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Myhep + Mydekla - 12 weeks


Availability: In stock

Special Price $ 649

BRAND : Myhep + Mydekla
STRENGTH : 400mg & 60 mg
INGREDIENT : HepatitisC-Mylan-Sofosbuvir-400mg-Myhep-Daclatasvir-60mg-Mydekla
COUNT : 28 Tablets

Description of Myhep + Mydekla - 12 weeks

Myhep Mydekla is containing an anti viral agent as active ingredients like Sofosbuvir & Daclatasvir.

Myhep Mydekla tablets are two medicine fixed dose combination with better anti-viral activity.

Myhep Mydekla is prescription medication which is used by patients with a valid prescription recommended by medical practitioner.

Myhep Mydekla are combination of two non structural proteins inhibitors like NS5A & NS5B, these proteins are responsible for viral production.

Myhep-Sofosbuvir (uridine monophosphate analogue prohibitor of HCV polymerase

Mydekla-Daclatasvir (HCV NS5A inhibitor)

Pharmacology of Myhep + Mydekla - 12 weeks

After oral administration of Myhep Mydekla tablets, it will undergo some mechanism for exhibiting the anti-viral activity. This may include as;


Generally sofosbuvir is an anti-viral medicine, which is occurred as prodrug gets converted into an active substance called as uridine triphosphate.

This active form of sofosbuvir is get intervened into viral RNA by HCV NS5B polymerase & acts as chain obstructor.


Generally Daclatasvir is not used as monotherapy; it is combined with some other anti-viral agents like sofosbuvir for better anti-viral effects.

In this condition, Daclatasvir is pharmacologically considered as a HCV NS5A prohibitor.

After administration, the intracellular uptake of Daclatasvir into the site of NS5A protein occurs.

This binding leads to cause disruption of viral replication complex & concludes as blockade of viral HCV RNA production.

Pharmacokinetics of Myhep Mydekla


After intake of Myhep Mydekla, absorption occurs very quickly & reaches its maximal plasma concentration time by;

Sofosbuvir: 0.5 to 1 hour & Daclatasvir: 2 hours

Then the absolute bioavailability of Daclatasvir occurs by 67%.


After absorption, sofosbuvir is highly binds to human plasma protein by 61 to 65%.

Daclatasvir has broadly bound to protein by approximately 99%.

The apparent volume of distribution of Daclatasvir is occurs by 47L.


The metabolism of both anti-viral agents like Sofosbuvir & Daclatasvir occurs in liver majorly.

Sofosbuvir: cathepsin A, carboxyl esterase 1 or HINT 1

Daclatasvir: CYP3A4


The elimination route of sofosbuvir is majorly by hepatic metabolism

Circulating metabolite of sofosbuvir GS-331007: glomerular filteration & active tubular secretion

Daclatasvir: biliary excretion

Sofosbuvir: 80% in urine, 14% in feces

Daclatasvir: 88% in feces, 6.6% in urine

The median terminal half life period of Myhep Mydekla;

Sofosbuvir: 0.4 hours; GS-331007: 27 hours

Daclatasvir: 12 to 15 hours

Indication of Myhep + Mydekla - 12 weeks

Myhep Mydekla tablets are widely used in the therapy of chronic hepatitis C viral infection associated with genotype I or III.

In chronic or decompensated cirrhosis (child Pugh B or C), Myhep Mydekla is used in combination of ribavirin.

There is a chance of losing virological response occurs, if patients with HCV genotype III with cirrhosis condition using Myhep Mydekla for 12 weeks.

Dose & Dosage's of Myhep + Mydekla - 12 weeks

Before begin the therapy with Myhep Mydekla, patients must be investigated thoroughly whether HBV infection suspected or not.

Check the HBsAg & anti-HBc levels for avoiding the condition like reoccurrence of HBV infection.

Hepatic function test should be taken frequently.

Recommended dosage;

For genotype I;

Without cirrhosis patients: The suggested dose is one tablet of Myhep Mydekla should be given orally as once daily.

Compensated cirrhosis patients: The suggested dose is one tablet of Myhep Mydekla should be administered orally as single dose.

