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Pavulon

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Pavulon

INDICATIONS

PAVULON® (pancuronium bromide) injection is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

DOSAGE AND ADMINISTRATION

NOTE: CONTAINS BENZYL ALCOHOL (see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS: Pediatric Use)

PAVULON® (pancuronium bromide) injection 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 PAVULON® (see PRECAUTIONS: DRUG INTERACTIONS), the lower end of the recommended initial dosage range may suffice when PAVULON® (pancuronium bromide injection) 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 PAVULON® (pancuronium bromide injection) 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 PAVULON® (pancuronium bromide injection) is used to provide skeletal muscle relaxation for endotracheal intubation, a bolus dose of 0.06 to 0.1 mg/kg are recommended. Conditions satisfactory in 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. Due to the potential toxicity of benzyl alcohol in neonates, solutions containing benzyl alcohol must not be used in this patient population (see CONTRAINDICATIONS).

Cesarean 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

0.9% sodium chloride injection 5% dextrose and sodium chloride injection
5% dextrose 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, PAVULON® (pancuronium bromide injection) 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.

HOW SUPPLIED

PAVULON® (pancuronium bromide injection) is packaged in the following forms:

2 mL ampuls — 2 mg/mL — boxes of 25, NDC#0052-0444-26;
5 mL ampuls — 2 mg/mL — boxes of 25, NDC#0052-0444-25;
10 mL vials — 1 mg/mL — boxes of25, NDC#0052-0443-25.

Storage

Both concentrations of PAVULON® (pancuronium bromide injection) will maintain full clinical potency for six months if kept at a room temperature of 18° to 22°C (65° to 72°F); or for 3 years when refrigerated at 2° to 8°C (36° to 46°F).

Caution

Federal law prohibits dispensing without prescription.

Organon Inc., West Orange, New Jersey 07052

Last reviewed on RxList: 1/11/2011
This monograph has been modified to include the generic and brand name in many instances.

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