Lopinavir and Ritonavir Tablets USP (100mg+25mg) Technical Specification:

Product Name:Lopinavir and Ritonavir Tablets USP (100mg+25mg)
Brand Name:Generics
Strength:(200mg+50mg), (100mg+25mg)
Dosage Form:Film-coated tablets
Packing:120 Tab Bottle
Route of Administration:For Oral Use Only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antivirals
Indication: Lopinavir and ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients (6 months and older weighing at least 15 kg).
Storage:Store protected from moisture at a temperature not exceeding 25°C.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Lopinavir and Ritonavir Tablets USP (100mg+25mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Lopinavir and Ritonavir Tablets USP (100mg+25mg)
    Composition:
    Each film-coated tablet contains:
    Lopinavir USP…………………….….100mg
    Ritonavir USP……………………25mg
    Excipients…………………………. q.s.
    Colours: Iron Oxide Red

THERAPEUTIC INDICATIONS:

Lopinavir and ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients (6 months and older weighing at least 15 kg).

Direct acting antivirals.

Nucleoside and Nucleotide reverse transcriptase inhibitors.

CAUTION & WARNING:

CAUTION: Do not throw away consumer package insert.

Swallow whole do not chew or crush.

WARNING: Do not skip/discontinue the dose for effective treatment.

Do not stop taking your medicine or change your dosage without consulting your doctor.

 ***Suitable for Vegetarians & Vegans.

Keep out of the reach and sight of children.

STORAGE & DOSAGE:

Storage:  Store protected from moisture at a temperature not exceeding 25°C.

Dosage: As directed by the Physician.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals is your premier source for Lopinavir and Ritonavir Tablets, a critical component in the treatment of HIV/AIDS. Our dedication to pharmaceutical innovation and patient well-being ensures that every tablet meets stringent global standards for safety and efficacy. We understand the importance of access to high-quality antiretroviral medications. Taj Pharmaceuticals is committed to affordability, ensuring that individuals living with HIV/AIDS can access the treatment they need without financial burden. Innovation is at the core of our mission. We continually strive to advance drug formulations, improve patient outcomes, and minimize side effects. Our research and development efforts focus on enhancing the effectiveness and tolerability of Lopinavir and Ritonavir Tablets. Choose Taj Pharmaceuticals for Lopinavir and Ritonavir Tablets, and experience pharmaceutical excellence that prioritizes your health and quality of life. We stand with you in the fight against HIV/AIDS, offering the quality and affordability you deserve.

What is Lopinavir and Ritonavir Tablets and its uses

Lopinavir and Ritonavir Tablets are a combination medication used in the treatment of HIV (human immunodeficiency virus) infection. This combination is often referred to by its brand name, Kaletra. Here’s an overview of Lopinavir and Ritonavir Tablets and their primary uses:

  • Composition:
    Lopinavir:
    Lopinavir is a protease inhibitor, which is a type of antiretroviral drug that inhibits the activity of the protease enzyme, essential for the replication of the HIV virus.
    Ritonavir: Ritonavir is another protease inhibitor. It is often used in combination with Lopinavir to increase its effectiveness by boosting its levels in the bloodstream.
  • Primary Uses:
    Lopinavir and Ritonavir Tablets are primarily used in the treatment of HIV infection. They are part of a combination antiretroviral therapy (ART) regimen, which typically includes multiple drugs from different classes.
    The primary goal of this combination medication is to suppress HIV replication in the body, reduce the viral load to undetectable levels, preserve immune function, and slow the progression of HIV disease.
  • Pre-Exposure Prophylaxis (PrEP):
    In some cases, this combination may also be used as preexposure prophylaxis (PrEP) to prevent HIV transmission in individuals at high risk of contracting the virus.
  • Post-Exposure Prophylaxis (PEP):
    After potential exposure to HIV, such as through unprotected sex or needlestick injuries, Lopinavir and Ritonavir Tablets may be prescribed as postexposure prophylaxis (PEP) to prevent HIV infection.
  • Prevention of Mother-to-Child Transmission (PMTCT):
    Lopinavir and Ritonavir Tablets may be used as part of PMTCT programs to reduce the risk of transmitting HIV from an HIVpositive pregnant woman to her baby during childbirth or breastfeeding.

It’s important to note that these tablets are not a cure for HIV, and they do not eliminate the virus from the body. Instead, they are a critical component of HIV management, helping individuals living with HIV lead healthier lives, reduce the risk of transmitting the virus, and improve overall health outcomes when used as part of a comprehensive antiretroviral treatment regimen. The specific combination of drugs and treatment plan can vary depending on individual factors and the stage of HIV infection, so it’s essential for individuals with HIV to work closely with their healthcare provider.

