GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Darunavir Ethanolate & Ritonavir Tablet (400mg+50mg)
B. Darunavir Ethanolate & Ritonavir Tablet (600mg+100mg)
C. Darunavir Ethanolate & Ritonavir Tablet (800mg+100mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Darunavir Ethanolate & Ritonavir Tablet (400mg+50mg)
Each film coated tablet contains:
Darunavir Ethanolate Equivalent to Darunavir………400mg
Ritonavir USP………………...50mg
Excipients……………………...q. s
Color: Titanium Dioxide USP

B) Darunavir Ethanolate & Ritonavir Tablet (600mg+100mg)
Each film coated tablet contains:
Darunavir Ethanolate Equivalent to Darunavir………600mg
Ritonavir USP………………...100mg
Excipients……………………...q. s
Color: Yellow Oxide of Iron USP-NF

C) Darunavir Ethanolate & Ritonavir Tablet (800mg+100mg)
Each film coated tablet contains:
Darunavir Ethanolate Equivalent to Darunavir………800mg
Ritonavir USP………………...100mg
Excipients……………………...q. s
Color: Indigo Carmine Lake

THERAPEUTIC INDICATIONS:

Darunavir is an antiviral medicine that is used to treat HIV (human immunodeficiency virus). HIV can cause acquired immunodeficiency syndrome (AIDS). Darunavir must be given in combination with ritonavir and other antiviral medications and should not be used alone.
Ritonavir is a protease inhibitor used for the treatment of HIV/AIDS. It is seldom employed for its own antiviral activity but instead serves as a booster for other protease inhibitors.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
Keep container tightly closed.
Tablet to be swallowed as a whole, not to be chewed or crushed.

KEEP MEDICINE OUT OF REACH OF CHILDREN.
NOT TO EXCEED PRESCRIBED DOSAGE.
WARNING:
Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage:
Store at temperature not exceeding 30℃.
Store in cool & dry place.
Protect from Light & moisture.
Dosage:
As directed by the Physician.

Darunavir Ethanolate & Ritonavir Tablets (600mg+100mg) Technical Specification:

Product Name:Darunavir Ethanolate & Ritonavir Tablets
Brand Name:Generic
Strength:(400mg+50mg), (600mg+100mg), (800mg+100mg)
Dosage Form:Tablets (film-coated)
Route of Administration:Via Oral Route
Packing:30 Tablets in a bottle
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Protease Inhibitors, Antiviral
Indication: Darunavir is an antiviral medicine that is used to treat HIV (human immunodeficiency virus). HIV can cause acquired immunodeficiency syndrome (AIDS). Darunavir must be given in combination with ritonavir and other antiviral medications and should not be used alone. Ritonavir is a protease inhibitor used for the treatment of HIV/AIDS. It is seldom employed for its own antiviral activity but instead serves as a booster for other protease inhibitors.
Storage:Store at a temperature not exceeding 30℃. Store in a cool & dry place. Protect from Light & moisture.

Darunavir Ethanolate & Ritonavir Tablet (600mg+100mg) Manufacturers, Suppliers in India:

Taj Pharmaceuticals is of the prominent Darunavir Ethanolate & Ritonavir Tablet (600mg+100mg) Manufacturers in India that brings the best quality products. Our company Taj Pharma carries a rich experience in the niche manufacturing of Darunavir Ethanolate & Ritonavir Tablet (600mg+100mg).

Darunavir Ethanolate & Ritonavir Tablet (600mg+100mg) is a protease inhibitor used with other HIV protease inhibitor drugs as well as ritonavir for the effective management of HIV-1 infection. As a second-generation protease inhibitor, Darunavir Ethanolate & Ritonavir Tablet (600mg+100mg) is designed to combat resistance to standard HIV therapy. It was initially approved by the FDA in 2006.

Darunavir Ethanolate & Ritonavir Tablet (600mg+100mg) is being studied as a possible treatment for SARS-CoV-2, the coronavirus responsible for COVID-19, due to in vitro evidence supporting its ability to combat this infection.

Taj Pharmaceuticals is a reputed manufacturer and Darunavir Ethanolate & Ritonavir Tablet (600mg+100mg) Suppliers in India prefer Taj Pharma is best known for the topmost standards and consistent quality of its products.

Taj Pharma is a well-known Darunavir Ethanolate & Ritonavir Tablet (600mg+100mg) Manufacturer in India that gives the assurance of high-quality and high standards. Strict quality control ensures that every batch of medicine brings a harmonious standard.

