• Save 12%
search

DAKTARIN ORAL GEL 80G 20MG / G

  • FARMA 1000 Srl
  • 042110027

Antifungal and antibacterial of the oral cavity.

Indicated to counteract infections of the mouth.

info_outline View product sheet
Final Price €14.96
Regular Price €17.00
Save 12%
Quantity
check_circle Available (15 Items)
48h
  Convenient and safe payments

Even with a credit card

  Shipping in 48h-72h all over the world

FREE in Italy over € 39.90

  Fast returns and 14 days to reconsider

14 days to reconsider

  90 years of pharmaceutical experience at your service

Always at your service

Drugs Others products at unbeatable price

FARMA 1000 Srl

Discover all products

DAKTARIN ORAL GEL 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 equals 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 tract: 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, given in four divided doses. The daily dose should not exceed 250 mg (10 ml of oral gel) four times a day. Continue the treatment for at least one week after the 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), ie: - 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. • 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 nauseous (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%), altered taste (4.5%), oral cavity 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

System and organ classification Adverse drug reactions
Frequency
Very common (≥ 1/10) Common (≥1 / 100 y Uncommon (≥1 / 1,000 a Not known
Disorders of the immune system Anaphylactic reaction, Hypersensitivity
Nervous system disorders Dysgeusia
Respiratory, thoracic and mediastinal disorders Suffocation
Gastrointestinal disorders Nausea (children), vomiting (children) Dry mouth, Nausea (adults), Oral disorders, Vomiting (adults), Regurgitation (children) Diarrhea, Stomatitis, Tongue discoloration
Hepatobiliary disorders Hepatitis
Skin and subcutaneous tissue disorders Angioedema, Toxic epidermal necrolysis, Stevens-Johnson syndrome, Urticaria, Rash, Acute Generalized Exanthemic Pustulosis (AGEP), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
General disorders and administration site conditions Alteration of taste

Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-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 Children: Particular 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. Check 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. Excipients: DAKTARIN oral gel contains 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, 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. Lactation: 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.

Expiry 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 is contraindicated in the co-administration of the following drugs, subject to metabolism via the CYP3A4 enzyme system (see section 4.3 Contraindications): - 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. Miconazole oral 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. 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 metabolised by the CYP2C9 enzyme system (see section 4.4 Special warnings and special precautions for use): - 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.

Overdose

Symptoms In case of accidental overdose, vomiting and diarrhea may occur. Treatment Treatment 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, glycerine.

042110027
15 Items