GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Valganciclovir Tablets USP 450mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Valganciclovir Tablets USP 450mg
Each film-coated tablet contains:
Valganciclovir USP
Equivalent to Valganciclovir hydrochloride …………….450mg
Excipients………………………………. q. s
Color: Sunset yellow FCF

THERAPEUTIC INDICATIONS:

Valganciclovir is an antiviral. It is used to treat infections caused by viruses. This medicine is also used to prevent CMV disease in patients who have received an organ transplant (e.g., heart, kidney, or kidney-pancreas transplant).

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
Do not use if seal over bottle opening is broken or missing.
Dispense in a tight, light-resistance, container.
Keep store in tightly closed container.
Dispense in original container.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

STORAGE: Store at 20° to 25°C (68° to 77°F). See USP controlled room temperature.
Store in dry place protected from light and moisture.
DOSAGE: As directed by the Physician.
Attach dispensing label as per end country.

Valganciclovir Tablets USP 450mg Technical Specification:

Product Name:Valganciclovir Tablets USP
Brand Name:Generic
Strength:(450mg)
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:Antiretrovirals, HIV, AIDS.
Indication: Valganciclovir is an antiviral. It is used to treat infections caused by viruses. This medicine is also used to prevent CMV disease in patients who have received an organ transplant (e.g., heart, kidney, or kidney-pancreas transplant).
Storage:Store at 20° to 25°C (68° to 77°F). See USP controlled room temperature.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  1. Valganciclovir Tablets USP 450mg

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

  1. Valganciclovir Tablets USP 450mg
    Each film-coated tablet contains:
    Valganciclovir USP
    Equivalent to Valganciclovir hydrochloride …………….450mg
    Excipients………………………………. q. s
    Color: Sunset yellow FCF

THERAPEUTIC INDICATIONS:

Valganciclovir is an antiviral. It is used to treat infections caused by viruses. This medicine is also used to prevent CMV disease in patients who have received an organ transplant (e.g., heart, kidney, or kidney-pancreas transplant).

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.

Do not use if seal over bottle opening is broken or missing.

Dispense in a tight, light-resistance, container.

Keep store in tightly closed container.

Dispense in original container.

Keep medicine out of reach of children.

SWALLOW WHOLE DO NOT CHEW OR CRUSH.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

STORAGE: Store at 20° to 25°C (68° to 77°F). See USP controlled room temperature.

Store in dry place protected from light and moisture.

DOSAGE: As directed by the Physician.

Attach dispensing label as per end country.

Why Taj Pharmaceuticals?

When it comes to Valganciclovir Tablets USP, Taj Pharma stands out as a trusted and preferred choice. Our unwavering commitment to delivering pharmaceutical excellence ensures that you receive the highest quality medication for your health needs. We prioritize quality control at every step of the manufacturing process, guaranteeing the safety and efficacy of Valganciclovir Tablets USP. Beyond quality, we are dedicated to making healthcare more affordable, ensuring that you can access the treatment you require without breaking the bank.

At Taj Pharma, we understand the importance of reliable and consistent pharmaceuticals, especially when it comes to managing conditions that require Valganciclovir. Our products are backed by years of research and development, and our team of experts is committed to providing you with accurate information and support. When you choose Taj Pharma, you’re choosing a partner in your healthcare journey, a partner you can trust.

What are Valganciclovir Tablet USP and its use?

Valganciclovir Tablets USP is a medication that contains the active ingredient valganciclovir. It is primarily used for the treatment of certain viral infections, with its main focus on the management of cytomegalovirus (CMV) infections.

  • Active Ingredient: Valganciclovir is an antiviral medication that is converted into ganciclovir, its active form, in the body. Ganciclovir is effective against CMV and herpesvirus infections.

Uses:

Cytomegalovirus (CMV) Retinitis: Valganciclovir Tablets USP are commonly prescribed to treat CMV retinitis, an opportunistic infection that affects the eyes. CMV retinitis is often seen in individuals with weakened immune systems, such as those with HIV/AIDS.

