Malasiya Product

Fusys Tablets

Fusys Tablets

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:

When you should consult your doctor?

You should consult your doctor if you experience any of the following:
Usually the preparation is well tolerated. During a long-term usage of high doses there can be possible follow side effects:

nausea, vomiting, heartburn, diarrhea.

hyperexcitability of CNS, headache.

Urinary system:
formation of urinary, cystine and oxalate concernments.
Skin and subcutaneous tissue: allergic reactions.

Blood system:
It can cause erythrocyte hemolysis in patients with insufficiency of glucose-6-phosphatdehydrogenase of hematocytes.

What to do if you miss a dose?

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise take it as soon as you remember and then go back to taking it as you would normally.

Things you MUST NOT DO while on this medicine?

Ascozin® increases salicylates (increases a risk of crystalluria), ethynilestradiol, benzylpenicillin and tetracyclines concentrations in blood, and decreases per oral contraceptives concentration in blood. It reduces anticoagulation effect of coumarin derivatives. It improves iron drugs absorption in intestine. It increases general clearance of ethyl alcohol. Quinolone drugs, calcium chloride, salicylate, corticosteroid decrease vitamin C reserve when used for a long term. Corticosteroids (cortisone and prednisolone), which are administered in concrete diseases (arthritis, bronchial astma etc), also reduce vitamin C and zinc levels.
Concurrent usage of ascorbic acid and deferoxamine enhances tissue toxicity of iron, especially in cardiac muscle that can cause decompensation of blood circulatory system. It can be used only in 2 hours after deferoxamine injection. A long-term administration of high doses in patients, who are treated by disulfiram, inhibits disulfamide-alcohol reaction.
High doses of the preparation decrease efficacy of tricyclic depressants.

What to do if you accidentally take too much (overdose) of the medicine?

nausea, vomiting, intestine spasm, diarrhea; it is possible allergic reaction, kidney dysfunction, blood pressure increase, hyperexcitability of CNS, sleep disturbance.

It is symptomatic.

Is it safe in pregnancy and breast-feeding?

Tell your doctor immediately if you become pregnant while taking this medication. For safety of any drug during pregnancy or breastfeeding – please consult your doctor.

Storage Conditions:

Store in a dry, protected from light place at a temperature not more than 25° C.
Keep it out of reach of children.

Drug Description


Active substance:
1 tablet contains Fluconazole 50 mg, 100 mg or 200 mg.

Additional ingredients:
lactose, microcrystalline cellulose, povidone K30, talcum, magnesium stearate, starch glycolate sodium, crosscarmellose sodium.

Indications and dosage.

Infections, caused by Candidas, including generalized candidosis, including candidemia, disseminated candidosis and other forms of invasive candidal infections (candidal infection of endocardium, eye, respiratory and urinary tract); mucous membrane candidiasis, including oral cavity, throat and esophagus; non-invasive bronchopulmonary candidal infections; candiduria; mucocutaneous and chronic atrophic candidiasis of tunica mucosa of mouth (caused by dental prosthesis wearing); genital candidiasis - vaginal candidiasis (acute or recurrent ), prophylaxis of vaginal candidiasis recurrence (in occurrence frequency of 3 or more times per year), and also of candidal balanitis; cryptococcal meningitis and infections of other localisations; dermatomycosis, including tinea pedis, tinea cruris, tinea unguium (onychomycosis), and also pityriasis versicolor; deep endemic mycosis, including coccidioidomycosis, paracoccidioidomycosis, sporotrichosis and histoplasmosis; fungal infections prophylaxis (cryptococcosis, oropharyngeal candidiasis) in patients, who receive cytostatic or radiation therapy, in patients with AIDS.


