Daktarin

Daktarin (Miconazole) by Aspin 20 mg/g oral gel is sugar-free. It is a topical antifungal gel used in the mouth to treat oral candidiasis and relieve white patches, burning, and soreness. Anti-infectives and antiseptics for local oral treatment and Imidazole derivatives.

Mechanism of Action: Miconazole possesses an antifungal activity against the common dermatophytes (fungi) and yeasts, as well as an antibacterial activity against certain gram-positive bacilli and cocci (bacteria).

Miconazole inhibits the biosynthesis of ergosterol in fungi and changes the composition of other lipid components in the membrane, resulting in fungal cell necrosis (to break down and die).

Package contains: Each pack of Daktarin contains a gel tube of 20 grams.

Composition:

Daktarin Oral Gel (Miconazole Oromucosal Gel BP)

Each gram contains: Miconazole (Ph. Eur) 20 mg

Dosage: As prescribed by the physician. To be sold on the prescription of a registered medical practitioner only.

Indications / Uses: It is indicated for the treatment of Candidiasis of the oropharyngeal cavity & Gl tract (gastrointestinal tract), in adults and pediatric patients > 4 months and older. For more details (see Contraindications, Warnings, and Precautions).

Detailed uses: Miconazole Oromucosal Gel BP is commonly used to treat oropharyngeal candidiasis (commonly called oral thrush), which is a fungal infection of the mouth and throat caused mainly by Candida albicans.

The gel is applied inside the mouth, where it acts locally to kill the fungus. When some of the gel is swallowed, it also helps reduce fungal infection in the upper gastrointestinal (GI) tract, such as the esophagus.

Dosage and Administration: Avoid applying the gel to the back of the throat due to the risk of choking (Particularly in infants).

Oropharyngeal candidosis:

Infants: 4-24 months: 1.25 mL of gel, applied four times a day after meals. Each dose is to be divided into smaller portions and the gel applied to the affected area(s) with a clean finger. The gel is not to be swallowed immediately, but kept in the mouth as long as possible.

Adults and children 2 years of age and older: 2.5 mL of gel, applied four times a day after meals. The gel is not to be swallowed immediately, but kept in the mouth as long as possible. Continue the treatment for at least a week after the symptoms have disappeared.

For oral candidosis, dental prostheses are to be removed at night and brushed with the gel.

Gastrointestinal tract candidosis: The gel may be used for infants (4 months of age), children, and adults who have difficulty swallowing tablets. The dosage is 20 mg per kg body weight per day, administered in 4 divided doses. The daily dose should not exceed 250 mg (10 mL Oral Gel) four times a day.

Continue the treatment for at least a week after the symptoms have disappeared.

Contraindications: DAKTARIN Oral Gel are contraindicated in the following situations: Known hypersensitivity. In infants <4 months of age or in those whose swallowing reflex is not yet sufficiently developed. In patients with liver dysfunction.

Co-administration with drugs that are subject to metabolism by CYP3A4. Substrates known to prolong the QT-interval for example, astemizole, bepridil, cisapride, dofetilide, halofantrine, mizolastine, pimozide, quinidine, sertindole and terfenadine.

Ergot alkaloids.
HMG-CoA reductase inhibitors such as simvastatin and lovastatin.
Triazolam and oral midazolam.
Warfarin.

Warning and Precautions: Caution should be exercised if concomitant use of DAKTARIN Oral gel with; warfarin, phenytoin, or sulfonylureas is planned. Serious skin reactions have been reported in patients. Use cautiously in patients with liver disease.

Miconazole is systemically absorbed and is known to inhibit CYP2C9 and CYP3A4, 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.

If the concomitant use of DAKTARIN Oral Gel with coumarin anticoagulants such as warfarin is planned, caution should be exercised and the anticoagulant effect must be carefully monitored and titrated.

It is advisable to monitor miconazole and phenytoin levels, if these 2 drugs are used concomitantly. In patients using certain oral hypoglycemics such as sulfonylureas, an enhanced therapeutic effect leading to hypoglycemia may occur during concomitant treatment with miconazole and appropriate measures must be considered.

It is important to take into consideration the variability of the maturation of the swallowing function in infants, especially when giving miconazole DAKTARIN 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.

Particularly in infants and young children (aged 4 months to 2 years), caution is required, to ensure that the gel does not obstruct the throat. Hence, the gel is not to be applied to the back of the throat.

Adverse Effects / Side Effects: It is generally well tolerated, but some side effects may occur, rare adverse effects may include:

Nervous System Disorders: Dysgeusia
Gastrointestinal Disorders: Dry mouth, Nausea, Oral discomfort, Vomiting
General Disorders and Administration
Site Conditions: Product taste abnormal.

Adverse Reactions Reported by Pediatric Patients are Gastrointestinal Disorders: Nausea, Regurgitation and Vomiting.

Adverse Reactions Identified during Post-Marketing are

Immune System Disorders (Very rare): Anaphylactic reaction, Angioedema, Hypersensitivity.
Respiratory, Thoracic and Mediastinal Disorders (Very rare): Choking (see Contraindications).
Gastrointestinal Disorders (Very rare): Diarrhoea, Stomatitis, Tongue discoloration.
Hepatobillary Disorders (Very rare): Hepatitis.
Skin and Subcutaneous Tissue Disorders (Very rare): Angioedema, Toxic epidermal necrolysis, Stevens-Johnson syndrome, Urticaria, Rash, Acute generalized exanthematous pustulosis, Drug reaction with eosinophilia and systemic symptoms.

Pregnancy and Breastfeeding: Preferred to avoid use during pregnancy, unless the benefits outweigh the risks to the fetus. Its excretion in human milk is not known.

Instructions: Keep out of the reach of children.

Do not store above 30°C. Protect from light.

Full prescribing information available upon request.

Manufacturer & Buy Online:

Daktarin gel is manufactured by: Aspin Pharma (Pvt.) Ltd.

This is to the manufacturer: https://aspin.com.pk

You can buy it online at: https://www.naheed.pk

It is available online, or you can purchase it from any nearby pharmacy. It is currently (2026) available at the retail price of around 205 rupees.