Drugs & Vitamins

Baraclude tablets Active Ingredients: Entecavir tablets Representative Names: Baraclude tablets What are Entecavir tablets? What should I tell my health care provider before I take this medicine? How should this medicine be used? What if I miss a dose? What drug(s) may interact with Entecavir? What side effects may I notice from receiving Entecavir? What should I watch for while taking Entecavir? Where can I keep my medicine? What are Entecavir tablets? (Back to top) ENTECAVIR (Baraclude™) is used to treat infections due to the hepatitis B virus. Entecavir can slow the liver damage caused by hepatitis B. It will not cure or prevent hepatitis B infection. Generic entecavir tablets are not yet available. What should I tell my health care provider before I take this medicine? (Back to top) They need to know if you have any of these conditions: •kidney disease •liver disease •HIV infection or AIDS •an unusual reaction to Entecavir, other medicines, foods, dyes, or preservatives •pregnant or trying to get pregnant •breast-feeding How should this medicine be used? (Back to top) Take entecavir tablets by mouth. Follow the directions on the prescription label. Take entecavir 2 hours before and at least 2 hours after eating. Swallow tablets with a drink of water. Try to take your dose at the same time each day. Do not take your medicine more often than directed. Do not stop taking this medicine except on your prescriber's advice. Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed. What if I miss a dose? (Back to top) If you miss a dose, but then remember it during that same day, take it as soon as you can. Then take your next dose at the regularly scheduled time the following day. Do not take 2 doses at once to make up for a missing dose. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. If you are still unsure about what to do if you miss a dose, check with your prescriber. What drug(s) may interact with Entecavir? (Back to top) •amiloride •amphotericin B •antiinflammatory drugs (NSAIDs, such as ibuprofen) •certain antibiotics given by injection •cimetidine •cisplatin •cyclosporine •ketoconazole •megestrol •metformin •midodrine •morphine •pamidronate •pancuronium •quinine •ranitidine •some antibiotics such as trimethoprim and vancomycin •some medicines for colds, hay fever, or allergies •some medicines to control the heart rhythm such as digoxin, disopyramide, dofetilide, procainamide, and quinidine •some medicines for mental depression or psychotic disorders •some medicines used to control high blood pressure such as enalapril, lisinopril, and ramipril •some medicines used to treat viral infections such as acyclovir, cidofovir, foscarnet, ganciclovir, valacyclovir, and valganciclovir •tacrolimus •triamterene •trospium •zoledronic acid Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines. What side effects may I notice from receiving Entecavir? (Back to top) Side effects that you should report to your prescriber or health care professional as soon as possible: •breathing difficulties or shortness of breath •dark yellow or brown urine •dizziness •irregular heartbeat •loss of appetite for several days or longer •not passing urine as often as usual or blood in your urine •passing out or fainting •severe diarrhea •unusual muscle pain •unusual weakness, tiredness, or discomfort •unusual stomach pain or discomfort •vomiting •yellowing of the eyes or skin Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome): •headache •heartburn or indigestion •insomnia or trouble sleeping •mild diarrhea •nausea •sleepiness What should I watch for while taking Entecavir? (Back to top) You must visit your prescriber or health care professional for regular checks on your progress during and after treatment with entecavir. You will need regular blood tests to check for liver function and hepatitis B virus levels. Discuss any new symptoms with your prescriber or health care professional. Tell your prescriber or health care professional at once if you have nausea and vomiting accompanied by severe stomach pain. Some people have worsening of hepatitis after stopping entecavir therapy. Do not stop taking entecavir unless your prescriber instructs you to. Entecavir will not cure hepatitis B infection and you can still get other illnesses or complications associated with your disease. Taking entecavir does not reduce the risk of passing hepatitis B infection to others through sexual or blood contact. Do not have sexual contact without protection; talk to your health care professional about practicing 'safe sex', such as using condoms. Be careful about cuts, abrasions and other possible sources of blood contact. Do not share razors, toothbrushes or other personal items that might have contact with blood. Never share a needle or syringe with anyone. Where can I keep my medicine? (Back to top) Keep out of the reach of children in a container that small children cannot open. Store between 15—30 degrees C (59—86 degrees F). Keep the container tightly closed. Throw away any unused medicine after the expiration date. Last Updated:08/16/2007 CLINICAL PHARMACOLOGY© GOLD STANDARD MULTIMEDIA INC, ALL RIGHTS RESERVED

Note: The above information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist, or other healthcare professional. It should not be construed to indicate that the use of the product is safe, appropriate, or effective for you. Consult your healthcare professional before taking the product.