Decompensated cirrhosis patients: The suggested dose is one tablet of Myhep Mydekla should be combined with ribavirin as once daily.

For genotype III;

Without cirrhosis patients: The suggested dose is one tablet of Myhep Mydekla should be given orally as once daily.

Compensated or decompensated cirrhosis: The suggested dose is one tablet of Myhep Mydekla should be combined with ribavirin as once daily

Dosage of ribavirin;

Patients with less than 75kg: 1000mg of ribavirin are recommended per day.

Patients with at least 75kg: 1200mg of ribavirin should be recommended (600mg two times a day).

Side Effects of Myhep + Mydekla - 12 weeks

Symptomatic bradycardia while combining with amiodarone

Increased bilirubin

Increased lipase









Increased AST, ALT

Contraindication of Myhep + Mydekla - 12 weeks

Myhep Mydekla tablets are combined with ribavirin should be contraindicated to pregnancy & lactating women.

Some hypersensitivity reactions are formed while patients are contraindicated to the component of Myhep Mydekla tablets.

Drug Interaction of Myhep + Mydekla - 12 weeks

The combination of Myhep Mydekla with CYP3A inducers causes depletion of Daclatasvir plasma concentration.

The concurrent use of Myhep Mydekla with CYP3A inhibitors leads to cause increased Daclatasvir plasma concentration.

The co administration of Myhep Mydekla with P-gp or BCRP substrates leads to cause elevation of exposure of adverse effects associated to these substrates.

The concurrent use of Myhep Mydekla with warfarin causes changes in prothrombin time & INR values leads to bleeding defects.

Myhep Mydekla tablets co administered with protease inhibitors causes depletion of effect of concentration of Daclatasvir.

Myhep Mydekla tablets with amiodarone causes bradycardia.

Myhep Mydekla tablets are combined with lipid lowering agents causes increased concentration of these drugs.

Myhep Mydekla tablets combined with drugs like anti-convulsants or anti-mycobacterials causes loss of effect of concentration of sofosbuvir.

Myhep Mydekla with st Johns wort causes loss of therapeutic activity of the Myhepor Mydekla.

Precaution of Myhep + Mydekla - 12 weeks

HBV reactivation;

This fatal case is occurs majorly in the patients with HCV/HBV co infection.

HBV reactivation occurs in patients who are receiving anti-HCV agents & fail to receive anti-HBV agents.

Prevent the problem by;

Counting the HBsAg & anti-HBc levels

Monitor the hepatic function test

Initiate the management associated to HBV infection

 Loss of virological response;

This case is occurs due to combination of Daclatasvir with other anti-viral agents.

Prevent the condition by monitoring the patients frequently for identifying the resistance to the suspected virus.


This fatal case is occurs by combining the Myhep Mydekla tablets with amiodarone.

Avoid this combination

Monitor the ECG

Counsel the patients before begin the therapy about the risk associated with these combination treatment.

Initiate the alternative measurements for reducing the cardiac related issues.

Risk related to ribavirin;

Ribavirin is not safe to use during pregnancy, it may causes embryo fetal damage.

Combination with P-gp inducers;

The concomitant use of Myhep Mydekla with P-gp inducers causes loss of activity of sofosbuvir & Daclatasvir.

Avoid this concomitant use.

Usage & Safety profile of Myhep + Mydekla - 12 weeks Pregnancy & Lactation

Pregnancy category of Myhep Mydekla;

Sofosbuvir: B

Daclatasvir: B3

Ribavirin: X

Ribavirin should not be used in pregnancy condition.

Breast feeding should not be recommended.

Storage of Myhep + Mydekla - 12 weeks

The storage conditions of Myhep Mydekla are;

Myhep stored at temperature below 30oC.

Mydekla tablet container should be stored at temperature 25oC; allowed between 15oC & 30oC.

Keep the container away from the moisture, heat & light.

Missed dose

In case of missed dose, patient should be consult with medical practitioner & follow the instructions.

Avoid self medication.

On the other hand the missed dose should be skipped if possible.