Mydekla

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BRAND :  MYDEKLA PRICE :  140$ STRENGTH : 60MG ACTIVE INGERIDENTS:  MYDEKLA-DACLATASVIR-60MG COMPANY NAME :  MYLAN TABLETS COUNT :  28 TABLETS read more

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Drug profile

Mydekla is a single dose therapy, used in combination not alone

Mydekla tablets are containing Daclatasvir, an anti-viral compound useful in the treatment of chronic hepatitis C viral infection caused by genotypes III

Mydekla targets HBV NS5A to suppress the viral multiplication; it is applicable in the strength of 60mg

 

Brand name: Mydekla

Active ingredients: Daclatasvir

Strength: 60MG

Mfg: Mylan pahrmaceuticals

Package: 28 tablets in a container

Classification: Anti-viral agent

 

Prescribing information of Mydekla

Mydekla is highly effective against HCV genotype III; there is no continue side effects occur

One of the major disadvantage occur in Daclatasvir therapy; while combining with sofosbuvir there is a chance of reducing virological response in HCV genotype III patients

The main indication of Mydekla, where it has prescribed frequently for;

Chronic hepatitis C viral infection caused by genotype III


Mechanism of Mydekla

The mechanism of action involved in Mydekla is very simple, it is NS5A inhibitor, a protein which is essential for hepatitis C viral production.

Mydekla after metabolism occurs; it exhibits NS5A inhibitory activity against Hepatitis C virus and causes termination of viral production and virion aggregation

 

Absorption

The absorption of Mydekla tablet held rapidly, reaches peak plasma concentration within 2 hours after drug intake

The oral bioavailability of Mydekla tablet reaches 67%

 

Distribution

Mydekla is highly bound to the human plasma protein around 99%

The volume of distribution at steady state level occurs 47L

 

Metabolism

Mydekla containing Daclatasvir is a CYP3A substrate, which is responsible for metabolism

 

Elimination

The route of elimination;

Feces: 88%

Urine: 6.6%

The terminal half life period of Mydekla is relatively occurred at 12 to 15 hours

 

How to take Mydekla tablets

Mydekla should be administered with or without food; Mydekla tablets are used as single dose therapy

 

Dosage regimens

The usual recommended dosage of Mydekla is 60mg, should be given in combination with sofosbuvir

Mydekla should be used in HCV genotype I or III infections

Genotype III:

In decompensated cirrhosis: The usual dosage is 60mg of Mydekla with 400mg of sofosbuvir and weight based ribavirin should be taken as single dose

The safety and effectiveness of Mydekla tablet in pediatric patients has not been established with <18 years

In adult patient without cirrhosis or with compensated cirrhosis:

The recommended dosage is 60mg of Mydekla with 400mg of sofosbuvir should be given as a single dose

Genotype I:

In adult patient without cirrhosis or with compensated cirrhosis:

The recommended dosage is 60mg of Mydekla with 400mg of sofosbuvir should be given as a single dose

In decompensated cirrhosis:

The usual dosage is 60mg of Mydekla with 400mg of sofosbuvir and weight based ribavirin should be taken as single dose

 

Dosage modification:

Mydekla with strong CYP3A inhibitors used, the dosage of Mydekla should be reduced into 30mg

Mydekla With moderate CYP3A, the dosage of Mydekla should be 90mg as a single dose

Mydekla with CYP3A inducers, usage of Mydekla tablet is contraindicated

 

Mydekla caused side effects

Diarrhea

Nausea

Bradycardia

HBV reactivation

Elevation of lipase

Headache

Fatigue

 

Drug interaction

Mydekla with amiodarone cause symptomatic bradycardia

Mydekla is a P-gp, BCRP, organic anion transporting polypeptide inhibitors, whereas co administration of these drugs with Mydekla causes increasing the systemic exposure of these drugs, which could elevate the adverse effects

Mydekla is a CYP3A substrate, while using moderate or strong CYP3A inducers with Mydekla tablets may causes depletion of plasma levels and therapeutic effects of Mydekla

Mydekla concurrent use with CYP3A strong inhibitors causes elevation of plasma level of Mydekla

Strong CYP3A inhibitors: clarithromycin, itraconazole, posaconazole, voriconazole, ketaconazole, atazanavir/ritonavir

Moderate CYP3A inducers: dexamethasone, rifapentine, modafinil, efavirenz, Bosentan

Moderate CYP3A inhibitors: ciprofloxacin, atazanavir, erythromycin, verapamil, diltiazem, fluconazole

Mydekla combined with acetyl sulfisoxazole may causes reduction in metabolism of Mydekla

Mydekla with lipid lowering drugs causes increasing the effect of concentration of lipid lowering drugs

 

Food drug interaction

No food drug interaction occur, consult with physician about diet while using Mydekla tablet

Whereas herbal product likes st. Johns wort with Mydekla tablets causes loss of therapeutic effect of Mydekla

 

Possible contraindications

Mydekla concurrent use with CYP3A strong inducers, leads to depletion of virological response of Mydekla

Contraindicated drugs like;

Herbal product st Johns wort

Anti-mycobacterials rifampin

Anti convulsants phenytoin, Phenobarbital, carbamazepine

Anaphylactic reactions

 

Safety measures

Care should be taken while using in renal and hepatic impairment patients, because of no dosage adjustment preferred

Patients, who are having HCV/HBV co infection, have chance of reactivation of HBV infection after completion of therapy

Some adverse reactions occurred due to drug interaction, it may include as;

  1. Severe adverse effects occurred due to concomitant drugs
  2. Lack of therapeutic effect of Mydekla and cause advancement of resistance

The safety and efficacy of Mydekla tablets in liver transplanted patients has not been well established

While using with amiodarone, causes serious bradycardia it is controlled by providing counsel to the suspected patients, or prescribe alternative medicines

 

Pregnancy and lactation

Mydekla is combined with ribavirin causes fetal damage, it should not be recommended

Ribavirin pregnancy category: X

Breast feeding should not be recommended while combining with ribavirin

 

Storage and handling

The storage condition of Mydekla tablet container should be stored at 20oC and 25oC

Container should be keep away from heat, moisture, and light

 

Missed dose

Mydekla is a prescription medicine; if a patient fails to take the dose of Mydekla must consult with medical practitioner and take the dose as soon as possible.

Otherwise the missed dose should be skipped and follow the regular dosing schedule

 

Over dosage

 If over dosage occurs in patients who are receiving Mydekla tablet, vital symptoms should be monitored frequently and provide supportive measures.

Mydekla is difficult to eradicate from the body because it is highly bound to human plasma protein

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