Fluconazole Stada 150mg medicine for fungal infection (1 blister x 1 tablet)

Dosage form Box of 1 blister x 1 tablet
Specifications Fluconazol

Ingredient

Composition information	Content
Fluconazol	150mg

Uses

indications

Fluconazole Stada 150mg is indicated for the following fungal infections:

In adults:

Cryptococcus meningitis. Candida esophagus. Effectiveness.

Preventive recurrence of Cryptococcus meningitis in patients with high risk of recurrence. Hematoma stem cell transplant).

Treatment of mucosal candidiasis (pharyngeal, esophagus), invasive candidiasis infection, Cryptococcus meningitis and fungal infection prevention in patients with immunodeficiency. Fuconazole may be used to prevent recurrence of cytococcus meningitis in children with high risk of recurrence.

Pharmacokology

Fluconazole is a high selective inhibitor on the alpha-demethyl process of sterol C-14 depends on cytochrom P450 in mushrooms. Demethylation process in mammal cells is much less sensitive to the inhibition of fluconazole. The loss of normal sterols then correlation with the accumulation of 14 alpha-methyl sterols in mushrooms and can create antifungal effects of fluconazole.

Fluconazole is a triazol antifungal that inhibits enzymes dependent on Cytochrom P450 in sensitive mushrooms, destroying the synthesis of Ergosterol in the fungal cell membrane. The drug has anti -Blastomyces dermatitidis, Candida spp. and Trichophyton spp.

Dynamic pharmacokinetics

Fluconazole is well absorbed through the gastrointestinal tract after oral, oral use is 90% or more compared to intravenous injection. The average peak concentration in plasma is 6.72 micrograms/ml which has been reported in healthy people after taking the dose of 400 mg. The peak concentration of plasma is achieved within 1 to 2 hours after drinking. Plasma concentrations are proportional to the dose ranging from 50 to 400 mg. Using dose noise leads to increased plasma concentrations, stable concentrations achieved within 5 to 10 days but can be achieved at the 2th test if using the attack dose.

fluconazole is widely distributed and the apparent distribution is close to the total amount of water in the body. The concentration in breast milk, discharge, saliva, vaginal fluid and peritoneal fluid similar to the concentration achieved in plasma. The concentration in cerebrospinal fluid is about 50 to 90% of plasma concentrations, even without meningitis. Linking with protein is only about 12%.

About 80% of the use is excreted in the form of unchanged urine and about 11% in the form of metabolism. Fluconazole's waste sale time is about 30 hours and increases in patients with fluconazole renal failure.

The concentration of the pharmacological effect of Fluconazole has been found in hair and nails after taking normal daily doses and 1 time/week dose.

Before taking Fluconazole Stada 150mg medicine for fungal infection (1 blister x 1 tablet)

How to use

Fluconazole 150mg drug is used orally, swallowed the whole tablet and does not depend on the meal.

Capsules are not suitable for babies and children.

Use the drug in this object.

Dosage

Cryptococcus meningitis

The starting dose of 400 mg on the first day. Next dose: 200 - 400 mg x 1 time/day, use at least 6-8 weeks.

In case of life -threatening infections, daily risk may increase to 800 mg. Maintain treatment to prevent recurrence of Cryptococcus meningitis in patients with a high risk of recurrence is 200 mg x 1 time/day.

Coccidioidomycosis infection

Take the dose of 200 - 400 mg x 1 time/day. Used for 11 - 24 months or longer depending on the condition. The dose of 800 mg/day can be considered for some cases, especially meningitis.

Invasive Candida infection

The starting dose of 800 mg on the first day. Next dose: 400 mg x 1 time/day. Often used for 2 weeks depending on the condition.

mucosa infection

mushrooms

Starting dose: 200 - 400 mg on the first day.

Next dose: 100 - 200 mg x 1 time/day. Used for 7 - 21 days, longer time can be used in patients with serious immunodeficiency.

esophagus Candida

Starting dose: 200 - 400 mg on the first day.

