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Daclatasvir Dihydrochloride 60mg

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Daclatasvir Dihydrochloride 60mg

Daclatasvir is a direct-acting antiviral medication targeting the hepatitis C virus (HCV). It inhibits the NS5A protein, essential for viral replication, and is used in combination with other antivirals (e.g., sofosbuvir) for treating chronic HCV, especially genotypes 1, 3, and sometimes 4–6. 

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Product description

Description

Daclatasvir is a direct-acting antiviral medication targeting the hepatitis C virus (HCV). It inhibits the NS5A protein, essential for viral replication, and is used in combination with other antivirals (e.g., sofosbuvir) for treating chronic HCV, especially genotypes 1, 3, and sometimes 4–6. 

Prescription

Prescription-only medication—daclatasvir must be prescribed and taken under medical supervision within a combination regimen. 

Dosage

  • Standard adult dose: 60 mg orally once daily as part of an HCV treatment regimen. 
  • Dose modifications are required when co-administering with certain CYP3A4 modulators:
    • 30 mg daily with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) 
    • 90 mg daily with moderate CYP3A4 inducers (e.g., efavirenz)

Therapeutic Category

Antiviral (NS5A inhibitor)—part of direct-acting antiviral (DAA) therapy for chronic hepatitis C. 

Active Ingredients/Composition

Each tablet contains 60 mg of daclatasvir (equivalent to 66 mg of daclatasvir dihydrochloride). Inactive ingredients typically include lactose, microcrystalline cellulose, croscarmellose sodium, silicon dioxide, magnesium stearate, and film coating components. 

Vitamins

None.

Minerals

None.

Variant

Available in 30 mg, 60 mg, and 90 mg strengths in tablet form (film-coated). The 60 mg dosage is the most commonly used. 

Consume Type

Oral tablets, meant to be swallowed whole. They may be taken with or without food. 

Directions/Usage

Taken once daily in combination with sofosbuvir, with or without ribavirin. Treatment duration depends on HCV genotype, presence of cirrhosis, or post-transplant status—commonly 12 weeks. 

Common Side Effects

When used with sofosbuvir: headache, fatigue, nausea. In triple therapy (with ribavirin added): same plus potential hemolytic anemia. There’s also a risk of significant bradycardia when combined with amiodarone. 

Package Type

Typically supplied in blister packs of tablets. For example, “Daklinza” (brand name) comes in blistered film-coated tablets. 

Storage Advice

While specific storage details were not found, standard practice for film-coated tablets applies: store at room temperature, away from heat, moisture, and direct sunlight. Keep out of reach of children.

Safety Advice

  • Use only as part of a prescribed antiviral regimen—do not use as monotherapy.

  • Drug interactions: CYP3A4 inducers/inhibitors significantly affect dosing. Strong inducers are contraindicated; dose adjustments are needed for moderate inducers and inhibitors.

  • Caution in patients with HBV co-infection due to risk of hepatitis B reactivation.
  • Serious bradycardia possible when combined with amiodarone.

Product Substitutes

Generic versions of daclatasvir (60 mg tablets) are available, e.g., manufactured by Mylan under names such as MyDacla. These are bioequivalent to Daklinza®. 

Manufacturer/Marketer

  • Brand: Daklinza®, originally marketed by Bristol-Myers Squibb. 
  • Generics: Available from manufacturers such as Mylan Laboratories (India) under names like MyDacla or licensed generics. 

Country of Origin

  • Daklinza® is primarily manufactured in Ireland for Bristol-Myers Squibb. 
  • Generic versions (e.g., Mylan’s) are produced in India.

 

Additional information

Additional information

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