GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Clofazimine Capsules BP 100mg
B. Clofazimine Capsules BP 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Clofazimine Capsules BP 100mg
Each soft gelatin capsule contains:
Clofazimine BP………………….100mg
Excipients…………………………...q. s
Approved colors are used in empty capsule shells.


B. Clofazimine Capsules BP 50mg
Each soft gelatin capsule contains:
Clofazimine BP………………………50mg
Excipients………………………………q. s
Approved colors are used in empty capsule shells.

THERAPEUTIC INDICATIONS:

Clofazimine is a drug used to treat leprosy. It can slow down the growth and weakly kill Mycobacterium leprae, the bacterium that causes leprosy. It is used in combination with rifampicin and dapsone for the treatment of the many forms of leprosy.
It is specifically used for multibacillary (MB) leprosy and erythema nodosum leprosum. Evidence is insufficient to support its use in other conditions.
It is taken by mouth.

CAUTION & WARNING:

CAUTION: 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 room temperature between 15°C to 30°C.
Protect from Light & heat.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Dosage: For-Sensitive Lepromatous (multibacillary) Leprosy. Administer 100mg Clofazimine daily with meals in combination with two other anti-leprosy drugs for at least 2 years and if possible, until negative skin smears are obtained, followed by monotherapy with an appropriate anti-leprosy drug.
Note: *Not suitable for children under 5 years.

Clofazimine Capsules BP 100mg Technical Specification:

Product Name:Clofazimine Capsules BP 100mg
Brand Name:Clofataj
Strength:100mg, 50mg
Dosage Form:Soft Gelatin Capsules
Route of Administration:Via Oral Route
Packing:10s, 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:Anti-leprosy
Indication: Clofazimine is a drug used to treat leprosy. It can slow down the growth and weakly kill Mycobacterium leprae, the bacterium that causes leprosy.
Storage:Store at 20° to 25°C (68° to 77°F). Protect from Light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Clofazimine Capsules BP 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Clofazimine Capsules BP 100mg
    Each soft gelatin capsule contains:
    Clofazimine BP………………….100mg
    Excipients……………………………q. s
    Approved colors are used in empty capsule shells.

THERAPEUTIC INDICATIONS:

Clofazimine is a drug used to treat leprosy. It can slow down the growth and weakly kill Mycobacterium leprae, the bacterium that causes leprosy. It is used in combination with rifampicin and dapsone for the treatment of the many forms of leprosy.
It is specifically used for multibacillary (MB) leprosy and erythema nodosum leprosum. Evidence is insufficient to support its use in other conditions.
It is taken by mouth.

CAUTION & WARNING:

CAUTION:  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 room temperature between 15°C to 30°C. Protect from Light & heat.
Read enclosed leaflet before use.
Keep medicine out of reach of children.
Dosage:  For-Sensitive Lepromatous (multibacillary) Leprosy. Administer 100mg Clofazimine daily with meals in combination with two other anti-leprosy drugs for at least 2 years and if possible, until negative skin smears are obtained, followed by monotherapy with an appropriate anti leprosy drug.
Note: *Not suitable for children under 5 years.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals is a reputable pharmaceutical company known for its commitment to producing high-quality medications, including Clofazimine Capsules. With years of experience in the pharmaceutical industry, Taj Pharmaceuticals has developed a strong reputation for reliability and expertise. Their experienced team of professionals is dedicated to delivering pharmaceutical solutions that make a difference. One of the key reasons why Taj Pharmaceuticals is a trusted choice for Clofazimine Capsules is its unwavering commitment to quality assurance. The company places a strong emphasis on quality control throughout the manufacturing process. Their state-of-the-art facilities adhere to international quality standards, ensuring that each Clofazimine Capsule meets stringent quality criteria. Taj Pharmaceuticals also invests significantly in research and development. This commitment to advancing pharmaceuticals helps in delivering effective and safe medications to patients. Their focus on innovation extends to creating innovative formulations and improving existing ones, keeping them at the forefront of pharmaceutical development. Compliance with regulatory guidelines is another hallmark of Taj Pharmaceuticals. They adhere to strict Good Manufacturing Practices (GMP) and other relevant compliances to guarantee the safety and efficacy of their products. This commitment to compliance ensures that Clofazimine Capsules are manufactured with the highest standards of quality. The company’s global reach is noteworthy. Taj Pharmaceuticals exports its products to numerous countries, expanding access to Clofazimine Capsules for patients worldwide. This global presence showcases their dedication to serving a diverse patient population and making essential medications accessible to people around the world. Taj Pharmaceuticals’ patient-centric approach is evident in their focus on the needs of patients and healthcare providers. They prioritize the development of medications that address medical conditions effectively, contributing to improved patient outcomes. Additionally, Taj Pharmaceuticals provides reliable customer support and information to healthcare professionals and patients, ensuring that individuals using Clofazimine Capsules have access to guidance and assistance when required. In summary, Taj Pharmaceuticals’ extensive experience, commitment to quality, research and development efforts, compliance with regulatory standards, global presence, patient-centered approach, and reliable customer support make them a reputable and trusted choice for Clofazimine Capsules. Their dedication to providing high-quality pharmaceutical products contributes to better healthcare outcomes for patients worldwide.

