HERAZOLE

HERAZOLE
Packing1 blister pack of 1 capsule
Shelf life36 months
CompositionFluconazole 200 mg
Posology and pharmaceutical formHard capsule

Summary of product characteristic

Indications, posology and method of administration

THERAPEUTIC INDICATIONS
Fluconazole is indicated in the following fungal infections:
Fluconazole is indicated in adults for the treatment of:
- Cryptococcal meningitis.
- Coccidioidomycosis.
- Invasive candidiasis.
- Mucosal candidiasis including oropharyngeal, oesophageal candidiasis, candiduria and chronic mucocutaneous candidiasis.
- Chronic oral atrophic candidiasis (denture sore mouth) if dental hygiene or topical treatment are insufficient.
- Vaginal candidiasis, acute or recurrent; when local therapy is not appropriate.
- Candidal balanitis when local therapy is not appropriate.
- Dermatomycosis including tinea pedis, tinea corporis, tinea cruris, tinea versicolor and dermal candida infections when systemic therapy is indicated.
- Tinea unguinium (onychomycosis) when other agents are not considered appropriate.
Fluconazole is indicated in adults for the prophylaxis of:
- Relapse of cryptococcal meningitis in patients with high risk of recurrence.
- Relapse of oropharyngeal or oesophageal candidiasis in patients infected with HIV who are at high risk of experiencing relapse.
- To reduce the incidence of recurrent vaginal candidiasis (4 or more episodes a year).
- Prophylaxis of candidal infections in patients with prolonged neutropenia (such as patients with haematological malignancies receiving chemotherapy or patients receiving Hematopoietic Stem Cell Transplantation.
Fluconazole is indicated in term newborn infants, infants, toddlers, children, and adolescents aged from 0 to 17 years old:
Fluconazole is used for the treatment of mucosal candidiasis (oropharyngeal, oesophageal), invasive candidiasis, cryptococcal meningitis and the prophylaxis of candidal infections in immunocompromised patients. Fluconazole can be used as maintenance therapy to prevent relapse of cryptococcal meningitis in children with high risk of reoccurrence.
Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
Consideration should be given to official guidance on the appropriate use of antifungals.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
The dose should be based on the nature and severity of the fungal infection. Treatment of infections requiring multiple dosing should be continued until clinical parameters or laboratory tests indicate that active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection.
Adults:

*Indications*		*Posology*	*Duration of treatment*
Cryptococcosis	Treatment of cryptococcal meningitis.	Loading dose: 400 mg on day 1. Subsequent dose: 200 mg to 400 mg once daily.	Usually at least 6 to 8 weeks. In life threatening infections the daily dose can be increased to 800 mg.
Cryptococcosis	Maintenance therapy to prevent relapse of cryptococcal meningitis in patients with high risk of recurrence.	200 mg once daily	Indefinitely at a daily dose of 200 mg.
Coccidioidomycosis		200 mg to 400 mg once daily.	11 months up to 24 months or longer depending on the patient. 800 mg daily may be considered for some infections and especially for meningeal disease.
Invasive candidiasis		Loading dose: 800 mg on day 1. Subsequent dose: 400 mg once daily.	In general, the recommended duration of therapy for candidemia is for 2 weeks after first negative blood culture result and resolution of signs and symptoms attributable to candidemia.
Treatment of mucosal candidiasis	Oropharyngeal candidiasis.	Loading dose: 200 mg to 400 mg on day 1. Subsequent dose: 100 mg to 200 mg once daily.	7 to 21 days (until oropharyngeal candidiasis is in remission). Longer periods may be used in patients with severely compromised immune function.
	Oesophageal candidiasis.	Loading dose: 200 mg to 400 mg on day 1. Subsequent dose: 100 mg to 200 mg once daily.	14 to 30 days (until oesophageal candidiasis is in remission). Longer periods may be used in patients with severely compromised immune function.
	Candiduria.	200 mg to 400 mg once daily.	7 to 21 days. Longer periods may be used in patients with severely compromised immune function.
	Chronic atrophic candidiasis.	50 mg once daily.	14 days.
	Chronic mucocutaneous candidiasis.	50 mg to 100 mg once daily.	Up to 28 days. Longer periods depending on both the severity of infection or underlying immune compromisation and infection.
Prevention of relapse of mucosal candidiasis in patients infected with HIV who are at high risk of experiencing relapse	Oropharyngeal candidiasis.	100 mg to 200 mg once daily or 200 mg 3 times per week.	An indefinite period for patients with chronic immune suppression.
	Oesophageal candidiasis.	100 mg to 200 mg once daily or 200 mg 3 times per week.	An indefinite period for patients with chronic immune suppression.
Genital candidiasis	Acute vaginal candidiasis. Candidal balanitis.	150 mg	Single dose.
Genital candidiasis	Treatment and prophylaxis of recurrent vaginal candidiasis (4 or more episodes a year).	150 mg every third day for a total of 3 doses (day 1, 4, and 7) followed by 150 mg once weekly maintenance dose.	Maintenance dose: 6 months.
Dermatomycosis	- Tinea pedis - Tinea corporis - Tinea cruris - Andida infections	150 mg once weekly or 50 mg once daily.	2 to 4 weeks, tinea pedis may require treatment for up to 6 weeks.
	Tinea versicolor	300 mg to 400 mg once weekly.	1 to 3 weeks.
	Tinea versicolor	50 mg once daily	2 to 4 weeks.
	Tinea unguium (onychomycosis)	150 mg once weekly.	Treatment should be continued until infected nail is replaced (uninfected nail grows in). Regrowth of fingernails and toenails normally requires 3 to 6 months and 6 to 12 months, respectively. However, growth rates may vary widely in individuals, and by age. After successful treatment of long-term chronic infections, nails occasionally remain disfigured.
Prophylaxis of candidal infections in patients with prolonged neutropenia		200 mg to 400 mg once daily.	Treatment should start several days before the anticipated onset of neutropenia and continue for 7 days after recovery from neutropenia after the neutrophil count rises above 1000 cells per mm3.

