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Drug Details

DAKTARIN Oral Gel

• Drug Class Description
  Antifungals.
• Generic Name
  Miconazole
• Presentation
  Oral gel. White gel with orange taste.
• Description
  Each gram of Daktarin Oral Gel contains 20 mg of miconazole.
• Indications
  POM Oral treatment and prevention of fungal infections of the oropharynx and gastrointestinal tract, and of super infections due to Gram-positive bacteria. P Oral treatment and prevention of fungal infections of the oropharynx and of superinfections due to Gram-positive bacteria.
• Adult Dosage
  

  For oral administration.

  Dosage is based on 15 mg/kg/day (0.625 ml/kg/day).

  Adults:

  1-2 spoonfuls (5-10 ml) of gel four times per day.

  Elderly:

  As for adults.

  Children aged 6 years and over:

  One spoonful (5 ml) of gel four times per day.

  Children aged 2-6 years:

  One spoonful (5 ml) of gel twice per day.

  Infants 4 months- 2 years:

  Half a spoonful (2.5 ml) of gel twice per day. Each dose should be divided into smaller portions.

  The lower age limit should be increased by 1-2 months for infants who are pre-term, or infants exhibiting slow neuromuscular development.

  For localised lesions of the mouth, a small amount of gel may be applied directly to the affected area with a clean finger.

  For topical treatment of the oropharynx, the gel should be kept in the mouth for as long as possible.

  Treatment should be continued for up to 2 days after the symptoms have cleared.

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

• Child Dosage
  Under 2 years, 2.5 mL twice daily; 2 - 6 years, 5 mL twice daily; over 6 years, 5 mL four times daily. All orally. For localised lesions, apply directly with finger. For topical treatment, retain gel in mouth as long as possible. Continue treatment for up to 2 days after symptoms have cleared.
• Contra Indications
  

  Known hypersensitivity to miconazole or to any of the excipients.

  In infants less than 4 months of age or in those whose swallowing reflex is not yet sufficiently developed.

  In patients with liver dysfunction.

  Coadministration of the following drugs that are subject to metabolism by CYP3A4:

  - Substrates 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

• Special Precautions
  

  If the concomitant use of Daktarin and anticoagulants is envisaged, the anti-coagulant effect should be carefully monitored and titrated.

  It is advisable to monitor miconazole and phenytoin levels, if these two drugs are used concomitantly.

  In patients using certain oral hypoglycaemics such as sulphonylureas, an enhanced therapeutic effect leading to hypoglycaemia may occur during concomitant treatment with miconazole and appropriate measures should be considered.

  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 each dose should be divided into smaller portions. Observe the patient for possible choking.

  The lower age limit should be increased by 1-2 months for infants who are pre-term, or infants exhibiting slow neuromuscular development.

• 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 coadministration of the following drugs that are subject to metabolism by CYP3A4 

  - Substrates 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

  When coadministered 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 events. If necessary, their dosage should be reduced and, where appropriate, plasma levels monitored:

  Drugs subject to metabolism by CYP2C9;

  - Oral anticoagulants such as warfarin

  - Oral hypoglycaemics 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.

• Adverse Drug Reactions
  

  Adverse drug reactions from spontaneous reports during the worldwide postmarketing experience with Daktarin that meet threshold criteria are included in Table 2below. The adverse drug reactions are ranked by frequency, using the following convention:

  Very common 1/10

  Common 1/100 and <1/10

  Uncommon 1/1,000 and <1/100

  Rare 1/10,000 and <1/1,000

  Very rare <1/10,000, including isolated reports

  The frequencies provided below 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.

   

  Immune system disorders

  Very rare Allergic conditions, including angioneurotic edema and anaphylactic reactions; Lyell syndrome (Toxic Epidermal Necrolysis), Stevens Johnson syndrome, urticaria, rash

   

  Gastrointestinal system disorders

  Very rare Choking, nausea*, vomiting* and diarrhoea

  Hepatobiliary disorders

  Very rare Hepatitis

  *Nausea and vomiting were observed commonly during clinical trials.