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Pharmacological group: Antifungal preparations for systemic use. Triazole derivatives. Itraconazole. ATX code J02A C02.
Composition:
Active ingredient: Itraconazole
1 capsule contains itraconazole, pellets in terms of itraconazole 100 mg; auxiliary substances: hypimloose (hydroxypropylmethylcellulose (E 5)), sucrose; The composition of the shell capsule: gelatin, titanium dioxide (E 171), Azorubin (E 122), Indigo (E 132).
Indications:
Vulvovaginal candidiasis; Flyheads; Dermatomikosis caused by the sensitive to the causative agents (Trichophyton SPP., Microsporum SPP., Epidermophyton Floccosum), for example, dermatophyte stop, groin dermatomycosis, drumatties of the body, dermatophyte of hands; Orofarental candidiasis; onichomicoses caused by dermatophytes and / or yeast histoplasmosis;
Systemic myoses (in cases where antifungal therapy of the first line can not be applied or in the event of the ineffective treatment by other antifungal drugs, which may be due to the existing pathology, the insensitivity of the pathogen or the toxicity of the drug): Aspergillosis and candidiasis; Cryptococcosis (including cryptococcal meningitis): Treatment of patients with cryptococcosis and all patients with cryptococcosis of the central nervous system (CNS); Supporting therapy in patients with AIDS patients in order to prevent the relapse of the existing fungal infection.
Contraindications:
Capsules are contraindicated to patients with known hypersensitivity to a valid substance or any of the aids. The simultaneous use of Itraconazole and CYP3A4 substrates are contraindicated. Simultaneous use may cause an increase in the concentrations of these drug plasma, which can lead to strengthening or prolongation of therapeutic and adverse reactions and states that can potentially threaten life.
For example, the concentrations of these medicines can lead to an increase in Qt interval and ventricular tachyarithmiums, including cases of flickering of ventricles, and potential fatal arrhythmias. Data drugs are indicated in the section “Interaction with other drugs and other types of interactions.” It is contraindicated to the use of hatching capsules to patients with ventricular dysfunction, such as stagnant heart failure, or stagnant heart failure in history, with the exception of the treatment of infections threatening life (see section “Features of application”). It is not necessary to use Itraconazole capsules during pregnancy, except for the treatment of states, Threatening life of pregnant women (see section “Application during pregnancy or breastfeeding”). Women of reproductive age should apply effective methods of contraception during treatment with Itraconazole capsules, as well as to the end of the menstrual cycle after graduation Treatment.
Method of administration and dosage:
Itraconazole capsules are used inside immediately after eating to ensure maximum absorption.
Capsules should be swallowed entirely.
Detailed diagrams and doses of reception See in the packaging of the drug.
Optimal clinical and mycological effects are achieved 1-4 weeks after the end of treatment for skin infections, vulvovaginal and oropharyngeal candidiasis, and after 6-9 months after completion of treatment for nail plate infection. This is due to the fact that the withdrawal of the drug from the tissues of the skin, nails and mucous membranes occurs more slowly than from blood plasma.
Elderly patients. The use of Itracon in elderly patients is not recommended.
Patients with impaired renal function. Clinical data on the use of oral forms of the drug in patients with impaired renal function are limited. Oral bioavailability of the drug may be reduced in patients with renal insufficiency. Caution should be exercised when using this drug in such patients and a dose adjustment should be considered.
Patients with impaired liver function. Clinical data on the use of oral forms of the drug in patients with impaired liver function are limited. Caution should be exercised when using this drug in such patients.
Overdose:
In general, adverse reactions reported in case of overdose had a similar profile to adverse reactions that occurred when taking itraconazole (see section “Adverse Reactions”). In case of overdose, supportive measures should be taken. If justified, activated carbon can be prescribed. Itraconazole cannot be removed by hemodialysis. There is no specific antidote.
Shelf life:
3 years.
Storage conditions:
Store in its original packaging at a temperature not exceeding 25 °C.
Produced in Ukraine
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