Telbyvudyn | Sebivo tablets 600 mg, 28 pcs.
Special Price
$169.75
Regular Price
$182.00
In stock
SKU
BID510666
Release form
Tablets.
Tablets.
Release form
Tablets.
Packing
28 pieces.
Pharmacological action
Sebivo is an antiviral drug active against hepatitis B virus, a synthetic thymidine analogue of nucleoside.
Sebo blocks the activity of the hepatitis B virus DNA polymerase enzyme. Telbivudine is efficiently phosphorylated by cell kinases to an active triphosphate form with a half-life of 14 hours in the cell. Telbivudin-5'-triphosphate competitively binds and inhibits hepatitis B virus DNA polymerase (reverse transcriptase) , disrupting the interaction of the enzyme with its endogenous substrate - thymidine-5 ' triphosphate. The inclusion of telbivudine-5'-triphosphate in the structure of viral DNA causes its chain to break and suppress hepatitis B virus replication. The drug inhibits the synthesis of the second (EC + 0.12 - 0.24 M) hepatitis B molecular chain more than the first (EC 50 + 0.4) - 1.3 M). Telbivudin-5'phosphate in concentrations up to 100 M did not inhibit the DNA polymerase ( , Or ) Of human cells. The drug in concentrations up to 10 M did not have a significant toxic effect on the structure of mitochondria, as well as on the content and function of DNA, and did not increase the formation of lactic acid in the human body.
Sebo has specific antiviral activity against hepatitis B. The drug is not effective against other RNA and DNA viruses, including HIV
Indications
Chronic hepatitis B in adult patients with confirmed virus replication and an active inflammatory process in the liver.
Contraindications
Hypersensitivity to telbivudine or any component of the drug.
The use of the drug in children and adolescents under the age of 18 is not recommended due to insufficient data on efficacy and safety.
Caution: for patients after liver transplantation, patients aged 65 years and older.
Patients with QC
Use during pregnancy and lactation
Sebivo can be used during pregnancy if the expected benefit to the mother outweighs the potential risk to the fetus.
There are no data on the effect of telbivudine on transmission of hepatitis B virus from mother to fetus. Measures should be taken to prevent neonatal hepatitis B virus infection.
It is not known whether telbivudine is excreted in human milk. Women taking Sebivo should give up breastfeeding.
Special instructions
In patients ceased treatment of hepatitis B with Sebivo, severe cases of exacerbation of hepatitis B have been noted. It is recommended that careful clinical and laboratory monitoring of liver function be performed for at least several months after discontinuation of hepatitis B. If necessary, hepatitis B therapy should be resumed.
By the 52nd week of treatment with the drug, an increase in the level of KFK (degree 3/4) was observed in 7.5% of patients taking telbivudine and in 3.1% of patients taking lamivudine. The mean CPK level was higher in patients taking telbivudine. However, from the 53rd week of treatment with telbivudine, an increase in the level of CK was not observed. In most cases, an increase in the level of CPK was asymptomatic. Usually, against the background of constant therapy with the drug, a decrease in the concentration of CPK was noted.
for several weeks, months after the start of treatment with the drug, cases of the development of uncomplicated myopathy were noted (constant diffuse pain and muscle tension and / or muscle weakness of unclear ethology, regardless of the degree and time of the increase in the level of CPK). Myopathy has also been observed with other synthetic thymidine nucleoside analogues.
Factors that trigger the development of myopathy in patients receiving telbivudine treatment are unknown.
Patients should immediately inform their doctor of any incidence of persistent pain, muscle tension, or muscle weakness. If myopathy is confirmed, treatment with the drug should be discontinued.
Composition
1 tablet contains telbivudine 600 mg
excipients: microcrystalline cellulose, povidone (polyvinylpyrrolidone), sodium carboxymethyl starch type A, magnesium stearate, silicon dioxide colloidal anhydrous, titanium dioxide, molybdenum polyethylene, molybdenum nitroxide, molybdenum nitroxide, molybdenum nitroxide, molybdenum nitroxide, molybdenum nitroxide, molybdenum oxide, molybdenum oxide, molybdenum acid chloride
Dosage and administration of
For the treatment of chronic hepatitis B, the recommended dose of Sebivo is 600 mg (1 tablet) 1 time / inside, regardless of food intake.
Sebo may be used to treat chronic hepatitis B in patients with impaired renal function.
In patients with impaired renal function with a CC more than 50 ml / min, dose adjustment is not required. In patients with CC less than 50 ml / min, a correlation of the interval between doses is necessary.
Side effects of
From the central nervous system and peripheral nervous system: often - slight dizziness (sometimes neuropathic, headache).
From the digestive system: often - increased levels of amylase in the blood, diarrhea, increased levels of lipase, nausea.
From the hepatobiliary system: often - an increase in ALT, sometimes - an increase in AST.
From the skin and subcutaneous tissue: often a rash.
From the musculoskeletal system: often - increased levels of CPK in the blood, sometimes - myopathy, arthralgia, myalgia.
