Entecavir

Entecavir Manufacturers

• Teva Pharmaceuticals Usa Inc
  

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  Entecavir | Teva Pharmaceuticals Usa Inc

  

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  2.1 Timing of Administration

  Entecavir tablets should be administered on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).

  2.2 Recommended Dosage in Adults

  Compensated Liver Disease

  The recommended dose of entecavir tablets for chronic hepatitis B virus infection in nucleoside-inhibitor-treatment-naïve adults and adolescents 16 years of age and older is 0.5 mg once daily.

  The recommended dose of entecavir tablets in adults and adolescents (at least 16 years of age) with a history of hepatitis B viremia while receiving lamivudine or known lamivudine or telbivudine resistance substitutions rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L is 1 mg once daily.

  Decompensated Liver Disease

  The recommended dose of entecavir tablets for chronic hepatitis B virus infection in adults with decompensated liver disease is 1 mg once daily.

  2.3 Recommended Dosage in Pediatric Patients

  Pediatric use information is approved for Bristol-Myers Squibb Company’s Baraclude® (entecavir) tablets. However, due to Bristol-Myers Squibb Company’s marketing exclusivity rights, this drug product is not labeled with that information.

  2.4 Renal Impairment

  In adult subjects with renal impairment, the apparent oral clearance of entecavir decreased as creatinine clearance decreased [see Clinical Pharmacology (12.3)]. Dosage adjustment is recommended for patients with creatinine clearance less than 50 mL/min, including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), as shown in Table 2. The once-daily dosing regimens are preferred.

  Table 2: Recommended Dosage of Entecavir Tablets in Adult Patients With Renal Impairment * If administered on a hemodialysis day, administer entecavir tablets after the hemodialysis session.

  Creatinine Clearance (mL/min)

  Usual Dose (0.5 mg)

  Lamivudine-Refractory or Decompensated Liver Disease
  (1 mg)

  50 or greater

  0.5 mg once daily

  1 mg once daily

  30 to less than 50

  0.5 mg every 48 hours

  0.5 mg once daily
  OR
  1 mg every 48 hours

  10 to less than 30

  0.5 mg every
  72 hours

  1 mg every 72 hours

  Less than 10
  Hemodialysis* or CAPD

  0.5 mg every 7 days

  1 mg every 7 days

  Pediatric use information is approved for Bristol-Myers Squibb Company’s Baraclude® (entecavir) tablets. However, due to Bristol-Myers Squibb Company’s marketing exclusivity rights, this drug product is not labeled with that information.

  2.5 Hepatic Impairment

  No dosage adjustment is necessary for patients with hepatic impairment.

  2.6 Duration of Therapy

  The optimal duration of treatment with entecavir tablets for patients with chronic hepatitis B virus infection and the relationship between treatment and long-term outcomes such as cirrhosis and hepatocellular carcinoma are unknown.

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• Par Pharmaceutical, Inc.
  

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  Entecavir | Mylan Institutional Inc.

  

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  Nitrofurantoin macrocrystals capsules should be given with food to improve drug absorption and, in some patients, tolerance.

  Adults: 50 mg to 100 mg four times a day – the lower dosage level is recommended for uncomplicated urinary tract infections.

  Pediatric Patients: 5 to 7 mg/kg of body weight per 24 hours, given in four divided doses (contraindicated under one month of age).

  Therapy should be continued for one week or for at least 3 days after sterility of the urine is obtained. Continued infection indicates the need for reevaluation.

  For long-term suppressive therapy in adults, a reduction of dosage to 50 mg to 100 mg at bedtime may be adequate. For long-term suppressive therapy in pediatric patients, doses as low as 1 mg/kg per 24 hours, given in a single dose or in two divided doses, may be adequate. SEE WARNINGS SECTION REGARDING RISKS ASSOCIATED WITH LONG-TERM THERAPY.

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• Camber Pharmaceuticals, Inc.
  

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  Entecavir | Camber Pharmaceuticals, Inc.

  

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  2.1 Timing of Administration
  

  Entecavir tablets should be administered on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).

  2.2 Recommended Dosage in Adults
  

  Compensated Liver Disease
  The recommended dose of entecavir tablets for chronic hepatitis B virus infection in nucleoside­inhibitor-treatment-naïve adults and adolescents 16 years of age and older is    0.5 mg once daily.
  The recommended dose of entecavir tablets in adults and adolescents (at least 16 years of age) with a history of hepatitis B viremia while receiving lamivudine or known lamivudine or telbivudine resistance substitutions rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L is 1 mg once daily.
  Decompensated Liver Disease
  The recommended dose of entecavir tablets for chronic hepatitis B virus infection in adults with decompensated liver disease is 1 mg once daily.

