Clinical and pharmacological group: & nbsp

Antiviral drugs (excluding HIV)

Included in the formulation
  • Sowaldi
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  • АТХ:

    J.05.A.X.15   Sofosbuvir

    Pharmacodynamics:

    Prodrug. In the body, it is metabolized to the active form (GS-461203). Inhibits RNA polymerases, through which the hepatitis C virus copies its own RNA.

    Pharmacokinetics:

    After oral administration, it is completely absorbed in the gastrointestinal tract. The maximum concentration in the blood plasma is achieved after 0.5-2 hours. The connection with plasma proteins is 65%.

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

    The elimination half-life is 15 minutes. Elimination with feces.

    Indications:

    It is used for the treatment of chronic hepatitis C genotypes 1, 2, 3 and 4. It is used as part of complex therapy for chronic hepatitis C.

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

    Contraindications:

    Pregnancy and lactation, age under 18 years, 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:

    Inside, 400 mg once a day for 12 weeks.

    The highest daily dose: 400 mg.

    The highest single dose: 400 mg.

    Side effects:

    Central and peripheral nervous system: faint.

    Circulatory system: peripheral edema.

    Hematopoietic system: anemia, lymphopenia, thrombocytopenia, and leukopenia.

    Respiratory system: shortness of breath.

    Digestive system: diarrheal phenomena, diarrhea.

    Endocrine system: hypothyroidism.

    Sense organs: rarely - retinopathy.

    Dermatological reactions: rash, photosensitivity reactions.

    Allergic reactions.

    Overdose:

    Cases of overdose are not described.

    Treatment is symptomatic.

    Interaction:

    Rifampicin reduces the effectiveness of cofosbuvira up to 90%.

    Ritonavir potentiates the action of sophosbuvira.

    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 when using antacids due to a decrease in the acidity of gastric juice.

    Proton pump inhibitors and histamine H blockers2-receptors reduce the concentration of cofosbuvir in blood plasma, reducing the effectiveness of the drug.

    Reduces the effectiveness of hormonal contraceptives containing estradiol.

    Special instructions:

    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.

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