General disorders: often - mild fatigue (4%), sometimes mild fatigue (0.3%), discomfort.
Some patients who discontinued treatment with telbivudine experienced severe cases of acute exacerbation of hepatitis B. There is no data on the treatment of exacerbations of hepatitis B after discontinuation of telbivudine therapy.
Drug Interactions
Telbivudine is excreted mainly by the kidneys, therefore, when prescribing Sebivo with drugs that affect kidney function, an increase in plasma concentrations of telbivudine and / or simultaneously used drugs is possible.
In vitro, telbivudine at concentrations 12 times higher than therapeutic did not inhibit the metabolic processes occurring with the participation of microsomal isoenzymes 1A2, 2C9, 2C19, 2D26, 2E1, and 3A4 cytochrome P450 in the liver. In animals, telbivudine does not induce cytochrome P450 isoenzymes. Given the above results and known ways of eliminating telbivudine, there is a low potential for the interaction of Sebivo with other drugs at the level of cytochrome P450.
The pharmacokinetic parameters of telbivudine in equilibrium did not change after repeated use in combination with lamivudine, adefovir dipivoxil, cyclosporine or peginterferon-alpha 2a.
In a pilot clinical trial investigating a combination of telbivudine 600 mg / day. and peginterferon alfa-2a (180 mcg once a week sc), an increased risk of developing peripheral neuropathy was noted. Caution should be exercised when prescribing Sebivo in combination with peginterferon alfa-2a.
It is not known whether the risk of developing myopathy increases with the simultaneous use of telbivudine with drugs that cause myopathy. When prescribing Sebivo along with drugs that cause myopathy, the expected benefits of therapy and the potential risk of developing myopathy should be assessed, and also provide monitoring of patients for the timely detection of pain, muscle tension or muscle weakness of unknown etiology.
On the background of monotherapy with nucleoside / nucleotide analogues or their administration in combination with antiretroviral agents, there have been cases of the development of lactic acidosis and severe hepatomegaly with steatosis, including fatal.
Overdose
No cases of overdose have been reported. Telbivudine is well tolerated in doses up to 1800 mg / day, 3 times the recommended daily doses. The maximum tolerated dose of telbivudine has not been determined.
Treatment: In case of an overdose, telbivudine should be discontinued and appropriate general supportive therapy prescribed.
Storage conditions
Keep out of the reach and sight of children at temperatures not exceeding 30 РC.
Shelf life
3 years.
Deystvuyushtee substance
Telbivudine
Conditions of sale of drugstores Terms and conditions of vocational
dosage form
tablets
Indications
Indications
Hepatitis
Tablets.
Packing
28 pieces.
Pharmacological action
Sebivo is an antiviral drug active against hepatitis B virus, a synthetic thymidine analogue of nucleoside.
Sebo blocks the activity of the hepatitis B virus DNA polymerase enzyme. Telbivudine is efficiently phosphorylated by cell kinases to an active triphosphate form with a half-life of 14 hours in the cell. Telbivudin-5'-triphosphate competitively binds and inhibits hepatitis B virus DNA polymerase (reverse transcriptase) , disrupting the interaction of the enzyme with its endogenous substrate - thymidine-5 ' triphosphate. The inclusion of telbivudine-5'-triphosphate in the structure of viral DNA causes its chain to break and suppress hepatitis B virus replication. The drug inhibits the synthesis of the second (EC + 0.12 - 0.24 M) hepatitis B molecular chain more than the first (EC 50 + 0.4) - 1.3 M). Telbivudin-5'phosphate in concentrations up to 100 M did not inhibit the DNA polymerase ( , Or ) Of human cells. The drug in concentrations up to 10 M did not have a significant toxic effect on the structure of mitochondria, as well as on the content and function of DNA, and did not increase the formation of lactic acid in the human body.
Sebo has specific antiviral activity against hepatitis B. The drug is not effective against other RNA and DNA viruses, including HIV
Indications
Chronic hepatitis B in adult patients with confirmed virus replication and an active inflammatory process in the liver.
Contraindications
Hypersensitivity to telbivudine or any component of the drug.
The use of the drug in children and adolescents under the age of 18 is not recommended due to insufficient data on efficacy and safety.
Caution: for patients after liver transplantation, patients aged 65 years and older.
Patients with QC
Use during pregnancy and lactation
Sebivo can be used during pregnancy if the expected benefit to the mother outweighs the potential risk to the fetus.
There are no data on the effect of telbivudine on transmission of hepatitis B virus from mother to fetus. Measures should be taken to prevent neonatal hepatitis B virus infection.
It is not known whether telbivudine is excreted in human milk. Women taking Sebivo should give up breastfeeding.
Special instructions
In patients ceased treatment of hepatitis B with Sebivo, severe cases of exacerbation of hepatitis B have been noted. It is recommended that careful clinical and laboratory monitoring of liver function be performed for at least several months after discontinuation of hepatitis B. If necessary, hepatitis B therapy should be resumed.
