Solution for injections is transparent, colorless.
1 ml
levobupivacaine hydrochloride 5.633 mg,
which corresponds to the content of levobupivacaine 5 mg
Excipients: sodium chloride - 9 mg, sodium hydroxide solution 2.5M - up to pH 4.0-6.5, hydrochloric acid 2.5M solution - up to pH 4.0-6.5, water d / u - up to 1 ml.
10 ml - polypropylene ampoules (10) - cardboard packs.
Solution for injections is transparent, colorless.
1 ml
levobupivacaine hydrochloride 8.449 mg,
which corresponds to the content of levobupivacaine 7.5 mg
Excipients: sodium chloride - 9 mg, sodium hydroxide solution 2.5M - up to pH 4.0-6.5, hydrochloric acid 2.5M solution - up to pH 4.0-6.5, water d / u - up to 1 ml.
10 ml - polypropylene ampoules (10) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
PHARMACHOLOGIC EFFECT
Levobupivacaine is a local anesthetic and long-acting analgesic. Levobupivacaine blocks the transfer of impulses in sensory and motor nerve fibers, mainly due to the effect on the potential-dependent sodium channels of the cell membrane, although it also causes blockade of the potassium and calcium channels. In addition, levobupivacaine interferes with the transmission and carrying out of impulses in other tissues: the most important role in the development of clinical adverse reactions is played by its effect on the cardiovascular and CNS.
The dose of levobupivacaine is expressed in the amount of free base, while the dose of racemic bupivacaine is expressed in the amount of the hydrochloride salt. Thus, the levobupivacaine solution contains 13% more active substance than the bupivacaine solution. In clinical studies, it has been shown that, at the same prescribed concentrations, the clinical efficacy of levobupivacaine and bupivacaine is similar.
In studies of clinical pharmacology using the ulnar blockade model, it was demonstrated that levobupivacaine has the same clinical effect as bupivacaine.
Data on the safety of levobupivacaine when administered for more than 24 h are limited.
PHARMACOKINETICS
Distribution
In clinical studies in humans, it has been shown that the distribution of levobupivacaine after intravenous administration is basically the same as that of bupivacaine.The concentration of levobupivacaine in the blood plasma depends on the dose of the drug and on the route of administration, since the absorption of the drug from the site of administration is influenced by tissue vascularization.
In vitro studies have shown that the binding of the drug to human plasma proteins is> 97% at a concentration of 0.1 Ојg / ml to 10 Ојg / ml.
In clinical pharmacology studies, with iv iv administration of 40 mg levobupivacaine, mean T 1/2 was approximately 80 В± 22 min, C max 1.4 В± 0.2 Ојg / ml and AUC 70 В± 27 Ојg В· min / ml.
When epidurally administered 75 mg (0.5%) and 112.5 mg (0.75%) of levobupivacaine, and brachial plexus blocking with levobupivacaine at a dose of 1 mg / kg (0.25%) and 2 mg / kg (0.5%), the average C max and AUC 0-24) of the drug are approximately proportional to the administered dose. After epidural administration of 112.5 mg (0.75%) of levobupivacaine, the average values ​​of C max and AUC are 0.58 μg / ml and 3.56 μg / h / ml, respectively.
V d after intravenous administration is 67 liters.
Metabolism
Levobupivacaine is largely metabolized, in urine and feces the unchanged drug is not detected. The main metabolite of levobupivacaine, 3-hydroxylevepupivacaine, is secreted into the urine in the form of conjugates with glucuronic acid and sulfate ester. In vitro studies, it has been shown that cytochrome CYP3A4 and CYP1A2 isoenzymes participate in the metabolism of levobupivacaine, with the formation of desbutyl-levobupivacaine and 3-hydroxylevepupivacaine, respectively. These studies have shown that the metabolism of levobupivacaine and bupivacaine is similar.
Ratsemizatsii levobupivakina in vivo is not revealed.
