Orungal - Instructions For Use, Reviews, Price, Analogues

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

Orungal

Orungal: 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: Orungal

ATX code: J02AC02

Active ingredient: itraconazole (itraconazole)

Manufacturer: Janssen Pharmaceuticals N. V. (Janssen Pharmaceutica NV) (Belgium), Janssen-Cilag S.p. A. (Janssen-Cilag, SpA) (Italy)

Description and photo update: 2019-19-08

Prices in pharmacies: from 2337 rubles.

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Orungal is a triazole derivative, an antifungal agent of systemic action.

Release form and composition

• Capsules: size No. 0, gelatinous solid, with a transparent pink body and an opaque blue cap; contents - cream-colored pellets (4 or 6 pcs. in a blister, in a cardboard box 1 blister; 5 pcs. in a blister, in a cardboard box 3 blisters; 14 pcs. in a blister, in a cardboard box 1, 2, 3 or 6 blisters);
• Oral solution: light orange or yellow, with cherry aroma (150 ml each in dark glass bottles, in a cardboard box 1 bottle complete with a 10 ml measuring cup).

The active substance is itraconazole, its content:

• 1 capsule - 100 mg;
• 1 ml of solution - 10 mg.

Additional components of capsules:

• Excipients: hypromellose, sucrose, macrogol 20,000;
• Shell composition: gelatin, titanium dioxide (E171), azorubin dye (E122), indigo carmine dye (E132).

Auxiliary components of the solution: concentrated hydrochloric acid, sodium saccharinate, propylene glycol, sodium hydroxide, hydroxypropylbetadex, sorbitol solution 70%, purified water, caramel flavor, cherry 1 and cherry 2 flavors.

Pharmacological properties

Pharmacodynamics

Orungal is an antifungal drug.

Itraconazole is a triazole derivative that is active against dermatophytes (Trichophyton, Microsporum, Epidermophyton floccosum); yeast / yeast-like fungi (Candida spp., including Candida krusei, Candida glabrata, Candida albicans, Cryptococcus neoformans, Trichosporon spp., Pityrosporum spp., Geotrichum spp.), Histoplasma spp., Aspergilcoothus spp., Sp. spp., Fonsecaea spp., Blastomyces dermatitidis, Penicillium marneffei, Pseudallescheria boydii, and other yeast / molds.

The mechanism of antifungal action is based on a violation of the synthesis of ergosterol, which is an important component of the fungal cell membrane.

Pharmacokinetics

The maximum oral bioavailability of itraconazole is observed when taken immediately after meals. C _max (maximum concentration) of a substance in plasma is reached in 3-4 hours.

When carrying out a long course of C _ss (equilibrium concentration) in plasma is achieved in 1-2 weeks.

3-4 hours after taking the C _{ss of the} substance is 0.4; 1.1 or 2 μg / ml (dosing regimen - 1 time per day, 100 mg, 1 time per day, 200 mg, or 2 times a day, 200 mg, respectively).

Binds to plasma proteins at a level of 99.8%.

In the blood, the concentration of itraconazole is 60% of the plasma concentration.

The accumulation of the substance in keratin tissues, especially in the skin, is approximately 4 times higher than accumulation in plasma, the rate of its excretion is determined by the regeneration of the epidermis.

The concentration of itraconazole in plasma 7 days after the cessation of therapy cannot be detected, the substance in the skin remains at a therapeutic level for 2-4 weeks after the end of the four-week course of taking Orungal. In the keratin of the nail plates, itraconazole is detected as early as 7 days after the start of application and persists for at least 6 months after the completion of a three-month course. Also, the substance is determined in sebum, in a lower concentration - in sweat.

There is a good distribution of itraconazole in tissues that are susceptible to fungal infections. Concentrations in the liver, kidneys, lungs, stomach, bones, muscles and spleen are 2–3 times higher than the corresponding plasma values. The substance remains at a therapeutic level in the tissues of the vagina for another 2 or 3 days (after taking 200 mg for three days 1 or 2 times a day, respectively).

Metabolism occurs in the liver, resulting in the formation of a large number of metabolites. The active metabolite hydroxy-itraconazole has an antifungal effect comparable to itraconazole.

