Symeprevir (Simeprevirum)

Pharmacodynamics Pharmacokinetics Indications Carefully Contraindications Dosing and Administration Side effects
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Clinical and pharmacological group: & nbsp

Antiviral drugs

Included in the formulation
  • Sovrirad®
    capsules inwards 
    Janssen-Sylag International N.V.     Belgium
    • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    АТХ:

    J.05.A.E.   Protease Inhibitors

    J.05.A.E.14   Symeprevir

    Pharmacodynamics:

    The protease inhibitor NS3 / 4A of the hepatitis C virus, involved in viral replication. The blockade of the viral protease leads to a disruption in the maturation of viral particles of the hepatitis C virus of genotypes 1a and 1b.

    Pharmacokinetics:

    After oral administration, it is completely absorbed in the gastrointestinal tract. The maximum concentration in blood plasma is reached after 4-6 hours. The connection with plasma proteins is more than 99.9%.

    Therapeutic effect develops after the reception. Metabolism in the liver.

    Half-life is 40 h. Elimination with feces.

    Indications:

    It is used in complex therapy with ritovirin and peginterferon alfa for the treatment of chronic hepatitis C of genotype 1.

    ICD-10

    I.B15-B19.B18.2   Chronic viral hepatitis C

    Contraindications:

    Individual intolerance.

    Carefully:

    Elderly - over 65 years of age, severe renal failure.

    Pregnancy and lactation:

    Recommendations for FDA - Category C. Contraindicated in pregnancy and during lactation, as well as for men during pregnancy partners.

    Dosing and Administration:

    150 mg (1 capsule) 1 time / day with meals.

    The highest daily dose: 150 mg.

    The highest single dose: 150 mg.

    Side effects:

    Respiratory system: shortness of breath.

    Digestive system: dyspepsia, diarrhea.

    Dermatological reactions: photosensitivity reactions.

    Allergic reactions.

    Overdose:

    Cases of overdose are not described.

    Treatment is symptomatic.

    Interaction:

    Rifampicin reduces the effectiveness of simeprevir up to 90%.

    Ritonavir potentiates the action of simeprevir.

    Simultaneous use with indinavir leads to hyperbilirubinemia.

    Reduces the effectiveness of saquinavir with simultaneous admission.

    Slows the metabolism of irinotecan, increasing its toxicity.

    Potentiates the action of lidocaine, amiodarone, quinidine, diltiazem.

    Strengthens the effect of warfarin, which can lead to bleeding.

    Absorption of the drug is significantly reduced with the use of antacids, due to a decrease in the acidity of gastric juice.

    Proton pump inhibitors and histamine H2 receptor blockers reduce the concentration of simeprevir in the blood plasma, reducing the effectiveness of the drug.

    Reduces the effectiveness of hormonal contraceptives containing estradiol.

    Special instructions:

    It is not used as a monotherapy.

    If it is necessary to appoint with nifedipine, verapamil, felodipine, nicardipine, it is necessary to titrate the dose of calcium channel blockers under ECG control.

    Instructions
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