GENERIC NAME OF THE MEDICINAL PRODUCT:

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets (200mg/300mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets (200mg/300mg)
Composition:
Each film-coated tablet contains:
Emtricitabine ……………………200mg
Tenofovir Disoproxil………….245mg
(Equivalent to 300mg of Tenofovir Disoproxil Fumarate or 136mg of Tenofovir).
Excipients…………………………. 76mg
Lactose (as monohydrate)
Colours: Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

The indication applied is for the use of Emtricitabine/Tenofovir disoproxil Zentiva in the treatment of Human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy.
Treat and prevent HIV/AIDS Immunodeficiency Virus (HIV).
Nucleoside and Nucleotide reverse transcriptase inhibitors.

CAUTION & WARNING:

CAUTION: Do not throw away consumer package insert.
Swallow whole do not chew or crush.
Keep the container tightly closed.
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.
Emtricitabine and Tenofovir should not be used to treat hepatitis B virus infection (HBV; an ongoing liver infection).
Keep out of the reach and sight of children.

STORAGE & DOSAGE:

Storage: Store protected from moisture at a temperature not exceeding 30°C.
Dosage: As directed by the Physician.

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets (200mg/300mg) Technical Specification:

Product Name:Emtricitabine and Tenofovir Disoproxil Fumarate Tablets
Brand Name:Generics
Strength:200mg/300mg
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: The indication applied is for the use of Emtricitabine/Tenofovir disoproxil Zentiva in the treatment of Human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy.
Storage:Store protected from moisture at a temperature not exceeding 30°C.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Emtricitabine and Tenofovir Disoproxil Fumarate Tablets (200mg/300mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Emtricitabine and Tenofovir Disoproxil Fumarate Tablets (200mg/300mg)
    Composition:
    Each film-coated tablet contains:
    Emtricitabine ……………………200mg
    Tenofovir Disoproxil………….245mg
    (Equivalent to 300mg of Tenofovir Disoproxil Fumarate or 136mg of Tenofovir).
    Excipients…………………………. 76mg
    Lactose (as monohydrate)
    Colours: Titanium Dioxide USP

THERAPEUTIC INDICATIONS:

The indication applied is for the use of Emtricitabine/Tenofovir disoproxil Zentiva in the treatment of Human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy.

Treat and prevent HIV/AIDS Immunodeficiency Virus (HIV).

Nucleoside and Nucleotide reverse transcriptase inhibitors.  

CAUTION & WARNING:

CAUTION: Do not throw away consumer package insert.

Swallow whole do not chew or crush.

Keep the container tightly closed.

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.

 Emtricitabine and Tenofovir should not be used to treat hepatitis B virus infection (HBV; an ongoing liver infection).

Keep out of the reach and sight of children.

STORAGE & DOSAGE:

Storage:  Store protected from moisture at a temperature not exceeding 30°C.

Dosage: As directed by the Physician.  

Why Taj Pharmaceuticals?

Taj Pharmaceuticals is your trusted source for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, a critical component of HIV treatment. Our unwavering dedication to quality assurance ensures that every tablet meets stringent global standards for safety and efficacy. At Taj Pharmaceuticals, we understand the importance of affordability in healthcare. Our commitment to offering cost-effective medications makes life-saving treatments accessible to a broader population, ensuring that no one is left behind in the fight against HIV. As a pharmaceutical leader, innovation is at the heart of our mission. We continuously strive to improve drug formulations, enhance patient outcomes, and minimize side effects. Our research and development efforts are geared towards advancing treatment options, so you can live a healthier and more fulfilling life while managing HIV. Choose Taj Pharmaceuticals for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, and experience pharmaceutical excellence that puts your well-being first. We’re here to support you on your journey to better health, providing the quality and affordability you deserve.