Prophylaxis Against CMV Infection: In certain cases, Valganciclovir may be used as a preventive measure (prophylaxis) to reduce the risk of CMV infection in individuals undergoing solid organ transplantation, particularly kidney, heart, or kidney-pancreas transplantation.

  • How It Works: Valganciclovir and its active form, ganciclovir, work by inhibiting the replication of CMV and herpesvirus in the body. This helps to control the spread of the virus and prevent its damaging effects.
  • Dosage: The dosage of Valganciclovir Tablets USP can vary depending on the specific condition being treated and the patient’s medical history. It is crucial to follow the prescribed dosage and administration instructions provided by a healthcare professional.
  • Monitoring: When taking Valganciclovir, patients may require regular monitoring to assess the effectiveness of the treatment and to check for any potential side effects or adverse reactions.
  • Side Effects: Like many medications, Valganciclovir Tablets USP can have side effects, which may include nausea, vomiting, diarrhea, lowered white blood cell counts, and an increased risk of certain infections. It’s essential to discuss potential side effects with your healthcare provider.
  • Precautions: Valganciclovir may not be suitable for everyone, and precautions should be taken, especially during pregnancy and breastfeeding. Individuals with kidney problems or a history of blood disorders should inform their healthcare provider before starting this medication.
  • Drug Interactions: Valganciclovir may interact with other medications, so it’s important to inform your healthcare provider about all the drugs, supplements, and herbal products you are taking.

How does Valganciclovir Tablets USP work?

Valganciclovir Tablets USP works by inhibiting the replication of certain viruses, primarily cytomegalovirus (CMV), and herpesviruses. Valganciclovir is a prodrug, which means it is converted into its active form, ganciclovir, within the body. Ganciclovir is the antiviral agent responsible for its therapeutic effects.

Here’s how Valganciclovir Tablets USP works at a cellular level:

  • Inhibition of Viral DNA Synthesis: Ganciclovir, the active form of Valganciclovir, works by interfering with the replication of viral DNA. Inside infected cells, the virus needs to replicate its genetic material to create new virus particles. Ganciclovir is structurally similar to guanosine, a building block of DNA.
  • Phosphorylation: After Valganciclovir is taken orally, it is absorbed into the bloodstream and then converted into ganciclovir through a series of chemical reactions in the body. This conversion involves the addition of phosphate groups to Valganciclovir molecules, converting it into ganciclovir triphosphate.
  • Incorporation into Viral DNA: Ganciclovir triphosphate is similar enough in structure to guanosine triphosphate (GTP), which is a necessary component for DNA synthesis. As a result, the viral DNA polymerase, an enzyme involved in DNA replication, mistakenly incorporates ganciclovir triphosphate into the growing viral DNA chain instead of guanosine triphosphate.
  • Termination of DNA Chain: Once ganciclovir triphosphate is incorporated into the viral DNA, it acts as a “chain terminator.” This means that it cannot be extended further, effectively stopping the replication of the viral DNA.
  • Prevention of Virus Spread: By interfering with viral DNA synthesis, Valganciclovir halts the multiplication of the virus within infected cells. This inhibits the spread of the virus to other cells and reduces the viral load in the body.
  • Control of Infection: In the context of cytomegalovirus (CMV) infections, which are often seen in individuals with weakened immune systems, Valganciclovir helps control the progression of the infection and prevents it from causing further damage, particularly in cases of CMV retinitis (eye infection).

Benefits of Valganciclovir Tablets USP:

  • Effective Treatment for CMV Infections: Valganciclovir is highly effective in treating CMV infections, particularly CMV retinitis. CMV infections can be severe, especially in individuals with weakened immune systems, and Valganciclovir can help control the infection, preventing further damage.
  • Oral Administration: Valganciclovir is available in tablet form, making it more convenient for patients to take, especially compared to intravenous (IV) treatments. This is particularly important for long-term treatment, as it reduces the need for frequent hospital visits.
  • Prophylactic Use: Valganciclovir can also be used prophylactically (as a preventive measure) to reduce the risk of CMV infection in individuals undergoing solid organ transplantation, where CMV reactivation can be a concern.
  • Effective in Suppressing Viral Replication: Valganciclovir works by inhibiting the replication of CMV and herpesviruses, which helps control the spread of the virus within the body.

