Pavulon (Solution) Instructions for Use

Marketing Authorization Holder

Organon (India), Ltd. (India)

ATC Code

M03AC01 (Pancuronium bromide)

Active Substance

Pancuronium bromide

Dosage Form

Pavulon

Injection solution 4 mg/2 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

2 ml – ampoules (10) – plastic contour packaging (1) – cardboard packs.

Clinical-Pharmacological Group

Peripherally acting non-depolarizing competitive-type muscle relaxant

Pharmacotherapeutic Group

Depolarizing peripheral-acting muscle relaxant

Pharmacological Action

Pancuronium bromide is a peripherally acting non-depolarizing competitive-type muscle relaxant. It is a bis-quaternary ammonium compound of steroid structure. It disrupts neuromuscular transmission by blocking the nicotinic cholinergic receptors of skeletal muscles and preventing the depolarizing action of the neurotransmitter acetylcholine.

Muscle relaxant effect develops within 4-6 minutes after intravenous administration and lasts for about 60 minutes. The resulting muscle relaxation is not accompanied by muscle twitching and postoperative muscle pain. Pancuronium bromide does not cause histamine release from mast cells and does not possess ganglion-blocking activity.

It has moderate m-cholinolytic activity on the m₂-cholinergic receptors of the heart. It causes miosis and a decrease in intraocular pressure.

Indications

For skeletal muscle relaxation during surgical operations, status asthmaticus (as part of combination therapy), tetanus.

ICD codes

Dosage Regimen

Administer intravenously only. Determine the dose individually based on body weight, clinical indication, and patient condition.

For adult patients, use an initial intravenous bolus dose of 0.04-0.1 mg/kg. For most procedures, a dose of 0.06-0.08 mg/kg provides adequate relaxation.

For endotracheal intubation, administer 0.06-0.1 mg/kg. Onset of action typically occurs within 4-6 minutes, with a duration of approximately 60 minutes.

For pediatric patients, use the same initial dose of 0.04-0.1 mg/kg. Adjust based on clinical response and patient factors.

For maintenance dosing during prolonged surgery, administer supplemental doses of 0.01-0.02 mg/kg. Administer supplements as required, typically at 40-60 minute intervals.

In patients with renal impairment or hepatic impairment, reduce the initial and maintenance doses. Exercise extreme caution due to prolonged elimination and potential for accumulation.

In geriatric patients, use a reduced dose at the lower end of the recommended range. Titrate carefully to effect.

Monitor neuromuscular function with a peripheral nerve stimulator to guide dosing and assess recovery. Ensure facilities for controlled ventilation and reversal agents are immediately available.

Adverse Reactions

Possible: moderate tachycardia, some increase in blood pressure.

Rarely: inflammatory reactions at the injection site.

In isolated cases: bronchospasm. Some decrease in thromboplastin and prothrombin time has been described.

Contraindications

Hypersensitivity to pancuronium bromide; myasthenia gravis.

Use in Hepatic Impairment

Use with caution in patients with impaired liver function.

Use in Renal Impairment

Use with caution in patients with impaired renal function.

Pediatric Use

Use is possible according to the dosing regimen.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

Pancuronium bromide should be used only in a hospital setting with special equipment for artificial ventilation by anesthesiologists.

Use with caution in patients with impaired liver and/or kidney function, chronic heart failure, neuromuscular diseases, and in elderly individuals.

The effect of pancuronium bromide is enhanced in hypokalemia, hypermagnesemia, hypocalcemia, hypoproteinemia, dehydration, under conditions of acidosis, hypercapnia, and cachexia.

Drug Interactions

Pharmacological antagonists of pancuronium bromide are anticholinesterase agents.

The effect of pancuronium bromide is enhanced when used in combination with anesthetics, aminoglycoside antibiotics, diuretics, beta- and alpha-adrenergic blocking agents, MAO inhibitors, diphenin, quinidine, metronidazole, nitroglycerin, diazepam, opioid analgesics; it is weakened when combined with propanidid, norepinephrine, theophylline, heparin, azathioprine, potassium chloride, sodium chloride, calcium chloride.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.