GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Abacavir Tablet USP 300mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Abacavir Tablet USP 300mg
Each Film-coated tablet contains:
Abacavir Sulfate USP
Equivalent to abacavir…………………………………300mg
Excipients……………….q.s.
Colour: Sunset Yellow FCF

THERAPEUTIC INDICATIONS:

Abacavir is used to treat HIV (human immunodeficiency virus) infection. Abacavir contains the active ingredient abacavir. Abacavir belongs to a group of anti-retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: It is dangerous to take this preparation exept in accordance with the medical advice
Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) excusions permitted to 15°C to 30°C [see USP Controlled Room Temperature].
Dispense in tight, light resistant Container.
Dosage: As directed by the Physician.
The usual dose is 1 tablet twice a day or 2 tablets once a day.
Do not skip doses.
Attach dispensing label as per end country.

Abacavir Tablets USP 300mg Technical Specification:

Product Name:Abacavir Tablets USP
Brand Name:Generic
Strength:300mg
Dosage Form:Tablets (Film-coated)
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-HIV, AIDS, Antiretroviral
Indication: Abacavir is used to treat HIV (human immunodeficiency virus) infection.
Storage:Store at 20° to 25°C (68° to 77°F) excusions permitted to 15°C to 30°C [see USP Controlled Room Temperature].

Abacavir Tablets USP 300mg Manufacturers, and Suppliers in India:

Taj Pharmaceuticals is of the prominent  Abacavir Tablets USP 300mg Manufacturers in India, bringing the best quality products. Our company Taj Pharma has rich experience in the niche manufacturing of Abacavir Tablets USP 300mg.

Taj Pharmaceuticals is a reputed manufacturer and Abacavir Tablets USP 300mg 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 Abacavir Tablets USP 300mg Manufacturer in India that assures high- quality and high standards. Strict quality control ensures that every batch of medicine brings a harmonious standard.

Abacavir Tablets USP 300mg manufactured at Taj Pharma follows ISH; i.e., the product is manufactured to comply with USP quality standards, considered the Best in the world. Further, Taj Pharma uses Abacavir Tablets USP 300mg grade best active ingredient to manufacture its Injections to comply with international standards of European products.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Abacavir Tablet USP 300mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Abacavir Tablet USP 300mg
    Each Film-coated tablet contains:
    Abacavir Sulfate USP
    Equivalent to abacavir………………300mg
    Excipients……………………………….q.s.
    Colour: Sunset Yellow FCF

THERAPEUTIC INDICATIONS:

Abacavir is used to treat HIV (human immunodeficiency virus) infection. Abacavir contains the active ingredient abacavir. Abacavir belongs to a group of anti-retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Warning: It is dangerous to take this preparation exept in accordance with the medical advice
Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F) excusions permitted to 15°C to 30°C [see USP Controlled Room Temperature].
Dispense in tight, light resistant Container.
Dosage: As directed by the Physician.
The usual dose is 1 tablet twice a day or 2 tablets once a day.
Do not skip doses.
Attach dispensing label as per end country.

Why Taj Pharmaceuticals? 

Taj Pharmaceuticals is a reputable pharmaceutical company with a global presence, known for its commitment to delivering high-quality healthcare solutions. When it comes to Abacavir Tablets USP, Taj Pharmaceuticals offers several compelling reasons to consider them as your pharmaceutical provider.

Quality and Safety: Taj Pharmaceuticals places a strong emphasis on quality assurance. They strictly adhere to rigorous quality control standards and comply with international pharmaceutical regulations. This dedication to quality ensures that Abacavir Tablets USP are manufactured to the highest standards, prioritizing patient safety. Through thorough testing and adherence to safety requirements, Taj Pharmaceuticals ensures the safety and effectiveness of its medications.

Proven Efficacy: Abacavir Tablets USP are developed with a focus on efficacy. Taj Pharmaceuticals invests in research and development to ensure that their medications effectively manage and treat specific medical conditions. This commitment to proven therapeutic outcomes gives patients confidence in the efficacy of their treatments.

