Fluconazole capsules. 150mg 1 pc Biocom

$0.70

Fluconazole capsules. 150mg 1 pc Biocom

Quantity:

SKU: 02063544660 Categories: , , Tag:

Description

Composition
Active substance:
Fluconazole – 0.150 g
Excipients:
Lactose monohydrate (milk sugar) – 0.19265 g, pregelatinized starch – 0.00175 g povidone (polyvinylpyrrolidone, low molecular weight) – 0.00175 g colloidal silicon dioxide (Aerosil) – 0.00035 g magnesium stearate – 0.0035 g ;
Composition gelatin capsules: a housing: gelatin – 0.045408 g, titanium dioxide E 171 – 0.000461 g, yellow iron oxide coloring E 172 – 0.000231 g .; cap: gelatin – 0.029648 g, titanium dioxide E 171 – 0.000301 g, yellow iron oxide coloring E 172 – 0.000151 g
Description:
Hard gelatin capsules № 1 opaque yellow color with a yellow lid. Contents of capsules – powder white or white with a yellowish tinge.
Product form:
Capsules 150 mg.
1 capsule in blisters.
1 contour cellular packaging together with instructions for use in a pile of cardboard.
Contraindications
-Simultaneous receiving terfenadine (with the constant fluconazole receiving 400 mg / day or more) or astemizole and other drugs interval prolonging Q-T;
-Increased sensitivity to the drug or close in structure to azole compounds;
– lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
-children’s age (up to 3 years).
Carefully.
Hepatic and / or renal failure, simultaneous reception of potentially hepatotoxic drugs, alcoholism, rash during treatment with fluconazole in patients with superficial fungal infection and invasive / systemic fungal infections, simultaneous terfenadine and fluconazole less than 400 mg / day, potentially proaritmogennoe state in patients with multiple risk factors (organic heart disease, electrolyte disturbances, concomitant use of drugs that cause arrhythmias).
Dosage
150 mg
Indications
-kriptokokkoz including cryptococcal meningitis and other localizations of this infection (including lung, skin), in patients with a normal immune response, and patients with various forms of immunosuppression (including in patients with AIDS, transplantation authorities); preparation can be used for prevention cryptococcal infection in AIDS patients;
-generalizovanny candidiasis including candidemia, disseminated candidiasis and other forms of invasive Candida infection (infection of the peritoneum, endocardium, eyes, respiratory and urinary tracts). Treatment may be conducted in patients with malignant tumors, patients in intensive care, patients undergoing a course of cytostatic or immunosuppressive therapy, and the presence of other factors predisposing to candidiasis;
-kandidoz mucous membranes, including oral cavity and pharynx (including atrophic oral candidiasis associated with wearing dentures, oropharyngeal candidiasis), esophagus, non-invasive bronchopulmonary candidiasis, candiduria, candidiasis of the skin; prevention of relapse of oropharyngeal candidiasis in patients with AIDS;
-genitalny candidiasis: vaginal candidiasis (acute and chronic recurrent), prophylactic use to reduce the frequency of relapses vaginal candidiasis (3 or more episodes a year); Candida balanitis;
-profilaktika fungal infections in patients with malignancies who are predisposed to such infections as a result of chemotherapy, cytostatics or radiation therapy;
-mikozy skin, including tinea pedis, body, groin; pityriasis versicolor, onychomycosis; Skin candidiasis;
-glubokie endemic mycoses, including coccidioidomycosis, paracoccidioidomycosis, sporotrichosis and histoplasmosis in patients with normal immune systems.
Interaction with other drugs
In applying fluconazole increases warfarin prothrombin time (on average 12%). In this connection, it is recommended to closely monitor the performance of the prothrombin time in patients receiving the drug in combination with coumarin anticoagulants.
Fluconazole increases the plasma half-life of oral hypoglycemic agents – sulfonylureas (chlorpropamide, glibenclamide, glipizide, tolbutamide) in healthy people. The combined use of fluconazole and oral hypoglycemic agents in diabetic patients is allowed, however, the physician should bear in mind the possibility of hypoglycemia.
The simultaneous use of fluconazole and phenytoin can lead to an increase in the plasma concentration of phenytoin to a clinically significant degree. Therefore, if necessary, concomitant use of these drugs need to monitor the concentration of phenytoin adjusted the dose to maintain drug levels within the therapeutic range.
