GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Febuxostat Tablet 40mg
B. Febuxostat Tablet 80mg
C. Febuxostat Tablet 120mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a. Febuxostat Tablet 40mg
Each film-coated tablet contains:
Febuxostat…………………….40mg
Excipients………………………q.s.
Colour: Ponceau 4R

b. Febuxostat Tablet 80mg
Each film-coated tablet contains:
Febuxostat…………………….80mg
Excipients………………………q.s.
Colour: Quinoline Yellow

c. Febuxostat Tablet 120mg
Each film-coated tablet contains:
Febuxostat…………………….120mg
Excipients………………………q.s.
Colour: FD&C Yellow 6

THERAPEUTIC INDICATIONS:

Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat is indicated in adults.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
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: Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end county.

Febuxostat Tablet 40mg Bahrain Technical Specification:

Product Name:Febuxostat Tablet Bahrain
Brand Name:Generics
Strength:40mg, 80mg, 120mg
Dosage Form:Tablet (Film-coated)
Route of Administration:Via oral Route
Packing:30s, 90s, 100s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antigout Drugs, Antihyperuricemic agents.
Indication: Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat is indicated in adults.
Storage:Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect it from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Febuxostat Tablet 40mg
  • Febuxostat Tablet 80mg
  • Febuxostat Tablet 120mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  •  Febuxostat Tablet 40mg
    Each film-coated tablet contains:
    Febuxostat…………………….40mg
    Excipients………………………q.s.
    Colour: Ponceau 4R
  • Febuxostat Tablet 80mg
    Each film-coated tablet contains:
    Febuxostat…………………….80mg
    Excipients………………………q.s.
    Colour: Quinoline Yellow
  • Febuxostat Tablet 120mg
    Each film-coated tablet contains:
    Febuxostat…………………….120mg
    Excipients………………………q.s.
    Colour: FD&C Yellow 6

THERAPEUTIC INDICATIONS:

Treatment of chronic hyperuricemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat is indicated in adults.

CAUTION & WARNING:

CAUTION:
Read the enclosed leaflet before use.
Keep the 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: Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect it from moisture.

Dosage: As directed by the Physician.
Attach dispensing label as per end county.

Why Taj Pharmaceuticals?

Elevate your healthcare experience with Taj Pharmaceuticals as your reliable source for Febuxostat Tablets. With a strong foundation of pharmaceutical expertise spanning decades, Taj Pharmaceuticals is committed to delivering the highest quality medications to improve your quality of life.

  • Quality Assurance: At Taj Pharmaceuticals, quality is not just a promise, but a practice. Our Febuxostat Tablets adhere to stringent quality standards, ensuring consistent and reliable therapeutic results for those who rely on them.
  • Effective Gout Management: Febuxostat Tablets are primarily used to treat gout, a painful form of arthritis caused by the buildup of uric acid crystals in the joints. By reducing uric acid levels in the body, these tablets help manage gout symptoms and prevent flare-ups.
  • Expertise You Can Trust: With our wealth of pharmaceutical knowledge and experience, Taj Pharmaceuticals understands the importance of providing medications that contribute to your well-being. Count on us for trusted solutions that make a positive impact on your health.
  • Patient-Centric Approach: Your health is our priority. Taj Pharmaceuticals is dedicated to enhancing the lives of individuals who rely on medications like Febuxostat. Trust us to provide effective treatment options that promote your overall well-being.
  • Global Recognition: Taj Pharmaceuticals has garnered recognition worldwide for its contributions to healthcare. Our commitment to innovation, quality, and accessibility positions us as a preferred provider of essential medications.

Choose Taj Pharmaceuticals for your Febuxostat Tablet needs and experience pharmaceutical excellence combined with a genuine commitment to your health. With us, you’re not just getting medication; you’re receiving the assurance of quality and reliability for a healthier life.

What are Febuxostat Tablets and their uses?

Febuxostat Tablets is a medication primarily used to treat a medical condition known as gout. A gout is a form of arthritis characterized by sudden and severe attacks of pain, redness, and swelling in one or more joints, often the big toe. This condition is caused by the build-up of uric acid crystals in the affected joints.