Tablets for oral use. The daily dosage depends on character and severity of fungal infection. The treatment of infections, which require repeated usage of the preparation, must be continued until clinic-laboratory effect reaching (decay of fungal infection).
In candidemia, disseminated candidosis and other invasive candidosis the usual dose is 400 mg during the first day, then – 200 mg per day. The daily dose can be increased up to 400 mg per day if there is a need.
For adults in oropharyngeal candidiasis it is usually administered 50-100 mg of Fluconazole 1 time per day during 7-14 days. In patients with acute depressed immunity the treatment is prolonged if it is necessary.
In atrophic candidiasis of tunica mucosa of mouth caused by dental prosthesis wearing the preparation is administered in 50 mg dose 1 time per day during 14 days concurrently with local antiseptic drugs for dental prosthesis treatment.
In other mucous membrane candidiasis (except generalized candidosis), for example esophagitis, non-invasive bronchopulmonary candidal infections; candiduria, cutis and mucous membrane candidiasis an effective dose is usually 50-100 mg in the treatment duration of 14-30 days.
For prophylaxis of oropharyngeal candidiasis recurrence in patients with AIDS after the course of primary therapy by Fluconazole it is administered 150 mg 1 time per week. In vaginal candidiasis Fluconazole is used in 150 mg single dose per oral. For reduction of disease recurrence rate the preparation is used in 150 mg dose 1 time per month. The therapy duration is determined individually (from 4 to 12 months). In some cases usage frequency is increased.
In balanitis, caused by Candida fungis, Fluconazole is administered per oral in 150 mg single dose.
For candidiasis prophylaxis the recommended dose is 50-400 mg 1 time per day depending on the degree of risk of fungal infection development. In presence of high risk of generalized infection, for example in patients with foreseen marked and long-term neutropenia, the recommended dose is 400 mg 1 time per day. Fluconazole is administered before several days to foreseen neutropenia occurrence; after increased number of neutrophilic granulocytes over 1000 in 1 mm3 the treatment is prolonged for 7 days more.
In cryptococcal meningitis and cryptococcal infections of other localisations it is usually administered 400 mg in the 1st day, and the treatment is continued in 200-400 mg dose 1 time per day. The treatment duration in cryptococcal meningitis is usually not less than 6-8 weeks. For prophylaxis of cryptococcal meningitis recurrence in patients with AIDS (after the end of the course of primary treatment) the therapy by Fluconazole in 200 mg dose per day can be prolonged.
In dermatomycosis, including tinea pedis, tinea cruris and in candidal infections the recommended dose is 150 mg 1 time per week or 50 mg 1 time per day. The therapy duration as usual is 2 – 4 weeks, but in mycisis of legs it may be necessary more long-term treatment (up to 6 weeks).
In pityriasis versicolor the recommended dose is 300 mg 1 time per week during 2 weeks; some patients need the 3rd dose of Fluconazole - 300 mg, whereas in some cases it is enough a single dose of 300-400 mg of the preparation. Alternative treatment scheme is the preparation usage of 50 mg 1 time per day during 2-4 weeks. In onychomycosis (tinea unguium) the recommended dose is 150 mg 1 time per week. The treatment should be continued until change of affected nail on health one. For repeated fingernail and toenail growth it is usually necessary 3-6 and 6-12 months correspondingly, but growth rate may be varied within wide diapason in different people and in dependence on age.
In deep endemic mycosis it may be necessary long-term (up to 2 years) administration of the preparation in 200-400 mg dose per day. The therapy duration is determined individually; it is usually 11-24 months in coccidioidomycosis, 2-17 months in paracoccidioidomycosis, 1-16 months in sporotrichosis and 3-17 months in histoplasmosis.
For the treatment of elderly patients in absence of kidney insufficiency symptoms the preparation is used in usual dose.
For patients (including children) with kidney dysfunctions in multiuse of the preparation it is necessary to use a loading dose that is from 50 to 400 mg. The daily dose is determined by the table (depending on indexes) after loading dose usage.

Creatinine clearance, ml/minute

Percentage of the recommended dose



≤50 (without dialysis)


Patients on regular dialysis

100% after each course of dialysis

At the change from intravenous infusion to oral usage or contra verse it is not necessary to change the daily dose.

For children less than 7 years old Fluconazole is administered by the doctor's recommendation.
The daily dose for children does not exceed the dose for adults. In mucous membrane candidiasis the recommended dose of Fluconazole for children is 3 mg/kg. In the first day it may be used a loading dose of 6 mg/kg for faster reaching of stable balanced concentration.
For the treatment of generalized candidosis and cryptococcal infections the dose of Fluconazole for children is 6-12 mg/kg per day depending on the disease severity.
For fungal infection prophylaxis in patients with depressed immunity in which the risk of infection development is related to neutropenia that is a result of cytostatic chemical or radiation therapy, the preparation is administered 3-12 mg/kg/day depending on severity and keeping period of induced neutropenia.
The duration of the treatment by Fluconazole for children depends on results of mycological examination and clinical presentation.
It is determined individually.

Side effects and drug interactions.


Central and peripheral nervous system:
headache, dizziness, convulsion, change of taste.

Cardio-vascular system:
QT-interval lengthening, paroxysmal ventricular tachycardia of the "pirouette" type.

Gastrointestinal tract: stomach ache, diarrhoea, dyspepsia, nausea, vomiting.

Liver and bile-excreting system:
often – toxic hepatic impairment, including single cases of fatal outcome, increase of levels of alkaline phosphatise, bilirubin, alanine aminotransferase (ALT) and aspartate aminotransferase (AST); sometimes – hepatic incompetence, hepatitis, hepatocellular necrosis, jaundice.

Laboratory data: leucopenia, including neutropenia and agranulocytosis, thrombocytopenia, hypercholesterolemia, hypertriglyceridemia and hypokaliemia.

Immune system:
anaphylaxis, including angioneurotic oedema, face oedema and skin itch, urticaria.

Skin and its appendixes: alopecia, exfoliative skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrosis.