Excretion from plasma occurs in two phases, the final T _1/2 (half-life) is 24-36 hours. About 35% of the dose is excreted within 7 days in the urine in the form of metabolites, unchanged - less than 0.03%. With feces, approximately 3-18% of the dose is excreted.

In renal failure and liver cirrhosis, the plasma concentration of itraconazole and its T _{1/2 is} slightly higher.

Reduced bioavailability of itraconazole can be observed in some immunocompromised patients, in particular with neutropenia, AIDS, or after organ transplant surgery.

Indications for use

For Orungal capsules - treatment of mycoses caused by pathogens sensitive to itraconazole:

• Pityriasis versicolor;
• Candidomycosis with lesions of the skin and / or mucous membranes (including vulvovaginal candidiasis);
• Dermatomycosis;
• Onychomycosis caused by dermatophytes and / or yeasts and molds;
• Deep visceral candidiasis;
• Fungal keratitis;
• Systemic mycoses: sporotrichosis, blastomycosis, systemic candidiasis, paracoccidioidomycosis, systemic aspergillosis, histoplasmosis, cryptococcosis (including cryptococcal meningitis), as well as other systemic and tropical mycoses.

For Orungal solution:

• Treatment of oral and / or esophageal candidiasis in immunocompromised and HIV-positive patients;
• Prevention of systemic fungal infections in people with malignant blood diseases and in patients who have undergone bone marrow transplantation with a high risk of developing neutropenia (less than 500 cells / μL).

Contraindications

Absolute:

• Simultaneous use of ergot alkaloids (dihydroergotamine, ergometrine, ergotamine or methylergometrine);
• Co-administration of midazolam (oral) or triazolam;
• Concomitant use of drugs that are metabolized with the participation of the CYP3A4 enzyme and are capable of increasing the QT interval (for example, mizolastine, astemizole, cisapride, pimozide, quinidine, sertindole, dofetilide, levomethadone, terfenadine);
• Concomitant use of HMG-CoA reductase inhibitors, metabolized with the participation of the CYP3A4 enzyme (for example, lovastatin or simvastatin);
• Lactation period;
• Relative:
• Pregnancy;
• Hypersensitivity to any component emerging in Orungal.

Relative:

• Children and old age;
• Cirrhosis of the liver;
• Chronic renal failure
• Chronic heart failure;
• Hypersensitivity to other drugs of the azole group.

Instructions for the use of Orungal: method and dosage

Capsules

In this form, Orungal should be taken orally immediately after meals: swallow the capsules whole and drink plenty of liquid.

Recommended dosage regimens depending on indications:

• Dermatomycosis of smooth skin: 200 mg (2 capsules) 1 time a day for 7 days or 100 mg (1 capsule) 1 time a day for 15 days;
• Vulvovaginal candidiasis: 200 mg 2 times a day for 1 day or 200 mg 1 time a day for a 3-day course;
• Pityriasis versicolor: 200 mg once a day for 7 days;
• Oral candidiasis: 100 mg once a day for a 15-day course;
• Lesions of highly keratinized areas of the skin (feet and hands): 200 mg 2 times a day for a course of 7 days or 100 mg 1 time a day for 30 days;
• Fungal keratitis: 200 mg once a day for 21 days. Depending on the clinical picture of the disease, the duration of therapy can be adjusted.

In case of impaired immunity (for example, in patients with organ transplants, acquired immunodeficiency syndrome or neutropenia), the bioavailability of itraconazole may decrease. In this case, it is necessary to increase the standard dose of Orungal by 2 times.

Treatment of onychomycosis is carried out by pulse therapy:

• The defeat of the toenails, including with the defeat of the nail plates on the hands: 200 mg 2 times a day for 1 week. The general course of therapy consists of 3 weekly cycles with intervals of 3 weeks between cycles;
• The defeat of the nails on the hands: 200 mg 2 times a day for 1 week. The general course of therapy consists of 2-week cycles with an interval of 3 weeks between cycles.

Also, with onychomycosis, it is possible to carry out continuous therapy - 200 mg 1 time per day for 3 months.

