Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
The safety and effectiveness of local anesthetics depend upon proper dosage, correct technique, adequate precautions, and readiness for emergencies. The lowest dosage that gives effective anesthesia should be used in order to avoid high plasma levels and serious systemic side effects. Injection of repeated doses of bupivacaine may cause significant increase in blood levels with each additional dose, due to accumulation of the drug or its metabolites or due to slow metabolic degradation.
Tolerance varies with the status of the patient. Debilitated, elderly patients and acutely ill patients should be given reduced doses commensurate with age and physical condition. Because of the long duration of anesthesia, when bupivacaine with epinephrine is used for dental injections, patients should be cautioned about the possibility of inadvertent trauma to tongue, lips, and buccal mucosa and advised not to chew solid foods or test the anesthetized area by biting or probing.
Changes in sensorium, such as excitation, disorientation, drowsiness, may be early indications of a high blood level of the drug and may occur following inadvertent intravascular administration or rapid absorption of bupivacaine. Solutions containing a vasoconstrictor should be used cautiously in areas with limited blood supply, in the presence of diseases that may adversely affect the patient's cardiovascular system, or in patients with peripheral vascular disease. Caution is advised in administration of repeat doses of bupivacaine to patients with severe liver disease.
If sedatives are employed to reduce patient apprehension, use reduced doses, since local anesthetic agents, like sedatives, are central nervous system depressants which in combination may have an additive effect. Serious dose-related cardiac arrhythmias may occur if preparations containing a vasoconstrictor such as epinephrine are employed in patients during or following the administration of chloroform, halothane, cyclopropane, trichloroethylene, or other related agents.
In deciding whether to use these products concurrently in the same patient, the combined action of both agents upon the myocardium, the concentration and volume of vasoconstrictor used, and the time since injection, when applicable, should be taken into account. The administration of local anesthetic solutions containing epinephrine or norepinephrine to patients receiving mono-amine oxidase inhibitors or tricyclic antidepressants may produce severe, prolonged hypertension.
Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential. Concurrent administration of vasopressor drugs and of ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents.
Long-term studies in animals to evaluate the carcinogenic potential of bupivacaine hydrochloride have not been conducted. The mutagenic potential and the effect on fertility of bupivacaine hydrochloride has not been determined.
There are no adequate and well-controlled studies in pregnant women. Bupivacaine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Bupivacaine hydrochloride produced development toxicity when administered subcutaneously to pregnant rats and rabbits at clinically relevant doses.
This does not exclude the use of bupivacaine at term for obstetrical anesthesia or analgesia. Bupivacaine hydrochloride was administered subcutaneously to rats at doses of 4.
No embryo-fetal effects were observed in rats at the high dose which caused increased maternal lethality. In a rat pre- and post-natal development study dosing from implantation through weaning conducted at subcutaneous doses of 4.
Cardiovascular disease. Monitor cardiovascular and respiratory vital signs. Hypertensive vascular disease. Risk of respiratory arrest in ophthalmic surgery. Moderate to severe hepatic impairment. Renal impairment. Malignant hyperthermia. Head and neck administration.
Avoid intravascular or intrathecal injection. Documentation SDS. Package Insert. Subscribe to the newsletter. Septodont uses cookies to give you the best possible experience whilst browsing our sites. Contact Title Select These doses may be repeated once every three hours. Do not exceed a total daily dosage of mg in 24 hours.
The duration of anesthetic effect may be prolonged by the addition of epinephrine. When using a "continuous" catheter technique, test doses should be given prior to both the initial and all supplemental doses, because a catheter in the epidural space can migrate into a blood vessel or through the dura [see Dosage and Administration 2.
Administer injections slowly, with frequent aspirations before and during the injection to avoid intravascular injection. Perform syringe aspirations before and during each supplemental injection in continuous intermittent catheter techniques. In obstetrics, use ONLY the 0. Repeat doses should be preceded by a test dose containing epinephrine if not clinically contraindicated. Use only the single-dose vials for caudal or epidural anesthesia; avoid use of the multiple-dose vials for these procedures, which contain a preservative [see Dosage and Administration 2.
This test dose may serve as a warning of unintended intravascular or intrathecal injection. Closely monitor for early clinical signs of toxicity following each test dose [see Warnings and Precautions 5. Allot adequate time for onset of spinal block to detect possible intrathecal injection.
