Binding of Entecavir to human serum proteins in vitro was approximately 13%. Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature. gallium nitrate, entecavir. Obesity and prolonged nucleoside inhibitor exposure may be risk factors. Get emergency medical help if you have even mild symptoms such as: feeling dizzy, light-headed, tired, or very weak; Entecavir may also cause severe liver symptoms. Either increases effects of the other by decreasing renal clearance. One percent of Entecavir-treated subjects in these four studies compared with 4% of lamivudine-treated subjects discontinued for adverse events or abnormal laboratory test results. You may report side effects to the FDA at 1-800-FDA-1088. Last updated on Nov 1, 2021. Consult your doctor for more details. This information does not assure that this product is safe, effective, or appropriate for you. Entecavir was evaluated in two clinical trials of pediatric subjects 2 years of age and older with HBeAg-positive chronic HBV infection and compensated liver disease. Either increases effects of the other by decreasing renal clearance. The most common adverse reactions among lamivudine-treated subjects were headache, fatigue, and dizziness. The current match involves a Texas lawsuit . 2. Paired, adequate liver biopsy samples were available for 89% of subjects. SIDE EFFECTS: See also Warning section.Headache, tiredness, dizziness, or nausea may occur. The mean duration of prior lamivudine therapy was 2.7 years, and 85% had lamivudine resistance subsitutions at baseline by an investigational line probe assay. Keep all medical and lab appointments. Npoje s vysokm obsahom antioxidantov, ako s vitamny C a E, preukzatene zlepuj erektiln funkciu tm, e brnia pokodeniu buniek, produkujcich oxid dusnat," hovor Pearlmanov. It is not known whether entecavir will prevent cirrhosis or liver cancer. When your supply of Entecavir tablets starts to run low, call your healthcare provider or pharmacy for a refill. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. See Drug Interactions, below. Either increases effects of the other by decreasing renal clearance. tobramycin, entecavir. If you log out, you will be required to enter your username and password the next time you visit. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Pregnancy Exposure Registry Maternal toxicity was also observed at this dose level. Long-term oral carcinogenicity studies of Entecavir in mice and rats were carried out at exposures up to approximately 42 times (mice) and 35 times (rats) those observed in humans at the highest recommended dose of 1 mg/day. Medically reviewed by Drugs.com. 0.15 mg once dailya Minor/Significance Unknown. The optimal duration of therapy with Entecavir is unknown. In cell culture, Entecavir selected for an M184I substitution in HIV reverse transcriptase at micromolar concentrations, confirming inhibitory pressure at high Entecavir concentrations. The principal clinical outcome event assessments are shown in Table 6. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. A majority of these exacerbations were associated with a 2 log10/mL reduction in viral load that preceded or coincided with the ALT elevation. Either increases effects of the other by decreasing renal clearance. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. losartan, entecavir. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. zonisamide, entecavir. All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. The pharmacokinetics, safety and antiviral activity of Entecavir in pediatric subjects were initially assessed in Study AI463028. HBV isolates from lamivudine- refractory subjects failing Entecavir therapy were susceptible in cell culture to adefovir but remained resistant to lamivudine. Minor (1)telavancin, entecavir. Your healthcare provider should monitor your health and do regular blood tests to check your liver if you stop taking Entecavir tablets. Following a single 1 mg dose of Entecavir administered 2 hours before the hemodialysis session, hemodialysis removed approximately 13% of the Entecavir dose over 4 hours. Results are shown in Table 7. General information about the safe and effective use of Entecavir tablets. Please confirm that you would like to log out of Medscape. You should not take entecavir if you have HIV (human immunodeficiency virus) that is not being treated. The cumulative probability of developing rtT184, rtS202, or rtM250 Entecavir resistance-associated substitutions (in the presence of rtM204I/V with or without rtL180M substitutions) at Weeks 48, 96, 144, 192, and 240 was 6.2%, 15%, 36.3%, 46.6%, and 51.5%, respectively. For a 0.5 mg oral dose, Cmax at steady state was 4.2 ng/mL and trough plasma concentration (Ctrough) was 0.3 ng/mL. DOSAGE AND ADMINISTRATION Mom & Baby Devices Surgicals Sexual Wellness Treatments Home Medicines Entavir 1mg Tablet 10'S Entavir 1mg Tablet 10'S Choose Generic substitutes to Save up to 50% off Viral infections Rx required Best Price* 1,000.05 MRP 1,219.57 (Inclusive of all taxes) * Get the best price on this product on orders above Rs 1499 Histologic, virologic, biochemical, and serologic responses in nucleoside-treatment-nave 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, 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, CrCl 30-49 mL/min: Reduce to 0.5 mg/day or 1 mg