Levobupivacaine Molteni
Long-Acting Local Anaesthetic for Regional Anaesthesia and Pain Relief
Quick Facts About Levobupivacaine Molteni
Key Takeaways
- Levobupivacaine Molteni is a long-acting local anaesthetic used for epidural, spinal, and peripheral nerve block anaesthesia, as well as postoperative and labour pain relief.
- It is the S-enantiomer of bupivacaine and offers a superior cardiovascular safety profile compared to racemic bupivacaine at equivalent anaesthetic potency.
- This medication must only be administered by or under the supervision of physicians experienced in regional anaesthesia, with resuscitation equipment immediately available.
- The maximum recommended single dose is 150 mg, with a 24-hour maximum of 400 mg. Doses must be carefully adjusted based on patient weight, age, and physical condition.
- Common side effects include low blood pressure, nausea, and anaemia; serious but rare complications include cardiac arrest, seizures, and severe allergic reactions.
What Is Levobupivacaine Molteni and What Is It Used For?
Quick Answer: Levobupivacaine Molteni is a local anaesthetic that numbs or provides pain relief to specific areas of the body. It is used for surgical anaesthesia, labour analgesia, and postoperative pain management in both adults and children.
Levobupivacaine Molteni belongs to a group of medicines known as local anaesthetics. These medicines work by reversibly blocking the transmission of nerve impulses, producing a temporary loss of sensation (anaesthesia) or pain relief (analgesia) in specific regions of the body. Unlike general anaesthetics, local anaesthetics allow the patient to remain conscious during procedures, which can reduce the risks associated with general anaesthesia and facilitate faster recovery.
Levobupivacaine is the pure left-handed (S-enantiomer) form of bupivacaine, one of the most widely used local anaesthetics in clinical practice. By isolating this single enantiomer, researchers were able to retain the anaesthetic potency of bupivacaine while significantly reducing the risk of cardiac and central nervous system toxicity. This improved safety profile has made levobupivacaine a preferred choice for procedures requiring large volumes of long-acting local anaesthetic, particularly in obstetric and major surgical settings.
Uses in Adults and Adolescents (12 Years and Older)
In adult and adolescent patients, Levobupivacaine Molteni is used for a variety of clinical applications. For major surgical procedures, it is administered as an epidural anaesthetic — an injection into the space surrounding the spinal cord — to numb the lower half of the body. This technique is commonly employed for abdominal, pelvic, and lower limb surgery, as well as for caesarean section delivery, where it provides effective surgical anaesthesia while allowing the mother to remain awake and alert for the birth.
For minor surgical procedures, levobupivacaine can be used for peripheral nerve blocks, where the anaesthetic is injected near specific nerves to numb a targeted region such as the eye, mouth, arm, or leg. It is also used for local infiltration — injection directly into the tissues at the surgical site — and for intrathecal (spinal) anaesthesia, where a small dose is injected into the cerebrospinal fluid surrounding the spinal cord to produce rapid, profound anaesthesia of the lower body.
Beyond surgical anaesthesia, Levobupivacaine Molteni plays a critical role in pain management. It is widely used for labour analgesia, providing effective pain relief during childbirth via epidural administration. For postoperative pain management, it can be administered as a continuous epidural infusion, delivering sustained pain relief for up to 24 hours or longer following surgery, reducing the need for systemic opioid analgesics and their associated side effects.
Uses in Children (Under 12 Years of Age)
In paediatric patients, Levobupivacaine Molteni is approved for anaesthesia of specific body regions before surgery and for pain relief following minor surgical procedures. The most common paediatric application is the ilioinguinal and iliohypogastric nerve block, used to provide anaesthesia and postoperative analgesia for inguinal hernia repair. The safety and efficacy of levobupivacaine have not been established in infants under 6 months of age.
What Should You Know Before Receiving Levobupivacaine Molteni?
Quick Answer: Levobupivacaine Molteni must not be given if you are allergic to levobupivacaine or similar local anaesthetics, have very low blood pressure, or require paracervical block during labour or intravenous regional anaesthesia. Inform your doctor about all medical conditions and medications before your procedure.
