Daclatasvir 60 mg Tablets are oral antiviral tablets containing daclatasvir as the active pharmaceutical ingredient. Daclatasvir belongs to the direct-acting antiviral (DAA) class and has been used as part of combination treatment for chronic hepatitis C virus (HCV) infection. The 60 mg strength is one of the established tablet strengths of daclatasvir.
For buyers, healthcare professionals, distributors and pharmaceutical procurement teams, understanding the Daclatasvir 60 mg composition, strength, dosage form and storage requirements is important when evaluating pharmaceutical products for supply and distribution.
What Are Daclatasvir 60 mg Tablets?
Daclatasvir 60 mg Tablets are film-coated oral tablets containing 60 mg of daclatasvir, generally supplied as daclatasvir dihydrochloride. Daclatasvir is an antiviral medicine that acts directly on HCV proteins involved in viral replication. It is used in combination with other medicines rather than as a standalone treatment.
The exact approved indication, treatment combination and duration can vary according to the patient's HCV genotype, clinical condition and applicable regulatory guidance.
Daclatasvir 60 mg Tablets Composition
The main active ingredient is:
Active Ingredient: Daclatasvir
Strength: 60 mg
Dosage Form: Film-coated tablet
Salt/Form: Daclatasvir dihydrochloride
According to the EMA product information for Daklinza, each 60 mg tablet contains daclatasvir equivalent to 60 mg of the active substance. The tablet formulation also contains pharmaceutical excipients. These include anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, silicon dioxide and magnesium stearate in the tablet core. The film coating contains ingredients including hypromellose, titanium dioxide, macrogol 400 and colouring agents.
The composition can differ between manufacturers and marketed formulations. Buyers should therefore check the manufacturer's approved product specification, package insert and certificate of analysis for the specific product being purchased.
Daclatasvir 60 mg Strength
Daclatasvir 60 mg is a recognized tablet strength. Regulatory product information also identifies a 30 mg strength, meaning daclatasvir tablets may be available in different strengths depending on the product and market.
The appropriate strength and treatment regimen should be determined by a qualified healthcare professional. Daclatasvir should not be used, substituted or combined with other antiviral medicines without appropriate medical guidance because treatment selection can depend on other medicines, HCV genotype and patient-specific factors.
How Should Daclatasvir 60 mg Tablets Be Stored?
Proper storage helps maintain the quality and stability of pharmaceutical tablets throughout their shelf life.
For the EMA-authorized Daklinza formulation, no special storage conditions are required. The product should be kept out of the sight and reach of children and should not be used after the expiry date shown on the packaging.
For commercially supplied Daclatasvir 60 mg Tablets, always follow the storage conditions printed on the individual manufacturer's packaging and product information. Different manufacturers or packaging configurations may have specific requirements.
Important Storage Practices
- Keep tablets in their original packaging.
- Follow the storage temperature stated on the product label.
- Protect the medicine from unsuitable environmental conditions where specified.
- Keep the package properly closed where applicable.
- Store out of reach of children.
- Do not use tablets after the stated expiry date.
- Avoid using damaged or improperly stored packs.
Why Product Specifications Matter for Pharmaceutical Buyers
For pharmaceutical distributors, hospitals and procurement teams, product specifications are important when sourcing Daclatasvir 60 mg Tablets. Buyers should verify the active ingredient, strength, dosage form, manufacturer, batch number, expiry date, packaging, storage requirements and applicable regulatory documentation before purchasing.
When sourcing pharmaceutical products internationally, buyers should also confirm that the product meets the import requirements of the destination country.
Frequently Asked Questions
What is the composition of Daclatasvir 60 mg Tablets?
Daclatasvir 60 mg Tablets contain 60 mg of daclatasvir as the active pharmaceutical ingredient, generally supplied as daclatasvir dihydrochloride. Excipients vary according to the manufacturer.
What is the strength of Daclatasvir Tablets?
Daclatasvir is available in recognized tablet strengths including 30 mg and 60 mg in regulatory product information.
What is the dosage form of Daclatasvir 60 mg?
Daclatasvir 60 mg is supplied as an oral film-coated tablet in the referenced regulatory product information.
How should Daclatasvir 60 mg Tablets be stored?
Storage conditions depend on the specific manufacturer's product. The EMA product information for Daklinza states that it does not require special storage conditions. Buyers should follow the storage instructions provided with their specific product.
Can Daclatasvir 60 mg be used alone?
Daclatasvir treatment is generally used as part of a combination antiviral regimen. The appropriate combination depends on the patient's clinical circumstances and current treatment guidance. A healthcare professional should determine the treatment regimen.
Conclusion
Daclatasvir 60 mg Tablets contain 60 mg of daclatasvir and are available as an oral film-coated tablet. Understanding the Daclatasvir 60 mg composition, strength and storage information can help pharmaceutical buyers, distributors and healthcare professionals evaluate product specifications before procurement. Always verify the manufacturer's current product information, packaging and storage instructions before purchasing or distributing the medicine.