MYHEP-DVIR
Drug profile :
Myhep dvir tablet, a combination of two most effective anti-viral agents called as Sofosbuvir & Daclatasvir. This tablet is most effective against serious condition like hepatitis C viral infection induced by genotype I or III.
Myhep dvir tablet is the merger of two non structural proteins like NS5A & NS5B inhibitors.
This phosphoprotein is important for viral production.
Myhep dvir tablets are used as single dose therapy, which is most efficient for treating the hepatitis condition.
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| MYHEP-DVIR |
Prescribing information :
Myhep dvir tablets are utilized to treat the propelled hepatitis C viral diseases related with genotypes I or III.
For the most part Daclatasvir is utilized as a part of mix with sofosbuvir for better against viral action.
In decompensated cirrhosis condition, Myhep dvir ought to be utilized simultaneously with ribavirin
Mechanism:
After oral confirmation of Myhep dvir tablets, it might experience some structure for showing the counter pervasive action.
Myhep dvir: Sofosbuvir and Daclatasvir
Sofosbuvir is the most exceptional threatening to viral medicine, which is accessible as prodrug.
After intracellular absorption of sofosbuvir prompts make a working structure known as uridine straightforward of triphosphate.
NS5B polymerase introduces the sofosbuvir into hepatitis C viral RNA and causes chain obstacle.
Daclatasvir is in addition like sofosbuvir segment; it shows two verifiable pathways;
Cis: cis-acting of basally phosphorylated NS5A intervene the HCV replication complex.
Trans: hyperphosphorylated NS5A changes HCV amassing and persuading particle progress.
Daclatasvir related with;
Intervene with movement of new HCV duplication complex
Constraint of intracellular viral RNA amalgamation
Constraint of virion collecting and discharge
Absorption
Peak plasma concentration time of Myhep dvir; Sofosbuvir 0.5 to 2 hours, Daclatasvir within 2 hours
Food does not affect the absorption of Myhep dvir.
Daclatasvir bioavailability is occurs by 67%.
Distribution
The human plasma protein binding capacity of;
Sofosbuvir 61 to 65%, Daclatasvir 99%
The circulating metabolite of sofosbuvir has minimal binding effect.
Metabolism
The metabolism of Myhep dvir is majorly occurs in liver.
Sofosbuvir by cathepsin A or carboxyl esterase 1
Daclatasvir by CYP3A isoenzymes in lesser extent
Excretion
Elimination of sofosbuvir through urine 80%, feces 14% & respiration 2.5%
Daclatasvir through urine 88% & feces 6.6%
Half lives of Myhep dvir;
Sofosbuvir 0.4 hours, GS-331007: 27 hours
Daclatasvir 12 to 15 hours
When to take the drug
The dose of Myhep dvir is one tablet should be given as a once a day dose by taking with or without food.
In serious decompensated cirrhosis, Myhep dvir should be administered in combination with ribavirin.
Dosage regimens
On the basis of body weight of the patients the dose of ribavirin should be calculated.
An starting dose of ribavirin is 600mg as once daily, followed by increasing the dose to 1000mg.
ü < 75kg of body weight, ribavirin dose is 1000mg
ü 75kg of body weight, ribavirin dose is 1200mg
Genotype III induced HCV;
Without cirrhosis:
The normal administrating dose of Myhep dvir is one tablet should be taken as once daily.
Compensated, decompensated or post liver transplant:
Concomitant use with ribavirin should give One Myhep dvir tablet
Ribavirin dose should be taken with food.
Genotype I induced HCV;
Without cirrhosis & compensated cirrhosis:
The normal administrated dose of Myhep dvir is one tablet should be given orally as once daily.
Decompensated cirrhosis:
The recommended dose of Myhep dvir is one tablet should be combined with weight based ribavirin.
Drug caused side effects
Serious bradycardia during combination with amiodarone
HBV reactivation
Fatigue
Headache
Insomnia
Nausea
Pruritus
Asthenia
Anemia
Loss of appetite
Flu like syndrome
Pyrexia
Diarrhea
Rash
Neutropenia
Myalgia
Irritability
Pancytopenia
Increasing bilirubin, creatine kinase, lipase, AST & ALT
Drug- drug interaction
Interaction with CYP3A inducers causes absence of action because of diminished concentration of Daclatasvir.
Myhep dvir simultaneously utilize with CYP3A intense inhibitors, prompts raise the plasma concentration of Daclatasvir.
Interaction with warfarin prompts deliver changes in INR esteems and prothrombin time causes draining clutters.
Interaction with P-gp or BCRP powerful inhibitors causes expanded hazard identified with these substrates.
Interaction with protease inhibitors or NNRTI causes raising or exhausting the concentration of Daclatasvir individually.
Interaction with amiodarone, produces perilous bradycardia impacts.
Interaction with lipid bringing down operators causes expanded concentration of these specialists.
Interaction with any hostile to convulsants, against mycobacterials or herbal items causes expanded grouping of these medications prompts draining the sofosbuvir concentration.
Interaction with P-gp inducers causes loss of against viral action of Myhep dvir.
Food drug interaction
There is no possible food drug interaction occurs during the therapy.
By taking advice from the physician the Diet should be maintained
Concomitant use of ribavirin with Myhep dvir, should not be taken on an empty stomach.
Possible contraindications
Myhep dvir combined with ribavirin, this concomitant use is contraindicated to the pregnancy period.
Hypersensitivity reactions are produced during treatment, if patients are contraindicated to the component present in the Myhep dvir tablet.
Safety measures
HBV reoccurrence:
This may occurs in HCV/HBV co contaminated patients, who are experienced HCV against viral treatment yet not get the HBV unfriendly to viral treatment.
Before occasion of HBV defilement;
Patients must be inside and out checked whether suspected with HBV pollution or not.
This condition is kept away from earlier by checking the HBsAg and threatening to HBc levels before begins the treatment using with Hepcinat in addition to.
After occasion of HBV ailment;
Hepatic limit test should be watched
Outfit organization related with HBV ailments.
Bradycardia;
Avoid synchronous usage of Hepcinat in addition to with amiodarone
Screen the ECG of patients routinely
Give elective pharmaceuticals to dealing with the cardiovascular limits.
Due to drug interactions;
Avoid orderly use of Hepcinat in addition to with P-gp strong inducers; this may cause loss of supportive effect of Hepcinat in addition to.
Hepcinat in addition to with warfarin, screen the prothrombin time and INR regards irregularly to keep the depleting issue.
Pregnancy and lactation
The pregnancy category of Myhep dvir is B (Sofosbuvir is B & Daclatasvir C)
The pregnancy category of Myhep dvir with ribavirin is X
This concurrent use is contraindicated to pregnancy & lactation period.
Storage and handling
Myhep dvir tablet container should be stored by keeping at temperature of below 30oC
This container should be free from moisture, heat & light.
Missed dose
Myhep dvir is a single dose therapy, if patient does not take the dose of Myhep dvir tablet must be consult with physician and follow the advice.
Otherwise the missed dose should be avoided and continue the regular schedule.
Over dosage
The maximum dose of Sofosbuvir is 1200mg, in case of over dosage condition;
Patients may provide with supportive measures
Alternative medicines should be recommended
Sofosbuvir over load is eliminated from the body by undergoing hemodialysis; 4 hours of process should remove nearly 18% of sofosbuvir content from the body
Daclatasvir is difficult to remove because it is highly bound to human plasma protein, but provide supportive measures to reduce the signs and symptoms.
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