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Mydekla 60
Hepatitis CBrand: MylanPrescription Required

Mydekla 60

Molecular Salt: Daclatasvir

MyDekla 60 mg (Daclatasvir Dihydrochloride) is a direct-acting antiviral (DAA) inhibitor drug specified for patients with chronic Hepatitis C viral (HCV) infection with genotype 1 or 3. After entering the system, Daclatasvir Dihydrochloride starts its action by blocking the activities of a special protein (NS5A) responsible for multiplication (RNA replication and virion assembly) of viral cells.

It is taken along with other antiviral medications (sofosbuvir/ribavirin) used for HCV infection. Combining these therapies, assist in attaining a sustained virologic response (SAR) after 12 weeks of daily therapy.

Additional advantages:

• •  Reducing complications associated with the liver

• •  Decreasing the chances of getting liver cancer (hepatocellular carcinoma)

• •  Advanced scarring of the liver (cirrhosis)

• •  HIV-1 co-infection

• •  Recurring HCV infection after the liver transplant operation

• •  Improvement in the quality of life of patients

Initial testing before starting the therapy:

• •  Test all patients if they had a history of or have Hepatitis B viral (HBV) infection.

• •  Test HCV genotype 1 patients with cirrhosis, if they have NS5A (protein inhibited by daclatasvir) resistance

Administration:

The tablet is given orally in a form of 60 mg dose once daily with or without food for 12 weeks. It is taken along with sofosbuvir or ribavirin. Once swallowed, within 2 hours, daclatasvir gets readily absorbed (bio-available). It binds (99%) with viral cells and distributes throughout the site of infection. Furthermore, after metabolizing in the liver, approximately 50% of the drug gets eliminated from the body in between 12 to 15 hours.

Suggested dosage regimen of MyDekla 60mg (Daclatasvir Dihydrochloride):

Type 1:

• •  Lacking cirrhosis/cirrhosis with a functional system: MyDekla 60 mg (Daclatasvir) plus sofosbuvir

• •  Cirrhosis with an unfunctional system/HCV after transplant operation: MyDekla 60 mg (Daclatasvir) plus sofosbuvir and ribavirin.

Type 3:

• •  Lacking cirrhosis: MyDekla 60 mg (Daclatasvir) plus sofosbuvir

• •  Cirrhosis with a functional/unfunctional system/HCV after transplant operation: MyDekla 60 mg (Daclatasvir) plus sofosbuvir and ribavirin.

Note: The duration and frequency of dosage can be changed based on the genotype of HCV and the initial experience of the patients. It is mostly dependent on the doctor’s judgement.

When should MyDekla 60 mg (Daclatasvir) be avoided or used cautiously?

If patients,

• •  Had Hepatitis B viral (HBV) infection

• •  Are seen with HCV reactivation

• •  Feel their heartbeat is very slow (bradycardia) (Caution: Immediately consult your doctor)

• •  Had a liver transplant before the initiation of dosage

• •  Are suffering from heart problems and complications in the liver other than HCV infection

• •  Are taking any sort of non-prescribed or prescribed drugs, herbal medicines, or dietary supplements

• •  Are pregnant and planning to breastfeed

Side-effects of MyDekla 60 mg (Daclatasvir):

Serious Side-effects:

• •  Slow heart rate (bradycardia)

• •  Hepatitis B viral reactivation

Most Common Side-effects:

• •  Tiredness (Fatigue)

• •  Headache

Side-effects in combination with sofosbuvir and ribavirin:

• •  Low count of red blood cells (RBCs) (Anemia)

• •  Nausea

Uncommon Side-effects:

• •  Difficulty in sleeping (Insomnia)

• •  Shortness of breath (dyspnea)

• •  Vomiting

• •  Diarrhea

• •  Severe rashes on the skin

• •  Confusion

• •  Weakness

• •  Dizziness

Note: These are not all possible side effects of MyDekla 60 mg (Daclatasvir). Please ask your doctor for more information regarding the same.

Manufacturer

Mylan

Dosage / Formulation

(60mg)

Packaging Size

28 Tablets

Storage Protocol

Store below 30°C

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