This kit contains active and inactive bulk materials to compound a ranitidine hydrochloride oral suspension. The instructions describe how to prepare 250 mL of a compounded oral suspension containing 16.8 mg/mL ranitidine hydrochloride (15 mg/mL as ranitidine). Other concentrations are possible. Exact strength of compounded suspension must be defined by the prescriber.
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
This kit contains active and inactive bulk materials to compound a ranitidine hydrochloride oral suspension. These instructions describe how to prepare 250 mL of a compounded oral suspension containing 16.8 mg/mL ranitidine hydrochloride (15 mg/mL as ranitidine). Other concentrations are possible. Exact strength of compounded suspension must be defined by the prescriber.
Instructions for Compounding
Ranitidine hydrochloride, 16.8 mg/mL (15 mg/mL as ranitidine) oral suspension
1 Remove and Inspect the Contents of the Kit
Ensure that the safety seals are present and intact on the ranitidine hydrochloride and oral 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 seal from the oral suspension bottle. Break the perforated seal and remove the cap from the ranitidine hydrochloride bottle.
3 Transfer Ranitidine Hydrochloride to the Suspension Bottle
Uncap the suspension bottle. Pour a small amount of suspension liquid (approximately one-third to one-half the volume of the ranitidine hydrochloride bottle) into the ranitidine hydrochloride bottle. Cap the ranitidine hydrochloride bottle and shake well several times to dissolve the ranitidine hydrochloride powder. Empty the contents into the suspension bottle. Cap and mix the suspension bottle. Repeat this step 3 times. Visually ensure that all of the ranitidine hydrochloride has been dissolved and transferred to the suspension bottle.
4 Complete the Mixing Process
Insert the press-in bottle adaptor into the suspension bottle. Recap the suspension bottle. Mix 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 oral suspension vehicle label, since the label is no longer accurate once compounding is completed.
Store the unused kit at room temperature of 15-30°C (59-86°F). Once prepared, store the mixed suspension between 2-8°C (36-46°F) . The compounded suspension is stable for at least eight weeks when stored under refrigeration, based upon real-time and accelerated stability studies.
Each lot of suspension vehicle is tested to meet microbial limits per USP Microbial Limit Test <61>. In addition, the suspension vehicle formulation has passed the USP <51> Antimicrobial Effectiveness Test.
An oral dispenser is provided in the kit and may be used to facilitate delivery of the suspension.
U.S. Patents Pending
Fusion Pharmaceuticals LLC
768 Calle Plano
Camarillo, CA 93012
CS43-A1 rev 1
ranitidine 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
Part 1 of 2
ranitidine hydrochloride powder, for suspension