  2.3 Recommended Dosage in Pediatric Patients
  

  Pediatric use information is approved for Bristol-Myers Squibb Company's Baraclude® (entecavir) tablets. However, due to Bristol-Myers Squibb Company's marketing exclusivity rights, this drug product is not labeled with that information.

  2.4 Renal Impairment
  

  In adult subjects with renal impairment, the apparent oral clearance of entecavir decreased as creatinine clearance decreased [see Clinical Pharmacology (12.3)]. Dosage adjustment is recommended for patients with creatinine clearance less than 50 mL/min, including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), as shown in Table 1. The once-daily dosing regimens are preferred.

  
  Table 1: Recommended Dosage of Entecavir Tablets in Adult Patients with Renal Impairment
  
  Creatinine Clearance (mL/min)
  Usual Dose (0.5 mg)
  Lamivudine-Refractory or Decompensated Liver Disease (1 mg)
  50 or greater
  0.5 mg once daily
  1 mg once daily
  30 to less than 50
  0.5 mg every 48 hours
  0.5 mg once daily
  OR
  1 mg every 48 hours
  10 to less than 30
  0.5 mg every 72 hours
  1 mg every 72 hours
  Less than 10
  Hemodialysisb or CAPD
  0.5 mg every 7 days
  1 mg every 7 days
  
  
  
  
  
  
  

  b    If administered on a hemodialysis day, administer entecavir tablets after the hemodialysis session.
  Pediatric use information is approved for Bristol-Myers Squibb Company's Baraclude® (entecavir) tablets. However, due to Bristol-Myers Squibb Company's marketing exclusivity rights, this drug product is not labeled with that information.

  2.5 Hepatic Impairment
  

  No dosage adjustment is necessary for patients with hepatic impairment.

  2.6 Duration of Therapy
  

  The optimal duration of treatment with entecavir tablets for patients with chronic hepatitis B virus infection and the relationship between treatment and long-term outcomes such as cirrhosis and hepatocellular carcinoma are unknown.

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• Aurobindo Pharma Limited
  

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  Entecavir | Aurobindo Pharma Limited

  

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  2.1 Timing of Administration
  

  Entecavir tablets should be administered on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).

  2.2 Recommended Dosage in Adults

  
  Compensated Liver Disease
  
  The recommended dose of entecavir tablets for chronic hepatitis B virus infection in nucleoside-inhibitor-treatment-naïve adults and adolescents 16 years of age and older is 0.5 mg once daily.
  
  The recommended dose of entecavir tablets in adults and adolescents (at least 16 years of age) with a history of hepatitis B viremia while receiving lamivudine or known lamivudine or telbivudine resistance substitutions rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L is 1 mg once daily.
  
  Decompensated Liver Disease
  
  The recommended dose of entecavir tablets for chronic hepatitis B virus infection in adults with decompensated liver disease is 1 mg once daily.

  2.3 Recommended Dosage in Pediatric Patients

  
  Pediatric use information is approved for Bristol-Myers Squibb Company’s entecavir tablets. However, due to Bristol-Myers Squibb Company’s marketing exclusivity rights, this drug product is not labeled with that information.

  2.4 Renal Impairment
  

  In adult subjects with renal impairment, the apparent oral clearance of entecavir decreased as creatinine clearance decreased [see Clinical Pharmacology (12.3)]. Dosage adjustment is recommended for patients with creatinine clearance less than 50 mL/min, including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), as shown in Table 2. The once-daily dosing regimens are preferred.

  
  b  If administered on a hemodialysis day, administer entecavir tablets after the hemodialysis session. Table 2:  Recommended Dosage of Entecavir Tablets in Adult Patients with Renal Impairment
  Creatinine Clearance (mL/min)
  Usual Dose (0.5 mg)
  Lamivudine-Refractory or Decompensated Liver Disease (1 mg)
  50 or greater
  0.5 mg once daily
  1 mg once daily
   
  30 to less than 50
   
  0.5 mg every 48 hours
  0.5 mg once daily
  OR
  1 mg every 48 hours
  10 to less than 30
  0.5 mg every 72 hours
  1 mg every 72 hours
  Less than 10
  Hemodialysisb or CAPD
  0.5 mg every 7 days
  1 mg every 7 days
  

       

  Pediatric use information is approved for Bristol-Myers Squibb Company’s entecavir tablets. However, due to Bristol-Myers Squibb Company’s marketing exclusivity rights, this drug product is not labeled with that information.

  2.5 Hepatic Impairment

  
  No dosage adjustment is necessary for patients with hepatic impairment.

  2.6 Duration of Therapy
  

  The optimal duration of treatment with entecavir tablets for patients with chronic hepatitis B virus infection and the relationship between treatment and long-term outcomes such as cirrhosis and hepatocellular carcinoma are unknown.

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  No Recall

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