactions). It is recommended that patients be informed about the signs of serious skin reactions, and that use of Daktarin oral gel be discontinued at the first appearance of skin rash.
Effects on the Ability to Drive or Operate Machinery: Daktarin Oral Gel does not affect the alertness or driving ability.
Use in Pregnancy: There are no adequate and well-controlled studies in pregnant women. At clinically relevant exposures, animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of miconazole Daktarin oral gel during pregnancy unless the benefit of therapy to the patient is considered to outweigh the risks to the fetus.
Use in Lactation: It is not known whether miconazole or its metabolites are excreted in human milk (see Precautions).

 

Use In Pregnancy & Lactation

Post-marketing experience: Adverse drug reactions from spontaneous reports during the worldwide post-marketing experience with Daktarin that meet threshold criteria are included. The adverse drug reactions are ranked by frequency using the following convention: Very common (≥1/10); common (≥1/100 and <1/10); uncommon (≥1/1000 and <1/100); rare (≥1/10000 and <1/1000); and very rare (<1/10000) including isolated reports. The frequencies provided reflect reporting rates for adverse drug reactions from spontaneous reports. Post-marketing reports of adverse drug reactions: Immune system disorders: Very rare: Anaphylactic reactions, hypersensitivity. Respiratory, thoracic and mediastinal disorders: Very rare: Choking (See Contraindications). Gastrointestinal system disorders: Very rare: Diarrhea, Stomatitis, Tongue discoloration. Hepatobiliary disorders: Very rare: Hepatitis. Skin and subcutaneous system disorders: Very rare: Angioedema, Toxic epidermal necrolysis, Stevens-Johnson syndrome, Urticaria, Rash, Acute generalized exanthematous pustulosis, Drug reaction with eosinophilia and systemic symptoms.

 

When using any concomitant medication, consult the corresponding label for information on the route of metabolism. Miconazole can inhibit the metabolism of drugs metabolized by the CYP3A4 and CYP2C9 enzyme systems. This can result in an increase and/or prolongation of their effects, including adverse effects.
Oral miconazole is contraindicated with the co-administration of the following drugs that are subject to metabolism by CYP3A4 (see Contraindications): Substrates known to prolong the QT-interval for example, astemizole, bepridil, cisapride, dofetilide, halofantrine, mizolastine, pimozide, quinidine, sertindole and terfenadine; Ergot alkaloids; HMG-CoA reductase inhibitors such as simvastatin and lovastatin; Triazolam and oral midazolam.
Miconazole oral gel is contraindicated with the co-administration of the following drug that is subject to metabolism by CYP2C9 (see Contraindications): Warfarin.
When co-administered with oral miconazole, the following drugs 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: Drugs subject to metabolism by CYP2C9 (see Precautions): Oral anticoagulants such as warfarin; Oral hypoglycemics such as sulfonylureas; Phenytoin.
Other drugs subject to metabolism by CYP3A4: HIV protease inhibitors such as saquinavir; Certain antineoplastic agents such as vinca alkaloids, busulfan and docetaxel; Certain calcium channel blockers such as dihydropyridines and verapamil; Certain immunosuppressive agents: cyclosporine, tacrolimus, sirolimus(rapamycin).
Others: alfentanil, alprazolam, brotizolam, buspirone, carbamazepine, cilostazol, disopyramide, ebastine, methylprednisolone, midazolam IV, reboxetine, rifabutin, sildenafil, and trimetrexate.

Storage

Action

Oropharyngeal anti-infectives