Itraconazole Sandoz - instructions for use, dose, side effects, contraindications

Excipients: sugar granules 192.0 mg (composition of granules: sucrose not more than 92%, in terms of anhydrous, corn starch up to 100%, starch hydrolyzate (mono- and polysaccharides) up to 100%, hypromellose 150.0 mg, macrogol-20000 18 , 0 mg;

Capsule body composition: titanium dioxide 1.152 mg, gelatin 56.448 mg;

capsule capsule composition: titanium dioxide 0.768 mg, gelatin 37.632 mg.

Description:

Hard gelatin capsules No. 0 with an opaque case and a lid of white color.

Contents of capsules: pellets are white or almost white.

Pharmacotherapeutic group:Antifungal agent

ATX: & nbsp

J.02.A.C.02 Itraconazole

Pharmacodynamics:

Itraconazole Sandoz® is a synthetic antifungal agent containing itraconazole, a triazole derivative.

Has a broad spectrum of action, the mechanism of which is due to the suppression of the synthesis of ergosterol cell membrane of fungi. Active against dermatophytes (Trichophyton spp., Microsporum spp., Eridermophyton floccosum) of yeasts Candida spp. (including Candida albicans, Candida parapsilosis, Candida krusei, Candida tropicalis), molds fungi (Cryptococcus neoformans, Aspergillus spp., Trichosporon spp., Geotrichum spp., Penicillium marneffei, Pseudallescheria boydii, Histoplasma spp., Coccidioides immitis, Paracoccidioides brasiliensis, Sporothrix schenckii, Fonsecaea spp., Cladosporium spp .., Blastomyces dermatitidis), Malassezia spp. Some strains may be are stable: Candida glabrata, Candida krusei, Candida tropicalis, Absidia spp., Fitsarium spp., Mucor spp., Rhizomucor spp., Rhizopus spp., Scedosporium prolificans, Scopulariopsis spp. Resistance to azoles develops slowly and is often the result of several genetic mutations. The described mechanisms of development of resistance include overexpression of the gene ERG11, encoding the enzyme 14α-dimethylase, which is the main target of the action of azoles, and point mutations ERG11, leading to a decrease in the binding of enzymes to azoles and / or activation of transport systems, which leads to an increase in the excretion of azoles. Cross-resistance was observed Candida spp. to preparations of the azole group, although resistance to a single drug of this group does not necessarily mean the presence of resistance to other preparations of the azole group. Stresses have been reported Aspergillus fumigates, resistant to infraconazole.

Pharmacokinetics:

When ingestion is well absorbed, the maximum bioavailability of itraconazole is noted when taken immediately after a meal. After a single dose, the maximum concentration in the blood plasma (C_max) is achieved after 2-5 hours. For prolonged use, the equilibrium concentration of itraconazole in the blood plasma is reached 2 weeks after the start of treatment and 3-4 hours after the last dose of the drug is 0.5 μg / ml - with the use of 100 mg of itraconazole 1 once a day; 1.1 μg / ml - with 200 mg once a day and 2 μg / ml - with 200 mg twice daily.

99.8% of the active substance binds to plasma proteins. Itraconazole is well distributed in various tissues of the body, and the concentration in the lungs, kidneys, liver, bones, stomach, spleen, skeletal muscles is 2-3 times higher than the concentration in the plasma.The concentration of itraconazole in tissues that contain keratin (especially in the skin) is 4 times higher than the concentration in the blood plasma. The half-life (T_1/2) is 24-36 hours.

Itraconazole is metabolized in the liver, mainly with the participation of cytochrome P450 isoenzyme CYP3A4, with the formation of active metabolites, including hydroxyitraconazole.

Itraconazole is excreted in the urine in the form of inactive metabolites; about 35% with urine and about 54% with feces for one week. Renal excretion of unchanged substance is less than 0.03% of the dose, while excretion with feces varies from 3 to 18% of the dose.

