- Approval Id
- 838634815a4eb8c6
- Drug Name
- AMBISOME FOR INJECTION 50 MG/VIAL
- Product Name
- AMBISOME FOR INJECTION 50 MG/VIAL
- Approval Number
- SIN12021P
- Approval Date
- 2002-07-15
- Registrant
- GILEAD SCIENCES SINGAPORE PTE. LTD.
- Licence Holder
- GILEAD SCIENCES SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong><br>
AmBisome should be administered by intravenous infusion, using a controlled infusion device, over a period of approximately 120 minutes.</p>
<p>An in-line membrane filter may be used for the intravenous infusion of AmBisome; provided <strong>THE MEAN PORE DIAMETER OF THE FILTER IS NOT LESS THAN 1.0 MICRON</strong>.</p>
<p><strong>NOTE: An existing intravenous line must be flushed with 5% Dextrose Injection prior to infusion of AmBisome. If this is not feasible, AmBisome must be administered through a separate line.</strong></p>
<p>Infusion time may be reduced to approximately 60 minutes in patients in whom the treatment is well-tolerated. If the patient experiences discomfort during infusion, the duration of infusion may be increased.<br>
The recommended initial dose of AmBisome for each indication for adult and pediatric patients is as follows:</p>
<img src="/TGIF/Ambisome-Table1.png" alt="Ambisome Dosage Table 1" /><br><br>
<p>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.<br>
Doses recommended for visceral leishmaniasis are presented below:</p>
<img src="/TGIF/Ambisome-Table2.png" alt="Ambisome Dosage Table 2" /><br><br>
<p><strong>For immunocompetent patients</strong> who do not achieve parasitic clearance with the recommended dose, a repeat course of therapy may be useful.</p>
<p><strong>For immunocompromised patients</strong> who do not clear parasites or who experience relapses, expert advice regarding further treatment is recommended. For additional information see <strong>DESCRIPTION OF CLINICAL STUDIES</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>INDICATIONS AND USAGE</strong><br>
<em>AmBisome is indicated for the following:</em></p>
<ul>
<li>Empirical therapy for presumed fungal infection in febrile, neutropenic patients.</li>
<li>Treatment of Cryptococcal Meningitis in HIV infected patients (see <strong>DESCRIPTION OF CLINICAL STUDIES</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>Treatment of patients with <em>Aspergillus</em> species, <em>Candida</em> species and/or <em>Cryptococcus</em> species infections (see above for the treatment of Cryptococcal Meningitis) refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate.</li>
<li>Treatment of visceral leishmaniasis. In immunocompromised patients with visceral leishmaniasis treated with AmBisome, relapse rates were high following initial clearance of parasites (see <strong>DESCRIPTION OF CLINICAL STUDIES</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
</ul>
<p>See <strong>DOSAGE AND ADMINISTRATION</strong> for recommended doses by indication.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong><br>
AmBisome is contraindicated in those patients who have demonstrated or have known hypersensitivity to amphotericin B deoxycholate or any other constituents of the product unless, in the opinion of the treating physician, the benefit of therapy outweighs the risk.</p>
- Atc Code
- J02AA01
- Atc Item Name
- amphotericin B
- Pharma Manufacturer Name
- GILEAD SCIENCES SINGAPORE PTE. LTD.
