Myhep and Mydekla 12 Weeks

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BRAND :  MYHEP & MYDEKLA PRICE :  775$ STRENGTH : 400MG & 60 MG ACTIVE :  MYHEP-SOFOSBUVIR-400MG-MYDEKLA-DACLATASVIR-60MG-12WEEKS COMPANY NAME :  MYLAN TABLETS... read more

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Drug profile

Myhep Mydekla tablets are anti-viral medication, containing two most predominant ingredients such as Sofosbuvir and Daclatasvir

Myhep Mydekla tablets are single dose therapy, it is a prescription medicine used by the patients only under the knowledge of medical practitioner who are well practiced

Mydekla tablet is not used alone, for better action it should be combined with Myhep tablet.

In some condition Myhep Mydekla is combined with ribavirin, an anti-viral medicine used in decompensated (Child Pugh B or C) cirrhosis


Brand name: Myhep Mydekla

Active components: Myhep-Sofosbuvir, Mydekla-Daclatasvir

Strength of the components: 400mg & 60mg respectively

Mfg: Mylan pharmaceuticals

Package: 28 tablets in a container

Category: Anti-viral drug


Prescribing information for Myhep Mydekla

The main indication of Myhep Mydekla is;

This combination tablets are used to treat the chronic hepatitis C viral infection caused by genotype I or III

The major limitation occurred while using Myhep Mydekla tablets are reduction of constant virological response rate in hepatitis C genotype I or III infected patients.


Mechanism of Myhep Mydekla

The activity of Myhep Mydekla tablets are occurred by involving in some mechanism;

Myhep:

Myhep containing sofosbuvir has anti-hepaciviral activity, which is directly acting drug exhibits its action by prohibiting NS5B RNA reliant RNA polymerase enzyme; essential for hepatitis viral multiplication.

Sofosbuvir is metabolized to form uridine triphosphate, an essential active metabolite which exposes an anti-viral activity.

The infusion of this active metabolite into hepatitis viral RNA with the help of NS5B polymerase and causes viral chain discontinuation

Mydekla:

Mydekla containing Daclatasvir expels anti-viral activity by prohibiting NS5A protein which is needful in viral production and virion accumulation


Absorption

The peak plasma concentration of Mydekla tablets occurs within the range of 2 hours

The absolute bioavailability of Mydekla is 67%

The peak plasma concentration of Myhep tablets occurs within the range of 0.5 to 2 hours approximately.

The food will not creates any variation in absorption of Myhep Mydekla tablets, may be taken with or without food


Distribution

The volume of distribution in Mydekla tablet is 47L

The human plasma protein bound with Mydekla tablet is nearly 99%

The blood to plasma ratio of Myhep is relatively 0.7

The human plasma protein bound with Myhep occurs nearly 61 to 65%


Metabolism

Myhep is metabolized hepatically and formed as pharmacologically active metabolite uridine triphosphate, metabolism undergone with the help of cathepsin A or carboxylesterase 1

Mydekla metabolism occurred with the help of CYP3A4


Elimination

88% of Daclatasvir is excreted through feces 53% as an unchanged form, 6.6% excreted through urine.

The terminal half life period of Daclatasvir is occurred at 12 to 15 hours

Sofosbuvir metabolites are excreted through 80% in urine, 14% in feces & 2.5% in exhaled air

The terminal half life period of sofosbuvir is nearly 0.51 hours


How to take the Tablet Myhep Mydekla

Myhep Mydekla tablets are administered with or without food, in the condition of hepatitis C viral infection originated by genotype I or III

Myhep Mydekla is single dose regimen


Dosage regimens

Generally Daclatasvir is not used alone, it is combined with sofosbuvir

The recommended dosage of Myhep Mydekla is one tablet should be taken as a single dose

If sofosbuvir is discontinued, Daclatasvir also get stopped

Genotype I:

Patient suffered without cirrhosis or with compensated cirrhosis:

The recommended dosage of Myhep Mydekla is one tablet should be taken as a single dose with or without food

In decompensated cirrhosis patients:

Myhep Mydekla should be combined with ribavirin as a single dose

Genotype III:

Patient suffered without cirrhosis or with compensated cirrhosis:

The recommended dosage of Myhep Mydekla is one tablet should be taken as a single dose with or without food

In decompensated cirrhosis patients:

Myhep Mydekla should be combined with ribavirin as a single dose

The dosage of ribavirin;

On basis of body weight & hemoglobin level of patients, dose can be calculated.