Combination with rifampicin leads to a decrease in AUC and 25% shortening the half-life of fluconazole from plasma by 20%. Therefore, patients receiving concomitant rifampicin, the dose of fluconazole is advisable to increase.
It is recommended to monitor blood concentration of cyclosporine in patients receiving fluconazole, because fluconazole and cyclosporine use in patients with kidney transplant administration of fluconazole in a dose of 200 mg / day results in a slow increase in the plasma concentration of cyclosporine.
Patients who receive high dose of theophylline or who have a chance of developing theophylline toxicity, should be monitored for early detection of symptoms of theophylline overdose, since administration of fluconazole resulting in a lower average plasma clearance rate of theophylline.
With simultaneous application of fluconazole and cisapride described cases undesirable reactions of the heart, including paroxysmal ventricular tachycardia (torsades de points).
There are reports about the interaction of fluconazole and rifabutin, accompanied by an increase in serum levels of the latter. With simultaneous application of fluconazole and rifabutin uveitis cases are described. We must carefully monitor patients while receiving rifabutin and fluconazole.
In patients receiving the combination of fluconazole and zidovudine, an increase in the concentration of zidovudine, which is caused by a decrease in the conversion of the latter into its main metabolite, so you should expect an increase in the side effects of zidovudine.
Fluconazole increases the concentration of midazolam – psychomotor effects increase the risk (is more pronounced when applying fluconazole orally); tacrolimus – the risk of nephrotoxicity.
Hydrochlorothiazide, increases the concentration of fluconazole in the plasma by 40%.
Overdose
Symptoms: hallucinations, paranoid behavior.
Treatment: symptomatic, gastric lavage, forced diuresis. Hemodialysis for 3 hours reduces the plasma concentration of approximately 50%.
pharmachologic effect
Pharmacodynamics:
Fluconazole – representative of the class of triazole antifungal agents, is a potent selective inhibitor of the synthesis of sterols in fungal cells. The drug is effective for opportunistic mycosis, including caused by Candida spp., Cryptococcus neoformans, Microsporum spp., Trichophyton spp. Fluconazole is also shown activity in models of endemic mycoses, including infections caused by Blastomyces dermatitidis, Coccidioides immitis and Histoplasma capsulatum.
Pharmacokinetics:
After oral administration, fluconazole is well absorbed, its bioavailability – 90%. The maximum concentration of an empty stomach after ingestion of 150 mg of 90% of plasma levels when administered intravenously at a dose of 2.5 – 3.5 mg / l. Simultaneous food intake does not affect absorption of the drug, taken orally. The maximum concentration achieved within 0.5-1.5 hours after administration, half life of fluconazole is approximately 30 hours. Plasma concentrations are directly proportional in a dose dependent manner. 90% of the level of equilibrium concentration achieved by 4-5 day of drug treatment (at reception times 1 / day).
Introduction “shock” dose (the first day), a 2-times the normal daily dose, achieves a level corresponding to 90% of the equilibrium concentration of the second day. The apparent volume of distribution is close to the total water content in the body. Binding to plasma proteins – 11-12%.
Fluconazole penetrates well into all body fluids. Drug concentrations in saliva and sputum are similar to those in plasma. In patients with fungal meningitis the fluconazole content in cerebrospinal fluid is 80% of its level in plasma.
In the stratum corneum, epidermis, dermis and sweat liquid are achieved high concentrations which exceed serum.
It is an inhibitor of CYP2C9 isozyme in the liver.
The pharmacokinetics of fluconazole depends essentially on the renal function, the inverse relationship exists between the half-life and creatinine clearance (CC). Fluconazole is derived mainly kidneys; about 80% of the administered dose is excreted in the urine unchanged. Fluconazole metabolites were found in the peripheral blood.
Pregnancy and breast-feeding
Use of the drug in pregnant women is inappropriate, except in severe or life-threatening forms of fungal infections if the expected benefit to the mother outweighs the potential risk to the fetus.
