DR. DOPING

Instructions

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Instructions / Instruction for use: Naropin

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Dosage form: solution for injection

Active substance: Ropivacaine *

ATX

N01BB09 Ropivacaine

Pharmacological group:

Local Anesthetics

The nosological classification (ICD-10)

R52.0 Acute pain: Acute pain syndrome; Acute pain syndrome with osteoarthritis; Acute pain syndrome of traumatic origin; Severe pain of a neurogenic nature; Severe pain; Pain syndrome at delivery

Z100.0 * Anesthesiology and premedication: Abdominal surgery; Adenomectomy; Amputation; Angioplasty of the coronary arteries; Carotid artery angioplasty; Antiseptic treatment of skin in wounds; Antiseptic treatment of hands; Appendectomy; Atheroctomy; Balloon coronary angioplasty; Vaginal hysterectomy; Venous bypass; Interventions on the vagina and cervix; Interventions on the bladder; Interference in the oral cavity; Reconstructive-reconstructive operations; Hand hygiene of medical personnel; Gynecological Surgery; Gynecological interventions; Gynecological operations; Hypovolemic shock during surgery; Disinfection of purulent wounds; Disinfection of the edges of wounds; Diagnostic Interventions; Diagnostic procedures; Diathermocoagulation of the cervix; Long-term surgeries; Replacement of fistulous catheters; Infection in orthopedic surgical interventions; Artificial heart valve; Kistectomy; Short-term outpatient surgery; Short-term operations; Short-term surgical procedures; Cryotyreotomy; Blood loss during surgical interventions; Bleeding during surgery and in the postoperative period; Laser coagulation Laserocoagulation; Laser retinopathy of the retina; Laparoscopy; Laparoscopy in gynecology; Likvornaya fistula; Small gynecological operations; Small surgical interventions; Mastectomy and subsequent plastic surgery; Mediastinotomy; Microsurgical operations on the ear; Mukinging operations; Suturing; Minor surgery; Neurosurgical operation; Eclipse of the eyeball in ophthalmic surgery; Orchiectomy; Pancreatectomy; Pericardectomy; The rehabilitation period after surgical operations; Reconvalence after surgical intervention; Percutaneous transluminal coronary angioplasty; Pleural Thoracocentesis; Pneumonia postoperative and post traumatic; Preparing for surgical procedures; Preparing for a surgical operation; Preparation of the surgeon's arms before surgery; Preparation of the colon for surgical interventions; Postoperative aspiration pneumonia in neurosurgical and thoracic operations; Postoperative nausea; Postoperative hemorrhage; Postoperative granuloma; Postoperative shock; Early postoperative period; Myocardial revascularization; Resection of the apex of the tooth root; Resection of the stomach; Bowel resection; Resection of the uterus; Liver resection; Small bowel resection; Resection of a part of the stomach; Reocclusion of the operated vessel; Gluing of tissues during surgical interventions; Suture removal; Condition after eye surgery; Condition after surgery in the nasal cavity; Condition after gastrectomy; Condition after resection of the small intestine; Condition after tonsillectomy; Condition after removal of duodenum; Condition after phlebectomy; Vascular Surgery; Splenectomy; Sterilization of surgical instrument; Sterilization of surgical instruments; Sternotomy; Dental surgery; Dental intervention on periodontal tissues; Strumectomy; Tonsillectomy; Thoracic surgery; Total gastrectomy; Transdermal intravascular coronary angioplasty; Transurethral resection; Turbinectomy; Removal of a tooth; Cataract removal; Removing Cysts; Removal of tonsils; Removal of myoma; Removal of mobile milk teeth; Removal of polyps; Removal of a broken tooth; Removal of the uterus; Removal of seams; Urethrotomy; Fistula of the luminal ducts; Frontoetmoidogamotomy; Surgical infection; Surgical treatment of chronic ulcers of extremities; Surgery; Surgery in the anus; Surgery on the large intestine; Surgical practice; Surgical procedure; Surgical interventions; Surgical interventions on the digestive tract; Surgical interventions on the urinary tract; Surgical interventions on the urinary system; Surgical interventions on the genitourinary system; Surgical intervention on the heart; Surgical procedures; Surgical operations; Surgical operations on veins; Surgical intervention; Vascular Surgery; Surgical treatment of thromboses; Cholecystectomy; Partial resection of the stomach; Extraperitoneal hysterectomy; Percutaneous transluminal coronary angioplasty; Percutaneous transluminal angioplasty; Coronary artery bypass grafting; Extirpation of the tooth; Extirpation of infant teeth; Extirpation of pulp; Extracorporeal circulation; Extraction of the tooth; Extraction of teeth; Extraction of cataracts; Electrocoagulation; Endourological interventions; Episiotomy; Ethmoidotomy; Complications after tooth extraction

