Baraclude Tablet: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Baraclude Tablet (entecavir) is a prescription antiviral medicine in the nucleoside analogue class, used to treat chronic hepatitis B virus infection in adults with liver damage from the virus. It works by blocking an enzyme the virus needs to copy itself, helping to lower viral activity and reduce liver damage. It is available as tablets and as an oral solution, and is taken once daily on an empty stomach.

What is Baraclude Tablet

Baraclude is a prescription antiviral medicine used to treat long-term (chronic) infection with hepatitis B virus (HBV) in adults who have liver damage from the virus. It is available as tablets and as an oral solution.

Baraclude Tablet uses

• Treatment of chronic hepatitis B virus infection in adults with signs of active virus activity and evidence of liver damage or inflammation

Benefits of Baraclude Tablet

• May lower the amount of hepatitis B virus in the body
• May lower the ability of the virus to multiply and infect new liver cells
• May reduce damage to the liver caused by hepatitis B
• Reduces HBV viral replication
• Helps lower HBV DNA levels
• Can improve liver inflammation
• May help reduce progression of chronic liver disease when treatment is effective

How Baraclude Tablet works

Entecavir blocks a key enzyme the hepatitis B virus needs to copy itself (called reverse transcriptase), which stops the virus from multiplying and infecting new liver cells.

Baraclude Tablet dosage

Take this medicine once a day on an empty stomach to help it work better; this means at least 2 hours after a meal and at least 2 hours before your next meal. Try to take it at the same time every day to help you remember.

If using the oral solution, measure your dose carefully with the spoon provided: hold the spoon upright, fill it to the mark for your prescribed dose, swallow the medicine directly from the spoon, then rinse the spoon with water after each use and let it air dry. Do not mix or dilute the oral solution with water or anything else.

Do not change your dose or stop taking this medicine without talking to your healthcare provider, since your hepatitis B may get worse if you stop.

If you miss a dose, take it as soon as you remember, then take your next dose at the regular time; if it is almost time for your next dose, skip the missed dose; do not take two doses at the same time. Do not let your supply run out; get a refill before you run out.

Available forms and strengths

• Film-coated tablets (0.5 mg and 1 mg)
• Oral solution (0.05 mg/mL)

Side effects of Baraclude Tablet

Common

• Headache
• Tiredness (fatigue)
• Dizziness
• Nausea
• Rash
• Diarrhea
• Indigestion
• Vomiting
• Sleepiness (somnolence)
• Trouble sleeping (insomnia)

Serious

• Lactic acidosis (buildup of acid in the blood) - symptoms include feeling very weak or tired, unusual muscle pain, trouble breathing, stomach pain with nausea and vomiting, feeling cold especially in arms and legs, feeling dizzy or lightheaded, fast or irregular heartbeat
• Severe worsening of hepatitis (liver inflammation) after stopping the medicine
• Liver enlargement (hepatomegaly) with fatty liver (steatosis) - symptoms include yellowing of skin or eyes (jaundice), dark urine, light-colored stools, loss of appetite, nausea, lower stomach pain
• Severe allergic (anaphylactoid) reaction
• Low platelet counts
• Low white blood cell counts (leukopenia, neutropenia)
• Hair loss (alopecia)
• Pancreatitis

Warnings and precautions

• Hepatitis B can become severely worse if you stop taking this medicine. Your liver function will need to be monitored closely for several months after stopping treatment, and treatment may need to be restarted.
• This medicine is not recommended for people who have both HIV and hepatitis B infection unless they are also receiving full combination treatment for HIV, because it could lead to the HIV virus becoming resistant to certain HIV medicines.
• A serious and sometimes fatal condition called lactic acidosis, along with severe liver enlargement and fatty liver, has been reported with this type of medicine.
• This medicine does not cure hepatitis B and does not stop you from spreading the virus to others through sex, sharing needles, or blood contact.
• People who have taken lamivudine before and developed resistance to it have a higher chance of this medicine stopping working over time (developing resistance).
• It is not known if this medicine is safe to use during pregnancy. It should only be used during pregnancy if your doctor decides the benefit is worth the potential risk. There is a pregnancy registry to track outcomes for women who take this medicine while pregnant.
• Women should not breastfeed while taking this medicine, since it is not known if it passes into human breast milk and it has been found in the milk of rats.
• This medicine is removed from the body mainly by the kidneys, so people with reduced kidney function need a lower dose or need to take it less often. Your doctor may need to adjust your dose or dosing schedule.
• No dose change is needed for people with liver problems, but this medicine has not been well studied in people who have had a liver transplant, and extra monitoring may be needed.
• This medicine can cause dizziness, tiredness, and sleepiness, which may affect your ability to drive or use machines safely.

Storage

• Store tablets or oral solution at room temperature, 15° to 30°C (59°F to 86°F)
• They do not require refrigeration
• Do not store tablets in a damp place such as a bathroom medicine cabinet or near the kitchen sink
• Keep the container tightly closed
• Store the oral solution in its original carton, protected from light
• Discard the medicine when it is outdated or no longer needed by returning the unused portion to your pharmacist for proper disposal
• Keep out of the sight and reach of children and pets

When to see a doctor

• Get medical help right away if you feel very weak or tired, have unusual muscle pain, have trouble breathing, have stomach pain with nausea and vomiting, feel cold in your arms and legs, feel dizzy or lightheaded, or have a fast or irregular heartbeat — these can be signs of lactic acidosis, a medical emergency.
• Get medical help right away if your skin or the white of your eyes turn yellow, your urine turns dark, your stools turn light in color, you lose your appetite for several days, or you have nausea or lower stomach pain — these can be signs of serious liver problems.
• Contact your doctor immediately if you take more than the prescribed amount of this medicine.
• Tell your healthcare provider right away about any new or unusual symptoms you notice after stopping this medicine, since hepatitis B can worsen after stopping treatment.

Alternatives

• Tenofovir disoproxil fumarate
• Tenofovir alafenamide
• Peginterferon alfa in selected patients