Affordability and Accessibility: Recognizing the importance of affordable healthcare, Taj Pharmaceuticals strives to make Abacavir Tablets USP accessible to patients without compromising on quality. They offer cost-effective options, ensuring that patients can obtain the medications they need without financial burden.

Global Reach and Distribution: With a global presence, Taj Pharmaceuticals ensures that patients in various regions have access to Abacavir Tablets USP. Their extensive distribution network is designed to reach patients wherever they are, making healthcare more accessible worldwide.

Customer-Centric Approach: Taj Pharmaceuticals places a strong focus on customer satisfaction. They are dedicated to providing exceptional service and support to healthcare professionals and patients alike, aiming to create a positive and supportive healthcare experience.

Environmental Responsibility: In addition to its commitment to healthcare, Taj Pharmaceuticals also prioritizes environmental responsibility. They strive to minimize their ecological footprint through sustainable and environmentally responsible manufacturing practices.

When considering a pharmaceutical provider for Abacavir Tablets USP, Taj Pharmaceuticals stands out as a trusted partner in healthcare, known for its unwavering dedication to quality, safety, affordability, and customer satisfaction.

What are Abacavir Tablets USP and its uses:

Abacavir Tablets USP is a medication used in the treatment of HIV (human immunodeficiency virus) infection. It is part of a class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs), which work to inhibit the replication of the virus within the body. Abacavir specifically targets HIV-1, the most common strain of the virus.

Uses of Abacavir Tablets USP:

  • HIV Infection: Abacavir Tablets USP are primarily used as part of combination therapy for the treatment of HIV infection. HIV is a virus that attacks the immune system, leading to a weakening of the body’s ability to fight off infections. Abacavir, when used in combination with other antiretroviral medications, helps suppress the replication of the virus, reducing the viral load in the bloodstream and slowing down the progression of the disease.
  • Prevention of Mother-to-Child Transmission: Abacavir can also be used in pregnant women who are HIV-positive to reduce the risk of transmitting the virus to their unborn child. It is an essential component of strategies aimed at preventing mother-to-child transmission (PMTCT) of HIV.
  • Post-Exposure Prophylaxis (PEP): In some cases, Abacavir may be prescribed as part of a post-exposure prophylaxis regimen for individuals who have been exposed to HIV through high-risk activities, such as unprotected sex or needle-sharing. PEP aims to reduce the likelihood of HIV infection after potential exposure.

It’s important to note that Abacavir Tablets USP are not a cure for HIV infection. They are used to manage the virus and slow its progression, improving the immune system’s function and overall health. Treatment with Abacavir should be initiated and monitored by a healthcare provider experienced in HIV care. Additionally, the medication must be taken consistently and as directed to be effective, and discontinuing it without medical guidance can lead to the development of drug resistance.

How Does Abacavir Tablets USP Work?

Abacavir Tablets USP works by inhibiting the replication of the human immunodeficiency virus (HIV), specifically HIV-1, which is the most common strain of the virus. Abacavir belongs to a class of medications known as nucleoside reverse transcriptase inhibitors (NRTIs). To understand how Abacavir works, let’s break down the process of HIV replication and how the drug interferes with it:

  • HIV Replication Process: HIV is a retrovirus that contains genetic material in the form of RNA. To replicate, the virus needs to convert its RNA into DNA and integrate this DNA into the host cell’s genetic material. This process is facilitated by an enzyme called reverse transcriptase.
  • Reverse Transcription: When HIV infects a human cell (typically CD4 T cells, which are a key part of the immune system), it releases its RNA into the cell. Reverse transcriptase, an enzyme produced by the virus, converts the viral RNA into viral DNA.
  • Integration: The newly formed viral DNA is then integrated into the host cell’s DNA, essentially becoming part of the cell’s genetic material. This integrated viral DNA is known as a provirus.
  • Replication: Once integrated, the provirus can give rise to new virus particles. When the host cell activates and produces new viral proteins and RNA, these components come together to form new virus particles, which are released from the cell to infect other cells.