Next dose: 100 - 200 mg x 1 time/day. Treatment from 14 - 30 days, longer time can be used in patients with serious immunodeficiency.

Urinary mushrooms

Take the dose of 200 - 400 mg x 1 time/day. Treatment from 7 to 21 days, longer time can be used in patients with serious immunodeficiency.

Chronic oral candidiasis

Take the dose of 50 mg x 1 time/day. Treatment for 14 days.

chronic mucosal mucosa

use the dose of 50 - 100 mg x 1 time/day. It is possible to treat up to 28 days, longer time depending on the severity of the disease and the patient's immunity.

Prevention of recurrence of candidiasis in HIV -infected patients with high risk of recurrence

Preventing Candida Mauses, esophagus: 100 - 200 mg x 1 time/day or 200 mg x 3 times/week.

Genital Candida infection

Acute vaginal mushrooms, foreskin inflammation: 150 mg single dose.

Treatment and prevention of recurrent vaginal candidiasis (4 or more sessions per year): 150 mg every 3 days (day 1, day 4 and 7), then use the maintenance dose of 150 mg x 1 time/ week.

Skin fungal infections (legs, thighs, multi -head, ...), Candida infection: 150 mg x 1 - 3 weeks or 50 mg x 1 time/day for 2-4 weeks.

Nail mushrooms: 150 mg x 1 time/week until thin infection is replaced by new nails.

Prevention of fungal infections in patients with prolonged leukopenia

Take the dose of 200 - 400 mg x 1 time/day. Should start a few days before the onset of leukopenia and continue to 7 days after the number of white blood cells is recovered above 1000 cells/mm3.

Special subjects

Elderly

Dosage should be adjusted according to the kidney function (refer to the dose for patients with renal failure below).

kidney failure

No urination in case of single dose.

In case of multiple doses in patients with renal impairment (including children), it is advisable to start at a dose of 50 - 400 mg, based on daily recommendations. After the starting dose, the next dose should be indicated based on the following table:

Creatinine clearance (ml/min) The percentage of recommended dose percentage

50 Blood 100% after each hemorrhage On non -separation days, patients should be adjusted according to creatinine clearance.

Hepatic failure

Restricted data in patients with liver failure, thus should be careful when using fluconazole for patients with liver dysfunction.

Children

Do not exceed 400 mg per day.

The treatment time is based on the patient's response. Fluconazole should be used once a day.

For children with impaired renal function, the dose is similar to patients with renal failure.

Babies, children (from 28 days to 11 years old):

Mucus fungus infection: The starting dose of 6 mg/kg on the first day, the next dose: 3 mg/kg used 1 time/day.

Cryptococcus meningitis, invasive Candida infection 6 - 12 mg/kg x 1 time/day, depending on the severity of the disease.

Maintain treatment to prevent recurrence of Cryptococcus meningitis in children is at higher risk of recurrence: 6 mg/kg x 1 time/day, depending on the severity of the disease.

Preventive Candida infection in immunodeficiency patients: 3 - 12 mg/kg x 1 time/day, depending on the degree and time of leukopenia.

Nien Little (from 12 - 17 years old)

Depending on the weight of the body and the development of puberty, the doctor will consider prescribing the dose of adults or children. Clinical data shows that children have higher fluconazole clearance than adults. A dose of 100, 200, 400 mg in adults respectively 3, 6, 12 mg/kg respectively in children.

There is no safety and efficiency data with indications for children's genital infections. If you need to treat genital candidiasis in adolescents, the dosage is similar to the dose in adults.

Babies are full monthly (from 0 - 27 days)

Children from 0 to 14 days: Dosage calculated by mg/kg, used every 72 hours and no more than 12 mg/kg every 72 hours.

Children from 15 to 27 days: Dosage calculated by mg/kg, used every 48 hours and does not exceed 12 mg/kg every 48 hours.

How to use: The drug is taken orally, swallowed the whole tablet and does not depend on the meal.