Composition and release form

Solution for injection 1 ml

active substance:

ropivacaine hydrochloride 2 mg; 7.5 mg; 10 mg

auxiliary substances: sodium chloride (8.6, 7.5 and 7.1 mg, respectively); hydrochloric acid or sodium hydroxide (up to pH 4-6); water for injections

in packs of contour cells 5 amp. 10 or 20 ml each; in a pack of cardboard 1 package.

Description of dosage form

A clear, colorless solution.

Characteristic

The solution of Naropin is a sterile isotonic aqueous solution, contains no preservatives and is intended for single use only. pKa of ropivacaine - 8.1; the partition coefficient is 141 (n-octanol / phosphate buffer, pH 7.4 at 25 ° C).

Pharmachologic effect

Pharmacological action - local anesthetic.

Indication of the drug Naropin

Anesthesia during surgical interventions:

epidural block during surgical interventions, including cesarean section;

blockade of large nerves and nerve plexuses;

blockade of individual nerves and infiltration anesthesia.

Kupirovanie acute pain syndrome:

prolonged epidural infusion or intermittent bolus administration, for example, to eliminate postoperative pain or anesthetic delivery;

blockade of individual nerves and infiltration anesthesia;

prolonged blockade of peripheral nerves;

intraarticular injection.

Kupirovanie acute pain in pediatrics:

caudal epidural blockade in newborns and children up to 12 years of age, inclusive;

prolonged epidural infusion in newborns and children up to 12 years of age, inclusive.

Contraindications

hypersensitivity to the components of the drug;

known hypersensitivity to local anesthetics of the amide type.

With caution, the medication should be administered to impaired elderly patients or patients with severe concomitant diseases such as blockade of intracardiac conductivity of grade II and III (sinoatrial, atrioventricular, intraventricular), progressive liver disease, severe hepatic insufficiency, severe chronic renal failure, with hypovolemic shock therapy . For these patient groups, regional anesthesia is often preferred. When carrying out "large" blockades in order to reduce the risk of developing severe adverse events, it is recommended to pre-optimize the patient's condition and also adjust the dose of anesthetic.

Caution should be exercised when injecting local anesthetics in the head and neck area due to the possible increased incidence of serious side effects.

With intraarticular administration of the drug, caution should be exercised if there is a suspected recent extensive injury to the joint or a surgical operation with the opening of extensive joint surfaces due to the possibility of increased absorption of the drug and a higher concentration of the drug in the plasma.

Particular attention should be paid to the use of the drug in children under 6 months due to immaturity of organs and functions.

Patients on a diet with sodium restriction must take into account the sodium content in the preparation.

Application in pregnancy and lactation

Pregnancy

There was no evidence of the effect of ropivacaine on fertility and reproductive function, as well as teratogenic effects. There have been no studies to evaluate the possible effect of ropivacaine on fetal development in women.

Naropin® can be used during pregnancy only if it is justified by the clinical situation (in obstetrics, the use of the drug for anesthesia or analgesia is well justified).

Studies of the effect of the drug on reproductive function were carried out on animals. In studies on rats, ropivacaine had no effect on fertility and reproduction in two generations. When maximum doses were administered to pregnant rats, the mortality of offspring was increased in the first three days after delivery, which may be explained by the toxic effect of ropivacaine on the mother, which leads to a disruption of the maternal instinct.

Studies of teratogenicity in rabbits and rats have not shown the side effects of ropivacaine on organogenesis or fetal development in the early stages. Also, during perinatal and postnatal studies in rats receiving the maximum tolerated dose of the drug, there were no side effects at late stages of fetal development, labor activity, lactation, viability, or growth in offspring. During perinatal and postnatal comparative studies of ropivacaine with bupivacaine, it was shown that unlike ropivacaine, the toxic effect of bupivacaine was observed at significantly lower doses of the drug and at lower concentrations of unbound bupivacaine in the blood.

