Diflucan

1. Composition
2. Pharmacological Effect
3. Indications for Use
4. Contraindications
5. Adult Use
6. Children Use
7. Use at Children up to 4 weeks
8. Use in Elderly People
9. Side Effects
10. Special Instructions
11. Effects on Ability to Drive Vehicles and Management Mechanisms

Composition

Diflucan capsules
1 capsule contains:

• Active component: 50 mg fluconazole;
• Additives: lactose, corn starch, colloidal silicon dioxide, magnesium stearate, sodium lauryl sulfate.

Diflucan powder for suspension
5 ml of ready-to-use suspension contains:

• Active component: 50 mg fluconazole;
• Additives: sucrose, colloidal silica, titanium dioxide, xanthan gum, sodium citrate, citric acid, sodium benzoate, natural orange additive.

Diflucan solution for intravenous injections:
1 ml of solution contains:

• Active components: 2 mg fluconazole;
• Additives: sodium chloride, solution for injections.

Pharmacological Effect

Diflucan is an antifungal medication.

Indications for Use

• Cryptococcosis, including cryptococcal meningitis and infections of other localizations and at patients with a normal immune response, patients with AIDS, organ transplant recipients and patients with other forms of immunodeficiency; maintenance therapy to prevent relapse of cryptococcosis at patients with AIDS;
• Generalized candidiasis including candidemia, disseminated candidiasis and other types of acute Candida infections, such as infections of the peritoneum, endocardium, eyes, respiratory and urinary tract, including patients with cancer who are under intensive care and receiving cytotoxic or immunosuppressive agents, as well as in patients with other factors predisposing candidiasis development;
• Mucous membranes candidiasis, including oral cavity, pharynx and esophagus mucous membranes, non-invasive bronchopulmonary infections, candiduria, mucocutaneous and chronic atrophic oral candidiasis (associated with wearing dentures), including patients with normal or suppressed immune function;
• Prevention of oropharyngeal candidiasis relapse in patients with AIDS;
• Genital candidiasis; acute or recurrent vaginal candidiasis;
• Prophylaxis to reduce the frequency of vaginal candidiasis relapses (3 or more courses per year);
  Balanitis Candida;
• Prevention of fungal infections in patients with malignancy who are predisposed to such infections as a result of cytotoxic chemotherapy or radiotherapy;
• Skin fungal infections, including tinea pedis, groin, pityriasis versicolor, onychomycosis and skin candida infection;
• Deep endemic mycoses in patients with normal immunity, coccidioidomycosis, paracoccidioidomycosis, sporotrichosis and histoplasmosis.

Contraindications

• hypersensitivity to fluconazole, other azole drug components or substances with similar structure as in case of fluconazole;
• terfenadine concomitant use during repeated use of fluconazole 400 mg/day or more;
• cisapride concurrent use.

Precautions: impaired liver function during treatment against fluconazole intake; rash at patients with superficial fungal infection and acute/systemic fungal infections; simultaneous administration of terfenadine and fluconazole less than 400 mg / day; potentially pro-arrhythmic condition at patients with multiple risk factors (organic heart disease, electrolyte imbalance and promote development of such concomitant therapy violations).

Adult Use

1. For cryptococcal meningitis and cryptococcal infections of other localization in the 1 st day it is usually administered 400 mg, and then continue treatment with the dose of 200-400 mg 1 time per day. The duration of cryptococcal infections treatment depends on clinical and mycological effect presence; cryptococcal meningitis treatment lasts at least 6-8 weeks.For prevention of cryptococcal meningitis relapse in patients with AIDS, after full course completion of primary therapy, Diflucan may be taken for a long time.
2. When candidemia, disseminated candidiasis and the dose for other acute Candida infection typically comprises of 400 mg on the 1 st day and the following dosage is reduced to 200 mg a day. Depending on the clinical response, the dose may be increased to 400 mg a day. The duration of therapy depends on clinical response.
3. For oropharyngeal candidiasis, the drug is usually administered at 50-100 mg 1 time a day dose for 7-14 days. If necessary, patients with severe immune function suppression treatment can last for a longer time. In atrophic oral candidiasis associated with prosthetic dentures, the drug is usually administered in the dose of 50 mg 1 time per day for 14 days in combination with local antiseptic agents for prosthesis disinfection.In other Candida mucous membranes infections, such as esophagitis, noninvasive bronchopulmonary infections, candiduria, candidiasis of skin and mucous membranes, etc., an effective dose is usually 50-100 mg / a day, treatment duration is 1430 days.For prevention of oropharyngeal candidiasis relapse in AIDS patients, the full course can be assigned to 150 mg 1 time per week after completion of primary therapy.
4. in case of vaginal candidiasis, Diflucan is administered in a single oral dose of 150 mg.To reduce vaginal candidiasis relapses frequency this drug can be used in the dose of 150 mg 1 time per month. The duration of therapy is determined individually; it varies between 4 and 12 months. Some patients may require the more frequent use of the drug. Single dose use for children under 18 years and at patients older than 60 years old without a doctor’s prescription is not recommended.When balanitis caused by Candida, it is prescribed in a single dose of 150 mg orally.
5. For candidiasis prevention, Diflucan recommended dosage is 50-400 mg 1 time per day, depending on risk degree of fungal infection. For patients with a high risk of generalized infection, such as severe or long-lasting neutropenia, the recommended dose is 400 mg 1 time per day. It is administered a few days before expected neutropenia development and after its increase over 1000 mm3, treatment should last for 7 days.
6. In case of skin infections including tinea pedis, smooth skin, groin and candida infections recommended dose is 150 mg 1 time per week or 50 mg 1 time per day. Duration of therapy is usually 2-4 weeks, but with athlete’s foot may require a more prolonged treatment (up to 6 weeks).At pityriasis versicolor recommended dose is 300 mg 1 time per week for 2 weeks; some patients have required a third dose of 300 mg/week, while for individual patients sufficient single dose is 300-400 mg.An alternative regimen drug is used at 50 mg 1 time a day for 2-4 weeks.When tinea unguium (onychomycosis), recommended dose is 150 mg 1 time per week. Treatment should be continued until infected nail replacement. For nails re-growth, it is usually required 3-6 and 6-12 months, respectively. However, the growth rate can vary widely from person to person and also depends on age. After successful treatment of long-lasting chronic infections, nails form changing is sometimes observed.
7. At deep endemic mycoses, it may be required drug use at a dose of 200-400 mg/day for up to 2 years. The duration of therapy is determined individually; it is 11-24 months — in case of coccidioidomycosis; 2-17 months — in case of paracoccidioidomycosis; 1-16 months — in case of sporotrichosis and 3-17 months – when histoplasmosis.

