Rx Item-Entecavir 0.5MG 30 TAB-Cool Store- by Camber Pharma USA Gen Baraclude

Rx Item-Entecavir 0.5MG 30 TAB-Cool Store- by Camber Pharma USA , Clinical Information:
Generic Code And Description: 58934 Entecavir Oral Tablet 0.5 Mg
Strength: 0.5 Mg
Dose Form: Tablet
Product Category: : Rx Pharmaceuticals
Fine Line Class: 850085008510 All Rx Products
DEA Class: None Omp Family:
Drug Class: 8183200 Nucleoside And Nucleotide Antivirals
Active Ingredients: 10730 Entecavir 142217694
Inactive Ingredients: 13405 Soy Drug Class: Drug Class: 8183200 Nucleoside And Nucleotide Antivirals , OMP Family: , Temparature Zone: 20 Cool-Store Cont Temp, Unit Dose Indicator: NO, Item Size: 30 , Brand Label Flag: GENERIC , Storage Temperature Zone: 20 Cool-Store Cont Temp, Item Size Code:30 , Item Strength Code:0.5MG , Item Abbreviation: Entecavir , Generic Form: TAB

These highlights do not include all the information needed to use entecavir tablets safely and effectively. See full prescribing information for entecavir tablets.
ENTECAVIR tablets, for oral use.
Initial U.S. Approval: 2005

WARNING: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY
See full prescribing information for complete boxed warning.
• 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 for at least several months after discontinuation. Initiation of anti-hepatitis B therapy may be warranted. (5.1)
• Entecavir tablets are not recommended for patients co-infected with human immunodeficiency virus (HIV) and hepatitis B virus (HBV) who are not also receiving highly active antiretroviral therapy (HAART), because of the potential for the development of resistance to HIV nucleoside reverse transcriptase inhibitors. (5.2)
• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogue inhibitors. (5.3)


INDICATIONS AND USAGE

Entecavir tablets are a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults and children at least 2 years of age with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. (1) (1)
DOSAGE AND ADMINISTRATION

• Nucleoside-inhibitor-treatment-naïve with compensated liver disease (greater than or equal to 16 years old): 0.5 mg once daily. (2.2)
• Nucleoside-inhibitor-treatment-naïve and lamivudine-experienced pediatric patients at least 2 years of age and weighing at least 10 kg: dosing is based on weight. (2.3)
• Lamivudine-refractory or known lamivudine or telbivudine resistance substitutions (greater than or equal to 16 years old): 1 mg once daily. (2.2)
• Decompensated liver disease (adults): 1 mg once daily. (2.2)
• Renal impairment: Dosage adjustment is recommended if creatinine clearance is less than 50 mL/min. (2.4)
• Entecavir tablets should be administered on an empty stomach. (2.1)



DOSAGE FORMS AND STRENGTHS

• Tablets: 0.5 mg and 1 mg (3, 16)
CONTRAINDICATIONS

• None. (4)
WARNINGS AND PRECAUTIONS

• Severe acute exacerbations of hepatitis B virus infection after discontinuation: Monitor hepatic function closely for at least several months. (5.1, 6.1)
• Co-infection with HIV: Entecavir tablets are not recommended unless the patient is also receiving HAART. (5.2)
• Lactic acidosis and severe hepatomegaly with steatosis: If suspected, treatment should be suspended. (5.3)

ADVERSE REACTIONS

• In adults, the most common adverse reactions (≥3%, all severity grades) are headache, fatigue, dizziness, and nausea. The adverse reactions observed in pediatric patients were consistent with those observed in adults. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Hetero Labs Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
USE IN SPECIFIC POPULATIONS

• Liver transplant recipients: Limited data on safety and efficacy are available. (8.8)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 12/2019

Rx Item-Entecavir 0.5MG 30 TAB-Cool Stor
Item No. RX502664, 502664, NDC No.: 31722-0833-30, 31722-833-30, 3172283330, 31722083330, 0833-30, 083330 UPC No. 3-31722-83330-1, 331722-833301, 331722833301

Rx Item-Entecavir 0.5MG 30 TAB-Cool Stor
Item No. RX502664, 502664, NDC No.: 31722-0833-30, 31722-833-30, 3172283330, 31722083330, 0833-30, 083330 UPC No. 3-31722-83330-1, 331722-833301, 331722833301

Rx Item-Entecavir 0.5MG 30 TAB-Cool Stor
Rx items can only be ordered by a valid licence holder in scope of practice by-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physica

Rx Item-Entecavir 0.5MG 30 TAB
Item No. RX502664, 502664, NDC No.: 31722-0833-30, 31722-833-30, 3172283330, 31722083330, 0833-30, 083330 UPC No. 3-31722-83330-1, 331722-833301, 331722833301