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SAVACAP 50

Quick Overview

SAVACAP 50


Each vial contains: Caspofungin Acetate


equivalentto Caspofungin ..........50 mg


Excipients .............................  q.s.

SAVACAP 50

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SAVACAP 50

Each vial contains: Caspofungin Acetate

equivalentto Caspofungin ..........50 mg

Excipients             q.s.


CHEMISTRY: (4R,5S)-5-[(2-Aminoethyl)annino] -N2- (10,12-dimethyltetradecanoyI)-4-hydroxy-L-ornithyl-L- threonyl-trans-4-hydroq-L-proly1-(S)-4-hydroq-4-(p- hydroxypheny1)-L-threonyl-threo-3-hydrog-L-ornithyl- trans-3-hydroq-L-proline cyclic (6—>1)-peptide diacetate.

CATEGORY: Antifungal agent

 

PHARMACOLOGY:


Pharmacodynamics

Caspofungin an echinocandin inhibits the synthesis of p (1, 3)-D-glucan, an essential component of the cell wall of susceptible Aspergifius species and Candida species. p (1, 3)-D-glucan is not present in mammalian cells. Caspofungin has shown activity against Candida species and in regions of active cell growth of the hyphae of Aspergifius fumigatus.

Pharmacokinetics

Absorption

Bioavailability- poorly absorbed from GI tract; must be administered LV.

Distribution

Plasma concentrations of Caspofungin decline in a polyphasic manner following single 1-hour LV. infusions. A short a -phase occurs immediately post infusion, followed by a 0 -phase (half-life of 9 to 11 hours) that characterizes much of the profile and exhibits clear log- linear behavior from 6 to 48 hours post dose during which the plasma concentration decreases 10-fold. Caspofungin is extensively bound to albumin (-97%) and distribution into red blood cells is minimal.

Metabolism

Caspofungin is slowly metabolized by hydrolysis and N­acetylation. Additional metabolism involves hydrolysis into constitutive amino acids and their degradates, including dihydroxyhomotyrosine and N-acetyl­dihydrmhomotyrosine.

Excretion

After single intravenous administration of Caspofungin, excretion of Caspofungin and its metabolites in humans was 35% of dose in feces and 41% of dose in urine. A small amount of Caspofungin is excreted unchanged in urine (-1.4% of dose).

INDICATIONS:

Caspofungin is indicated in adults and pediatric patients (3 months and older) for:

  • Empirical therapy for presumed fungal infections in febrile, neutropenic patients.
  • Treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. Caspofungin has not been studied in endocarditis, osteomyelitis, and meningitis due to Candida.
  • Treatment of esophageal candidiasis.
  • Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies (e.g., amphotericin B, lipid formulations of amphotericin B, itraconazole). Caspofungin has not been studied as initial therapy for invasive aspergillosis.

DOSAGE AND ADMINISTRATION:

Recommended Dosing in Adult Patients 18 years of age]

The usual dose is 50 mg once daily (following a 70 mg loading dose for most indications).

Use in children:

Recommended Dosing in Pediatric Patients [3 months to 17 years of age]

The maximum loading dose and the daily maintenance dose should not exceed 70 mg, regardless of the patient's calculated dose.

Use in specific populations

Patients with Hepatic Impairment

Adult patients with mild hepatic impairment do not need a dosage adjustment. For adult patients with moderate hepatic impairment 35 mg once daily is recommended based upon pharmacokinetic data. However, where recommended, a 70 mg loading dose should still be administered on Day 1.

Patients with Renal Impairment

No dosage adjustment is necessary for patients with renal impairment. Caspofungin is not dialyzable; thus, supplementary dosing is not required following hemodialysis.

Patients Receiving Concomitant Inducers of Drug Clearance

Adult patients on rifampin should receive 70 mg of Caspofungin once daily. Adult patients on nevirapine, efavirenz, carbamazepine, dexamethasone, or phenytoin may require an increase in dose to 70 mg of Caspofungin once daily.