q48hr, CrCl 10-29 mL/min: Reduce to 0.3 mg/day or 1 mg q72hr, CrCl <10 mL/min, hemodialysis, or CAPD: 0.1 mg/day or 1 mg q7days, >30 kg: 0.5 mg (10 mL oral solution or one 0.5-mg tab), >30 kg: 1 mg (20 mL oral solution or one 1-mg tab), elvitegravir/cobicistat/emtricitabine/tenofovir DF, Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with use of nucleoside analog inhibitors, including this drug administered alone or in combination with antiretrovirals, A majority of cases have been in women; obesity and prolonged nucleoside inhibitor exposure may be risk factors; particular caution should be exercised when administering nucleoside analogue inhibitors to any patient with known risk factors for liver disease; however, cases have also been reported in patients with no known risk factors, Lactic acidosis reported with therapy, often in association with hepatic decompensation, other serious medical conditions, or drug exposures; patients with decompensated liver disease may be at higher risk for lactic acidosis, Treatment should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations), This drug has not been evaluated in HIV/HBV co-infected patients who were not simultaneously receiving effective HIV treatment; limited clinical experience suggests there is a potential for development of resistance to HIV nucleoside reverse transcriptase inhibitors if the drug is used to treat chronic hepatitis B virus infection in patients with HIV infection that is not being treated, Therefore, therapy is not recommended for HIV/HBV co-infected patients not also receiving HAART; before initiating therapy, HIV antibody testing should be offered to all patients; this drug has not been studied as a treatment for HIV infection and is not recommended for this use, In animal reproduction studies, no adverse developmental effects were observed with entecavir at clinically relevant exposures; no developmental toxicities were observed at systemic exposures (AUC) approximately 25 (rats) and 200 (rabbits) times exposure at maximum recommended human dose (MRHD) of 1 mg/day. Forty-six percent (38/82) of Entecavir-treated subjects and 2% (1/41) of placebo-treated subjects achieved HBV DNA <50 IU/mL at Week 48. Lamivudine-refractory subjects (n=157) who failed to achieve the study-defined complete response by Week 96 were offered continued Entecavir treatment. Minor (1)azilsartan, entecavir. The following adverse reactions are discussed in other sections of the labeling: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Minor (1)valganciclovir, entecavir. Minor/Significance Unknown. Minor/Significance Unknown. cyclosporine, entecavir. The mean age of subjects was 35 years, 75% were male, 57% were Asian, 40% were Caucasian, and 13% had previously received interferon-. Histologic Improvement and change in Ishak Fibrosis Score are shown in Table 9. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Minor (1)procainamide, entecavir. Healthy subjects who received single Entecavir doses up to 40 mg or multiple doses up to 20 mg/day for up to 14 days had no increase in or unexpected adverse events. Safely throw away Entecavir tablets that are out of date or no longer needed. Minor/Significance Unknown. Minor/Significance Unknown. Minor/Significance Unknown. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. The observed drug accumulation index is approximately 2-fold with once-daily dosing, suggesting an effective accumulation half-life of approximately 24 hours. Entecavir was superior to lamivudine on a primary endpoint of Histologic Improvement (using the Knodell Score at Week 48). Either increases effects of the other by decreasing renal clearance. Entecavir is substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. In a pre/postnatal development study, Entecavir was administered orally to pregnant rats at 0.3, 3, and 30 mg per kg per day from gestation day 6 to lactation/post-partum day 20. mannitol, entecavir. Inform patients using the oral solution to hold the dosing spoon in a vertical position and fill it gradually to the mark corresponding to the prescribed dose. View Entecavir's uses, side-effects, drug interactions, expert advice and user FAQs only on 1mg.com. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 1. In animal reproduction studies, no adverse developmental effects were observed with Entecavir at clinically relevant exposures. At baseline, subjects had a mean Knodell Necroinflammatory Score of 7.8, mean serum HBV DNA as measured by Roche COBAS Amplicor PCR assay was 9.66 log10 copies/mL, and mean serum ALT level was 143 U/L. Co., Ltd. captopril, entecavir. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. Minor (1)mefenamic acid, entecavir. Do not stop this medication without talking to your doctor. In healthy subjects, the bioavailability of the tablet was 100% relative to the oral solution. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. Severe Acute Exacerbation of Hepatitis after Discontinuation of Treatment. Either increases effects of the other by decreasing renal clearance. Hepatobiliary disorders: Increased transaminases. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. Prospective pregnancy data from the APR are not sufficient to adequately assess the risk of birth defects, miscarriage or adverse maternal or fetal outcomes. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. Either increases levels of the other by decreasing renal clearance. Inform patients that if they have or develop HIV infection and are not receiving effective HIV treatment, Entecavir tablets may increase the risk of development of resistance to HIV medication [see Warnings and Precautions (5.2) ]. Results for selected study endpoints at Week 48 are shown in Table 13. Rx Only Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. Some patients may find it difficult to accurately measure the prescribed dose using the provided dosing spoon; therefore, patients/caregivers should refer to the steps in the Patient Information section that demonstrate the correct technique of using the provided dosing spoon to measure the prescribed Entecavir tablets dose. Minor (1)sulindac, entecavir. For subjects originally assigned to Entecavir, at the end of the open-label phase (Week 48), 8% of subjects had HBV DNA <300 copies/mL by PCR, the mean change from baseline HBV DNA by PCR was 4.20 log10 copies/mL, and 37% of subjects with abnormal ALT at baseline commonly, these are "non-preferred" brand drugs or specialty Either increases effects of the other by decreasing renal clearance. Entecavir has not been evaluated in HIV/HBV co-infected patients who were not simultaneously receiving effective HIV treatment [see Warnings and Precautions (5.2) ]. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. Either increases effects of the other by decreasing renal clearance. Either increases levels of the other by decreasing renal clearance. Minor (1)candesartan, entecavir. Minor/Significance Unknown. Minor/Significance Unknown. You dont feel like eating food for several days or longer. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Minor/Significance Unknown. Minor/Significance Unknown. Lactic acidosis with Entecavir use has been reported, often in association with hepatic decompensation, other serious medical conditions, or drug exposures. foscarnet, entecavir. Either increases effects of the other by decreasing renal clearance. b Children with body weight greater than 30 kg should receive 20 mL (1 mg) of oral solution or one 1 mg tablet once daily. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. Either increases levels of the other by decreasing renal clearance. Minor/Significance Unknown. Method of action: Antivirals For Systemic Use Treatment option: Hepatitis,Hepatitis B,Liver Disease,Infection,Chronic Hepatitis,Chronic Hepatitis B Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. Minor/Significance Unknown. 10. Either increases levels of the other by decreasing renal clearance. Either increases effects of the other by decreasing renal clearance. Pill with imprint TEVA 5787 is Pink, Round and has been identified as Entecavir 1 mg. In Study AI463048, 100 subjects were randomized to treatment with Entecavir and 91 subjects to treatment with adefovir dipivoxil. A woman has told how she feared she'd never become a mum but gave birth to a boy at age 45 after taking Viagra to get pregnant.. Carin Rockind, 48, welcomed a "miracle" baby after trying to have a . Minor/Significance Unknown. Dispose of unused medicines through community take-back disposal programs when available or place Entecavir tablets in an unrecognizable closed container in the household trash. Your healthcare provider will test the level of the hepatitis B virus in your blood regularly. Minor/Significance Unknown. Minor/Significance Unknown. Likewise, the pharmacokinetics of known CYP substrates are unlikely to be affected by coadministration of Entecavir. Information last revised August 2021. Entecavir was administered orally to pregnant rats (at 2, 20, and 200 mg per kg per day) and rabbits (at 1, 4, and 16 mg per kg per day) during organogenesis (on gestation Days 6 through 15 [rat] and 6 through 18 [rabbit]). Minor/Significance Unknown. Do not use Entecavir tablets for a condition for which it was not prescribed. Protect from light. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. Substitutions rtM204I/V with or without rtL80I/V, rtV173L, or rtL180M, which are associated with lamivudine and telbivudine resistance, also confer decreased phenotypic susceptibility to Entecavir. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. Minor/Significance Unknown. Hepatitis B may become active or get worse in the months after you stop using entecavir. Either increases effects of the other by decreasing renal clearance. However, VIAGRA may be taken anywhere from 30 minutes to 4 hours before sexual activity ()Based on effectiveness and toleration, may increase to a maximum of 100 mg or decrease to 25 mg ()Maximum recommended dosing frequency is once per day () The efficacy and safety of Entecavir have not been established in patients less than 2 years of age. Either increases effects of the other by decreasing renal clearance. Minor (1)foscarnet, entecavir. tenofovir DF increases levels of entecavir by decreasing renal clearance. Some people using entecavir develop lactic acidosis, which can be fatal. Do not share personal items that can have blood or body fluids on them, like toothbrushes or razor blades. Liver-related HBV disease. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. Therapy with Entecavir tablets are not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy (HAART), 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, Recommended Once-Daily Dose of Oral Solution (mL), a Laboratory Abnormalities Reported in Four Entecavir Clinical Trials Through 2 Years, Subjects with ALT Elevations>10ULN and >2Reference, Clinical Trial Experience in Pediatric Subjects, Nucleoside-inhibitor-nave Subjects with Compensated Liver Disease, HBeAg-negative (anti-HBe-positive/HBV DNA-positive), Lamivudine-refractory Subjects with Compensated Liver Disease, Subjects with Decompensated Liver Disease. Twenty-four percent (20/82) of subjects in the Entecavir- treated group and 2% (1/41) of subjects in the placebo-treated group met the primary endpoint. Minor/Significance Unknown. Available for Android and iOS devices. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. Minor (1)mannitol, entecavir. Either increases effects of the other by decreasing renal clearance. The highest recommended Viagra dose for treating erectile dysfunction (ED) is 100 mg per day, according to the drug's manufacturer. What are the possible side effects of Entecavir? Minor (1)olmesartan, entecavir. Inactive ingredients in Entecavir Tablets: lactose monohydrate, microcrystalline cellulose, crospovidone, povidone, magnesium stearate. Either increases effects of the other by decreasing renal clearance. PRINCIPAL DISPLAY PANEL Bottle Label have received medicine for HBV before. It is not known if Entecavir will harm your unborn baby. Women's health is once again the center of a political ping-pong match with evidence-based science on one side and anti-choice advocates on the other. Either increases effects of the other by decreasing renal clearance. Clinical Adverse Reactions Reported in 3% of entecavir -treated Patients, Plus Selected Clinical Adverse Reactions in Four entecavir Clinical Trials - Through 2 Years of . Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. Toxicity may result from coadministration of emtricitabine and tenofovir with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion .entecavir and elvitegravir/cobicistat/emtricitabine/tenofovir DF both increase nephrotoxicity and/or ototoxicity. HBeAg-negative (anti-HBe-positive/HBV DNA-positive): Study AI463027 was a multinational, randomized, double-blind study of Entecavir 0.5 mg once daily versus lamivudine 100 mg once daily for a minimum of 52 weeks in 638 (of 648 randomized) nucleoside-inhibitor-nave subjects with HBeAg-negative (HBeAb-positive) chronic hepatitis B virus infection and compensated liver disease. HIV or AIDS (or if you have been exposed to HIV); if you also take lamivudine (Epivir, Epzicom, Trizivir) or telbivudine (Tyzeka). Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. etidronate, entecavir. Kidney Disease. At baseline, subjects had a mean Knodell Necroinflammatory Score of 7.8, mean serum HBV DNA as measured by Roche COBAS Amplicor PCR assay was 7.58 log10 copies/mL, and mean serum ALT level was 142 U/L. Of 7 subjects whose HBV had an rtA181 substitution at baseline, 2 also had substitutions at rtT184, rtS202, or rtM250 at baseline and another 2 developed them while on treatment with Entecavir. b Subjects received once-daily doses of 0.030 mg/kg up to a maximum of 1 mg. Renal impairment: The pharmacokinetics of Entecavir following a single 1 mg dose were studied in subjects (without chronic hepatitis B virus infection) with selected degrees of renal impairment, including subjects whose renal impairment was managed by hemodialysis or continuous ambulatory peritoneal dialysis (CAPD). Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. For all subjects who discontinued treatment (regardless of reason), Table 5 presents the proportion of subjects in each study who experienced post-treatment ALT flares. Minor (1)creatine, entecavir. Yung Shin Pharmaceutical Industrual Co., Ltd. manufacture(63126-101, 63126-102), pack(63126-101, 63126-102), label(63126-101, 63126-102). Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug. The pharmacokinetics of Entecavir are unlikely to be affected by coadministration with agents that are either metabolized by, inhibit, or induce the CYP450 system. Entecavir triphosphate is a weak inhibitor of cellular DNA polymerases , , and and mitochondrial DNA polymerase with Ki values ranging from 18 to >160 M. Entecavir Tablets USP, 0.5 mg Nucleoside reverse transcriptase inhibitors (NRTIs), Boxed Warning, Warnings and Precautions (5.1), Boxed Warning, Warnings and Precautions (5.3), Drug class: nucleoside reverse transcriptase inhibitors (NRTIs). Minor/Significance Unknown. Qty 1. No subject in either treatment arm experienced an on-treatment hepatic flare (ALT>2 baseline and >10 ULN) through Week 48. You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. "Vitamn C njdete v ovoc, ako s pomarane a jahody, a vitamn E v . The trial population was 82% male, 39% Caucasian, and 37% Asian, with a mean age of 49 years; 89% of subjects had HBeAg-negative disease at the time of transplant. Minor/Significance Unknown. Because of low enrollment, safety and efficacy have not been established in the US Hispanic population. Following multiple daily doses ranging from 0.1 to 1 mg, Cmax and area under the concentration-time curve (AUC) at steady state increased in proportion to dose. A majority of these cases have been in women. 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