Agimidin drug 100mg Agimexpharm treat chronic hepatitis B (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Lamivudin
Ingredient Agimexpharm
Ingredient
| Composition information | Content |
| Lamivudin | 100mg |
Uses
indications
Agimidin drug indicated in the following cases:
lamivudin (2 ’, 3’-dideoxythiactidin) belongs to the nucleotid group inhibits the reverse code enzyme. Lamivudin has the same structure as Zalcitabin. Lamivudine is transformed by enzymes in cells into active derivatives as Lamivudin-5’-Triphosphate (3TC-TP). Due to the similar structure of Deoxyctidin Triphosphate is a natural substrate for reverse transcription enzymes, 3TC-TP competes with the natural Deoxyctidin Triphosphate and the Summary of the virus's DNA is ended early. Lamivudin has very low toxicity for cells.
Lamivudin has the effect of inhibiting the hepatitis B virus in chronic patients. Despite being well tolerated, but not using lamivudin alone, because it is easy to produce drugs. This drug resistance due to an enzyme mutant transcription, reduces sensitivity more than 100 times and loses antiviral effects on patients.
Treatment of chronic hepatitis B with lamivudin for a while, the anti -drug mutant strains will appear on the polymerase enzyme. The lamivudine anti -anti -lamivudin mutants are M552V (valin methionine in codon 552) and M552i (isoleucin instead of methionine). Despite the appearance of anti-HBE antibodies, HBV DNA increased after stopping lamivudin and ALT increased, recurrent disease. Lamivudine resistance rate after 1 year of treatment is 24%, after 2 years is 38%, after 3 years is 50%.
Lamivudin and zidovudin combination therapy in patients who have not been treated before, reduces about 10 times the virus density in plasma, lasts more than 1 year.
Pharmacokinetics
absorption
After drinking, Lamivudin absorbed quickly and the serum peak concentration reached about 1 hour (drinking at hunger), 3.2 hours (drinking at full time). Food slows down but does not reduce the absorption of the drug. Biology of lamivudin is taken orally in adults usually from 80 to 85%.
Distribution
The ratio is attached to low plasma proteins (
Metabolism
lamivudin is metabolized in cells into triphosphate. Drugs are metabolized less in the liver.
Elimination
The drug is excreted mainly through the kidneys in the form of unchanged. Half life in lymphocytes in peripheral blood is 10 - 19 hours. Half -life eliminated after drinking one -time dose is 5-7 hours in adults; is 2 hours in children from 4 months to 14 years old.
Patients with renal failure
Studies in patients with renal failure show that removing lamivudine is affected by kidney dysfunction. Dosage should be reduced in patients with creatinine clearance
Patients with liver failure
The lamivudin pharmacokinetics are not affected by liver failure. The limited data in liver transplant patients shows that liver function decline does not significantly affect the pharmacokinetics of lamivudin unless accompanied by kidney dysfunction.Elderly
In elderly patients, lamivudin pharmacokinetics index shows that normal aging accompanied by renal failure influenced by lamivudin has no clinical significance, except in patients with creatinine clearance
Before taking Agimidin drug 100mg Agimexpharm treat chronic hepatitis B (3 blisters x 10 tablets)
How to use
therapy with lamivudin should be started by an experienced doctor in the treatment of chronic hepatitis B.
Dosage
adults
recommended dose is 100 mg x 1 time/day.
In patients with unslaced liver disease, lamivudin should be used in combination with the second drug, without cross -resistance to lamivudin, to reduce the risk of resistance and to achieve rapid virus inhibition.
Treatment time
Optimal treatment time is unknown.
In patients with chronic hepatitis B HBeAg, non-cirrhosis, it is necessary to be treated at least 6-12 months after the HBeAg serum conversion is determined (HBeAg and HBV DNA and HBEAB appears), to limit the risk of viral recurrence, or until HBsAg serum transformation or negative. ALT and HBV DNA concentration should be monitored in regular serum after stopping treatment to detect any late virus recurrence.
In patients with chronic hepatitis B with negative HBeAg (Precore mutation) without cirrhosis, so the treatment should be at least until the HBS serum conversion or negative evidence.
In patients with liver or cirrhosis and in liver transplant, do not stop treatment.
If stopping lamivudine, patients need to be monitored periodically signs of recurrent hepatitis.