By the 52nd week of treatment with the drug, an increase in the level of KFK (degree 3/4) was observed in 7.5% of patients taking telbivudine and in 3.1% of patients taking lamivudine. The mean CPK level was higher in patients taking telbivudine. However, from the 53rd week of treatment with telbivudine, an increase in the level of CK was not observed. In most cases, an increase in the level of CPK was asymptomatic. Usually, against the background of constant therapy with the drug, a decrease in the concentration of CPK was noted.
for several weeks, months after the start of treatment with the drug, cases of the development of uncomplicated myopathy were noted (constant diffuse pain and muscle tension and / or muscle weakness of unclear ethology, regardless of the degree and time of the increase in the level of CPK). Myopathy has also been observed with other synthetic thymidine nucleoside analogues.
Factors that trigger the development of myopathy in patients receiving telbivudine treatment are unknown.
Patients should immediately inform their doctor of any incidence of persistent pain, muscle tension, or muscle weakness. If myopathy is confirmed, treatment with the drug should be discontinued.
Composition
1 tablet contains telbivudine 600 mg
excipients: microcrystalline cellulose, povidone (polyvinylpyrrolidone), sodium carboxymethyl starch type A, magnesium stearate, silicon dioxide colloidal anhydrous, titanium dioxide, molybdenum polyethylene, molybdenum nitroxide, molybdenum nitroxide, molybdenum nitroxide, molybdenum nitroxide, molybdenum nitroxide, molybdenum oxide, molybdenum oxide, molybdenum acid chloride
Dosage and administration of
For the treatment of chronic hepatitis B, the recommended dose of Sebivo is 600 mg (1 tablet) 1 time / inside, regardless of food intake.
Sebo may be used to treat chronic hepatitis B in patients with impaired renal function.
In patients with impaired renal function with a CC more than 50 ml / min, dose adjustment is not required. In patients with CC less than 50 ml / min, a correlation of the interval between doses is necessary.
Side effects of
From the central nervous system and peripheral nervous system: often - slight dizziness (sometimes neuropathic, headache).
From the digestive system: often - increased levels of amylase in the blood, diarrhea, increased levels of lipase, nausea.
From the hepatobiliary system: often - an increase in ALT, sometimes - an increase in AST.
From the skin and subcutaneous tissue: often a rash.
From the musculoskeletal system: often - increased levels of CPK in the blood, sometimes - myopathy, arthralgia, myalgia.
General disorders: often - mild fatigue (4%), sometimes mild fatigue (0.3%), discomfort.
Some patients who discontinued treatment with telbivudine experienced severe cases of acute exacerbation of hepatitis B. There is no data on the treatment of exacerbations of hepatitis B after discontinuation of telbivudine therapy.
Drug Interactions
Telbivudine is excreted mainly by the kidneys, therefore, when prescribing Sebivo with drugs that affect kidney function, an increase in plasma concentrations of telbivudine and / or simultaneously used drugs is possible.
In vitro, telbivudine at concentrations 12 times higher than therapeutic did not inhibit the metabolic processes occurring with the participation of microsomal isoenzymes 1A2, 2C9, 2C19, 2D26, 2E1, and 3A4 cytochrome P450 in the liver. In animals, telbivudine does not induce cytochrome P450 isoenzymes. Given the above results and known ways of eliminating telbivudine, there is a low potential for the interaction of Sebivo with other drugs at the level of cytochrome P450.
The pharmacokinetic parameters of telbivudine in equilibrium did not change after repeated use in combination with lamivudine, adefovir dipivoxil, cyclosporine or peginterferon-alpha 2a.
In a pilot clinical trial investigating a combination of telbivudine 600 mg / day. and peginterferon alfa-2a (180 mcg once a week sc), an increased risk of developing peripheral neuropathy was noted. Caution should be exercised when prescribing Sebivo in combination with peginterferon alfa-2a.
It is not known whether the risk of developing myopathy increases with the simultaneous use of telbivudine with drugs that cause myopathy. When prescribing Sebivo along with drugs that cause myopathy, the expected benefits of therapy and the potential risk of developing myopathy should be assessed, and also provide monitoring of patients for the timely detection of pain, muscle tension or muscle weakness of unknown etiology.
On the background of monotherapy with nucleoside / nucleotide analogues or their administration in combination with antiretroviral agents, there have been cases of the development of lactic acidosis and severe hepatomegaly with steatosis, including fatal.
Overdose
No cases of overdose have been reported. Telbivudine is well tolerated in doses up to 1800 mg / day, 3 times the recommended daily doses. The maximum tolerated dose of telbivudine has not been determined.
Treatment: In case of an overdose, telbivudine should be discontinued and appropriate general supportive therapy prescribed.
Storage conditions
Keep out of the reach and sight of children at temperatures not exceeding 30 РC.
Shelf life
3 years.
Deystvuyushtee substance
Telbivudine
Conditions of sale of drugstores Terms and conditions of vocational
dosage form
tablets
Indications
Indications
Hepatitis
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