Valacyclovir Tablets 500mg Technical Specification:

Product Name:Valacyclovir Tablets 500mg
Brand Name:Generics
Strength:500mg, 1000mg
Dosage Form:Film-coated Oral Tablets
Route of Administration:Via Oral Route
Packing:2s, 3s, 5s, 6s, 10s, 15s, 50s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antiviral
Indication: Valacyclovir is used to treat infections caused by certain types of viruses. In children, it is used to treat cold sores around the mouth (caused by herpes simplex) and chickenpox (caused by varicella zoster). In adults, it is used to treat shingles (caused by herpes zoster) and cold sores around the mouth.
Storage:Store in cool & Dry place. Do not store in the bathroom.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Valacyclovir Tablets 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Valacyclovir Tablets 500mg
    Each tablet contains:
    Valacyclovir hydrochloride USP
    Equivalent to Valacyclovir ………………….500mg
    Excipients…………………………………………q.s.
    Colour: Titanium Dioxide

THERAPEUTIC INDICATIONS:

Valacyclovir is used to treat infections caused by certain types of viruses. In children, it is used to treat cold sores around the mouth (caused by herpes simplex) and chickenpox (caused by varicella zoster). In adults, it is used to treat shingles (caused by herpes zoster) and cold sores around the mouth.

CAUTION & WARNING:

CAUTION:  TABLET SHOULD BE SWALLOWED WHOLE & DO NOT CHEWED OR CRUSHED.

It is recommended to extend the treatment for 10 days for the first outbreak of genital herpes as the infection can flare up again after the 5th day.

5 days should be enough for subsequent flare ups.

****Oral Tablet.

WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.

Prescription only medication for an anti-viral pro-drug treatment for herpes.

Keep medicine out of reach and sight of children

STORAGE & DOSAGE:

STORAGE: Store in cool & Dry place. Do not store in the bathroom.

DOSAGE: As directed by the physician.

NOTE: Valacyclovir 500mg comes in tablet form and should be taken twice a day whole with water, for five days.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals is a renowned pharmaceutical company known for its commitment to providing high-quality medications to improve the health and well-being of individuals around the world. When it comes to Valacyclovir Tablets, Taj Pharmaceuticals stands out for several compelling reasons:

  • Quality Assurance: Taj Pharmaceuticals places a strong emphasis on maintaining the highest standards of quality in the production of Valacyclovir Tablets. Their manufacturing facilities adhere to strict quality control measures, ensuring that each tablet meets rigorous quality and safety standards.
  • Global Reach: Taj Pharmaceuticals has a global presence, allowing individuals worldwide to access Valacyclovir Tablets to manage and treat various viral infections effectively.
  • Research and Development: Taj Pharmaceuticals invests in research and development to continuously improve its formulations and stay at the forefront of pharmaceutical innovation. This commitment to advancing healthcare solutions ensures that patients receive the most effective and up-to-date treatments.
  • Affordability: Taj Pharmaceuticals strives to make essential medications like Valacyclovir Tablets accessible and affordable to a wide range of patients. This affordability ensures that individuals can obtain the treatment they need without financial constraints.
  • Experienced Team: The company boasts an experienced team of professionals, including scientists, researchers, and healthcare experts, who work collaboratively to develop and deliver high-quality medications.
  • Compliance with Regulatory Standards: Taj Pharmaceuticals adheres to strict regulatory guidelines and quality assurance protocols to ensure that Valacyclovir Tablets meet or exceed international pharmaceutical standards.
  • Patient-Centric Approach: Taj Pharmaceuticals is dedicated to improving patients’ lives by providing effective and safe medications. Their patient-centric approach underscores their commitment to healthcare excellence.

In summary, Taj Pharmaceuticals is a trusted pharmaceutical company that prioritizes quality, affordability, and patient well-being when it comes to Valacyclovir Tablets and other medications. Their dedication to pharmaceutical excellence makes them a reliable choice for individuals seeking effective antiviral treatments.

What is Valacyclovir Tablets and its uses:

Valacyclovir Tablets are a medication used to treat various viral infections, primarily those caused by the herpes simplex virus (HSV) and the varicella zoster virus (VZV). Here are the key uses of Valacyclovir Tablets:

  • Herpes Simplex Virus Infections (HSV):
    Genital Herpes: Valacyclovir is commonly prescribed to manage and alleviate the symptoms of genital herpes, a sexually transmitted infection (STI) caused by HSV2. It can help reduce the frequency and severity of outbreaks, relieve pain and discomfort, and shorten the duration of active lesions.
    Cold Sores (Oral Herpes): Valacyclovir can also be used to treat recurrent cold sores (fever blisters) caused by HSV1. It helps speed up the healing process and reduces the pain and itching associated with oral herpes outbreaks.
  • Herpes Zoster (Shingles):
    Valacyclovir is effective in treating shingles, a painful skin rash caused by the reactivation of the varicella zoster virus (VZV), the same virus responsible for chickenpox. It can reduce the duration and severity of shingles symptoms and help prevent complications such as postherpetic neuralgia.
  • Suppressive Therapy:
    Valacyclovir may be prescribed for long term, suppressive therapy in individuals with frequent recurrent herpes outbreaks. It helps to reduce the frequency of outbreaks and may also lower the risk of transmitting the virus to sexual partners.
  • Herpes Simplex Virus Prophylaxis:
    In some cases, Valacyclovir may be used to prevent herpes simplex virus infections in individuals with compromised immune systems, such as those undergoing organ transplantation.