Clinical resistance
In patients with chronic hepatitis B positive HBeAg or HBeAg negative, the development of HBV mutant YMDD (Tyrosin-methionin-aspartat) can reduce response to lamivudine, which is manifested by an increase in HBV DNA and ALT from previous treatment. In order to reduce the risk of drug resistance in patients with lamivudine monomers, it is advisable to consider replacing or supplementing an non -cross -resistant substance with lamivudin if HBV DNA is still detected during or after 24 weeks of treatment.
To treat HIV-infected patients and are currently receiving or planning to treat lamivudin or combining lamivudin-zidovudin, lamivudin dose is the dose for HIV treatment (usually 150 mg/time x 2 times daily in combination with other antiviral drugs) should be maintained.
Special subjects
kidney failure
LAMIVUDIN (AUC) serum concentration increases in medium and severe renal impairment patients due to reduced renal clearance. Therefore, the dose should be reduced for patients with creatinine clearance
Lamivudine dose adjustment table according to creatinine clearance (to treat hepatitis B):
Creatinine clearance
(ml/min)
first dosemaintenance dose
Once every day
Hepatic failure
The data obtained in patients with liver failure, including people with end -stage liver disease waiting for graft, shows that lamivudin pharmacokinetics are not significantly affected by liver dysfunction. Based on these data, there is no need to adjust the dose in patients with liver failure, except with renal failure.
Elderly
In elderly patients, normal aging accompanied by renal failure when taking Lamivudin has no clinical significance, except for patients with creatinine clearance
Children
Safety and effectiveness of lamivudin in infants, children and adolescents under 18 have not been established.
Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.
What to do when overdose?
Overdose:
There are very little information about overdose.
Cases of severe poisoning after treatment or long -term medication will show signs: pancreatitis, peripheral neuritis, fatty liver, acute kidney failure, acidosis.
Management:
There is no specific antidote. Hematomopiatric or peritoneal appraisal after 4 hours only takes away a negligible amount.
Severe poisoning treatment includes drug stops, symptomatic treatment and support.
In an emergency, call the 115 emergency center immediately or go to the nearest local health station.
What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.
Side Effects
The rate of side effects below is on adults, treated with HIV or HBV with lamivudin combined with other drugs resistant to retrovirus.
Very common, ADR> 10/100
Stop lamivudin immediately if there are clinical signs, symptoms or test results show that pancreatitis may occur. Lamivudin must be stopped immediately if there are clinical signs, symptoms or test results showing lactic acidosis, or toxic to the liver (liver, fat, even if the transaminase is not very high).
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
contraindicated
Agimidine drugs contraindicated in the following cases:
Be cautious when using
Lactic acidosis and grease degenerative liver
Cases of lactic acidosis appears (without oxygen deficiency), sometimes fatal, often related to serious liver and fatty liver, which has been reported with the use of similar substances nucleosid. Lamivudin is a nucleosid similar to that, this risk cannot be excluded. Lamivudine should be discontinued if there is an increase in the concentration of aminotransferase enzyme, the liver progresses or metabolic or lactic acidosis is unknown. Benign digestive symptoms, such as nausea, vomiting and abdominal pain, may be a sign of lactic acidosis.
Severe cases, sometimes died, related to pancreatitis, liver or fatty liver, renal failure and blood lactate higher. Be careful when prescribing nucleosid similar substances to any patient (especially obese women) with large liver, hepatitis or other risk factors for liver and fatty liver disease (including some drugs and alcohol products). Patients with hepatitis C and treatment with interferon alpha and ribavirin may cause special risk. These patients should be monitored.
The drama of hepatitis.
Drama in treatment
The spontaneous drama of chronic hepatitis B is relatively common and is characterized by an increase in ALT in the serum. After starting with antiviral treatment, serum alt may increase in some patients while HBV DNA concentration in serum decreases. In patients with compensation liver disease, the increase in serum ALT is usually not accompanied by an increase in serum bilirubin concentration or signs of liver disease.
A group of HBV viruses reduces the sensitivity to Lamivudin (HBV YMDD mutant) has been determined with expanded treatment therapy. In some patients, the development of HBV mutant YMDD can make hepatitis worse, first detected by serum hyperplasia and re -appearing HBV DNA. In patients with YMDD mutant HBV, consider switching to or adding an alternative drug without cross -resistant to lamivudin based on treatment guidelines.