Contraindications
There are specific situations in which Levobupivacaine Molteni must not be used. Your anaesthetist will carefully screen for these contraindications before administering the medication. The drug is contraindicated in patients who have a known allergy (hypersensitivity) to levobupivacaine, to any other amide-type local anaesthetic (such as bupivacaine, ropivacaine, or lidocaine), or to any of the excipients contained in the formulation.
Levobupivacaine Molteni must not be used for intravenous regional anaesthesia (also known as Bier block), a technique in which a local anaesthetic is injected into a vein of a limb that has been isolated from the systemic circulation by a tourniquet. This technique carries an unacceptable risk of systemic toxicity if the tourniquet fails. Additionally, it must not be used for paracervical block during labour — an injection around the cervix — due to the risk of causing foetal bradycardia and other adverse effects on the unborn child.
Patients with severe hypotension (very low blood pressure) should not receive levobupivacaine, as the drug may further reduce blood pressure through its sympatholytic effects, particularly during epidural or spinal administration.
Warnings and Precautions
Certain patient populations require closer monitoring or dose adjustments when receiving Levobupivacaine Molteni. You should inform your doctor or anaesthetist before the procedure if any of the following conditions apply to you:
- Heart problems: Patients with cardiovascular disease, including conduction abnormalities, heart failure, or coronary artery disease, may be more susceptible to the cardiotoxic effects of local anaesthetics and require reduced doses and enhanced cardiac monitoring.
- Neurological conditions: Diseases affecting the central or peripheral nervous system may alter the response to local anaesthetics and increase the risk of neurological complications.
- General debility or acute illness: Frail, debilitated, or acutely unwell patients have reduced physiological reserve and may be more sensitive to the systemic effects of levobupivacaine. Reduced doses are recommended.
- Advanced age: Elderly patients often have reduced hepatic blood flow and impaired drug metabolism, which can prolong the duration of action and increase the risk of systemic toxicity. Dose reduction and careful titration are essential.
- Liver disease: As levobupivacaine is extensively metabolised by the liver, patients with hepatic impairment may have significantly reduced clearance of the drug, increasing the risk of accumulation and toxicity during prolonged use or repeated dosing.
Pregnancy and Breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, inform your doctor before receiving Levobupivacaine Molteni. The use of this medication during pregnancy requires careful consideration of the benefits and risks in each individual case.
Levobupivacaine is widely and safely used during labour and delivery for epidural analgesia and for epidural anaesthesia during caesarean section. However, it must not be used for paracervical block during labour. Furthermore, it should not be administered during the first trimester of pregnancy unless considered essential by the treating physician, as the effects of levobupivacaine on early foetal development have not been fully characterised in human studies.
Regarding breastfeeding, it is not definitively known whether levobupivacaine is excreted into human breast milk. However, experience with the closely related compound bupivacaine suggests that only very small amounts would be expected to pass into breast milk. Based on this evidence, breastfeeding is generally considered safe following the use of levobupivacaine as a local anaesthetic. You should inform your anaesthetist if you are breastfeeding so that this can be factored into your care plan.
There are no available data on the effects of levobupivacaine on human fertility.
Driving and Operating Machinery
You should not drive, cycle, or operate tools or machinery while you are under the effects of Levobupivacaine Molteni. This medication can have significant effects on your coordination, sensation, and motor function, depending on the type of block performed. You should wait until all effects of both the anaesthetic and the surgical procedure have fully resolved before undertaking these activities. Discuss the expected recovery timeline with your anaesthetist or nurse before leaving the hospital or clinic.
Sodium Content
Levobupivacaine Molteni 2.5 mg/ml contains approximately 3.3 mg of sodium per ml of solution, equivalent to approximately 33 mg sodium per 10 ml ampoule. This corresponds to 1.65% of the maximum recommended daily sodium intake for adults. This should be taken into account for patients on a controlled sodium diet.
How Does Levobupivacaine Molteni Interact with Other Drugs?