Uses of Febuxostat Tablets:

  • Gout Treatment: Febuxostat is prescribed to individuals with gout to lower uric acid levels in the blood. It works by inhibiting the enzyme xanthine oxidase, which plays a key role in the production of uric acid. By reducing uric acid production, Febuxostat helps prevent the formation of urate crystals in the joints, thereby alleviating gout symptoms and preventing gout attacks.
  • Prevention of Gout Flare-ups: In addition to treating acute gout attacks, Febuxostat may also be used as a preventive measure to reduce the frequency and severity of gout flare-ups in individuals with recurrent gout.
  • Management of Hyperuricemia: Febuxostat can be used to manage hyperuricemia (elevated uric acid levels) in conditions other than gout, such as certain types of kidney stones. Elevated uric acid levels can contribute to the formation of kidney stones.

It’s important to note that Febuxostat is not a pain reliever for acute gout attacks. Instead, it is a medication that addresses the underlying cause of gout by lowering uric acid levels over time. For immediate relief of gout pain during an attack, other medications, such as nonsteroidal anti-inflammatory drugs (NSAIDs) or colchicine, are typically used in combination with Febuxostat.

How do Febuxostat Tablets work?

Febuxostat Tablets work by inhibiting the activity of an enzyme called xanthine oxidase. This enzyme plays a crucial role in the metabolic pathway that leads to the production of uric acid in the body. Here’s how Febuxostat works to lower uric acid levels:

  • Normal Uric Acid Metabolism: Uric acid is a waste product that forms when the body breaks down purines, which are substances found in certain foods and are also produced naturally by the body. Under normal circumstances, uric acid is filtered by the kidneys and excreted in the urine, maintaining balanced levels in the bloodstream.
  • Xanthine Oxidase Activity: Xanthine oxidase is an enzyme that converts two precursor substances, hypoxanthine and xanthine, into uric acid. This enzyme is essential for the final step in uric acid synthesis.
  • Inhibition by Febuxostat: When Febuxostat is taken orally, it is absorbed into the bloodstream and reaches the target tissues, primarily the liver. In the liver, Febuxostat works as a xanthine oxidase inhibitor. It binds to the enzyme, preventing it from converting hypoxanthine and xanthine into uric acid.
  • Reduced Uric Acid Production: By inhibiting xanthine oxidase, Febuxostat effectively reduces the production of uric acid in the body. This leads to a decrease in the concentration of uric acid in the blood.
  • Preventing Uric Acid Crystals: Lowering uric acid levels is crucial for individuals with gout because it helps prevent the formation of urate crystals in the joints. These crystals are the underlying cause of gout attacks and the associated symptoms of pain, inflammation, and swelling.
  • Gout Management: Febuxostat is particularly effective in managing gout by reducing the frequency and severity of gout attacks and preventing the long-term complications associated with elevated uric acid levels.

Benefits of Febuxostat Tablets:

  • Gout Management: The primary benefit of Febuxostat Tablets is their effectiveness in managing gout, a painful form of arthritis caused by elevated uric acid levels and the formation of urate crystals in the joints. By lowering uric acid levels, Febuxostat helps reduce the frequency and severity of gout attacks, providing relief from pain and inflammation.
  • Prevention of Gout Flare-ups: Febuxostat can be used as a preventive measure to reduce the risk of recurrent gout attacks. By maintaining lower uric acid levels over time, it helps prevent the formation of urate crystals, which are responsible for triggering gout flares.
  • Hyperuricemia Management: In conditions where elevated uric acid levels contribute to health issues beyond gout, such as certain types of kidney stones, Febuxostat can help manage hyperuricemia by reducing uric acid production.

