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DAKTARIN is a brand name for Miconazole. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Oral treatment of candidosis of the oropharynx. Miconazole gel is for use in adults, children and infants 4 months and older.
Verbatim from this product's MHRA label. Tap a section to expand.
For oral administration. The provided measuring device is equivalent to 122 mg for 5 ml. 25 ml (1/4 measuring spoon) of gel, 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(s) with a clean finger.
The gel should not be applied to the back of the throat due to possible choking. The gel should not be swallowed immediately, but kept in the mouth as long as possible. 5 ml (1/2 measuring spoon) of gel, applied four times a day after meals.
The gel should not be swallowed immediately, but kept in the mouth as long as possible. The treatment should be continued for at least a week after the symptoms have disappeared. For oral candidosis, dental prostheses should be removed at night and brushed with the gel.
5). Patients should be advised that if they experience unexpected bleeding or bruising, nosebleeds, coughing up blood, blood in the urine, black tarry stools or coffee ground vomit, to stop treatment with miconazole and seek medical advice.
8). If a reaction suggesting hypersensitivity or irritation should occur, the treatment should be discontinued. It is advisable to monitor miconazole and phenytoin levels, if these two drugs are used concomitantly. 5 Interactions with Other Medicinal Products and Other Forms of Interaction).
Choking in infants and young children 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 should not be applied to the back of the throat.
Each dose should 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.
It is important to take into consideration the variability of the maturation of the swallowing function in infants, especially when giving miconazole 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.
g. 8). 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. This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
5 mg/g. 5 ml dose is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not have any noticeable effects. This medicine contains benzyl benzoate which may cause allergic reactions. 3 picograms of benzyl alcohol per gram.
2 Pharmacokinetic Properties) 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 Section
1. 4) In patients with liver dysfunction. Coadministration of the following drugs that are subject to metabolism by CYP3A4: (See Section
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Miconazole in United Kingdom.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Benzyl alcohol may cause allergic reactions and mild local irritation. Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called “gasping syndrome”) in young children. Do not give to your newborn baby (up to 4 weeks old), unless recommended by your doctor.
Do not use for more than a week in young children (less than 3 years old), unless advised by your doctor or pharmacist. Ask your doctor or pharmacist for advice if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
Ask your doctor or pharmacist for advice if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”). This medicine contains polysorbate which can cause allergic reactions.
5 Interaction with other medicinal products and other forms of interaction When using any concomitant medication the corresponding label should be consulted for information on the route of metabolism. Miconazole can inhibit the metabolism of drugs metabolised by the CYP3A4 and CYP2C9 enzyme systems.
This can result in an increase and/or prolongation of their effects, including adverse effects. , astemizole, cisapride, dofetilide, mizolastine, pimozide, quinidine, sertindole and terfenadine • Ergot alkaloids • HMG-CoA reductase inhibitors such as simvastatin and lovastatin • Triazolam and oral midazolam When coadministered with oral miconazole the following drugs should be used with caution because of a possible increase or prolongation of the therapeutic outcome and/or adverse events.
4 Special warnings and precautions for use); • Oral anticoagulants such as warfarin, • Oral hypoglycaemics such as sulphonylureas • 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: cyclosporin, tacrolimus, sirolimus (= rapamycin) • Others: carbamazepine, cilostazol, disopyramide, buspirone, alfentanil, sildenafil, alprazolam, brotizolam, midazolam IV, rifabutin, methylprednisolone, trimetrexate, ebastine and reboxetine.
6 Fertility, Pregnancy and lactation In animals, miconazole has shown no teratogenic effects but is foetotoxic at high oral doses. The significance of this to man is unknown. However, as with other imidazoles, Daktarin Oral Gel should be avoided in pregnant women if possible.
The potential hazards should be balanced against the possible benefits. It is not known […]