Mydekla 60mg (Daclatasvir)

Daclatasvir
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Mylan

Mydekla 60mg (Daclatasvir)

ManufacturerMylanBrand nameMydeklaInternational trade nameDaklinzaActive substanceDaclatasvirStrength60mgCategoryHepatitis C

Description of Mydekla 60mg (Daclatasvir 60mg)

Mydekla 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. Mydekla 60mg (Daclatasvir 60mg) is used by combining with other anti-virals for treating the HCV infection in chronic stage majorly in adults. Mydekla 60mg (Daclatasvir 60mg) is usually combined with Sofosbuvir, with or without ribavirin.

Medical use /Indication of Mydekla 60mg (Daclatasvir 60mg)

Mydekla 60mg (Daclatasvir 60mg) is useful in the treatment like chronic hepatitis C viral infection associated with genotype I or III infections.

In this condition Mydekla 60mg (Daclatasvir 60mg) should be combined with Sofosbuvir for better activity.

In decompensated cirrhosis or liver transplant condition, Mydekla 60mg (Daclatasvir 60mg) should be concomitant with Sofosbuvir & ribavirin on weight basis.

Mechanism of Action Mydekla 60mg (Daclatasvir 60mg)

Mydekla 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. Mydekla 60mg (Daclatasvir 60mg) has ability to merge to viral RNA. There are two pathway involved in the mechanism of Mydekla 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. Mydekla 60mg (Daclatasvir 60mg) is used to confuse the hyperphosphorylated NS5A proteins thus concludes as interceding with activity of newly produced HCV. Mydekla 60mg (Daclatasvir 60mg) works as blockade of; Intercellular viral RNA synthesis Virion assembly/ secretion in-vivo

Side effects of Mydekla 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 Mydekla 60mg (Daclatasvir 60mg)

Mydekla 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 Mydekla 60mg (Daclatasvir 60mg)Mydekla 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. Mydekla 60mg (Daclatasvir 60mg) combined with warfarin causes bleeding effects by altering the prothrombin time & INR values. Mydekla 60mg (Daclatasvir 60mg) with protease inhibitors causes increased Daclatasvir effect of concentration, to prevent this problem by reducing the dose of Mydekla 60mg (Daclatasvir 60mg) to 30mg as once daily. Mydekla 60mg (Daclatasvir 60mg) combined with NNRTI, causes decreased Daclatasvir concentration, overcome the problem by increasing the dose of Mydekla 60mg (Daclatasvir 60mg) to 90mg. Mydekla 60mg (Daclatasvir 60mg) with strong CYP3A inhibitors causes increased Daclatasvir concentration. Mydekla 60mg (Daclatasvir 60mg) with moderate CYP3A inducers causes reduced concentration of Daclatasvir. Mydekla 60mg (Daclatasvir 60mg) with amiodarone causes serious bradycardia Mydekla 60mg (Daclatasvir 60mg) with lipid lowering medicines causes increased concentration of these medicines.

Precaution of Mydekla 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 Mydekla 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 Mydekla 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 Mydekla 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 Mydekla 60mg (Daclatasvir 60mg)

Without cirrhosis or Compensated cirrhosis: One Mydekla 60mg (Daclatasvir 60mg) with sofosbuvir or 12 weeks. Decompensated cirrhosis: One Mydekla 60mg (Daclatasvir 60mg) with sofosbuvir combined with ribavirin for 12 weeks Post transplant: One Mydekla 60mg (Daclatasvir 60mg) + sofosbuvir combined with ribavirin for 12 weeks. Genotype III; Without cirrhosis: One Mydekla 60mg (Daclatasvir 60mg) tablet should be combined with sofosbuvir for 12 weeks. Compensated or decompensated cirrhosis: One Mydekla 60mg (Daclatasvir 60mg) with sofosbuvir combined with ribavirin for 12 weeks

Contraindication of Mydekla 60mg (Daclatasvir 60mg)

The combination of Mydekla 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 Mydekla 60mg (Daclatasvir 60mg).

Pregnancy of Mydekla 60mg (Daclatasvir 60mg)

Pregnancy category of Mydekla 60mg (Daclatasvir 60mg) is B Mydekla 60mg (Daclatasvir 60mg) with sofosbuvir pregnancy category is B Ribavirin pregnancy category is X Ribavirin should not be used in pregnancy condition.

Lactation of Mydekla 60mg (Daclatasvir 60mg)

While taking Mydekla 60mg (Daclatasvir 60mg), Breast feeding should not be recommended.

Geriatric of Mydekla 60mg (Daclatasvir 60mg)

Mydekla 60mg (Daclatasvir 60mg), No dosage adjustment should be recommended

Pediatric of Mydekla 60mg (Daclatasvir 60mg)

The safety & effectivity of Mydekla 60mg (Daclatasvir 60mg) in pediatric patients below 18 years should not be evaluated.

Dosage of Mydekla 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 Mydekla 60mg (Daclatasvir 60mg) with sofosbuvir or 12 weeks. Decompensated cirrhosis: One Mydekla 60mg (Daclatasvir 60mg) with sofosbuvir combined with ribavirin for 12 weeks Post transplant: One Mydekla 60mg (Daclatasvir 60mg) + sofosbuvir combined with ribavirin for 12 weeks. Genotype III; Without cirrhosis: One Mydekla 60mg (Daclatasvir 60mg) tablet should be combined with sofosbuvir for 12 weeks. Compensated or decompensated cirrhosis: One Mydekla 60mg (Daclatasvir 60mg) with sofosbuvir combined with ribavirin for 12 weeks

Storage of Mydekla 60mg (Daclatasvir 60mg)

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

Missed dose of Mydekla 60mg (Daclatasvir 60mg)

In case of patients fail to take the dose of Mydekla 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 

Brand name:
Mydekla
International trade name:
Daklinza
Active substance:
Daclatasvir
Strength:
60mg
Category:
Hepatitis C
Manufacturer:
Mylan
Packaging:
28 Tablets
Product form:
Tablet

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