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Baraclude (Generic Entecavir)

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Entecavir can harm the liver seriously or fatally and result in lactic acidosis, a disease (a buildup of acid in the blood). If you have received prolonged treatment for hepatitis B virus (HBV) infection, are overweight, or are a woman, your chance of developing lactic acidosis may be increased. Tell your doctor whether you now have liver disease or have ever had it. Please see your physician right away if you suffer any of the following symptoms: Yellowing of the skin or eyes, dark urine, light bowel movements, trouble breathing, stomach pain or swelling, nausea, vomiting, unusual muscle pain, loss of appetite for at least a few days, lack of energy, extreme weakness, or exhaustion, feeling chilly, especially in the arms or legs, dizziness or lightheadedness, or rapid or irregular heartbeat are all symptoms to watch out for.

Without first seeing your doctor, do not discontinue taking entecavir. Hepatitis may worsen if you stop taking entecavir. The first few months after stopping entecavir are when this is most likely to occur. Follow the entecavir directions exactly. Don’t forget to take your medication or run out of entecavir. Call your doctor right away if you have any of the following side effects after stopping entecavir: Extreme fatigue, weakness, nausea, vomiting, appetite loss, skin or eye yellowing, dark urine, light bowel motions, or pain in the muscles or joints.

Entecavir may make treating your HIV infection more challenging if you have the human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) and are not currently taking medication for either condition. If you have HIV, AIDS, or suspect you may have been exposed to HIV, let your doctor know. If there is a potential that you may have been exposed to HIV, your doctor may do an HIV infection test on you before to starting entecavir medication as well as at any point while you are receiving it. HIV infection cannot be treated with entecavir.

Prior to, throughout, and for a few months following your entecavir therapy, keep all appointments with your doctor and the laboratory. During this period, your doctor will prescribe specific tests to monitor how your body is responding to entecavir.

For a copy of the manufacturer’s information for the patient, ask your pharmacist or doctor.

The dangers of using entecavir should be discussed with your doctor.

Why is this medication prescribed?

Entecavir is used to treat adults and children 2 years of age and older who have liver damage who have chronic (long-term) hepatitis B infection (viral-induced liver swelling). Nucleoside analogues are a class of drugs that includes entecavir. Hepatitis B virus (HBV) levels in the body are lowered as a result of its action. Entecavir does not treat chronic hepatitis B or prevent its consequences, such as liver cancer or cirrhosis of the liver. Entecavir does not stop the transmission of HBV to others.

How should this medicine be used?

Entecavir is available as a liquid and tablet for oral use. On an empty stomach, at least 2 hours after eating, and at least 2 hours before the next meal, it is typically taken once daily. Entecavir should be taken every day at about the same time. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Follow the entecavir directions exactly. Never take it in larger or less amounts or more frequently than directed by your doctor.

To use the oral entecavir solution, perform the following actions:

  1. Holding the medicine spoon upright, slowly pour entecavir solution into it until it reaches the mark that corresponds to your dose.
  2. Check to see that the top of the liquid is level with the mark that corresponds to your dose while holding the spoon with the volume markings facing you.
  3. Straight from the measuring spoon, swallow the drug. Avoid combining the drug with any liquid, including water.
  4. After each usage, wash the spoon with water and let it air dry.
  5. The spoon must be kept in a secure location where it won’t be misplaced because you must use it each time you take your prescription. Call your physician or pharmacist if you do misplace the dosing spoon.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking entecavir,

  • If you have an allergy to entecavir, any other drugs, or any of the ingredients in entecavir tablets or oral solution, inform your doctor right away. Request a list of the components from your pharmacist.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Mention any of the following medications as well as the ones in the IMPORTANT WARNING section if applicable: aminoglycoside antibiotics such amikacin, gentamicin, streptomycin, and tobramycin (Tobi); or drugs to prevent organ rejection like tacrolimus or cyclosporine (Gengraf, Neoral, Sandimmune) (Prograf). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Inform your doctor if you have ever had kidney illness or if you have ever had a liver transplant (operation to replace a defective liver).
  • Inform your physician if you are nursing a baby, intend to get pregnant, or are already pregnant. Call your doctor if you become pregnant while taking entecavir. If you are using entecavir, you should not breastfeed.
  • Be sure to inform your doctor or dentist that you are taking entecavir if you are undergoing surgery, including dental surgery.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Entecavir could have negative effects. If this symptom is severe or does not go away, let your doctor know:

  • Headache

Some adverse effects can be very harmful. Call your doctor right away if you encounter any of the signs and symptoms detailed in the IMPORTANT WARNING section.

Other adverse effects of entecavir could exist. If you experience any strange issues while taking this drug, call your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this prescription tightly wrapped in the container it came in, out from the reach of children and animals. Store it away from excess heat, light, and moisture at room temperature (not in the bathroom medicine cabinet or near the kitchen sink).

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Baraclude®
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