Hepcinat and Natdac 12 Weeks Natco Tablets Uses, MRP, Price india
HEPCINAT AND NATDAC 12 WEEKS
Drug profile
Hepcinat Natdac tablet are anti-viral medication, containing two most predominant ingredients such as Sofosbuvir and DaclatasvirHepcinat Natdac are single dose therapy, it is a prescription medicine used by the patients only under the knowledge of medical practitioner who are well practiced
Natdac tablet is not used alone, for better action it should be combined with Hepcinat tablet.
In some condition Hepcinat Natdac is combined with ribavirin, an anti-viral medicine used in decompensated (Child Pugh B or C) cirrhosis
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| Hepcinat Natdac |
PRODUCT DETAILS:
Brand name: Hepcinat NatdacActive components: Hepcinat-Sofosbuvir, Natdac-Daclatasvir
Strength of the components: 400mg & 60mg respectively
Mfg: Natco pharma
Package: 28 tablets in a container
Category: Anti-viral drug
Price: Hepcinat Natdac price in india
The main indication of Hepcinat Natdac 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 Hepcinat Natdac tablet are reduction of constant virological response rate in hepatitis C genotype I or III infected patients.
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
The absolute bioavailability of Natdac is 67%
The peak plasma concentration of Hepcinat tablets occurs within the range of 0.5 to 2 hours approximately.
The food will not creates any variation in absorption of Hepcinat Natdac tablets, may be taken with or without food
The human plasma protein bound with Natdac tablet is nearly 99%
The blood to plasma ratio of Hepcinat is relatively 0.7
The human plasma protein bound with Hepcinat occurs nearly 61 to 65%
Natdac metabolism occurred with the help of CYP3A4
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
Hepcinat Natdac is single dose regimen
The recommended dosage of Hepcinat Natdac is one tablet should be taken as a single dose
If sofosbuvir is discontinued, Daclatasvir also get stopped
Patient suffered without cirrhosis or with compensated cirrhosis:
The recommended dosage of Hepcinat Natdac is one tablet should be taken as a single dose with or without food
In decompensated cirrhosis patients:
Hepcinat Natdac should be combined with ribavirin as a single dose
The recommended dosage of Hepcinat Natdac is one tablet should be taken as a single dose with or without food
In decompensated cirrhosis patients:
Hepcinat Natdac 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 Natdac has not been established <18 years
Hepcinat used in ≥12 years or weight of ≥35kg
Concurrent use with moderate CYP3A inducers, the dosage of Natdac increased to 90mg
Concomitant use of Natdac with CYP3A strong inducers should be avoided, it is contraindicated
The most common side effects occurred during the therapy;
Headache
Fatigue
Nausea
Diarrhea
Elevation of lipase
Cardiac problems like symptomatic bradycardia
Insomnia
Pruritus
Asthenia
Rashes
Loss of appetite
Irritability
Neutropenia
Anemia
Chills
Influenza like symptoms
Pyrexia
Myalgia
Pancytopenia
Hepcinat Natdac tablet concomitant with amiodarone causes serious symptomatic bradycardia
Hepcinat Natdac tablet concomitant with anti-convulsants, anti-mycobacterials or herbal products like st Johns wort causes decrease in effect of concentration of Hepcinat Natdac
Hepcinat Natdac 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 Hepcinat combines with P-gp or BCRP inhibitors leads to cause elevation of sofosbuvir plasma concentration
No food drug interaction occurs
While using Hepcinat Natdac tablet, caution should be taken
Diet should be discussed with consultant
Hepcinat Natdac with herbal product like st. Johns wort causes decreasing the therapeutic effect of Hepcinat Natdac
Some contraindications occurs while using Hepcinat Natdac tablets
In decompensated cirrhosis, combines with ribavirin contraindicated in pregnancy condition
While taking Hepcinat Natdac tablets, with CYP3A strong inducers causes loss of therapeutic response of Hepcinat Natdac tablets. Avoid this concomitant to reduce the adverse effects
Hepcinat Natdac 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
While combining with ribavirin, not recommended for pregnancy
Pregnancy category: X, causes fetal death
Breast feeding should not be recommended
Container should be keep away from heat, light and moisture
Otherwise the missed dose should be skipped and follow the regular dosing schedule
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
Phone no: +919940472902
E-MAIL: millionhealthpharmaceuticals@gmail.com
WEBSITE URL: https://pillsbag.com/products/hepcinat-and-natdac-12-weeks
Prescribing information for Hepcinat Natdac
The main indication of Hepcinat Natdac 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 Hepcinat Natdac tablet are reduction of constant virological response rate in hepatitis C genotype I or III infected patients.