Excretion
After iv introduction, levobupivacaine is excreted on average for 48 hours at 95%, with 71% excreted through the kidneys. 24% through the intestine.
When administered as an IV infusion, the total plasma clearance of levobupivacaine is 39 l / h, and the final T 1/2 is 1.3 h.
Special patient groups
Impaired liver function
Data on the pharmacokinetics of levobupivacaine in patients with impaired liver function are not available (see section "Special instructions").
Impaired renal function
There are no data on the pharmacokinetics of levobupivacaine in patients with impaired renal function. Levobupivacaine is largely metabolized, an unchanged drug in the urine is not detected.
INDICATIONS
For a dosage of 5 mg / ml
Adults
Anesthesia during surgical interventions
- for large surgical interventions, for example, epidural (including anesthesia during cesarean section), intrathecal, blockade of peripheral nerves;
- with small surgical interventions, for example, infiltration anesthesia, peribulbar blockade (in eye surgery).
Coping with pain syndrome
- Continuous epidural infusion, single or multiple bolus epidural administration of the drug to stop the pain, especially in the postoperative period or during labor.
Children
- Anesthesia (ilio-inguinal and ilio-hypogastric blockades).
For a dosage of 7.5 mg / ml
Adults
Anesthesia during surgical interventions
- for large surgical interventions, for example, epidural anesthesia, intrathecal, blockade of peripheral nerves;
- with small surgical interventions, for example, infiltration anesthesia, peribulbar blockade (in eye surgery).
Pain relief syndrome
- prolonged epidural infusion, single or multiple bolus epidural administration of the drug for relief of pain syndrome, especially in the postoperative period.
Children
- Anesthesia (ilio-inguinal and ilio-hypogastric blockades).
DOSING MODE
The introduction of levobupivacaine should be carried out by a specialist who has the appropriate skills of anesthesia, or under his supervision.
To dilute levobupivacaine 0.9% (9 mg / ml) sodium chloride solution for injection is used with aseptic rules.
It was shown that clonidine 8.4 Ојg / ml, morphine 0.05 mg / ml and fentanyl 4 Ојg / ml were compatible with levobupivacaine in a 0.9% (9 mg / ml) solution of sodium chloride.
Before use, a visual assessment of the drug is necessary. The solution can be used only if it is transparent and does not contain visible particles.
When diluting levobupivacaine with alkaline solutions, a precipitate may form. The drug can not be diluted with sodium bicarbonate or simultaneously administered with it. Levobupivacaine should not be mixed with other drugs, except those listed in the section above.
In Table 1 below, the recommended doses are given for the most commonly used blockades. For anesthesia (for example, with epidural administration of levobupivacaine for the purpose of arresting the pain syndrome), lower doses are indicated. If you need deep or prolonged anesthesia with a complete motor blockade (eg, epidural or peribulbar), higher concentrations of the drug may be used. Before and during the administration, an aspiration test should be performed to prevent the levobupivacaine from entering the vascular bed.
Data on the safety of levobupivacaine therapy for more than 24 hours are limited. To reduce the risk of developing severe neurological complications, careful monitoring of the patient and the duration of administration of the drug (see section "Special instructions") should be made.
An aspirate sample should be taken before and during the bolus dose in slow and gradually increasing doses at a rate of 7.5-30 mg / min. At the same time, it is necessary to carefully monitor the vital signs and constantly maintain verbal contact with the patient.
When symptoms of a toxic effect appear, the drug should be discontinued immediately.
Maximum doses of the drug
The maximum dose of levobupivacaine is calculated depending on the patient's body weight and physical status, and the dose of the drug is determined by its concentration, location and route of administration. Individual differences in the time of onset of action of the drug and in the duration of the blockade are possible.According to clinical studies, with epidural administration of levobupivacaine, a sensory blockade adequate for surgery appears within 10-15 minutes, and regresses after 6-9 hours.
