Flumycon (leaflet) – syrup, tablets, dosage of the drug, contraindications, possible side effects

Flumycon is a drug used in internal medicine, dermatology, urology and gynecology to treat various types of fungal infections. It has antifungal and anti-infective properties. Flumycon is available by prescription.

Flumycon, Producent: Teva Pharmaceuticals Polska

Indications for use of the drug Flumycon

The active substance of Flumycon is fluticasone (has anti-inflammatory, antipruritic and immunosuppressive properties). It is available as a syrup, solution for infusion and capsules. It is used to treat:

in adults:

1. cryptococcal meningitis,
2. coccidioidomycosis,
3. invasive candidiasis,
4. mucosal yeast infections (including infections of the throat, esophagus, yeast in the urine, and chronic yeast infections of the skin and mucous membranes)
5. chronic atrophic yeast stomatitis (associated with the use of dentures) when oral hygiene or local treatment is inadequate;
6. vaginal candidiasis, whether acute or recurrent, when local treatment is inadequate;
7. yeast balanitis when local treatment is inadequate,
8. mycoses of the skin, including feet, torso and lower legs,
9. Tinea versicolor, yeast infections of the dermis, when systemic treatment is recommended;
10. onychomycosis, when other treatments are not considered appropriate.

in children and adolescents up to 18 years of age:

1. yeast infection of the mucous membranes (mouth, throat and esophagus),
2. invasive candidiasis and cryptococcal meningitis, and to prevent yeast infections in immunocompromised patients,
3. maintenance treatment to prevent relapse of cryptococcal meningitis in children at high risk of relapse.

Flumycon is also given prophylactically in the following infections:

1. relapses of cryptococcal meningitis in patients at increased risk of relapse;
2. recurrence of oropharyngeal and oesophageal yeast infections in HIV-infected patients who are at increased risk of relapse;
3. recurrence of vaginal yeast infection (4 or more infections per year); fungal infections in patients with prolonged neutropenia (e.g. in patients with blood cancers, receiving chemotherapy or in patients with haematopoietic stem cell transplantation.

Dosage of Flumycon

1. Oral, pharyngeal and esophageal candidiasis in adults and children – orally or intravenously:
2. adults: 200-400 mg on day 1, then 100-200 mg / day, for 7-21 days in oropharyngeal candidiasis, for 14-30 days in oesophageal candidiasis;
3. infants and children up to 11 years of age: on the 1st day 6 mg / kg body weight / day, then 3 mg / kg body weight / day.
4. The occurrence of yeasts in the urine – orally or intravenously:
5. adults: 200-400 mg / day, for 7-21 days.
6. Chronic atrophic oral candidiasis (associated with the use of dentures) if oral hygiene or local treatment is inadequate – orally or intravenously:
7. adults: 50 mg once / day for 1 days, additionally disinfecting dentures.
8. Invasive candidiasis in adults and children – orally or intravenously:
9. adults: 800 mg on day 1, then 400 mg / day. Treatment usually continues for 2 weeks after the first negative blood culture result and resolution of symptoms;
10. infants and children up to 11 years of age: 6-12 mg / kg body weight / day.
11. Chronic candidiasis of the skin and mucous membranes – orally or intravenously:
12. adults: 50-100 mg / day, for up to 28 days.
13. Genital candidiasis (acute or recurrent vaginal candidiasis, balanitis yeast) when local treatment is insufficient – orally:
14. adults: 150 mg once. In the treatment and prevention of recurrence of vaginal yeast infections (4 or more infections per year) – on days 1, 4 and 7 150 mg, then 150 mg once / week, for 1 months. Safety and efficacy in children have not been established. and youth. If necessary, the dosage for adolescents over 6 years of age should be the same as for adults.
15. Mycoses of the skin (including feet, torso, lower legs), dermal candidiasis, when systemic treatment is recommended – orally:
16. adults: 150 mg once a week or 1 mg once a day for 50-1 weeks, in athlete’s foot – up to 2 weeks
17. Tinea versicolor – orally:
18. adults: 300-400 mg once / week for 1-7 days or 21 mg once / day for 50-1 days.
19. Onychomycosis when other drugs are inappropriate – by mouth:
20. adults: 150 mg once a week until the infected nail is replaced with a new one.
21. Cryptococcal meningitis in adults and children – orally or intravenously:
22. adults: 400 mg on day 1, then 200-400 mg once / day, usually for 1-6 weeks. In life-threatening infections, the dose may be increased to 8 mg / day;
23. infants and children up to 11 years of age 6-12 mg / kg body weight / day. In the prevention of relapses in patients at increased risk of relapse after full initial treatment, 200 mg once a day can be administered for a long time (1 mg / kg body weight / day in infants and children up to 11 years of age).
24. Coccidioidomycosis – orally or intravenously:
25. adults: 200-400 mg / day, sometimes 800 mg / day, usually for 11-24 months.
26. For the prevention of recurrence of oral and esophageal candidiasis in HIV-infected people (who are at increased risk of relapse) – orally or intravenously:
27. adults: 100-200 mg / day or 200 mg 3 × / week, for an unlimited period of time.
28. Prevention of fungal infections in immunocompromised patients with prolonged neutropenia (e.g. in people with blood cancers receiving chemotherapy or bone marrow transplantation) in adults and children – orally or intravenously:
29. adults: 200-400 mg / day a few days before expected neutropenia. Continue treatment up to 7 days after elevation of the neutrophil count> 1000 / mm3;
30. infants and children up to 11 years of age 3-12 mg / kg body weight / day.
31. adults: 200-400 mg on day 1, then 100-200 mg / day, for 7-21 days in oropharyngeal candidiasis, for 14-30 days in oesophageal candidiasis;
32. infants and children up to 11 years of age: on the 1st day 6 mg / kg body weight / day, then 3 mg / kg body weight / day.
33. adults: 200-400 mg / day, for 7-21 days.
34. adults: 50 mg once / day for 1 days, additionally disinfecting dentures.
35. adults: 800 mg on day 1, then 400 mg / day. Treatment usually continues for 2 weeks after the first negative blood culture result and resolution of symptoms;
36. infants and children up to 11 years of age: 6-12 mg / kg body weight / day.
37. adults: 50-100 mg / day, for up to 28 days.
38. adults: 150 mg once. In the treatment and prevention of recurrence of vaginal yeast infections (4 or more infections per year) – on days 1, 4 and 7 150 mg, then 150 mg once / week, for 1 months. Safety and efficacy in children have not been established. and youth. If necessary, the dosage for adolescents over 6 years of age should be the same as for adults.
39. adults: 150 mg once a week or 1 mg once a day for 50-1 weeks, in athlete’s foot – up to 2 weeks
40. adults: 300-400 mg once / week for 1-7 days or 21 mg once / day for 50-1 days.
41. adults: 150 mg once a week until the infected nail is replaced with a new one.
42. adults: 400 mg on day 1, then 200-400 mg once / day, usually for 1-6 weeks. In life-threatening infections, the dose may be increased to 8 mg / day;
43. infants and children up to 11 years of age 6-12 mg / kg body weight / day. In the prevention of relapses in patients at increased risk of relapse after full initial treatment, 200 mg once a day can be administered for a long time (1 mg / kg body weight / day in infants and children up to 11 years of age).
44. adults: 200-400 mg / day, sometimes 800 mg / day, usually for 11-24 months.
45. adults: 100-200 mg / day or 200 mg 3 × / week, for an unlimited period of time.
46. adults: 200-400 mg / day a few days before expected neutropenia. Continue treatment up to 7 days after elevation of the neutrophil count> 1000 / mm3;
47. infants and children up to 11 years of age 3-12 mg / kg body weight / day.

