Bupivacaine liposomal injection
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Liposomal injection of bupivacaine.
Drugs List
Therapeutic Indications
Uses
Anaesthetic for field blocks
Local anaesthetic for nerve block peripheral
Brachial plexus block or femoral nerve block for treatment of post-operative pain.
Field block for treatment of somatic post-operative pain from small to medium sized surgical wounds.
Dosage
Due to the complexity and specialist nature of using anaesthesia, specific dosing information on this agent is not included. When using this agent, specialist literature, national guidelines and Trust policies should be consulted to ensure appropriate dosage and assessment of all relevant patient factors.
Administration
For infiltration and perineural use only.
Contraindications
Children under 1 year
Breastfeeding
Obstetric paracervical anaesthesia
Pregnancy
Precautions and Warnings
Children aged 1 to 18 years
Elderly
Females of childbearing potential
Cardiovascular disorder
G6PD deficiency
Hepatic impairment
Methaemoglobinaemia
Pulmonary compromise
Renal impairment
Advise patient ability to drive or operate machinery may be impaired
Advise patient not to drive until they know how the medicine affects them
Different formulations are not bioequivalent
Resuscitation facilities must be immediately available
Treatment to be initiated by medically trained personnel
Monitor for signs and symptoms of allergic reaction
Monitor for signs of neurological toxicity
Monitor patient for signs of methaemoglobinaemia
Monitor patients with hepatic impairment
Monitor vital signs, respiration & cardiac function
Discontinue therapy immediately & permanently if methaemoglobinaemia occurs
Female: Ensure adequate contraception during treatment
High plasma concentrations of local anaesthetics during treatment or unintended intravascular injection of local anaesthetic solution may cause acute emergencies that are due to neurological or cardiovascular toxicity. Significant increases in plasma concentrations can be caused by repeated dose administration due to slow accumulation of the active substance or its metabolites. Toxic local anaesthetic blood concentrations depress cardiac conductivity and excitability resulting in atrioventricular block, ventricular arrhythmia, and cardiac arrest. The impact of toxic local anaesthetic blood concentrations in decreasing cardiac output and arterial blood pressure are due to the depression of myocardial contractility and peripheral vasodilation.
Caution is required when co-administering bupivacaine liposomal and bupivacaine hydrochloride, especially when administering to highly vascular areas where higher systemic absorption is expected. Bupivacaine liposomal can be administered simultaneously with bupivacaine hydrochloride in the same syringe as long as the ratio of the milligram dose of bupivacaine hydrochloride solution to bupivacaine liposomal does not exceed 1:2. The total amount of bupivacaine hydrochloride and bupivacaine liposomal being administered at the same time should not exceed 400mg equivalents of bupivacaine hydrochloride.
Bupivacaine liposomal is not recommended for use as a femoral nerve block if early mobilization and ambulation is part of the patient's recovery plan. If bupivacaine is used, sensory and/or motor loss may occur however, this is temporary and the degree of loss and duration varies depending on the site of injection and dosage administered.
Caution is required when bupivacaine is used in patients with impaired cardiovascular function because they may be less able to compensate for functional changes associated with the prolongation of atrioventricular conduction produced by bupivacaine.
Pregnancy and Lactation
Pregnancy
Bupivacaine liposomal is contraindicated during pregnancy.
The manufacturer does not recommend using bupivacaine liposomal during pregnancy and in women of childbearing potential not using contraception. Animal studies have shown reproductive toxicity. Human data is limited and as such potential risk cannot be ruled out.
Lactation
Bupivacaine liposomal is contraindicated during breastfeeding.
The manufacturer advises that the patient either discontinues bupivacaine liposomal or discontinues breastfeeding taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman. Bupivacaine and its metabolite are present in human milk at low levels. Effects on exposed infants or its effects on milk production is unknown.
Side Effects
Abdominal discomfort
Abdominal distension
Alanine aminotransferase increased
Anxiety
Apnoea
Arthralgia
Aspartate aminotransferase increased
Atelectasis
Atrial fibrillation
Blurred vision
Bradycardia
Burning sensation
Cardiac arrest
Chills
Confusion
Constipation
Contusion
Convulsions
Decreased limb mobility
Diarrhoea
Diplacusis
Discolouration of nails
Dizziness
Drug rash
Dry mouth
Dysgeusia
Dyspepsia
Dysphagia
Dyspnoea
Dysrhythmia
Erythema
Falls
Feeling hot
Flushing
General pruritus
Groin pain
Haematochezia
Headache
Hyperhidrosis
Hypersensitivity reactions
Hypertension
Hypoaesthesia
Hypoxia
Incision site erythema
Increases in hepatic enzymes
Joint stiffness
Joint swelling
Lethargy
Local Anaesthetic Systemic Toxicity
Methaemoglobinaemia
Monoplegia
Motor disturbances
Muscle injury
Muscle spasm
Muscle twitch
Muscle weakness
Musculoskeletal chest pain
Nausea
Non-cardiac chest pain
Oedema
Oral hypoaesthesia
Oral paraesthesia
Oral pruritus
Oropharyngeal pain
Pain
Pain / soreness (injection site)
Painful extremities
Paralysis
Peripheral oedema
Presyncope
Procedural pain
Pruritus
Pyrexia
Rash
Salivary hypersecretion
Seizures
Sensory loss
Seroma
Serum creatinine increased
Severe hypotension
Sinus tachycardia
Skin irritation
ST segment elevation
Syncope
Tachyarrhythmia
Tachycardia
Upper abdominal pain
Urinary retention
Urticaria
Visual disturbances
Vomiting
White blood cell count raised
Wound complication
Reference Sources
Summary of Product Characteristics: Exparel liposomal 133mg/10ml prolonged-release dispersion for injection. Pacira Ltd. Revised January 2021.
Summary of Product Characteristics: Exparel liposomal 266mg/20ml prolonged-release dispersion for injection. Pacira Ltd. Revised January 2021.
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