DOPTELET 20mg Price

Overview

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This medicine contains an important and useful components, as it consists of
Avatrombopagis available in the market in concentration

Name

Entecavir

Precaution

Entecavir is an antiviral medication primarily used in the treatment of chronic hepatitis B virus (HBV) infection. As with any antiviral agent, there are several precautions to consider: - **Pregnancy and Breastfeeding**: Entecavir is classified as a category C drug during pregnancy. While animal studies have shown some adverse effects, there are no well-controlled studies in humans. Therefore, entecavir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Entecavir is excreted in human milk, and because its effects on a nursing infant are unknown, breastfeeding is not recommended during treatment. - **Renal Impairment**: Entecavir is excreted primarily through the kidneys, so dosage adjustments are necessary in patients with impaired renal function. Patients with a creatinine clearance (CrCl) less than 50 mL/min should receive a reduced dose of entecavir to prevent drug accumulation and reduce the risk of toxicity. - **Hepatic Impairment**: While entecavir does not require dose adjustments in patients with mild to moderate liver impairment, caution should be used in those with severe hepatic dysfunction. Additionally, patients with cirrhosis should be carefully monitored for potential side effects, including lactic acidosis, as there may be a higher risk in patients with compromised liver function. - **Monitoring Parameters**: Regular monitoring of renal function (creatinine, glomerular filtration rate) is recommended, especially in patients with pre-existing kidney issues. Additionally, liver function tests should be monitored to track potential hepatic deterioration during therapy. Monitoring for the emergence of HBV resistance is also advised, particularly in patients with suboptimal responses to treatment. - **Misuse and Dependency**: Entecavir does not have addictive properties, and there is no known risk of misuse or dependency. However, improper discontinuation or interruption of treatment can lead to the development of drug-resistant strains of HBV.

Indication

Entecavir is primarily indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults and pediatric patients over 2 years of age. It is used to reduce the levels of HBV DNA, improve liver function, and decrease the risk of cirrhosis, liver failure, and hepatocellular carcinoma. - **Chronic Hepatitis B**: Entecavir is approved for both the treatment of chronic hepatitis B in patients with compensated liver disease and those with decompensated liver disease. It works by inhibiting the replication of HBV within the liver, reducing viral load and thus preventing further liver damage. - **Prevention of HBV Recurrence After Liver Transplantation**: Entecavir can also be used to prevent the recurrence of HBV in patients who have undergone liver transplantation, helping to avoid reinfection of the new liver. - **Off-label Uses**: Although its primary indication is HBV, entecavir has been investigated in the treatment of other viral infections like hepatitis D and HIV (as part of combination therapy), but these uses are not approved by regulatory agencies and should be considered off-label.

Contra indication

There are several key contraindications to consider with entecavir use, particularly regarding its impact on certain patient populations: - **Hypersensitivity to Entecavir**: Patients with a known allergy or hypersensitivity to entecavir or any of its components should not use this medication. - **Severe Renal Impairment**: Entecavir is contraindicated in patients with end-stage renal disease (ESRD) or those requiring dialysis, unless careful dose adjustment and monitoring are performed. Its renal clearance may be significantly reduced in these populations, leading to toxicity. - **HIV Co-infection with Lamivudine or Adefovir Resistance**: Entecavir should not be used as monotherapy in HIV patients who are co-infected with HBV and who have resistance to lamivudine or adefovir, as this can lead to rapid resistance development and poor treatment outcomes. It is crucial to ensure proper HIV management alongside HBV therapy.

