Teknazol - Instructions For Use, Price, Reviews, Capsule Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Teknazole

Teknazol: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Teknazol

ATX code: J02AC02

Active ingredient: itraconazole (Itraconazole)

Manufacturer: Nobel Ilach Sanayi Ve Tijaret A. Sh. (Nobel Ilac Sanayii ve Ticaret AS) (Turkey)

Description and photo update: 2020-28-01

Prices in pharmacies: from 408 rubles.

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Teknazole is an oral medicine with antifungal action.

Release form and composition

The drug is available in the form of capsules: hard gelatinous, odorless, with a transparent brown body and a matte pink lid; contents - spherical micropellets of white or almost white color (4 or 15 pcs. in blisters, in a cardboard box 1 blister with 4 or 15 capsules or 2 blisters with 15 capsules and instructions for use of Teknazol).

Composition for 1 capsule:

• active substance: itraconazole - 100 mg;
• auxiliary components: macrogol, hypromellose, neutral micropellets (corn starch, sucrose);
• capsule body and cap: gelatin, patent blue V E131 dye, E171 titanium dioxide, E150 caramel dye, N122 azorubin dye.

Pharmacological properties

Pharmacodynamics

Teknazole is a synthetic broad-spectrum antifungal drug. It belongs to the derivatives of triazole and inhibits the synthesis of ergosterol in the cell membranes of the fungus.

Itraconazole is active against the following fungi:

• yeast fungi of the genus Candida (including Candida parapsilosis and Candida albicans), fungi of the genus Malassezia;
• mold fungi (Aspergillus spp., Geotrichum spp., Histoplasma spp., Fonsecaea spp., Cladosporium spp., Trichosporon spp., Cryptococcus neoformans, Pseudallescheria boydii, Sporothilischeria paraccidium, Sporothilisis schenididesisis, Penthicides schenckii, Penthicides, dermalisis, Pensicillium spp.
• dermatophytes (Microsporum spp., Trichophyton spp., Epidermophyton floccosum).

Some strains of Candida tropicalis, Candida krusei, Candida glabrata, Scedosporium proliferous, Absidia spp., Rhizomucor spp., Scopulariopsis spp., Fusarium spp., Rhizopus spp., Mucor spp. Can be resistant to Teknazol. and Scopulariopsis spp.

In case of mycoses, the effectiveness of therapy should be assessed 2–4 weeks after the end of treatment, and in case of onychomycosis - after 6–9 months (as the nails grow back).

Pharmacokinetics

Itraconazole is completely absorbed from the gastrointestinal tract. Taking Teknazole immediately after a meal increases its bioavailability. If itraconazole is taken as a solution on an empty stomach, the rate of reaching the maximum plasma concentration and the value of the equilibrium plasma concentration increase by about 25% compared with taking the drug after meals.

To reach the maximum plasma concentration, 3-4 hours are required. The equilibrium plasma concentration value when taking 100 mg of itraconazole once a day is 0.4 μg / ml, when taking 200 mg once a day - 1.1 μg / ml, and when taking 200 mg twice a day - 2 μg / ml.

The time to reach the maximum plasma concentration of the active substance after taking itraconazole solution inside is 2 hours (if Teknazole is taken on an empty stomach) or 5 hours (if itraconazole is taken after meals).

With long-term treatment, the onset of equilibrium plasma concentration is 1–2 weeks. About 99.8% of itraconazole binds to plasma proteins.

The drug is well distributed in tissues and organs (including the mucous membrane of the vagina), penetrates into the secretion of sweat and sebaceous glands. In the lungs, liver, kidneys, spleen, stomach, skeletal muscles and bones, the concentration of itraconazole exceeds the plasma concentration by 2–3 times, and in tissues that contain keratin - 4 times.

In the skin, therapeutic concentrations of the drug remain for 2-4 weeks after the termination of the 4-week course. In keratin of nails, the therapeutic concentration of itraconazole is achieved after 1 week of therapy and remains for another 6 months after the end of the 3-month course of treatment. In the sweat and sebaceous glands, the concentration of the active substance is quite low.

Itraconazole metabolism occurs in the liver. As a result, active metabolites are formed, one of which is hydroxyitraconazole. Teknazole inhibits the isoenzymes CYP3A4, CYP3A5 and CYP3A7 of the cytochrome P _{450 system}.

It is excreted from the plasma by the kidneys (mainly in the form of metabolites and a small part in the form of unchanged itraconazole) and unchanged through the intestines (about 3-18%). The half-life is 1-1.5 days. Dialysis is ineffective.

Indications for use

• dermatomycosis (fungal skin diseases);
• blastomycosis;
• histoplasmosis;
• candidiasis of the oral mucosa;
• vulvovaginal candidiasis;
• paracoccidioidosis;
• sporotrichosis;
• onychomycosis caused by yeast-like fungi or dermatophytes;
• multicolored (pityriasis) versicolor;
• systemic mycoses: systemic candidiasis, systemic aspergillosis, cryptococcosis (including cryptococcal meningitis) in immunocompromised patients and cryptococcosis of the central nervous system in persons with any immune status in case of ineffective first-line therapy;
• other rare tropical and systemic mycoses.

