(cyclobenzaprine hydrochloride 1 mg/mL, in oral suspension with MSM - compounding kit)
FusePaq™ compounding kits provide a convenient approach to rapidly compound prescription medications, as all components are pre-measured. This kit is manufactured according to US FDA current Good Manufacturing Practice (cGMP).
For Prescription Compounding Only
When compounded according to directions, this kit makes 250 mL of an oral suspension containing 1 mg/mL cyclobenzaprine hydrochloride with MSM.
Ensure that the safety seals are present and intact on the cyclobenzaprine hydrochloride, flavor, and suspension vehicle bottles. If the seals are not intact, do not use the kit.
2 Prepare for Mixing
Wear gloves and eye protection during compounding operations. Remove the seals from the flavor and suspension bottles. Break the perforated seal and remove the cap from the cyclobenzaprine hydrochloride bottle.
3 Transfer Cyclobenzaprine Hydrochloride to the Flavor Bottle
Flip the tip up on the suspension bottle cap. Squeeze suspension into the cyclobenzaprine hydrochloride bottle until at least half full. Cap the cyclobenzaprine hydrochloride bottle and shake well several times. Ensure that the cyclobenzaprine hydrochloride powder has been completely dissolved. Empty the contents into the flavor bottle. Cap the flavor bottle and mix well. Again fill the cyclobenzaprine hydrochloride bottle with liquid suspension vehicle, then cap and shake bottle. Transfer contents to flavor bottle. Repeat the rinsing of the cyclobenzaprine hydrochloride bottle with suspension one last time. Transfer the remaining suspension vehicle into the flavor bottle.
4 Complete the Mixing Process
Press the oral syringe adaptor into the flavor bottle. Recap the flavor bottle which now contains the cyclobenzaprine hydrochloride, suspension, and flavor. Shake well by inverting repeatedly several times.
5 Re-label the Compounded Suspension
Label the compounded suspension per the pharmacy's standard practice. Remove or obscure the flavor vehicle label, since the label is no longer accurate once compounding is completed.
Store the unused kit at room temperature of 15-30C (59-86F). Once prepared, store the mixed suspension between 15-30C (59-86F). The compounded suspension is stable for at least eight weeks based upon real-time and accelerated stability studies. Each lot of suspension vehicle and flavor vehicle is tested to meet microbial limits per USP Microbial Limit Test 61. In addition, the suspension vehicle and flavor vehicle formulations have each passed the USP 51 Antimicrobial Effectiveness Test.
An oral syringe is provided in the kit and may be used to facilitate accurate delivery of the suspension.
U.S. Patents Pending
Fusion Pharmaceuticals LLC
768 Calle Plano
Camarillo, CA 93012
CS34-A1 rev 2
cyclobenzaprine hydrochloride kit
HUMAN PRESCRIPTION DRUG
Item Code (Source)
1 KIT ( KIT) in 1 KIT
QUANTITY OF PARTS
Total Product Quantity
1 BOTTLE, GLASS
1 BOTTLE, PLASTIC
1 BOTTLE, PLASTIC
Part 1 of 3
cyclobenzaprine hydrochloride powder, for suspension