Naropin
Painkillers

Naropin

Naropin

Naropin is a local anesthetics. Available in three dosages: 2 mg, 7.5 mg and 10 mg. The action is aimed at reversibly blocking nerve impulses along the fibers. Recommended for epidural anesthesia during surgical interventions, as well as for nerve block.

Information

Indications for use (instruction): Naropin

Naropin 7.5 mg/ml and 10 mg/ml

  • For adults and children over 12 years of age for anesthesia during surgical interventions:
    • epidural anesthesia during surgical interventions, including cesarean section;
    • blockade of the large nerves;
    • blockade of peripheral nerves.

Naropin 2 mg/ml

  • For adults and children over 12 years of age for the relief of acute pain:
    • prolonged epidural infusion or periodic bolus injections to eliminate postoperative pain or to anesthetize labor;
    • blockade of peripheral nerves;
    • prolonged blockade of peripheral nerves by continuous infusion or periodic painful injections, for example, to eliminate postoperative pain.
  • For infants from 1 year old and children up to 12 years old for relief of acute pain (during and after surgery):
    • peripheral blockade with a single injection of the drug.
  • For newborns, infants from 1 year of age and children up to 12 years of age for caudal epidural block (during and after surgery):
    • prolonged epidural infusion.

How to use

Naropin should be administered only by doctors with experience in conducting regional anesthesia or under their supervision. To achieve a sufficient degree of anesthesia, the minimum possible doses of the drug must be used.

Adults and children over 12 years old

Recommended doses of the drug are given below; dosage should be adjusted in accordance with the degree of blockade and the general condition of the patient.

Surgical anesthesia usually requires higher doses and higher concentrations than analgesia to relieve acute pain, for which a concentration of 2 mg/ml is usually recommended. However, a concentration of 7.5 mg/ml is recommended for intra-articular injections.

There are significant individual fluctuations with respect to the onset and duration of the effect.

1) The dose for blockade of the nerve plexus should be adjusted depending on the injection site and the patient's condition. With interstitial blockade and blockade of the supraclavicular brachial plexus, an increase in the frequency of serious adverse reactions is possible regardless of the type of local anesthetic used.

2) With the introduction of an additional dose of ropivacaine using any other technique, the same patient should not exceed a total dose of 225 mg.

3) After the drug entered the market, the development of chondrolysis was reported in patients receiving long-term infusion for intra-articular local anesthesia. Prolonged intraarticular infusion is not an approved route of administration of the drug.

It is important to take extra care to prevent accidental intravascular injections. Before and during the injection of the total dose, it is recommended to carefully conduct an aspiration test. The total dose should be administered slowly, at a rate of 25–50 mg / min or in separate doses, constantly monitoring the patient's condition. For epidural administration, a test dose of 3–5 ml of xylocaine adrenaline is recommended. Accidental intravascular administration can cause, for example, a short-term increase in heart rate, and accidental intrathecal administration can lead to signs of spinal blockade. If symptoms of intoxication occur, the administration of the drug should be stopped immediately.

When carrying out epidural blockade during surgical interventions, single doses of up to 250 mg of ropivacaine are used, which are well tolerated.

When the brachial plexus is blocked by administering 40 ml of Naropin at a concentration of 7.5 mg/ml, the maximum plasma concentrations of ropivacaine in some patients may approach the level at which mild symptoms of the toxic effects of the drug on the central nervous system were described. Therefore, it is not recommended to use doses exceeding 40 ml of the drug Naropin with a concentration of 7.5 mg/ml (300 mg of ropivacaine).

During prolonged infusion or repeated painful injections, the risk of toxic plasma concentrations or local nerve damage should be considered. The total doses of up to 675 mg of ropivacaine, which was administered within 24 hours, were well tolerated by adult patients during anesthesia during surgical interventions and during relief of postoperative pain. Good tolerance was also observed in adults with prolonged epidural infusion, which was performed after surgery for 72 hours at an infusion rate of up to 28 mg/hour. In a limited number of patients, the introduction of higher doses of the drug (up to 800 mg/day) was accompanied by the appearance of a relatively small number of adverse reactions.

Relief of postoperative pain. The blockade is carried out before surgery by administering the drug Naropin 10 mg/ml or 7.5 mg/ml after surgery by epidural bolus administration of the drug Naropin 7.5 mg/ml. Analgesia is supported by epidural infusion of the drug Naropin 2 mg/ml. Clinical studies have shown that infusion at a rate of 6–14 ml (12–28 mg) per hour usually provides satisfactory anesthesia for moderate to severe postoperative pain, and in most cases only a weak and non-progressive motor block is observed. The maximum duration of epidural block is 3 days. However, careful monitoring of the analgesic effect of the drug should be carried out in order to remove the catheter as soon as the pain state allows this. This technique can significantly reduce the need for additional use of opioid analgesics.

