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

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

Canditral

Canditral: 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. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Canditral

ATX code: J02AC02

Active ingredient: itraconazole (Itraconazole)

Manufacturer: Glenmark Pharmaceuticals, Ltd. (Glenmark Pharmaceuticals, Ltd.) (India)

Description and photo update: 2019-12-07

Prices in pharmacies: from 974 rubles.

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Canditral is a broad-spectrum antifungal drug.

Release form and composition

The drug is produced in the form of capsules: size No. 0, gelatinous, hard, red capsule body with white overprint - canditral, white cap with black overprint of the pharmaceutical company logo in the form of the letter G; inside the capsules there are pellets - round microgranules from white with a beige tint to white (in blister packs of 4 or 6 pcs., in a cardboard box 1 pack; in blister packs of 7 pcs., in a cardboard box 1 or 2 packs. Each pack also contains instructions for the use of Canditral).

1 capsule contains:

• active substance: itraconazole - 100 mg;
• auxiliary components: methyl methacrylate, dimethylaminoethyl methacrylate and butyl methacrylate copolymer (Eudragit E-100), sucrose, hypromellose (hydroxypropyl methylcellulose E-5);
• capsule shell: gelatin, methyl parahydroxybenzoate, sodium lauryl sulfate, propyl parahydroxybenzoate, purified water; additionally in the cap composition - titanium dioxide, in the ink composition - iron dye black oxide; additionally in the capsule body: dye azorubin (carmoisin), crimson dye (Ponso 4R), in the ink - titanium dioxide.

Pharmacological properties

Pharmacodynamics

Canditral is an antifungal drug, its active ingredient is itraconazole, which is a synthetic derivative of triazole. The mechanism of action is due to the inhibition of the synthesis of an important component of the cell membrane of fungi - ergosterol.

Itraconazole has a wide spectrum of action, dermatophytes [Trichophyton speciales (spp.), Epidermophyton floccosum, Microsporum spp.], Yeast, yeast-like and mold fungi, including Candida albicans, Candida krusei, Candida glabratcus, and other Candida krusei, Candida glabratcus neoformans, Trichosporon spp., Pityrosporum spp., Geotrichum spp., Histoplasma spp., Aspergillus spp., Paracoccidioides brasiliensis, Fonsecaea spp., Sporothrix schenckii, Cladosporium spp., Pseudalis marischeria

Pharmacokinetics

After oral administration, the maximum concentration of itraconazole in blood plasma occurs in 3-4 hours. The use of the capsules immediately after meals ensures maximum bioavailability.

Equilibrium plasma concentration (C _ss) is achieved within 7-14 days of therapy. The C _ss level depends on the dose of Canditral: with a dosage regimen of 100 mg once a day, it is 0.0004 mg / ml, 200 mg once a day - 0.0011 mg / ml, 200 mg 2 times a day - 0.002 mg / ml.

The binding of itraconazole to plasma proteins is 99.8%. It penetrates well into tissues and organs, and is distributed in them. The concentration of the active substance in bones, skeletal muscles, lungs, stomach, liver, kidneys, spleen is 2-3 times higher than the level of its content in plasma. It is determined in the secretion of the sebaceous and sweat glands. The accumulation of itraconazole in the skin and tissues containing keratin is 4 times higher than its concentration in plasma.

The rate of excretion of the drug depends on the level of regeneration of the epidermis. Plasma itraconazole is undetectable 7 days after stopping treatment. At the same time, its therapeutic concentration in the skin remains for 14-28 days after the termination of the course of treatment lasting 28 days, in the vaginal mucosa - for 2 days after 3 days of treatment at a daily dose of 200 mg or 3 days after a one-day course of therapy at a dose 200 mg 2 times a day. In the keratin of the nails, the therapeutic level of the substance is determined 7 days after the start of taking Canditral and persists for 180 days after the completion of therapy for 90 days.

It is metabolized in the liver to form hydroxyitraconazole and other active metabolites.

Itraconazole is characterized by biphasic elimination from plasma, the terminal half-life (T _1/2) is 24-36 hours.

3–18% of the dose is excreted through the intestines, less than 0.03% of the dose through the kidneys. Within 7 days, up to 35% of the dose is excreted in the urine in the form of metabolites.

In renal failure, liver cirrhosis, AIDS (acquired immunodeficiency syndrome), neutropenia and other immune disorders, including the condition after organ transplantation, itraconazole bioavailability may decrease.

In patients with liver cirrhosis, T _{1/2 of the} drug is increased.

Indications for use

• dermatomycosis;
• onychomycosis caused by yeast and / or dermatophytes and molds;
• fungal keratitis;
• systemic candidiasis and aspergillosis, cryptococcosis (including cryptococcal meningitis, in patients with immunodeficiency or cryptococcosis of the central nervous system - only if it is impossible to use first-line drugs or their ineffectiveness), histoplasmosis, sporotrichosis, blastomycosis, paracoccidioidomycosis and other systemic or tropical mycoses
• deep visceral candidiasis;
• candidiasis with lesions of the skin and mucous membranes, including vulvovaginal candidiasis;
• pityriasis versicolor.

