New Myhep Dvir ( Daclatasvir + Sofosbuvir ) Mylan Tablets Uses, Dose ....
MYHEP DVIR tablet is a Mylan pharmaceutical Medicine which is first FDA affirmed item goes under the mix of two prominent hostile to viral mixes like Sofosbuvir and Daclatasvir. MYHEP DVIR tablet is best and deliver less number of reactions. Sofosbuvir is a present as prodrug and shows its activity by changing over into dynamic moiety. Daclatasvir isn’t utilized as single, must be use in blend of other hostile to viral operator called sofosbuvir and removes noticeable impact against hepatitis infection.
MYHEP DVIR TABLET DRUG PROFILE
MYHEP DVIR tablet is a effective combination of two esteemed anti-viral compounds like Sofosbuvir & Daclatasvir.
Sofosbuvir is a present as prodrug and exhibits its action by converting into active moiety.
Daclatasvir is not used as single, must be use in combination of other anti-viral agent called sofosbuvir and expels prominent effect against hepatitis virus
MECHANISM OF ACTION
MYHEP DVIR notwithstanding tablet has two fragments Sofosbuvir and Daclatasvir
Daclatasvir performs Non essential 5A protein is the key for viral duplication. Daclatasvir interfere with the activity of NS5A protein, this may prompts viral destruction.
Sofosbuvir is a prohibitor of nucleotide basic, especially blocks HCV non-helper protein 5B RNA subordinate RNA polymerase.
Sofosbuvir encounter intracellular absorption, which convey pharmacologically powerful compound like uridine basic triphosphate
Sofosbuvir intercede into RNA of hepatitis C contamination with the help of NS5B polymerase. This may goes about as chain eliminator.
PRESCRIBING INFORMATION OF MYHEP DVIR TABLET
The most common usage of MYHEP DVIR tablet is produce anti-viral activity against chronic hepatitis C viral infection caused by genotype I or III.
The major drawback of this combination therapy is given as follows;
Patient suspected with hepatitis C viral infection associated genotype III may loses their virological response due to the combination of sofosbuvir with Daclatasvir.
Absorption
Peak plasma concentration of MYHEP DVIR;
Sofosbuvir: 0.5 to 2 hours Daclatasvir: within 2 hours
Effect of food : it should be administered with or without food. Oral bioavailability occurred in Daclatasvir is 67%
Distribution
Plasma protein binding capacity
Sofosbuvir 61 to 65%
Daclatasvir nearly 99%
Sofosbuvir metabolite has minimal binding effect
Metabolism
Metabolism of sofosbuvir is involved in liver, with the help of carboxyl esterase 1 or cathepsin A
Nearly 99% of Daclatasvir is binding to protein and it is substrate of CYP3A.
Elimination
Elimination occurs in urine, feces, exhaled air
Sofosbuvir: 80% through urine, 14% through feces & 2.5% through exhaled air Daclatasvir: 88% in feces; 6.6% in urine
The terminal half life period of MYHEP DVIR;
WHEN TO TAKE MYHEP DVIR
MYHEP DVIR tablet should be administered with or without food. It is considered as single dose regimen.
MYHEP DVIR dosing regimen
MYHEP DVIR: Sofosbuvir 400mg & Daclatasvir 60mg
The usual dose of MYHEP DVIR tablet is one tablet should be taken as a single dose by administering with food or without food.
On severe condition, MYHEP DVIR must be combine with ribavirin. Patients suffering in HCV genotype I or III with decompensated cirrhosis or post transplantation; the initial dose of ribavirin is 600mg as a single dose, elevating dose up to 1000mg. In compensated cirrhosis; the starting dose of ribavirin should be calculated on the basis of body weight of the suspected patients. In patient with weight of at least 75kg: 1200mg of ribavirin should be considered.
In patient with weight of less than 75kg: 1000mg of ribavirin should be used.
In genotype I
Patient suffered without cirrhosis & compensated cirrhosis: MYHEP DVIRdose is one tablet should be taken with or without food as a single dose. In decompensated cirrhosis or post liver transplantation: MYHEP DVIRprescribed dose is one tablet to be taken as a single dose by combining with ribavirin on weight basis manner.
In genotype III:
Patient struggling without cirrhosis: The usual dose of MYHEP DVIR is one tablet to be taken as a single dose. Compensated, decompensated cirrhosis or post liver transplantation in Patients:
The standard dose is one MYHEP DVIR tablet should be combined with ribavirin as a single dose.
While receiving ribavirin, patient must be administered food.
Ribavirin should be taken as twice daily.