Side Effect

While generally well-tolerated, entecavir can cause a range of side effects. These are typically mild but can occasionally be more severe: - **Common Side Effects**: - **Headache**: A common side effect, usually mild, but may require discontinuation if severe. - **Fatigue**: Patients may feel unusually tired, particularly in the initial stages of treatment. - **Nausea and Vomiting**: Some individuals may experience gastrointestinal discomfort, which can often be mitigated by taking entecavir with food. - **Dizziness**: Lightheadedness or dizziness is another commonly reported symptom. - **Serious Side Effects**: - **Lactic Acidosis**: A rare but potentially fatal condition characterized by an accumulation of lactic acid in the blood, often associated with the use of nucleoside analogs like entecavir. Symptoms include deep, rapid breathing, abdominal pain, muscle cramps, and fatigue. - **Hepatomegaly and Steatosis**: In patients with advanced liver disease, entecavir can sometimes cause liver enlargement or fatty liver. Patients should be closely monitored for signs of liver distress. - **Long-term Effects**: Chronic use of entecavir in patients with advanced liver disease should be monitored for signs of hepatic decompensation, including jaundice, ascites, and hepatic encephalopathy.

Pregnancy Category ID

3

Mode of Action

Entecavir is a nucleoside analog that inhibits the reverse transcriptase activity of the hepatitis B virus (HBV), an essential enzyme in the viral replication cycle. Its mode of action can be described as follows: - **Pharmacodynamics**: Entecavir is phosphorylated within infected liver cells into its active triphosphate form, which competes with the natural substrate, deoxyguanosine triphosphate, for incorporation into the growing viral DNA chain. This incorporation leads to chain termination, effectively halting viral replication. - **Pharmacokinetics**: Entecavir has a half-life of about 128 to 149 hours, allowing for once-daily dosing. It is primarily excreted unchanged in the urine, and its elimination is affected by renal function. The drug does not require hepatic metabolism, reducing the likelihood of drug-drug interactions involving the liver enzymes. Entecavir’s ability to effectively suppress HBV replication makes it one of the most potent antiviral agents for chronic hepatitis B, and its high barrier to resistance contributes to its long-term effectiveness.

Interaction

Entecavir has several important drug interactions that can impact its efficacy and safety profile. - **Nephrotoxic Drugs**: Concomitant use of nephrotoxic drugs (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs], certain antibiotics, or diuretics) should be approached with caution, as these agents may exacerbate entecavir-related renal toxicity, particularly in patients with pre-existing renal dysfunction. - **Rifampin**: Rifampin, an antibiotic used primarily for tuberculosis, can reduce the effectiveness of entecavir by inducing hepatic enzymes that accelerate entecavir metabolism. This interaction may require dose adjustments and more frequent monitoring of HBV DNA levels. - **HIV Medications**: Entecavir can interact with certain antiretroviral drugs, especially those used for HIV co-infection. For example, the combination of entecavir with zidovudine or lamivudine may lead to additive antiviral effects, but this can also increase the risk of drug resistance in the long term if not properly managed. - **Food and Alcohol**: There are no specific food interactions with entecavir, but alcohol should be avoided or consumed in moderation as it can exacerbate liver damage in HBV-infected individuals. Alcohol consumption may reduce the effectiveness of antiviral therapies and impair liver function.

Pregnancy Category Note

Information not available

Adult Dose

The standard dose of entecavir for the treatment of chronic hepatitis B is as follows: - **Initial Treatment (Nucleoside-naive)**: 0.5 mg orally once daily. - **Previous Nucleoside Therapy (Lamivudine or Adefovir Resistance)**: 1 mg orally once daily. For patients with renal impairment, the dose may need to be reduced. Entecavir should be taken on an empty stomach, either 2 hours before or after a meal, to optimize absorption.

Child Dose

The pediatric dose of entecavir for chronic hepatitis B is based on body weight: - **Children ≥2 years**: - **Weight 22 kg or more**: 0.5 mg once daily. - **Weight less than 22 kg**: 0.15 mg/kg once daily, with a maximum of 0.5 mg per dose. Pediatric patients should be closely monitored for efficacy and potential side effects, especially those related to growth and development, as long-term antiviral therapy may impact these parameters.

Renal Dose

Dose adjustments are necessary for patients with renal impairment to prevent drug accumulation: - **CrCl 30-49 mL/min**: 0.25 mg once daily. - **CrCl <30 mL/min or on dialysis**: 0.25 mg once every 48 hours. Renal function should be monitored regularly during entecavir treatment, particularly in patients with pre-existing renal conditions.

Administration

Information not available