Daktarin Oral Gel

Daktarin Oral Gel

miconazole

Manufacturer:

Janssen-Cilag

Distributor:

DKSH
Full Prescribing Info
Contents
Miconazole.
Description
Each gram of oral gel contains miconazole 20 mg.
It also contains the following excipients: Glycerol, purified water, pregelatinized potato starch, alcohol, polysorbate, sodium saccharin, cocoa and orange flavor.
Daktarin Oral Gel is supplied with a measuring spoon of 5 mL (corresponding to miconazole 124 mg).
Action
ATC Code: A01AB09 and A07AC01.
Pharmacology: Pharmacodynamics: Miconazole possesses an antifungal activity against the common dermatophytes and yeasts as well as an antibacterial activity against certain gram-positive bacilli and cocci.
Its activity is based on the inhibition of the ergosterol biosynthesis in fungi and the change in the composition of the lipid components in the membrane, resulting in fungal cell necrosis.
Pharmacokinetics: Absorption: Miconazole is systemically absorbed after administration. Administration of a 60-mg dose of miconazole as the oral gel results in peak plasma concentrations (Cmax) of 31-49 ng/mL, occurring approximately 2 hrs post-dose.
Distribution: Absorbed miconazole is bound to plasma proteins (88.2%), primarily to serum albumin and red blood cells (10.6%).
Metabolism and Elimination: The absorbed portion of miconazole is largely metabolized; <1% of an administered dose is excreted unchanged in the urine. The terminal half-life (t½) of plasma miconazole is 20-25 hrs in most patients. The elimination t½ of miconazole is similar in renally impaired patients. Plasma concentrations of miconazole are moderately reduced (approximately 50%) during hemodialysis.
Toxicology: Preclinical Safety Data: Preclinical data reveal no special hazard for humans based on conventional studies of local irritation, single- and repeated-dose toxicity, genotoxicity and toxicity to reproduction.
Indications/Uses
Therapeutic and prophylactic treatment of candidiasis of the oropharyngeal cavity and the gastrointestinal tract.
Dosage/Direction for Use
Oropharyngeal Candidiasis: Adults and Children ≥2 years: 2.5 mL (½ measuring spoon) of gel applied 4 times daily.
Infants 6-24 months: 1.25 mL (¼ measuring spoon) of gel, applied 4 times daily. Each dose should be divided into smaller portions and the gel should be applied to the affected area(s).
The treatment should be continued for at least a week after the symptoms have disappeared. For oral candidiasis, dental prostheses should be removed at night and brushed with the gel.
Gastrointestinal Tract Candidiasis: Adults with Difficulty Swallowing Tablets, Children and Infants (≥6 months): 20 mg/kg body weight/day, administered in 4 divided doses. The daily dose should not exceed 250 mg (10 mL oral gel) 4 times daily.
The treatment should be continued for at least a week after the symptoms have disappeared.
Administration: The gel should not be swallowed immediately, but kept in the mouth as long as possible.
Overdosage
Symptoms: In the event of accidental overdose, vomiting and diarrhea may occur.
Treatment: Treatment is symptomatic and supportive. A specific antidote is not available.
In the event of accidental ingestion of large quantities of Daktarin, an appropriate method of gastric emptying may be used, if considered necessary (see Interactions).
Contraindications
Known hypersensitivity to miconazole or to any of the excipients of Daktarin Oral Gel. Liver dysfunction.
Co-administration of the following drugs that are subject to metabolism by CYP3A4 (see Interactions): Substrates known to prolong QT-interval eg, astemizole, bepridil, cisapride, dofetilide, halofantrine, mizolastine, pimozide, quinidine, sertindole and terfenadine; ergot alkaloids; HMG-CoA reductase inhibitors eg, simvastatin and lovastatin; triazolam and oral midazolam.
Infants <6 months or in those whose swallowing reflex is not yet sufficiently developed.
Special Precautions
If the concomitant use of Daktarin Oral Gel and anticoagulants eg, warfarin, is envisaged, the anticoagulant effect should be carefully monitored and titrated.
It is advisable to monitor miconazole and phenytoin levels, if they are used concomitantly.
In patient using certain oral hypoglycemics eg, sulfonylureas, an enhanced therapeutic effect leading to hypoglycemia may occur during concomitant treatment with miconazole and appropriate measures should be considered (see Interactions).
Effects on the Ability to Drive or Operate Machinery: Daktarin Oral Gel does not affect the alertness or driving ability.
Use in children: Particularly in infants and young children, 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 and the full dose should be divided into smaller parts. Observe the patient for possible choking.
Use In Pregnancy & Lactation
Although there is no evidence that miconazole is embryotoxic or teratogenic in animals, potential hazards of prescribing Daktarin Oral Gel during pregnancy should always be weighed against the expected therapeutic benefits.
There are no data available on the excretion of miconazole in human milk; therefore, caution should be exercised when prescribing Daktarin Oral Gel to nursing women.
Adverse Reactions
The safety of Daktarin Oral Gel was evaluated in 88 adult patients with oral candidiasis or oral mycoses who participated in 1 randomised, active-controlled, double-blind clinical trial and 3 open-label clinical trials. These patients took at least 1 dose of Daktarin Oral Gel and provided safety data.
Adverse drug reactions (ADRs) reported by Daktarin Oral Gel-treated adult patients in the 4 clinical trials are shown in Table 1.

