Itraconazole Capsule 100 mg
- Itraconazole Capsule USP 100 mg
Therapeutic Class: Anti-Infectives
Dosage Forms: Hard Capsules
Brand Name: Itraconex-100™
How it works?
Uses of Itraconazole Capsule 100 mg
If you’re dealing with certain fungal infections, Itraconazole Capsule 100 mg might be the treatment your doctor recommends. This medication is specifically designed to fight fungal infections that are likely sensitive to it, helping you get back to feeling your best.
Itraconazole is used to treat a variety of fungal conditions, including:
- Vulvovaginal candidiasis, a common yeast infection affecting the vaginal area.
- Pityriasis versicolor, a skin condition that causes patches of discolored skin.
- Dermatophytoses, which are fungal infections of the skin caused by fungi like Trichophyton, Microsporum, and Epidermophyton species. This includes conditions such as tinea pedis (athlete’s foot), tinea cruris (jock itch), tinea corporis (ringworm on the body), and tinea manuum (fungal infection of the hands).
- Oral candidiasis, also known as thrush, which affects the mouth.
- Onychomycosis, a fungal infection of the nails caused by dermatophytes or yeasts, leading to thickened, discolored, or brittle nails.
By targeting these infections, Itraconazole Capsule 100 mg helps clear up symptoms and restore your skin, nails, or mucous membranes to health. Always follow your healthcare provider’s instructions to ensure the best results with this medication.
Precautions of Itraconazole Capsule 100 mg
Here are some important safety precautions to take about Itraconazole Capsule 100 mg:
Heart Failure Risk:
Itraconazole can worsen or cause congestive heart failure. Avoid using it if you have a history of heart failure unless it’s for a life-threatening infection. Stop the medication right away if you experience shortness of breath, swelling, or sudden weight gain.
Liver Monitoring:
Itraconazole is processed by the liver and may cause serious liver damage. If you have liver disease, you’ll need close monitoring with regular liver function tests. Watch for symptoms like yellowing of the skin or eyes (jaundice) and dark urine.
Drug Interactions:
Itraconazole can interact with many medicines such as simvastatin, lovastatin, quinidine, cisapride, midazolam, and triazolam. These combinations may lead to dangerous heart rhythm problems or toxic effects. Always inform your doctor about all medications and supplements you are taking.
Pregnancy and Breastfeeding:
Avoid itraconazole during pregnancy unless absolutely necessary, as it may harm the unborn baby. It passes into breast milk, so breastfeeding mothers should avoid it or stop nursing while taking the medication.
Dosages administration of Itraconazole Capsule 100 mg
Here are the treatment schedules for adults based on the specific fungal infection:
- Vulvovaginal candidiasis: 200 mg twice daily for 1 day
- Pityriasis versicolor: 200 mg once daily for 7 days
- Tinea corporis and tinea cruris: 100 mg once daily for 15 days
- Tinea pedis and tinea manuum: 100 mg once daily for 30 days
- Oral candidiasis: 100 mg once daily for 14 days
- Onychomycosis: 200 mg once daily for 3 months
For skin infections, the best clinical and fungal clearance results are usually seen 1 to 4 weeks after completing treatment. For nail infections, it may take 6 to 9 months after stopping treatment to see optimal effects. This delay happens because itraconazole leaves the skin and nails more slowly than it does the bloodstream.
For patients with Acquired Immune Deficiency Syndrome (AIDS) or neutropenia, a higher dose of 200 mg once daily for 14 days is recommended to treat oral candidiasis, as itraconazole absorption can be reduced in these groups.
The duration of treatment for systemic fungal infections should be tailored based on how well the infection responds both clinically and mycologically.
Side effects of Itraconazole Capsule 100 mg
Here is important information about potential side effects and special considerations when using Itraconazole Capsule 100 mg:
Cardiac Effects:
Itraconazole can weaken the heart’s pumping ability (negative inotropic effect) and has been linked to cases of congestive heart failure. This risk appears higher with daily doses of 400 mg compared to lower doses. Calcium channel blockers, which also reduce heart strength, may increase this effect when taken together with itraconazole. Additionally, itraconazole can interfere with how the body processes these calcium channel blockers.
Liver Effects:
Rare but serious liver damage, including fatal acute liver failure, has been reported with itraconazole use. Patients on itraconazole should have their liver function monitored. Treatment should be avoided or carefully considered in those with existing liver problems, elevated liver enzymes, or previous liver toxicity from other drugs, unless the benefits outweigh the risks.
