Baraclude SolutionGeneric Name: Entecavir
Baraclude Solution may increase the risk of severe and sometimes fatal lactic acidosis (buildup of lactic acid in the blood) or liver problems when used alone or with other medicines. Contact your doctor right away if you experience muscle pain, fast or irregular heartbeat, stomach pain, trouble breathing, unusually cold feeling in the arms or legs, unusual tiredness or fatigue, yellowing of the skin or eyes, dark urine, pale stools, or persistent loss of appetite.
A severe worsening of your condition may occur if you stop taking Baraclude Solution. Do not change your dose or stop taking Baraclude Solution without first talking to your doctor. Lab tests, including liver function tests, may be performed for at least several months after you stop taking Baraclude Solution.
Baraclude Solution should not be used in patients who also have HIV infection and are not receiving highly active antiretroviral therapy (HAART). If you have an HIV infection or think that you may have been exposed to HIV, talk with your doctor before you begin to take Baraclude Solution.
Baraclude Solution is used for:
Treating hepatitis B virus infection in certain patients.
Baraclude Solution is a nucleoside analogue. It works by reducing the amount of hepatitis B virus in the blood. It also helps prevent the hepatitis B virus from multiplying and infecting new liver cells.
Do NOT use Baraclude Solution if:
- you are allergic to any ingredient in Baraclude Solution
- you have HIV infection and you are not receiving HAART
Contact your doctor or health care provider right away if any of these apply to you.
Before using Baraclude Solution:
Some medical conditions may interact with Baraclude Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have HIV infection, have liver or kidney problems, or are on dialysis
- if you have had a liver transplant or if you are obese
- if you have been taking nucleoside analogues for a long time
Some MEDICINES MAY INTERACT with Baraclude Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) because they may increase the risk of Baraclude Solution's side effects. Ask your doctor if you are unsure if any of your medicines may harm the kidneys
This may not be a complete list of all interactions that may occur. Ask your health care provider if Baraclude Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Baraclude Solution:
Use Baraclude Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Baraclude Solution. Talk to your pharmacist if you have questions about this information.
- Take Baraclude Solution by mouth on an empty stomach, at least 2 hours after a meal and at least 2 hours before the next meal.
- Use the measuring spoon that comes with Baraclude Solution to measure your dose. Hold the dosing spoon vertically and fill it slowly to the prescribed dose. Rinse the dosing spoon with water after each dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
- Baraclude Solution works best if it is taken at the same time each day.
- Continue to take Baraclude Solution even if you feel well. Do not miss any doses.
- If you miss a dose of Baraclude Solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Baraclude Solution.
Important safety information:
- Baraclude Solution may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Baraclude Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Baraclude Solution does not stop the spread of HIV to others through blood or sexual contact. Use barrier methods of birth control (eg, condoms) if you have HIV infection. Do not share needles, injection supplies, or items like toothbrushes or razors. A vaccine is available to protect people at risk from becoming infected with hepatitis B virus.
- Baraclude Solution is not a cure for hepatitis B virus infection. Remain under the care of your doctor.
- When your medicine supply is low, get more from your doctor or pharmacist as soon as you can. Do not stop taking Baraclude Solution, even for a short period of time. If you do, the virus may grow resistant to Baraclude Solution and become harder to treat.
- Lab tests, including liver and kidney function and HIV antibody testing, may be performed while you use Baraclude Solution and for several months after you stop Baraclude Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Baraclude Solution with caution in the ELDERLY; they may be more sensitive to its effects.
- Baraclude Solution should be used with extreme caution in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Baraclude Solution while pregnant. It is not known if Baraclude Solution is found in breast milk. Do not breast-feed while taking Baraclude Solution.
Possible side effects of Baraclude Solution:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Diarrhea; dizziness; drowsiness; headache; indigestion; nausea; tiredness; trouble sleeping; vomiting.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark-colored urine; difficulty breathing; fast or irregular heartbeat; feeling cold, especially in the arms or legs; light-colored bowel movements; loss of appetite for several days; muscle pain; severe dizziness or lightheadedness; severe or prolonged nausea or vomiting; severe tiredness; stomach pain (with or without nausea or vomiting); weakness; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.Proper storage of Baraclude Solution:
Store Baraclude Solution at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Baraclude Solution out of the reach of children and away from pets.
- If you have any questions about Baraclude Solution, please talk with your doctor, pharmacist, or other health care provider.
- Baraclude Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Baraclude Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
- Baraclude Prescribing Information (FDA)
- Baraclude Consumer Overview
- Baraclude Detailed Consumer Information (PDR)
- Baraclude Advanced Consumer (Micromedex) - Includes Dosage Information
- Entecavir Professional Patient Advice (Wolters Kluwer)