Entecavir 1 mg

Proper Use Drug information provided by: Take this medicine exactly as directed by your doctor. Do not take it more often, and do not take it for a longer time than your doctor ordered. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine. Also, do not stop taking this medicine without checking with your doctor first. Read and follow carefully the patient information leaflet before starting entecavir treatment and each time you refill. Ask your doctor or pharmacist if you have any questions. Take this medicine on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal). Measure the oral liquid correctly using the marked measuring spoon that comes with the package. Rinse the dosing spoon with water after each use. Dosing The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. • For oral dosage forms (solution or tablets): • For chronic hepatitis B infection: • Adult...

Description and Brand Names Drug information provided by: US Brand Name • Baraclude Descriptions Entecavir is used to treat liver infection caused by hepatitis B virus. It belongs to the family of medicines called antivirals. Antivirals are used to treat infections that are caused by viruses. This medicine will not cure the hepatitis B virus, but it will keep it from reproducing and causing more liver damage. This medicine is available only with your doctor's prescription. This product is available in the following dosage forms: • Solution • Tablet Before Using In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Allergies Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Pediatric Appropriate studies have not been performed on the relationship of age to the effects of entecavir in children younger than 2 years of age. Safety and efficacy have not been established. Geriatric Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of entecavir in the elderly. However, elderly patient...

Dosage Forms & Strengths tablet • 0.5mg • 1mg oral solution • 0.05mg/mL Chronic Hepatitis B Indicated for treatment of CHB with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease Nucleoside inhibitor treatment-naïve with compensated liver disease (adults and adolescents ≥16 yr): 0.5 mg PO qDay Lamivudine-refractory or known lamivudine or telbivudine resistance substitutions (adults and adolescents ≥16 yr): 1 mg PO qDay Decompensated liver disease (adults): 1 mg PO qDay Indication is based on the following • Histologic, virologic, biochemical, and serologic responses in nucleoside-treatment-naïve and lamivudine-resistance with HBeAg-positive or HBeAg-negative chronic HBV infection and compensated liver disease • Virologic, biochemical, serologic, and safety data are available from a controlled study with chronic HBV infection and decompensated liver disease • Virologic, biochemical, serologic, and safety data are available for a limited number of adults with HIV/HBV coinfection who have received prior lamivudine therapy Renal Impairment Usual daily dose (0.5 mg) • CrCl ≥50 mL/min: No dosage adjustment required • CrCl 30-49 mL/min: Reduce to 0.25 mg/day or 0.5 mg q48hr • CrCl 10-29 mL/min: Reduce to 0.15 mg/day or 0.5 mg q72hr • CrCl <10 mL/min, hemodialysis, or CAPD: 0.05 mg/day or 0.5 mg q7days Lamivudine-refractory/decompensated liver disease daily dose (1 mg) • CrCl ≥5...

WARNING: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions ( ]. Limited clinical experience suggests there is a potential for the development of resistance to HIV (human immunodeficiency virus) nucleoside reverse transcriptase inhibitors if entecavir tablet is used to treat chronic hepatitis B virus (HBV) infection in patients with HIV infection that is not being treated. Therapy with entecavir tablet is not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART) [see Warnings and Precautions ( ]. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogue inhibitors alone or in combination with antiretrovirals [see Warnings and Precautions ( ]. 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Timing of Administration 2.2 Recommended Dosage in Adults Compensated Liver Disease The recommended dose of entecavir tablets for chronic hepatitis B virus infection in...

Warning Oral route (Tablet; Solution) Severe acute exacerbations of Serious side effects of Entecavir Along with its needed effects, entecavir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur while taking entecavir: Incidence not known • Abdominal or stomach discomfort • cough • decreased appetite • • difficulty with swallowing • • • fast, shallow breathing • general feeling of discomfort • • muscle • • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue • right upper abdominal or stomach pain and fullness • sleepiness • tightness in the chest • unusual tiredness or weakness Other side effects of Entecavir Some side effects of entecavir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Less common • Acid or sour stomach • • • • • stomach discomfort, upset, or pain Rare • Trouble sleeping • Unusual drowsiness Incidence not known • • thinning of the hair For Healthcare Professionals Applies to entecavir: oral solution, oral tablet. General ...

Baraclude Generic Name Entecavir DrugBank Accession Number DB00442 Background Entecavir is an oral antiviral drug used in the treatment of hepatitis B infection. It is marketed under the trade name Baraclude (BMS). Entecavir is a guanine analogue that inhibits all three steps in the viral replication process, and the manufacturer claims that it is more efficacious than previous agents used to treat hepatitis B (lamivudine and adefovir). It was approved by the U.S. Food and Drug Administration (FDA) in March 2005. Type Small Molecule Groups Approved, Investigational Structure Learn more Pharmacodynamics Entecavir is a guanosine nucleoside analogue with selective activity against hepatitis B virus (HBV). It is designed to selectively inhibit the Hepatitis B virus, blocking all three steps in the replication process. Entecavir is more efficient than an older Hepatitis B drug, lamivudine. Mechanism of action By competing with the natural substrate deoxyguanosine triphosphate, entecavir functionally inhibits all three activities of the HBV polymerase (reverse transcriptase, rt): (1) base priming, (2) reverse transcription of the negative strand from the pregenomic messenger RNA, and (3) synthesis of the positive strand of HBV DNA. Upon activation by kinases, the drug can be incorporated into the DNA which has the ultimate effect of inhibiting the HBV polymerase activity. Target Actions Organism A other Humans Absorption Absorption Following oral administration in healthy subjec...

What Is Baraclude? Baraclude (entecavir) is an antiviral nucleoside drug indicated for the treatment of chronic What Are Side Effects of Baraclude? Common side effects of Baraclude include: • nausea, • vomiting, • diarrhea, • upset stomach, • temporary hair loss, • headache, • skin rash, • fatigue, • dizziness, or • sleep problems (insomnia). Baraclude may also cause severe liver symptoms. Tell your doctor if you have any liver symptoms including: • low fever, • stomach pain, • loss of appetite, • dark urine, • clay-colored stools, or • Seek medical care or call 911 at once if you have the following serious side effects: • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights; • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out; • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors. This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects. Dosage for Baraclude Baraclude tablets are available for oral administration in strengths of 0.5 mg and 1 mg. Baraclude should be administered on an empty stomach (at least 2 hours after a meal and 2 hours before the ne...