Pipecuronium Bromide for Injection

Pipecuronium is a non-depolarizing neuromuscular blocker. Pipecuronium blocks the signal transmission process between motor nerves and skeletal muscles by competing with the neurotransmitter acetylcholine to bind to nicotinic receptors in the motor endplate area of skeletal muscles. Unlike depolarizing neuromuscular blockers such as succinylcholine, pipecuronium does not cause muscle tremors. Pipecuronium has no hormonal activity. The neuromuscular blocking effect of pipecuronium can be eliminated by the use of cholinesterase inhibitors such as neostigmine, pyridostigmine or edrophonium. The neuromuscular blocking effect of pipecuronium is highly selective for skeletal muscles. Pipecuronium has neither ganglion blocking effect nor antivagal effect and sympathomimetic activity, even if the drug dose is several times the ED90 dose (the dose required to produce 90% muscle tremor inhibition). So far, no cardiovascular adverse reactions of pipecuronium have been observed. Studies on dose-response curves have shown that the ED50 (the dose required to produce 50% muscle tremor inhibition) and ED90 of pipecuronium bromide for stable anesthesia are 0.03 and 0.05 mg/kg, respectively. At a dose of 0.05 mg/kg, it is sufficient to provide adequate muscle relaxation for a large number of surgical operations with an average duration of 40 to 50 minutes. The time from administration to the onset of maximum neuromuscular blocking effect (onset time) depends on the dose administered, ranging from 1.5 minutes to 5 minutes. When the dose reaches 0.07-0.08 mg/kg, the onset time is the shortest. Further increasing the dose no longer shortens the onset time, but can significantly prolong the duration of action.

Chemical name: 2β, 6β-di(4-dimethylpiperazinyl)-3α, 17β-diethylacyloxy-5α-androstane dibromide Chemical structure: Molecular formula: C35H62Br2N4O4 Molecular weight: 762.7 Excipients: Mannitol

This product is white or off-white freeze-dried powder.

Picuronium bromide is mainly used for muscle relaxation during general anesthesia, and is mostly used for anesthesia in long-term surgeries (more than 20-30 minutes).

Like other neuromuscular blockers, the dose of pipecuronium should be individualized. The dose should be determined based on the method of anesthesia, the duration of the surgical procedure, interactions with other medications before and during anesthesia, concomitant diseases, and the patient's physical condition. To monitor neuromuscular blockade and recovery, the use of a peripheral nerve stimulator is recommended. The first dose of pipecuronium should be injected intravenously, followed by maintenance doses injected in divided doses to maintain muscle relaxation, or continuous infusion to achieve the desired muscle relaxation time. Like other neuromuscular blockers, pipecuronium should be used under the guidance of an experienced physician and with appropriate artificial respiration equipment. The following doses are general principles for the first and maintenance doses of pipecuronium. Under stable anesthesia conditions, appropriate muscle relaxation can be guaranteed during medium and long-term surgery regardless of whether pipecuronium is used for endotracheal intubation. For adult patients who need moderate or long-term surgery, intravenous administration can be used. If it is necessary to achieve muscle relaxation for induction of intubation, the general dose is 0.06-0.08 mg/kg; when used in combination with succinylcholine, the dosage of pipecuronium bromide is 0.04-0.06 mg/kg. For patients with renal insufficiency, the dose of pipecuronium bromide is generally recommended not to exceed 0.04 mg/kg. When repeated administration, the repeated dose is 1/4 to 1/3 of the initial dose. The increase in dose prolongs the muscle relaxation time.

Systemic allergic reactions and histamine release reactions to neuromuscular blockers have been reported. Although such adverse reactions have not been reported with pipecuronium, vigilance should always be maintained in treating such adverse reactions. In particular, caution should be exercised when using pipecuronium in patients with known prior allergic reactions to neuromuscular blockers, as cross-sensitivity reactions between neuromuscular blockers have been reported. At doses up to 0.10 mg/kg, it does not cause ganglion blockade or antivagal effects, and only slight effects on the cardiovascular system, blood pressure, or heart rate are observed. For patients who use halothane or fentanyl during induction of anesthesia, bradycardia and hypotension may occur. Picuronium does not cause histamine release reactions, but allergic reactions are occasionally seen.