Darunavir Ethanolate & Ritonavir Tablet (600mg+100mg) manufactured at Taj Pharma follows USP (United States Pharmacopeia); i.e. the product is manufactured to comply with USP quality standards which are considered the Best in the world. Further, Taj Pharma uses Darunavir Ethanolate & Ritonavir Tablet (600mg+100mg) grade best active ingredient to manufacture its Injections to comply with international standards of European products.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Darunavir Ethanolate & Ritonavir Tablet (400mg+50mg)
  • Darunavir Ethanolate & Ritonavir Tablet (600mg+100mg)
  • Darunavir Ethanolate & Ritonavir Tablet (800mg+100mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Darunavir Ethanolate & Ritonavir Tablet (400mg+50mg)
    Each film-coated tablet contains:
    Darunavir Ethanolate
    Equivalent to Darunavir………400mg
    Ritonavir USP…………………50mg
    Excipients………………………q. s
    Color: Titanium Dioxide USP
  • Darunavir Ethanolate & Ritonavir Tablet (600mg+100mg)
    Each film-coated tablet contains:
    Darunavir Ethanolate
    Equivalent to Darunavir………600mg
    Ritonavir USP…………………100mg
    Excipients………………………q. s
    Color: Yellow Oxide of Iron USP-NF
  • Darunavir Ethanolate & Ritonavir Tablet (800mg+100mg)
    Each film-coated tablet contains:
    Darunavir Ethanolate
    Equivalent to Darunavir………800mg
    Ritonavir USP…………………100mg
    Excipients………………………q. s
    Color: Indigo Carmine Lake


THERAPEUTIC INDICATIONS:

Darunavir is an antiviral medicine that is used to treat HIV (human immunodeficiency virus). HIV can cause acquired immunodeficiency syndrome (AIDS). Darunavir must be given in combination with ritonavir and other antiviral medications and should not be used alone.

Ritonavir is a protease inhibitor used for the treatment of HIV/AIDS. It is seldom employed for its own antiviral activity but instead serves as a booster for other protease inhibitors.

CAUTION & WARNING:

CAUTION:
Read the enclosed leaflet before use.
Keep the container tightly closed.
Tablet to be swallowed as a whole, not to be chewed or crushed.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
NOT TO EXCEED THE PRESCRIBED DOSAGE.

WARNING:
Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage:
 Store at a temperature not exceeding 30℃.
Store in a cool & dry place.
Protect from Light & moisture.

Dosage:  As directed by the Physician.

Why Taj Pharmaceuticals?

Discover Effective HIV Treatment with Taj Pharmaceuticals: Darunavir Ethanolate & Ritonavir Tablet

Taj Pharmaceuticals is a trusted leader in the pharmaceutical industry, offering a powerful solution for HIV treatment – the Darunavir Ethanolate & Ritonavir Tablet. With a strong history of pharmaceutical expertise, Taj Pharmaceuticals ensures high-quality medications through stringent quality checks and testing. This tablet combines Darunavir Ethanolate and Ritonavir, essential components in HIV management, promising potent and reliable results. Our patient-centered approach ensures accessibility and affordability without compromising on quality. Collaborating closely with healthcare professionals, Taj Pharmaceuticals ensures that the Darunavir Ethanolate & Ritonavir Tablet aligns with the latest medical standards. This comprehensive solution addresses various aspects of the virus’s life cycle, potentially minimizing drug resistance.

Taj Pharmaceuticals has a global reach, making this treatment accessible worldwide. As a reliable name in the pharmaceutical sector, Taj Pharmaceuticals’ Darunavir Ethanolate & Ritonavir Tablet showcases a commitment to patient well-being, medical expertise, and enhanced healthcare outcomes in the realm of HIV treatment.

What is Darunavir Ethanolate & Ritonavir Tablet and its uses?

Darunavir ethanolate and ritonavir tablet is a medication that combines two active ingredients, darunavir, and ritonavir, to create an effective treatment for HIV (Human Immunodeficiency Virus) infection. Here’s an overview of these components and their uses:

  • Darunavir: Darunavir is an antiretroviral drug classified as a protease inhibitor. It works by blocking an enzyme called protease, which is crucial for the replication of HIV in the body. By inhibiting this enzyme, darunavir helps to reduce the amount of active virus in the bloodstream, slowing down the progression of the disease and improving the immune system’s function.
  • Ritonavir: Ritonavir is another protease inhibitor that was initially developed to boost the effectiveness of other protease inhibitors like darunavir. It accomplishes this by increasing the concentration of these medications in the blood, allowing for lower doses to be taken while maintaining their therapeutic effects. In combination with darunavir, ritonavir serves to enhance the antiviral activity and bioavailability of darunavir.

