Daktarin oral gel 80g 20mg 042110027

DAKTARIN * GEL OS 80G 20MG / G

Therapeutic indications

Curative and prophylactic treatment of candidiasis of the oropharyngeal cavity and gastrointestinal tract. As a therapeutic or prophylactic measure against other mycoses of the digestive tract, or against systemic mycoses, such as candidiasis, South American blastomycosis and coccidioidomycosis.

Dosage and method of use

The measuring spoon (measuring cup) provided is equivalent to 124 mg per 5 ml.Candidiasis of the oropharyngeal cavity- Infants (4-24 months): 1.25 ml of gel (1/4 measuring spoon) to be applied four times a day after meals. Each dose should be divided into smaller portions and the gel should be applied to the infected area with a clean finger. The gel should not be applied to the throat due to possible choking. The gel should not be swallowed immediately, but should be kept in the mouth as long as possible. - Adults and children over 2 years of age: 2.5 ml of gel (1/2 scoop) to be applied four times a day after meals. The gel should not be swallowed immediately, but should be kept in the mouth as long as possible. Continue the treatment for at least one week after the symptoms disappear. In the case of oral candidiasis, remove the dentures for the night and brush them with the gel.Candidiasis of the gastrointestinal tractThe gel can be used for infants (≥ 4 months of age), children and adults. The dose is 20 mg / kg of body weight per day, given in four divided doses. The daily dose should not exceed 250 mg (10 ml of oral gel) four times a day. Continue treatment for at least one week after symptoms disappear.

Contraindications

• Hypersensitivity to the active substance, to other imidazole derivatives or to any of the excipients listed in section 6.1. • In infants less than 4 months of age or in whom swallowing is not yet sufficiently developed (see section 4.4) • In patients with hepatic dysfunction • In patients receiving concomitant drugs metabolised by the CYP3A4 enzyme system (see section 4.5), i.e. - QT interval prolonging substances (astemizole, bepridil, cisapride, dofetilide, halofantrine, mizolastine, pimozide, quinidine, sertindole and terfenadine) - ergot alkaloids - HMG-CoA reductase inhibitors such as simvastatin and lovastatin - midazolam by mouth. • In patients using miconazole oral gel concomitantly with the following drugs that are subject to CYP2C9 metabolism (see section 4.5): - oral anticoagulants such as warfarin

Side effects

The safety of DAKTARIN Oral Gel was 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, active-controlled, double-blind, and three open-label clinical trials. The other 23 patients were pediatric patients with oral candidiasis who participated in a randomized, active-controlled, open-label clinical trial (age ≤1 month - 10.7 years). These patients received at least one dose of DAKTARIN Oral Gel and safety data were collected. Based on pooled safety data from the 5 clinical studies (adults and children), the most commonly reported adverse reactions (incidence ≥1%) were nausea (6.3%), taste disturbance (3.6%), vomiting (3.6%), oral cavity disorders (2.7%), regurgitation (1.8%) and dry mouth (1.8%). Dysgeusia was reported in 0.9% of patients. Based on pooled safety data from 4 clinical trials in adults, the most commonly reported adverse reactions included nausea (4.5%), taste disturbance (4.5%), oral disorders (3.4%) , dry mouth (2.3%), dysgeusia (1.1%) and vomiting (1.1%). In 1 pediatric study, adverse reactions reported included nausea (13.0%), vomiting (13.0%) and regurgitation (8.7%). Including the adverse reactions from the clinical studies mentioned above, 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 the different frequencies: very common (≥ 1/10), common (≥ 1/100 to

Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: https://www.agenziafarmaco.gov.it/content/segnalazioni-reazioni-avversa

