Descrizione Clinica
Oral hygiene Daktarin oral gel 80g 20mg/g Daktarin
DAKTARIN 20 MG/G
active ingredients
A gram of gel contains: Active Principle: miconazole 20 mg. Excipients with known effect: ethyl alcohol 7.85 mg per gr For the complete list of excipients, see paragraph 6.1Excellent
The excipients DAKTARIN oral gel are: Polysorbitan monolaurate, sodium sac, purified water, pregelatinized potato starch, orange aroma, cocoa aroma, ethyl alcohol, glycerin.Therapeutic indications
Treatment and profiling of the candidiasis of the gold-pharyngeal cavity and gastrointestinal tract. As a therapeutic or prophylactic measure against other mycosis of the digestive tube, or against systemic mycosis, such as candidiasis, South American blastomycosis and coccidioidomycosis.Contraindications
• Hypersensitivity to the active ingredient, other derivatives of imidazole or any of the excipients listed in the paragraph 6.1. • In infants with less than 4 months of age or in which swallowing is not yet sufficiently developed (see paragraph 4.4) • In patients with liver dysfunction • In patients receiving metabolized drugs from the CYP3A4 enzymatic system (see paragraph 4.5), i.e.: - Substances extending the QT range (astemizole, bepridil, cisapride, dofetilide, alofantrine, mizolastina, pimozide, chinidine, sertindolo and terfenadine) - Alcaloids of the hergot - HMG-CoA inhibitors reductase as simvastatin and oral lozolamtian - Tria. • In patients using oral miconazole gel in conjunction with the following drugs that are subject to CYP2C9 metabolism (see paragraph 4.5): - oral anticoagulants such as warfarinPopulation
The dosed teaspoon (mixurine) provided is 124 mg per 5 ml. Candidosis of gold-pharyngeal cavity - Milkers (4-24 months): 1.25 ml of gel (1/4 of scoop) to be applied four times a day after meals. Each dose must be divided into smaller portions and the gel must be applied to the area affected by the infection with a clean finger. The gel should not be applied in the throat due to the possible suffocation. The gel should not be swallowed immediately, but must be held in the mouth as long as possible. - Adults and children over 2 years old: 2.5 ml gel (1/2 scoop) to be applied four times a day after meals. The gel should not be swallowed immediately, but must be held in the mouth as long as possible. Continue treatment for at least a week after the disappearance of symptoms. In the case of oral candidiasis, remove dental prostheses for the night period and brush them with the gel. Gastrointestinal Tract Candidosis The gel can be used for infants (≥ 4 months of age), children and adults. The dose is 20 mg/kg body weight per day, administered in four divided doses. The daily dose should not exceed 250 mg (10 ml oral gel) four times a day. Continue treatment for at least a week after the disappearance of symptoms.Conservation
Store at a temperature not exceeding 25°CWarnings
It is advisable to check the levels of miconazole and phenytoin, in case of concomitant intake of the two drugs. In patients in treatment with some oral hypoglycemizers, such as sulfaniluree, there may be an increased therapeutic effect that can lead to hypoglycemia if they take miconazole simultaneously. Therefore, appropriate precautions must be taken (see paragraph 4.5). It is important to consider the variability of the development of swallowing in infants, especially when administered oral Daktarin gel in infants aged 4-6 months. The lower age limit must be increased to 5-6 months of age for infants born prematurely or in which swallowing is not yet sufficiently developed. Reactions of severe hypersensitivity, including anaphylaxis and angioedema, were reported during treatment with Daktarin. If a reaction resulting from hypersensitivity or irritation occurs, the treatment must be stopped. Severe skin reactions (such as Toxic Epidermal Necrolysis and Stevens-Johnson syndrome) were reported in patients receiving Daktarin (see paragraph 4.8). It is recommended that patients be informed about signs of severe skin reactions, and that the use of Daktarin should be stopped at the first appearance of skin rash. Blowing in infants and children Particular attention should be paid during administration of DAKTARIN milking gels and children (age from 4 months to 2 years) to prevent the gel from destroying the throat. For this, the gel should not be applied in the throat. Each dose must be divided into smaller portions and applied in the mouth with a clean finger. Check the patient to avoid possible suffocation. Due to the risk of suffocation, the gel should not be applied to the nipple of a nursing woman for infant administration. DAKTARIN oral gel contains 7.85 mg of alcohol (ethanol) for 1000 mg which is equivalent to 0.00785 mg/mg (0.785% mg/mg). The amount in 1000 mg of this medicine is equivalent to less than 1 mL of beer or 1 mL of wine. The small amount of alcohol in this medicine will not produce significant effects. DAKTARIN oral gel contains less than 1 mmol (23 mg) of sodium per g, i.e. it is essentially “without sodium”.Interactions