Special patient groups

Renal insufficiency: data on the pharmacokinetics after oral use of itraconazole in this group of patients are limited. It is recommended that caution be used when appointing patients with renal insufficiency, a dose adjustment may be required.

Liver failure: Itraconazole is predominantly metabolized in the liver. Since patients with impaired hepatic function T_1/2 slightly increased, caution should be exercised in prescribing the drug and monitoring the concentrations of itraconazole in the blood plasma in this group of patients. FROM_max with cirrhosis decreased by 47%, a T_1/2 increases approximately 2-fold.

Indications:

Mycoses caused by susceptible pathogens, including:

- Pskin, nail and mucous membranes: vulvovaginal candidiasis, candidiasis of the oral mucosa, pityriasis, dermatomycosis, fungal keratitis, onychomycosis caused by dermatophytes and / or yeasts and mold fungi;

- fromsystemic mycoses: systemic aspergillosis and candidiasis, cryptococcosis (including cryptococcal meningitis, in patients with immunodeficiency and in all patients with cryptococcosis of the central nervous system (CNS) itraconazole should be appointed only in cases where the first-line drugs can not be used in this case or are ineffective), histoplasmosis, sporotrichosis, paracoccidioidomycosis, blastomycosis, deep visceral candidiasis, and other seldom occurring systemic or tropical mycoses.

Contraindications:

- Hypersensitivity to itraconazole or other components of the drug;

- joint assignment with substrates CYP3A4 (methadone, disopyramide, dronedaron, halofantrine, irinotecan, midazolam (for oral administration), lourazidone, felodipine, lercanidipine, nisoldipine, ivabradine, ranolazine, eplerenone, lovastatin); colchicine (in patients with renal or hepatic insufficiency);

- simultaneous reception with drugs that can lengthen QT interval (terfenadine, astemizole, misolastine, cisapride, dofetilide, triazolam, pimozide, quinidine, beprideil, sertindole levacetylmethadol);

- simultaneous administration with ergot alkaloids (dihydroergotamine, ergotamine, ergometrine, methylergomethrin);

- simultaneous administration with inhibitors of hydroxy-methylglutaryl-CoA reductase (atorvastatin, simvastatin, lovastatin);

- chronic heart failure (currently or in history, except for the treatment of dangerous or life-threatening infections);

- Children under 3 years old (for this dosage form);

- pregnancy and lactation;

- deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption syndrome.

Carefully:

In patients with increased sensitivity to other azoles, with ischemic heart disease, valvular heart disease, obstructive pulmonary disease, renal insufficiency, hepatic insufficiency, in cirrhosis, in elderly patients, in children, when combined with other medicines (cf.section "Interaction with other drugs").

Pregnancy and lactation:

Adequate controlled studies on the use of itraconazole in pregnant women have not been carried out, and animal studies have shown that taking the drug is accompanied by reproductive toxicity and an increase in the incidence of congenital anomalies in the skeleton, genitourinary system, cardiovascular system and eyes, so use in pregnancy is contraindicated.

Itraconazole penetrates into breast milk in small quantities, but when using the drug during lactation it is necessary to resolve the issue of stopping breastfeeding.

Dosing and Administration:

Inside, immediately after eating. Capsules should be swallowed whole, not liquid.

Lesion of skin, nails and mucous membranes:

- vulvovaginal candidiasis - 200 mg twice a day for 1 day or 200 mg once a day for 3 days.

- candidiasis of the oral mucosa - 100 mg once a day for 15 days.

- pityriasis - 200 mg once a day for 7 days.

- dermatomycosis - 200 mg once a day for 7 days or 100 mg once a day for 15 days. When the skin is bruised, stop - 200 mg twice a day for 7 days or 100 mg once a day (100 mg per day) for 30 days.

- fungal keratitis - 200 mg once a day for 21 days.

- onychomycosis caused by dermatophytes and / or molds - 200 mg twice a day for 7 days followed by a break for 3 weeks (2 courses are recommended for the treatment of lesions of the nail plates of the hands, for the treatment of lesions of the nail plates of the feet, 3 courses are recommended) or 200 mg once a day without breaks , the duration of treatment should be no more than 3 months.