Click on icon to see table/diagram/image

The safety of Daktarin Oral Gel was evaluated in 23 paediatric patients with oral candidiasis who participated in 1 randomised, active-controlled, open-label clinical trial in paediatric patients aged ≤1 month to 10.7 years. These patients took at least 1 dose of Daktarin Oral Gel and provided safety data.
Adverse drug reactions reported for Daktarin Oral Gel-treated paediatric patients in 1 clinical trial is presented in Table 2.

Click on icon to see table/diagram/image

Post-Marketing Experience: ADRs first identified during post-marketing experience with Daktarin Oral Gel are included as follows. Frequencies are provided from spontaneous reporting rates according to the following convention: Very common ≥1/10; common: ≥1/100 and <1/10; uncommon: ≥1/1000 and <1/100; rare: ≥1/10,000 and <1/1000; very rare: <1/10,000 including isolated reports.
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.
Hepatobiliary Disorders: Very Rare: Hepatitis.
Skin and Subcutaneous Tissue Disorders: Very Rare: Toxic epidermal necrolysis, Stevens-Johnson syndrome, urticaria, rash.
Drug Interactions
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.
Oral miconazole is contraindicated with the co-administration of drugs that are subject to metabolism by CYP3A4 (see Contraindications).
When co-administered 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 effects. If necessary, their dosage should be reduced, and where appropriate, plasma levels monitored: Drugs subject to metabolism by CYP2C9 (see Precautions): Oral anticoagulants eg, warfarin; oral hypoglycemics eg, sulfonylureas; phenytoin.
Other drugs subject to metabolism by CYP3A4: HIV protease inhibitors eg, saquinavir; certain antineoplastic agents eg, vinca alkaloids, busulfan and docetaxel; certain calcium-channel blockers eg, dihydropyridines and verapamil; certain immunosuppressive agents eg, cyclosporine, tacrolimus, sirolimus (rapamycin); others: Alfentanil, alprazolam, brotizolam, buspirone, carbamazepine, cilostasol, disopyramide, ebastine, methylprednisolone, midazolam IV, reboxetine, rifabutin, sildenafil and trimetrexate.
Caution For Usage
To open the tube, unscrew the cap then pierce the seal of the tube by means of the pin on the top of the cap.
Storage
Store below 25°C.
ATC Classification
A01AB09 - miconazole ; Belongs to the class of local antiinfective and antiseptic preparations. Used in the treatment of diseases of the mouth.
Presentation/Packing
Oral gel 2% (tube, white, homogenous) x 10 g.
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