Drama after stopping treatment
Hepatitis acute drama is recorded in patients who have stopped treating hepatitis B and is often detected by an increase in serum ALT and re -appearance of HBV DNA. In phase -III clinical trials with non -active treatment, the ALT ratio after treatment (more than 3 times the reference level) is higher in the group that is treated with lamivudin (21%) compared to the placebo group (8%). However, the percentage of patients with an increase in ALT after treatment associated with an increase in bilirubin is low and similar in both treatment groups. For patients treated with lamivudine, most of the increase in ALT after treatment occurs from 8 to 12 weeks after treatment. Most events are self -limited, but some deaths have been recorded.
Drama in patients with cirrhosis
People with liver transplants and patients with higher risk of cirrhosis are at higher risk due to viral copy activity. Due to poor liver function in these patients, the recurrence of hepatitis when stopping lamivudine or ineffective during treatment can become serious and even die. These patients should be monitored with clinical parameters, viruses and serums related to hepatitis B, monitor liver and kidney function and antiviral response during treatment (at least each month) and, if stopped for any reason, at least 6 months after treatment. Testing parameters must be monitored including serum, bilirubin, albumin, blood urea nitrogen, creatinine and viral condition: antigen/HBV antibodies and serum HBV levels when possible.
For patients with evidence of the recurrence of hepatitis after treatment, there is no enough data on the benefits of starting re -treatment with lamivudine.
Mitochondrial dysfunction
Similar substances nucleosid and nucleotid have been shown in vitro and in vivo, causing a different degree of mitochondrial damage. There have been reports on mitochondrial dysfunction in newborns exposed to the uterus and/or after birth with nucleosid similar substances. The main adverse effects reported are hematological disorders (anemia, neutropenia), metabolic disorders (hyperlemen in blood). Some late neurological disorders have been reported (increasing tone, convulsions, abnormal behaviors). Neurological disorders may be transient or permanent. Any child who is exposed to the uterus with substances similar to nucleosid and nucleotid, which should be clinically monitored and followed in the laboratory and should be fully checked in mitochondrial dysfunction in cases where there are signs or symptoms involved.
Pediatric patients
Lamivudin has been used for children 2 years and older and adolescents with chronic hepatitis B are still compensated. However, due to the limitations of data, the use of lamivudine for this group of patients is not recommended.
Hepatitis Delta or hepatitis C
The effect of lamivudine in patients with hepatitis delta or hepatitis C has not been established and need to be cautious.
immune treatment
Data is limited to the use of lamivudin in HBeAg patients with negative (Precore mutations) and in patients who receive immunosuppressive mode, including cancer chemotherapy. Lamivudin should be used carefully in these patients.
Supervisor
During treatment with lamivudine patients should be monitored regularly. Alt and HBV should be monitored for a period of 3 months and in HBeAg patients who are positive HBeAg should be evaluated every 6 months.
HIV infection
To treat HIV -infected patients and are currently receiving or planning to treat lamivudin or combination of lamivudin - zidovudin, lamivudine dose is prescribed for HIV infection (usually 150 mg/time, 2 times daily in combination with other antiviral drugs) should be maintained. For patients with HIV -infections that are not treated with Retrovirus anti -Retrovirus, there is a risk of HIV mutations when using lamivudine alone to treat chronic hepatitis B.
Hepatitis B transmission
Restricted information on the transmission of hepatitis B virus from mother - fetus in pregnant women being treated with lamivudin. Should comply with the regulations on hepatitis B virus vaccination in infants.
Patients should be advised that lamivudin treatment has not been shown to reduce the risk of the transmission of hepatitis B virus to others and therefore must take appropriate preventive measures.
Interaction with other pharmaceutical products
Do not use Agimidin with any other drug products that contain lamivudin or drugs containing emtricitabin.
Do not use lamivudin combination with cladribin.
The excipients of this drug have lactose
Patients with rare genetic problems in tolerance Galactose, Lapp Lapp Lactase or Glucose-Galactose should not use this drug.
The effect of the drug on the ability to drive and operate machinery
There is no information on the effect of the drug on the ability to drive and operate machines but should note the side effects causing dizziness, headache, fatigue of the drug.
Use drugs for women during pregnancy and lactation
Pregnancy
Some data on pregnant women shows more than 1,000 results from the first trimester and more than 1,000 results from the second and third trimester in pregnant women are indicated to use Lamivudin, showing no malformations in the fetus/newborn. Under 1% of these women have been treated for HBV, while most are treated HIV at a higher doses and coordinated with other drugs. Lamivudin can be used during pregnancy if necessary in terms of clinical.