Systemic fungal infections:

- systemic candidiasis - 100-200 mg once a day for 3 weeks - 7 months, if necessary, increase the dose to 200 mg twice a day (morning and evening) in case of an invasive or disseminated disease.

- systemic aspergillosis - 200 mg once a day for 2-5 months. If necessary, increase the dose to 200 mg twice a day (morning and evening) in case of an invasive or disseminated disease.

- systemic cryptococcosis (no signs of meningitis) - 200 mg once a day for 2 to 12 months.

- cryptococcal meningitis - 200 mg twice a day for 2 months - 1 year.

- systemic histoplasmosis - an initial dose of 200 mg once a day, followed by an increase in the dose to 200 mg twice a day for 8 months.

- systemic sporotrichosis - 100 mg once a day for 3 months.

- systemic paracoccidioidomycosis - 100 mg once a day for 6 months.

- systemic blastomycosis - 100-200 mg 1-2 times a day for 6 months.

- systemic chromomycosis - 100-200 mg once a day for 6 months. The effectiveness of treatment is estimated after 2-4 weeks after discontinuation of therapy (with systemic fungal infections), after 6-9 months - with onychomycosis (as the nails change).

Special categories of patients

Pediatric practice

Data on the use of itraconazole for the treatment of children are limited. Application of the drug Itraconazole Sandoz® capsules for children are not recommended unless the expected benefit of the treatment exceeds the potential risk.

Elderly patients

Data on the use of itraconazole for the treatment of elderly patients are limited. Application of the drug Itraconazole Sandoz^® Capsules for the treatment of elderly patients are not recommended except when the expected benefit of the treatment exceeds the potential risk.When choosing a dose of the drug for the treatment of elderly patients, it is recommended to take into account the functional state of the liver, kidneys and heart, as well as the presence of other concomitant diseases and the intake of other medications.

Impaired liver function

Itraconazole is predominantly metabolized in the liver. Since in patients with impaired liver function the full half-life of itraconazole is slightly increased, it is recommended to monitor the concentrations of itraconazole in the plasma and, if necessary, adjust the dose of the drug (see section "Special instructions").

Impaired renal function

Data on the use of the drug in patients with impaired renal function are limited, so in such patients the drug should be taken with caution. It is recommended to periodically monitor the concentration of itraconazole in the blood plasma and, if necessary, adjust the dose of the drug. Against the background of renal failure, it is possible to reduce the exposure of itraconazole, it may be necessary to adjust the dose of the drug.

Patients with immunodeficiency (including patients with neutropenia and after organ transplantation procedure)

Bioavailability of itraconazole for oral administration may be reduced in some patients with impaired immunity, for example, in patients with neutropenia, patients with acquired immune deficiency syndrome (AIDS) or undergoing organ transplant surgery.

Acquired Immunodeficiency Syndrome

The attending physician should assess the need to prescribe maintenance therapy with itraconazole to a patient with AIDS who has previously been treated for systemic fungal infections, such as sporotrichosis, blastomycosis, histoplasmosis, cryptococcosis (both meningeal and non-meninge), who are at risk of recurrence.

Side effects:

According to the World Health Organization (WHO), the undesirable effects are classified according to the frequency of their development as follows: very often (≥1/10), often (from ≥1 / 100 to <1/10), infrequently (from ≥1 / 1,000 to <1/100), rarely (from ≥1 / 10,000 to <1 / 1,000), very rarely (<1 / 10,000); frequency is unknown - according to available data, it was not possible to establish the frequency of occurrence.

From the nervous system and sense organs

infrequently: headache;

rarely: hypoesthesia, paresthesia, dysgeusia (violation of taste perception), visual impairment (including diplopia and blurred vision), persistent or temporary hearing loss (see "Special instructions"), ringing in the ears;

frequency is unknown: tremor.