Administer orally, regardless of meals or as an intravenous infusion; the route of administration depends on the clinical condition of the patient. The maximum dose for children and adolescents is 400 mg / day. In adolescents over 12 years of age, the dosage depends on body weight and maturity. For newborns, use the same doses as for infants and children, but for newborns 1-14. on the day, administer every 72 h (max. 12 mg / kg body weight / 72 h), and in newborns on 15–27. every 48 h (max. 12 mg / kg body weight / 48 h). In renal insufficiency (creatinine clearance 11-50 ml / min), the usually recommended dose should be administered on the first day, followed by half of the usually recommended dose. For patients undergoing hemodialysis, administer the usual dose after each treatment. In people with impaired liver function, the drug should be used with caution.

Flumycon and contraindications

Contraindication to the use of Flumycon is the parallel intake of astemizole, cisapride, pimozide. Terfenadine should not be used in patients receiving multiple doses of fluconazole above 400 mg / day.

Flumycon – warnings

1. There is an increased risk of cardiac arrhythmias in patients with: congenital or acquired prolongation of the QT interval on the ECG, cardiomyopathy, especially in the case of heart failure, sinus bradycardia, arrhythmias, people taking concurrent medications that may cause cardiac arrhythmias (e.g. halofantirin), with electrolyte disturbances (especially low potassium, magnesium or calcium levels).
2. People with galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not use Flumycon because it contains lactose.
3. Flumycon should not be used when treating scalp ringworm.
4. Caution should be exercised in patients with hepatic impairment.
5. In the event of symptoms that may indicate liver dysfunction, such as: fatigue, malaise, dark urine, light stool, jaundice, nausea or vomiting, anorexia, consult a doctor immediately, as it may be necessary to discontinue use of the drug.
6. It is not recommended for pregnant women.
7. Do not take the drug during breastfeeding because it passes into breast milk.

Flumycon and possible side effects

Flumycon can cause, among other things: insomnia, somnolence, convulsions, paraesthesia, dizziness, taste change, peripheral vertigo, constipation, dyspepsia, flatulence, dry mouth, cholestasis, jaundice, increased bilirubin, drug rash, urticaria, pruritus, increased sweating, muscle pain , fatigue, malaise, asthenia, fever.