Since the elimination of itraconazole from the skin and nail tissue is slower than from blood plasma, optimal mycological and clinical effects are achieved 2-4 weeks after the end of treatment for skin infections and 6-9 months after the end of therapy for nail infections.

Recommended dosage regimens of Orungal for systemic mycoses:

• Chromomycosis: 100-200 mg 1 time per day for 6 months;
• Histoplasmosis: from 200 mg once a day to 200 mg twice a day for 8 months;
• Cryptococcosis (excluding meningitis): 200 mg 1 time per day, treatment can last from 2 to 12 months;
• Cryptococcal meningitis: 200 mg 2 times a day, the duration of therapy is from 2 to 12 months;
• Sporotrichosis: 100 mg once a day for 3 months;
• Aspergillosis: 200 mg once a day for 2-5 months. In invasive and disseminated forms of the disease, the dose is increased to 200 mg 2 times a day;
• Candidiasis: 100-200 mg 1 time per day, therapy can last from 3 weeks to 7 months. For invasive and disseminated forms of the disease, the dose is increased to 200 mg 2 times a day;
• Paracoccidioidomycosis: 100 mg 1 time per day for 6 months;
• Blastomycosis: from 100 mg 1 time per day to 200 mg 2 times a day in a 6-month course.

For all systemic mycoses, the duration of treatment can be adjusted depending on the clinical effectiveness of Orungal.

Oral solution

In this dosage form, Orungal should be taken orally on an empty stomach. Rules for taking the drug: take a solution, rinse your mouth and only then swallow it. You should not rinse your mouth with clean water after that.

Recommended dosage regimens:

• Treatment of candidiasis of the oral cavity and / or esophagus: 200 mg (2 measuring cups) per day in 1-2 doses. The course of treatment is 1 week. In the absence of a positive effect, the therapy is extended for another 1 week;
• Treatment of oral and / or esophageal candidiasis in patients with resistance to fluconazole: 200-400 mg per day in 1-2 doses. The course of treatment is 2 weeks. In the absence of a positive effect, therapy is extended for another 2 weeks;
• Prevention of systemic fungal infections: 5 mg / kg / day in 2 divided doses. Orungal should be started 1 week before the start of cytostatic therapy or 1 week after bone marrow transplantation and continue until the neutrophil count is restored (at least 1000 cells / μl).

Side effects

Orungal is generally well tolerated. In rare cases, the following side effects are possible:

• From the digestive system: a transient increase in the level of liver enzymes in the blood plasma, abdominal pain, diarrhea / constipation, nausea, dyspepsia, vomiting, hepatitis; in isolated cases - toxic liver damage (cases of acute liver failure with a fatal outcome are known);
• From the side of the central and peripheral nervous system: headache, peripheral neuropathy, vertigo;
• From the reproductive system: menstrual irregularities;
• On the part of the cardiovascular system: pulmonary edema, congestive heart failure;
• Dermatological and allergic reactions: pruritus, rash, urticaria, alopecia, photosensitivity, Stevens-Johnson syndrome, angioedema, anaphylactic and anaphylactoid reactions;
• Others: edematous syndrome, hypokalemia.

Overdose

Overdose has not been reported.

In case of an accidental overdose during the first 60 minutes after taking Orungal, gastric lavage is indicated. Perhaps the appointment of activated carbon.

There is no specific antidote. Itraconazole is not removed from the body by hemodialysis.

special instructions

For patients with immunodeficiency and for patients with cryptococcosis of the central nervous system, Orungal is prescribed only if there are contraindications to the use of first-line drugs or they are ineffective.

In patients with impaired renal and hepatic function during treatment, the concentration of itraconazole in plasma should be monitored and, if necessary, the dose of Orungal should be adjusted.

Women of childbearing age receiving itraconazole need to use reliable contraceptive methods throughout the course of therapy and until the onset of the first menstrual period after its completion.

Orungal should be discontinued if neuropathy develops.

There is insufficient data on the clinical safety of the drug in children, therefore, in pediatric practice, it is used only if the expected benefits outweigh the potential risks. According to some reports, itraconazole is used for the prevention of fungal infections in children with neutropenia (5 mg / kg 2 times a day).