Capsules are not suitable for babies and children.

Use the drug in this object.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose?

Fluconazole is eliminated in the country. A 3 -hour hemolyzed blood absorbency reduces about 50% of plasma concentrations.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

When using Fluconazole Stada 150mg, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Digestive: Nausea, vomiting, diarrhea, abdominal pain, flatulence, taste disorders.

Neurology: headache, dizziness.

Impact on the liver: increased liver enzymes, jaundice.

Hematology: leukopenia, thrombocytopenia, high blood lipid.

Uncommon, 1/1000

Hair loss is sometimes reported in patients using fluconazole, especially for long -term treatment.

Rare, 1/10000

Skin reaction: Peeling, poisonous epidermal necrosis and Stevens-Johnson syndrome most common in AIDS patients.

Anaphylaxis and eagles.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using Fluconazole Stada 150mg, you need to read the user manual and consult the information below.

contraindicated

Fluconazole Stada is contraindicated in the following cases:

Hypersensitivity to fluconazole, with related Azole or any ingredients of the drug.

Granting porphyrin metabolism disorders.

Based on the results of a multi -dose interactive study, contraindicated simultaneously with terfenadine in patients using Fluconazole multi -dose 400 mg/day or higher.

Contrain to the simultaneous use of fluconazole with drugs that extend QT and are metabolized through Cytochrome P450 (CYP) 3A4 such as Cisapride, Astemizole, Pimozide, Quinidine and Erythromycin.

Be cautious when using

using Fluconazole can cause excessive development of non -sensitive candidiasis strains (outside C. Albicans), including C. Krusei, patients need other antifungal drugs instead.

Scalp mushroom

fluconazole has been studied to treat scalp fungus in children.

Fluconazole has been shown to be not superior to Griseofulvin and the success rate is less than 20%. Therefore, fluconazole should not be used for scalp fungus.

cryptococcosis

Effective evidence of fluconazole in the treatment of cryptococcosis in other positions (such as cryptococcosis of lungs and skin) is limited, should limit the use of drugs.

Into -ending fungal disease

Evidence of the effectiveness of fluconazole in treating other forms of endemic fungal diseases such as paracoccidioidomycosis, sportotrichosis amphotericin B and fluconazole may have a mild force in the treatment of C. albicans, without interaction in the treatment Fumigatus.

The ability to drive and operate machinery

There has been no research on the influence of fluconazole on the ability to drive or operate machinery. Patients should be warned of the possibility of dizziness or epilepsy while using fluconazole and should not drive or operate machines if any symptoms occur.

Pregnancy

Avoid using Fluconazole during pregnancy.

breastfeeding period

fluconazole is secreted into breast milk. Achieving the same concentration in the mother's plasma and should not take medicine for nursing women.

Drug interaction

rifampicin: Reducing fluconazole concentration in plasma.

hydrochlorothiazid: Increases fluconazole concentration in plasma

Cyclosporin, Midazolam, Nortriptyline, Phenytoin, Rifabutin, blood glucose drugs Sulfonylurea and Nateganid, Tacrolimus, Triazolam, Warfarin and Zidovudin increase the concentration of these drugs in plasma. Fluconazole may affect the metabolism of some drugs if used simultaneously, mainly by inhibiting Cytochrom P450 ISOENZYM CYP3A4 and CYP2C9.

sulfamethoxazol: Fluconazole can inhibit the formation of a toxic metabolic of sulfamethoxazol.

terfenadin: The increase in terfenadin levels after high doses of fluconazole has led to ECG electrocardiogram abnormalities.

Cisaprid: Increased Cisaprid concentration and related toxicity.

Astemizol, Cisaprid, or Terfenadin: Risk of arrhythmia.

amitriptylin: Increased amitriptylin levels.

Theophylin: Fluconazole can also reduce theophyllin clearance.

Steroid contraceptives: The effectiveness of oral contraceptives can be affected.

Storage

Storage in closed packaging, dry place, temperature not exceeding 30 degrees C.

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