Itraconazole Capsules

Active Ingredients: Itraconazole

Itraconazole Capsules are an antifungal drug that is used to treat serious fungal infections in adults. This medication can be used for infections in any part of the body, including the lungs, mouth or throat, toenails, or fingernails.

Itraconazole belongs to a class of drugs known as azole antifungals. It is in the subgroup triazole, which is indicated to treat systemic infections. The active ingredient prevents the fungi from producing ergosterol, an essential substance for the fungal cell membrane.

After oral administration, this drug reaches peak plasma concentrations after 2-5 hours. The terminal half-life of this drug ranges from 16 to 28 hours and increases to 34 to 42 hours after repeated dosing. It is rapidly absorbed after oral administration and the oral bioavailability is about 55%. These capsules have maximal oral bioavailability when taken immediately after a full meal. Patients with reduced gastric acidity or patients with achlorhydria have reduced absorption. This drug binds to proteins in the plasma, about 99.8% of the drug and it is distributed in a large volume in the body with extensive distribution into tissues. Its concentrations in the lungs, kidneys, liver, bone, stomach, spleen, and muscles are 2-3 times higher than the concentrations in plasma, while the concentration in the skin is 4 times higher. Concentrations in the cerebrospinal fluid are lower than those in plasma.

This drug is metabolized by the liver and it is excreted mainly as inactive metabolites in urine (35%) and in feces (54%) after one week of oral dose. The concentration in the skin persists for 2 to 4 weeks after the treatment, and in nails, it can be detected 1 week after the start of the treatment and can last for 6 months after a 3-month treatment period.

AdvaCare Pharma is a global supplier of Itraconazole Capsules. AdvaCare excels at the production of high-quality yet cost-effective treatments. This medication is manufactured in our GMP-certified facilities located in China, India, and the USA.

AdvaCare Pharma is a GMP manufacturer of Itraconazole Capsules. Our strategically located facilities ensure that our company has complete control over the supply chain, meaning higher quality products and lower costs for transportation and importation. Over the past 20 years, we have built a solid reputation as a leading manufacturer of pharmaceutical products across 65 countries.

What is Itraconazole used for?

How are Itraconazole Capsules used?

This medication is manufactured to be taken orally. Itraconazole Capsules should be taken after eating a full meal. The capsule must be swallowed whole.

What dose should be taken?

The usual dose for adults is 100-200mg.

The usual dose for children is 100mg or less.

The exact dosage is dependent on medical condition, response to the treatment, age, and weight. Refer to a doctor or pharmacist for guidelines on dosage to get individualized advices. Do not exceed what they advise.

Who can benefit the most from Itraconazole Capsules?

These capsules are used for treating fungal infections in immunocompromised and non-immunocompromised patients. Patients with blastomycosis, histoplasmosis, and aspergillosis can benefit the most from this drug. It can also be used for treating onychomycosis of the toenail and the fingernail due to dermatophytes (tinea unguium).

Are only Itraconazole Capsules enough for treating fungal infections?

It depends on the severity of the health condition. In some cases, only Itraconazole is enough for treating fungal infections, however, in many cases other supplements and drugs are needed.

Who can use Itraconazole Capsules?

These capsules can be used for both children and adults but the dosage depends on the current health status and the patient’s age. Itraconazole should be used with caution in the following patient categories.

Pediatric This medication should be used with caution in the pediatric population and should be used only for severe fungal infections or immunocompromised patients. There are not many studies that confirm the safety of itraconazole in the pediatric population.

The efficacy and safety of itraconazole have not been established through studies in pediatric patients.

Pregnant Itraconazole belongs to the category C drugs for pregnant women. There are not many studies on pregnant women, but animal studies demonstrate a risk to the fetus, and in some cases, the potential benefits of the drug may outweigh the risks. It might lead to a dose-related increase in maternal toxicity, embryotoxicity, and teratogenicity in rats. This medicine might also cross the placenta and this represents a risk for the fetus. It can also lead to skeletal defects, encephaloceles, and/or macroglossia.

Itraconazole is contraindicated during pregnancy in women with onychomycosis.

Nursing This medicine is excreted through the women’s milk and it might lead to potential risks to the infant. The benefits of breastfeeding, the patient’s clinical need, and any potential risk to the nursing infant should be considered when administering Itraconazole to women who are breastfeeding.

Geriatric These capsules should be used in older patients only when the potential benefits outweigh the potential risks. The dosage should be carefully selected due to their decreased hepatic, renal, or cardiac function, and also the concomitant diseases or other drugs that the patient is taking. Some of the reported side effects in older patients who take this drug are hearing loss, especially in cases when Itraconazole is taken in concurrent administration of quinidine.

Other warnings

Itraconazole can lead to serious hepatotoxicity including liver failure and even death. This usually happens in cases when patients have a pre-existing liver disease and can happen even in the first week of treatment. If patients develop some symptoms or signs, they should consult with a healthcare professional to examine the liver parameters.

Treatment with Itraconazole might lead to cardiac dysrhythmias or sudden death, especially in patients who are taking drugs like cisapride, pimozide, methadone, or quinidine concomitantly with itraconazole and/or other CYP3A4 inhibitors.

Patients with ventricular dysfunction should not use these capsules for the treatment of onychomycosis because it might lead to serious consequences. The medication might also lead to congestive heart failure in rare cases.

If you think you took a higher dose, call a healthcare professional or local poison control center, or go to the nearest hospital emergency room right away.

Inform your doctor about any prescribed or unprescribed drugs that you are taking at the moment.

As with all pharmaceuticals, some unwanted effects can occur from the use of Itraconazole Capsules.

For a comprehensive understanding of all potential side effects, consult a medical professional.

If any symptoms persist or worsen, or you notice any other symptoms, please call your doctor immediately.

Possible interactions may occur with other pharmaceutical products. Consult with a doctor or pharmacist about any medications you are taking before beginning treatment.

Patients should not take this drug if they have a fungal nail infection and are pregnant or planning to become pregnant within 2 months after the treatment. Breastfeeding women should consult with a gynecologist before taking this drug.

The usage of this drug might lead to liver problems. Patients who have liver problems should inform their doctors before taking Itraconazole. Blood tests should be performed to check the patient’s current health condition.

This drug might lead to dizziness or blurred/double vision. Patients who take this drug should not drive or use machines.

Alcohol should be avoided, as it may worsen the adverse effects caused by Itraconazole.

Patients should inform their doctors if they notice any side effects and immediately limit the usage of Itraconazole.

A Double-Blind, Randomized, Placebo-Controlled Trial of Itraconazole Capsules as Antifungal Prophylaxis for Neutropenic Patients

The goal of this research was to evaluate the efficacy of itraconazole capsules in prophylaxis for fungal infections in neutropenic patients.

It is a prospective, double-blind, placebo-controlled, randomized trial in which patients with hematologic malignancies or those who received autologous bone marrow transplants received either itraconazole (100mg orally twice daily; n = 104) or placebo (n = 106).

In the placebo group, fungal infections (either superficial or systemic) occurred more frequently compared to the treatment group (15% vs. 6%; P = .03). Patients also experienced severe and prolonged neutropenia, but those treated with itraconazole required less empirical amphotericin B (22% vs. 61%; P = .0001) and had fewer systemic fungal infections (6% vs. 19%; P = .04).

The conclusion is that itraconazole capsules at a dosage of 100mg every 12 hours to patients with severe and prolonged neutropenia reduce the incidence of systemic fungal infections and decrease the need for empirical amphotericin B.