The maximum recommended single dose of the drug is 150 mg. To maintain a prolonged motor and sensory blockade with prolonged interventions, it may be necessary to re-administer the anesthetic. The maximum dose of levobupivacaine, which can be administered within 24 hours, is 400 mg. In the treatment of pain syndrome in the postoperative period, the dose of the drug should not exceed 18.75 mg / h.
Maximum doses of the drug in obstetrical practice
For anesthesia during caesarean section, the drug should not be administered at a concentration greater than 5.0 mg / ml (see section "Contraindications"). The maximum recommended dose is 150 mg.
With epidural infusion for the purpose of analgesia of birth, the dose of levobupivacaine should not exceed 12.5 mg / h.
Maximum doses of the drug in children
The maximum recommended dose of the drug for analgesia in children (with ilio-inguinal or ilio-hypogastric blockade) is 1.25 mg / kg on one side.
It is necessary to correct the maximum dose depending on the body weight, constitution and the patient's physical status.
The efficacy and safety of levobupivacaine outside these indications is not established.
Maximum doses of the drug in patients of special groups
In elderly and debilitated patients, as well as in acute diseases, the dose of levobupivacaine should be reduced in accordance with the data of the physical status.
When administering the drug for pain relief in the postoperative period, it is necessary to take into account the dose of the anesthetic administered during the surgical intervention.
Data on the use of the drug in patients with severe liver damage are not available (see sections "Special instructions" and "Pharmacokinetics").
Table 1. Recommended doses of the drug for the most commonly used blockades
Concentration (mg / ml) 1 Dose Degree of motor blockade
Anesthesia during surgical interventions
Epidural bolus 2 (slow) administration of the drug during surgical interventions
Adults 5.0-7.5 10-20 ml (50-150 mg) From moderate to full
Slow epidural administration of preparation 3 in a caesarean section 5.0 15-30 ml (75-150 mg) Moderate to full
Intrathecal injection 5.0 3 mL (15 mg) Moderate to full
Blockade of peripheral nerves 2.5-5.0 1-40 ml (2.5-150 mg) Moderate to full
Ilio-inguinal or ilio-hypogastric blockade in children <12 years 2.5 0.5 ml / kg (1.25 mg / kg on one side) Not applicable
5.0 0.25 ml / kg (1.25 mg / kg on one side)
Anesthesia in ophthalmic operations (peribulbar blockade) 7.5 5-15 ml (37.5-112.5 mg) Moderate to full
Local infiltration anesthesia
Adults 2.5 1-60 ml (2.5-150 mg) Not applicable
Pain management 4
Anesthesia of labor (epidural bolus injection 5 ) 2.5 6-10 ml (15-25 mg) Moderate to full
Analgesia of labor (epidural infusion) 1.25 4-10 ml / h (5-12.5 mg / h) From moderate to full
Anesthesia in the postoperative period 1.25 10-15 ml / h (12.5-18.75 mg / h) From moderate to full
2.5 5-7.5 ml / h (12.5-18.75 mg / h)
1 - levobupivacaine in the form of a solution d / and for the preparation of infusions exists in concentrations of 5.0 mg / ml and 7.5 mg / ml.
2 - Enter for 5 minutes.
3 - administered within 15-20 minutes.
4 - when using the drug in combination with other drugs to stop the pain, for example, with opioid analgesics, the dose of levobupivacaine should be reduced; it is also preferable to use lower solution concentrations (eg, 1.25 mg / ml).
5 - the minimum recommended interval between intermittent injections is 15 minutes.
The solution does not contain preservatives and should be used immediately after opening the ampoule. Remains of the solution must be disposed of.
