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dacihep-60mg

PRODUCT DETAILS

Brand name : Dacihep
Active substance : Daclatasvir
Strength : 60mg
Pack : 28 tablets in a container
Manufactured by : Zydus Heptiza
Category : Anti-viral drug

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Dacihep 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. Dacihep is used by combining with other anti-virals for treating the HCV infection in chronic stage majorly in adults. Dacihep is usually combined with Sofosbuvir, with or without ribavirin.

CATEGORY

Dacihep is belongs to class like;
Anti-hepaciviral drug
HCV NS5A protein inhibitor

MECHANISM

Dacihep 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. Dacihep has ability to merge to viral RNA. There are two pathway involved in the mechanism of Dacihep; 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. Dacihep is used to confuse the hyperphosphorylated NS5A proteins thus concludes as interceding with activity of newly produced HCV. Dacihep works as blockade of; Intercellular viral RNA synthesis Virion assembly/ secretion in-vivo

Genotype I

Without cirrhosis or Compensated cirrhosis: One Dacihep with sofosbuvir or 12 weeks. Decompensated cirrhosis: One Dacihep with sofosbuvir combined with ribavirin for 12 weeks Post transplant: One Dacihep + sofosbuvir combined with ribavirin for 12 weeks. Genotype III; Without cirrhosis: One Dacihep tablet should be combined with sofosbuvir for 12 weeks. Compensated or decompensated cirrhosis: One Dacihep with sofosbuvir combined with ribavirin for 12 weeks

WARNING & PRECAUTION

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 Dacihep with other drugs 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 Dacihep & sofosbuvir with ribavirin should produce fetal harm during pregnancy period.

Symptomatic bradycardia

This lethal case should be occurred during the concomitant use of Dacihep 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.

DRUG INTERACTION

Dacihep combined with the strong inducers of CYP3A causes depletion of plasma evels of Daclatasvir which concludes as loss of therapeutic activity of Dacihep. Dacihep tablet combined with P-gp or BCRP substrates causes increased systemic exposure of these substrates & elevates the adverse effects related to this substrates. Dacihep combined with warfarin causes bleeding effects by altering the prothrombin time & INR values. Dacihep with protease inhibitors causes increased Daclatasvir effect of concentration, to prevent this problem by reducing the dose of Dacihep to 30mg as once daily. Dacihep combined with NNRTI, causes decreased Daclatasvir concentration, overcome the problem by increasing the dose of Dacihep to 90mg. Dacihep with strong CYP3A inhibitors causes increased Daclatasvir concentration. Dacihep with moderate CYP3A inducers causes reduced concentration of Daclatasvir. Dacihep with amiodarone causes serious bradycardia Dacihep with lipid lowering drugs causes increased concentration of these drugs.

CONTRAINDICATIONS

The combination of Dacihep & sofosbuvir with ribavirin is contraindicated to pregnancy & lactating period. Hypersensitivity reactions are produced during the therapy while patients are contraindicated to component of Dacihep.

PREGNANCY

Pregnancy category of Dacihep is B Dacihep with sofosbuvir pregnancy category is B Ribavirin pregnancy category is X Ribavirin should not be used in pregnancy condition.

LACTATION

Breast feeding should not be suggested.

PEDIATRICS

The safety & effectivity of Dacihep in pediatric patients below 18 years should not be evaluated.

GERIATRICS

No dosage adjustment should be recommended

OVER DOSAGE

No specific anti-toxin is required for treating the over dosage of Dacihep. Patient should be provided with general supportive measures. The signs & symptoms of Dacihep 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.

MISSED DOSE

If patients missed a dose then should be consult with medical practitioner & follow the instructions. On the other hand missed dose should be skipped. Avoid self medication Maintain the regular dosing schedule.

SIDE EFFECTS

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

RENAL & LIVER IMPAIRMENT

Dosage modification should not be recommended in both renal & hepatic impaired patients.

STORAGE

Store the container at temperature 25℃ (77℉). Keep the container away from moisture, heat & light.

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