How does Lopinavir and Ritonavir Tablets work?

Lopinavir and Ritonavir Tablets work as antiretroviral medications to inhibit the replication of the HIV (human immunodeficiency virus) within the body. This combination tablet contains two different drugs, each with a specific mechanism of action that targets various stages of the HIV life cycle. Here’s how Lopinavir and Ritonavir Tablets work:

  • Lopinavir:
    Lopinavir is a protease inhibitor, a class of antiretroviral drugs that targets a key enzyme in the HIV replication process called protease.
    During HIV replication, the virus creates long chains of viral proteins that need to be cut into smaller functional pieces by the protease enzyme. This proteolytic processing is essential for the formation of new, infectious viral particles.
    Lopinavir inhibits the activity of the protease enzyme, preventing it from effectively cleaving the viral proteins. As a result, the virus cannot produce mature, infectious particles.
  • Ritonavir:
    Ritonavir is also a protease inhibitor, but its primary role in this combination therapy is to boost the levels of Lopinavir in the bloodstream.
    Ritonavir inhibits a specific enzyme called cytochrome P450 3A4, which is responsible for breaking down Lopinavir in the liver and gut.
    By inhibiting the breakdown of Lopinavir, Ritonavir effectively increases the concentration of Lopinavir in the blood, making it more effective in inhibiting HIV replication.

Together, Lopinavir and Ritonavir act synergistically to target different stages of the HIV life cycle. Lopinavir inhibits the protease enzyme crucial for viral maturation, while Ritonavir enhances the bioavailability of Lopinavir by slowing its metabolism in the body. This combination approach helps reduce the viral load in the bloodstream, slow the progression of HIV disease, and improve the immune system’s function. It’s important to note that while Lopinavir and Ritonavir Tablets are effective in suppressing HIV replication, they do not cure HIV infection. HIV remains present in the body, but these medications help control the virus, allowing individuals with HIV to lead healthier lives and reduce the risk of transmitting the virus to others when used as part of a comprehensive antiretroviral treatment regimen.

Benefits of Lopinavir and Ritonavir Tablets:

  • Effective HIV Suppression: Lopinavir and Ritonavir Tablets are highly effective at suppressing HIV replication in the body, leading to a reduction in the viral load. This is critical for preserving immune function and slowing the progression of HIV disease.
  • Convenience: The combination of Lopinavir and Ritonavir in a single tablet simplifies the treatment regimen for individuals living with HIV. It reduces the number of pills that need to be taken each day, improving adherence to treatment.
  • Prevention of Transmission: When used as pre-exposure prophylaxis (PrEP) in high-risk individuals or as part of combination therapy in those with HIV, these tablets can significantly reduce the risk of HIV transmission.
  • Well-Tolerated: In comparison to some other antiretroviral medications, Lopinavir and Ritonavir Tablets are generally well-tolerated, with a lower incidence of severe side effects.
  • Improvement in Quality of Life: By controlling HIV replication, these tablets can lead to an improved quality of life for individuals living with HIV. They reduce the frequency of opportunistic infections, improve overall health, and increase life expectancy.

Side Effects of Lopinavir and Ritonavir Tablets:

  • Gastrointestinal Issues: Nausea, vomiting, diarrhea, and abdominal discomfort are common side effects of these tablets. Taking them with food can help reduce gastrointestinal symptoms.
  • Metabolic Changes: Lopinavir and Ritonavir can lead to metabolic changes, including increased cholesterol and triglyceride levels. Regular monitoring of blood lipids is essential.
  • Fat Redistribution: Some individuals may experience changes in body fat distribution, such as fat loss from the face and limbs and fat accumulation in the abdomen and back.
  • Liver Function: Elevations in liver enzymes may occur in some individuals. Regular liver function tests are recommended during treatment.
  • Pancreatitis: Although rare, pancreatitis (inflammation of the pancreas) can occur and requires immediate medical attention if symptoms like severe abdominal pain, nausea, and vomiting develop.
  • Drug Interactions: These tablets may interact with other medications, potentially affecting their effectiveness or leading to increased side effects. It’s essential to inform healthcare providers about all medications being taken.
  • Cardiovascular Risk: Some protease inhibitors, including Lopinavir, may be associated with an increased risk of cardiovascular events, particularly in individuals with pre-existing risk factors.
  • Immune Reconstitution Inflammatory Syndrome (IRIS): In some cases, individuals starting antiretroviral therapy, including Lopinavir and Ritonavir Tablets, may experience an immune response against previously undiagnosed infections. This is known as IRIS and requires careful monitoring and management.