SIDE EFFECT
Undesirable reactions to levobupivacaine are consistent with those in the use of drugs of this class. The most frequent adverse reactions are a decrease in blood pressure, nausea, anemia, vomiting, dizziness, headache, fever, pain during the injection, back pain and fetal distress syndrome (when the drug is used in obstetric practice). Undesirable reactions recorded in clinical trials and post-registration observations are reflected in accordance with organ and organ damage and frequency of occurrence: very often (? 1/10); often (? 1/100, <1/10); infrequently (? 1/1000, <1/100); Unknown (based on available data).
Organ or organ system Frequency of occurrence Adverse reactions
Disorders from the blood and lymphatic system Very often Anemia
Immune system disorders Unknown Allergic reactions (in serious cases anaphylactic shock), hypersensitivity
Disturbances from the nervous system Often Dizziness, headache
Unknown Seizures, loss of consciousness, drowsiness, syncope, paresthesia, paraplegia, paralysis 1
Disturbances from the side of the organ of vision Unknown Blurred vision, ptosis 2 , miosis 3 , enophthalmos 2
Cardiac disorders Unknown AV blockade, cardiac arrest, ventricular tachyarrhythmias, tachycardia, bradycardia
Vascular disturbances Very often Hyperemia 2
Unknown Stop breathing, laryngeal edema, apnea, sneezing
Disorders from the gastrointestinal tract Very often Nausea
Often Vomiting
Unknown Hypesaesthesia of the oral mucosa, impaired control of sphincter function 1
Disturbances from the skin and subcutaneous tissue Unknown Angioneurotic edema, urticaria, pruritus, hyperhidrosis, anhidrosis 2 , erythema
Disturbances from musculoskeletal and connective tissue Often Back pain
Unknown Muscle twitching, muscle weakness
Disturbances from the kidneys and urinary tracts Unknown Bladder dysfunction 1
Pregnancy, postpartum and perinatal conditions Often Fetal distress syndrome
Violations from the genitals and the mammary gland Unknown Priapism 1
Common disorders and disorders at the injection site Often Increased body temperature
Laboratory and instrumental data Not known Decreased cardiac output, changes on electrocardiogram
Trauma, intoxication and complications of manipulation Often Pain during procedure
1 - may be a symptom or sign of horse tail syndrome.
2 - may be a symptom or sign of transient Horner's syndrome.
With the use of local anesthetics, unwanted reactions rarely develop, but they can occur with an overdose or with a random intravascular injection and are serious in nature.
Cases of cross-sensitivity to various anesthetic agents of the amide group are described.
Accidental intrathecal administration of the drug may lead to spinal anesthesia at a very high level.
The effect of the drug on the cardiovascular system is associated with a decrease in conduction, excitability and contractility of the myocardium. Usually this is preceded by signs of toxic CNS damage, for example, convulsions, at the same time, in rare cases, cardiac arrest occurs without any prodromal neurologic symptoms.
The defeat of the nervous system is a rare but well-diagnosed complication of regional, in particular, epidural and spinal anesthesia. It can be associated with direct damage to the spinal cord or spinal nerves, the syndrome of the anterior cerebrospinal artery, the introduction of an irritant or an unsterile solution. In rare cases, changes are kept constantly.
There is evidence of continued weakness or sensory disturbances associated with the administration of levobupivacaine. Sometimes these phenomena can be permanent. It is difficult to determine whether such long-term effects occur due to the toxic effect of the drug or are signs of undiagnosed traumatic injury during surgery or when other mechanical factors, in particular, the placement of the catheter and manipulation, are affected.
There have been reports of the development of horse tail syndrome or the appearance of symptoms and signs of possible damage to the base of the spinal cord or roots of the spinal nerves (including weakness of the lower extremities, paresthesia or paralysis, loss of control of bowel movement and / or urination and priapism) associated with levobupivacaine therapy. With the introduction of levobupivacaine for more than 24 hours, these phenomena were more severe and in some cases did not completely disappear (see section "Special instructions").