What is Clofazimine Capsules and its uses:

Clofazimine Capsules are a medication used primarily in the treatment of leprosy, a chronic infectious disease caused by the bacterium Mycobacterium leprae. Clofazimine is an antimicrobial agent that is part of the multidrug therapy regimen recommended by the World Health Organization (WHO) for the treatment of leprosy. Here are the primary uses of Clofazimine Capsules:

  • Leprosy Treatment: Clofazimine is a key component of multidrug therapy (MDT) for leprosy. It is used in combination with other medications like rifampicin and dapsone to effectively treat and cure leprosy. The combination of these drugs helps to kill the bacteria causing the disease and prevent its spread.
  • Treatment of Mycobacterial Infections: Clofazimine may also be used in the treatment of other mycobacterial infections, although its primary use is for leprosy. It has been explored as a potential treatment for infections caused by Mycobacterium tuberculosis and Mycobacterium avium complex (MAC).
  • Off-Label Uses: In some cases, healthcare providers may prescribe Clofazimine off-label for certain conditions, such as certain skin disorders and other infections. However, its primary and most well-established use remains in the treatment of leprosy.

It’s essential to note that Clofazimine Capsules should only be used under the supervision of a qualified healthcare professional, especially when used for conditions other than leprosy. The appropriate dosage and duration of treatment will be determined by the healthcare provider based on the specific medical condition and individual patient factors.

How do Clofazimine Capsules work?

Clofazimine Capsules work as an antimicrobial agent primarily by disrupting the growth and replication of bacteria, particularly Mycobacterium leprae, which causes leprosy. The exact mechanism of action of Clofazimine is not fully understood, but it is believed to involve several mechanisms:

  • Inhibition of DNA Synthesis: Clofazimine interferes with the synthesis of bacterial DNA by binding to the bacterial DNA and inhibiting its replication. This disruption in DNA synthesis hampers the ability of Mycobacterium leprae to reproduce and multiply within the host’s body.
  • Generation of Reactive Oxygen Species (ROS): Clofazimine is known to generate reactive oxygen species (ROS) within bacterial cells. ROS are highly reactive molecules that can damage bacterial cell membranes and other cellular components, leading to bacterial cell death. This oxidative stress is thought to contribute to Clofazimine’s bactericidal effects.
  • Altering Membrane Permeability: Clofazimine can alter the permeability of bacterial cell membranes, making them less effective as barriers. This disruption in the membrane structure can lead to leakage of essential cellular components, ultimately causing bacterial cell death.

It’s important to note that Clofazimine is most effective when used in combination with other drugs, such as rifampicin and dapsone, as part of a multidrug therapy regimen for leprosy. The combination therapy targets different aspects of the bacterium’s physiology, reducing the risk of drug resistance and increasing treatment effectiveness. The use of Clofazimine Capsules should always be supervised by a healthcare professional who can determine the appropriate dosage and treatment duration based on the specific medical condition being treated, such as leprosy or other mycobacterial infections.

Benefits of Clofazimine Capsules:

  • Effective Treatment for Leprosy: Clofazimine is a crucial component of multidrug therapy (MDT) for leprosy, which is recommended by the World Health Organization (WHO). When used in combination with other anti-leprosy drugs like rifampicin and dapsone, it provides an effective treatment that can cure leprosy and prevent further spread of the disease.
  • Treatment of Other Mycobacterial Infections: Clofazimine may also be used to treat certain mycobacterial infections, including Mycobacterium tuberculosis and Mycobacterium avium complex (MAC), particularly when drug-resistant strains are involved.
  • Potential Off-Label Uses: In some cases, healthcare providers may consider using Clofazimine off-label for conditions such as certain skin disorders or other infections. However, its primary and most established use remains in leprosy treatment.