Side Effects of Febuxostat Tablets:

  • Common Side Effects: While Febuxostat is generally well-tolerated, some individuals may experience mild side effects, including nausea, joint pain, rash, and abnormal liver function tests. These side effects are usually temporary and may resolve on their own.
  • Serious Side Effects: In rare cases, Febuxostat can lead to more severe side effects, such as severe skin reactions (Stevens-Johnson syndrome), liver problems, and cardiovascular events. It’s essential to seek immediate medical attention if you experience symptoms like rash, itching, jaundice, chest pain, or difficulty breathing.
  • Cardiovascular Risks: Some studies have suggested a potential increased risk of cardiovascular events (e.g., heart attack or stroke) associated with the use of Febuxostat, particularly in individuals with preexisting heart disease. This risk should be considered and discussed with a healthcare provider, especially in individuals with a history of cardiovascular issues.
  • Liver Function Monitoring: Regular monitoring of liver function is typically recommended while taking Febuxostat, as it can affect liver enzymes in some individuals.
  • Kidney Function: Febuxostat is primarily metabolized by the liver, but it can also affect kidney function. Kidney function should be monitored during treatment, particularly in individuals with preexisting kidney disease.
  • Allergic Reactions: Although rare, allergic reactions to Febuxostat can occur. Signs of an allergic reaction may include itching, rash, swelling, dizziness, or difficulty breathing. Seek medical attention if any of these symptoms occur.
  • Interactions with Other Medications: Febuxostat may interact with certain medications, including those used to lower blood thinners and those used to lower blood sugar levels. It’s important to inform your healthcare provider of all medications you are taking.

Frequently Asked Questions About Febuxostat Tablets:

Certainly, here are some frequently asked questions (FAQs) about Febuxostat Tablets:

What is Febuxostat, and what is its primary purpose?

Febuxostat is a medication primarily used to treat gout, a painful form of arthritis caused by elevated uric acid levels and the formation of urate crystals in the joints. It helps lower uric acid levels and reduce the frequency and severity of gout attacks.

How does Febuxostat work to treat gout?

Febuxostat works by inhibiting the activity of the enzyme xanthine oxidase, which plays a key role in the production of uric acid in the body. By reducing uric acid production, it helps prevent the formation of urate crystals in the joints.

Can Febuxostat be used to relieve pain during a gout attack?

No, Febuxostat is not a pain reliever for acute gout attacks. It is intended for long-term management and prevention of gout attacks. Pain relief during an acute attack typically requires other medications like nonsteroidal anti-inflammatory drugs (NSAIDs) or colchicine.

How long does it take for Febuxostat to lower uric acid levels and prevent gout attacks?

The time it takes for Febuxostat to lower uric acid levels and prevent gout attacks can vary from person to person. It may take several weeks to months for the full effects to be seen. Regular monitoring of uric acid levels is typically conducted by a healthcare provider.

Are there any dietary restrictions while taking Febuxostat?

While there are no specific dietary restrictions, it’s advisable to maintain a healthy diet and lifestyle, including limiting the consumption of foods high in purines (such as red meat, shellfish, and certain alcoholic beverages) and staying wellhydrated.

Can Febuxostat be used to treat conditions other than gout?

Febuxostat is primarily indicated for gout management. Its use for other conditions should be discussed with a healthcare provider, as it may have limited efficacy for conditions not related to uric acid metabolism.

What are the common side effects of Febuxostat?

Common side effects of Febuxostat may include nausea, joint pain, rash, and abnormal liver function tests. Most of these side effects are generally mild and temporary.

Are there any serious side effects associated with Febuxostat?

In rare cases, Febuxostat may lead to serious side effects, such as severe skin reactions, liver problems, and cardiovascular events. Seek immediate medical attention if you experience severe skin rashes, jaundice, chest pain, or difficulty breathing.

Should I continue taking Febuxostat Tablets even if I don’t have gout attacks?

The use of Febuxostat should be discussed with and monitored by a healthcare provider. Even if you are not experiencing gout attacks, your healthcare provider may recommend its continued use to prevent future attacks and maintain lower uric acid levels.

Can I drink alcohol while taking Febuxostat?

It’s generally advisable to limit alcohol consumption while taking Febuxostat, as alcohol can contribute to elevated uric acid levels and potentially trigger gout attacks. Discuss alcohol use with your healthcare provider to determine what is safe and appropriate for your individual situation.

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

Febuxostat 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 Febuxostat 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