Contraindications

Absolute:

• CHF (chronic heart failure), including indications of a history of CHF (except for the treatment of especially severe conditions that threaten life);
• period of pregnancy;
• period of breastfeeding;
• simultaneous ingestion of ergot alkaloids, midazolam and triazolam, eletriptan, nisoldipine;
• concomitant use of drugs that prolong the QT interval and are a substrate of the CYP3A4 isoenzyme (for example, astemizole, mizolastine, quinidine, terfenadine, cisapride, pimozide, etc.);
• concomitant use of HMG-CoA reductase inhibitors, in the metabolism of which the CYP3A4 isoenzyme is involved (for example, simvastatin, lovastatin);
• increased individual sensitivity to the main or auxiliary components of the drug.

Relative (Teknazol capsules are used with caution):

• hepatic and / or renal failure;
• hearing impairment;
• the presence of risk factors for CHF (severe pulmonary diseases, for example, chronic obstructive pulmonary disease; damage to the heart valves, coronary heart disease; other conditions that are accompanied by edematous syndrome);
• peripheral neuropathy;
• concomitant use of slow calcium channel blockers;
• children and adolescents up to 18 years old;
• elderly age.

Teknazol, instructions for use: method and dosage

Teknazol capsules are taken orally with the required amount of water. They must be swallowed whole without chewing. The drug should be taken immediately after meals.

Recommended doses and duration of therapy:

• dermatomycosis: 100 mg once a day (course of treatment - 15 days) or 200 mg once a day (course of treatment - 7 days);
• blastomycosis: the initial dose is 100 mg once a day, the maintenance dose is 200 mg twice a day (the course of treatment is 6 months);
• histoplasmosis: the initial dose is 200 mg once a day, the maintenance dose is 200 mg twice a day (the course of treatment is 8 months);
• oral mucosa candidiasis: 100 mg once a day (course of treatment - 15 days); in immunocompromised patients, the bioavailability of Teknazol may be reduced, which sometimes requires an increase in the daily dose by half;
• vulvovaginal candidiasis: 200 mg once a day (only 3 days) or 200 mg twice a day (only 1 day);
• paracoccidioidosis: 100 mg once a day (course of treatment - 6 months);
• sporotrichosis: 100 mg once a day (course of treatment - 3 months);
• onychomycosis: 200 mg twice a day (course of treatment - 1 week) or 200 mg once a day (course of treatment - 3 months); if the nail plates are affected on the legs (even if the nails on the hands are not affected), then it is necessary to carry out 3 courses at 3-week intervals; if only the fingernails are affected by the fungus, then 2 courses with a 3-week interval are sufficient;
• versicolor versicolor: 200 mg once a day (course of treatment - 7 days);
• systemic candidiasis: 100-200 mg once a day (the course of treatment varies from 3 weeks to 7 months); with the spread and progression of the disease, the dose of itraconazole is increased to 200 mg twice a day;
• systemic aspergillosis: 200 mg once a day (the course of treatment varies from 2 to 5 months); in case of progression and spread of the disease, the dose of Teknazol is increased to 200 mg twice a day;
• cryptococcal meningitis: 200 mg twice a day (course of treatment - 2-12 months);
• systemic cryptococcosis (without symptoms of meningitis): 200 mg once a day (course of treatment - 2–12 months);
• keratomycosis: 200 mg once a day (usually the duration of treatment is 3 weeks, but may vary depending on the response to therapy);
• dermatophytosis of the hands and feet: 100 mg once a day (course of treatment - 30 days) or 200 mg twice a day (course of treatment - 7 days);
• chromomycosis: 100-200 mg once a day (course of treatment - 6 months).

In children, Teknazol is used with caution and only if the expected benefit for the child or adolescent outweighs the possible risk.

Side effects

The adverse events of Teknazol described below are classified as follows: very often (≥ 1/10); often (from ≥ 1/100 to <1/10); infrequently (from ≥ 1/1000 to <1/100); rarely (from ≥ 1/10 000 to <1/1000); very rare (<1/10 000); with an unknown frequency (based on available data, it is impossible to accurately estimate the incidence of a side effect):

