Diflucan 10 mg/ml powder for oral suspension - United Kingdom[英国药品]

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Diflucan 10 mg/ml powder for oral suspension

2016-03-30 02:12:11 来源: 作者: 【大中小】浏览:417次评论:0条

1. Name of the medicinal product

Diflucan 10 mg/ml powder for oral suspension

2. Qualitative and quantitative composition

1 ml of reconstituted suspension contains 10 mg fluconazole.

Excipient(s) with known effect: 0.58 g sucrose per ml of reconstituted suspension.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Powder for oral suspension

White to off-white powder for oral suspension providing a white to off-white orange-flavoured suspension after reconstitution.

4. Clinical particulars

4.1 Therapeutic indications

Diflucan is indicated in the following fungal infections (see section 5.1).

Diflucan is indicated in adults for the treatment of:

• Cryptococcal meningitis (see section 4.4).

• Coccidioidomycosis (see section 4.4).

• 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

Diflucan 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 (see section 5.1)).

Diflucan is indicated in term newborn infants, infants, toddlers, children, and adolescents aged from 0 to 17 years old:

Diflucan is used for the treatment of mucosal candidiasis (oropharyngeal, oesophageal), invasive candidiasis and cryptococcal meningitis and the prophylaxis of candidal infections in immunocompromised patients. Diflucan can be used as maintenance therapy to prevent relapse of cryptococcal meningitis in children with high risk of reoccurrence (see section 4.4).

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.

4.2 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 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 daily	Indefinitely at a daily dose of 200 mg
Coccidioidomycosis		200 mg to 400 mg	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 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 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 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 daily	7 to 21 days. Longer periods may be used in patients with severely compromised immune function.
	- Chronic atrophic candidiasis	50 mg daily	14 days
	- Chronic mucocutaneous candidiasis	50 mg to 100 mg 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 daily or 200 mg 3 times per week.	An indefinite period for patients with chronic immune suppression
	- Oesophageal candidiasis	100 mg to 200 mg 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
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