How Abacavir Works:

Abacavir interferes with HIV replication by targeting the reverse transcription step:

  • Inhibition of Reverse Transcriptase: Abacavir is a nucleoside analog, meaning it is structurally similar to the building blocks (nucleosides) that the virus uses to create its DNA. However, when Abacavir is incorporated into the growing viral DNA chain, it lacks the necessary chemical groups to allow further DNA synthesis.
  • Chain Termination: When Abacavir is incorporated into the viral DNA chain during reverse transcription, it acts as a “chain terminator.” This means that once Abacavir is added, the DNA synthesis process is halted, and the DNA chain cannot continue to grow.
  • Preventing Integration: Since the viral DNA chain is incomplete and damaged due to the presence of Abacavir, it cannot effectively integrate into the host cell’s DNA. This disruption in the integration process prevents the virus from establishing a long-lasting infection within the host cell.

By interfering with the reverse transcription and integration steps of HIV replication, Abacavir helps to reduce the viral load in the bloodstream and slow down the progression of the disease. It is typically used in combination with other antiretroviral medications as part of highly active antiretroviral therapy (HAART) to achieve effective viral suppression in individuals living with HIV.

Benefits of Abacavir Tablets USP:

The benefits of Abacavir Tablets USP primarily revolve around their role in the treatment of HIV (human immunodeficiency virus) infection as part of combination antiretroviral therapy (ART). These benefits include:

  • Effective Viral Suppression: Abacavir is highly effective at reducing the viral load in the bloodstream. It works by inhibiting the replication of HIV, specifically the HIV-1 strain, which is the most common form of the virus. Lowering the viral load helps slow down the progression of HIV infection.
  • Improved Immune Function: By reducing the viral load and preserving CD4 T-cell counts, Abacavir helps maintain or improve the immune system’s function. This can lead to better overall health and a reduced risk of opportunistic infections. A stronger immune system also means individuals can better fight off common illnesses.
  • Prolonged Lifespan: Effective HIV treatment, including the use of Abacavir, has significantly extended the lifespan of individuals living with HIV. Many people who adhere to their treatment regimen and maintain viral suppression can live long and healthy lives. HIV is now considered a chronic, manageable condition.
  • Reduced Risk of Transmission: When viral load is undetectable due to successful treatment with Abacavir and other antiretroviral medications, the risk of HIV transmission to sexual partners is greatly reduced. This is often referred to as “Undetectable = Untransmittable” (U=U).
  • Enhanced Quality of Life: Effective HIV treatment can lead to an improved quality of life. Individuals on successful ART regimens often experience fewer HIV-related symptoms, better overall health, and the ability to lead productive and fulfilling lives.
  • Prevention of Mother-to-Child Transmission: Abacavir can also be used as part of strategies to prevent the transmission of HIV from a pregnant woman to her unborn child (mother-to-child transmission). This helps ensure that infants born to HIV-positive mothers have a reduced risk of acquiring the virus during pregnancy, childbirth, or breastfeeding.

It’s important to note that the benefits of Abacavir Tablets USP are most significant when the medication is taken as prescribed and in combination with other antiretroviral drugs. Treatment adherence is critical to maintaining viral suppression and achieving the best possible outcomes for individuals living with HIV. As with any medication, individuals considering Abacavir should discuss their treatment options and potential benefits with a healthcare provider who specializes in HIV care.

