Infecon Infusion

Infecon

COMPOSITION:
Each 100 ml contains :
Fluconazole USP 200 mg
Sodium Chloride BP 0.9% w/v
Water for Injection BP q.s.

INDICATIONS:
Infecon infusion is indicated for the treatment of :

  • Cryptococcal infections including meningitis, Systemic candida infections including candidemia, Disseminated candidiasis and Pneumonia.
  • Candida urinary tract infections and Peritonitis.
  • Oropharyngeal candidiasis and Oesophageal candidiasis.
  • Dermatophytosis, Pityriasis versicolor and Candidal balanitis.
  • Prophylaxis of fungal infections in immunocompromised patients.
  • To decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy or radiation therapy.

DESCRIPTION:
Infecon infusion is an iso-osmotic, sterile, nonpyrogenic solution of Fluconazole in sodium chloride. Fluconazole binds to the fungal cytochrome P450 enzyme lanosterol 14-α-demethylase, thereby halting conversion of lanosterol to ergosterol. This leads to a cascade of abnormalities in membrane permeability, membrane bound enzyme activity and coordination of chitin synthesis.Infecon is effective in infections caused by Candida, Cryptococcus, Aspergillus, Blastomyces, Coccidioides and Histoplasma. Peak plasma concentration (Cmax- 6.72µg/mL) occurs between 1-2 hours with a terminal plasma elimination half-life of approximately 30 hours.

CONTRAINDICATIONS:
Co-administration of Terfenadine is contraindicated in patients receiving Infecon at multiple doses of 400 mg or higher. Co-administration of other drugs known to prolong the QT interval and which are metabolized via the enzyme CYP3A4 such as Cisapride, Astemizole, Erythromycin, Pimozide and Quinidine are contraindicated in patients receiving Fluconazole. Infecon is contraindicated in patients with hypersensitivity to Fluconazole or any other contents of the formulation.

SIDE EFFECTS:
Diarrhoea, nausea, headache, skin rash, abdominal pain, vomiting may occur. If symptoms persist, please consult the physician.

DOSAGE:
The dosage, dosing frequency and duration of therapy should be decided on the severity of infections. Since oral absorption of Fluconazole is rapid and complete, the daily dose is the same for oral and intravenous administration.

Type of infection Dose
Cryptococcal infection including meningitis 400 mg on the first day, followed by 200 mg once daily for 10-12 weeks or till CSF becomes culture negative
Systemic candida infections including
Candidemia, Disseminated candidiasis
and Pneumonia
400 mg once daily (followed by 200 mg once daily for 4 weeks in systemic candidiasis)
Candida urinary tract infections and Peritonitis 50-200 mg once daily
Oropharyngeal candidiasis 200 mg on the first day, followed by 100 mg once daily for 2 weeks
Oesophageal candidiasis 200 mg on the first day, followed by 100 mg once daily for 2-3 weeks
Dermatophytosis and Pityriasis versicolor 50 mg once daily upto 6 weeks
Prophylaxis of fungal infections in immunocompromised patients 50-400 mg once daily
Prophylaxis in patients undergoing bone
marrow transplantation
400 mg once daily for 7 days

Pediatric Patients:

Type of infection Dose
Cryptococcal infection including meningitis 12 mg/kg on the first day, followed by 6 mg/kg once daily for 10-12 weeks or till CSF becomes culture negative
Systemic candida infections including candidemia and Disseminated candidiasis 6-12 mg/kg/day
Oropharyngeal candidiasis 6 mg/kg on the first day, followed by 3 mg/kg once daily for 2 weeks
Oesophageal candidiasis 6 mg/kg on the first day, followed by 3 mg/kg once daily for 2-3 weeks
Prophylaxis of fungal infections in immunocompromised patients 3-12 mg/kg daily for 2-4 weeks

STORAGE:
Store in a cool, dark & dry place. Keep out of reach of children.

PRESENTATION:
100 ml blow fill seal plastic bottle packed in a carton with insert.