Glutoboston (01 blisters x 01 capsules)

DOSAGE AND ADMINISTRATION

Administration: For oral use.

Dosage:

- Genital candidiasis:

+ Treatment of acute vaginal candidiasis, candidal balanitis: 150 mg single dose.

+ Treatment and prophylaxis of recurrent vaginalcandidiasis: 150 mg every 3 days; treatment time: 6 months.

- Dermatomycosis:

+ Treatment of tinea pedis, tinea corporis, tinea cruris, dermal Candida infections: 150 mg weekly; treatment time: 2-4 weeks, tinea pedis may require treatment for up to 6 weeks.

+ Treatment of pityriasis versicolor: 300 mg weekly, treatment should be continued until the infected nail is replaced completely.

Hepatic impairment

Limited data are available in patients with hepatic impairment, therefore fluconazole should be administered with caution to patients with liver dysfunction.

Renal impairment

The daily dose for adults with renal impairment should be based on the following table:

- No dose adjustment is required in single dose therapy for genital mycosis.

CONTRAINDICATIONS

- Hypersensitivity to fluconazole or to any of the excipients.

- 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, amiodarone and erythromycin are contraindicated in patients receiving fluconazole.

WARNINGS AND PRECAUTIONS

Precautions for use 

- It should be administered with caution to patients with renal or liver dysfunction.

- Fluconazole should be discontinued if the patient develops signs and symptoms suggesting progressive liver disease. Patients who develop abnormal liver function tests during fluconazole therapy must be monitored closely for the development of more serious hepatic injury. Taking fluconazole may cause superinfection with Candida species other than C. albicans, which are often inherently not susceptible to fluconazole (including C. krusei). Such cases may require alternative antifungal therapy.

- There have been some cases of QT prolongation and torsades de pointes in patients taking fluconazole. It should be administered with caution to patients with these potentially proarrhythmic conditions.

- There have been very rare cases of exfoliative dermatitis in severe patients who had life-threatening experiences while using fluconazole. In immunocompromised patients (eg, HIV-infected patients), if a skin rash develops during treatment with fluconazole, close monitoring is recommended and the drug is discontinued when lesions develop.

- Capsules contain lactose. Therefore, patients with galactose intolerance, the Lapp lactase deficiency or glucose-­galactose malabsorption should not take this medicine.

Precautions for pregnant and lactating women

Pregnancy

- There has been no fully research and close monitoring for using fluconazole for pregnant women. However, there have been reports of multiple congenital abnormalities in infants whose mothers were treated for at least three or more months with high doses (400 ­ 800 mg daily) of fluconazole for Coccidioides immitis in treatment time longer than 3 months. The relationship between fluconazole use and these events is unclear.

- Data from several hundred pregnant women treated with standard doses (<200 mg/day) of fluconazole, administered as a single or repeated dose in the first trimester, show no increased risk of undesirable effects in the fetus.

- Therefore, fluconazole should be used in pregnancy only when the benefit outweighs the possible risk to the fetus.

Breast­feeding

Fluconazole passes into breast milk equivalent to those in plasma. Therefore, breastfeeding is not recommended for treatment with fluconazole.

Effects on ability to work (operate machines, drive, working at high places and others)

No studies have been performed on the effects of fluconazole on the ability to drive or use machines. However, it is not recommended for use in machine operators, drivers, people working at height and other situations if it occurs symptoms such as dizziness and seizures.

SHELF-LIFE: 36 months from the manufacturing date.

Box of 01 blisters x 01 capsules