BARACLUDE 

Mfd. by :- BMS India Pvt Ltd (Fulfilled By : Magicine Pharma)

Baraclude 

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Magicine Pharma is registered with the Government Of NCT, India, Ministry Of Health in Government of Delhi, India, registration number DL-RAJ-122372 and as a wholesale distributor, department file No. 44208.

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PACKAGE

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Brand name - Baraclude 

Generic name - Entecavir 

Manufacturer - BMS India Pvt Ltd 

Salt composition - Entecavir (0.5 mg) 

Storage - Store at room temperature 

Dosage form - Oral 

Strength - 0.5 mg 

Packaging - Bottle of tablets 

Active ingredient - Entecavir 

Indication - treatment of chronic hepatitis B virus infection in adults and pediatric patients (2 years of age and older) 

Description  

Entecavir is a white to off-white powder. It is slightly soluble in water (2.4 mg/mL), and the pH of the saturated solution in water is 7.9 at 25° C ± 0.5° C. 

Baraclude film-coated tablets are for oral administration in strengths of 0.5 mg and 1 mg of entecavir. Baraclude 0.5 mg and 1 mg film-coated tablets contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, crospovidone, povidone, and magnesium stearate. The tablet coating contains titanium dioxide, hypromellose, polyethylene glycol 400, polysorbate 80 (0.5 mg tablet only), and iron oxide red (1 mg tablet only). Baraclude Oral Solution is available for oral administration as a ready-to-use solution containing 0.05 mg of entecavir per milliliter. Baraclude Oral Solution contains the following inactive ingredients: maltitol, sodium citrate, citric acid, methylparaben, propylparaben, and orange flavor. 

Baraclude is a Hepatitis B virus nucleoside analogue reverse transcriptase inhibitor, which is indicated for the treatment of chronic hepatitis B virus infection in adults and children, provided at least 2 years of age with an evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. It is not known that Baraclude is safe for children below 2 years of age. Baraclude will not cure HPV. It may decrease the ability of HPV to multiply.   

Pharmacodynamics  

Primary pharmacodynamics  

Entecavir is phosphorylated to the active triphosphate form (ETV-TP) by cellular nucleoside kinases. This was shown in different cell systems including infected hepatoma cell lines but the extent of phosphorylation of entecavir was dependent on cell-type. The triphosphate competes with the natural substrate, deoxyguanosine triphosphate (dGTP), of human HBV polymerase. In vitro studies on mechanism of action indicated that the three enzymatic activities of the viral polymerase were inhibited 1) priming activity, 2) reverse transcriptase activity resulting in first strand DNA synthesis and 3) DNA dependent DNA polymerase activity resulting in second-strand DNA synthesis.  

Secondary pharmacodynamics 

Entecavir did not show any significant potential for interactions in an in vitro receptor/channel ligand binding screen or enzyme-system assays at concentrations up to 100 µM. Unlike lamivudine or adefovir, ETV has no relevant activity against HIV-1 (EC50 > 10 µM).  

Pharmacodynamics drug interactions 

In vitro, co-administration of stavudine, didanosine, abacavir and zidovudine had no effect on HBV assays containing entecavir at the EC50. Entecavir at 0.8 to 4.2 x Cmax had no significant effects on EC50 values of stavudine, didanosine, abacavir, zidovudine, lamivudine and tenofovir in cells infected with three HIV strains.  

Usage of medicine 

Baraclude is used in the treatment of chronic Hepatitis B virus infection in adults and children provided at least 2 years of age. 

Alternate brands 

  • X Vir 0.5 mg tablet 

  • Entehep 0.5 mg tablet 

  • Entavir 0.5 mg tablet 

  • Entaliv 0.5 mg tablet 

Side effects 

Common side effects 

  • Headache 

  • Nausea 

  • Rashes 

  • Vomiting 

  • Fatigue 

  • Stomach ache 

  • Diarrhea 

  • Dizziness 

  • Tiredness  

Serious side effects 

  • Low fever 

  • Loss of appetite 

  • Dark-colored urine 

  • Clay-colored stools 

  • Jaundice 

  • Unusual muscle pain 

  • Fast or irregular heartbeat 

  • Feeling cold 

  • Trouble in breathing 

  • Feeling light-headed 

  • Feeling weak 

Dosage  

The dosage is based on your medical conditions. Please consult your healthcare provider for the same. 

Warnings and precautions 

  • Do not stop this medicine, unless your healthcare provider asks you. 

  • This medicine does not treat HIV. 

  • Seek help from your healthcare provider, if you experience (mentioned or other) side effects. 

Ques-1 What is Baraclude? 

Ans-1 Baraclude is a prescription medicine used in the treatment of chronic Hepatitis B virus infection in adults and children (at least 2 years of age). 

 

Ques-2 How should I take Baraclude? 

Ans-2 Take Baraclude exactly as your healthcare provider tells you. 

 

Ques-3 What are the possible side effects of Baraclude? 

Ans-3 There can be side effects such as dizziness, feeling weak, feeling light-headed, nausea, rashes, headache, stomach ache, fatigue, vomiting, tiredness, trouble in breathing, feeling cold, muscle pain, loss of appetite, low fever and diarrhea. Please consult your healthcare provider if you experience these or other side effects. 

 

Ques-4 In what strength is it available?  

Ans-4 It is available in the strength of 0.5 mg. 

 

Ques-5 What happens if I miss a dose? 

Ans-5 If you miss a dose, take it as soon as you remember. If it is near to the time of the next dose, do not take the previous dose. Continue from the next. Remember, do not double the dose. 

 

Ques-6 What should I avoid while consuming this medicine? 

Ans-6 Avoid food items heavily laced with salt. 

 

Ques-7 What are self care tips? 

Ans-7 Before consuming entecavir, tell your healthcare provider if you are allergic to it or you have any other allergies.  

 

Ques-8 Can I take this medicine during pregnancy? 

Ans-8 Please consult your healthcare provider.  

 

Ques-9 Can I drive after taking this medicine? 

Ans-9 Baraclude may make you feel drowsy and cause headache. Avoid driving and operating machines if you experience such side effects. 

 

Ques-10 What are the storage conditions? 

Ans-10 Store at room temperature. Protect from light and moisture. Keep all medicines away from children. 

 

Ques-11 Is it safe to consume alcohol with Baraclude? 

Ans-11 It is not exactly known whether it is safe to consume alcohol with Baraclude or not. Please consult your healthcare provider for the same. 

Above Content has been reviewed by Professionals