For patients who are being treated with lamivudin and then pregnant, they should consider the possibility of recurrence of hepatitis when stopping lamivudin.
Breastfeeding period
Hepatitis B in mothers is not contraindicated when breastfeeding if newborns are prevented with hepatitis B at birth and there is no evidence that low lamivudine concentration in breast milk leads to adverse reactions in breastfed babies. Therefore, breastfeeding may have to be considered in nursing mothers who are being treated with HBV with lamivudin, need to take into account the benefits of breastfeeding and the benefits of the mother's treatment. When the mother is transmitted HBV, although good backup, should consider stopping breastfeeding to reduce the risk of the appearance of Lamivudin resistance mutations in newborns.
Drug interaction
anti-penetration drugs and anti-membranes of HIV virus (Enfuvirtid, Maraviroc): Having a synergistic effect with HIV-1-1 Lamivudine.
HIV Integrase inhibitors (Raltegravir): No clinical significance on lamivudin pharmacokinetics.
HIV Protease inhibitors (Amprenavir/Fosamprenavir, Nelfinavir, Ritonavir, Saquinavir): Has a synergistic effect (In vitro) with Lamivudin. There is no evidence of antagonism between Lamivudin and Atazanavir or Darunavir. It is unclear that the pharmacokinetic interaction between Darunavir is enhanced by Ritonavir and Lamivudin. It is unclear that there is a pharmacokinetic interaction between a combined preparation with lopinavir and ritonavir and lamivudin when used simultaneously. LAMIVUDIN's plasma and AUC peak concentration increases when used simultaneously with nelfinavir; However, this has no clinical significance and does not need to adjust the dose. Tipranavir is simultaneously enhanced with ritonavir that does not affect the pharmacokinetics of Lamivudin.
Reverse code inhibitors are not nucleosid (Delavirdin, Efavirenz, Nevirapin): have a combination effect with Lamivudin on HIV-1. There is no need to adjust the dose when used simultaneously Efavirenz and Lamivudin. There is no pharmacokinetic interaction when simultaneously used lamivudin and rilpivirin.
Nucleosid and nucleotids inhibit the backward transcription (Abacavir, Emtricitabin, Stavudin, Tenofovir, Zidovudin): Zidovudine concentration in plasma increases by about 13% when used in combination with lamivudine but does not need to adjust the dose when used simultaneously. Abacavir, Stavudin reduces the AUC of Lamivudin but has no clinical significance. Tenofovir reduces 24% of lamivudine plasma concentrations. Do not simultaneously use lamivudin and emtricitabin (emtricitabin is the same substance as lamivudin, used simultaneously without benefits because the two drugs are equally resistant and does not have the effect of strengthening each other). Do not simultaneously use lamivudin and zalcitabin because lamivudin inhibits the phosphorylylation Zalcitabin inside the cell.
Interferon and Peginterferon: simultaneously use antiviral drugs Retrovirus (whether or not ribavirin) and interferon alpha (or peginterferon alpha) for humans and HIV and HVC can cause liver failure to cause death. Closely monitor patients to simultaneously use lamivudin and interferon alpha (or peginterferon alpha) with or without ribavirin in toxicity, especially liver failure and to stop the drug if necessary. If the condition is worse (for example, liver failure above 6 according to the Child-Pugh ladder), it may be necessary to stop or reduce the dose of interferon alpha (or peginterferon) and/or ribavirin. Ribavirin can reduce lamivudin phosphoryl. Patients who also have HIV and HCV are at risk of liver failure when taking simultaneous antiviral drugs and interferon alpha (or peginterferon alpha) with or without ribavirin.
methadon: No significant effect on lamivudin pharmacokinetics; No need to adjust the dose when used simultaneously.
trimethoprim/sulfamethoxazol increases the AUC of lamivudin 43% but does not need to adjust the dose.
buprenorphin: There is no clinical pharmacokinetic interaction; No dose adjustment if used simultaneously.
Cladribin: In vitro lamivudin inhibits the in intracellular phosphorylation of Cladribin, leading to the potential risk of Cladribin in the case of clinical treatment combining. Some clinical results also show that the interaction between lamivudine and cladribin. Therefore, the simultaneous use of lamivudine with cladribin is not recommended.
Storage
Leave a cool place, avoid light, temperatures below 30⁰C.
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