Itrazol Cpsules – Broad spectrum antifungal

ITRAZOL capsules is indicated for the treatment of the following conditions:

Gynaecological indications: Vulvovaginal candidosis.

Dermatological/ophthalmological indications:

  • Pityriasis versicolor, dermatomycosis, fungal keratitis and oral candidosis.
  • Onychomycosis, caused by dermatophytes and/or yeast.

Systemic mycoses: Systemic aspergillosis and candidosis, cryptococcosis (including cryptococcal meningitis), histoplasmosis, sporotrichosis, paracoccidioidomycosis, blastomycosis, and other rarely occurring systemic or tropical mycoses.

Dosage and administration

  • For optimal absorption, it is essential to administer ITRAZOL capsules immediately after a full meal. The capsules must be swallowed whole.
  • Gynaecological indications: Vulvovaginal candidosis: 200 mg b.i.d. for 1 day or 200 mg o.d. for 3 days
  • Dermatological/ophthalmological indications: Pityriasis versicolor: 200 mg o.d. for 7 days
  •  Dermatomycosis: 200 mg o.d for 7 days or 100 mg o.d 15 days.
  • Highly keratinized regions as in plantar tinea pedis and palmar tinea manus require 200 mg twice daily for 7 days, or 100 mg daily for 30 days.
  • Oral candidosis: 100 mg o.d. for 15 days.
  • In some immunocompromised patients, e.g. neutropenic, AIDS or organ transplant patients, the oral bioavailability of itraconazole may be decreased. Therefore, the does may need doubling.
  • Fungal keratitis: 200 mg o.d for 21 days

for more information about ITRAZOL Dosage and administration review patient information leaflet

Description

ITRAZOL is asynthetic broad-spectrum antifungal agent available in pink and blue capsules, each containing 100 mg itraconazole in a pellet formulation supplied in blister packs with either 4, 15 capsules. The inactive ingredients of the capsules are hydroxypropyl-methylcellulose 2930, poloxamer (Lutrol), saccharose, corn starch, methylene chloride and ethyl alcohol.

Properties

Pharmacodynamics: Itraconazole, triazole derivative, is active against infections with dermatophytes (Trichophyton spp., Microsporum spp., Epidermophyton floccosum), yeasts (Cryptococcus neoformans, Pityrosporum spp, Candida spp, including C. albicans, C. glabrata and C. krusei), Aspergillus spp., Histoplasma spp., Paracoccidioides brasiliensis, Sporothrix schenckii, Fonsecaea spp, Cladosporium spp, Blatomyces dermatitidis, and various other yeasts and fungi.

In vitro studies have demonstrated that itraconazole impairs the synthesis of ergosterol in fungal cells. Ergosterol is a vital cell membrane component in fungi. Impairment of tis systhesis ultimately results in an antifungal effect.

Contraindications

ITRAZOL capsules is contraindicated in patients with a known hypersensitivity to the drug or its excipients. ITRAZOL capsules should only be given to pregnant women in lifethreatening cases and when in these cases the potential benefit outweighs the potential harm to the foetus. Adequate contraceptive precautions should be taken by women of child-bearing potential using ITRAZOL capsules until the next menstrual period following the end of ITRAZOL therapy.

Terfenadine, astemizole, mizolastine, cisapride, dofetilide, quinidine, pimozide, CYP3A4 metabolised HMG CoA reductase inhibitors such as simvastatin and lovastatin triazolam and oral midazolam are contra-indicated with ITRAZOL capsules.

Warnings And Precautions

In a healthy volunteer study with Itraconazole IV, a transient asymptomatic decrease of the left ventricular ejection fraction was observed; this resolved before the next infusion. The clinical relevance of these findings to the oral formulations is unknown.

Itraconazole has been shown to have a negative inotropic effect and Itraconazole has been associated with reports of congestive heart failure. ITRAZOL should not be used in patients with congestive heart failure or with a history of congestive heart failure unless the benefit clearly outweighs the risk. This individual benefit/risk assessment should take into consideration factors such as the severity of the indication, the dosing regimen, and individual risk factors for congestive heart failure. These risk factors include cardiac disease, such as ischemic and valvular disease; significant pulmonary disease, such as chronic obstructive pulmonary disease; and renal failure and other edematous disorders. Such patients should be informed of the signs and symptoms of congestive heart failure, should be treated with caution, and should be monitored for signs and symptoms of congestive heart failure during treatment; if such signs or symptoms do occur during treatment, ITRAZOL should be discontinued.

Calcium channel blockers can have negative inotropic effects which may be additive to those of itraconazole; itraconazole can inhibit the metabolism of calcium channel blockers. Therefore, caution should be used when co-administering itraconazole and calcium channel blockers.

for more information about ITRAZOL Warnings And Precautions review patient information leaflet

Pregnancy and lactation

When administered at high doses to pregnant rats (40 mg/kg/day or higher) and mice (80 mg/kg/day or higher), itraconazole was shown to increase the incidence of fetal abnormalities and did produce adverse effects on the embryo, studies on the use of itraconazole in pregnant women are not available. Therefore, ITRAZOL capsules should only be given in life-threatening cases of systemic mycosis and when in these cases the potential benefit outweighs the potential harm to the foetus.

A very small amount of itraconazole is excreted in human milk.The expected benefits of ITRAZOL capsules therapy should therefore be weighed against the potential risk of breastfeeding. In case of doubt the patient should not breast-feed.

Adverse Reactions

The most frequently reported adverse experiences in association with the use of Itraconazole were of gastro intestinal origin, such as dyspepsia, nausea, vomiting, diarrhoea, abdominal pain and constipation. Other reported adverse experiences include headache, reversible increases in hepatic enzymes, hepatitis, menstrual disorder, dizziness and allergic reactions (such as pruritus, rash, urticaria and angio-oedema), peripheral neuropathy, Stevens-Johnson syndrome, alopecia, hypokalaemia, oedema, congestive heart failure and pulmonary oedema. Very rare cases of serious hepatotoxicity, including some cases of fatal acute liver failure, have occurred with the use of Itraconazole.

ITRAZOL CAPSULE اترازول كبسول
ITRAZOL CAPSULE اترازول كبسول

ITRAZOL CAPSULE PATIENT INFORMATION LEAFLET

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