GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Itraconazole Capsules 100mg
B. Itraconazole Capsules 200mg
C. Itraconazole Capsules 400mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Itraconazole Capsules 100mg
Each hard gelatin Capsule contains:
Itraconazole BP …………………100mg
(As Pallets)
Excipients ………………………. q.s.
Approved colours used in capsule shells.

B. Itraconazole Capsules 200mg
Each hard gelatin Capsule contains:
Itraconazole BP ………………….200mg
(As Pallets)
Excipients ………………………. q.s.
Approved colours used in capsule shells.


C. Itraconazole Capsules 400mg
Each hard gelatin Capsule contains:
Itraconazole BP………………….400mg
(As Pallets)
Excipients …………………………… q.s.
Approved colours used in capsule shells.

THERAPEUTIC INDICATIONS:

Itraconazole is an antifungal medication used to treat a number of fungal infections. This includes aspergillosis, blastomycosis, coccidioidomycosis, histoplasmosis, and paracoccidioidomycosis. It may be given by mouth or intravenously.

CAUTION & SCHEDULE:

CAUTION: Terfenadine or Astemizole should not be taken simultaneously when the patient is on this medication.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
FOR OPTIMAL ABSORPTION, ITRACONAZOLE CAPSULES SHOULD BE TAKEN IMMEDIATELY AFTER A FULL MEAL.
SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.
Read enclosed leaflet before use.

STORAGE & DOSAGE:

Storage: Store below 30 °C.
Protect from Light and moisture.
Dosage: As directed by the Physician.

Itraconazole Capsules 200mg Technical Specification:

Product Name:Itraconazole Capsules 200mg
Brand Name:Preventfung
Strength:100mg, 200mg, 400mg
Dosage Form:Capsules (Hard gelatin)
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Antifungal
Indication: Itraconazole capsule is used to treat fungal infections, such as aspergillosis (fungal infection in the lungs), blastomycosis (Gilchrist’s disease), or histoplasmosis (Darling’s disease).
Storage:Store below 30 °C. Protect from Light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Itraconazole Capsules 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Itraconazole Capsules 200mg
    Each hard gelatin Capsule contains:
    Itraconazole BP …………………200mg
    (As Pallets)
    Excipients ………………………. q.s.
    Approved colours used in capsule shells.

THERAPEUTIC INDICATIONS:

Itraconazole is an antifungal medication used to treat a number of fungal infections. This includes aspergillosis, blastomycosis, coccidioidomycosis, histoplasmosis, and paracoccidioidomycosis. It may be given by mouth or intravenously.

CAUTION & SCHEDULE:

CAUTION:  Terfenadine or Astemizole should not be taken simultaneously when the patient is on this medication.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
FOR OPTIMAL ABSORPTION, ITRACONAZOLE CAPSULES SHOULD BE TAKEN IMMEDIATELY AFTER A FULL MEAL.
SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A registered medical practitioner.
Read enclosed leaflet before use.

STORAGE & DOSAGE:

Storage: Store below 30 °C.
Protect from Light and moisture.
Dosage: As directed by the Physician.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals is a renowned pharmaceutical company that stands out for its commitment to excellence in producing Itraconazole Capsules and a wide range of pharmaceutical products. What sets Taj Pharmaceuticals apart is its unwavering dedication to maintaining the highest quality standards. The company’s manufacturing facilities employ state-of-the-art technology and adhere to strict Good Manufacturing Practices (GMP). This commitment to quality assurance ensures that their medications, including Itraconazole Capsules, consistently meet rigorous quality benchmarks, providing patients with reliable and effective treatments. Furthermore, Taj Pharmaceuticals places a strong emphasis on research and development (R&D). Their investment in scientific innovation and continuous improvement of products like Itraconazole Capsules demonstrates their commitment to advancing healthcare. This dedication to R&D contributes to the safety and efficacy of their medications. The company’s extensive product portfolio covers a wide spectrum of therapeutic areas, making Taj Pharmaceuticals a comprehensive provider of pharmaceutical solutions. Their diverse range of medications ensures that patients and healthcare providers have access to a broad array of treatment options for various medical conditions. Taj Pharmaceuticals has a global presence, supplying pharmaceuticals to numerous countries worldwide. This international reach underscores their mission to make essential medications accessible to people around the world, enhancing global healthcare. In addition to its commitment to quality, Taj Pharmaceuticals is deeply rooted in a patient-centric approach. They prioritize patient well-being, aiming to improve lives by providing safe and effective medications like Itraconazole Capsules. Moreover, the company collaborates closely with healthcare professionals to offer valuable support and information, ensuring that patients receive the best possible care. Taj Pharmaceuticals’ adherence to regulatory guidelines and standards is another hallmark of their operations. They are committed to meeting the stringent regulatory requirements set by health authorities in different countries. This commitment underscores their dedication to ensuring that their products consistently adhere to international quality and safety standards. Taj Pharmaceuticals is a pharmaceutical industry leader known for its unwavering commitment to quality, research, patient well-being, and global accessibility. Their dedication to producing high-quality Itraconazole Capsules and other pharmaceutical products makes them a trusted choice for healthcare providers and patients seeking reliable and effective medications.