• gastrointestinal tract: often - nausea, vomiting, impaired taste, abdominal pain, increased activity of liver enzymes, diarrhea; infrequently - constipation, dyspeptic disorders, hyperbilirubinemia, hepatitis; with an unknown frequency - acute liver failure, hepatotoxic effect;
• metabolism: infrequently - low concentration of potassium ions in the blood; with an unknown frequency - an increased level of triglycerides in the blood;
• respiratory system: with an unknown frequency - pulmonary edema;
• cardiovascular system: with an unknown frequency - congestive heart failure;
• nervous system: often - headache; infrequently - dizziness, peripheral neuropathy; with an unknown frequency - hypesthesia, paresthesia;
• sense organs: infrequently - visual impairment (including double vision and blurring); with an unknown frequency - constant or transient deafness, tinnitus;
• hematopoietic system: infrequently - a decrease in the number of leukocytes, platelets and neutrophils;
• musculoskeletal system: with an unknown frequency - muscle pain, arthralgia;
• genitourinary system: with an unknown frequency - urinary incontinence, frequent urination, impotence, menstrual irregularities;
• skin and subcutaneous fat: often - skin rash; infrequently - itchy skin; with an unknown frequency - urticaria, exfoliative dermatitis, pathological hair loss, erythema multiforme, photosensitivity, leukocytoclastic cutaneous vasculitis, Stevens-Johnson syndrome, toxic epidermal necrolysis;
• allergic reactions: with an unknown frequency - Quincke's edema, serum sickness, anaphylactoid and anaphylactic reactions;
• other reactions: infrequently - edema.

Overdose

Data on Teknazol overdose have not been reported. During the first hour, the patient's stomach is washed, activated charcoal is prescribed, and other necessary symptomatic therapy is performed.

There is no specific antidote for itraconazole. Hemodialysis is ineffective for removing the drug from the blood.

special instructions

In order to prevent re-infection, it is necessary to observe personal hygiene and carry out simultaneous treatment of sexual partners. It is not recommended to have sex during therapy.

If, after the completion of the course of treatment, signs of infection persist, the microbiological examination is repeated to confirm the diagnosis.

In patients with severe neutropenia, Teknazol can only be used in exceptional cases (if the first line of therapy is ineffective).

Treatment with itraconazole is discontinued if, during the treatment, the patient develops risk factors for CHF.

Influence on the ability to drive vehicles and complex mechanisms

No effect of Teknazole on human psychomotor abilities was noted.

Application during pregnancy and lactation

In pregnant women, the use of itraconazole is permissible only for systemic mycoses and in those cases when the effect expected from treatment exceeds the possible risk to the fetus.

Patients of reproductive age during treatment with the drug should use reliable methods of contraception.

Experimental studies have shown that itraconazole is embryotoxic and causes various fetal abnormalities.

Teknazol should not be used during lactation. If Teknazole is needed, breastfeeding should be discontinued.

Pediatric use

In children and adolescents under 18 years of age, itraconazole therapy is carried out with caution (if the expected benefit is greater than the potential risk).

With impaired renal function

In case of impaired renal function, drug therapy is carried out with caution, monitoring the concentration of itraconazole in the blood and adjusting its dose accordingly.

For violations of liver function

Teknazole is used with caution in case of liver dysfunction and liver diseases. If the course of treatment is more than 1 month, it is necessary to regularly monitor liver function.

Use in the elderly

Elderly patients should take Teknazol with caution.

Drug interactions

The absorption of itraconazole is impaired with the simultaneous use of drugs that reduce the acidity of gastric juice.

Phenytoin, rifabutin, rifampicin and other inducers of the CYP3A4 isoenzyme reduce the bioavailability of itraconazole, and erythromycin, indinavir, ritonavir, clarithromycin and other inhibitors of the CYP3A4 isoenzyme increase it.

Teknazol enhances the therapeutic and side effects of drugs that are metabolized with the participation of the CYP3A4 isoenzyme.

Itraconazole is used with caution in conjunction with HIV protease inhibitors, indirect anticoagulants, slow calcium channel blockers, some immunosuppressants (tacrolimus, cyclosporine, sirolimus), some antineoplastic agents (trimetrexate, busulfan, vinca alkaloids, glucocorticosteroids, some budesonide, methylprednisolone, dexamethasone) and other drugs (fentanyl, loperamide, alfentanil, disopyramide, repaglinide, carbamazepine, reboxetine, cilostazol, halofantrine, buspirone, alprazolam, ebastine, and intramusolamide).

Analogs

Teknazol analogs are Itrazol, Irunin, Itraconazole, Itraconazole Sandoz, Orunit, Orungamin, Orungal, Canditral, Rumikoz, etc.

Terms and conditions of storage

Store in a dark, dry place at a temperature not exceeding 25 ° C. Keep out of the reach of children.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Teknazol

According to reviews, Teknazole is a very effective drug for local and systemic fungal diseases. The result of treatment is observed in all cases, and it is quite quick. The drug has a broad spectrum of action and is usually well tolerated by patients.

Of the shortcomings, the most often mentioned are the high cost of the drug and possible adverse reactions.

Price for Teknazol in pharmacies

Price for Teknazol 100 mg capsules in packs of 4 is 390-410 rubles., in packs of 15 pcs. - 755-1050 rubles.

Teknazol: prices in online pharmacies

Drug name Price Pharmacy

Teknazole 100 mg capsules 4 pcs. 408 RUB Buy

Teknazole 100 mg capsules 15 pcs. 819 RUB Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!