Fluconazole is in the breast milk at the same concentration as in plasma, so its use is not recommended during breastfeeding.
Conditions of supply of pharmacies
Available without a prescription.
side effects
From the digestive system: nausea, vomiting, changes in taste, diarrhea, flatulence, abdominal pain, abnormal liver function (jaundice, hyperbilirubinemia, increased activity of alanine aminotransferase, aspartate aminotransferase, elevated alkaline phosphatase, hepatitis, gepatonekroz) including fatal.
From the nervous system: headache, dizziness, seizures.
From the side of hematopoiesis: leukopenia, thrombocytopenia, neutropenia, agranulocytosis.
From the cardiovascular system: increase duration interval Q-T, flicker / ventricular flutter.
Allergic reactions: skin rash, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), anaphylactoid reactions (including angioneurotic edema, swelling of the face, urticaria, itching).
Other: renal failure, alopecia, hypercholesterolemia, hypertriglyceridemia, hypokalemia.
special instructions
Treatment should be continued until clinical remission. Premature discontinuation of treatment leads to relapse.
Treatment can begin at the lack of culture results and other laboratory tests, but their presence is recommended corresponding correction fungicidal treatment.
During the treatment it is necessary to monitor blood counts, liver and renal function. In the event of renal dysfunction and liver to stop taking the drug.
In rare cases, fluconazole accompanied by toxic liver changes, including fatal primarily in patients with serious underlying medical conditions. In the case of hepatotoxic effects associated with fluconazole were observed their explicit dependence of the total daily dose, duration of therapy, sex or age of the patient. Hepatotoxic effect of fluconazole was usually reversible; its signs disappeared after discontinuation of therapy. When clinical signs of liver damage, which may be associated with fluconazole, the preparation should be discontinued.
AIDS patients are more prone to severe skin reactions at the application of many drugs. In cases where patients with superficial fungal infection develops a rash and it is regarded as definitely related to fluconazole, the drug should be discontinued. If a rash in patients with invasive / systemic fungal infections, they should be monitored closely and fluconazole cancel the appearance changes or bullous erythema multiforme.
Care must be taken while receiving fluconazole with cisapride, rifabutin or other drugs metabolized by cytochrome P-450 system.
Effects on ability to drive vehicles, machinery.
Fluconazole did not affect the ability to drive and engage in other potentially hazardous activities that require high concentration and psychomotor speed reactions.
Storage conditions
In a dry, dark place at a temperature not higher than 25 ° C. Keep out of the reach of children.
Dosing and Administration
Dosing inside.
Adults with cryptococcal meningitis and cryptococcal infections at other sites on the first day is usually administered 400 mg, and then continue treatment at a dose
200-400 mg 1 time / day. Duration of treatment with cryptococcal infection depends on the clinical effectiveness confirmed mycological investigation; in cryptococcal meningitis it is usually continued for at least 6-8 weeks.
For the prevention of relapse of cryptococcal meningitis in AIDS patients, after completion of a full rate primary treatment, fluconazole is administered in a dose of 200 mg / day for a long period of time.
When candidemia, disseminated candidiasis and other invasive Candida infections dose is usually 400 mg in the first day, and then – 200 mg. When insufficient clinical efficacy of the dose can be increased to 400 mg / day. The duration of therapy depends on clinical effectiveness.
When drug oropharyngeal candidiasis usually administered 50-100 mg 1 time / day; Duration of treatment – 7-14 days. If necessary, in patients with severe depression of immunity treatment may be longer.
To prevent a recurrence of oropharyngeal candidiasis in patients with AIDS after completing the full course of drug therapy primary may be designated by 150 mg 1 time per week.
In atrophic oral candidiasis associated with wearing dentures usually administered fluconazole at 50 mg 1 time / day for 14 days in combination with local antiseptic agents for treatment of prosthesis.