What is Emtricitabine and Tenofovir Disoproxil Fumarate Tablets and its uses:

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets are a combination medication used in the treatment of HIV (human immunodeficiency virus) infection. This medication is often marketed under brand names like Truvada, Descovy, and others. Here’s an overview of Emtricitabine and Tenofovir Disoproxil Fumarate Tablets and their primary uses:

  • Composition:
    Emtricitabine:
    It is a nucleoside reverse transcriptase inhibitor (NRTI) that interferes with the replication of HIV by inhibiting the reverse transcriptase enzyme, preventing the virus from converting its RNA into DNA within host cells.
    Tenofovir Disoproxil Fumarate: This is another NRTI that also targets HIV’s reverse transcriptase enzyme. It is converted into its active form, tenofovir, in the body.
  • Primary Use:
    Emtricitabine and Tenofovir Disoproxil Fumarate Tablets are primarily used for the treatment of HIV infection. They are used as part of a combination antiretroviral therapy (ART) regimen, which typically includes multiple drugs from different classes.
    This combination medication is used to suppress the replication of the virus, reduce the viral load in the body, preserve immune function, and slow the progression of HIV disease.
  • Pre-Exposure Prophylaxis (PrEP):
    Emtricitabine and Tenofovir Disoproxil Fumarate Tablets are also used as PrEP in individuals who are at high risk of contracting HIV. When taken consistently as PrEP, they can reduce the risk of HIV infection.
  • Post-Exposure Prophylaxis (PEP):
    In certain situations, such as after potential exposure to HIV through unprotected sex or needlestick injuries, this medication may be prescribed as PEP. PEP is a short-term course of antiretroviral drugs taken after potential exposure to prevent HIV infection.
  • Prevention of Mother-to-Child Transmission (PMTCT):
    Emtricitabine and Tenofovir Disoproxil Fumarate Tablets may be used as part of PMTCT programs to reduce the risk of transmitting HIV from an HIV positive pregnant woman to her baby during childbirth or breastfeeding.
  • Off Label Uses:
    In some cases, healthcare providers may prescribe this medication for off label uses, such as in the treatment of chronic hepatitis B infection.

It’s important to note that Emtricitabine and Tenofovir Disoproxil Fumarate Tablets are not a cure for HIV, and they do not eliminate the virus from the body. Instead, they are a vital 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 Emtricitabine and Tenofovir Disoproxil Fumarate Tablets work?

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets work as antiretroviral medications to inhibit the replication of the HIV virus within the body. These tablets contain two different drugs, emtricitabine and tenofovir disoproxil fumarate, each of which plays a specific role in interfering with the virus’s life cycle. Here’s how they work:

  • Emtricitabine (FTC):
    Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI).
    HIV is a retrovirus that converts its RNA genetic material into DNA using an enzyme called reverse transcriptase. This DNA is then integrated into the host cell’s DNA.
    Emtricitabine mimics one of the building blocks of DNA, known as a nucleoside. When it is taken up by the reverse transcriptase enzyme during viral replication, it gets incorporated into the growing viral DNA chain.
    Once incorporated, emtricitabine acts as a “chain terminator,” preventing the addition of more DNA building blocks to the viral DNA chain. This halts the synthesis of the viral DNA, inhibiting HIV replication.
  • Tenofovir Disoproxil Fumarate (TDF):
    Tenofovir disoproxil fumarate is also an NRTI.
    It is converted into its active form, tenofovir, in the body.
    Tenofovir works similarly to emtricitabine by competing with the natural building blocks of DNA during viral replication.
    Tenofovir, once incorporated into the viral DNA chain, disrupts its elongation and causes premature termination, preventing the completion of the viral DNA.

Together, emtricitabine and tenofovir disoproxil fumarate in the combination tablet work synergistically to block HIV replication at two different points in the reverse transcription process. By doing so, they reduce the viral load in the bloodstream and help maintain or improve the immune system’s function. It’s important to note that Emtricitabine and Tenofovir Disoproxil Fumarate Tablets do not cure HIV; they are part of a lifelong treatment regimen. By inhibiting viral replication, they help control the virus’s spread in the body, reduce the viral load, slow the progression of HIV disease, and improve overall health. These medications are typically used in combination with other antiretroviral drugs to maximize their effectiveness in suppressing the virus and minimizing the risk of developing drug resistance.