Uses: The Darunavir Ethanolate & Ritonavir Tablet is primarily prescribed for the treatment of HIV infection. It is used as part of a comprehensive antiretroviral therapy (ART) regimen to suppress the replication of the virus, lower viral load, and slow down the progression of the disease. The medication helps in maintaining a healthy immune system, reducing the risk of opportunistic infections, and increasing the overall quality of life for individuals living with HIV.

It’s important to note that this medication is typically prescribed as part of a combination therapy regimen, which may include other antiretroviral drugs, depending on the patient’s specific condition, viral resistance patterns, and treatment history. Proper adherence to the prescribed regimen is crucial to achieving the best therapeutic outcomes and preventing the development of drug-resistant strains of HIV.

As with any medication, Darunavir Ethanolate & Ritonavir Tablet may have potential side effects and interactions. Patients should always consult their healthcare providers before starting or changing any medication regimen, and regular monitoring is essential to assess the treatment’s effectiveness and manage any possible side effects.

How does Darunavir Ethanolate & Ritonavir Tablet work?

The combination of Darunavir Ethanolate & Ritonavir Tablet works by targeting specific stages of the HIV (Human Immunodeficiency Virus) life cycle to inhibit its replication and reduce its impact on the immune system. Let’s break down how each component contributes to the medication’s mechanism of action:

  • Darunavir: Darunavir is a protease inhibitor. HIV protease is an enzyme that plays a crucial role in the virus’s replication process. It cleaves large viral precursor proteins into smaller functional proteins, allowing the virus to assemble new viral particles. Darunavir inhibits the activity of HIV protease by binding to it, preventing the enzyme from cutting the precursor proteins. As a result, the virus is unable to produce mature and functional viral particles, reducing the amount of infectious virus in the bloodstream. This helps control viral replication and slows down the progression of the disease.
  • Ritonavir: Ritonavir is often used in combination with other protease inhibitors like darunavir to enhance their effectiveness. It works by inhibiting certain enzymes in the liver that metabolize other drugs, including darunavir. When combined with darunavir, ritonavir boosts the levels of darunavir in the blood by slowing down its metabolism and elimination. This increased concentration of darunavir enhances its antiviral activity, allowing for a lower dose of darunavir to be effective. Additionally, ritonavir also has some antiviral activity of its own, further contributing to the reduction of viral replication.
  • Combination Therapy: By combining darunavir with ritonavir, the medication capitalizes on their complementary mechanisms of action. Darunavir targets the viral protease directly, while ritonavir enhances the bioavailability and effectiveness of darunavir by inhibiting its metabolism. This combination approach offers a potent and synergistic effect, effectively suppressing viral replication and helping to manage HIV infection.

Benefits of Darunavir Ethanolate & Ritonavir Tablet:

  • Effective HIV Suppression: The primary benefit of Darunavir Ethanolate & Ritonavir Tablet is its ability to effectively suppress HIV replication. By inhibiting the protease enzyme and enhancing the antiviral activity of darunavir, the medication helps reduce viral load and maintain a low level of circulating virus in the bloodstream.
  • Improved Immune Function: Lowering the viral load through effective treatment can lead to improvements in the immune system’s function. This reduces the risk of opportunistic infections and other complications associated with untreated or poorly managed HIV infection.
  • Delayed Disease Progression: The combination of darunavir and ritonavir can significantly slow down the progression of HIV infection to AIDS (Acquired Immunodeficiency Syndrome). This can lead to a longer and healthier life for individuals living with HIV.
  • Reduced Transmission Risk: Effective antiretroviral therapy, like Darunavir Ethanolate & Ritonavir Tablet, can lower the viral load to undetectable levels. This not only benefits the individual’s health but also reduces the risk of transmitting the virus to others through sexual contact or sharing of needles.

