Modvir-B Tab

Modvir-B Tab

Pharmacodynamic (Mechanism of Action):
- Entecavir, a deoxyguanosine nucleoside analogue with activity against HBV reverse 
  transcriptase (rt), is efficiently phosphorylated to the active triphosphate form, which has
  an intracellular half- life of 15 hours. By competing with the natural substrate 
  deoxyguanosine triphosphate, entecavir triphosphate functionally inhibits all three 
  activities of the HBV reverse transcriptase: (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.
 Pharmacokinetic properties:
- Absorption:
  Entecavir peak plasma concentrations occurred between 0.5 and 1.5 hours. 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. Steady state was achieved after
  6 to 10 days of once-daily administration with approximately 2-fold accumulation. For a
  0.5mg oral dose, Cmax at steady state was 4.2 ng/mL and trough plasma concentration (Ctrough) 
  was 0.3 ng/mL. For a 1 mg oral dose, Cmax was 8.2 ng/mL and Ctrough was 0.5 ng/mL. The 
  bioavailability of the tablet was 100% relative to the oral solution. The oral solution and 
  tablet may be used interchangeably. Effects of food on oral absorption: Oral administration 
  of 0.5 mg of entecavir with a standard high-fat meal (945 kcal, 54.6 g fat) or a light meal 
  (379 kcal, 8.2 g fat) resulted in a delay in absorption (1.0–1.5 hours fed vs. 0.75 hours 
  fasted), a decrease in Cmax of 44%– 46%, and a decrease in AUC of 18%–20%.
- Distribution:
  The estimated apparent volume of distribution is in excess of total body water, suggesting 
  that entecavir is extensively distributed into tissues. Binding of entecavir to human serum 
  proteins in vitro was approximately 13%.
- Metabolism:
  No oxidative or acetylated metabolites were observed. Minor amounts of phase II 
  metabolites (glucuronide and sulfate conjugates) were observed. Entecavir is not a
  substrate, inhibitor, or inducer of the cytochrome P450 (CYP450) enzyme system.
- Exceretion:
  Entecavir is predominantly eliminated by the kidney with urinary recovery of unchanged 
  drug at steady state ranging from 62% to 73% of the administered dose. Renal clearance
  is independent of dose and ranges from 360 to 471 mL/min suggesting that entecavir 
  undergoes both glomerular filtration and net tubular secretion.

Each film coated tablet of  Modvir-B®   contains:
  Entecavir   1 mg      ( as Entecavir monohydrate )
- Each 1ml of  Modvir-B®  oral solution contains:
  Entecavir  0.05 mg  ( as Entecavir monohydrate )


- Coadministration of  Modvir-B® with drugs that reduce renal function or compete for active 
  tubular secretion may increase serum concentrations of either entecavir or the coadministered 
  drug. Coadministration of entecavir with lamivudine, adefovir dipivoxil, or tenofovir 
  disoproxil fumarate did not result in significant drug interactions. 
- The effects of coadministration of Modvir-B® with other drugs that are renally eliminated or 
  are known to affect renal function have not been evaluated, and patients should be monitored
  closely for adverse events when Modvir-B® is coadministered with such drugs.

It is not known whether Modvir-B®  is present in human breast milk, affects human milk 
  production, or has effects on the breastfed infant. The developmental and health benefits of
  breastfeeding should be considered along with the mother’s clinical need for Modvir-B® and 
  any potential adverse effects on the breastfed infant from Modvir-B® or from the underlying   
  maternal condition.
- It has not been demonstrated that Modvir-B® is safe to use during pregnancy. 
  Modvir-B® must not be used during pregnancy unless specifically directed by doctor. 
  It is important that women of childbearing age receiving treatment with Modvir-B® use an
  effective method of contraception to avoid becoming pregnant.
Dizziness, tiredness (fatigue) and sleepiness (somnolence) are common side effects which
  may impair your ability to drive and use machines.

Like all medicines, Modvir-B® can cause side effects, although not everybody gets them.
  Common (may affect up to 1 in 100 people):
- Headache, insomnia (inability to sleep), fatigue (extreme tiredness), dizziness, somnolence 
  (sleepiness), vomiting, diarrhoea, nausea, dyspepsia (indigestion), and increased blood levels of liver enzymes.
  Uncommon (may affect up to 1 in 1000 people):
- Rash, hair loss.
  Rare (may affect up to 1 in 10,000):
- Severe allergic reaction.

- If overdose occurs, the patient must be monitored for evidence of toxicity, and standard 
  supportive treatment applied as necessary.
  Following a single 1 mg dose of entecavir, a 4-hour hemodialysis session removed 
  approximately 13% of the entecavir dose.

- None.

Severe Acute Exacerbations of Hepatitis B:
  Severe acute exacerbations of hepatitis B virus infection have been reported in patients who 
  have discontinued anti-hepatitis B therapy: Monitor hepatic function closely for at least 
  several months.
* Patients Co-infected with HIV and HBV:
  Co-infection with HIV:  Modvir-B®  is not recommended unless the patient is also receiving 
* Lactic Acidosis and Severe Hepatomegaly with Steatosis:
  Lactic acidosis and severe hepatomegaly with steatosis: If suspected, treatment should be 
Use in Specific Populations:-
* Hepatic Impairment
  No dosage adjustment is necessary for patients with hepatic impairment.
* Liver Transplant Recipients
  If Modvir-B® treatment is determined to be necessary for a liver transplant recipient who
  has received or is receiving an immunosuppressant that may affect renal function, such as
  cyclosporine or tacrolimus, renal function must be carefully monitored both before and 
  during treatment with Modvir-B®.

Modvir-B® 1 tablet: ( Blister of 10 tablets, pack of three Blister).
- Modvir-B®  0.05 oral solution: ( Bottle of  100ml solution ).

- Modvir-B® 1 tablet: Store at a dry place at temperature below 25 °C.
- Modvir-B® 0.05 oral solution: Store at temperature below 25 °C.