From the digestive system

often: abdominal pain, nausea;

infrequently: vomiting, diarrhea or constipation, flatulence, dyspepsia, liver dysfunction;

rarely: pancreatitis, hepatotoxicity (including cases of fatal acute hepatic insufficiency), hyperbilirubinemia.

From the side of the cardiovascular system

rarely: development or exacerbation of heart failure, chronic heart failure;

frequency is unknown: arterial hypertension or hypotension.

From the respiratory system

rarely: shortness of breath, rhinitis, sinusitis, infections of the upper respiratory tract.

From the skin

infrequently: urticaria, skin rash, itching;

rarely: Lyell's syndrome (toxic epidermal necrolysis), acute generalized exanthematous pustulosis, erythema multiforme (including Stevens-Johnson syndrome), exfoliative dermatitis, leukoclastic vasculitis, alopecia, photosensitivity.

From the genitourinary system

infrequently: violation of the menstrual cycle;

rarely: frequent urination, erectile dysfunction.

On the part of the blood, the immune and lymphatic system

infrequently: hypersensitivity reactions;

rarely: leukopenia;

frequency is unknown: neutropenia, anaphylactic reactions, angioedema, serum sickness, anaphylactoid reactions.

Other

rarely: edema, increased activity of the creatine kinase of blood;

frequency is unknown: hypertriglyceridemia.

Undesirable reactions associated with the use of itraconazole in the form of a solution for oral administration and a solution for intravenous administration

Violations of the blood and lymphatic system:

granulocytopenia, thrombocytopenia

Disorders from the metabolism and nutrition:

hyperglycemia, Hyperkalemia, hypokalemia, hypomagnesemia.

Disorders from the psyche:

confusion of consciousness.

Disturbances from the nervous system:

peripheral neuropathy, dizziness, drowsiness.

Heart Disease:

failure of the left ventricle.

Disturbances from the respiratory system, organs of the chest and mediastinum:

pulmonary edema, dysphonia, cough.

Disorders from the liver and bile ducts:

hepatitis, jaundice, a violation of the liver.

Disturbances from the skin and subcutaneous tissues:

erythematous rash, hyperhidrosis.

Disturbances from musculoskeletal and connective tissue:

myalgia, arthralgia.

Disorders from the kidneys and urinary tract:

failure of kidney function, urinary incontinence.

General violations and violations at the site of introduction:

generalized edema, face swelling, chest pain, hyperthermia, pain, fatigue, chills.

Laboratory and instrumental data:

increased activity "hepatic" enzymes, alkaline phosphatase, lactate dehydrogenase, gamma-glutamyltransferase, increased urea concentration in the blood, deviations from the norm of the general analysis of urine.

Children

The safety of the drug was evaluated in 14 clinical studies (4 double-blind, placebo-controlled studies, 9 open trials and 1 study had an open phase, followed by a double blind) involving 165 pediatric patients aged 1-17 years. The most common side effects were headache, vomiting, abdominal pain, diarrhea, impaired liver function, nausea, urticaria.

The nature of adverse reactions occurring in children is similar to that observed in adult patients, however, the incidence of adverse reactions in children is higher.

Overdose:

Symptoms: in case of an overdose, dose-dependent secondary effects (see section "Side effect").

Treatment: there is no specific antidote. In case of an overdose, symptomatic and supportive treatment should be carried out - during the first hour it is necessary to wash the stomach, and, if necessary, appoint Activated carbon. Hemodialysis is ineffective.

Interaction:

Increase in the concentration of interacting drugs

Itraconazole is a potent inhibitor CYP3A4 and P-glycoprotein, can enhance and / or prolong the action of drugs whose metabolism is associated with CYP3A4.

Drugs that increase the concentration of itraconazole in the blood plasma

Strong inhibitors CYP3A4 can increase the bioavailability of itraconazole: antibacterial drugs (ciprofloxacin, clarithromycin, erythromycin), antiviral agents (darunavir, potentiated with ritonavir, fosamprenavir, potentiated with ritonavir, indinavir, ritonavir). These medications should be used with caution in case of need of a co-administration with itraconazole. Status of patients who receive therapy with potent inhibitors CYP3A4, should be carefully monitored for the development of symptoms of amplification or prolongation of pharmacological effects of itraconazole, if necessary, the dose of itraconazole should be reduce.

