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Diflucan 150 Capsules
2016-03-30 02:14:55 来源: 作者: 【 】 浏览:479次 评论:0
1. Name of the medicinal product

Diflucan 150 mg hard Capsules

 

2. Qualitative and quantitative composition

Each hard capsule contains fluconazole 150 mg

Excipient(s) of known effects: each hard capsule also contains 149.12 mg lactose monohydrate

For the full list of excipients, see section 6.1.

 

3. Pharmaceutical form

Hard capsule.

The 150 mg hard gelatin capsule has a turquoise blue body and turquoise blue cap overprinted with “Pfizer” and the code “FLU-150” with black ink. The capsule size is no. 1.

 

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, 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

- 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 f

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