Generic name: PYRIDOSTIGMINE BROMIDE 5mg in 1mL
Dosage form: injection, solution
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REGONOL® (pyridostigmine bromide injection USP) is for intravenous use only. This drug should be administered by or under the supervision of experienced clinicians familiar with the use of agents which reverse or antagonize the effects of neuromuscular blocking agents. Dosage must be individualized in each case. The dosage information which follows is derived from studies based upon units of drug per unit of body weight and is intended to serve as a guide only. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
NOTE: CONTAINS BENZYL ALCOHOL (see PRECAUTIONS).
Reversal doses of REGONOL® range from 0.1 to 0.25 mg/kg.5,10,11,12,13 The onset time to peak effect is dose-dependent; return of twitch height to 90% of control occurs within approximately 6 minutes following administration of a 0.25 mg/kg dose of REGONOL®.5,12 At lower doses, full recovery usually occurs within 15 minutes in most patients, although others may require a half-hour or more.
When REGONOL® is given intravenously to reverse the action of muscle relaxant drugs, it is recommended that atropine sulfate (0.6 to 1.2 mg) or an equipotent dose of glycopyrrolate be given immediately prior to or simultaneously with the administration of REGONOL®. Side effects, notably excessive secretions and bradycardia are thereby minimized. Please refer to the appropriate prescribing information prior to the use of glycopyrrolate or atropine sulfate.
To obtain maximum clinical benefits of REGONOL® and to minimize the possibility of overdosage, the monitoring of muscle twitch response to peripheral nerve stimulation is advised. REGONOL® should be administered after spontaneous recovery of neuromuscular function has begun.
Satisfactory reversal can be evident by adequate voluntary respiration, respiratory measurements and use of a peripheral nerve stimulator device. It is recommended that the patient be well-ventilated and a patent airway maintained until complete recovery of normal respiration is assured. Once satisfactory reversal has been attained following administration of REGONOL®, recurrence of paralysis is unlikely to occur.
Inadequate reversal of neuromuscular blockade by anticholinesterase drugs is possible with all curariform drugs, and is managed by manual or mechanical ventilation until recovery is judged adequate. The administration of additional doses of anticholinesterase reversal agents is not recommended since excessive dosages of such drugs may produce depolarizing block through their own pharmacological actions.
Use in Pediatrics
The safety and efficacy of REGONOL® (pyridostigmine bromide injection USP) in pediatric patients have not been established, therefore no dosing recommendations can be made (see PRECAUTIONS).