Dolutegravir 50 mg Tablets, manufactured and marketed by Kureasia Pharma, are a highly effective antiretroviral medication designed to manage Human Immunodeficiency Virus (HIV-1) infection in adults and adolescents. As an integrase strand transfer inhibitor (INSTI), Dolutegravir works by blocking the HIV integrase enzyme, which is essential for viral replication. By preventing the integration of viral DNA into the host cell genome, Dolutegravir helps reduce viral load, improve immune function, and slow disease progression when used as part of combination antiretroviral therapy (ART).
Each film-coated tablet contains Dolutegravir Sodium equivalent to 50 mg of Dolutegravir. The formulation ensures consistent bioavailability, optimal absorption, and effective plasma concentration to maintain viral suppression over time. Kureasia Pharma’s Dolutegravir Tablets are manufactured under stringent quality standards, adhering to Good Manufacturing Practices (GMP) and World Health Organization (WHO) guidelines to ensure purity, efficacy, and safety.
Mechanism of Action:
Dolutegravir specifically targets the HIV integrase enzyme, which facilitates the integration of viral DNA into the host cell’s DNA — a critical step in the HIV replication cycle. By binding to the active site of integrase, Dolutegravir inhibits the strand transfer step, preventing viral DNA from becoming part of the host’s genetic material. This mechanism effectively halts the formation of new infectious viral particles, thereby reducing viral replication and helping the body restore and maintain immune function.
Therapeutic Indications:
Dolutegravir 50 mg Tablets are indicated for the treatment of HIV-1 infection in:
Adults and adolescents aged 12 years and older weighing at least 40 kg.
Patients who are antiretroviral therapy (ART) naïve or have prior exposure to integrase inhibitors, depending on resistance profile.
Dolutegravir may be administered as part of a combination regimen with other antiretroviral agents such as nucleoside reverse transcriptase inhibitors (NRTIs) or non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Dosage and Administration:
The usual recommended dose is 50 mg once daily, taken orally with or without food. In patients with known or suspected integrase inhibitor resistance, the dose may be increased to 50 mg twice daily, as directed by a healthcare professional. Adherence to the prescribed regimen is crucial for maintaining viral suppression and preventing resistance development.
Pharmacokinetics:
Dolutegravir exhibits rapid absorption with peak plasma concentrations achieved within 2–3 hours of oral administration. It demonstrates a high barrier to resistance, minimal drug interactions, and a long elimination half-life, supporting convenient once-daily dosing. The drug is primarily metabolized by UGT1A1 with minor contributions from CYP3A enzymes, and excreted via feces and urine.
Safety Profile:
Dolutegravir is generally well tolerated. Commonly reported side effects include headache, insomnia, fatigue, and mild gastrointestinal disturbances. Rarely, hypersensitivity reactions, hepatotoxicity, or weight gain may occur. Routine monitoring of liver function and viral load is recommended during therapy.
Storage:
Store below 30°C in a dry place, protected from moisture and direct sunlight. Keep out of reach of children.
Quality Assurance:
Kureasia Pharma ensures that each batch of Dolutegravir 50 mg Tablets undergoes rigorous quality control testing for potency, stability, and purity. The company’s commitment to pharmaceutical excellence ensures reliable, safe, and affordable HIV therapy solutions that align with global health standards.
Conclusion:
Dolutegravir 50 mg Tablets by Kureasia Pharma represent a cornerstone in modern HIV management. With high efficacy, excellent tolerability, and a strong resistance profile, this medication supports long-term viral suppression, improves patient adherence, and enhances the quality of life for individuals living with HIV. Through continuous innovation and adherence to global quality benchmarks, Kureasia Pharma remains dedicated to advancing accessible and effective antiretroviral therapies for all