It’s important to note that Valacyclovir Tablets are most effective when taken as prescribed by a healthcare provider. The dosage and duration of treatment can vary depending on the specific infection and individual circumstances. If you believe you may benefit from Valacyclovir Tablets, consult a healthcare professional for a proper evaluation and treatment plan.

How do Valacyclovir Tablets Work?

Valacyclovir Tablets work by inhibiting the replication and spread of certain viruses, primarily the herpes simplex virus (HSV) and the varicella-zoster virus (VZV). Valacyclovir is a prodrug, which means it is converted into its active form, acyclovir, in the body. Acyclovir is the antiviral agent responsible for the medication’s therapeutic effects. Here’s how Valacyclovir Tablets work:

  • Viral DNA Replication Inhibition: Both HSV and VZV are DNA viruses, meaning their genetic material is made up of DNA strands. To replicate and multiply, these viruses rely on an enzyme called DNA polymerase. Acyclovir, the active form of Valacyclovir, is structurally similar to the building blocks of DNA. When it enters infected cells, it is selectively taken up by the viral thymidine kinase enzyme.
  • Phosphorylation: Once inside infected cells, acyclovir is converted into its active form, acyclovir triphosphate, through a series of phosphorylation steps. This active form is similar enough to the natural building blocks of DNA that it can be incorporated into the growing viral DNA chain during replication.
  • Termination of Viral DNA Chain: Acyclovir triphosphate, once incorporated into the viral DNA chain, acts as a “chain terminator.” It lacks a 3′-OH group necessary for further DNA chain elongation. As a result, viral DNA synthesis is halted, and the virus cannot complete the replication process.
  • Reduction of Viral Load: By inhibiting viral DNA replication, Valacyclovir effectively reduces the viral load in infected cells and the surrounding tissue. This leads to a decrease in the severity and duration of symptoms during active herpes outbreaks.
  • Latent Virus Suppression: Valacyclovir can also help suppress the reactivation of latent herpes viruses, such as during recurrent outbreaks of genital herpes or shingles. It does this by preventing the virus from re-entering its active replicative phase.

It’s important to note that Valacyclovir is most effective when taken early during the course of a herpes outbreak, preferably at the first signs of symptoms. This can help reduce the severity of the outbreak and the duration of symptoms. Additionally, Valacyclovir does not cure herpes infections but helps manage and alleviate symptoms while reducing the risk of transmission to others. Always take Valacyclovir as prescribed by a healthcare provider.

Benefits of Valacyclovir Tablets:

  • Effective Treatment for Herpes Infections: Valacyclovir is highly effective in managing and treating herpes simplex virus (HSV) infections, including genital herpes and oral herpes (cold sores). It can help reduce the severity and duration of outbreaks, alleviate symptoms, and promote faster healing.
  • Shingles Relief: Valacyclovir is also used to treat shingles (herpes zoster), a painful skin rash caused by the reactivation of the varicella-zoster virus (VZV). It can help alleviate pain, reduce the duration of symptoms, and prevent complications like postherpetic neuralgia.
  • Suppressive Therapy: For individuals with frequent recurrent herpes outbreaks, Valacyclovir can be prescribed as a long-term suppressive therapy. It helps reduce the frequency of outbreaks and may lower the risk of transmitting the virus to sexual partners.
  • Preventive Therapy: Valacyclovir may be used as prophylaxis to prevent herpes simplex virus infections in individuals with weakened immune systems, such as transplant recipients.

Side Effects of Valacyclovir Tablets:

While Valacyclovir is generally well-tolerated, it may cause some side effects in certain individuals. Common side effects may include:

  • Nausea: Some people may experience mild to moderate nausea while taking Valacyclovir. Taking the medication with food can help alleviate this side effect.
  • Headache: Headaches are a relatively common side effect of Valacyclovir but are typically mild and temporary.
  • Dizziness: Valacyclovir may cause dizziness in some individuals, especially when standing up quickly. It’s essential to be cautious when driving or operating heavy machinery if you experience dizziness.
  • Abdominal Pain: Occasionally, individuals may experience abdominal discomfort or pain while taking Valacyclovir.
  • Diarrhea: Diarrhea is a less common side effect but can occur in some cases.
  • Rash: In rare instances, Valacyclovir may cause a skin rash or itching.
  • Allergic Reactions: Severe allergic reactions to Valacyclovir are rare but can include symptoms such as hives, difficulty breathing, and swelling of the face, lips, tongue, or throat. Seek immediate medical attention if you experience these symptoms.

