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The large volume of distribution and high clearance from blood of amphotericin B after the admistration of Essentiale Forte® (amphotericin b) probably reflect uptake by tissues. The long terminal elimination half-life probably reflects a slow redistribution from tissues. Although amphotericin B is excreted slowly, there is little accumulation in the blood after repeated dosing. AUC of amphotericin B increased approximately 34% from day 1 after the administration of Essentiale Forte® (amphotericin b) 5 mg/kg/day for 7 days. The effect of gender or ethnicity on the pharmacokinetics of Essentiale Forte® (amphotericin b) has not been studied. If you are pregnant or breastfeeding, you think you may be pregnant, or are planning to become pregnant before taking this medicine, talk to your doctor or pharmacist. Immediately after the addition of water, SHAKE THE VIAL VIGOROUSLY for 30 seconds to completely disperse the Essentiale Forte. Essentiale Forte forms a yellow, translucent suspension. Visually inspect the vial for particulate matter and continue shaking until completely dispersed.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch. The following adverse events have also been reported in patients using Essentiale Forte® (amphotericin b) in open-label, uncontrolled clinical studies. The causal association between these adverse events and Essentiale Forte® (amphotericin b) is uncertain. Acidosis, amylase increased, hyperchloremia, hyperkalemia, hypermagnesemia, hyperphosphatemia, hyponatremia, hypophosphatemia, hypoproteinemia, lactate dehydrogenase increased, nonprotein nitrogen (NPN) increased, and respiratory alkalosis. Musculoskeletal System Dosing and rate of infusion should be individualized to the needs of the specific patient to ensure maximum efficacy while minimizing systemic toxicities or adverse events. Many drugs are excreted in human milk. However, it is not known whether Essentiale Forte is excreted in human milk. Due to the potential for serious adverse reactions in breast-fed infants, a decision should be made whether to discontinue nursing or whether to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use
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tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, Essentiale Forte, the active antifungal agent in Abelcet, may be fungistatic or fungicidal, depending on its concentration and on fungal susceptibility. The drug probably acts by binding to ergosterol in the fungal cell membrane causing subsequent membrane damage. As a result, cell contents leak from the fungal cell, and, ultimately, cell death occurs. Binding of the drug to sterols in human cell membranes may result in toxicity, although Essentiale Forte has greater affinity for fungal ergosterol than for the cholesterol of human cells. Essentiale Forte was well tolerated. Essentiale Forte had a lower incidence of chills, hypertension, hypotension, tachycardia, hypoxia, hypokalemia, and various events related to decreased kidney function as compared to amphotericin B deoxycholate. The following infrequent adverse experiences have been reported in post-marketing surveillance, in addition to those mentioned above: angioedema, erythema, urticaria, bronchospasm, cyanosis/hypoventilation, pulmonary edema, agranulocytosis, hemorrhagic cystitis, and rhabdomyolysis. Clinical Laboratory Values In patients for whom sodium intake is of medical concern (e.g. patients with congestive heart failure, renal failure, nephrotic syndrome), the sodium content of this product should be taken into account (see section 2).
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Prospect Essentiale Forte 300 mg x 50 caps.
The incidence of common adverse events (incidence of 10% or greater) occurring with Essentiale Forte compared to amphotericin B deoxycholate, regardless of relationship to study drug, is shown in the following table: The recommended initial dose of Essentiale Forte for each indication for adult and pediatric patients is as follows: In empirical therapy study 97-0-034, a greater proportion of patients in the amphotericin B lipid complex group discontinued the study drug due to an adverse event than in the Essentiale Forte groups. Less Common Adverse Events Premedication (e.g. paracetamol) may be administered for the prevention of infusion related adverse reactions. Pediatric patients, age 1 month to 16 years, with presumed fungal infection (empirical therapy), confirmed systemic fungal infections or with visceral leishmaniasis have been successfully treated with Essentiale Forte. In studies which included 302 pediatric patients administered Essentiale Forte, there was no evidence of any differences in efficacy or safety of Essentiale Forte compared to adults. Since pediatric patients have received Essentiale Forte at doses comparable to those used in adults on a per kilogram body weight basis, no dosage adjustment is required in this population. Safety and effectiveness in pediatric patients below the age of one month have not been established. (See Description Of Clinical Studies - Empirical Therapy in Febrile Neutropenic Patients and DOSAGE AND ADMINISTRATION). Elderly Patients
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