Vivacaine
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Questions & Answers
Side Effects & Adverse Reactions
LOCAL ANESTHETICS SHOULD BE EMPLOYED ONLY BY CLINICIANS WHO ARE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHER ACUTE EMERGENCIES WHICH MIGHT ARISE FROM THE BLOCK TO BE EMPLOYED, AND THEN ONLY AFTER INSURING THE IMMEDIATE AVAILABILITY OF OXYGEN, OTHER RESUSCITATIVE DRUGS, CARDIOPULMONARY RESUSCITATIVE EQUIPMENT, AND THE PERSONNEL RESOURCES NEEDED FOR PROPER MANAGEMENT OF TOXIC REACTIONS AND RELATED EMERGENCIES. (See also ADVERSE REACTIONS and PRECAUTIONS.) DELAY IN PROPER MANAGEMENT OF DOSE-RELATED TOXICITY, UNDERVENTILATION FROM ANY CAUSE, AND/OR ALTERED SENSITIVITY MAY LEAD TO THE DEVELOPMENT OF ACIDOSIS, CARDIAC ARREST AND, POSSIBLY, DEATH.
Small doses of local anesthetics injected into the head and neck area, as small as nine to eighteen milligrams, may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses. Confusion, convulsions, respiratory depression, and/or respiratory arrest, cardiovascular stimulation or depression and cardiac arrest have been reported. Reactions resulting in fatalities have occurred on rare occasions. In a few cases, resuscitation has been difficult or impossible despite apparently adequate preparation and appropriate management. These reactions may be due to intra-arterial injection of the local anesthetic with retrograde flow to the cerebral circulation. Patients receiving these blocks should have their circulation and respiration monitored and be constantly observed. Resuscitative equipment and personnel for treating adverse reactions should be immediately available. Dosage recommendations should not be exceeded (see DOSAGE AND ADMINISTRATION).
It is essential that aspiration for blood or cerebrospinal fluid (where applicable) be done prior to injecting any local anesthetic, both the original dose and all subsequent doses, to avoid intravascular injection. However, a negative aspiration does not ensure against an intravascular injection.
Reactions resulting in fatality have occurred on rare occasions with the use of local anesthetics, even in the absence of a history of hypersensitivity.
This solution, which contains a vasoconstrictor, should be used with extreme caution for patients whose medical history and physical evaluation suggest the existence of hypertension, arteriosclerotic heart disease, cerebral vascular insufficiency, heart block, thyrotoxicosis and diabetes, etc., as well as patients receiving drugs likely to produce alterations in blood pressure.
Bupivacaine with epinephrine 1:200,000 or other vasopressors should not be used concomitantly with ergot-type oxytocic drugs, because a severe persistent hypertension may occur. Likewise, solutions of bupivacaine containing a vasoconstrictor, such as epinephrine, should be used with extreme caution in patients receiving monoamine oxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types, because severe prolonged hypertension may result.
Until further experience is gained in children younger than 12 years, administration of bupivacaine in this age group is not recommended.
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.
Vivacaine™ (bupivacaine hydrochloride and epinephrine injection, USP), along with other local anesthetics, is capable of producing methemoglobinemia. The clinical signs of methemoglobinemia are cyanosis of the nail beds and lips, fatigue and weakness. If methemoglobinemia does not respond to administration of oxygen, administration of methylene blue intravenously 1-2 mg/kg body weight over a 5 minute period is recommended.
The American Heart Association has made the following recommendations regarding the use of local anesthetics with vasoconstrictors in patients with ischemic heart disease: "Vasoconstrictor agents should be used in local anesthesia solutions during dental practice only when it is clear that the procedure will be shortened or the analgesia rendered more profound. When a vasoconstrictor is indicated, extreme care should be taken to avoid intravascular injection. The minimum possible amount of vasoconstrictor should be used." (Kaplan, EL, editor: Cardiovascular disease in dental practice, Dallas 1986, American Heart Association.)
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Vivacaine™ (bupivacaine hydrochloride and epinephrine injection, USP) is indicated for the production of local anesthesia for dental procedures by infiltration injection or nerve block in adults.
Vivacaine™ (bupivacaine hydrochloride and epinephrine injection, USP) is not recommended for children.
History
There is currently no drug history available for this drug.
Other Information
Bupivacaine hydrochloride is (±) -1-Butyl-2', 6'-pipecoloxylidide monohydrochloride, monohydrate, a white crystalline powder that is freely soluble in 95 percent ethanol, soluble in water, and slightly soluble in chloroform or acetone. It has the following structural formula:
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Molecular Weight - 342.90 C18 H28 N2O • HCl • H2O |
Epinephrine is (-)-3, 4-Dihydroxy-α-[(methylamino)-methyl] benzyl alcohol. It has the following structural formula:
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Molecular Weight - 183.20 C9 H13 NO3 |
Bupivacaine is available in a sterile isotonic solution with epinephrine 1:200,000. Solutions of bupivacaine containing epinephrine may not be autoclaved.