In other localizations candidiasis (except genital candidiasis), such as esophagitis, noninvasive bronchopulmonary lesion, candiduria candidiasis of skin and mucous membranes, etc., the effective dose is usually 50-100 mg / day when the duration of treatment 14-30 days.
Vaginal candidiasis, fluconazole receiving a single oral dose of 150 mg. To reduce the frequency of relapses vaginal candidiasis preparation may be used in a dose of 150 mg 1 time per month. Duration of treatment is determined individually; it varies from 4 to 12 months. Some patients may require more frequent application.
When balanitis caused by Candida, Fluconazole is administered once at a dose of 150 mg orally.
For the prevention of candidiasis recommended dose is 50-400 mg fluconazole
1 time / day, depending on the degree of risk of fungal infection. When there is a high risk of systemic infection, for example in patients with an anticipated or expressed long persistent neutropenia, the recommended dose is 400 mg
1 time / day. Fluconazole is administered a few days before the expected occurrence of neutropenia; after increasing the number of neutrophils over 1000 / mm3, treatment was continued for 7 days.
When skin mycoses, mycoses including feet, groin skin and skin candidosis recommended dose is 150 mg 1 time per week or 50 mg 1 time / day. Duration of therapy in normal cases is 2-4 weeks, but in mycosis stop may require a long-term therapy (6 weeks).
When pityriasis versicolor – 300 mg 1 time per week for 2 weeks, some patients required a third dose to 300 mg per week, while in some cases it is sufficient single dose of 300-400 mg; alternative regimen is the use of 1 to 50 mg once a day for 2-4 weeks.
In onychomycosis recommended dose is 150 mg 1 time per week. Treatment should be continued until the replacement of the infected nail (nail sprouting uninfected). For the re-growth of the nails on the fingers and feet normally require 3-6 months
6-12 months, respectively.
When deep endemic mycosis may require use of the drug at a dose of 200-400 mg / day for up to 2 years. Duration of treatment is determined individually; it can be 11-24 months with coccidioidomycosis; 2-17 months with paracoccidioidomycosis; 1-16 months with sporotrichosis and 3-17 months with histoplasmosis.
In children, as well as with similar infections in adults, duration of treatment depends on the clinical and mycological effect. In children, the drug should not be used in a daily dose, which would be higher than that in adults. The drug is used on a daily basis
1 time / day.
When mucosal candidiasis recommended dose of fluconazole
3 mg / kg / day. On the first day it can be administered a loading dose of 6 mg / kg to more rapidly achieve constant equilibrium concentrations.
For the treatment of generalized candidiasis and cryptococcal infection (including meningitis), the recommended dose is 6-12 mg / kg / day for 10-12 weeks (until laboratory confirm the absence of pathogens in cerebrospinal fluid).
For the prevention of fungal infections in children immunocompromised, in whom the risk of infection associated with neutropenia that develops as a result of cytotoxic chemotherapy or radiation therapy, the drug is prescribed for 3-12 mg / kg / day, depending on the severity and duration of preservation-induced neutropenia.
Children with impaired renal function, the daily dose should be reduced (in the same proportion as in adults), in accordance with the severity of renal failure.
In elderly patients without renal dysfunction should follow the usual dose regimen of the drug. Patients with renal impairment (creatinine clearance less than 50 mL / min) dosing regimen should be adjusted as indicated below.
Use of the drug in patients with impaired renal function.
Fluconazole is derived mainly from the urine in unchanged form. For a single administration of a dose of his change is not required. When re-administering the drug to patients with impaired renal function must first enter the “shock” dose of 50 mg to 400 mg. Если клиренс креатинина (КК) составляет более 50 мл/мин, применяется обычная доза препарата (100 % рекомендуемой дозы). При КК от 11 до 50 мл/мин применяется доза, равная 50 % рекомендуемой. Больным, регулярно находящимся на диализе, одна доза препарата применяется после каждого сеанса гемодиализа.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

BIOCOM

There are no reviews yet.

Add your review