Quick Answer: Levobupivacaine may interact with antiarrhythmic drugs such as mexiletine, CYP3A4 inhibitors like ketoconazole, and CYP1A2 substrates such as theophylline. Always inform your anaesthetist about all medications you are taking.
Drug interactions with Levobupivacaine Molteni are an important clinical consideration. Although the drug is administered in a controlled hospital setting by healthcare professionals, it is essential that your anaesthetist has a complete and accurate list of all medications you are currently taking, including prescription medicines, over-the-counter drugs, and herbal or nutritional supplements. Some medicines may affect how levobupivacaine is metabolised in the body, potentially altering its duration of action or increasing the risk of toxicity.
Major Interactions
The most clinically significant interactions involve drugs that share similar pharmacological properties or that affect the hepatic enzymes responsible for metabolising levobupivacaine. Concurrent use of other local anaesthetics or structurally related drugs such as Class IB antiarrhythmics (e.g., mexiletine, lidocaine) may produce additive effects on the cardiovascular and central nervous systems. When levobupivacaine is used alongside these agents, the total combined dose of all local anaesthetic-type drugs must be carefully considered to avoid exceeding safe thresholds.
Levobupivacaine is primarily metabolised by the hepatic cytochrome P450 enzymes CYP3A4 and CYP1A2. Potent inhibitors of CYP3A4, such as ketoconazole (used for fungal infections and Cushing's syndrome), can significantly reduce the clearance of levobupivacaine, leading to higher plasma concentrations and a prolonged duration of action. This may increase the risk of systemic toxicity, particularly during continuous infusions or repeated dosing.
Minor Interactions
Theophylline, a drug used in the treatment of asthma and chronic obstructive pulmonary disease (COPD), is metabolised by CYP1A2 and may compete with levobupivacaine for this metabolic pathway. While the clinical significance of this interaction is generally considered modest, it may result in altered plasma levels of either drug, and patients receiving both agents should be monitored appropriately.
| Interacting Drug | Mechanism | Clinical Effect | Severity |
|---|---|---|---|
| Mexiletine and other Class IB antiarrhythmics | Additive sodium channel blockade | Increased risk of cardiac toxicity | Major |
| Ketoconazole | CYP3A4 inhibition | Reduced clearance, increased plasma levels | Major |
| Other local anaesthetics (e.g., lidocaine, bupivacaine) | Additive pharmacological effect | Increased risk of systemic toxicity | Major |
| Class III antiarrhythmics (e.g., amiodarone) | Additive cardiac conduction effects | Increased risk of arrhythmia | Major |
| Theophylline | CYP1A2 competition | Altered plasma levels of either drug | Moderate |
| Opioids (e.g., fentanyl, morphine) | Pharmacodynamic synergy | Enhanced analgesia; reduced levobupivacaine dose needed | Minor (beneficial) |
| Clonidine | Pharmacodynamic synergy | Prolonged duration of nerve block | Minor (beneficial) |
What Is the Correct Dosage of Levobupivacaine Molteni?
Quick Answer: Dosage depends on the type of procedure, the site of injection, and the patient's weight, age, and physical condition. The maximum single dose for adults is 150 mg, with a 24-hour maximum of 400 mg. This medication is always administered by a qualified physician.
The dosage of Levobupivacaine Molteni is highly individualised and is determined by several factors, including the type and extent of the surgical procedure, the specific nerve block technique employed, the patient's body weight and physical condition, and the desired duration and intensity of anaesthesia or analgesia. Your anaesthetist will carefully calculate the lowest effective dose to achieve the required block while minimising the risk of adverse effects.
Levobupivacaine Molteni is available in two concentrations: 2.5 mg/ml and 5 mg/ml. The choice of concentration depends on the clinical indication. Lower concentrations (1.25–2.5 mg/ml) are generally used for analgesia, where sensory block is desired with minimal motor blockade. Higher concentrations (5–7.5 mg/ml) are used for surgical anaesthesia, where more complete sensory and motor block is required.