Get to know more about Diflucan application for fungal infections:

Children Use

As with similar infections in adults, treatment duration at children depends on clinical and mycological effect. For children, the daily dose should not exceed that for adults. Diflucan is used daily, 1 time per day.

In case of mucosal candidiasis, the recommended dose is 3 mg/day per 1 kg body mass.

For generalized candidiasis and cryptococcal infection, treatment recommended dose is 6-12 mg/day per 1 kg body mass, depending on disease severity.

For fungal infections prevention in patients with immunodeficiency, at whom infection risk is associated with neutropenia developing as a result of cytotoxic chemotherapy or radiation therapy, the drug is prescribed for 3-12 mg/day per 1 kg body mass, depending on the severity and duration of preservation-induced neutropenia.

Use at Children up to 4 weeks

In infants, Fluconazole is displayed slowly. In the first two weeks of life, the drug is administered in the same dose (in mg/kg body mass) as in older children, but with 72 hours interval. Children up to 3 weeks and 4 are administered the same dose every 48 hr.

Use in Elderly People

In absence of renal failure drug symptoms, usual dose is administered.
Pregnancy and Lactation Period
Avoid the use of fluconazole during pregnancy, except in cases of severe and potentially life-threatening fungal infections, when expected treatment benefit exceeds the potential risk to the fetus.
Fluconazole is found in breast milk at the same concentration as in blood, so Diflucan use during lactation period is not recommended.

Side Effects

• the central and peripheral nervous system: headache, dizziness, convulsions, taste changes.
• the digestive tract system: abdominal pain, diarrhea, flatulence, nausea, indigestion, vomiting.
• the hepatic system: hepatotoxicity, including fatal cases but rare, increased levels of alkaline phosphatase, bilirubin, serum levels of ALT and AST, hepatic dysfunction, hepatitis, hepatocellular necrosis, jaundice.
• the skin and subcutaneous tissue disorders: rash, alopecia, exfoliative skin conditions including Stevens-Johnson syndrome and toxic epidermal necrolysis.
• the hematopoietic system and lymphatic system: leucopenia including neutropenia and agranulocytosis, thrombocytopenia.
• the immune system: anaphylaxis including angioedema, face edema, urticaria, pruritus.
• metabolic/Nutritional System: increased cholesterol and triglyceride levels in plasma, hypokalemia.

Special Instructions

In rare cases, fluconazole use was accompanied by toxic liver changes, including fatalities, primarily in patients with serious medical conditions. There was no explicit dependence of hepatotoxic effects appearance caused by fluconazole on total daily dose, therapy duration, patient’s sex and age.

Hepatotoxic fluconazole effects were usually reversible; its signs disappeared after therapy termination. It is necessary to monitor patients who during fluconazole treatment suffer from liver function disorder, in order to determine symptoms of more serious liver damage. In case of liver disorder clinical symptoms, which may be associated with fluconazole, Diflucan should be stopped taking in.

During fluconazole treatment at patients in rare cases, exfoliative cutaneous reactions appear, such as Stevens-Johnson syndrome and toxic epidermal necrolysis. AIDS patients are more prone to severe skin reactions development caused by many drugs application.

Effects on Ability to Drive Vehicles and Management Mechanisms

Trials show that there is no dependence between Diflucan intake and disability to drive a car.