Myasthenia gravis and patients allergic to pipecuronium or bromide ion.

Precautions for children: During pediatric surgery and when using diazepam, chlorammonium, fentanyl and other anesthesia, the recommended dosage for children is 0.08-0.09 mg/kg; the recommended dosage for neonates is 0.05-0.06 mg/kg. The above doses have a clinical efficacy of 25-35 minutes in surgical operations. If necessary, 1/3 of the initial dose can be added to extend the muscle relaxation effect by 25-35 minutes. Due to large individual differences, it is recommended to use a peripheral nerve stimulator to detect muscle relaxation. If necessary, neostigmine or atropine can be used to antagonize muscle relaxation. Or follow the doctor's advice. Precautions for pregnancy and lactation: There is currently insufficient data to evaluate the potential adverse effects of pipecuronium bromide on the fetus during animal or human pregnancy. The attending physician should weigh the pros and cons for pregnant patients and decide whether to use it. ● Caesarean section According to clinical studies, pipecuronium bromide as an auxiliary measure for general anesthesia for cesarean section does not affect the fetal Apgar score, muscle tone and cardiovascular adaptability. No other adverse reactions were observed in neonates. Pharmacokinetic studies have shown that only very low doses of pipecuronium bromide pass through the placental barrier and enter the umbilical cord blood. Warning: Because magnesium salts can enhance neuromuscular blockade, reversal of neuromuscular blockade caused by muscle relaxants may not achieve satisfactory results for patients with gestational hypertension receiving magnesium sulfate treatment. Elderly precautions: For the elderly, the onset of action of pipecuronium bromide is delayed by 50%, but there is no difference in the duration of drug effect. Please refer to other items or follow the doctor's advice.

The following drugs may affect the intensity and/or duration of action of non-depolarizing neuromuscular blocking drugs: 1. Enhance and/or prolong the action (1) Inhaled anesthetics (halothane, methoxyflurane, ether, enflurane, isoflurane, cyclopropane) (2) Intravenous anesthetics (ketamine, fentanyl, propanide, barbiturates, pyrimethamine) (3) High-dose local anesthetics (4) Other non-depolarizing muscle relaxants, pre-administration of succinylcholine (5) Certain antibiotics (aminoglycosides and peptide antibiotics, imidazoles, metronidazole, etc.) (6 ) Diuretics, β-adrenergic receptor blockers, vitamin B1. Monoamine oxidase inhibitors, guanidines, protamine, α-adrenergic receptor blockers, calcium antagonists, magnesium salts (7) Most antiarrhythmic drugs, including quinidine and intravenous lidocaine, enhance the blocking effect of non-depolarizing muscle relaxants 2. Changes in action Long-term use of corticosteroids, neostigmine, edrophonium chloride, pyridostigmine, norepinephrine, azathioprine, theophylline before surgery, and potassium chloride, sodium chloride, and calcium chloride before surgery. Depolarizing muscle relaxants weaken the effect of non-depolarizing muscle relaxants. 3. Uncertain reactions The use of depolarizing muscle relaxants after pipecuronium can cause an increase or decrease in neuromuscular blocking effects (depending on the dose, application time and individual sensitivity). 4. Others It is not recommended to mix pipecuronium with other solutions or drugs in the same syringe or infusion bag.

Protect from light, refrigerate, and store in a dry place at 2-8℃.

4mg

24 months

Sichuan Credit Pharmaceutical Co., Ltd.

• Founded in:

  2000-04-20

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  Pharmaceutical Industrial Park, Luzhou National High-tech Zone, Sichuan Province

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