Side Effects of Clofazimine Capsules:

  • Skin Discoloration: One of the most noticeable side effects of Clofazimine is skin discoloration. It can cause the skin to turn pink or reddish-brown, especially in light-skinned individuals. This discoloration is usually reversible once the medication is discontinued but may persist for months or years after treatment.
  • Gastrointestinal Disturbances: Clofazimine may cause gastrointestinal side effects such as abdominal pain, diarrhea, and nausea. These symptoms are usually mild to moderate and can often be managed with dietary adjustments or medications.
  • Eye Discoloration: In some cases, Clofazimine can cause the discoloration of the conjunctiva (the membrane covering the white part of the eye) and the cornea, leading to a brownish or purple hue. This side effect is generally harmless and reversible.
  • Suppression of Bone Marrow: Clofazimine can suppress the bone marrow’s ability to produce blood cells, potentially leading to anemia, leukopenia (reduced white blood cell count), and thrombocytopenia (reduced platelet count). Regular monitoring of blood counts is essential during treatment.
  • Gastrointestinal Obstruction: In rare cases, Clofazimine has been associated with gastrointestinal obstruction, particularly in patients with a history of abdominal surgery.
  • Hepatic Dysfunction: Clofazimine may cause liver enzyme elevations in some individuals, although severe liver damage is rare.

It’s crucial for individuals taking Clofazimine Capsules to be under the care of a healthcare provider who can monitor for potential side effects and adjust the treatment regimen as needed. The benefits of using Clofazimine in treating leprosy and certain mycobacterial infections typically outweigh the risk of side effects when used as directed by a medical professional.

Frequently Asked Questions About Clofazimine Capsules:

Certainly, here are some frequently asked questions (FAQs) about Clofazimine Capsules:

  1. What is Clofazimine used for?

Clofazimine is primarily used in the treatment of leprosy as part of multidrug therapy (MDT). It may also be used to treat certain mycobacterial infections, particularly when drug resistant strains are involved.

  1. How does Clofazimine work?

Clofazimine works by binding to the DNA of mycobacteria, disrupting their ability to replicate and survive. This action helps in killing the bacteria responsible for leprosy and other mycobacterial infections.

  1. What are the common side effects of Clofazimine?

Common side effects of Clofazimine include skin discoloration, gastrointestinal disturbances (abdominal pain, diarrhea, nausea), and eye discoloration. It may also suppress bone marrow function and lead to anemia, leukopenia, and thrombocytopenia.

  1. Is the skin discoloration caused by Clofazimine permanent?

Skin discoloration caused by Clofazimine is usually reversible once the medication is discontinued. However, it may persist for months or even years after treatment ends.

  1. How is Clofazimine taken?

Clofazimine is typically taken orally in the form of capsules. The dosage and duration of treatment depend on the specific condition being treated and should be determined by a healthcare provider.

  1. Can Clofazimine be used during pregnancy or breastfeeding?

Clofazimine should be used during pregnancy only if the potential benefits outweigh the risks. It may be excreted in breast milk, so its use during breastfeeding should be carefully considered in consultation with a healthcare provider.

  1. Are there any drug interactions with Clofazimine?

Clofazimine may interact with other medications, including antacids and drugs that affect the heart’s electrical activity (QT prolonging drugs). It’s important to inform your healthcare provider about all medications you are taking to prevent potential interactions.

  1. What precautions should be taken while using Clofazimine?

Patients taking Clofazimine should be monitored regularly for potential side effects, including blood cell counts, liver function, and eye examinations. It’s important to follow your healthcare provider’s instructions closely.

  1. Is Clofazimine available over the counter?

No, Clofazimine is a prescription medication and is not available over the counter. It should only be used under the supervision of a healthcare provider.

  1. Can Clofazimine cure leprosy completely?

When used as part of multidrug therapy (MDT) for leprosy, Clofazimine can effectively cure the disease and prevent its progression. However, the treatment should be completed as prescribed by a healthcare provider.

Please note that these FAQs are for informational purposes, and specific guidance regarding Clofazimine should be obtained from a qualified healthcare professional.

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

Clofazimine Capsules 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 Clofazimine Capsules, 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