Contraindications

Absolute:

• simultaneous use with the following drugs: drugs metabolized by the CYP3A4 enzyme capable of increasing the QT interval (terfenadine, astemizole, mizolastine, dofetilide, quinidine, cisapride, sertindole, pimozide, levomethadone); ergot alkaloids (ergotamine, methylergometrine, dihydroergotamine, ergometrine); midazolam and triazolam when taken orally; inhibitors of hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase, which are cleaved by the CYP3A4 enzyme (lovastatin, simvastatin);
• breast-feeding;
• age up to three years;
• individual hypersensitivity to Canditral's components.

With caution (relative contraindications), it is recommended to use Canditral capsules in severe heart failure, liver disease, liver failure, chronic renal failure, as well as in pediatrics.

During pregnancy, the appointment of itraconazole is allowed only in life-threatening conditions for the patient, when the expected clinical effect for the mother exceeds the potential threat to the fetus.

Canditral, instructions for use: method and dosage

Canditral capsules are taken orally, after meals.

Recommended dosage regimen:

• vulvovaginal candidiasis: 200 mg 2 times a day, course duration - 1 day or 200 mg 1 time a day for 3 days;
• pityriasis versicolor: 200 mg once a day, the course of therapy is 7 days;
• dermatomycosis of smooth skin: 200 mg once a day for 7 days or 100 mg once a day for 15 days;
• oral candidiasis: 100 mg once a day, the course of treatment is 15 days;
• fungal keratitis: 200 mg once a day, course duration 21 days;
• lesions of highly keratinized areas of the skin (hands, feet): 200 mg 2 times a day, the duration of the course is 7 days or 100 mg 1 time a day for 30 days.

The duration of the course may be adjusted, taking into account the dynamics of the treatment picture.

In some cases, a two-fold dose increase may be required when taking itraconazole orally, for example, in patients with impaired immunity (neutropenia, AIDS or organ transplantation) due to a decrease in its bioavailability.

Recommended dosage for the treatment of onychomycosis caused by molds, dermatophytes and / or yeasts:

• pulse therapy: 200 mg 2 times a day, the duration of one course is 7 days. In the treatment of fungal lesions of the nail plates of the hands, it is recommended to carry out 2 courses of therapy with a break in taking Canditral for 21 days, the nail plates of the feet (whether the nail plates of the hands are affected or not) - 3 courses of therapy with an interval of 21 days between each course. The clinical effect will become evident as the nails grow back after the end of treatment;
• continuous treatment of lesions of the nail plates of the feet (whether or not the nail plates of the hands are affected): 200 mg 1 time per day for 90 days.

The optimal mycological and therapeutic effect occurs 14-28 days after the end of Canditral's treatment for the treatment of skin diseases and 180-270 days after the end of the treatment of nail lesions.

The recommended dosage of Canditral for the treatment of systemic mycoses:

• candidiasis: 100-200 mg once a day, duration of treatment from 21 days to 210 days. For invasive or disseminated candidiasis, the daily dose should be 200 mg 2 times a day;
• aspergillosis: 200 mg once a day, the duration of the course of therapy is from 60 to 150 days. It is recommended to increase the dose by 2 times (200 mg 2 times a day) in case of invasive or disseminated form of pathology;
• cryptococcosis (excluding meningitis): 200 mg once a day, treatment can last from 60 to 360 days;
• cryptococcal meningitis: 200 mg 2 times a day, course of therapy from 60 to 360 days;
• histoplasmosis: 200 mg 1 or 2 times a day for 240 days;
• sporotrichosis: 100 mg once a day for 90 days;
• blastomycosis: 100 mg once a day or 200 mg twice a day for 180 days;
• chromomycosis: 100-200 mg once a day for 180 days;
• paracoccidioidomycosis: 100 mg once a day for 180 days.

Side effects

• from the nervous system: dizziness, headache, peripheral neuropathy;
• from the gastrointestinal tract: decreased appetite, dyspepsia, abdominal pain, nausea, vomiting, diarrhea, constipation;
• from the hepatobiliary system: hepatitis, a reversible increase in the activity of hepatic transaminases; very rarely - a severe form of toxic liver damage, acute liver failure (including fatal);
• allergic reactions: angioedema, skin rash, itching, urticaria; rarely - Stevens-Johnson syndrome (erythema multiforme exudative);
• on the part of the skin: photosensitivity, alopecia;
• others: congestive heart failure, hypokalemia, pulmonary edema, edema syndrome, dark urine, hypercreatinemia, menstrual irregularities.

Overdose

Overdose symptoms have not been established.

Treatment: if you accidentally take a high dose of Canditral, you should immediately (within the first hour) wash the stomach, take activated charcoal. There is no specific antidote. Hemodialysis is ineffective.

special instructions

After the cancellation of Canditral, the concentration of itraconazole in the plasma remains for a long time, therefore it is important to take into account its inhibitory effect when prescribing drugs that are metabolized under the influence of the CYP3A4 enzyme.