An intravascular or intrathecal injection is still possible even if results of the test dose are negative. The test dose itself may produce a systemic toxic reaction, high spinal, or cardiovascular effects from the epinephrine [see Warnings and Precautions 5.
The average dose of 1. Use the lowest effective dose and allow time between injections; it is recommended that the total dose for all injection sites, spread out over a single dental sitting, not exceed 90 mg for a healthy adult patient ten 1.
Inject slowly and with frequent aspirations. Therefore, presence of akinesia rather than anesthesia alone should determine readiness of the patient for surgery [see Warnings and Precautions 5. Possible early warning signs of central nervous system CNS toxicity are restlessness, anxiety, incoherent speech, lightheadedness, numbness and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, CNS depression, or drowsiness.
During major regional nerve blocks, such as those of the brachial plexus or lower extremity, the patient should have an indwelling intravenous catheter to assure adequate intravenous access. Tolerance to elevated blood levels varies with the status of the patient. Debilitated, elderly patients and acutely ill patients should be given reduced doses commensurate with their age and physical status.
Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucosephosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition [see Drug Interactions 7.
If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious CNS and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death.
Depending on the severity of the signs and symptoms, patients may respond to supportive care, i. A more severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen. Intra-articular infusions of local anesthetics including MARCAINE following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions.
The majority of reported cases of chondrolysis have involved the shoulder joint; cases of gleno-humeral chondrolysis have been described in pediatric and adult patients following intra-articular infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hours. There is insufficient information to determine whether shorter infusion periods are associated with chondrolysis.
The time of onset of symptoms, such as joint pain, stiffness and loss of motion can be variable, but may begin as early as the 2 nd month after surgery. Currently, there is no effective treatment for chondrolysis; patients who experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement.
Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful monitoring of the patient's hemodynamic status is essential [see Drug Interactions 7. In situations when concurrent therapy is necessary, careful monitoring of the patient's blood pressure and heart rate is essential [see Drug Interactions 7. There have been reports of cardiac arrest and death during the use of bupivacaine for intravenous regional anesthesia Bier Block.
The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people. Unintentional intrathecal injection during the intended performance of caudal or lumbar epidural block or nerve blocks near the vertebral column has resulted in underventilation or apnea "Total or High Spinal". A high spinal has been characterized by paralysis of the legs, loss of consciousness, respiratory paralysis, and bradycardia [see Adverse Reactions 6 ].
However, a negative aspiration for blood or cerebrospinal fluid does not ensure against an intravascular or intrathecal injection.
The test dose itself may produce a systemic toxic reaction, high spinal or epinephrine-induced cardiovascular effects [see Overdosage 10 ]. Monitor patients closely for blood pressure, heart rate, and ECG changes. Patients with hypertensive vascular disease may exhibit exaggerated vasoconstrictor response. Ischemic injury or necrosis may result. Serious dose-related cardiac arrhythmias may occur if preparations containing a vasoconstrictor such as epinephrine e. Small doses of local anesthetics e.
The injection procedures require the utmost care. These reactions may be due to intra-arterial injection of the local anesthetic with retrograde flow to the cerebral circulation. They may also be due to puncture of the dural sheath of the optic nerve during retrobulbar block with diffusion of any local anesthetic along the subdural space to the midbrain. Resuscitative equipment and drugs, and personnel for treating adverse reactions should be immediately available.
Dosage recommendations should not be exceeded [see Dosage and Administration 2. Clinicians who perform retrobulbar blocks should be aware that there have been reports of respiratory arrest following local anesthetic injection. Prior to retrobulbar block e. As with other anesthetic procedures, patients should be constantly monitored following ophthalmic blocks for signs of these adverse reactions, which may occur following relatively low total doses.
A concentration of 0. The following clinically significant adverse reactions have been reported and described in the Warnings and Precautions section of the labeling:.
The following adverse reactions from voluntary reports or clinical studies have been reported with bupivacaine or bupivacaine and epinephrine. Because many of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. A major cause of adverse reactions to this group of drugs is excessive plasma levels, which may be due to overdosage, unintentional intravascular injection, or slow metabolic degradation.
The most commonly encountered acute adverse reactions that demand immediate counter-measures were related to the CNS and the cardiovascular system.
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