DAKTARIN Oral gel

Uses

What is Daktarin oral gel® (Miconazole) used for?

Daktarin oral gel® is commonly used for the oral treatment of fungal infections of the oropharynx and gastrointestinal tract. Miconazole gel is used in adults, children, and infants from 4 months.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Daktarin oral gel® (Miconazole).

What is the dose of Daktarin oral gel® (Miconazole) for an adult?

Consult your doctor for information about the dose of Daktarin oral gel®. Recommended doses in some cases are listed below:

Oropharyngeal candidosis

Adults: 2.5 ml (1/2 measuring spoon) of gel, applied four times a day after meals.

The treatment should be continued for at least a week after the symptoms have disappeared.

Gastrointestinal tract candidosis

The dosage is 20 mg per 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. The treatment should be continued for at least a week after the symptoms have disappeared.

What is the dose of Daktarin oral gel® (Miconazole) for a child?

Consult your doctor for information about the dose of Daktarin oral gel®. Recommended doses in some cases are listed below:

Oropharyngeal candidosis

Infants (4-24 months): 1.25 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.

Children 2 years of age and older: 2.5 ml (1/2 measuring spoon) of gel, applied four times a day after meals.

Gastrointestinal tract candidosis

The gel may be used for infants (≥ 4 months of age), children, who have difficulty swallowing tablets.

The dosage is 20 mg per 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.

The treatment should be continued for at least a week after the symptoms have disappeared.

Directions

How should I take Daktarin oral gel® (Miconazole)?

For topically taken form, you should:

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

Symptoms of overdose:

• Vomiting;
• Diarrhea.

What should I do if I miss a dose?

If you miss a dose of Daktarin oral gel®, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Side effects

What side effects can occur from Daktarin oral gel® (Miconazole)?

As taking others medicines, taking Daktarin oral gel® can cause some side effects. Most of them are rarely occurring and do not need any supplementary treatment. However, it is always important for you to consult your doctor if you have any problem after taking this medicine.

Some of side effects are listed below:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Precautions/Warnings

What should I know before using Daktarin oral gel® (Miconazole)?

Before using Daktarin oral gel®, tell your doctor if you have:

Is it safe in specific conditions (e.g. pregnancy, breastfeeding, or surgery)?

There are no adequate studies in women for determining risk when using Daktarin oral gel® during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Daktarin oral gel®.

Interactions

What drugs may interact with Daktarin oral gel® (Miconazole)?

Daktarin oral gel® may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Products may interact with this drug include:

• Substrates are known to prolong the QT-interval e.g., astemizole, cisapride, dofetilide, mizolastine, pimozide, quinidine, sertindole, and terfenadine;
• Ergot alkaloids;
• HMG-CoA reductase inhibitors such as simvastatin and lovastatin;
• Triazolam and oral midazolam;
• Oral anticoagulants such as warfarin;
• Oral hypoglycemics 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.

Does food or alcohol interact with Daktarin oral gel® (Miconazole)?

Daktarin oral gel® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

How do I store Daktarin oral gel® (Miconazole)?

Daktarin oral gel® is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Daktarin oral gel® in the bathroom or the freezer. There may be different brands of Daktarin oral gel® that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Daktarin oral gel® down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

How is Daktarin oral gel® (Miconazole) available?

Daktarin oral gel® is available in the following dosage forms and strengths:

• Gel, 20 mg miconazole.