Lactation

The isolation of ropivacaine or its metabolites with breast milk has not been studied. Based on the experimental data, the dose of the drug received by the newborn is presumed to be 4% of the dose given to the mother (concentration of the drug in milk / plasma concentration of the drug). The total dose of ropivacaine affecting the baby during breastfeeding is significantly less than the dose that can enter the fetus when the mother's anesthetic is injected during childbirth.

If you need to use the drug during breastfeeding, consider the ratio of potential benefits to the mother and the possible risk to the baby.

Side effects

Undesirable reactions to Naropin® are similar to reactions with other local anesthetics of the amide type. They should be distinguished from the physiological effects arising from the blockade of the sympathetic nerves on the background of epidural anesthesia, such as lowering blood pressure, bradycardia, or effects associated with drug administration techniques such as local nerve damage, meningitis, post-puncture headache, epidural abscess.

Side effects inherent in local anesthetics

From the central and peripheral nervous system

Possible neuropathy and dysfunction of the spinal cord (anterior spinal artery syndrome, arachnoiditis, horse tail syndrome), are usually associated with the technique of conducting regional anesthesia, and not with the action of the drug.

As a result of a random intrathecal injection of the epidural dose, a complete spinal block can occur.

Serious complications are possible with systemic overdose and unintentional intravascular administration of the drug (see section "Overdose").

Acute Systemic Toxicity

Naropin can cause acute systemic toxic reactions when using high doses or with a rapid increase in its concentration in the blood with a random intravascular injection of the drug or its overdose (see the section "Overdose").

The most common side effects

Various side effects of the drug were reported, the vast majority of which was not due to the effect of the anesthetic used, but to the technique of conducting regional anesthesia.

Most often (> 1%), the following side effects were noted, which were regarded as having clinical significance, regardless of whether the causative relationship was established with the use of anesthetic: decreased blood pressure, nausea, bradycardia, vomiting, paresthesia, fever , headache, delayed urination, dizziness, chills, increased blood pressure, tachycardia, hypesthesia, anxiety.

The frequency of undesirable effects is as follows:

Often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); rarely (> 1/10000, <1/1000); very rarely (<1/10000), including individual messages.

Often

From the CVS: a decrease in blood pressure *.

From the digestive tract: nausea.

Often

From the nervous system: paresthesia, dizziness, headache.

From the CVS: bradycardia, tachycardia, hypertension.

From the digestive tract: vomiting **.

From the genitourinary system: delay urination.

General: back pain, chills, fever.

Infrequently

From the nervous system: anxiety, symptoms of toxicity from the side of the central nervous system (convulsions, large seizures, paresthesia in the perioral zone, dysarthria, numbness of the tongue, visual impairment, ringing in the ears, tremor, muscle cramps), hypoesthesia.

From the vascular system: fainting.

From the respiratory system: shortness of breath, shortness of breath.

General: hypothermia.

Rarely

From the CVS: arrhythmia, cardiac arrest.

General: allergic reactions (anaphylactic reactions, angioedema, hives).

* Decrease in blood pressure occurs in children often.

** Vomiting is very common in children.

Dosing and Administration

Naropin® should only be used by specialists who have sufficient experience in conducting regional anesthesia, or under their supervision.

Adults and children over 12 years of age:

In general, anesthesia in surgical interventions requires higher doses and more concentrated solutions of the drug than with the use of an anesthetic for analgesia. When using an anesthetic for analgesia, a dose of 2 mg / ml is usually recommended. For intraarticular administration, a dose of 7.5 mg / ml is recommended.

The doses indicated in Table 1 are considered sufficient to achieve a reliable blockade and are indicative when the drug is used in adults, because there is an individual variability in the rate of development of the blockade and its duration.

The data in Table 1 is an indicative guide for dosing the drug for the most commonly used blockades. When choosing a dose of the drug should be based on clinical experience, taking into account the physical condition of the patient.