What is Itraconazole Capsules and its uses:

Itraconazole Capsules are a pharmaceutical medication used to treat various fungal infections. Here are the primary uses of Itraconazole Capsules:

  • Fungal Infections: Itraconazole is an antifungal medication used to treat a wide range of fungal infections caused by various fungi, including dermatophytes, yeasts, and molds. These infections can affect different parts of the body, such as the skin, nails, mouth, throat, esophagus, and internal organs.
  • Dermatophyte Infections: Itraconazole Capsules are commonly used to treat dermatophyte infections, which are fungal infections that affect the skin, hair, and nails. Conditions such as ringworm (tinea corporis), athlete’s foot (tinea pedis), and fungal nail infections (onychomycosis) can be effectively managed with Itraconazole.
  • Systemic Fungal Infections: In some cases, Itraconazole may be prescribed to treat systemic fungal infections, which are infections that spread throughout the body and may affect internal organs like the lungs or the central nervous system.
  • Oral Thrush (Candidiasis): Itraconazole may also be used to treat oral thrush, a fungal infection of the mouth caused by the Candida species of yeast. This condition is common in individuals with weakened immune systems.
  • Esophageal Candidiasis: Itraconazole may be prescribed for the treatment of esophageal candidiasis, a fungal infection that affects the esophagus. It can cause symptoms such as difficulty swallowing and pain in the chest.
  • Prevention: In some cases, Itraconazole may be used as a preventive measure for individuals with a weakened immune system who are at risk of developing fungal infections.

It’s important to note that Itraconazole should only be used under the supervision of a healthcare professional, as its appropriate use depends on the type and severity of the fungal infection, as well as individual patient factors. The medication works by inhibiting the growth and multiplication of the fungal organisms, ultimately eradicating the infection and relieving associated symptoms.

How does Itraconazole Capsules work?

Itraconazole Capsules work by inhibiting the growth and reproduction of fungal organisms, ultimately treating fungal infections. Here’s how Itraconazole exerts its antifungal effects:

  • Inhibition of Ergosterol Synthesis: Fungi, like human cells, have cell membranes that contain a sterol compound called ergosterol. Ergosterol is essential for the structural integrity and normal functioning of fungal cell membranes. Itraconazole interferes with the fungal cells’ ability to synthesize ergosterol by inhibiting an enzyme called 14α-demethylase. This disruption leads to the accumulation of abnormal sterol compounds and weakens the fungal cell membrane.
  • Disruption of Fungal Cell Membrane: The accumulation of abnormal sterol compounds and the weakened fungal cell membrane result in increased permeability and susceptibility to damage. This disruption makes it difficult for the fungal cells to maintain their structural integrity.
  • Inhibition of Fungal Growth: By affecting the fungal cell membrane, Itraconazole impedes the growth of the fungal organisms. This prevents the fungi from replicating and spreading within the body.
  • Fungal Cell Death: Over time, as the fungal cells become increasingly compromised due to the inhibition of ergosterol synthesis and cell membrane disruption, they may undergo cell death, leading to the resolution of the fungal infection.

It’s important to note that Itraconazole is not effective against all types of fungi. Its effectiveness may vary depending on the specific fungal species causing the infection. Therefore, the choice of antifungal medication and the duration of treatment should be determined by a healthcare professional based on the type and severity of the fungal infection, as well as individual patient factors. Additionally, Itraconazole should be taken as prescribed, and the full course of treatment should be completed to ensure the eradication of the infection and prevent recurrence.

Benefits and Side Effects of Itraconazole Capsules:

Itraconazole Capsules offer several benefits in the treatment of fungal infections, but they may also be associated with certain side effects. Here’s an overview of the potential benefits and side effects:

Benefits:

  • Effective Antifungal Treatment: Itraconazole is effective in treating a wide range of fungal infections, including those affecting the skin, nails, mouth, throat, esophagus, and internal organs. It is often prescribed when other antifungal medications may not be suitable or effective.
  • Convenient Oral Administration: Itraconazole is available in oral capsule form, making it convenient for patients to take. This ease of administration can improve patient adherence to treatment.
  • Broad-Spectrum Activity: It can target various types of fungi, including dermatophytes, yeasts (such as Candida), and molds, making it suitable for a diverse range of fungal infections.