Benefits of Emtricitabine and Tenofovir Disoproxil Fumarate Tablets:

  • Effective HIV Suppression: These 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.
  • Prevention of Transmission: When used as pre-exposure prophylaxis (PrEP), Emtricitabine and Tenofovir Disoproxil Fumarate Tablets can significantly reduce the risk of HIV infection in individuals at high risk, such as those in serodiscordant relationships or engaging in high-risk behaviors.
  • 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.
  • Well-Tolerated: In comparison to some other antiretroviral medications, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets are generally well-tolerated, with a lower incidence of severe side effects.
  • Convenience: These tablets are typically taken once a day, which can improve treatment adherence compared to medications with more frequent dosing schedules.

Side Effects of Emtricitabine and Tenofovir Disoproxil Fumarate Tablets:

  • Nausea and Gastrointestinal Issues: Some individuals may experience mild gastrointestinal symptoms such as nausea, diarrhea, or abdominal discomfort.
  • Renal (Kidney) Effects: Tenofovir, one of the components, can affect kidney function in some individuals. Regular monitoring of kidney function is essential.
  • Bone Density: Long-term use of tenofovir may lead to reduced bone mineral density in some people, potentially increasing the risk of fractures.
  • Lactic Acidosis: Although rare, a severe condition called lactic acidosis can occur, characterized by symptoms such as rapid breathing, muscle pain, weakness, and abdominal discomfort. This requires immediate medical attention.
  • Liver Function: Elevations in liver enzymes may occur in some individuals. Regular liver function tests are recommended during treatment.
  • Immune Reconstitution Inflammatory Syndrome (IRIS): In some cases, individuals starting antiretroviral therapy, including Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, may experience an immune response against previously undiagnosed infections. This is known as IRIS and requires careful monitoring and management.
  • 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.
  • Allergic Reactions: Although rare, allergic reactions can occur, leading to symptoms such as skin rash, itching, or swelling.

It’s important to remember that the benefits of Emtricitabine and Tenofovir Disoproxil Fumarate 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 Emtricitabine and Tenofovir Disoproxil Fumarate Tablets:

Certainly, here are some frequently asked questions (FAQs) about Emtricitabine and Tenofovir Disoproxil Fumarate Tablets:

  1. What are Emtricitabine and Tenofovir Disoproxil Fumarate Tablets used for?

These tablets are primarily used in the treatment of HIV infection. They are also used as preexposure prophylaxis (PrEP) to prevent HIV transmission in high-risk individuals.

  1. How do Emtricitabine and Tenofovir Disoproxil Fumarate Tablets work?

Emtricitabine and tenofovir disoproxil fumarate are nucleoside reverse transcriptase inhibitors (NRTIs) that inhibit the replication of the HIV virus by interfering with the reverse transcription process.

  1. Are there any common side effects of these tablets?

Common side effects may include nausea, diarrhea, mild gastrointestinal discomfort, and, less commonly, renal effects. However, side effects can vary from person to person.

  1. Can these tablets cure HIV?

No, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets do not cure HIV. They are part of a lifelong treatment regimen aimed at controlling the virus and preserving immune function.

  1. How effective are these tablets as PrEP for preventing HIV infection?

When taken consistently and as prescribed, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets are highly effective at reducing the risk of HIV infection in individuals at high risk.

  1. Is it safe to take these tablets 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.

  1. Can these tablets be taken with other medications?

They may interact with other medications, potentially affecting their effectiveness or leading to increased side effects. Inform your healthcare provider about all medications and supplements you are taking.

  1. How often should these tablets be taken?

Typically, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets are taken once daily, but the dosing may vary depending on the specific situation and the regimen prescribed by a healthcare provider.

  1. Are there any long-term effects of taking these tablets?

Long-term use of tenofovir, one of the components, may lead to reduced bone mineral density in some individuals. Regular monitoring and discussion with a healthcare provider are essential.

  1. Can I stop taking these tablets once my viral load is undetectable?

It’s important not to stop HIV treatment without consulting a healthcare provider. Stopping treatment can lead to viral rebound and a decline in immune function.

Always consult with a healthcare professional for personalized information and guidance regarding Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, including their use, potential side effects, and interactions.

As Emtricitabine and Tenofovir Disoproxil Fumarate Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Emtricitabine and Tenofovir Disoproxil Fumarate 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

Emtricitabine and Tenofovir Disoproxil Fumarate 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 Emtricitabine and Tenofovir Disoproxil Fumarate 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