Influence on the ability to drive vehicles and complex mechanisms

According to the instructions, Orungal does not adversely affect the speed of reactions and the ability to increase concentration.

Application during pregnancy and lactation

• pregnancy: Orungal can only be used in case of life-threatening systemic mycoses, after assessing the ratio of the expected benefits with the possible risk;
• lactation period: the use of the drug is contraindicated.

Pediatric use

Orungal therapy for patients under 18 years of age is prescribed with caution.

With impaired renal function

In chronic renal failure, Orungal should be used under medical supervision.

For violations of liver function

With cirrhosis of the liver, Orungal should be used under medical supervision.

Use in the elderly

Orungal therapy for elderly patients is prescribed with caution.

Drug interactions

The absorption of itraconazole is impaired with low acidity of gastric juice, therefore, with the simultaneous administration of antacids (for example, aluminum hydroxide), it is recommended to take them no earlier than 2 hours after Orungal.

Patients with achlorhydria or receiving proton pump inhibitors or histamine H ₂ receptor blockers are advised to drink cola capsules after administration.

Potential inhibitors of the CYP3A4 isoenzyme (eg, clarithromycin, indinavir, erythromycin, ritonavir) increase the bioavailability of itraconazole.

Itraconazole can suppress the metabolism of drugs that are metabolized by the isoenzyme CYP3A4, as a result of which it is possible to enhance or prolong their effects, including side effects.

With the simultaneous use of the following drugs, it is necessary to monitor their plasma concentrations, severity of action and side effects, if necessary adjust the dose: oral anticoagulants metabolized by the CYP3A4 isoenzyme calcium channel blockers (for example, verapamil, dihydropyridine), HIV protease inhibitors (for example, indinavir, ritonavir, saquinavir), some glucocorticosteroids (including budesonide, methylprednisolone, dexamethasone), some immunosuppressive drugs (including tacrolimus, cyclosporin, sirolimus), some CYP3A4 inhibitors metabolized by the enzyme CYP3A4-coA-reductase inhibitors atorvastatin), certain anticancer drugs (eg, vinca alkaloids, docetaxel, busulfan, trimetrexate), midazolam (intravenous), ebastine, disopyramide, eletriptan, alfentanil,carbamazepine, brotizolam, cilostazol, rifabutin, halofantrine, alprazolam, buspirone, reboxetine, repaglinide, methylprednisolone, digoxin.

When carrying out treatment with Orungal, it is imperative to take into account drugs that cannot be used simultaneously (described in the section "Contraindications").

It is not recommended to simultaneously use calcium channel blockers, since they have a negative inotropic effect, which can enhance the similar effect of itraconazole.

It is not recommended to use Orungal in combination with drugs that are potential inducers of liver enzymes (including rifampicin, phenytoin, rifabutin, phenobarbital, isoniazid, carbamazepine).

Analogs

Orungal's analogs are: Irunin, Itrazol, Itraconazole, Canditral, Orungamin, Rumikoz, Izol, Orunzol, Trioxal, Vfend, Diaflu, Diflazon, Mikosist, Fluconazole.

Terms and conditions of storage

Keep out of the reach of children at a temperature: capsules - 15-30 ºС, solution - no more than 25 ºС.

Shelf life of capsules - 3 years, drops for oral administration - 2 years (after the first opening of the bottle - 1 month).

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Orungal

According to reviews, Orungal is an effective antifungal agent. The disadvantages include the high cost and the likelihood of developing adverse reactions.

Orungal price in pharmacies

The approximate price for Orungal is: solution for oral administration (1 bottle of 150 ml) - 3971–4234 rubles, capsules (14 pcs. 100 mg each) - 2638–4450 rubles.

Orungal: prices in online pharmacies

Drug name Price Pharmacy

Orungal 100 mg capsule 14 pcs. 2337 RUB Buy

Orungal capsules 100mg 14 pcs. 2837 RUB Buy

Orungal 10 mg / ml oral solution 150 ml 1 pc. 3899 RUB 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!