PREPARATION AND RECONSTITUTION FOR ADMINISTRATION

Do not mix or co-infuse Caspofungin with other medications, as there are no data available on the compatibility of Caspofungin with other intravenous substances, additives, or medications.

Preparation of Caspofungin Acetate for Infusion:

1.  Equilibrate the refrigerated vial of Caspofungin to room temperature.

2.  Aseptically add 10.0 mL of Sterile Water for Injection, Bacteriostatic to the vial.

Information for Preparation of Caspofungin

SAVACAP

vial

Total Drug

Content

(including

overfill)

Reconstitution

Volume to be

added

Resulting

Concentration

following

Reconstitution

50 mg

50.0 mg

10.0 nnL

5 nng/mL

70 mg

70.0 mg

10.0 mL

7 mg/mL

 

Mix gently until a clear solution is obtained. Visually inspect the reconstituted solution for particulate matter or discoloration during reconstitution and prior to infusion. Do not use if the solution is cloudy or has precipitated.

The reconstituted solution may be stored for up to one hour at s25°C (s77°F).

Caspofungin vials are for single use only; the remaining solution should be discarded.

This infusion solution must be used within 24 hours if stored at 25°C or within 48 hours if stored refrigerated at 2 to 8°C (36 to 46°F).

CONTRAINDICATIONS:

Caspofungin is contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to any component of this product.

WARNINGS AND PRECAUTIONS:

Concomitant Use with Cyclosporine

Caspofungin and cyclosporine should only be used concomitantly in those patients for whom the potential

benefit outweighs the potential risk. Patients who develop abnormal liver function tests during concomitant therapy should be monitored and the risk/benefit of continuing therapy should be evaluated.

Hepatic Effects

Patients who develop abnormal liver function tests during Caspofungin therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing Caspofungin therapy.

INTERACTIONS:

Caspofungin is not a substrate for glycoprotein and is a poor substrate for cytochrome P450 enzymes. Cyclosporine

Studies reported that Caspofungin did not increase the plasma levels of cyclosporine.

Tacrolimus

For patients receiving Caspofungin and tacrolimus, standard monitoring of tacrolinnus blood concentrations and appropriate tacrolimus dosage adjustments are recommended.

Rifampin

Adult patients on rifampin should receive 70 mg of Caspofungin daily.

Other inducers of drug clearance

Adults

When Caspofungin is co-administered to adult patients with inducers of drug clearance, such as efavirenz, nevirapine, phenytoin, dexannethasone, or carbamazepine, use of a daily dose of 70 mg of Caspofungin should be considered.

Pediatric Patients

When Caspofungin is co-administered to pediatric patients with inducers of drug clearance, such as rifampin, efavirenz, nevirapine, phenytoin, dexamethasone or carbamazepine, a Caspofungin dose of 70 mg daily (not to exceed an actual daily dose of 70 mg) should be considered.

PREGNANCY AND LACTATION:

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies with the use of Caspofungin in pregnant women. Caspofungin should be used during pregnancy only if the potential benefit justifies the potential riskto the fetus.

Nursing Mothers

It is not known whether Caspofungin is present in human milk. Because many drugs are excreted in human milk, caution should be exercised when Caspofungin is administered to a nursing woman.

Geriatric Use

No dose adjustment is recommended for the elderly; however, greater sensitivity of some older individuals cannot be ruled out.

EFFECT TO DRIVE & USE THE MACHINE: None

 

ADVERSE DRUG REACTIONS:

Hepatic effects

Anaphylaxis has been reported during administration of Caspofungin. Possible histamine-mediated symptoms have been reported including reports of rash, facial swelling, angioedema, pruritus, sensation of warmth, or bronchospasm.

OVERDOSAGE

Multiple doses above 150 mg daily have not been studied.

Caspofungin is not dialyzable.

PRESENTATION: 1 vial per monocarton.

STORAGE: Store at 2° to 8°C


 
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