However, it is impossible to determine whether these phenomena were associated with the action of levobupivacaine, a mechanical trauma of the spinal cord or roots of the spinal nerves, or the collection of blood in the region of the base of the spine.
Also, rare cases of transient Horner's syndrome (ptosis, miosis, enofthalm, unilateral sweating and / or hyperemia) associated with the use of local anesthetics, including levobupivacaine, are described. After discontinuing therapy, these phenomena disappear.
CONTRAINDICATIONS
- General contraindications to regional anesthesia;
- hypersensitivity to levobupivacaine or an auxiliary drug substances as well as local anesthetics amide group (see "Side effect".);
- in / regional anesthesia (as Bir blockade);
- significant reduction in blood pressure (e.g., cardiogenic or hypovolemic shock);
- paracervical block in obstetric practice (see "Application of pregnancy and during lactation.");
- dosage of 7.5 mg / ml contraindicated in obstetric practice because of the increased risk of cardiotoxicity with bupivacaine.
Carefully
- introduction of the drug for longer than 24 hours;
- levobupivacaine should be used with caution in patients receiving antiarrhythmic drugs with properties of local anesthetics (mexiletine) and class III antiarrhythmics (using the latest additive may develop toxic effects);
- regional anesthesia in patients with cardiovascular disease, in particular, with severe cardiac arrhythmias;
- in patients with previous diseases of the CNS;
- in patients receiving other local anesthetics or agents, similar in structure to local anesthetics of the amide type;
- patients with liver diseases or with decreased liver blood flow (e.g., cirrhosis or alcoholic liver disease).
PREGNANCY AND LACTATION
Pregnancy (for dosages of 5 mg / ml and 7.5 mg / ml) of
drug can not be used for pregnant paracervical blockade. Considering the cases of bradycardia in the fetus when administered bupivacaine, we can not exclude the same effect of levobupivacaine.
Clinical data on the use of levobupivacaine in the first trimester of pregnancy does not. It was registered drug teratogenicity in animal studies. At the same time, while system-level exposure levobupivacaine who achieved clinically in humans, in animals were reported embryotoxic effects. The potential risk to humans is unknown.Thus, when there is no obvious need for women in the first trimester of pregnancy should not be administered levobupivacaine.
Pregnancy (for dosages of 5 mg / mL)
At the moment there is extensive experience of bupivacaine for obstetric surgery (during pregnancy and delivery), the embryotoxic effect of the drug is not registered.
Pregnancy (for dosage 7.5 mg / ml)
Dosage 7.5 mg / ml contraindicated in obstetric practice because of the increased risk of cardiotoxicity with bupivacaine.
Breastfeeding
Information about whether levobupivacaine passes into breast milk, no penetrate. However, this formulation apparently released during lactation less than bupivacaine. Breast-feeding is possible after local anesthesia.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Be wary of medication to patients with liver diseases or with decreased liver blood flow (e.g., cirrhosis or alcoholic liver disease).
APPLICATION FOR CHILDREN
The maximum recommended dose for analgesia in children (if iliac or inguinal iliohypogastric blockade) is 1.25 mg / kg on one side.
Requires correction maximum dose based on body weight, constitution and physical status of the patient.
APPLICATION IN ELDERLY PATIENTS
Use with caution in elderly patients.
SPECIAL INSTRUCTIONS
All kinds of local or regional anesthesia should be performed in a well equipped medical facility personnel should have experience in regional anesthesia, and be able to diagnose the possible adverse reactions and treat accordingly.
Levobupivacaine can cause allergic reactions, disorders of the cardiovascular and neurological disorders.
In patients with cardiovascular disease, in particular, with severe heart rhythm disorders, regional anesthesia with levobupivacaine should be performed with caution (see "Precautions").