When using any other drug at the same time, the illustration sheet of the drug must be carefully consulted to have information about its metabolization path. Miconazole can inhibit the metabolism of metabolized drugs by the enzyme system CYP3A4 and CYP2C9, so it can cause an increase and/or an extension of their both therapeutic and unwanted effects. For this reason, the use of miconazole by mouth is contraindicated in the co-administration of the following drugs, subject to metabolism through the enzyme system CYP3A4 (see paragraph 4.3 Contraindications): - Substances prolonging the QT range (astemizole, bepridil, cisapride, dofetilide, alofantrine, mizolastina, pimozide, chinidine, sertindolo and terfenadine) - Alcaloids of the hergot - inhibitors of the HMG-CoA reductase as simvastatin and oral lovastatin - Oral anticoagulants such as warfarin Special precaution must be used in co-administration of oral miconazole and of the drugs listed below due to the possible increase or prolongation of both therapeutic and undesirable effects. If necessary, their dosage must be reduced and, possibly, their monitored plasma levels: • Metabolized drugs from the CYP2C9 enzymatic system (see paragraph 4.4 Special warnings and appropriate precautions of use): - oral hypoglycemics such as sulphonluree - phenytoin • Other metabolized drugs from the CYP3A4 enzymatic system: - HIV protease inhibitors such as saquinavir - some antineoplastic agents such as vinca alkaloids, busulphan and docetaxel - some calcium channel blockers such as dihydridedine and verapamil - some immunosuppressant agents: cyclosporin, tacrolimus, sirolimus (rapamicin) - others: alfentanil, alprazolam, brotizolam, buspirone, carbamazepine, cilostazole, disopiramide, ebastina, methylprednisolone, midazolam IV, reboxetine, refabutin, sildenafil and trimethylrexate.Effects
Safety DAKTARIN Oral Gel has been evaluated in 111 adult patients with oral candidiasis or oral mycosis who participated in 5 clinical studies. Of these 111 patients, 88 were adults with oral candidiasis or oral mycosis who participated in a randomized clinical trial, with active control, double-blind and three open clinical trials. The other 23 patients were pediatric patients with oral candidiasis who participated in a randomized clinical trial, with active control, in open (age ≤1 month - 10.7 years). These patients have taken at least one dose DAKTARIN Oral gel and security data have been detected. Based on the aggregated data from 5 clinical trials (adults and children), the most commonly reported adverse reactions (≥1% incidence) were nausea (6.3%), alteration of taste (3.6%), vomiting (3.6%), oral cavity (2.7%), regurgitation (1.8%) and dry mouth (1.8%). Dysgeusia was reported in 0.9% of patients. Based on aggregate safety data from 4 clinical studies in adults, the most commonly reported adverse reactions included nausea (4.5%), alteration of taste (4.5%), oral cavity (3.4%), dry mouth (2.3%), disgeusia (1.1%) and vomiting (1.1%). In 1 pediatric study, the reported adverse reactions included nausea (13.0%), vomiting (13.0%) and regurgitation (8.7%). Including adverse reactions from the above mentioned clinical studies, Table A shows the adverse reactions that have been reported with the use of DAKTARIN oral gel or tablets in post marketing experience. The following definitions apply for different frequencies: very common (≥ 1/10), common (from ≥ 1/100 toOverdosing
Synonyms In case of accidental overdose, vomiting and diarrhea can be manifested. Treatment Treatment is symptomatic and supportive. A specific antidote is not available.Pregnancy In animal studies, miconazole has not demonstrated teratogenic, but phetotoxic effects at high doses by mouth. The meaning of this correlation in human beings is not known. It is preferable to avoid use of DAKTARIN during pregnancy unless the benefits of therapy for the patient are considered to outweigh the risks to the foetus.Breast-feeding It is not known whether miconazole or its metabolites are excreted in human milk (see section 4.4), therefore caution should be exercised when prescribing DAKTARIN during lactation.
Source: Farmadati