Adults and Adolescents (12 Years and Older)
| Indication | Concentration | Dose | Motor Block |
|---|---|---|---|
| Epidural bolus for surgery | 5.0–7.5 mg/ml | 10–20 ml (50–150 mg) | Moderate to complete |
| Epidural for caesarean section | 5.0 mg/ml | 15–30 ml (75–150 mg) | Moderate to complete |
| Intrathecal (spinal) | 5.0 mg/ml | 3 ml (15 mg) | Moderate to complete |
| Peripheral nerve block | 2.5–5.0 mg/ml | 1–40 ml (2.5–150 mg max.) | Moderate to complete |
| Peribulbar block (eye surgery) | 7.5 mg/ml | 5–15 ml (37.5–112.5 mg) | Moderate to complete |
| Local infiltration | 2.5 mg/ml | 1–60 ml (2.5–150 mg max.) | Not applicable |
| Labour epidural bolus | 2.5 mg/ml | 6–10 ml (15–25 mg) | Minimal to moderate |
| Labour epidural infusion | 1.25 mg/ml | 4–10 ml/h (5–12.5 mg/h) | Minimal to moderate |
| Postoperative epidural infusion | 1.25–2.5 mg/ml | 5–15 ml/h (12.5–18.75 mg/h) | Minimal to moderate |
For epidural administration in surgical settings, the bolus dose should be administered slowly over at least 5 minutes, in incremental doses, at a rate of 7.5–30 mg per minute. During this time, the patient's vital signs should be continuously monitored and verbal contact maintained. For caesarean section, the epidural dose should be given over 15–20 minutes. Concentrations exceeding 5.0 mg/ml must not be used for obstetric epidural anaesthesia.
Clinical studies have demonstrated that sensory block sufficient for surgery typically develops within 10–15 minutes after epidural administration, with complete regression occurring after 6–9 hours. The recommended maximum single dose is 150 mg. When prolonged procedures require additional doses, the total dose over 24 hours should not exceed 400 mg. For continuous postoperative epidural infusions, the dose should not exceed 18.75 mg per hour.
Children (Under 12 Years of Age)
Paediatric Dosing — Ilioinguinal/Iliohypogastric Nerve Block
The recommended maximum dose is 1.25 mg/kg per side. Using the 2.5 mg/ml concentration, this equates to 0.5 ml/kg per side. Using the 5.0 mg/ml concentration, this equates to 0.25 ml/kg per side. The dose must be adjusted based on the child's body weight, body composition, and physical status. Safety and efficacy have not been established in children under 6 months of age.
Elderly and Debilitated Patients
Frail, elderly, or acutely ill patients should receive reduced doses of levobupivacaine, carefully adjusted to their physical condition. The elderly often have diminished hepatic function and reduced cardiac output, which can slow the metabolism and clearance of the drug. When calculating doses for these patients, the anaesthetist will also take into account any levobupivacaine already administered during the surgical procedure when planning postoperative analgesia.
Overdose
Because Levobupivacaine Molteni is administered by trained healthcare professionals in a clinical setting, overdose is unlikely. However, if an inadvertent overdose or accidental intravascular injection occurs, it can lead to serious systemic toxicity known as local anaesthetic systemic toxicity (LAST). Early symptoms of LAST include numbness of the tongue, lightheadedness, dizziness, blurred vision, and muscle twitching. More severe manifestations include difficulty breathing and seizures.
In the most serious cases, cardiovascular toxicity may develop, presenting as low blood pressure, abnormally fast or slow heart rate, cardiac arrhythmias, and potentially cardiac arrest. Immediate treatment includes stopping the injection, maintaining the airway, providing cardiovascular support, and administering intravenous lipid emulsion (Intralipid 20%), which has become the standard rescue therapy for local anaesthetic cardiotoxicity. If you experience any unusual symptoms during or after the administration of this medication, you should inform the medical team immediately.
What Are the Side Effects of Levobupivacaine Molteni?
