Sporanox Capsule

Sporanox Capsule Special Precautions

itraconazole

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
/
Four Star
Full Prescribing Info
Special Precautions
Sporanox has a potential for clinically important drug interactions (see Interactions).
In a healthy volunteer study with Sporanox 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 Sporanox has been associated with reports of congestive heart failure. Sporanox 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 eg, the severity of the indication, the dosing regimen and individual risk factors for congestive heart failure. These risk factors include cardiac disease eg, ischemic and valvular disease; significant pulmonary disease eg, 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, Sporanox 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.
Decreased Gastric Acidity: Absorption of itraconazole from Sporanox is impaired when the gastric acidity is decreased. In patients also receiving acid neutralising medicines (eg, aluminum hydroxide), these should be administered at least 2 hrs after the intake of Sporanox. In patients with achlorhydria eg, certain AIDS patients and patients on acid secretion supressors (eg, H2-antagonists, proton-pump inhibitors), it is advisable to administer Sporanox with a cola beverage.
Very rare cases of serious hepatotoxicity, including some cases of fatal acute liver failure, have occurred with the use of Sporanox. Most of these cases involved patients who had preexisting liver disease, were treated for systemic indications, had significant other medical conditions and/or were taking other hepatotoxic drugs. Some patients had no obvious risk factors for liver disease. Some of these cases have been observed within the 1st month of treatment, including some within the 1st week. Liver function monitoring should be considered in patients receiving Sporanox treatment. Patients should be instructed to promptly report to their physician signs and symptoms suggestive of hepatitis eg, anorexia, nausea, vomiting, fatigue, abdominal pain or dark urine. In these patients, treatment should be stopped immediately and liver function testing should be conducted. In patients with raised liver enzymes or active liver disease or who have experienced liver toxicity with other drugs, treatment should not be started unless the expected benefit exceeds the risk of hepatic injury. In such cases liver enzyme monitoring is necessary.
Hepatic Impairment: Itraconazole is predominantly metabolised in the liver. The terminal half-life of itraconazole in cirrhotic patients is somewhat prolonged. The oral bioavailability in cirrhotic patients is somewhat decreased. A dose adjustment may be considered.
Renal Impairment: The oral bioavailability of itraconazole may be lower in patients with renal insufficiency. A dose adjustment may be considered.
If neuropathy occurs that may be attributable to Sporanox, the treatment should be discontinued.
There is no information regarding the cross hypersensitivity between itraconazole and other azole antifungal agents. Caution should be used in prescribing Sporanox to patients with hypersensitivity to other azoles.
Effects on the Ability to Drive or Operate Machinery: No effects have been observed.
Use in pregnancy & lactation: When administered at high doses to pregnant rats (≥40 mg/kg/day) and mice (≥80 mg/kg/day), itraconazole was shown to increase the incidence of foetal abnormalities and did produce adverse effects on the embryo. Studies of the use of itraconazole in pregnant women are not available. Therefore, Sporanox 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 Sporanox therapy should therefore be weighed against the potential risk of breastfeeding. In case of doubt, the patient should not breastfeed.
Use in children: Since clinical data of the use of Sporanox in paediatric patients is limited, Sporanox should not be used in these patients unless the potential benefit outweighs the potential risks.
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