Potential Side Effects of Valganciclovir Tablets USP:

  • Hematologic Side Effects: Valganciclovir can affect blood cell counts, particularly white blood cells, which are essential for the immune system. This can lead to an increased risk of infections. Regular blood tests are often necessary to monitor these effects.
  • Gastrointestinal Effects: Common side effects include nausea, vomiting, diarrhea, and abdominal pain. These can be mild to moderate in intensity but may require dose adjustments or additional medications to manage.
  • Renal (Kidney) Impairment: Valganciclovir can affect kidney function, and kidney function should be monitored regularly during treatment. Dose adjustments may be necessary in individuals with pre-existing kidney conditions.
  • Neuropsychiatric Effects: Some patients may experience neuropsychiatric side effects, such as confusion, hallucinations, or seizures. These side effects are relatively rare but should be reported to a healthcare provider immediately.
  • Allergic Reactions: Allergic reactions to Valganciclovir are possible, although they are relatively rare. Symptoms of an allergic reaction may include rash, itching, swelling, severe dizziness, or difficulty breathing. Seek immediate medical attention if you experience these symptoms.
  • Other Potential Side Effects: Other less common side effects may include liver function abnormalities, fever, headache, and fatigue.

It’s essential to note that the benefits of Valganciclovir often outweigh the potential side effects, especially when treating severe CMV infections. Healthcare providers carefully assess the risks and benefits for each patient and may adjust treatment accordingly. Patients should communicate any side effects or concerns to their healthcare provider promptly.

Frequently Asked Questions about Valganciclovir Tablets USP:

  • What are Valganciclovir Tablets USP used for?

Valganciclovir Tablets USP are primarily used to treat cytomegalovirus (CMV) infections, including CMV retinitis. They may also be used prophylactically to prevent CMV infection in certain transplant patients.

  • How does Valganciclovir work?

Valganciclovir is converted into ganciclovir in the body, which inhibits the replication of CMV and herpesviruses by interfering with their DNA synthesis.

  • What is the recommended dosage for Valganciclovir Tablets USP?

The dosage of Valganciclovir Tablets USP can vary depending on the specific condition being treated and individual patient factors. It’s crucial to follow the prescribed dosage and administration instructions provided by a healthcare professional.

  • Can Valganciclovir Tablets USP be used for other viral infections?

Valganciclovir is primarily effective against CMV and herpesviruses. It is not typically used to treat other viral infections.

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

Common side effects may include nausea, vomiting, diarrhea, abdominal pain, and lowered white blood cell counts. However, side effects can vary among individuals.

  • How often should I have my blood tested while taking Valganciclovir?

Regular blood tests are often necessary to monitor white blood cell counts and kidney function, as Valganciclovir can affect these parameters.

  • Can Valganciclovir Tablets USP interact with other medications?

Yes, Valganciclovir may interact with certain medications, so it’s essential to inform your healthcare provider about all the drugs, supplements, and herbal products you are taking.

  • Are there any special precautions or warnings when taking Valganciclovir Tablets USP?

Valganciclovir should be used with caution in individuals with kidney problems, and kidney function should be monitored regularly. It may also cause neuropsychiatric side effects, so any unusual symptoms should be reported to a healthcare provider.

  • Can pregnant or breastfeeding women take Valganciclovir Tablets USP?

Valganciclovir may pose risks to a developing fetus, and breastfeeding is generally not recommended while taking this medication. Pregnant or breastfeeding women should discuss the potential risks and benefits with their healthcare provider.

  • How long should I take Valganciclovir Tablets USP?

The duration of treatment with Valganciclovir varies depending on the specific condition being treated. Your healthcare provider will determine the appropriate duration of therapy.

  • Can I drink alcohol while taking Valganciclovir Tablets USP?

Alcohol consumption while taking Valganciclovir should be discussed with a healthcare provider, as it may interact with the medication or exacerbate side effects.

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

Valganciclovir 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  Valganciclovir 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