Bicyclol
Bicyclol: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. For violations of liver function
- 12. Drug interactions
- 13. Terms and conditions of storage
- 14. Analogs
- 15. Terms of dispensing from pharmacies
- 16. Reviews
- 17. Price in pharmacies
Latin name: Bicyclol
ATX code: A05B
Active ingredient: bicyclol (bicyclol)
Producer: Beijing Union Pharmaceutical Factory (China)
Description and photo update: 2019-23-08
Bicyclol is a hepatoprotective agent.
Release form and composition
Dosage form - tablets: round, convex on both sides, almost white or white in color (9 pcs. In blisters, 2 packages in a cardboard box).
Active substance: bicyclol, in 1 tablet - 25 mg.
Auxiliary components: starch paste 10%, sodium carboxymethyl starch, sucrose, magnesium stearate, corn starch.
Pharmacological properties
Pharmacodynamics
The active component of Bicyclol is lignan in terms of chemical structure. Drug therapy for hepatitis of various etiologies helps to reduce the increased activity of hepatic transaminases.
The protective effect of bicyclol was confirmed as a result of studies that simulated different forms of liver damage: concavalin A (ConA) and BCG vaccine - immune damage; carbon tetrachloride (CCl 4) - liver fibrosis / necrosis, damage to biomembranes; D-galactosamine - damage to the DNA of the hepatocyte nucleus; acetaminophen (AR) - depletion of glutathione in hepatocytes. As a result of therapy, restoration of pathomorphological disorders in the structure of the liver tissue is observed to varying degrees of severity.
The effect is provided by inhibition of the production of tumor necrosis factor (TNF-α) by active neutrophils, macrophages and Kupffer cells. Also, bicyclol helps to reduce the intensity of free radical processes in cells, inhibition of oxidative activity associated with dysfunction of mitochondria, which makes it possible to prevent apoptosis and necrosis of hepatocytes. In addition, therapy leads to the restoration of damage to the nucleus and DNA of hepatocytes (provided by inhibition of hepatocyte apoptosis, stimulated by TNF-α and cytotoxic T cells).
As a result of the studies carried out in the AR model of liver damage, it was found that the preliminary use of bicyclol significantly reduces the degree of damage to hepatocytes, which is manifested in a decrease in the activity of ALT and ACT (alanine aminotransferase and aspartate aminotransferase), which are a marker of hepatocyte necrosis, as well as in the prevention of DNA defragmentation and a decrease in the release cytochrome C and apoptosis-inducing factors from mitochondria.
Bicyclol can inhibit the excretion of HBsAg, HBeAg and the replication of hepatitis B virus DNA.
In chronic viral hepatitis C of moderate activity, Bicyclol therapy in a daily dose of 150 mg for 12 weeks statistically significantly reduces the biochemical parameters of the inflammatory process in the liver (ALT and ACT activity, direct, indirect and total bilirubin), and also reduces the manifestations of asthenovegetative syndrome and increases quality of life of patients. This indicates anti-inflammatory and hepatoprotective effects when using the drug as monotherapy for chronic viral hepatitis C.
Bicyclol therapy for 12 weeks at a dose of 150 mg per day is well tolerated and has a favorable safety profile.
Pharmacokinetics
After oral administration, Bicyclol is rapidly absorbed and determined in the blood after 15 minutes.
T 1/2 ka and T 1/2 ke (half-life in the first and second phases of the biphasic model) are 0.84 and 6.26 hours, respectively. C max (maximum concentration of the substance) in blood plasma is 50 ng / ml, the time to reach it is 1.8 hours.
C max and AUC (area under the concentration-time curve) are directly dose dependent and correspond to the characteristics of linear pharmacokinetics. With max, when taking bicyclol after meals, it can increase.
With repeated use in a therapeutic dose, it does not cumulate. The degree of binding of Bicyclol to blood plasma proteins is 78%.