Table 1

Recommendations for dosing of Naropin® for adults

Types of anesthesia Concentration of the preparation, mg / ml Volume of solution, ml Dose, mg Start of action, min Duration of action, h
Anesthesia during surgical interventions:
Epidural anesthesia at the lumbar level:
Surgical interventions 7,5 15–25 113–188 10–20 3–5
10 15–20 150–200 10–20 4–6
Cesarean section 7,5 15–20 113–150 10–20 3–5
Epidural anesthesia at the thoracic level:
Postoperative pain blockade and surgery 7,5 5–15 38–113 10–20 -
Blockade of major plexus:
For example, blockade of the brachial plexus 7,5 10–40 75–300* 10–25 6–10
Conducting and infiltration anesthesia 7,5 1–30 7,5–225 1–15 2–6
Kupirovanie acute pain syndrome:
Epidural introduction at the lumbar level:
Bolus 2 10–20 20–40 10–15 0,5–1,5
Periodic administration (for example, with anesthetic delivery) 2 10–15 ( — 30 min) 20–30
Extended infusion for:
- anesthesia of childbirth 2 6–10 ml/h 12–20 mg/h - -
- after surgical analgesia 2 6–14 ml/h 12–28 mg/h - -
Blockade of peripheral nerves:
For example, blockade of the femoral nerve or interstitial blockade (prolonged infusions or repeated injections) 2 5–10 ml/h 10–20 mg/h - -
Epidural introduction at the thoracic level:
Extended infusion (for example, for postoperative analgesia) 2 6–14 ml/h 12–28 mg/h - -
Conducting blockade and infiltration anesthesia 2 1–100 2–200 1–5 2–6
Intra-articular administration
Arthroscopy of the knee joint ** 7,5 20 150*** - 2–6
* The dose for blockade of large plexus plexuses should be selected according to the site of administration and the patient's condition. Blockade of the brachial plexus with interlacial and supraclavicular access can be associated with a high incidence of serious adverse reactions, regardless of the local anesthetic used.** There have been reports of cases of chondrolisis in postoperative prolonged intra-articular infusion of local anesthetics. Naropin® should not be used for prolonged intra-articular infusion.

*** If Naropin® has been additionally used for other types of anesthesia, the maximum dose should not exceed 225 mg.

To familiarize with the factors influencing the method of execution of individual blockades, and with the requirements for specific groups of patients, standard guidelines should be used.

To prevent an anesthetic from entering the vessel, an aspirate sample must be performed before and during the administration of the preparation. If it is intended to use the drug in a high dose, it is recommended to enter a trial dose of 3-5 ml of lidocaine with epinephrine. A random intravascular injection is recognized by a temporary increase in heart rate, and a random intrathecal injection is indicated by the spinal block. If toxic symptoms occur, discontinue the drug immediately.

Before and during the administration of Naropin® (which should be done slowly or by increasing sequential doses of the drug at a rate of 25-50 mg / min), the vital functions of the patient must be closely monitored and verbal contact maintained.

Single administration of ropivacaine in a dose of up to 250 mg with epidural blockade for surgery is usually well tolerated by patients.

With blockade of the brachial plexus with 40 ml of the drug Naropin® 7.5 mg / ml, the maximum plasma concentrations of ropivacaine in plasma in some patients can reach a value characterized by mild symptoms of toxicity from the CNS. Therefore, the use of a dose above 40 ml of the drug Naropin® 7.5 mg / ml (300 mg of ropivacaine) is not recommended.

With prolonged blockade by prolonged infusion or repeated bolus administration, consideration should be given to the possibility of creating toxic concentrations of anesthetic in the blood and local nerve damage. The administration of ropivacaine for 24 hours at a dose of up to 800 mg in total for surgical interventions and for postoperative analgesia, and prolonged epidural infusion after surgery at a rate of up to 28 mg / h for 72 hours is well tolerated by adult patients.

For the relief of postoperative pain, the following scheme of drug use is recommended: if an epidural catheter was not installed during surgery, epidural blockage with a bolus injection of Naropin® (7.5 mg / ml) is performed after its installation. Analgesia is maintained by the infusion of Naropin® (2 mg / ml). In most cases, to relieve postoperative pain from moderate to severe, infusion at a rate of 6-14 ml / h (12-28 mg / h) provides adequate analgesia with minimal non-progressive motor blockade (using this technique, there was a significant decrease in the need for opioid analgesics ).