Quick Answer: Very common side effects include anaemia, low blood pressure, and nausea. Common side effects include headache, dizziness, vomiting, and fever. Rare but serious effects include cardiac arrest, seizures, and severe allergic reactions. Contact medical staff immediately if you experience any concerning symptoms.
Like all medicines, Levobupivacaine Molteni can cause side effects, although not everybody experiences them. Many of the side effects associated with levobupivacaine are related to the anaesthetic procedure itself rather than being specific pharmacological effects of the drug. The type and severity of side effects depend on the dose administered, the site of injection, the technique used, and the individual patient's sensitivity.
It is important to understand that while you are receiving levobupivacaine, you will be continuously monitored by healthcare professionals who are trained to recognise and manage any adverse effects that may occur. If you experience any unusual sensations or symptoms during or after your procedure, you should inform the medical team immediately.
Very Common
May affect more than 1 in 10 people
- Anaemia (feeling tired, weak, short of breath, or looking pale)
- Low blood pressure (hypotension)
- Nausea
Common
May affect up to 1 in 10 people
- Dizziness
- Headache
- Vomiting
- Foetal distress (discomfort to the unborn baby during obstetric use)
- Back pain
- Fever (elevated body temperature)
- Postoperative pain
Not Known Frequency — Cardiovascular
Frequency cannot be estimated from available data
- Heart block or cardiac arrest
- Rapid, slow, or irregular heartbeat
- Changes in heart rhythm (visible on ECG)
- Fainting (syncope)
Not Known Frequency — Other Serious Effects
Frequency cannot be estimated from available data
- Severe allergic reactions (anaphylaxis) with breathing difficulties, swelling of the face, lips, or throat, and very low blood pressure
- Allergic skin reactions with itching, redness, rash, hives, or excessive sweating
- Seizures (convulsions)
- Drowsiness or loss of consciousness
- Blurred vision
- Respiratory arrest (breathing stops)
- Tingling, numbness, or abnormal sensations in parts of the body
- Numbness of the tongue
- Muscle weakness or twitching
- Loss of bladder and bowel control
- Paralysis
- Prolonged, potentially painful erection (priapism)
- Horner syndrome (drooping eyelid, small pupil, sunken eye, facial sweating/flushing on one side)
In rare cases, certain side effects may be prolonged or permanent, particularly those involving nerve damage. However, it is often difficult to distinguish between effects caused by the anaesthetic and those resulting from the surgical procedure itself, the patient's position during surgery, or other factors. If you experience any persistent symptoms following your procedure, you should report them to your healthcare team for appropriate investigation and management.
How Should Levobupivacaine Molteni Be Stored?
Quick Answer: Keep out of the sight and reach of children. No special storage conditions are required. Use before the expiry date. Once opened, use immediately. Do not use if the solution contains visible particles or is not clear.
Levobupivacaine Molteni should be stored out of the sight and reach of children. This medication does not require any special storage conditions — it can be kept at room temperature. You should not use this medicine after the expiry date stated on the label and carton, where the expiry date refers to the last day of that month.
Once the ampoule has been opened, the solution should be used immediately. Levobupivacaine Molteni is intended for single use only; any remaining solution after use must be discarded. From a microbiological standpoint, once opened, the product should be used immediately. If diluted with 0.9% sodium chloride solution, chemical and physical stability has been demonstrated for 7 days at 20–22°C. When mixed with clonidine, morphine, or fentanyl, stability has been demonstrated for 40 hours at 20–22°C.
Before use, the solution should be visually inspected. Only clear solutions without visible particles should be used. Do not use this medicine if you notice any particles floating in the solution or if the solution appears cloudy or discoloured. Medicines should not be disposed of via household waste or wastewater. These precautions help to protect the environment.
What Does Levobupivacaine Molteni Contain?
Quick Answer: The active substance is levobupivacaine (as hydrochloride). Each ml of the 2.5 mg/ml solution contains 2.5 mg of levobupivacaine. Other ingredients include water for injections, sodium chloride, sodium hydroxide, and hydrochloric acid for pH adjustment.