With max in the liver is achieved in 4 hours. Metabolism occurs in the liver, cytochrome P 450 isoenzymes are involved in it. The main metabolite is 4,4'-hydroxybicyclol.
Within 24 hours, up to 30% of the drug is excreted from the body by the intestines. Approximately 1.3% of the dose is excreted in the urine, 0.03% in the bile.
Indications for use
According to the instructions, Bicyclol is used to treat chronic viral hepatitis B and C, accompanied by an increase in the activity of hepatic transaminases, in the following cases:
- previous courses of antiviral therapy were ineffective;
- there is no motivation for antiviral therapy;
- there is a hypersensitivity to drugs of standard antiviral therapy.
Contraindications
Absolute:
- sub- and decompensated cirrhosis of the liver (classes B and C according to the Child-Pugh classification);
- hepatocellular carcinoma;
- autoimmune hepatitis;
- deficiency of sucrase / isomaltase, fructose intolerance, glucose-galactose malabsorption;
- age up to 18 years;
- pregnancy and lactation;
- hypersensitivity to any component of the drug.
Bicyclol should be used with caution in the presence of concomitant diseases of the gastrointestinal tract, such as gastritis, pancreatitis and cholecystitis, since the drug can increase the activity of alkaline phosphatase (ALP), aspartate aminotransferase (AST) and gamma-glutamyl transpeptidase (GGTP).
Instructions for the use of Bicyclol: method and dosage
Bicyclol tablets should be taken orally after meals.
Adult patients are prescribed 1-2 tablets 3 times a day.
The duration of therapy is 12 weeks.
If necessary, the doctor can extend the course (using a single dose of 25 mg) up to 6 months.
Side effects
Bicyclol is usually well tolerated. The resulting reactions, as a rule, are expressed slightly or moderately, are transient, stop with the help of symptomatic therapy, or go away on their own after discontinuation of the drug.
Possible side effects:
- from the gastrointestinal tract: epigastric pain, bloating, nausea, vomiting;
- from the nervous system: dizziness, sleep disturbance, headache;
- on the part of the skin and subcutaneous tissue system: itching, skin rashes, urticaria;
- laboratory data: a transient increase in the concentration of glucose and creatinine in the blood, a decrease in the number of platelets, leukopenia, an increase in prothrombin time, an increase in the activity of transaminases, hemoglobin, the activity of alkaline phosphatase, ACT and GGTP, the concentration of total bilirubin.
Overdose
There is no information.
special instructions
During treatment, the indicators of liver function and the clinical picture of the disease should be systematically monitored.
In the presence of concomitant gastrointestinal diseases, therapy is recommended under additional control of the functional parameters of the hepatobiliary system.
Influence on the ability to drive vehicles and complex mechanisms
Studies on the effect of Bicyclol on reaction rate and the ability to concentrate have not been conducted. However, given the likelihood of developing dizziness, caution should be exercised when performing potentially hazardous activities and driving vehicles.
Application during pregnancy and lactation
Bicyclol is not prescribed during pregnancy / lactation.
Pediatric use
Bicyclol therapy is contraindicated in patients under 18 years of age.
For violations of liver function
Contraindication: hepatocellular carcinoma, autoimmune hepatitis, sub- and decompensated liver cirrhosis (according to the Child-Pugh classification - classes B and C).
Drug interactions
The interaction of bicyclol with other drugs has not been studied.
Terms and conditions of storage
Keep out of the reach of children, in a dry place at a temperature of 8-25 ° С.
The shelf life is 3 years.
Analogs
Bicyclol analogs are Rezalut Pro, Splenin.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews of Bicyclol
Reviews of Bicyclol are few. Those who have taken the drug most often come to the conclusion that it does not cure, but only temporarily improves the condition. It is noted that after discontinuation of therapy, all indicators return to their initial values. The market value is assessed as high.
Price for Bicyclol in pharmacies
The approximate price for Bicyclol (18 tablets) is 1,848-2,355 rubles.
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