Medications, the concentration of which in the blood plasma can increase when combined with itraconazole

Itraconazole and its main metabolite hydroxyitraconazole may interfere with the metabolism of drugs metabolized by the isoenzyme CYP3A4, and to prevent transportation of drugs under the action of P-glycoprotein. This can lead to an increase in the plasma concentration of these drugs and / or their active metabolites when taken together with itraconazole. The increase in plasma concentration, in turn, can cause the enhancement or prolongation of both the therapeutic and undesirable effects of these drugs, resulting in potentially life-threatening conditions. An increase in the concentration of certain drugs (terfenadine, astemizole, misolastine, cisapride, dofetilide, triazolam, pimozide, quinidine, beprideil, sertindole, levacetylmetadol) may lead to an increase in the interval QT and ventricular tachyarrhythmia, including cases of ventricular pirouette tachycardia, which is potentially life-threatening. After discontinuation of treatment, the plasma concentration of itraconazole decreases to almost indeterminate within 7 to 14 days, depending on the dose of the drug and the duration of treatment. In patients with cirrhosis of the liver or those who simultaneously take inhibitors of the isoenzyme CYP3A4, a decrease in the concentration of the drug can be very slow. This is especially important at the time of initiation of therapy with the use of drugs, the metabolism of which is affected itraconazole.

Interactive drugs are divided according to the following principle:

"Contraindicated" - under no circumstances should both joint use and their use be allowed within two weeks after discontinuation of itraconazole therapy.

"Not recommended" - this combination should be avoided during treatment with itraconazole and within two weeks after discontinuation of therapy, however, in some cases, if the expected benefit exceeds the risk for a particular patient,subject to appropriate monitoring and control, such a combination is permissible.

"Carefully" - When combined with itraconazole, careful monitoring, monitoring of the effectiveness and side effects of the drugs used is recommended.

Contraindicated joint use with the following drugs: levacetyl methadone, methadone, disopyramide, dofetilide, dronedaron, quinidine, halofantrine, astemizole, misolastine, terfenadine, ergot alkaloids (dihydroergotamine, ergometrine, methylergotamine, ergotamine), irinotecan, midazolam (for oral administration), lourazidone, pimozide, sertindole, triazolam, bepridil, felodipine, lercanidipine, nisoldipine, ivabradine, ranolazine, eplerenone, cisapride, atorvastatin, lovastatin, simvastatin, colchicine (in patients with hepatic or renal insufficiency).

Not recommended for joint use with the following drugs: tamsulosin, fentanyl, rifabutin, rivaroxaban, carbamazepine, dasatinib, nilotinib, trabetedin, aliskiren, everolimus, salmeterol, vardenafil, colchicine.

Carefully: alfentanil, buprenorphine for intravenous or sublingual administration, oxycodone, digoxin, coumarins, cilostazol, dabigatran, repaglinide, saxagliptin, praziquantel, ebastine, eletriptan, bortezomib, busulfan, docetaxel, erlotinib, Ixabepilone, lapatinib, trimetrexate, vinca alkaloids, alprazolam, aripiprazole, brotisolam, buspirone, haloperidol, midazolam for intravenous administration, perosporone, quetiapine, ramelteon, risperidone, maraviroc, indinavir, ritonavir, saquinavir, nad, the remaining blockers of "slow" calcium channels (including dihydropyridines and verapamil), aprepitant, domperidone, budesonide, ciclesonide, ciclosporin, dexamethasone, fluticasone, methyl prednisolone, sirolimus, tacrolimus, tessirolimus, reboxetine, fesoterodine, imidafenacin, sildenafil, solifenacin, tadalafil, tolterodine, alitretinoin for oral administration, zincalcet, mozavaptan, tolvaptan.

