Orungal capsules are used for the following indications:
Active substance: itraconazole;
1 capsule contains 100 mg of itraconazole;
Excipients: sucrose, hypromellose and polyethylene glycol 20,000;
Capsule shell: titanium dioxide (E 171), indigo (E 132), erythrosine (E 127), gelatin.
Orungal capsules are contraindicated in patients with known hypersensitivity to the active substance or any of the excipients.
The simultaneous use of Orungal and CYP3A4 substrates is contraindicated. Simultaneous use can cause an increase in the concentration of these preparations in blood plasma, which can lead to an increase or prolongation of therapeutic and adverse reactions and conditions that can potentially be life-threatening. For example, increased concentrations of these preparations can lead to an increase in the QT interval and ventricular tachyarrhythmias, in particular in atrial fibrillation, arrhythmias with potential death.
The use of Orungal capsules is contraindicated in patients with ventricular dysfunction, such as congestive heart failure, or a history of congestive heart failure, except for the treatment of life-threatening infections.
Orungal capsules should not be used during pregnancy, except for the treatment of conditions that threaten the life of a pregnant woman.
Women of reproductive age should use effective methods of contraception during treatment with Orungal capsules, as well as until the end of the menstrual cycle after the end of treatment.
Orungal capsules should be used orally immediately after meals to ensure maximum absorption. The capsules should be swallowed whole.
Pregnant
The preparation should not be administered to pregnant women, except in cases of life-threatening systemic mycoses, when the potential benefit to the mother outweighs the risk of negative effects on the fetus.
Children
The use of this preparation is not recommended for children.
Drivers
Studies of the effect on the reaction rate when driving or operating other mechanisms have not been conducted. It should be remembered about the possibility of such adverse reactions as dizziness, visual disturbances and hearing loss, which can lead to negative consequences while driving and working with other mechanisms.
In case of overdose, supportive measures should be taken. If warranted, activated carbon can be prescribed. Itraconazole cannot be removed by hemodialysis. There is no specific antidote.
General disorders and reactions at the injection site: generalized edema, facial edema, chest pain, fever, pain, fatigue, chills.
The simultaneous use of the following medicines with Orungal capsules is contraindicated:
CYP3A4 substrates that can prolong the QT interval, such as astemizole, bepridil, cisapride, dofetilide, levacetylmethadol (levomethadil), mizolastine, pimozide, quinidine, sertindole, and terfenadine. Simultaneous use can cause an increase in the concentration of these preparations in the blood plasma, which can lead to a prolongation of the QT interval and occasionally to cases of atrial fibrillation:
Keep out of the reach of children at a temperature not exceeding 30 ° C.
Shelf life is 3 years.
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