Daclahep 60mg (Daclatasvir)
Description of Daclahep 60mg (Daclatasvir 60mg)
Daclahep 60mg (Daclatasvir 60mg) is an anti-viral medication which is used for preventing the disease progression of hepatitis C viral infection by reduces the multiplication of virus in the body. Daclahep 60mg (Daclatasvir 60mg) is used by combining with other anti-virals for treating the HCV infection in chronic stage majorly in adults. Daclahep 60mg (Daclatasvir 60mg) is usually combined with Sofosbuvir, with or without ribavirin.
Medical use /Indication of Daclahep 60mg (Daclatasvir 60mg)
Daclahep 60mg (Daclatasvir 60mg) is useful in the treatment like chronic hepatitis C viral infection associated with genotype I or III infections.
In this condition Daclahep 60mg (Daclatasvir 60mg) should be combined with sofosbuvir for better activity.
In decompensated cirrhosis or liver transplant condition, Daclahep 60mg (Daclatasvir 60mg) should be concomitant with sofosbuvir & ribavirin on weight basis.
Mechanism of Action Daclahep 60mg (Daclatasvir 60mg)
Daclahep 60mg (Daclatasvir 60mg) is a NS5A protein inhibitor, NS5A is a HCV non structural phosphoprotein that is responsible for replicating function of charge of viral RNA augmentation on endoplasmic reticulum membranes. has ability to merge to viral RNA. There are two pathway involved in the mechanism of Daclahep 60mg (Daclatasvir 60mg); Cis acting function of basally phosphorylated NS5A is responsible for maintaining the HCV replication complex. HCV assembly & infectious particle formation is altered by Trans acting function of hyperphosphorylated NS5A. Daclahep 60mg (Daclatasvir 60mg) is used to confuse the hyperphosphorylated NS5A proteins thus concludes as interceding with activity of newly produced HCV. Daclahep 60mg (Daclatasvir 60mg) works as blockade of; Intercellular viral RNA synthesis Virion assembly/ secretion in-vivo
Side effects of Daclahep 60mg (Daclatasvir 60mg)
Chest pain or discomfort, Dizziness, Irregular heartbeat, Tiredness, Head ache , Nausea, Diarrhea, Insomnia, Dry skin, Influenza like syndrome, Dyspnea, Neutropenia, Pruritus, Thrombocytopenia, Bradycardia , Increased AST, ALT, Increased bilirubin, Hepatitis B reactivation .
Drug interaction of Daclahep 60mg (Daclatasvir 60mg)
Daclahep 60mg (Daclatasvir 60mg) combined with the strong inducers of CYP3A causes depletion of plasma evels of Daclatasvir which concludes as loss of therapeutic activity of Daclahep 60mg (Daclatasvir 60mg). Daclahep 60mg (Daclatasvir 60mg) tablet combined with P-gp or BCRP substrates causes increased systemic exposure of these substrates & elevates the adverse effects related to this substrates. Daclahep 60mg (Daclatasvir 60mg) combined with warfarin causes bleeding effects by altering the prothrombin time & INR values. Daclahep 60mg (Daclatasvir 60mg) with protease inhibitors causes increased Daclatasvir effect of concentration, to prevent this problem by reducing the dose of Daclahep 60mg (Daclatasvir 60mg) to 30mg as once daily. Daclahep 60mg (Daclatasvir 60mg) combined with NNRTI, causes decreased Daclatasvir concentration, overcome the problem by increasing the dose of Daclahep 60mg (Daclatasvir 60mg) to 90mg. Daclahep 60mg (Daclatasvir 60mg) with strong CYP3A inhibitors causes increased Daclatasvir concentration. Daclahep 60mg (Daclatasvir 60mg) with moderate CYP3A inducers causes reduced concentration of Daclatasvir. Daclahep 60mg (Daclatasvir 60mg) with amiodarone causes serious bradycardia Daclahep 60mg (Daclatasvir 60mg) with lipid lowering medicines causes increased concentration of these medicines.