Drug interactions:
Levofloxacin absorption is significantly decreases in concurrent usage with antacids, which contain magnesium and aluminium, and with drugs, which contain iron salt. Recommended time period between usages of Tigeron and mentioned above drugs should be not less than 2 hours. Bioavailability of Tigeron tablets is significantly decreased As far as during clinical trials it was not approved interaction of Levofloxacin and theophylline it was possible a significant decreasing of spastic threshold in concurrent usage of quinolones with theophylline, nonsteroidal anti-inflammatory drugs and other agents, which reduce spastic threshold. Levofloxacin concentration in presence of fenbufen was approximately 13% upper than those one during Levofloxacin usage only. Probenecid and cimetidine statistically reliably influence on Levofloxacin excretion. Kidney clearance of Levofloxacin is decreased in presence of probenecid by 34%, but in presence of cimetidine – by 24%. Due to this both drugs can block tubular excretion of Levofloxacin. Half-life period of cyclosporine is enlarged by 33% in concurrent usage with Levofloxacin.
In concurrent usage with antagonists of K vitamin, for example warfarin, coagulation tests (PT / international normalizing ratio) and/or bleeding, which may be severe, are increased. In consideration to this in patients, who concurrently take antagonists of K vitamin, coagulation indexes should be controlled. It is not recommended Levofloxacin concomitant usage with alcohol.

Warnings and precautions

Pregnancy and lactation:
It is necessary to avoid Fluconazole administration in women of childbearing age without contraceptive usage. The preparation is contraindicated during pregnancy and lactation periods.
The preparation is contraindicated in children less than 7 years old.

AIDS patients are more susceptible to severe skin reactions upon usage of a lot of many drugs. If skin rash, which may be associated with Fluconazole usage, appears in patients who are on the treatment of superficial fungal infection, it is necessary to contraindicate the preparation. If skin rash appears in patients with invasive/systemic fungal infections, it is necessary to observe the patients' states and stop Fluconazole usage in a case of polymorphic erythema. In a case of successful treatment of chronic nail infection by Fluconazole it is sometimes observed a change of nail shape.

Ability to influence reaction velocity while driving or operating any other mechanisms.
During the treatment it is necessary to avoid driving a car and activities with precision machines.

Overdosage and Contraindications

hallucinations and paranoiac behavior.

treatment is symptomatic (including gastric lavage and supporting therapy). Fluconazole is mainly excreted with urine, therefore forced diuresis can accelerate the preparation excretion. Dialysis during 3 hours decreases the concentration of the preparation in plasma approximately on 50%.

Ability to influence reaction velocity while driving or operating any other mechanisms.
During the treatment it is necessary to avoid driving a car and activities with precision machines.


Fusys® should not be administered in individual hypersensitivity to Fluconazole or other agents similar to azole substance by chemical structure.
Concurrent usage of Terfenadine is contraindicated in patients who use Fusys®. Cisapride is contraindicated in patients who receive Fusys®. Children age less than 7 years old. Lactation and pregnancy periods.

Clinical pharmacology.


Fusys® is an antifungal agent of triazole substances. Fluconazole has an intensive antifungal action and specifically blocks fungal sterol synthesis. It has a specific action against fungal enzymes, which are depended on cytochrome P450. It is active against different Candida spp. (including visceral candidiasis), Cryptococcus neoformans (including intracranial infections), Microsporum spp. and Trichophytum spp. Fluconazole is also active against endemic mycosis: Blastomyces dermatitidis, Coccidioides immitis (including intracranial infections), Hystoplasma capsulatum.

After per oral usage it is well absorbed in gastrointestinal tract, general bioaviability exceeds 90%. Meal does not influence on Fluconazole absorption. Maximal concentration in plasma is reached in 0.5 – 1.5 hours after intake. The period of half-excretion of Fluconazole from plasma is 30 hours, that allows to use it 1 time per day during the treatment course and provides the therapeutic effect in vaginal candidiasis after a single use of the preparation. The concentration of active substance in plasma is proportionate to the used dose. 11 – 12% of Fluconazole binds with plasma proteins.
In 90% of patients the stable concentration of Fluconazole is reached on 4 – 5 days of everyday single usage. This effect is reached to 2nd day of the treatment after a loading dose (twice a day) in the first day of the treatment.
Fluconazole well penetrates in fluids of the organism. Its concentrations in spittle and sputum are equivalent to the concentrations in plasma. The concentration of Fluconazole in spinal fluid is reached 80% from its concentration in plasma. The concentrations in epidermis, derma and sweat are reached the levels, which exceed plasma's ones.
It is excreted mainly with urine, and approximately 80% of it is excreted in unchanged form. Fluconazole clearance is directly proportional to creatinine clearance.

General physic-chemical properties:
white, circular tablets with bevelled edges and breakline on one side.


3 years.

Keep it out of reach of children, in a dry, dark place at temperature between 15 – 25 ºC.


Tablets of 50 mg № 4 are in a strip and in a carton box.
Tablets of 100 mg № 4 are in a strip and in a carton box.
Tablets of 200 mg № 4 are in a strip and in a carton box.

Conditions of supply:
By prescription.



Kusum Healthcare
Pin 110020
Tel: 011-41005147, 011-40514919
Fax: +91-11-40527575