Bupivacaine is related chemically and pharmacologically to the aminoacyl local anesthetics. It is a homologue of mepivacaine and is chemically related to lidocaine. All three of these anesthetics contain an amide linkage between the aromatic nucleus and the amino or piperidine group. They differ in this respect from the procaine-type local anesthetics, which have an ester linkage.
Sources
Vivacaine Manufacturers
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Septodont Inc.
![Vivacaine (Bupivacaine Hydrochloride And Epinephrine Bitartrate) Injection, Solution [Septodont Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Vivacaine | Septodont Inc.
As with all anesthetics, the dosage varies and depends upon the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, individual tolerance, and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. For specific techniques and procedures, refer to standard textbooks.
The 0.5% concentration with epinephrine is recommended for infiltration and block injection in the maxillary and mandibular area when a longer duration of local anesthetic action is desired, such as for oral surgical procedures generally associated with significant postoperative pain. The average dose of 1.8 mL (9 mg) per injection site will usually suffice; an occasional second dose of 1.8 mL (9 mg) may be used if necessary to produce adequate anesthesia after making allowance for 2 to 10 minutes onset time (see CLINICAL PHARMACOLOGY). The lowest effective dose should be employed and time should be allowed between injections; it is recommended that the total dose for all injection sites, spread out over a single dental sitting, should not ordinarily exceed 90 mg for a healthy adult patient (ten 1.8 mL injections of bupivacaine with epinephrine). Injections should be made slowly and with frequent aspirations. Until further experience is gained, bupivacaine in dentistry is not recommended for children younger than 12 years.
Parental drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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Septodont, Inc.
Vivacaine | Cardinal Health
(1 capsule = 2 mg): Patients should receive appropriate fluid and electrolyte replacement as needed.
Acute Diarrhea AdultsThe recommended initial dose is 4 mg (two capsules) followed by 2 mg (one capsule) after each unformed stool. Daily dose should not exceed 16 mg (eight capsules). Clinical improvement is usually observed within 48 hours.
ChildrenIn children 2 to 5 years of age (20 kg or less), the non-prescription liquid formulation of loperamide should be used; for ages 6 to 12, either loperamide hydrochloride capsules or the non-prescription liquid formulation of loperamide may be used. For children 2 to 12 years of age, the following schedule for capsules or liquid will usually fulfill initial dosage requirements:
Recommended First Day Dosage ScheduleTwo to five years:
1 mg t.i.d. (3 mg daily dose)
(13 to 20 kg)Six to eight years:
2 mg b.i.d. (4 mg daily dose)
(20 to 30 kg)Eight to twelve years:
2 mg t.i.d. (6 mg daily dose)
Recommended Subsequent Daily Dosage
(greater than 30 kg)Following the first treatment day, it is recommended that subsequent loperamide hydrochloride doses (1 mg/10 kg body weight) be administered only after a loose stool. Total daily dosage should not exceed recommended dosages for the first day.
Chronic Diarrhea ChildrenAlthough loperamide hydrochloride capsule has been studied in a limited number of children with chronic diarrhea; the therapeutic dose for the treatment of chronic diarrhea in a pediatric population has not been established.
AdultsThe recommended initial dose is 4 mg (two capsules) followed by 2 mg (one capsule) after each unformed stool until diarrhea is controlled, after which the dosage of loperamide hydrochloride capsules should be reduced to meet individual requirements. When the optimal daily dosage has been established, this amount may then be administered as a single-dose or in divided doses.
The average daily maintenance dosage in clinical trials was 4 to 8 mg (two to four capsules). A dosage of 16 mg (eight capsules) was rarely exceeded. If clinical improvement is not observed after treatment with 16 mg per day for at least 10 days, symptoms are unlikely to be controlled by further administration. Loperamide hydrochloride capsule administration may be continued if diarrhea cannot be adequately controlled with diet or specific treatment.
Children Under 2 YearsThe use of loperamide hydrochloride capsule in children under 2 years is not recommended. There have been rare reports of paralytic ileus associated with abdominal distention. Most of these reports occurred in the setting of acute dysentery, overdose, and with very young children less than 2 years of age.
ElderlyNo formal pharmacokinetic studies were conducted in elderly subjects. However, there were no major differences reported in the drug disposition in elderly patients with diarrhea relative to young patients. No dosage adjustment is required for the elderly.
Renal ImpairmentNo pharmacokinetic data are available in patients with renal impairment. Since the metabolites and the unchanged drug are mainly excreted in the feces, no dosage adjustment is required for patients with renal impairment (see PRECAUTIONS).
Hepatic ImpairmentAlthough no pharmacokinetic data are available in patients with hepatic impairment, loperamide hydrochloride capsule should be used with caution in such patients because of reduced first pass metabolism (see PRECAUTIONS).
![Vivacaine (Bupivacaine Hydrochloride And Epinephrine Bitartrate) Injection, Solution [Septodont, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=be99224e-dd49-4628-a5bf-ed8469ffd4a4&name=image-01.jpg)
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