Common Side Effects of Darunavir Ethanolate & Ritonavir Tablet:

  • Gastrointestinal Symptoms: Nausea, vomiting, diarrhea, and abdominal discomfort are common side effects. These usually subside as the body adjusts to the medication, but if they persist, consulting a healthcare provider is recommended.
  • Rash: Skin rashes or hypersensitivity reactions can occur. It’s important to report any unusual skin reactions to a healthcare provider promptly.
  • Elevated Lipid Levels: The medication can lead to increases in cholesterol and triglyceride levels, which might require monitoring and management.
  • Fat Redistribution: Some individuals may experience changes in fat distribution, such as loss of fat in the face, arms, and legs (lipoatrophy), or accumulation of fat in the abdomen and upper back (lipohypertrophy).
  • Liver Function: Darunavir and ritonavir can affect liver enzymes. Regular liver function tests are usually conducted to monitor for any potential issues.
  • Metabolic Effects: The medication might lead to insulin resistance and glucose intolerance, potentially contributing to diabetes.

Serious but Rare Side Effects:

  • Severe Skin Reactions: Serious skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis, can occur. These require immediate medical attention.
  • Liver Toxicity: While rare, severe liver toxicity can occur. Symptoms may include yellowing of the skin or eyes (jaundice), dark urine, and abdominal pain.
  • Pancreatitis: Inflammation of the pancreas (pancreatitis) is a rare but serious side effect that requires medical attention.

Frequently Asked Questions About Darunavir Ethanolate & Ritonavir Tablet:

Certainly, here are some frequently asked questions (FAQs) about Darunavir Ethanolate & Ritonavir Tablet:

What is Darunavir Ethanolate & Ritonavir Tablet?

Darunavir Ethanolate & Ritonavir Tablet is a combination medication used for the treatment of HIV infection. It contains two active ingredients, darunavir, and ritonavir, which work together to suppress HIV replication and maintain a healthy immune system.

How does Darunavir Ethanolate & Ritonavir Tablet work?

Darunavir inhibits the HIV protease enzyme, preventing the virus from assembling mature and functional viral particles. Ritonavir enhances the effectiveness of darunavir by increasing its concentration in the blood, boosting its antiviral activity.

What is the recommended dosage of Darunavir Ethanolate & Ritonavir Tablet?

Dosage varies depending on factors such as the patient’s weight, other medications, and treatment history. It’s important to follow the prescribed dosage and instructions provided by your healthcare provider.

Is this medication a cure for HIV?

No, Darunavir Ethanolate & Ritonavir Tablet is not a cure for HIV. It helps control the virus, reduce its replication, and improve immune function, but lifelong treatment is usually required to manage the infection.

What are the common side effects of this medication?

Common side effects may include gastrointestinal symptoms (nausea, vomiting, diarrhea), skin rash, elevated lipid levels, and changes in fat distribution. Always discuss any side effects with your healthcare provider.

Can I drink alcohol while taking Darunavir Ethanolate & Ritonavir Tablet?

It’s generally recommended to limit alcohol consumption while taking this medication, as alcohol can interact with certain drugs and potentially affect their effectiveness or increase the risk of side effects.

Can I take other medications while on Darunavir Ethanolate & Ritonavir Tablet?

Certain medications can interact with darunavir and ritonavir, potentially affecting their effectiveness or causing adverse effects. Always inform your healthcare provider about all the medications and supplements you are taking.

How often do I need to have my viral load and CD4 count monitored?

Regular monitoring of viral load and CD4 count is essential to assess the effectiveness of the treatment. Your healthcare provider will determine the frequency of these tests based on your individual situation.

Can pregnant women take Darunavir Ethanolate & Ritonavir Tablet?

Pregnant women with HIV may be prescribed this medication, but the decision should be made in consultation with a healthcare provider. Proper treatment during pregnancy can reduce the risk of mother-to-child transmission.

Can I switch to another medication if I experience side effects?

If you experience side effects, it’s important to communicate with your healthcare provider before making any changes to your medication regimen. They can provide guidance on managing side effects or adjusting your treatment if necessary.

As Darunavir Ethanolate & Ritonavir Tablet (600mg+100mg) Exporters; We can cater to export business queries from the following geographies. We are exporting our Darunavir Ethanolate & Ritonavir Tablet (600mg+100mg) product in 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, 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

Darunavir Ethanolate & Ritonavir Tablet (600mg+100mg) 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 Darunavir Ethanolate & Ritonavir Tablet, 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
Fax No: +91 22 2634 1274