For postoperative analgesia, Naropin® (2 mg / ml) can be administered continuously as an epidural infusion for 72 hours without or in combination with fentanyl (1-4 μg / ml). When using the drug Naropin® 2 mg / ml (6-14 ml / h) adequate anesthesia was provided in most patients. The combination of Naropin® and fentanyl resulted in an improvement in analgesia, causing side effects inherent in narcotic analgesics.

The use of Naropin® in concentrations above 7.5 mg / ml with caesarean section has not been studied.

Table 2

Recommendations for dosing of Naropin® for children under 12 years of age

Indicators Concentration of the preparation, mg / ml Volume of solution, ml/kg Dose, mg/kg
Coping of acute pain syndrome (pre- and post-operative):
Caudal epidural administration:
Blockade in the area below ThXII in children weighing up to 25 kg 2 1 2
Extended epidural infusion in children weighing up to 25 kg
Age from 0 to 6 months
Bolus * 2 0,5–1 1–2
Infusion up to 72 h 2 0,1 ml/kg/h 0,2 mg/kg/h
Age from 6 to 12 months
Bolus * 2 0,5–1 1–2
Infusion up to 72 h 2 0,2 ml/kg/h 0,4 mg/kg/h
Age from 1 to 12 years inclusive
Bolus ** 2 1
Infusion up to 72 h 2 0,2 ml/kg/h 0,4 mg/kg/h

* Smaller doses from the proposed interval are recommended for epidural administration at the thoracic level, while larger doses are recommended for epidural administration at the lumbar or caudal levels.

** Recommended for epidural administration at the lumbar level. It is reasonable to reduce the bolus dose for epidural analgesia at the thoracic level.

The doses indicated in Table 2 are the guide to the use of the drug in pediatric practice. At the same time, there is an individual variability in the rate of development of the block and its duration.

Children with overweight often require a gradual decrease in the dose of the drug; it is necessary to be guided by the ideal body weight of the patient. For background information on the factors that affect the methods of performing individual blockades and the requirements for specific groups of patients, refer to specialized manuals. The volume of the caudal epidural solution and the bolus volume for epidural administration should not exceed 25 ml for any patient.

To prevent unintentional intravascular injection of anesthetic, an aspirate sample should be carefully performed before and during the administration of the preparation. During the administration of the drug, the vital functions of the patient must be closely monitored. If toxic symptoms occur, discontinue the drug immediately.

Single administration of ropivacaine in a dose of 2 mg / ml (2 mg / kg, 1 ml / kg solution volume) for postoperative caudal analgesia provides adequate analgesia below the ThXII level in most patients. Children older than 4 years are well tolerated doses up to 3 mg / kg. The volume of the administered solution for epidural administration at the caudal level can be changed to achieve a different prevalence of the sensory block, as described in the specialized manuals.

Regardless of the type of anesthesia, bolus administration of the calculated dose is recommended.

The use of the drug in concentrations above 5 mg / ml, as well as intrathecal use of the drug Naropin ® in children has not been studied. The use of Naropin® in preterm infants has not been studied.

Instructions for use of the solution

The solution does not contain preservatives and is intended for single use only. Any amount of solution left in the container after use should be destroyed.

The unopened container with the solution must not be autoclaved.

Unopened blister packs ensure the sterility of the outer surface of the container and is preferred for use in conditions requiring sterility.

Overdose

Acute Systemic Toxicity

In case of accidental intravascular injection, blockages of nerve plexuses or other peripheral blockades were accompanied by seizures.

In the case of an incorrect injection of an epidural dose of an anesthetic intrathecally, a complete spinal block may occur.

A random intravascular injection of an anesthetic can cause an immediate toxic reaction.