Special warnings

It is advisable to check the levels of miconazole and phenytoin, in case of concomitant intake of the two drugs. In patients being treated with certain oral hypoglycaemics, such as sulfonylureas, an increased therapeutic effect may occur which can lead to hypoglycaemia if they are taken concomitantly with miconazole. Therefore, appropriate precautions should be taken (see section 4.5). It is important to take into account the variability of swallowing development in infants, particularly when Daktarin oral gel is administered to infants aged 4-6 months. The lower age limit should be raised to 5-6 months of age for infants born prematurely or whose swallowing is not yet sufficiently developed. Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with Daktarin. If a reaction due to hypersensitivity or irritation occurs, the treatment should be discontinued. Serious skin reactions (e.g. toxic epidermal necrolysis and Stevens-Johnson syndrome) have been reported in patients receiving Daktarin (see section 4.8). It is recommended that patients be informed of the signs of severe skin reactions, and that use of Daktarin should be discontinued at the first appearance of a skin rash.Suffocation in infants and childrenParticular care should be taken when administering DAKTARIN gel to infants and children (ages 4 months to 2 years) to prevent the gel from blocking the throat. For this, the gel should not be applied to the throat. Each dose should be divided into smaller portions and applied in the mouth with a clean finger. Monitor the patient to avoid possible suffocation. Due to the risk of choking, the gel should not be applied to the nipple of a nursing woman for administration to the infant. DAKTARINoral gelcontains 7.85 mg of alcohol (ethanol) per 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 relevant effects. DAKTARIN oral gel contains less than 1 mmol (23 mg) sodium per g, ie it is essentially “sodium-free”.

Pregnancy and breastfeeding

Pregnancy In animal studies, miconazole did not demonstrate teratogenic, but foetotoxic effects at high oral doses. The significance of this correlation in humans is unknown. It is preferable to avoid the use of DAKTARIN during pregnancy unless the benefits of therapy for the patient are considered to be greater than the risks for the fetus. Breastfeeding 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 breastfeeding.

Expiration and retention

Store at a temperature not exceeding 25 ° C

Interactions with other drugs

When used concomitantly with any other drug, the package leaflet of the latter should be carefully consulted for information on its route of metabolism. Miconazole can inhibit the metabolism of drugs metabolised by the CYP3A4 and CYP2C9 enzyme system, therefore it can cause an increase and / or prolongation of their therapeutic and undesirable effects. For this reason, the use of oral miconazole iscontraindicatedin the co-administration of the following drugs, subject to metabolism via the CYP3A4 enzyme system (see section 4.3Contraindications): - QT-prolonging substances (astemizole, bepridil, cisapride, dofetilide, halofantrine, mizolastine, pimozide, quinidine, sertindole and terfenadine) - ergot alkaloids - HMG-CoA reductase inhibitors such as simvastatin and lovastatin - oral midazolam oral miconazole gel is contraindicated in the co-administration of the following drugs which are metabolised by the CYP2C9 enzyme system (see section 4.3): - oral anticoagulants such as warfarin Special precaution should be used when co-administering miconazole for use and the drugs listed below due to the possible increase or prolongation of both therapeutic and undesirable effects. If necessary, their dosage should be reduced and, if necessary, their plasma levels monitored: • Drugs metabolised by the CYP2C9 enzyme system (see section 4.4 Special warnings and special precautions for use): - oral hypoglycemic agents such as sulphonylureas - phenytoin • Other drugs metabolised by the CYP3A4 enzyme system: - HIV protease inhibitors such as saquinavir - some antineoplastic agents such as vinca alkaloids, busulfan and docetaxel - some calcium channel blockers such as dihydropyridines and verapamil - some immunosuppressive agents: cyclosporine , tacrolimus, sirolimus (rapamycin) - others: alfentanil, alprazolam, brotizolam, buspirone, carbamazepine, cilostazol, disopyramide, ebastine, methylprednisolone, midazolam IV, reboxetine, rifabutin, sildenafil and trimetrexate.

Overdose

SymptomsIn case of accidental overdose, vomiting and diarrhea may occur.TreatmentTreatment is symptomatic and supportive. A specific antidote is not available.

Active principles

One gram of gel contains:Active principle:miconazole 20 mg. Excipients with known effect: ethyl alcohol 7.85 mg per gr For the full list of excipients, see section 6.1

Excipients

The other ingredients of DAKTARIN oral gel are:Polysorbitan monolaurate, sodium saccharin, purified water, pregelatinised potato starch, orange flavor, cocoa flavor,ethyl alcohol, glycerin.