The negative inotropic effect of itraconazole must be considered when treating patients with chronic heart failure (including history). For this category of patients, the appointment of the drug is indicated in exceptional cases when, according to the doctor, the expected clinical effect significantly exceeds the potential risk of developing heart failure.

With intravenous administration of itraconazole, there is an asymptomatic decrease in the left ventricular ejection fraction, which is transient.

Absorption of itraconazole is impaired with low stomach acidity. Therefore, with concomitant therapy with antacids (including aluminum hydroxide), it is recommended to take them only 2 hours (or more) after taking Canditral. With achlorhydria, taking H2-histamine blockers or proton pump inhibitors, it is recommended to drink the capsules with acidic drinks.

Due to the existing risk of severe toxic liver damage (including acute liver failure with a fatal outcome), itraconazole therapy is recommended to be accompanied by regular monitoring of liver function, starting from the first days of taking the drug.

If neuropathy occurs, the Canditral reception must be completed.

Cross-hypersensitivity to itraconazole and other azole antifungal drugs has not been established, therefore, Canditral should be taken with caution if hypersensitivity to other azoles is established.

Influence on the ability to drive vehicles and complex mechanisms

The use of Canditral does not affect the patient's psychomotor functions.

Application during pregnancy and lactation

The appointment of Canditral during pregnancy is indicated only in exceptional cases if the expected effect of therapy for a woman justifies the potential risk to the fetus.

Patients of childbearing age need to use reliable methods of contraception, both during the entire course of the drug use, and after its completion, until the first menstruation occurs.

The use of Canditral is contraindicated when breastfeeding, in cases of proven need for therapy, breastfeeding should be discontinued.

Pediatric use

The use of Kanditrala is contraindicated for the treatment of children under the age of three years.

It is recommended to prescribe the drug with caution for the treatment of children over three years of age.

The use of Canditral in pediatrics is indicated only in exceptional cases when the expected clinical effect outweighs the possible risk.

With impaired renal function

With caution, Canditral should be used in chronic renal failure.

Patients with impaired renal function may require dose adjustment of the drug due to a decrease in the bioavailability of itraconazole.

For violations of liver function

It is recommended to use Canditral with caution in case of liver diseases, liver failure.

Drug interactions

With the simultaneous use of Canditral:

• drugs that reduce the acidity of gastric juice: help to reduce the absorption of itraconazole;
• rifampicin, rifabutin, isoniazid, phenytoin, carbamazepine, other powerful inducers of the CYP3A4 enzyme: combined administration is not recommended due to the fact that a significant decrease in the bioavailability of itraconazole and its active metabolite is likely, causing a decrease in the effectiveness of Canditral;
• ritonavir, clarithromycin, indinavir, erythromycin and other potent inhibitors of the CYP3A4 enzyme: these drugs can potentiate an increase in the bioavailability of itraconazole;
• calcium channel blockers, including verapamil and dihydropyridine derivatives: it is not recommended to prescribe in connection with the possible pharmacokinetic interaction with itraconazole, caused by a common metabolic pathway, and an increase in the negative inotropic effect of the drug. Possible decrease in the metabolism of calcium channel blockers;
• oral anticoagulants, ritonavir, saquinavir, indinavir, pink vinca alkaloids, docetaxel, trimetrexate, busulfan, cyclosporin, sirolimus, tacrolimus, atorvastatin, budesonide, methylprednisolone, dexamethasone, budesonamol, ribastinol, alprednisolone, dexamethasone, budesonamol, digoxinfin (for intravenous administration), reboxetine, cilostazol, eletriptan, halofantrine, disopyramide, repaglinide: these drugs should be taken with caution, controlling their plasma concentration, therapeutic effect and side effects. If necessary, it is recommended to reduce the dose of the listed drugs in a timely manner;
• zidovudine, fluvastatin: the interaction of these drugs with itraconazole has not been established;
• ethinylestradiol, norethisterone: the metabolism of these drugs is not disturbed;
• diazepam, imipramine, propranolol, cimetidine, indomethacin, sulfamethazine, tolbutamide: the interaction of itraconazole and these drugs at the level of binding to plasma proteins has not been established.

Analogs

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

Terms and conditions of storage

Keep out of the reach of children.

Store at temperatures up to 25 ° C, protected from moisture and light.

The shelf life is 2.5 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Canditral

Reviews about Canditral are controversial. Some patients report high efficacy of the drug in the treatment of fungal diseases and good tolerance. At the same time, in some cases, users note a complete lack of a therapeutic effect or the occurrence of relapses.

Occasionally patients complain that transient or persistent deafness may appear while taking Canditral.

The price of Canditral in pharmacies

The price of Canditral for a package containing 14 capsules can be from 907 rubles.

Canditral: prices in online pharmacies

Drug name Price Pharmacy

Canditral 100 mg capsules 14 pcs. 974 RUB Buy

Canditral capsules 100mg 14 pcs. RUB 1003 Buy

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, 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!