In case of an overdose during the regional anesthesia, the symptoms of a systemic toxic reaction appear in a delayed manner 15-60 min after the injection due to a slow increase in the local anesthetic concentration in the blood plasma. Systemic toxicity, in the first place, is manifested by symptoms from the central nervous system and SSS. These reactions are caused by high concentrations of local anesthetic in the blood, which can result from (accidental) intravascular injection, overdose or exceptionally high adsorption from highly vascularized areas. CNS reactions are similar for all local anesthetics of the amide type, while reactions from the CVS are more dependent on the drug administered and its dose.

central nervous system

Manifestations of systemic toxicity from the side of the central nervous system develop gradually: first there are visual disturbances, numbness around the mouth, numbness of the tongue, hyperacusis, ringing in the ears, dizziness. Dysarthria, tremor and muscle twitching are more serious manifestations of systemic toxicity and may precede the appearance of generalized seizures (these signs should not be mistaken for the patient's neurotic behavior). With the progression of intoxication, loss of consciousness, seizures of a duration of several seconds to several minutes, accompanied by a violation of breathing, rapid development of hypoxia and hypercapnia due to increased muscle activity and inadequate ventilation can occur. In severe cases, even stopping breathing may occur. Emerging acidosis, hyperkalemia, hypocalcemia increases the toxic effects of anesthetic.

Subsequently, because of the redistribution of anesthetic from the central nervous system and its subsequent metabolism and excretion, a fairly rapid restoration of functions occurs, unless a large dose of the drug has been administered.

The cardiovascular system

Disorders from the CVS are signs of more serious complications. Reduction of blood pressure, bradycardia, arrhythmia and, in some cases, even cardiac arrest may occur due to the high systemic concentration of local anesthetics. In rare cases, cardiac arrest is not accompanied by a previous symptomatology of the CNS. In studies on volunteers, IV infusion of ropivacaine led to inhibition of conduction and contractility of the heart muscle. Symptoms on the part of the CVS are usually preceded by manifestations of toxicity from the CNS, which can be overlooked if the patient is sedated (benzodiazepines or barbiturates) or under general anesthesia.

In children, early signs of systemic toxicity of local anesthetics are sometimes more difficult to detect due to difficulties experienced by children in describing symptoms, or in the case of regional anesthesia combined with general anesthesia.

Acute Toxicity Treatment

When the first signs of acute systemic toxicity appear, discontinue the drug immediately.

When there are seizures and symptoms of CNS depression, the patient needs adequate treatment, the purpose of which is to maintain oxygenation, arrest seizures, support the activity of the CCC. It is necessary to provide oxygenation by oxygen, and if necessary - transition to mechanical ventilation. If after 15-20 s seizures do not stop, anticonvulsants should be used: thiopental sodium 1-3 mg / kg IV (provides rapid arrest of seizures) or diazepam 0.1 mg / kg IV (the effect develops more slowly than in action of sodium thiopental). Suxamethonium 1 mg / kg quickly cures seizures, but requires intubation and ventilation if it is used.

When oppressing the activity of CAS (lowering blood pressure, bradycardia), iv injection of 5-10 mg of ephedrine is necessary, and if necessary, repeat after 2-3 minutes. With the development of circulatory insufficiency or cardiac arrest, standard resuscitation should begin immediately. It is vitally important to maintain optimal oxygenation, ventilation and circulation of blood, and also to correct acidosis. When cardiac arrest, longer resuscitation measures may be required.

When treating systemic toxicity in children, it is necessary to adjust the dose according to the age and body weight of the patient.

Special instructions

Anesthesia should be conducted by experienced specialists. It is necessary to have equipment and medicines for resuscitation. Before starting large blockades, an intravenous catheter should be installed.

Personnel providing anesthesia should be appropriately trained and familiar with the diagnosis and treatment of possible side effects, systemic toxic reactions and other possible complications (see section "Overdose").

Complication of unintentional subarachnoidal administration may be a spinal block with respiratory arrest and a decrease in blood pressure. Convulsions develop more often with blockade of the brachial plexus and epidural block, probably due to accidental intravascular injection or rapid absorption at the injection site.

Execution of peripheral nerve blockages may require the injection of a large volume of local anesthetic into areas with a large number of vessels, often near large vessels, which increases the risk of intravascular administration and / or rapid systemic absorption, which can lead to a high concentration of the drug in the plasma.

Some procedures associated with the use of local anesthetics, such as injections in the head and neck, may be accompanied by an increased incidence of serious side effects, regardless of the type of local anesthetic used. Care must be taken to prevent injection into the area of inflammation.

Care should be taken when administering the drug to patients with blockade of intracardiac conductance of II and III degrees, patients with severe renal failure, elderly and weakened patients.