Patients with previous CNS diseases entering the local anesthetic in the CNS when administered epidurally may entail aggravation of these diseases. Therefore, when planning epidural anesthesia in such patients should implement appropriate clinical assessment.
epidural anesthesia
Concentrated levobupivacaine (0.5-0.75%) was dissolved under epidural anesthesia to be administered by fractional 3-5 ml, gradually increasing the dose, the interval between administrations should be sufficient to determine the time to toxic manifestations in case of contact with the drug in the lumen or intrathecally. Cases of severe bradycardia, decreased blood pressure and respiratory failure, cardiac arrest during the use of local anesthetics (some of these cases have been fatal). If necessary, introducing a high dose of levobupivacaine, such as epidural block, it is recommended to introduce a preliminary test dose with 3-5 ml lidocaine with epinephrine. Unintentional penetration of the drug into the bloodstream can be recognized by the rise time of the heart rate,and the random hit him in the intrathecal space - the symptoms of spinal blockade. Prolonged (intermittent) levobupivacaine administered through the catheter must perform aspiration test (before the first and each subsequent additional injection). Getting the drug into the vessel is possible even in the absence of blood in the syringe during aspiration of the sample. When performing an epidural it is recommended to first enter a test dose and monitor the effect of levobupivacaine to the beginning of the administration of all medication in its entirety.Getting the drug into the vessel is possible even in the absence of blood in the syringe during aspiration of the sample. When performing an epidural it is recommended to first enter a test dose and monitor the effect of levobupivacaine to the beginning of the administration of all medication in its entirety.Getting the drug into the vessel is possible even in the absence of blood in the syringe during aspiration of the sample. When performing an epidural it is recommended to first enter a test dose and monitor the effect of levobupivacaine to the beginning of the administration of all medication in its entirety.
Any topical anesthetic agent for the epidural injection may cause a decrease in blood pressure and bradycardia. In this regard, all patients venous access should be provided. Also, make sure you have the appropriate solutions, vasopressors. anesthetics with anticonvulsant, muscle relaxants, atropine and equipment for resuscitation (see. "Overdose" section).
epidural analgesia
There are postmarketing data on the development of cauda equina syndrome and signs of neurotoxicity (see. Section "Side effects") that have been associated in time with the introduction of levobupivacaine for the purpose of epidural analgesia for 24 hours or more. When drug infusion longer than 24 hours, such phenomena were more severe, in some cases after these residual effects persisted. In this connection, introduction of the drug for longer than 24 hours should be carried out very carefully and only when the benefits of the patient far exceeds the risk.
When administered to any local anesthetic is necessary to perform aspiration of blood or cerebrospinal fluid (where necessary) before the main injection and each subsequent dose to avoid contact with the drug in the lumen or intrathecally. However, a negative aspiration test is not a guarantee against getting the drug into the bloodstream or intrathecal space. In patients receiving other local anesthetics or agents, similar in structure to local anesthetics of the amide type, levobupivacaine should be used with caution due to additive toxic action of these drugs.
Regional blockade of major nerve trunks
In order to ensure a functional venous access to a patient should be on / in the liquid flow through the indwelling catheter. To the plasma is not created a high concentration of the drug and did not develop severe adverse reactions, use the smallest dose of levobupivacaine, which allows to achieve effective anesthesia. It is impossible to introduce a large amount of anesthetic at high speed, possibly fractionally drug to be administered, gradually increasing the dose.
Local anesthesia in the area of head and neck
The introduction of even small doses of levobupivacaine in the head and neck (under retrobulbar blockade, blockade during dental procedures and stellate ganglion blockade) may cause severe adverse reactions similar to those in systemic toxic effects following accidental intravascular injection of the drug in high dose. The introduction of the drug requires extreme caution. Perhaps the development of reactions caused by intra-arterial injection of the anesthetic, and hit him in the cerebral blood flow retrograde through. Undesired reactions may also be linked to puncture the dura mater when the optic nerve; retrobulbar blockade with diffusion of any local anesthetic along the subdural space to the midbrain.It is necessary to carry out continuous monitoring and careful monitoring of the respiratory and cardiac function in patients who have carried out these types of blockages. You should also be available for resuscitation equipment and personnel with appropriate training.