Precaution of Daclahep 60mg (Daclatasvir 60mg)
HBV reactivation :
In HBV/HCV co infected patients, HBV reoccurrence occurs after completion of HCV anti-viral agents but not getting the HBV anti-viral agents. This fatal case causes hepatic failure & finally leads to death. Overcome the problem by measuring HBsAg & anti-HBc before starting the treatment. Initiate the patient management for HBV infection. Hepatic function test should be performed.
Increased exposure of loss of virological responses :
The concurrent use of Daclahep 60mg (Daclatasvir 60mg) with other medicines may leads to loss of therapeutic effect of Daclatasvir & possible advancement of resistance. Dosage modification should be involved during combinational treatment. The adverse reactions related to the concomitant use should be monitored.
Risk due to ribavirin :
The combination of Daclahep 60mg (Daclatasvir 60mg) & sofosbuvir with ribavirin should produce fetal harm during pregnancy period.
Symptomatic bradycardia
This lethal case should be occurred during the concomitant use of Daclahep 60mg (Daclatasvir 60mg) with amiodarone. This should be prevented by avoiding this combination. Monitor the ECG during the treatment. Initiate the alternative therapy for reducing the cardiac disorders. Counsel the patient before starting the treatment about the risk related to this combinational therapy.
Over dosage of Daclahep 60mg (Daclatasvir 60mg)
No specific anti-toxin is required for treating the over dosage of Daclahep 60mg (Daclatasvir 60mg). Patient should be provided with general supportive measures. The signs & symptoms of Daclahep 60mg (Daclatasvir 60mg) over dosage should be monitored. Hemodialysis should not be applicable; it is difficult to remove from the body because it is highly bounds to human plasma protein.
Contraindication of Daclahep 60mg (Daclatasvir 60mg)
The combination of Daclahep 60mg (Daclatasvir 60mg) & sofosbuvir with ribavirin is contraindicated to pregnancy & lactating period. Hypersensitivity reactions are produced during the therapy while patients are contraindicated to component of Daclahep 60mg (Daclatasvir 60mg).
Pregnancy of Daclahep 60mg (Daclatasvir 60mg)
Pregnancy category of Daclahep 60mg (Daclatasvir 60mg) is B Daclahep 60mg (Daclatasvir 60mg) with sofosbuvir pregnancy category is B Ribavirin pregnancy category is X Ribavirin should not be used in pregnancy condition.
Lactation of Daclahep 60mg (Daclatasvir 60mg)
While taking Daclahep 60mg (Daclatasvir 60mg), Breast feeding should not be recommended.
Geriatric of Daclahep 60mg (Daclatasvir 60mg)
Daclahep 60mg (Daclatasvir 60mg), No dosage adjustment should be recommended
Pediatric of Daclahep 60mg (Daclatasvir 60mg)
The safety & effectivity of Daclahep 60mg (Daclatasvir 60mg) in pediatric patients below 18 years should not be evaluated.
Dosage of Daclahep 60mg (Daclatasvir 60mg)
Before starting the treatment; Patient’s HBsAg & anti-HBc levels should be monitored. Hepatic function test should be performed
Genotype I
Without cirrhosis or Compensated cirrhosis: One Daclahep 60mg (Daclatasvir 60mg) with sofosbuvir or 12 weeks. Decompensated cirrhosis: One Daclahep 60mg (Daclatasvir 60mg) with sofosbuvir combined with ribavirin for 12 weeks Post transplant: One Daclahep 60mg (Daclatasvir 60mg) + sofosbuvir combined with ribavirin for 12 weeks. Genotype III; Without cirrhosis: One Daclahep 60mg (Daclatasvir 60mg) tablet should be combined with sofosbuvir for 12 weeks. Compensated or decompensated cirrhosis: One Daclahep 60mg (Daclatasvir 60mg) with sofosbuvir combined with ribavirin for 12 weeks
Storage of Daclahep 60mg (Daclatasvir 60mg)
Store the container at temperature 25℃ (77℉). Keep the container away from moisture, heat & light.
Missed dose of Daclahep 60mg (Daclatasvir 60mg)
In case of patients fail to take the dose of Daclahep 60mg (Daclatasvir 60mg), must be consult with medical practitioner & follow the dose. Prevent the missed dose by following the regular dosing schedule. Avoid self medication
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