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pancuronium bromide injection, USP Dosage and Administration

DOSAGE AND ADMINISTRATION

Pancuronium 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 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. Since potent inhalational anesthetics or prior use of succinylcholine may enhance the intensity and duration of pancuronium bromide (see PRECAUTIONS: Drug Interactions), the lower end of the recommended initial dosage range may suffice when pancuronium bromide is first used after intubation with succinylcholine and/or after maintenance doses of volatile liquid inhalational anesthetics are started. To obtain maximum clinical benefits of Pancuronium Bromide Injection, USP and to minimize the possibility of overdosage, the monitoring of muscle twitch response to a peripheral nerve stimulator is advised.

In adults under balanced anesthesia the initial intravenous dosage range is 0.04 to 0.1 mg/kg. Later incremental doses starting at 0.01 mg/kg may be used. These increments slightly increase the magnitude of the blockade and significantly increase the duration of blockade because a significant number of myoneural junctions are still blocked when there is clinical need for more drug.

If Pancuronium Bromide Injection, USP is used to provide skeletal muscle relaxation for endotracheal intubation, a bolus dose of 0.06 to 0.1 mg/kg is recommended. Conditions satisfactory for intubation are usually present within 2 to 3 minutes (see PRECAUTIONS).

Dosage in Children

Dose response studies in children indicate that, with the exception of neonates, dosage requirements are the same as for adults. Neonates are especially sensitive to nondepolarizing neuromuscular blocking agents, such as Pancuronium Bromide Injection, USP, during the first month of life. It is recommended that a test dose of 0.02 mg/kg be given first in this group to measure responsiveness.

Caesarean Section

The dosage to provide relaxation for intubation and operation is the same as for general surgical procedures. The dosage to provide relaxation, following usage of succinylcholine for intubation (see PRECAUTIONS: Drug Interactions), is the same as for general surgical procedures.

Compatibility

Pancuronium Bromide Injection, USP is compatible in solution with:

0.9% sodium chloride injection

5% dextrose injection

5% dextrose and sodium chloride injection

Lactated Ringer's injection

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

When mixed with the above solutions in glass or plastic containers, Pancuronium Bromide Injection, USP will remain stable in solution for 48 hours with no alteration in potency or pH; no decomposition is observed and there is no absorption to either the glass or plastic container.

Risk of Medication Errors

Accidental administration of neuromuscular blocking agents may be fatal. Store pancuronium bromide with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product.

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