DACTANIL

DACTANIL
17 May

DACTANIL

Anti-Fungal

 -The active component of Daktanil® Oral Gel is miconazole 
   that is an imidazole antifungal agent with antimicrobial 
   activity against some Gram-Positive bacteria including 
   staphylococci and streptococci.
 - Miconazole inhibits the biosynthesis of ergosterol in fungi 
   and changes the composition of other lipid components in 
   the cell membrane, resulting in leakage of the essential 
   intracellular constituents, and finally  lead to fungal cell 
   necrosis.
 - Daktanil® Oral Gel  is poorly absorbed from
   gastro-intestinal tract with little systemic side effects.   

Indecation

  -Therapeutic and prophylactic treatment of candidiasis of the 
    oropharyngeal cavity and the gastrointestinal tract.
- Oral and intestinal fungal infections.
 

Dosage & Administration

  Oropharyngeal candidiasis: 
  - Infants (6–24 months): 1.25 ml four times a day.
  - Children (2–6 years): 2.5 ml four times a day.                                              
  - Children (above 6 years): 5 ml four times a day.
  - Adults: 5 ml to 10 ml four times a day.
  - The gel should be applied to the affected area(s).
  - The gel should be kept in the mouth as long as possible 
    before being swallowed .
  -The treatment should be continued for at least a week after 
   the symptoms have disappeared.   
  Gastrointestinal tract candidiasis:
  -Infants ,Children and Adults: 20 mg per kg body weight per 
   day, administrated in four divided doses. 
  -The treatment should be continued for at least a week after 
   the symptoms have disappeared.

 - Each 1g contains:
   Miconazole                       20 mg
 

 - Hypersensitivity to Miconazole.
 - In infants less than 6 months of age or in those whose 
   swallowing reflex is not yet sufficiently developed .
 - In patients with liver dysfunction .

  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, therefore oral Daktanil® is 
  contraindicated with the co- administration of the following 
   drugs that are subject to metabolism by CYP3A4 : 
 - Substrates known to prolong the QT-interval e.g.: 
   astimazole, bepridil, cisapride, dofetilide, halofantrine, 
   mizolastine, pimozide, quinidine, sertindole and  
   terfenadine.
 - Ergot alkaloids, Triazolam and oral midazolam .
 - HMG-CoA reductase inhibitors such as simvastatin and 
   lovastatin.
 - HIV protease inhibitors such as saquinavir.
 - Certain antineoplastic agents such as vinca alkaloids, 
   busulfan and docetaxel.
 - Certain calcium channel blockers such as dihydropyri
   dines and verapamil.
 - Certain immunosuppressive agents: cyclosporine, 
   tacrolimus, sirolimus (rapamycin).
 

  - Use during pregnancy: It should only be used during the 
    first trimester of pregnancy when considered essential to 
    the welfare of the patient.
  - Use during lactation :It is not known whether miconazole 
    is excreted in breast milk . However, problems in humans 
    have not been documented, caution should be exercised. 

 - Mild Gastro-intestinal disturbances(nausea, vomiting and 
  diarrhoea) usually on long-term treatment, and in very rare 
  cases allergic reactions may be observed .
 - In very rare cases hepatitis .

 - Caution should be exercised and advisable to monitor 
   Miconazole and the following drugs levels(If  Daktanil®  
   are administered concomitantly with one of the following 
   drugs ,because their activity can be potentiated):-
 - Oral anticoagulants such as warfarin. 
 - Phenytoin.
 - Certain hypoglycemics such as sulfonylurea group.

- Store at a temperature below 25 °C .
 

  -Tube of 20g Oral Gel.