There are reports of rare cases of cardiac arrest with the use of Naropin® for epidural anesthesia or peripheral nerve blockade, especially after accidental intravascular drug administration, in elderly patients and in patients with concomitant cardiovascular diseases.

In some cases, resuscitation was difficult. Heart failure, as a rule, requires more prolonged resuscitation.

Since Naropin® is metabolized in the liver, caution should be exercised when using the drug in patients with severe liver disease; in some cases, because of delayed elimination, it may be necessary to reduce re-injected doses of anesthetic.

Usually, in patients with renal insufficiency, when administering the drug once or when using the drug for a short period of time, it is not necessary to adjust the dose. However, acidosis and a decrease in the concentration of proteins in the blood plasma, often developing in patients with chronic renal failure, may increase the risk of systemic toxic effects of the drug (see section "Method of administration and dose"). The risk of systemic toxicity is also increased when the drug is used in patients with low body weight and patients with hypovolemic shock.

Epidural anesthesia can lead to a decrease in blood pressure and bradycardia. The introduction of vasoconstrictors or an increase in BCC can reduce the risk of such side effects. It should be timely corrected for a decrease in blood pressure by iv injection of 5-10 mg of ephedrine, if necessary, repeated.

With intraarticular administration of the drug, caution should be exercised if there is a suspected recent extensive injury to the joint or a surgical operation with the opening of extensive joint surfaces, due to the possibility of increased absorption of the drug and a higher concentration of the drug in the plasma.

Patients receiving Class III antiarrhythmic drugs (eg, amiodarone) should be closely monitored, ECG monitoring is recommended because of the risk of cardiovascular effects.

Avoid prolonged use of Naropin® in patients taking strong inhibitors of P4501A2 (such as fluvoxamine and enoxacin).

Consideration should be given to the possibility of cross-over-hypersensitivity with simultaneous use of the drug Naropin® with other local anesthetics of the amide type.

Patients on a diet with sodium restriction must take into account the sodium content in the preparation.

The use of the drug in newborns requires consideration of the possible immaturity of the organs and the physiological functions of the newborn. The clearance of the unbound fraction of ropivacaine and pipeloxylidine (PPK) depends on the body weight and age of the child in the first years of life. The influence of age is expressed in the development and maturity of liver function, the clearance reaches a maximum value at the age of about 1-3 years. T1 / 2 ropivacaine is 5-6 hours in newborns and children aged 1 month compared with 3 hours in older children. In connection with insufficient development of liver function, systemic exposure of ropivacaine is higher in newborns, moderately higher - in children from 1 to 6 months compared with older children. Significant differences in the concentrations of ropivacaine in blood plasma of newborns, revealed in clinical studies, suggest an increased risk of systemic toxicity in this group of patients, especially with prolonged epidural infusion.

The recommended doses for newborns are based on limited clinical data.

When using ropivacaine in newborns, monitoring of systemic toxicity (monitoring signs of toxicity from the CNS, ECG, control of blood oxygenation) and local neurotoxicity should be monitored, which should be continued after the infusion is completed due to the slow elimination of the drug in newborns.

The use of the drug in concentrations above 5 mg / ml, as well as intrathecal use of the drug Naropin ® in children has not been studied.

Naropin® is potentially capable of causing porphyria and can be used in patients diagnosed with acute porphyria only in cases where there is no safer alternative. In the case of hypersensitivity patients should take the necessary precautions.

There have been reports of cases of chondrolisis in postoperative prolonged intra-articular infusion of local anesthetics. In most of the cases described, an infusion into the shoulder joint was performed. Causal relationship with the use of anesthetics is not established. Naropin® should not be used for prolonged intra-articular infusion.

Impact on the ability to drive vehicles and other mechanisms. In addition to the analgesic effect, Naropin® can have a weak transient effect on motor function and coordination. Given the profile of the side effects of the drug, care must be taken when driving vehicles and performing other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

A comment

Before using the drug, read the instructions for use.

Conditions of leave from pharmacies

On prescription.

Conditions for storing Naropin

At temperatures not higher than 30 ° C (do not freeze).

Keep out of the reach of children.

Shelf life of Naropin

3 years.

Do not use after the expiry date printed on the package.