Clinical trials were also conducted in which Naropin at a dose of 2 mg/ml was used alone or in combination with fentanyl (1–4 μg/ml) for 72 hours as an epidural infusion for postoperative analgesia. Naropine 2 mg/ml (6–14 mg/h) provided adequate pain relief in most patients. The combination of Naropin with fentanyl provided better analgesia, but it caused undesirable opioid effects.

In caesarean sections, the epidural use of ropivacaine at a concentration of more than 7.5 mg / ml spinal is not documented.

When conducting a prolonged blockade of peripheral nerves by prolonged infusion or repeated injections, the risk of achieving a toxic concentration of the drug in blood plasma or causing local neurological damage should be considered. In clinical studies, femoral blockade before surgery was achieved by administering 300 mg of Naropin at a concentration of 7.5 mg/ml, and interstitial blockade was achieved by administering 225 mg of Naropin at a concentration of 7.5 mg/ml. Further, analgesia was supported by the introduction of the drug Naropin at a dose of 2 mg/ml. The infusion rate or periodic injections of 10–20 mg per hour for 48 hours provided sufficient analgesia and were well tolerated.

Children under 12 years old

There are cases of individual variations. Overweight children often require a gradual reduction in dose, which is calculated by ideal body weight. The volume of the drug for caudal epidural block with a single injection of the drug and the volume of the drug for epidural block with the introduction of painful doses of the drug should not exceed 25 ml for any patient.

The use of ropivacaine in doses of 7.5 and 10 mg/ml for children can lead to systemic toxic effects and the effect of the drug on the central nervous system. Thus, for use in such patients, a lower level of concentration (2 mg/ml) is more acceptable.

The dose guidelines for peripheral blockade in infants and children constitute the methodological basis for the use of the drug in children without serious illness. For children with serious illnesses, the use of lower doses of the drug and careful monitoring are recommended.

The use of ropivacaine in premature infants has not been documented.

It is important to be very careful to prevent accidental intravascular injections. Before and during the injection of the total dose, it is recommended to carefully conduct an aspiration test. During the administration of the drug, the vital functions of the patient should be closely monitored. If signs of toxic effects occur, the drug should be discontinued immediately.

When using calculated doses, fractionation of the total dose is recommended, regardless of the route of administration of the drug.

A caudal epidural injection of ropivacaine at a dose of 2 mg/ml provides adequate postoperative analgesia below the T12 level in most children, when a dose of 2 mg/kg is applied in a volume of 1 ml/kg. Caudal epidural injection volume can be adjusted to achieve control over the spread of sensory blockade. Doses up to and including 3 mg/kg at a concentration of ropivacaine of 3 mg/ml have been safely used in children over 4 years of age.

The experience with caudal blockade in children weighing more than 25 kg is limited.

Children.

The drug is used in pediatric practice.

For more information on the application, see the instructions.

Contraindications

Hypersensitivity to ropivacaine or any of the excipients.

Hypersensitivity to local amide type anesthetics.

General contraindications associated with epidural or regional anesthesia, regardless of which local anesthetic is used.

Intravenous regional anesthesia.

Paracervical anesthesia in obstetrics.

Epidural anesthesia in patients with hypovolemia.

Composition

Active substance: ropivacaine;

1 ml of ropivacaine hydrochloride monohydrate, which corresponds to ropivacaine hydrochloride 2 mg or 7.5 mg or 10 mg.

Excipients: sodium chloride, 2M sodium hydroxide solution and/or 2M hydrochloric acid solution, water for injection.

Release form

For 2 mg/ml – 100 ml per container, 1 container in blister packs, 5 blister packs in a carton box.

For 7.5 mg/ml and 10.0 mg/ml —– 10 ml per ampoule, 1 ampoule in blister packs, 5 blister packs in a carton box.

Storage conditions

Store at a temperature not exceeding 30 °C. Do not freeze. Keep out of the reach of children.

Directions for use, disposal practices

Naropine, an injection, does not contain preservatives and is intended for single use only. Residues should be disposed of. An open infusion bag can be used within 24 hours. Unopened packaging should not be re-autoclaved. If the necessary ampoules or packages for infusion are sterile from the outside, blister packs should be chosen.

Manufacturer

For 2 mg/ml – AstraZeneca Petty Ltd., 10-14 Kartoum Road, North Ryde, New South Wales 2113, Australia.

For 7.5 mg/ml 10.0 mg/ml – AstraZeneca AB, Forskargatan 18 Sodertalier, 15185, Sweden.

Sanitary and hygienic conclusion

No.2381 dated 12/05/2019
Registration certificate:
for 2 mg/ml – UA/9384/01/01
for 7.5 mg/ml – UA/9670/01/02
for 10 mg/ml – UA/9670/01/03