Contents

Miconazole

Indication

Curative and prophylactic treatment of candidosis of the oropharyngeal cavity and the gastrointestinal tract.

Dosage / Direction For Use

Provided measuring spoon is equivalent to 124 mg/5 mL.Oropharyngeal candidiasis: Infants 4-24 months: 1.25 mL (¼ measuring spoon) of gel, applied 4 times/day. Each dose should be divided into smaller portions and the gel should be applied to the affected area(s). The gel should not be swallowed immediately but kept in the mouth as long as possible. Adults and Children ≥2 years 2.5 mL (½ measuring spoon) of gel applied 4 times/day. 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.Gastrointestinal Candidiasis: The gel may be used for infants (≥6 months of age), children and adults who have difficulty in swallowing tablets. The dosage is 20 mg/kg body wt/day, administered in 4 divided doses. The daily dose should not exceed 250 mg (10 mL Oral Gel) 4 times/day. The treatment should be continued for at least a week after the symptoms have disappeared.

Overdosage

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).

Administration

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Contraindication

Daktarin Oral Gel is contraindicated in the following situations: In patients with known hypersensitivity to miconazole or to any of the excipients; in infants <6 months of age or in those whose swallowing reflex is not yet sufficiently developed; in patients with liver dysfunction; co-administration of the following drugs that are subject to metabolism by CYP3A4 (see Interactions with Other Medicinal Products and Other Forms of 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.

Special Precaution

If the concomitant use of Daktarin Oral Gel and anticoagulants 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.Effects on the Ability to Drive or Operate Machinery: Daktarin Oral Gel does not affect the alertness or driving ability.Use in Pregnancy & Lactation: Although there is no evidence that Daktarin Oral Gel is embryotoxic or teratogenic in animals, potential hazards of prescribing these drugs 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 mothers.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.

Adverse Reactions

Post-marketing experience: Adverse drug reactions from spontaneous reports during the worldwide post-marketing experience with Daktarin that meet threshold criteria are included. The adverse drug reactions are ranked by frequency using the following convention: Very common (≥1/10); common (≥1/100 and <1/10); uncommon (≥1/1000 and <1/100); rare (≥1/10000 and <1/1000); and very rare (<1/10000) including isolated reports. The frequencies provided reflect reporting rates for adverse drug reactions from spontaneous reports and do not represent more precise estimates of incidence that might be obtained in clinical or epidemiological studies.Post-marketing reports of adverse drug reactions: Immune system disorders: Very rare: Allergic conditions including angioneurotic edema and anaphylactic reactions. Respiratory, thoracic and mediastinal disorders: Very rare: Choking. Gastrointestinal system disorders: Very rare: Nausea, vomiting and diarrhea. Hepatobiliary disorders: Very rare: Hepatitis. Skin and subcutaneous system disorders: Very rare: Lyell syndrome (toxic epidermal necrolysis), Stevens-Johnson syndrome, urticaria, rash.

Drug Interaction

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 metabolized by the CYP3A4 and CYP2C9 enzyme systems. This can result in an increase and/or prolongation of their effects, including adverse effects.Drugs which should not be used during treatment with miconazole: Oral miconazole is contraindicated with the co-administration of the following drugs that are subject to metabolism by CYP3A4 (see Contraindications): 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.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 when appropriate, plasma levels monitored: Others: Oral hypoglycemics (CYP2C9), phenytoin (CYP2C9), carbamazepine, buspirone, alfentanil, sildenafil, alprazolam, brotizolam, midazolam IV, rifabutin, methylprednisolone, trimetrexate, ebastine and reboxetine.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: cyclosporine, tacrolimus, sirolimus (rapamycin); others: alfentanil, alprazolam, brotizolam, buspirone, carbamazepine, cilostasol, disopyramide, ebastin, methylprednisolone, midazolam IV, reboxetine, rifabutin, sildenafil and trimetrexate.

Storage

Store at temperatures not exceeding 30°C.

Description

Each gram of oral gel contains miconazole 20 mg.Daktarin Oral Gel also contains the following inactive ingredients: Glycerol, purified water, pregelatinized potato starch, alcohol, polysorbate, sodium saccharin, cocoa and orange flavor.

Action

Miconazole is a bactericidal and fungicidal broad-spectrum antifungal agent.Pharmacology: 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: The oral bioavailability is low (25-30%) because there is little absorption of miconazole from the intestinal tract.Dosages of 1000 mg in healthy volunteers produce plasma levels of 1.16 mcg/mL, 2-4 hrs after intake. These levels are insufficient for the treatment of superficial and systemic mycoses. The absorbed part of miconazole is mostly metabolized. Less than 1% of the administered dosage is found unchanged in the urine. There are no active metabolites and the terminal half-life is about 20 hrs.