Common Side Effects of Abacavir Tablets USP:

  • Hypersensitivity Reaction: One of the most concerning side effects of Abacavir is a severe hypersensitivity reaction, which can be life-threatening. Symptoms may include fever, rash, nausea, vomiting, diarrhea, abdominal pain, fatigue, and respiratory symptoms (such as cough and shortness of breath). Hypersensitivity reactions typically occur within the first six weeks of treatment. It’s essential to discontinue Abacavir immediately and seek medical attention if these symptoms occur.
  • Nausea and Vomiting: Some individuals may experience mild to moderate nausea and vomiting when taking Abacavir.
  • Headache: Headaches are a relatively common side effect of this medication.
  • Fatigue: Feeling tired or fatigued is another possible side effect.
  • Diarrhea: Diarrhea can occur in some individuals taking Abacavir.
  • Abdominal Pain: Abdominal discomfort or pain may be experienced by some users.
  • Changes in Liver Enzymes: Abacavir may lead to changes in liver enzyme levels in some individuals, although severe liver problems are rare.
  • Sleep Disturbances: Insomnia or other sleep disturbances can occur in some cases.

It’s important to note that while hypersensitivity reactions are a serious concern with Abacavir, they are relatively rare. However, all individuals prescribed Abacavir should undergo HLA-B5701 genetic testing before starting the medication to assess their risk of hypersensitivity. If the test is positive, Abacavir should not be used. Individuals taking Abacavir should also be closely monitored by their healthcare provider for any signs of adverse reactions, especially during the initial weeks of treatment. Adherence to the prescribed dosing schedule is crucial to the success of HIV treatment with Abacavir and other antiretroviral medications. If you experience any side effects or have concerns about your treatment, be sure to discuss them with your healthcare provider.

Frequently Asked Questions About Abacavir Tablets USP:

Here are some frequently asked questions (FAQs) about Abacavir Tablets USP:

  • What is Abacavir Tablets USP?

Abacavir Tablets USP is a medication used in the treatment of HIV (human immunodeficiency virus) infection. They belong to the class of drugs known as nucleoside reverse transcriptase inhibitors (NRTIs).

  • How does Abacavir Tablets USP work?

Abacavir inhibits the replication of HIV by interfering with the reverse transcription process, preventing the virus from converting its RNA into DNA and integrating it into the host cell’s genetic material.

  • What are the benefits of Abacavir Tablets USP?

The benefits include effective viral suppression, improved immune function, prolonged lifespan for people living with HIV, reduced risk of transmission, enhanced quality of life, and prevention of mother-to-child transmission during pregnancy.

  • Is Abacavir Tablets USP a cure for HIV?

No, Abacavir Tablets USP are not a cure for HIV. They are used to manage the virus and slow its progression, but HIV remains a chronic condition that requires ongoing treatment.

  • When should I take Abacavir Tablets USP?

Abacavir should be taken as prescribed by your healthcare provider. It is typically part of a combination antiretroviral therapy (ART) regimen and should be taken consistently according to the recommended dosing schedule.

  • What should I do if I miss a dose of Abacavir Tablets USP?

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one.

  • What are the common side effects of Abacavir Tablets USP?

Common side effects may include nausea, vomiting, headache, fatigue, diarrhea, abdominal pain, and changes in liver enzyme levels. A severe hypersensitivity reaction is a rare but potentially life-threatening side effect.

  • What is a hypersensitivity reaction, and how can I recognize it?

A hypersensitivity reaction to Abacavir is a severe and potentially life-threatening allergic reaction. Symptoms may include fever, rash, nausea, vomiting, diarrhea, abdominal pain, fatigue, and respiratory symptoms (cough and shortness of breath). If you experience these symptoms, discontinue Abacavir immediately and seek medical attention.

  • Can I drink alcohol while taking Abacavir Tablets USP?

It is generally safe to consume alcohol in moderation while taking Abacavir. However, excessive alcohol consumption should be avoided as it can affect overall health and medication adherence.

  • Should I undergo genetic testing before starting Abacavir?

Yes, it is recommended to undergo HLAB5701 genetic testing before starting Abacavir. A positive test result indicates an increased risk of hypersensitivity to Abacavir, and the medication should not be used in such cases. Always consult with your healthcare provider for personalized information and guidance regarding Abacavir Tablets USP and HIV treatment.

As Abacavir Tablets USP Exporters; We can cater to export business queries from the following geographies. We are exporting our Abacavir Tablets USP 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

Abacavir Tablets USP 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 Abacavir Tablets USP, 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