Prevduo Dosage

Important Dosage and Administration Information

• PREVDUOTM should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents. Doses of PREVDUOTM should be individualized, and a peripheral nerve stimulator should be used to determine the time of initiation of PREVDUOTM and should be used to determine the need for additional doses.

• PREVDUOTM is for intravenous use only and should be injected slowly over a period of at least 1 minute. The PREVDUOTM dosage is weight-based [see Dosage and Administration (2.2)].

• Prior to PREVDUOTM administration and until complete recovery of normal ventilation, the patient should be well ventilated and a patent airway maintained. Satisfactory recovery should be judged by adequacy of skeletal muscle tone and respiratory measurements in addition to the response to peripheral nerve stimulation.

• Peripheral nerve stimulation devices capable of delivering a train-of-four (TOF) stimulus are essential to effectively using PREVDUOTM.

• There must be a twitch response to the first stimulus in the TOF of at least 10% of its baseline level, i.e., the response prior to NMBA administration, prior to the administration of PREVDUOTM.

• Prior to administration, visually inspect PREVDUOTM for particulate matter and discoloration.

• TOF monitoring should continue to be used to evaluate the extent of recovery of neuromuscular function and the possible need for an additional dose of PREVDUOTM.

• TOF monitoring alone should not be relied upon to determine the adequacy of reversal of neuromuscular blockade as related to a patient’s ability to adequately ventilate and maintain a patent airway following tracheal extubation.

• Patients should continue to be monitored for adequacy of reversal from NMBAs for a period of time that would assure full recovery based on the patient’s medical condition and the pharmacokinetics of neostigmine and the NMBA used.

Dosage in Adults

A 0.03 mg/kg to 0.07 mg/kg dose of Neostigmine methylsulfate (0.006 mg/kg to 0.014 mg/kg dose of Glycopyrrolate) Injection will generally achieve a TOF twitch ratio of 90% (TOF0.9) within 10 to 20 minutes of administration, with minimization of neostigmine-induced bradycardia due to the included 0.2 mg of glycopyrrolate per 1 mg neostigmine. Dose selection should be based on the extent of spontaneous recovery that has occurred at the time of administration, the half-life of the NMBA being reversed, and whether there is a need to rapidly reverse the NMBA.

• The 0.03 mg/kg dose of neostigmine methylsulfate (0.006 mg/kg of glycopyrrolate) is recommended for:
• Reversal of NMBAs with shorter half-lives, e.g., rocuronium, or
• When the first twitch response to the TOF stimulus is substantially greater than 10% of baseline or when a second twitch is present.

• The 0.07 mg/kg dose of neostigmine methylsulfate (0.014 mg/kg of glycopyrrolate) dose is recommended for:
• Reversal of NMBAs with longer half-lives, e.g., vecuronium and pancuronium, or
• When the first twitch response is relatively weak, i.e., not substantially greater than 10% of baseline or
• There is need for more rapid recovery

The recommended maximum total dose is 0.07 mg/kg of neostigmine methylsulfate or up to a total of 5 mg of neostigmine methylsulfate, whichever is less.

Dosage in Pediatric Patients age 2 years and above

For pediatric population age >2 years, adult guidelines should be followed when PREVDUOTM is administered. Pediatric patients require PREVDUOTM doses similar to those for adult patients.

PREVDUOTM is not recommended for use in pediatric patients less than 2 years of age, as the blood pressure in pediatric patients, particularly infants and neonates, is sensitive to changes in heart rate [see Use in Specific Populations (8.4)].

Instructions for Use (Administration Technique)

a) Inspect the outer carton for:
- absence of external particles
- drug product name
- dosage form
- drug strength
- fill volume
- route of administration
- expiration date

b) Take out the plastic tray from the outer carton and remove the prefilled syringe from tray.

c) Perform visual inspection of the prefilled syringe for:
- absence of physical damage to syringe
- absence of external particles
- absence of internal particles (particulate matter)
- discoloration
- drug product name
- drug strength
- fill volume
- expiration date

d) Remove tip cap by twisting off

e) Discard the tip cap.

f) Expel the air bubble by pushing the plunger rod. Adjust the dose (if applicable).

g) Connect the prefilled syringe to an appropriate intravenous connection. Ensure that the prefilled syringe is securely attached to the needle or needleless luer access device (NLAD).

h) Press the plunger rod slowly to deliver the medication through needle or needleless luer access device (NLAD) over a period of at least 1 minute. Ensure that appropriate pressure is maintained on the plunger rod during the entire administration.

i) Remove the prefilled syringe from needle or needleless luer access device (NLAD) and discard into appropriate receptacle.

When needle is connected to syringe, to prevent needle-stick injuries, needles should not be recapped.

NOTES:
- All steps given in the ‘instructions for use’ must be performed sequentially
- Do not re-sterilize the syringe
- Do not use this product on a sterile field
- Do not introduce any other fluid into the syringe at any time
- This product is for single use only