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Sofosbuvir and Daclatasvir

Sofosbuvir Daclatasvir is two prime parts which has against viral property restricting to hepatitis C viral contamination. Both the parts are utilized as single dosage, accessible in the quality of 400mg sofosbuvir and 60mg Daclatasvir

Typically Daclatasvir isn't utilized alone; it ought to join with sofosbuvir and assumes a crucial part in hepatitis C viral contamination

Sofosbuvir and Daclatasvir ought to be joined with other hostile to viral drug like ribavirin utilized as a part of the condition, for example, decompensated cirrhosis

Both sofosbuvir and Daclatasvir are non auxiliary protein inhibitor, which associated with HCV diseases by repressing the NS5B and NS5A. The Viral RNA polymerase catalyst is basic for viral replication, which get precludes by sofosbuvir

This settled measurement mix significantly showed in hepatitis C contamination identified with genotype III

The primary disservice of sofosbuvir and Daclatasvir is;

In hepatitis C genotype III tainted patients, the kept up virological reaction rate are turned out to be abbreviated, while utilizing Daclatasvir joined with sofosbuvir for 12 weeks.

list of brands;

Hepcinat Natdac- Natco pharma

Sofovir Daclahep-Hetero healthcare

Myhep Mydekla- Mylan pharmaceuticals

Sovihep Dacihep- Zydus hepatica

Resof HepCfix- Dr.Reddy’s

Virso Dactovin- Strides

Viroclear Dalsiclear- Abbott

Drug profile

Sofosbuvir Daclatasvir tablets are hostile to viral medicine

Sofosbuvir Daclatasvir tablets are single measurements treatment, it is a doctor prescribed medication utilized by the patients just under the information of restorative expert who are all around rehearsed

Daclatasvir isn't utilized alone, for better activity it ought to be joined with Sofosbuvir tablet.

In some condition Sofosbuvir Daclatasvir is joined with ribavirin, a hostile to viral pharmaceutical utilized as a part of decompensated (Child Pugh B or C) cirrhosis

 

Active components: Sofosbuvir, Daclatasvir

Strength of the components: 400mg & 60mg respectively

Category: Anti-viral drug

 

Prescribing information for Sofosbuvir Daclatasvir

The primary sign of Sofosbuvir Daclatasvir is;

This mix tablets are utilized to treat the constant hepatitis C viral disease caused by genotype I or III

The significant restriction happened while utilizing Sofosbuvir Daclatasvir tablets are lessening of steady virological reaction rate in hepatitis C genotype I or III contaminated patients.

 

Mechanism of Sofosbuvir Daclatasvir

The activity of Sofosbuvir Daclatasvir tablets are occurred by involving in some mechanism;

Sofosbuvir:

Sofosbuvir has hostile to hepaciviral movement, which is specifically acting medication displays its activity by disallowing NS5B RNA dependent RNA polymerase protein; fundamental for hepatitis viral duplication.

Sofosbuvir is processed to frame uridine triphosphate, a fundamental dynamic metabolite which uncovered a hostile to viral action.

The mixture of this dynamic metabolite into hepatitis viral RNA with the assistance of NS5B polymerase and causes viral chain cessation

Daclatasvir:

Daclatasvir removes hostile to viral action by restricting NS5A protein which is needful in viral generation and virion collection

 

Absorption

The maximum plasma concentration of Daclatasvir tablets occurs within 2 hours

The mean bioavailability of Daclatasvir is 67%

The maximum plasma concentration of Sofosbuvir tablets occurs within the range of 0.5 to 2 hours relatively.

The nourishment won't makes any variety in retention of Sofosbuvir Daclatasvir tablets, might be taken with or without sustenance


Distribution

Volume of distribution in Daclatasvir tablet is 47L

Daclatasvir bounds to human plasma protein nearly 99%

Blood to plasma ratio of Sofosbuvir is relatively 0.7

The Sofosbuvir bounds to human plasma protein nearly 61 to 65%


Metabolism

Sofosbuvir metabolized in liver and formed as dynamic metabolite uridine triphosphate, metabolism experienced with the assistance of cathepsin A or carboxylesterase 1

Daclatasvir digestion happened with the assistance of CYP3A4


Elimination

Nearly 88% of Daclatasvir is eliminated via feces;

53% as parent form; 6.6% eliminated through urine.