It’s essential to inform your healthcare provider of any side effects you experience while taking Valacyclovir. While most side effects are mild and manageable, your healthcare provider can provide guidance and adjust your treatment plan if necessary. Additionally, it’s crucial to take Valacyclovir as prescribed to maximize its benefits and minimize the risk of side effects.

Frequently Asked Questions About Valacyclovir Tablets:

Here are some frequently asked questions about Valacyclovir Tablets:

  1. What is Valacyclovir used for?

Valacyclovir is primarily used to treat herpes simplex virus (HSV) infections, including genital herpes and oral herpes (cold sores). It is also used to treat shingles (herpes zoster) and as suppressive therapy for recurrent herpes outbreaks.

  1. How does Valacyclovir work?

Valacyclovir is converted into its active form, acyclovir, in the body. Acyclovir inhibits the replication of the herpes virus by interfering with its DNA synthesis, preventing it from multiplying and spreading.

  1. Is Valacyclovir a cure for herpes?

Valacyclovir does not cure herpes infections. It helps manage and alleviate symptoms, reduces the frequency and severity of outbreaks, and may lower the risk of transmitting the virus to others.

  1. How should I take Valacyclovir Tablets?

Follow your healthcare provider’s instructions on dosing and duration. Valacyclovir is typically taken orally with or without food. It’s essential to finish the prescribed course even if symptoms improve.

  1. Can Valacyclovir prevent herpes transmission to a partner?

While Valacyclovir can reduce the risk of transmitting herpes, it does not eliminate it entirely. It’s important to use safe practices such as using condoms and informing sexual partners of your herpes status to minimize the risk of transmission.

  1. Can Valacyclovir be used during pregnancy or breastfeeding?

Consult your healthcare provider before taking Valacyclovir if you are pregnant or breastfeeding. They will weigh the potential benefits and risks to determine the appropriate course of treatment.

  1. What should I do if I miss a dose of Valacyclovir?

If you miss a dose, take it as soon as you remember. If it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to catch up.

  1. Are there any drug interactions with Valacyclovir?

Inform your healthcare provider about all the medications, supplements, and herbal products you are taking, as some drugs may interact with Valacyclovir. Common interactions include those with probenecid and certain antiviral medications.

  1. Can Valacyclovir cause side effects?

While Valacyclovir is generally well tolerated, it may cause side effects such as nausea, headache, dizziness, abdominal pain, diarrhea, or a skin rash. Serious allergic reactions are rare but possible.

  1. How long does it take for Valacyclovir to work?

Valacyclovir may provide relief from herpes symptoms within a few days of starting treatment. The duration of therapy varies depending on the type of infection and individual circumstances.

Always consult your healthcare provider for personalized guidance and information specific to your medical condition and treatment plan.

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

Valacyclovir 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 Valacyclovir 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
Fax No: +91 22 2634 1274

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Valacyclovir Tablets 500mg
B. Valacyclovir Tablets 1000mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Valacyclovir Tablets 500mg
Each tablet contains:
Valacyclovir hydrochloride USP
Equivalent to Valacyclovir ………………….500mg
Excipients…………………………………………q.s.
Colour: Titanium Dioxide


B. Valacyclovir Tablets 1000mg
Each tablet contains:
Valacyclovir hydrochloride USP
Equivalent to Valacyclovir ………………….1000mg
Excipients…………………………………………q.s.
Colour: Lake Indigo Carmine

THERAPEUTIC INDICATIONS:

Valacyclovir is used to treat infections caused by certain types of viruses. In children, it is used to treat cold sores around the mouth (caused by herpes simplex) and chickenpox (caused by varicella zoster). In adults, it is used to treat shingles (caused by herpes zoster) and cold sores around the mouth.

CAUTION & WARNING:

CAUTION: TABLET SHOULD BE SWALLOWED WHOLE & DO NOT CHEWED OR CRUSHED.
It is recommended to extend the treatment for 10 days for the first outbreak of genital herpes as the infection can flare up again after the 5th day.
5 days should be enough for subsequent flare ups.
****Oral Tablet.
WARNING: TO BE SOLD BY THE RETAILERS ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
Prescription only medication for an anti-viral pro-drug treatment for herpes.
KEEP MEDICINE OUT OF REACH AND SIGHT OF CHILDREN

STORAGE & DOSAGE:

STORAGE: Store in cool & Dry place. Do not store in the bathroom.
DOSAGE: As directed by the physician.
NOTE: Valacyclovir 500mg comes in tablet form and should be taken twice a day whole with water, for five days.