It’s important to remember that the benefits of Lopinavir and Ritonavir Tablets often outweigh the potential side effects, especially in the context of HIV treatment and prevention. Healthcare providers carefully assess the risks and benefits for each patient and closely monitor for adverse effects during treatment. Patients receiving this medication should communicate any concerning symptoms to their healthcare team promptly.

Frequently Asked Questions About Lopinavir and Ritonavir Tablets:\

Certainly, here are some frequently asked questions (FAQs) about Lopinavir and Ritonavir Tablets:

  1. What are Lopinavir and Ritonavir Tablets used for?

Lopinavir and Ritonavir Tablets are primarily used in the treatment of HIV (human immunodeficiency virus) infection. They are also used for preexposure and postexposure prophylaxis (PrEP and PEP) to prevent HIV transmission in high-risk individuals.

  1. How do I take Lopinavir and Ritonavir Tablets?

These tablets are typically taken orally as prescribed by a healthcare provider. The dosing regimen may vary depending on the specific treatment plan and individual factors.

  1. What is the difference between Lopinavir and Ritonavir?

Lopinavir and Ritonavir are both protease inhibitors, but Ritonavir is used in this combination to boost the levels of Lopinavir in the bloodstream, enhancing its effectiveness.

  1. Are there any common side effects of Lopinavir and Ritonavir Tablets?

Common side effects may include gastrointestinal issues (nausea, vomiting, diarrhea), metabolic changes, changes in body fat distribution, and elevated liver enzymes. However, side effects can vary among individuals.

  1. Is it safe to take Lopinavir and Ritonavir during pregnancy?

The safety of these tablets during pregnancy should be discussed with a healthcare provider. In some cases, they may be recommended to prevent mother-to-child transmission of HIV.

  1. Can I drink alcohol while taking Lopinavir and Ritonavir Tablets?

It’s generally recommended to limit alcohol consumption while taking these tablets, as alcohol may increase the risk of certain side effects and affect liver function.

  1. Can Lopinavir and Ritonavir interact with other medications?

Yes, these tablets can interact with other medications, potentially affecting their effectiveness or increasing the risk of side effects. It’s crucial to inform your healthcare provider about all medications and supplements you are taking.

  1. Is there a risk of developing drug resistance while on Lopinavir and Ritonavir?

Adherence to the prescribed dosing schedule is crucial to minimize the risk of developing drug resistance. Missing doses or not taking the medication consistently can lead to treatment failure and the emergence of drug-resistant strains of HIV.

  1. How often should I get tested for HIV while taking these tablets?

Regular HIV testing is recommended to monitor the effectiveness of treatment and to ensure that the viral load remains undetectable. The frequency of testing may vary depending on individual factors and treatment goals.

  1. What should I do if I experience side effects while taking Lopinavir and Ritonavir Tablets?

If you experience any concerning side effects or symptoms, it’s essential to contact your healthcare provider promptly. They can assess the situation and make necessary adjustments to your treatment plan.

Always consult with your healthcare provider for personalized information and guidance regarding Lopinavir and Ritonavir Tablets, including their use, potential side effects, and interactions.

As Lopinavir and Ritonavir Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Lopinavir and Ritonavir Tablets product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Lopinavir and Ritonavir Tablets Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Lopinavir and Ritonavir Tablets, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com 
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Lopinavir and Ritonavir Tablets USP (200mg+50mg)
B. Lopinavir and Ritonavir Tablets USP (100mg+25mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Lopinavir and Ritonavir Tablets USP (200mg+50mg)
Composition:
Each film-coated tablet contains:
Lopinavir USP…………………….….200mg
Ritonavir USP……………………50mg
Excipients…………………………. q.s.
Colours: Titanium Dioxide USP

B. Lopinavir and Ritonavir Tablets USP (100mg+25mg)
Composition:
Each film-coated tablet contains:
Lopinavir USP…………………….….100mg
Ritonavir USP……………………25mg
Excipients…………………………. q.s.
Colours: Iron Oxide Red


THERAPEUTIC INDICATIONS:

Lopinavir and ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients (6 months and older weighing at least 15 kg).
Direct acting antivirals.
Nucleoside and Nucleotide reverse transcriptase inhibitors.

CAUTION & WARNING:

CAUTION: Do not throw away consumer package insert.
Swallow whole do not chew or crush.
WARNING: Do not skip/discontinue the dose for effective treatment.
Do not stop taking your medicine or change your dosage without consulting your doctor.
***Suitable for Vegetarians & Vegans.
Keep out of the reach and sight of children.

STORAGE & DOSAGE:

Storage: Store protected from moisture at a temperature not exceeding 25°C.
Dosage: As directed by the Physician.