Less than 75kg: 1000mg of ribavirin; in genotype I or III 600mg of ribavirin as an initial dose and followed as 1000mg/per

At least 75 kg: in decompensated cirrhosis 1200mg of ribavirin given as twice daily

The safety and efficacy of Mydekla has not been established <18 years

Myhep used in ≥12 years or weight of ≥35kg


Dosage adjustment in drug interaction;

If concurrent use with strong CYP3A inhibitors, the dosage of Mydekla is reduced to 30mg while co administration

Concurrent use with moderate CYP3A inducers, the dosage of Mydekla increased to 90mg

Concomitant use of Mydekla with CYP3A strong inducers should be avoided, it is contraindicated


Myhep Mydekla caused side effects

The most common side effects occurred during the therapy;

Headache

Fatigue

Nausea

Diarrhea

Elevation of lipase

Cardiac problems like symptomatic bradycardia

Insomnia

Pruritus

Myalgia

Pancytopenia

Asthenia

Rashes

Loss of appetite

Irritability

Neutropenia

Anemia

Chills

Influenza like symptoms

Pyrexia


Drug interaction

While combining Myhep Mydekla with strong CYP3A inducers causes loss of virological reaction rate of both products

Myhep Mydekla with HMG CoA reductase inhibitors, this combination leads to cause increasing the exposure of these drugs (statins)

CYP3A strong inducers like st Johns wort, rifampin, phenytoin or carbamazepine

If Myhep combines with P-gp or BCRP inhibitors leads to cause elevation of sofosbuvir plasma concentration

Myhep Mydekla tablets concomitant with amiodarone causes serious symptomatic bradycardia

Myhep Mydekla tablets concomitant with anti-convulsants, anti-mycobacterials or herbal products like st Johns wort causes decrease in effect of concentration of Myhep Mydekla


Food drug interaction

Myhep Mydekla with herbal product like st. Johns wort causes decreasing the therapeutic effect of Myhep Mydekla

No food drug interaction occurs

While using Myhep Mydekla tablets, caution should be taken

Diet should be discussed with consultant


Possible contraindications

Some contraindications occurs while using Myhep Mydekla tablets

In decompensated cirrhosis, combines with ribavirin contraindicated in pregnancy condition

Some anaphylactic reaction occurs if patients are contraindicated to the components present in Myhep Mydekla


Safety measures

Myhep Mydekla causes serious bradycardia while concurrent use with amiodarone, to prevent this condition some alternative medicine is given or discontinue the amiodarone if possible. Counsel the patients about the exposure of bradycardia during the treatment

Using Myhep Mydekla with ribavirin, should not be recommended in pregnancy condition because of producing fetal damage due to ribavirin

While taking Myhep Mydekla tablets, with CYP3A strong inducers causes loss of therapeutic response of Myhep Mydekla tablets. Avoid this concomitant to reduce the adverse effects


Pregnancy and lactation

Myhep Mydekla use in pregnancy, safe to use. The pregnancy category is B1

While combining with ribavirin, not recommended for pregnancy

Pregnancy category: X, causes fetal death

 Breast feeding should not be recommended


Storage and handling

The storage condition of Myhep Mydekla should be stored at room temperature below 30oC (86oF) & 20oC and 25oC (68oF and 77oF) respectively

Container should be keep away from heat, light and moisture


Missed dose

Both Myhep Mydekla tablets are single dose therapy, if patient fails to take the dose of these tablets, must consult the physician and take the dose within the time as per the instruction given by medical practitioner

Otherwise the missed dose should be skipped and follow the regular dosing schedule


Over dosage

The over dosage of Myhep Mydekla tablets are occurred due to missed dose , if once over dosage occurs the patients must be monitored frequently for endorsement of toxicity and provide safety measures

Hemodialysis is a procedure used to eliminate the component from body, sofosbuvir removes with separation coefficient of 54% whereas Daclatasvir is problematic because nearly 99% of drug bounded to human plasma protein

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