Dosage / Direction for Use: Oropharyngeal candidiasis Adult & childn ≥2 yr 2.5 mL (½ measuring spoon) qid. Infant 4-24 mth 1.25 mL (¼ measuring spoon) qid. Or alternatively, apply the gel sufficiently to cover affected area qid. GIT candidiasis Childn ≥6 mth 20 mg/kg body wt/day in 4 divided doses. Max dose: 250 mg qid.
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).
Contraindications: Hypersensitivity. Liver dysfunction.
Special Precautions: 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.
Side Effects / Adverse Reactions: GI discomfort eg, nausea, vomiting & diarrhea (w/ long-term treatment).
Interactions: Inhibits the metabolism of drugs metabolized by CYP3A4 & CYP2C9 enzyme systems.