Bedapt Daptomycin Caution For Usage

Instructions for Use: Preparation of Daptomycin for injection for Administration: Daptomycin for injection is supplied in single-dose vials, each containing 500 mg daptomycin as a sterile, lyophilized powder. The contents of a Daptomycin for injection 500 mg vial are reconstituted, using aseptic technique, to 50 mg/mL as follows: Note: To minimize foaming, AVOID vigorous agitation or shaking of the vial during or after reconstitution.
1. Remove the polypropylene flip-off cap from the Daptomycin for injection vial to expose the central portion of the rubber stopper.
2. Wipe the top of the rubber stopper with an alcohol swab or other antiseptic solution and allow to dry. After cleaning, do not touch the rubber stopper or allow it to touch any other surface.
3. Slowly transfer 10 mL of 0.9% sodium chloride for injection through the center of the rubber stopper into the Daptomycin for injection vial, pointing the transfer needle toward the wall of the vial. It is recommended that a beveled sterile transfer needle that is 21 gauge or smaller in diameter, or a needleless device is used, pointing the transfer needle toward the wall of the vial.
4. Ensure that all of the Daptomycin for injection powder is wetted by gently rotating the vial.
5. Allow the wetted product to stand undisturbed for 10 minutes.
6. Gently rotate or swirl the vial contents for a few minutes, as needed, to obtain a completely reconstituted solution.
7. Slowly remove reconstituted liquid (50 mg daptomycin/mL) from the vial using a beveled sterile needle that is 21 gauge or smaller in diameter.
Adults: Intravenous Injection over a period of 2 minutes: For intravenous (IV) injection over a period of 2 minutes in adult patients, reconstituted daptomycin for injection is administered at a concentration of 50 mg/mL.
Intravenous Infusion over a period of 30 minutes: For IV infusion over a period of 30 minutes in adult patients, reconstituted daptomycin for injection (concentration of 50 mg/mL) is further diluted, using aseptic technique, with 0.9% sodium chloride injection.
Pediatric Patients (1 to 17 Years of Age): Intravenous Infusion over a period of 30 or 60 minutes: For IV infusion over a period of 30 minutes in pediatric patients, reconstituted Daptomycin for injection (concentration of 50 mg/mL) is further diluted, using aseptic technique, into a 50 mL IV infusion bag containing 0.9% sodium chloride for injection. The infusion rate should be maintained at 1.67 mL/min over the 30-minute period.
For IV infusion over a period of 60 minutes in pediatric patients, reconstituted Daptomycin for injection (concentration of 50 mg/mL) is further diluted, using aseptic technique, into an IV infusion bag containing 25 mL of 0.9% sodium chloride for injection. The infusion rate should be maintained at 0.42 mL/min over the 60-minute period.
Unlike in adults, Daptomycin for injection should not be administered by injection over a two (2) minute period in pediatric patients [see Pediatric Patients (1 to 17 Years of Age) under Dosage & Administration].
Inspect parenteral drug products visually for particulate matter prior to administration.
No preservative or bacteriostatic agent is present in this product. Aseptic technique must be used in the preparation of final IV solution. Stability studies have shown that the reconstituted solution is chemically and physically stable in the vial for 12 hours at room temperature (25°C) and up to 48 hours if stored under refrigeration at 2 to 8°C (36 to 46°F).
The diluted solution is chemically and physically stable in the infusion bag for 12 hours at room temperature (25°C) and 48 hours if stored under refrigeration. The combined storage time (reconstituted solution in vial and diluted solution in infusion bag) must not exceed 12 hours at room temperature (25°C) or 48 hours under refrigeration.
In-Use Storage Conditions for Daptomycin for Injection Once Reconstituted in Acceptable Intravenous Diluents: Stability studies have shown that the reconstituted solution is stable in the vial for 12 hours at room temperature and up to 48 hours if stored under refrigeration at 2 to 8°C (36 to 46°F).
The diluted solution is stable in the infusion bag for 12 hours at room temperature and 48 hours if stored under refrigeration. The combined storage time (reconstituted solution in vial and diluted solution in infusion bag) should not exceed 12 hours at room temperature or 48 hours under refrigeration.
Incompatibilities: Daptomycin for injection is not compatible with dextrose-containing diluents.
Do not use Daptomycin for injection in conjunction with ReadyMED elastomeric infusion pumps (Cardinal Health, Inc.). Stability studies of Daptomycin for injection solutions stored in ReadyMED elastomeric infusion pumps identified an impurity (2-mercaptobenzothiazole) leaching from this pump system into the Daptomycin for injection solution.
Other than the nine drugs listed in Compatible Intravenous Solutions and Other Medicinal Products [see Compatible Intravenous Solutions and Other Medicinal Products as follows], additives and other medications should not be added to Daptomycin for injection single-dose vials or infusion bags, or infused simultaneously with Daptomycin for injection through the same IV line, because only limited data are available on compatibility. If the same IV line is used for sequential infusion of different drugs, flush the line with a compatible intravenous solution before and after infusion with Daptomycin for injection.
Compatible Intravenous Solutions and Other Medicinal Products: Daptomycin for injection is compatible with 0.9% sodium chloride for injection and lactated Ringer's injection.
The following have been shown to be compatible when coadministered with Daptomycin for injection through the same IV line from separate infusion bags: aztreonam, ceftazidime, ceftriaxone, gentamicin, fluconazole, levofloxacin, dopamine, heparin, and lidocaine.