Daktarin*Oral gel 80g 20mg/g

NAME
DAKTARIN 20 MG / G ORAL GEL

PHARMACOTHERAPEUTIC CATEGORY
Stomatological.

ACTIVE PRINCIPLES
Miconazole.

EXCIPIENTS
Polysorbitan monolaurate, sodium saccharin, purified water, pregelatinised dipate starch, orange flavor, cocoa flavor, ethyl alcohol, glycerin.

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.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance, to other imidazole derivatives or to any of the excipients; in infants less than 4 months of age or in whom swallowing is not yet sufficiently developed; in patients with hepatic dysfunction; in patients receiving drugs metabolised by the CYP3A4 enzyme system concomitantly, ie: substances that prolong the QT interval (astemizole, bepridil, cisapride, dofetilide, halofantrine, mizolastine, pimozide, quinidine, sertindole and terfenadine); ergot alkaloids; HMG-CoAreductase inhibitors such as simvastatin and lovastatin; triazolam and midazolam by mouth.

DOSAGE
The measuring spoon (measuring cup) provided is equivalent to 124 mg per 5 ml. Candidosis of the oropharyngeal cavity. Infants (4-24 months): 1.25 ml of digel (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 affected 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 (half a 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 treatment for at least one week after symptoms disappear. In the case of oral candidiasis, remove the dentures for the night period and brush them with the gel. Gastrointestinal tract candidiasis The gel can be used for infants (> = 4 months of age), children and adults. The dose is 20 mg / kg of body weight per day, administered 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.

STORAGE
Store at a temperature not exceeding 25 degrees C.

WARNINGS
In case of concomitant use of the medicinal product and oral anticoagulant drugs, such as warfarin, the anticoagulant effect should be carefully monitored and titrated. 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 taken concomitantly with miconazole. Therefore, appropriate precautions must be taken. It is important to take into account the variability of the development of swallowing in infants, in particular when the oral gel drug 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 the medicinal product. If a reaction due to hypersensitivity or irritation occurs, the treatment must be stopped. Serious skin reactions (e.g. toxic epidermal necrolysis and Stevens-Johnson syndrome) have been reported in patients receiving the drug. It is recommended that patients be informed of the signs of severe skin reactions, and that use of the medicinal product should be discontinued at the first appearance of a skin rash. Choking in infants and children: particular care should be taken when administering the gel drug to infants and children (aged 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 into 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.

INTERACTIONS
Miconazole can inhibit the metabolism of drugs metabolised by the CYP3A4 and CYP2C9 enzymatic system, therefore it can cause an increase and / or prolongation of their therapeutic and undesirable effects. For this reason, the use of oral miconazole is contraindicated in the co-administration of the following drugs, subject to metabolism through the CYP3A4 enzyme system: substances that prolong the QT interval (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 by mouth. Particular precaution should be used when co-administering oral miconazole and the following drugs 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 metabolized by the CYP2C9 enzyme system: oral anticoagulants such as warfarin; oral hypoglycemic agents such as sulfonylureas; 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.

SIDE EFFECTS
Based on the pooled safety data from the 5 clinical studies (adults and children), the most commonly reported adverse reactions were nausea, taste disturbance, vomiting, oral cavity disorders, regurgitation and dry mouth. 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, taste disturbance, oral cavity disorder, dry mouth, dysgeusia and vomiting. In 1 pediatric study, adverse reactions reported included nausea, vomiting and regurgitation. Including the adverse reactions from the clinical studies mentioned above, the list below shows the adverse reactions that have been reported with the use of the oral gel or tablet drug in post marketing experience. The following definitions apply for the different frequencies: very common (> = 1/10), common (> = 1/100 to <1/10), uncommon (> = 1/1000 to <1/100) , rare (> = 1 / 10,000 to <1/1000), very rare (<1 / 10,000) and not known. In clinical trials, the frequency of nausea and vomiting was very common in pediatric patients compared to common in adults and regurgitation was common in pediatric patients while not 'reported in adults. As identified from post-marketing experience, choking in infants and children may occur. The frequency, type and severity of other adverse reactions in children are expected to be similar to those in adults. >> Adverse drug reactions in patients treated with the oral gel drug. Disorders of the immune system. Not known: anaphylactic reaction, hypersensitivity '. Nervous system disorders. Uncommon: dysgeusia. Respiratory, thoracic and mediastinal disorders. Not known: suffocation. Gastrointestinal disorders. Very common: nausea (children), vomiting (children); common: dry mouth, nausea (adults), oral disorders, vomiting (adults), regurgitation (children); not known: diarrhea, stomatitis, tongue discoloration. Hepatobiliary disorders. Not known: hepatitis. Skin and subcutaneous tissue disorders. Not known: angioedema, toxic epidermal necrolysis, Stevens-Johnson syndrome, urticaria, rash, generalized acute exanthemic pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS). General disorders and administration site conditions. Common: taste disturbance. The reporting of suspected adverse reactions that occur after the authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine.

PREGNANCY AND BREASTFEEDING
In animal studies, miconazole did not demonstrate iteratogenic, but foetotoxic effects at high oral doses. The significance of this correlation in humans is not known. It is preferable to avoid the use of the drug during pregnancy unless the benefits of therapy for the patient are considered greater than the risks for the fetus. It is not known whether miconazole or its metabolites are excreted in human milk, therefore caution should be exercised when prescribing the drug during lactation.