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

The terminal half life period of sofosbuvir is reaches at 0.51 hours; Daclatasvir half life period is 12 to 15 hours


How to take the Tablet Sofosbuvir Daclatasvir

Sofosbuvir Daclatasvir tablets are given with or without food, in the condition of chronic hepatitis C viral infection originated by genotype I or III

Sofosbuvir Daclatasvir is single dose therapy


Dosage regimens

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

The suggested dosage of Sofosbuvir Daclatasvir 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 usual dosage of Sofosbuvir Daclatasvir is one tablet should be taken as a single dose with or without food

In decompensated cirrhosis patients:

Sofosbuvir Daclatasvir should be altogether with ribavirin as a single dose

Genotype III:

Patient suffered without cirrhosis or with compensated cirrhosis:

The recommended usual dosage of Sofosbuvir Daclatasvir is one tablet should be administered as a single dose with or without food

In decompensated cirrhosis patients:

Sofosbuvir Daclatasvir should be concomitant with ribavirin as a once a day

The dosage of ribavirin;

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

Below 75kg:

The dosage is 1000mg of ribavirin; suggested for genotype I or III 600mg of ribavirin as an primary dose and followed as 1000mg/per

Slightly 75 kg:

In decompensated cirrhosis 1200mg of ribavirin given as twice daily

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

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

Dosage adjustment in drug interaction;

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

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

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


Sofosbuvir Daclatasvir caused side effects

The most common side effects occurred during the therapy;

Headache

Loss of appetite

Irritability

Neutropenia

Anemia

Chills

Influenza like symptoms

Pyrexia

Myalgia

Pancytopenia

Fatigue

Nausea

Diarrhea

Elevation of lipase

Cardiac problems like symptomatic bradycardia

Insomnia

Pruritus

Asthenia

Rashes


Drug interaction

While consolidating Sofosbuvir Daclatasvir with solid CYP3A inducers causes loss of virological response rate of Daclatasvir

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

In the event that Sofosbuvir joins with P-gp or BCRP inhibitors prompts cause rise of sofosbuvir plasma focus

Sofosbuvir Daclatasvir tablets attendant with amiodarone causes genuine symptomatic bradycardia

Sofosbuvir Daclatasvir tablets attendant with hostile to convulsants, against mycobacterials or natural items like st Johns wort causes diminish as a result of fixation

Sofosbuvir Daclatasvir with HMG CoA reductase inhibitors, this mix prompts because expanding the presentation of these medications (statins)


Food drug interaction

No food drug interaction occurs

While administrating Sofosbuvir Daclatasvir tablets, caution should be taken

Diet should be consult with physician

Sofosbuvir Daclatasvir with herbal product like st. Johns wort causes depleting the therapeutic effect


Possible contraindications

A few contraindications happens while utilizing Sofosbuvir Daclatasvir tablets

In decompensated cirrhosis, joins with ribavirin contraindicated in pregnancy condition

Some anaphylactic response happens if patients are contraindicated to the segments show in Sofosbuvir Daclatasvir


Safety measures

While taking Sofosbuvir Daclatasvir tablets, with CYP3A solid inducers causes loss of remedial reaction of Sofosbuvir Daclatasvir tablets. Stay away from this accompanying to diminish the unfriendly impacts

Sofosbuvir Daclatasvir causes genuine bradycardia while simultaneous use with amiodarone, to keep this condition some elective solution is given or ends the amiodarone if conceivable. Insight the patients about the introduction of bradycardia amid the treatment

Utilizing Sofosbuvir Daclatasvir with ribavirin, ought not be prescribed in pregnancy condition as a result of creating fetal harm because of ribavirin


Pregnancy and lactation

Sofosbuvir Daclatasvir use in pregnancy, considered as effective. The pregnancy category is B1

While concomitant with ribavirin, not suggested for pregnancy

Pregnancy category: X, causes fetal harm

 Breast feeding should not be recommended


Storage and handling

The storage condition of Sofosbuvir Daclatasvir 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 Sofosbuvir Daclatasvir tablets are single dosage treatment, if tolerant neglects to take the measurement of these tablets, must counsel the doctor and take the measurement inside the time according to the direction given by therapeutic expert

Generally the missed measurement ought to be skipped and take after the standard dosing plan


Over dosage

The over dose of Sofosbuvir Daclatasvir tablets are happened because of missed measurement , if once finished dose happens the patients must be observed oftentimes for support of harmfulness and give wellbeing measures

Hemodialysis is a technique used to take out the part from body, sofosbuvir evacuates with partition coefficient of 54% though Daclatasvir is hazardous on the grounds that almost 99% of medication limited to human plasma protein


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