MYHEP DVIR TABLET CAUSED SIDE EFFECTS
- Neutropenia
- Myalgia
- Irritability
- Pancytopenia
- Increase of, Creatine kinase, bilirubin, lipase, AST & ALT
- HBV reoccurrence may occurs
- Serious bradycardia while combining with amiodarone
- Fatigue
- Headache
- Insomnia
- Nausea
- Pruritus
- Asthenia
- Anemia
- Loss of appetite
- Flu like syndrome
- Pyrexia
- Diarrhea
- Rash
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
DRUG- DRUG INTERACTION
MYHEP DVIR consisting of two most effective component like sofosbuvir & Daclatasvir;
Daclatasvir is a CYP3A substrate, while taking MYHEP DVIR tablet with CYP3A strong inducers may leads to reduce the therapeutic effect of Daclatasvir.
MYHEP DVIR combined with drugs inhibits the CYP3A may elevates the plasma level of Daclatasvir
Alteration in INR or prothrombin time may occur in patient receiving warfarin with MYHEP DVIR tablets. MYHEP DVIR tablet combine with P-gp or BCRP inhibitors, may leads to cause prolonging the adverse effects of these substrates.
MYHEP DVIR tablet concurrently used with protease inhibitors causes increasing the effect of concentration of Daclatasvir MYHEP DVIR tablets are concomitantly used with non-nucleoside reverse transcriptase inhibitor causes diminishing the effect of concentration of Daclatasvir
MYHEP DVIR tablet co administered with amiodarone causes severe bradycardia.
MYHEP DVIR tablets are concurrently used with lipid-lowering drugs causes an increasing concentration of these drugs.
MYHEP DVIR tablet concurrently used with anticonvulsants, anti-mycobacterial or herbal products like st. Johns wort causes decreasing the effect of concentration of sofosbuvir.
Sofosbuvir is a P-GP or BCRP drug transporter substrate, while concomitating MYHEP DVIR tablet with P-GP inducers causes reducing the plasma concentration of sofosbuvir. This may result as the loss of therapeutic effect.
FOOD DRUG INTERACTION
Food drug interaction is not possible during the therapy.
Maintained in diet after getting advice from the physician
Concomitant use of ribavirin, should not be taken on an empty stomach.
POSSIBLE CONTRAINDICATIONS
While MYHEP DVIR tablet combined with ribavirin which is contraindicated in pregnant women.
Anaphylactic reactions may occur because the patients may contraindicate to the component present in the MYHEP DVIR tablet.
SAFETY MEASURES
MYHEP DVIR tablet warning;
The major demerit of MYHEP DVIR tablet is;
1. Reoccurrence of HBV infections in the patients who are co-infected with both HCV & HIV
This adverse condition may be reduced by;
Examine the patients who are going to receive the MYHEP DVIR tablet formerly with HBV infection present or not. The patients who are not taking anti-hepatitis B viral drugs may occur.
To avoid this condition, patients must be investigated by undergone liver function test.
2. Serious bradycardia may occur
This may occur due to concomitant use of MYHEP DVIR with amiodarone, cause increase the effect of concentration of amiodarone leads to increase the risk associated to amiodarone.
SAFETY PRECAUTION TAKE CARE WHILE USING MYHEP DVIR
HBV reactivation:
In HCV/HIV co-infected patients who have completed the directly acting anti-viral therapy and not receiving anti-hepatitis B viral therapies; HBV reappearance has been expressed.
This condition causes liver injury may lead to death. To overcome this problem by measuring the HBsAg & anti-HBc counts and also take liver function test by monitoring the bilirubin, AST & ALT levels.
Bradycardia:
Severe life-threatening bradycardia occurs during the combinational therapy of MYHEP DVIR tablet with amiodarone.
To overcome this condition;
Patient should be counsel prior starting the treatment. Cardiac monitoring should be takes place periodically Provide substitute for reducing the adverse effects
Avoid concomitant use of MYHEP DVIR tablet with P-gp inducers, for prevent the loss of therapeutic effect. Concurrent uses of MYHEP DVIR with rifampin or st. Johns wort are not suggested. Risk related to combinational therapies; while concomitating the MYHEP DVIR with other medication care should be taken to avoid the interaction related adverse effects.
HOW TO ORDER MYHEP DVIR TABLETS FROM INDIA
If you wish to order MYHEP DVIR (Sofosbuvir 400mg & Daclatasvir 60mg)tablets online from India at an affordable price, you just have to fill the “ASK Price” form. We will get in touch with you as soon as your order gets placed.
Oddway International is a leading exporter, supplier & distributor of MYHEP DVIR (Sofosbuvir 400mg & Daclatasvir 60mg) Tablets manufactured by Mylan Pharmaceuticals Ltd. from India. We export MYHEP DVIR tablets to China, Russia, Hong Kong, UK, USA, Vietnam, Ukraine, Singapore, Philippines, UAE, Saudi Arabia, Morocco and other countries. To know more call us at +91–9873336444 or email at sales@oddwayinternational.com
DISCLAIMER
This information should not be used to decide whether or not to take this Product or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this Product . It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this product. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this product.
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