Use of the drug in surgical ophthalmology
specialists who perform retrobulbar blockade should be aware of the possibility of respiratory failure at the local administration of the anesthetic. As with other embodiments, regional anesthesia, before the retrobulbar blockade is necessary to ensure the availability of equipment, personnel and medicines for the treatment of disorders such as depression or respiratory arrest, seizures, agitation or inhibition of cardiac activity. As well as after other types of anesthesia after retrobulbar blockade must be constant monitoring to keep track of the described undesired reactions.
Special patient groups
Use in oslavlennyh and elderly patients, and in patients with acute diseases
Levobupivacaine and debilitated elderly patients and in patients with acute disease should be used with caution (see. The section "Method of use and dosage").
Impaired liver function
Because levobupivacaine is metabolized in the liver in patients with liver diseases or with decreased liver blood flow (e.g., cirrhosis or alcoholic liver disease) preparation must be used with caution (see. the section "Precautions").
This medication contains 3.6 mg / ml sodium thing to consider in the application in patients receiving a diet with a controlled sodium.
Effects on ability to drive and operate machinery
Levobupivacaine can have a significant impact on the ability to drive and use machines. It is necessary to warn patients about the inadmissibility of driving and using machinery to solve all anesthesia effects and immediate effects of surgery.
OVERDOSE
After inadvertent intravascular injection of local anesthetic immediate toxic reaction can occur. If overdose its plasma concentration sometimes reaches a peak only at 2 hours after administration (depending on the injection site) thus toxic lesion symptoms may be delayed. Possible extension of the effect of the drug.
Systemic adverse reactions following overdose or inadvertent intravascular injection of long-acting local anesthetic include symptoms of the cardiovascular and central nervous system.
CNS effects
Should enter immediately upon the development of seizures in / sodium thiopental or diazepam, titrating the dose accordingly. Thiopental sodium and diazepam, too, can have a depressing effect on the central nervous system, respiratory and cardiovascular activity. Thus, the introduction of these drugs can develop apnea. Drugs that block neuromuscular transmission, should be used only if it is possible to maintain the patency of the airway and treat a patient with complete muscle relaxation.
In the absence of timely treatment of seizures, subsequent hypoxia and hypercapnia, as well as depression of cardiac activity under the influence of local anesthetics may cause cardiac arrhythmias, ventricular fibrillation and cardiac arrest.
Effect on cardiovascular system
Pretreatment with fluids and / or vasopressor use to prevent or reduce the decline in AD. By reducing the blood pressure is shown in / in infusion crystalloids and colloids and / or vasopressor administration in increasing doses (e.g., ephedrine 5-10 mg). It should also be like all the other reasons for the decrease in blood pressure can be eliminated quickly.
With the development of severe bradycardia advisable atropine at a dose of 0.3-1 mg, which can increase the heart rate to acceptable values. In the event of cardiac arrhythmias should be the appropriate treatment, ventricular fibrillation requires emergency cardioversion.
DRUG INTERACTION
In in vitro studies have shown that participate in the metabolism of levobupivacaine isozymes of cytochrome P450 CYP3A4 and CYP1A2. In the conversion of levobupivacaine may affect inhibitors isoenzyme CYP3A4 (in particular, ketoconazole) and CYP1A2 isoenzyme (eg methylxanthines), although clinical trials of such interactions was conducted.
Levobupivacaine should be used with caution in patients receiving antiarrhythmic drugs with properties of local anesthetics (mexiletine) and class III antiarrhythmics (using the latest additive may develop toxic effects).
Clinical trials of levobupivacaine action evaluation when combined with epinephrine was conducted.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be kept out of the reach of children at 15 to 30 В° C. Shelf life - 3 years.
Do not use after the expiration date printed on the package.