Common Side Effects:

  • Gastrointestinal Issues: Some individuals may experience gastrointestinal side effects, such as nausea, vomiting, diarrhea, or abdominal discomfort. Taking the medication with food or a full meal may help alleviate these symptoms.
  • Headache: Headaches can occur as a side effect of Itraconazole use, though they are generally mild and transient.
  • Skin Reactions: Skin rashes or itching may occur in some individuals.
  • Elevated Liver Enzymes: Itraconazole can occasionally lead to an increase in liver enzymes, which is usually reversible upon discontinuation of the medication. Regular monitoring of liver function may be necessary during treatment.

Less Common Side Effects:

  • Heart-Related Issues: Rarely, Itraconazole may cause heart-related issues, including irregular heart rhythms (arrhythmias). It is important for individuals with pre-existing heart conditions to discuss the potential risks with their healthcare provider.
  • Peripheral Neuropathy: Some individuals may experience peripheral neuropathy, characterized by symptoms such as tingling, numbness, or weakness in the extremities.
  • Hormonal Effects: Itraconazole may interfere with certain hormones, which can lead to menstrual irregularities in women.
  • Allergic Reactions: While rare, allergic reactions to Itraconazole may occur and may include symptoms like rash, itching, swelling, severe dizziness, or difficulty breathing. Seek immediate medical attention if these symptoms occur.

It’s important to note that the likelihood and severity of side effects can vary from person to person. Individuals should report any unusual or severe side effects to their healthcare provider promptly. Additionally, Itraconazole may interact with other medications, so it is essential to inform your healthcare provider about all medications and supplements you are taking before starting Itraconazole treatment. Overall, the benefits of Itraconazole in treating fungal infections often outweigh the potential risks when used under medical supervision.

Frequently Asked Questions About Itraconazole Capsules:

Certainly! Here are some frequently asked questions (FAQs) about Itraconazole Capsules:

  1. What is Itraconazole used for?

Itraconazole is an antifungal medication used to treat a variety of fungal infections, including skin infections, nail infections, oral thrush, esophageal candidiasis, and systemic fungal infections.

  1. How should I take Itraconazole Capsules?

Itraconazole capsules are typically taken by mouth with a full meal to enhance absorption. Follow your healthcare provider’s instructions regarding the dosing schedule and duration of treatment. Do not crush or chew the capsules.

  1. Can I drink alcohol while taking Itraconazole?

It is generally recommended to avoid alcohol while taking Itraconazole, as alcohol may interact with the medication and increase the risk of side effects.

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

If you miss a dose, take it as soon as you remember. However, 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 make up for a missed one.

  1. Are there any food or drug interactions with Itraconazole?

Yes, Itraconazole can interact with certain medications and foods. It may interact with medications that affect the heart rhythm or are metabolized by the liver. Always inform your healthcare provider about all medications, supplements, and herbal products you are taking to avoid potential interactions.

  1. How long should I take Itraconazole for a fungal infection?

The duration of treatment with Itraconazole depends on the type and severity of the fungal infection. Your healthcare provider will determine the appropriate duration, and it is important to complete the full course of treatment as prescribed.

  1. What are the common side effects of Itraconazole Capsules?

Common side effects of Itraconazole may include gastrointestinal symptoms (nausea, vomiting, diarrhea), headache, skin rash, and elevated liver enzymes. If you experience severe or unusual side effects, contact your healthcare provider.

  1. Can Itraconazole be used during pregnancy or breastfeeding?

Itraconazole should be used during pregnancy only if the potential benefits outweigh the risks. It may pass into breast milk, so discuss its use with your healthcare provider if you are breastfeeding.

  1. Can Itraconazole cause heart problems?

Rarely, Itraconazole may cause heart related issues, such as irregular heart rhythms (arrhythmias). Inform your healthcare provider about any pre-existing heart conditions.

  1. Is Itraconazole available over-the-counter (OTC)?

Itraconazole is not available over-the-counter and requires a prescription from a healthcare provider.

These FAQs provide general information about Itraconazole Capsules. It is essential to consult your healthcare provider for personalized guidance and recommendations based on your specific medical condition and needs.

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

Itraconazole 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 Itraconazole 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