Reduction of the concentration of interacting drugs

Co-administration with meloxicam causes a decrease in its concentration in the blood. It is necessary to monitor the effectiveness of therapy, it may be necessary to increase the dose of meloxicam.

Reduction of the concentration of itraconazole in the blood

It is not recommended simultaneous use of drugs that are strong inducers of liver enzyme systems (rifabutin, isoniazid, rifampicin, carbamazepine, phenobarbital, phenytoin, efavirenz, nevirapine), because they significantly reduce the bioavailability of itraconazole and its metabolites, which leads to a significant decrease in the effectiveness of the drug.

The bioavailability of itraconazole depends on the acidity of the gastric juice. If concurrently used drugs that reduce the pH of gastric juice (proton pump inhibitors, blockers H₂-gistaminovyh receptors) it is recommended to drink itraconazole sour drinks (excluding grapefruit juice).

Antacid preparations should not be taken at least 1 hour before taking itraconazole and within 2 hours after.

It is forbidden to use itraconazole and grapefruit together (including grapefruit juice), since itraconazole may be weakened. Apparently, this is due to the fact that grapefruit juice reduces the concentration of itraconazole in the plasma by inhibiting its absorption in the gastrointestinal tract (GI tract).

Application in pediatric practice

Studies of drug interactions were conducted only in adults.

Special instructions:

In patients receiving long-term treatment itraconazole, it is recommended to monitor liver function. Since patients with impaired hepatic and renal function T_1/2 itraconazole is slightly increased, it is recommended to monitor the concentration of itraconazole in the plasma and, if necessary, adjust its dose.

It was found that itraconazole has a negative inotropic effect. There have been reports of cases of heart failure associated with itraconazole. The most common heart failure was observed with a total daily dose of 400 mg. At lower daily doses, no such regularity was revealed. The risk of chronic heart failure is presumably proportional to the daily dose. When symptoms of chronic heart failure appear, itraconazole should be discontinued.

Do not use the drug in patients with heart failure (including history), except for the treatment of dangerous and life-threatening infections.Risk assessment should be carried out strictly on an individual basis, taking into account factors such as severity of cardiac dysfunction, severity of infection, presumed dosing regimen, concomitant diseases (coronary heart disease, heart valve disease, severe respiratory system diseases (eg, chronic obstructive pulmonary disease) renal and hepatic function, other diseases accompanied by fluid retention and edema, such patients should be informed of the symptoms and manifestations heart failure, treatment should be conducted with caution.When there is or worsening of symptoms of chronic heart failure or its decompensation, itraconazole should be discontinued.

The blockers of "slow" calcium channels can have a negative inotropic effect and, as a consequence, potentiate this effect of itraconazole. When using this combination, special care should be taken in view of the increased risk of heart failure (some combinations are absolutely contraindicated, see the section "Interaction with other medicines").

Patients with reduced gastric acidity (achlorhydria, antacids, proton pump inhibitors, H blockers₂-gistaminovyh receptors), it is recommended to drink the drug with acidic drinks (see section "Interaction with other drugs").

If there is a neuropathy that can be associated with taking itraconazole, the drug should be stopped.

There is no evidence of cross-sensitivity to itraconazole and other azole antifungal agents. Itraconazole should be administered with caution to patients with hypersensitivity to other azoles.

Women of childbearing age who receive itraconazole, it is necessary to use reliable methods of contraception throughout the course of treatment until the onset of the first menstruation after completion of its admission.

Cross-resistance: with systemic candidiasis, if a fluconazole-resistant fungal strain is suspected Candida, there is no reason to assume that it will be sensitive to itraconazole. In this case, it is expedient to determine the sensitivity spectrum of the pathogen before the initiation of therapy with itraconazole.

It is not recommended to replace itraconazole in capsules for other dosage forms (for example, oral solution), since at equal dosage the solution has a stronger therapeutic effect than the capsules.

