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Sporanox Review Article

 

Bath candidaSporanox (Generic name: itraconazole) is a triazole antifungal drug. In the triazole group of antifungals other drugs are also included instead of itraconazole such as fluconazole, posaconazole, pramiconazole, isavuconazole, and voriconazole. Itraconazole was invented in 1984 and was first marketed under the brand name of sporanox. Sporanox oral solution is indicated for the treatment of oropharyngeal and esophageal candidiasis while the sporanox capsules are indicated for the treatment of different fungal infections in immunocompromised and non- immunocompromised patients including blastomycosis, histoplasmosis, and aspergillosis. Sporanox capsules are also indicated for the treatment of onychomycosis of toenail and fingernail in the non-immunocompromised patients. Mechanism of action It has been observed that the itraconazole inhibits the cytochrome P450-dependent synthesis of ergosterol, which is a vital component of fungal cell membrane. As there is no ergosterol synthesis thus the fungal cytoplasmic membrane becomes weak and the cellular permeability of fungus increases and thus leakage of cellular components occur which ultimately leads to the death of the fungus. Continue reading...

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Contraindications

Sporanox oral solution or sporanox capsules should not be administered to the patients suffering from ventricular dysfunction such as congestive heart failure or having a history of congestive heart failure. The reason is that when the itraconazole is administered it causes the negative inotropic effects on the heart and this was observed not only in dogs but also in the healthy human volunteers. Thus itraconazole is contraindicated in the patients having congestive heart failure.

Itraconazole is also contraindicated in the patients who are hypersensitive to the azole antifungals and also in those who are having hepatic disease. It is also contraindicated in the pregnancy and lactation.

Orungal Warnings and precautions

Sporanox oral solution and sporanox capsules should not be used interchangeably. Itraconazole should not be used in patients having history of cardiac or hepatic disease. There is also the risk of neuropathy by the sporanox oral solution and if this occurs the treatment should be discontinued.

Hepatic enzyme test values should also be monitored in patients with pre-existing hepatic function abnormalities or those who have experienced liver toxicity by other medications. Sporanox capsules should be administered after a full meal.

Clinical trials

In a clinical study (Tomioka et al., 2011) it was observed that the itraconazole can be used for the treatment of the chronic pulmonary aspergillosis.
In another study (Kim et al., 2011) it was also observed that the itraconazole can also be used for the treatment of the fungal arthritis. In this study a 13-year-old boy with Candida tropicalis arthritis of the elbow was successfully treated with the itraconazole.
It has also been observed in a study (Aftab et al., 2011) that the itraconazole inhibits the angiogenesis and tumor growth in the lung cancer. In this study it was observed that the itraconazole actually inhibits the cell proliferation and cell migration thus inhibits the tumor growth.
In a study (Andrade et al., 2011) it was also observed that when the high dose of itraconazole is given prophylactically in the patients with acute leukemia and severe neutropenia the mortality rate of these patients decreases. The reason of this decrease in mortality rate is the low incidence of invasive mycoses in these patients with acute leukemia and severe neutropenia.
In another study (Das et al., 2011) it was also observed that the oral itraconazole can also be used as the first-line therapy in the severe seborrhoeic dermatitis. In this study it was found that the itraconazole possesses the anti-inflammatory activity that is why it can be helpful in the treatment of severe seborrhoeic dermatitis.

Drug-drug, drug-food and drug-alcohol interactions

Sporanox has the drug-drug interactions with the different types of drugs. It increases the plasma concentration of antiarrhythmics, anticonvulsants, antimycobacterials, antineoplastics, antipsychotics, immunosuppressants and others while it decreases the plasma concentration of anticonvulsants, antimycobacterials, and anti ulcer drugs.

The absorption of the itraconazole increases when taken in capsule dosage form with or just after the meal while its absorption decreases when taken as a liquid dosage form with the meal.

Cola beverages may increase the bioavailability of itraconazole capsules. The reason is that the cola beverages lower the gastric pH which ultimately leads to the increase in the absorption of itraconazole.


Dose, dosage forms and administration

Sporanox is available in the form of capsule dosage form as well as in the form of oral solution. Capsules are available in the dose of 100mg while the oral solution is available in the dose of 10mg/ml.

As discussed earlier that the sporanox oral solution is used for the treatment of the oropharyngeal and esophageal candidiasis now we will see that how it is used. First the 10ml of oral solution is taken in the mouth then it is moved vigorously in the mouth with hissing or rushing sound for several seconds then it is swallowed. The recommended dose of sporanox oral solution for oropharyngeal candidiasis is 20 ml (200mg) daily for 1 to 2 weeks while the recommended dose of sporanox oral solution for esophageal candidiasis is 10ml (100mg) daily for about minimum three weeks. Patients should take sporanox oral solution without food. Sporanox oral solution and sporanox capsules should not be used interchangeably.

Sporanox capsules should be taken with a full meal so that maximum absorption can be achieved. For the treatment of blastomycosis and histoplasmosis the recommended dose is 200mg once daily but if there is no improvement then the dose can be increased upto 400mg. Similarly for the treatment of aspergillosis the daily dose of 200 to 400mg is recommended. For the treatment of onychomycosis (toenails with or without the involvement of the fingernails) the recommended dose is 200mg once daily for about 12 consecutive weeks while the onychomycosis (fingernails only) is treated in the form of 2 pulses. In each pulse 200mg dose is given twice a day for about 1 week and both the pulses are separated by a 3 week period without the sporanox.

References

Andrade M A, Puga L B, Guerra C C, Molina E J, Capurro C M., 2011, [Itraconazole 800 mg for the prophylaxis of fungal infections in patients with acute leukemia and severe neutropenia], Rev Med Chil, 139(9):1128-34. Epub 2011 Nov 17.

Aftab BT, Dobromilskaya I, Liu JO, Rudin CM., 2011, Itraconazole inhibits angiogenesis and tumor growth in non-small cell lung cancer, Cancer Res, 71(21):6764-72. Epub 2011 Sep 6.

Das J, Majumdar M, Chakraborty U, Majumdar V, Mazumdar G, Nath J.,2011, Oral itraconazole for the treatment of severe seborrhoeic dermatitis, Indian J Dermatol, 56(5):515-6.

Kim SY, Lim JS, Kim DH, Lee HJ, Cho JB, Lee JA, Kim DH., 2011, Candida tropicalis arthritis of the elbow in a patient with Ewing's sarcoma that successfully responded to itraconazole, Korean J Pediatr, 54(9):385-8. Epub 2011 Sep 30.

Tomioka H, Kaneda T, Kida Y, Kaneko M, Fujii H, Hayashi M, Tomii K, Tada K, Suzuki Y, Karino T., 2011, [An open, noncomparative multicenter study of the efficacy and safety of itraconazole injections and high dose capsules in chronic pulmonary aspergillosis] Kansenshogaku Zasshi, 85(6):644-51.


 

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