Pharmacological action
Clinical and pharmacological group
Antiviral drug active against HIV
Pharmacotherapy group
Antiviral [HIV] agent
Indications
Treatment of HIV infection in adults and children aged 6 years and older with a body weight of 20 kg or more who have previously received antiretroviral therapy (in combination with a low dose of ritonavir and other antiretroviral drugs).
Contraindications
* Hypersensitivity to darunavir or to any of the components of the drug.
* Concomitant use with drugs that are primarily metabolized by the cytochrome P450 3A4 isoenzyme, and an increase in plasma concentrations is associated with the occurrence of serious and/or life-threatening side effects (narrow therapeutic range). These drugs include antihistamines (astemizole, terfenadine), alfuzosin, quetiapine, sildenafil (used for the treatment of pulmonary arterial hypertension), rifampicin, sedatives/hypnotics (triazolam, midazolam for oral use), gastrointestinal motility stimulants (cisapride), preparations containing St. John’s wort extract, preparations containing alkaloids ergot (ergotamine, dihydroergotamine, ergometrine and methylergometrine), antiarrhythmic drugs (amiodarone, bepridil, quinidine, lidocaine for systemic use), HMG-Coa reductase inhibitors (simvastatin, lovastatin), neuroleptics (pimozide, sertindol). See also the section “Interaction with other medicinal products”.
* Concomitant use with a combination of lopinavir/ritonavir.
* Severe hepatic insufficiency (Child-Pugh class C).
* Children under 6 years of age.
With caution
* Mild to moderate hepatic impairment (Child-Pugh class A and B)
* Allergy to sulfonamides
* Age over 65 years
* When taking concomitant medications that are highly bound to alpha-1-acid glycoprotein.
* In patients with chronic hepatitis (including those with chronic viral hepatitis B and C).
* In patients with hemophilia.
How to take, course of use and dosage
Inside. Darunavir should always be given in combination with a low dose of ritonavir as a means of improving its pharmacokinetic characteristics, as well as in combination with other antiretroviral drugs. The possibility of prescribing ritonavir should be considered before starting darunavir/ ritonavir therapy.
After starting darunavir therapy, patients should not change or discontinue therapy without consulting their healthcare provider.
Dosages of 75 mg and 150 mg are designed for use in children’s practice. In adults, to achieve therapeutic doses, these dosages require taking a large number of tablets, which on the one hand makes them difficult to swallow, on the other – can cause allergic reactions due to the increased intake of excipients contained in the tablets, so they should only be used if other dosages are not available.
Form of production
Tablets, film-coated from light yellow to dark yellow, round, biconvex; on the cross-section, the tablet is white or white with a yellowish tinge of color.
Active ingredient
Darunavir
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
Indications
HIV infection
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