The active substance in Levobupivacaine Molteni is levobupivacaine, present as levobupivacaine hydrochloride. The 2.5 mg/ml formulation contains 2.5 mg of levobupivacaine per millilitre of solution, meaning each 10 ml ampoule contains a total of 25 mg of levobupivacaine. The 5 mg/ml formulation contains 5 mg per millilitre, with each 10 ml ampoule containing 50 mg.
The other ingredients (excipients) are:
- Water for injections — serves as the solvent
- Sodium chloride — used to adjust the tonicity (osmolarity) of the solution to be isotonic with body fluids
- Sodium hydroxide — used for pH adjustment
- Hydrochloric acid — used for pH adjustment
Levobupivacaine Molteni is a clear, colourless solution supplied in polypropylene ampoules. Each ampoule contains 10 ml of solution, and the product is supplied in packs of 10 ampoules. The solution must not be mixed with alkaline solutions such as sodium bicarbonate, as this may cause the active ingredient to precipitate out of solution.
The marketing authorisation holder and manufacturer is L. Molteni & C. dei F.lli Alitti Società di Esercizio SpA, based in Scandicci (Florence), Italy. This medicine is authorised within the European Economic Area under various names, including Levobupivacaine Molteni (Netherlands, Poland), Levobupivacaine Medac (France), and Levobupivacaina Molteni (Italy).
Frequently Asked Questions
Levobupivacaine Molteni is a local anaesthetic used for surgical anaesthesia via epidural, intrathecal (spinal), or peripheral nerve block techniques. It is also used for pain relief during labour (epidural analgesia), postoperative pain management via continuous epidural infusion, and local infiltration at surgical sites. In adults and adolescents, it is approved for both major and minor surgical procedures. In children, it is used primarily for ilioinguinal and iliohypogastric nerve blocks during hernia repair surgery.
Yes. Levobupivacaine is the pure S-enantiomer of bupivacaine and has been shown in multiple clinical studies and volunteer trials to have a significantly lower potential for cardiovascular and central nervous system toxicity compared to racemic bupivacaine. This means that in the event of accidental intravascular injection, levobupivacaine is associated with a wider margin of safety before life-threatening cardiac events occur. The anaesthetic efficacy is considered equivalent for most clinical applications.
The duration of anaesthetic effect depends on the dose, concentration, and the specific technique used. For epidural anaesthesia, sensory block typically begins within 10–15 minutes of administration and lasts for 6–9 hours. For continuous epidural infusions used for postoperative pain or labour analgesia, the effect is maintained for as long as the infusion continues. For peripheral nerve blocks, the duration varies depending on the nerve blocked and the concentration used, but generally ranges from 4 to 12 hours.
Yes, breastfeeding is generally considered safe after receiving levobupivacaine. Based on experience with the closely related compound bupivacaine, only very small amounts of the drug are expected to pass into breast milk, and these are not considered clinically significant for the nursing infant. However, you should inform your anaesthetist that you are breastfeeding so they can factor this into your overall care plan.
If you experience any unusual symptoms during or after receiving Levobupivacaine Molteni, you should inform the medical team immediately. Key symptoms to watch for include numbness of the tongue, dizziness, blurred vision, muscle twitching, difficulty breathing, rapid or irregular heartbeat, and any signs of allergic reaction such as rash, itching, or swelling. Since you will typically be in a clinical setting with continuous monitoring, the medical team is equipped to recognise and manage any adverse effects promptly.
Yes, Levobupivacaine Molteni can be used in children for ilioinguinal and iliohypogastric nerve blocks, typically for hernia repair surgery. The recommended maximum dose is 1.25 mg/kg per side. However, the safety and efficacy of levobupivacaine have not been established in infants under 6 months of age, and it should not be used in this age group. Your child's anaesthetist will carefully calculate the appropriate dose based on the child's weight and physical condition.
References
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About Our Medical Team
This article has been written and medically reviewed by our editorial team of licensed physicians specialising in anaesthesiology, clinical pharmacology, and pain medicine. Our team follows the GRADE evidence framework and adheres to international guidelines from ESRA, ASRA, and WHO.
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