Mechanism of Hepcinat Natdac
The activity of Hepcinat Natdac tablet are occurred by involving in some mechanism;Hepcinat:
Hepcinat 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
Natdac:
Natdac containing Daclatasvir expels anti-viral activity by prohibiting NS5A protein which is needful in viral production and virion accumulationAbsorption
The peak plasma concentration of Natdac tablets occurs within the range of 2 hoursThe absolute bioavailability of Natdac is 67%
The peak plasma concentration of Hepcinat tablets occurs within the range of 0.5 to 2 hours approximately.
The food will not creates any variation in absorption of Hepcinat Natdac tablets, may be taken with or without food
Distribution
The volume of distribution in Natdac tablet is 47LThe human plasma protein bound with Natdac tablet is nearly 99%
The blood to plasma ratio of Hepcinat is relatively 0.7
The human plasma protein bound with Hepcinat occurs nearly 61 to 65%
Metabolism
Hepcinat Natdac tablet is metabolized hepatically and formed as pharmacologically active metabolite uridine triphosphate, metabolism undergone with the help of cathepsin A or carboxylesterase 1Natdac 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 Hepcinat Natdac
Hepcinat Natdac tablet are administered with or without food, in the condition of hepatitis C viral infection originated by genotype I or IIIHepcinat Natdac is single dose regimen
Dosage regimens
Generally Daclatasvir is not used alone, it is combined with sofosbuvirThe recommended dosage of Hepcinat Natdac 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 Hepcinat Natdac is one tablet should be taken as a single dose with or without food
In decompensated cirrhosis patients:
Hepcinat Natdac should be combined with ribavirin as a single dose
Genotype III:
Patient suffered without cirrhosis or with compensated cirrhosis:The recommended dosage of Hepcinat Natdac is one tablet should be taken as a single dose with or without food
In decompensated cirrhosis patients:
Hepcinat Natdac 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 Natdac has not been established <18 years
Hepcinat used in ≥12 years or weight of ≥35kg
Dosage adjustment in drug interaction;
If concurrent use with strong CYP3A inhibitors, the dosage of Natdac is reduced to 30mg while co administrationConcurrent use with moderate CYP3A inducers, the dosage of Natdac increased to 90mg
Concomitant use of Natdac with CYP3A strong inducers should be avoided, it is contraindicated
Hepcinat Natdac 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
Asthenia
Rashes
Loss of appetite
Irritability
Neutropenia
Anemia
Chills
Influenza like symptoms
Pyrexia
Myalgia
Pancytopenia
Drug interaction
While combining Hepcinat Natdac with strong CYP3A inducers causes loss of virological reaction rate of both productsHepcinat Natdac tablet concomitant with amiodarone causes serious symptomatic bradycardia
Hepcinat Natdac tablet concomitant with anti-convulsants, anti-mycobacterials or herbal products like st Johns wort causes decrease in effect of concentration of Hepcinat Natdac
Hepcinat Natdac 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 Hepcinat combines with P-gp or BCRP inhibitors leads to cause elevation of sofosbuvir plasma concentration
Food drug interaction
No food drug interaction occurs
While using Hepcinat Natdac tablet, caution should be taken
Diet should be discussed with consultant
Hepcinat Natdac with herbal product like st. Johns wort causes decreasing the therapeutic effect of Hepcinat Natdac
Possible contraindications
Some anaphylactic reaction occurs if patients are contraindicated to the components present in Hepcinat NatdacSome contraindications occurs while using Hepcinat Natdac tablets
In decompensated cirrhosis, combines with ribavirin contraindicated in pregnancy condition
Safety measures
Using Hepcinat Natdac with ribavirin, should not be recommended in pregnancy condition because of producing fetal damage due to ribavirinWhile taking Hepcinat Natdac tablets, with CYP3A strong inducers causes loss of therapeutic response of Hepcinat Natdac tablets. Avoid this concomitant to reduce the adverse effects
Hepcinat Natdac 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
Pregnancy and lactation
Hepcinat Natdac use in pregnancy, safe to use. The pregnancy category is B1While 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 Hepcinat Natdac should be stored at room temperature below 30oC (86oF) & 20oC and 25oC (68oF and 77oF) respectivelyContainer should be keep away from heat, light and moisture
Missed dose
Both Hepcinat Natdac tablet 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 practitionerOtherwise the missed dose should be skipped and follow the regular dosing schedule
Over dosage
The over dosage of Hepcinat Natdac tablet are occurred due to missed dose , if once over dosage occurs the patients must be monitored frequently for endorsement of toxicity and provide safety measuresHemodialysis 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
CONTACT DETAILS:
Phone no: +919940472902
E-MAIL: millionhealthpharmaceuticals@gmail.com
WEBSITE URL: https://pillsbag.com/products/hepcinat-and-natdac-12-weeks
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