Special populations:
Elderly:
Dosage should be adjusted based on the renal function.
Renal impairment:
Fluconazole is predominantly excreted in the urine as unchanged active substance.
No adjustments in single dose therapy are necessary. In patients (including paediatric population) with impaired renal function who will receive multiple doses of fluconazole, an initial dose of 50 mg to 400 mg should be given, based on the recommended daily dose for the indication. After this initial loading dose, the daily dose (according to indication) should be based on the following table:

*Creatinine clearance (ml/min)*	*Percent of recommended dose*
> 50	100%
≤ 50 (no haemodialysis)	50%
Haemodialysis	100% after each haemodialysis

Patients on haemodialysis should receive 100% of the recommended dose after each haemodialysis; on non-dialysis days, patients should receive a reduced dose according to their creatinine clearance.
Hepatic impairment:
Limited data are available in patients with hepatic impairment, therefore fluconazole should be administered with caution to patients with liver dysfunction.
Paediatric population:
A maximum dose of 400 mg daily should not be exceeded in paediatric population.
As with similar infections in adults, the duration of treatment is based on the clinical and mycological response. Fluconazole is administered as a single daily dose.
The pharmacokinetics of fluconazole has not been studied in paediatric population with renal insufficiency.
Infants, toddlers and children (from 28 days to 11 years old):

*Indication*	*Posology*	*Recommendations*
Mucosal candidiasis	Initial dose: 6 mg/kg Subsequent dose: 3 mg/kg once daily	Initial dose may be used on the first day to achieve steady state levels more rapidly.
- Invasive candidiasis - Cryptococcal meningitis	Dose: 6 to 12 mg/kg once daily	Depending on the severity of the disease.
- Maintenance therapy to prevent relapse of cryptococcal meningitis in children with high risk of recurrence.	Dose: 6 mg/kg once daily	Depending on the severity of the disease.
- Prophylaxis of Candida in immunocompromised patients	Dose: 3 to 12 mg/kg once daily	Depending on the extent and duration of the induced neutropenia (see Adults posology).

Adolescents (from 12 to 17 years old):
Depending on the weight and pubertal development, the prescriber would need to assess which posology (adults or children) is the most appropriate. Clinical data indicate that children have a higher fluconazole clearance than observed for adults. A dose of 100, 200 and 400 mg in adults corresponds to a 3, 6 and 12 mg/kg dose in children to obtain a comparable systemic exposure.
Safety and efficacy for genital candidiasis indication in paediatric population has not been established. If treatment for genital candidiasis is imperative in adolescents (from 12 to 17 years old), the posology should be the same as adult posology.
Term newborn infants (0 to 27 days):
Neonates excrete fluconazole slowly. There are few pharmacokinetic data to support this posology in term newborn infants.

*Age group*	*Posology*	*Recommendations*
Term newborn infants (0 to 14 days)	The same mg/kg dose as for infants, toddlers and children should be given every 72 hours	A maximum dose of 12 mg/kg every 72 hours should not be exceeded
Term newborn infants (from 15 to 27 days)	The same mg/kg dose as for infants, toddlers and children should be given every 48 hours	A maximum dose of 12 mg/kg every 48 hours should not be exceeded

Method of administration:
Fluconazole is taken orally. Swallow the tablet whole, regardless of meals.
CONTRAINDICATIONS
- Hypersensitivity to the active substance, to related azole substances, or to any of the excipients
- Coadministration of terfenadine is contraindicated in patients receiving fluconazole at multiple doses of 400 mg per day or higher based upon results of a multiple dose interaction study.
- Coadministration of other medicinal products known to prolong the QT interval and which are metabolised via the cytochrome P450 (CYP) 3A4 such as cisapride, astemizole, pimozide, quinidine and erythromycin are contraindicated in patients receiving fluconazole.

This information is for reference only. Please read the leaflet inside.

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