Data on the use of itraconazole in the elderly are limited. The use of the drug in this group of patients is recommended only if the intended benefit exceeds the potential risk, after assessing renal and hepatic functions, the state of the cardiovascular system, concomitant diseases and their therapy.

Effects on liver function: in very rare cases with the use of itraconazole, severe toxic liver damage developed (several cases of acute hepatic insufficiency with a lethal outcome are described). In most cases, this occurred with patients who already had liver disease in patients with other serious illnesses that the drug was prescribed to treat systemic diseases, as well as in patients receiving other drugs that have a hepatotoxic effect. However, in some patients there were no concomitant diseases or obvious risk factors forlesions of the liver. Several such cases occurred in the first month of therapy, and some in the first week of treatment. In this regard, it is recommended to regularly monitor liver function in patients receiving itraconazole therapy. In case of symptoms of toxic hepatitis (anorexia, nausea, vomiting, weakness, abdominal pain, darkening of urine), it is necessary to immediately stop treatment and conduct a study of liver function. Patients with an increase in the activity of "liver" enzymes or liver disease in the active phase, or with a transferred toxic liver damage due to the use of other drugs should not be prescribed drug treatment Itraconazole Sandozo®, except when the expected benefit justifies the risk of liver damage. In such cases it is necessary during the treatment to monitor the activity of "liver" enzymes. Itraconazole mainly metabolized in the liver. Since in patients with impaired liver function the full half-life of itraconazole is slightly increased, it is recommended to monitor the concentrations of itraconazole in the plasma and, if necessary, adjust the dose of the drug.

Impaired renal function: data on the use of the drug in patients with impaired renal function are limited, so in such patients the drug should be taken with caution. It is recommended to monitor the concentrations of itraconazole in the plasma and, if necessary, adjust the dose of the drug.

Patients with immunodeficiency: the bioavailability of itraconazole for oral administration may be reduced in some immunocompromised patients, for example in patients with neutropenia, patients with AIDS or undergoing organ transplant surgery.

Acquired Immunodeficiency Syndrome: The attending physician should evaluate the need for supportive therapy for a patient with AIDS who has previously been treated for systemic fungal infections, such as sporotrichosis, blastomycosis, histoplasmosis, and cryptococcosis (both meningeal and non-meninge) who are at risk of recurrence.

Patients with life-threatening systemic fungal infections: due to pharmacokinetic characteristics, drug use Itraconazole Sandoz® capsules are not recommended for the start of treatment of life-threatening systemic mycoses.

Application in pediatric practice: since clinical data on the use of the drug Itraconazole Sandoz® in children is not enough, it is recommended to prescribe the drug to children only if the possible benefit exceeds the potential risk.

Hearing Loss: reported rare cases of temporary or persistent hearing loss in patients taking itraconazole. In some cases, loss hearing arose on the background of simultaneous reception with quinidine (see the sections "Contraindications" and "Interaction with other drugs"). Hearing was usually restored after the end of therapy with the drug Itraconazole Sandoz®, however, in some patients, hearing loss was irreversible.

Special precautions when destroying an unused preparation

There is no need for special precautions when destroying an unused preparation.

Effect on the ability to drive transp. cf. and fur:

Usually the drug Itraconazole Sandoz^® does not affect the ability to drive and work with machinery, however, when taking the drug, blurred vision, dizziness and hearing loss may occur.If these side effects occur, you should refrain from driving and working with machinery.

Form release / dosage:Capsules, 100 mg.

Packaging:

For 6, 7, 10 or 15 capsules are placed in a blister of PVC / Al or PVC / PVDC / Al.

By 1, 2, 3 or 4 blisters are placed in a cardboard box together with instructions for medical use.

Storage conditions:

Store in a dark place at a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-002916

Date of registration:16.03.2015

Expiration Date:16.03.2020

Date of cancellation:2020-03-16

The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia

Manufacturer: & nbsp

SANDOZ ILAC SANAYI VE TICARET, A.S. Turkey

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp28.11.2017

Illustrated instructions

Instructions

Itraconazole Sandoz® (Itraconazole Sandoz®)