Hearing Loss:
Some patients have experienced temporary or permanent hearing loss while taking itraconazole, especially when combined with quinidine, which should not be used together with itraconazole. Hearing loss usually improves after stopping the medication.
Immunocompromised Patients:
Patients with weakened immune systems, such as those with neutropenia, AIDS, or who have had organ transplants, may absorb itraconazole less effectively when taken orally.
Use in Severe Fungal Infections:
Itraconazole capsules are not recommended to start treatment in patients with immediately life-threatening systemic fungal infections due to how the drug is absorbed and processed.
Use in AIDS Patients:
Itraconazole may be used in AIDS patients who have been treated for systemic fungal infections like sporotrichosis, blastomycosis, histoplasmosis, or cryptococcosis and who are at risk of their infection returning.
Always discuss these considerations with your healthcare provider before starting itraconazole treatment.
Storage instruction of Itraconazole Capsule 100 mg
Store below 30°C and protect from light.
Keep the medicine out of reach of children.
Packing details of Itraconazole Capsule 100 mg
10 × 10 Alu/PVC Blister.
Itraconazole Capsules USP 100 mg are available in an Alu/PVC blister of 10 capsules. Such 10 blisters in a unit carton with pack insert.
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Top GMP Certified Itraconazole Capsule 100 mg Manufacturer
At Conical Pharmaceuticals, we are a trusted manufacturer of Itraconazole Capsules 100 mg, produced at our GMP‑certified large‑scale facility in Ahmedabad, India. Alongside this, we manufacture a wide range of high‑quality antifungal medicines, serving the needs of large‑scale distributors, international importers, private label brands, retail chains, and pharmacies. Our commitment is to deliver consistent quality and reliable supply to support global healthcare partners.
We are recognized as a global exporter of antifungal formulations, with planning to strong distribution across Central America (Belize, Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, Panama), Central Africa (Cameroon, Chad, DRC, Equatorial Guinea, Gabon, Republic of the Congo), the CIS countries, and key markets such as Iran, Malaysia, Thailand, and Saudi Arabia.
To ensure smooth import processes, we provide complete documentation including GMP Certificate, Free Sale Certificate, COPP, COA, and tailored dossiers.
We supply Itraconazole Capsules 100 mg with a lead time of 45–60 days, offering custom packaging and custom formulations to meet specific buyer requirements. As a bulk supplier, we fulfill hospital, tender, and distributor demand worldwide. Our strong R&D team guarantees that every formulation is safe, effective, and of the highest quality.
In addition, we act as a CDMO partner, offering contract manufacturing and private labeling for both branded and generic requirements, giving our partners confidence in every collaboration.
Your trusted partner for Itraconazole Capsules 100 mg for global export.
CUSTOM PACKAGING
Options available in size and style to meet your exact specifications and branding needs
SAMPLES AVAILABLE
Test before committing to bulk orders with complimentary samples for quality verification
LEAD TIME
45–60 days for timely delivery, ensuring reliable supply chain management
SHELF LIFE
Shelf Life: 24 months.
Frequently Asked Questions
Questions are useful tools, they open lines of communication; give us information; improve interactions, facilitate analysis, and many more.
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Itraconazole 100 mg capsules are prescribed to treat fungal infections, including onychomycosis (nail infections), dermatomycoses (skin infections), and systemic fungal infections.
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Common side effects of itraconazole capsules 100 mg include abdominal pain, nausea, rash, and liver function changes. Serious but rare effects may involve heart failure, severe liver damage, or allergic reactions.
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India has several GMP‑certified manufacturers. Companies like Conical Pharmaceuticals are recognized for consistent quality, regulatory compliance, and global export capabilities.
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Yes, many Indian manufacturers offer third‑party manufacturing and private labeling services, allowing distributors and brands to market itraconazole capsules 100 mg under their own label.
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Yes. Indian exporters, including Conical Pharmaceuticals, actively supply itraconazole capsules 100 mg to the CIS countries (such as Russia, Ukraine, Kazakhstan, Belarus, Armenia, and others). To ensure smooth import processes, Conical provides complete documentation including GMP certificates, COPP, COA, and tailored dossiers meeting international regulatory standards and supporting distributors, hospitals, and government tenders across the CIS region.
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Yes. While 100 mg is the most common strength, manufacturers can produce custom strengths and formulations depending on buyer requirements and regulatory approvals. Conical Pharmaceuticals specifically offers itraconazole in 100 mg and 200 mg tablets, ensuring flexibility for diverse therapeutic needs and international market demands.