Vivacaine 5 mg/mL

bupivacaine hydrochloride and epinephrine bitartrate · INJECTION, SOLUTION · Septodont, Inc.

No Recall HistoryCurrently in Shortage

Plain English

Vivacaine is a injection, solution containing bupivacaine hydrochloride and epinephrine bitartrate at 5 mg/mL, taken submucosal. Manufactured by Septodont, Inc..

Key Facts

Brand Name: Vivacaine
Generic Name: bupivacaine hydrochloride and epinephrine bitartrate
NDC Code (Product): 0362-9011
Manufacturer: Septodont, Inc.
Strength: 5 mg/mL
Dosage Form: INJECTION, SOLUTION
Route: SUBMUCOSAL
Marketing Status
Application #: ANDA077250
Marketing Start: 06/01/2013

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

erythema2 reports

pain2 reports

drug ineffective1 reports

hypersensitivity1 reports

hypoaesthesia oral1 reports

ileus paralytic1 reports

injection site discomfort1 reports

medication error1 reports

temporomandibular joint syndrome1 reports

wrong drug administered1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE 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® is not recommended for children.

Dosage & Administration

DOSAGE AND ADMINISTRATION As with all local 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 …

Warnings

WARNINGS 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 ENSURING 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 …

Contraindications

CONTRAINDICATIONS Vivacaine® (bupivacaine hydrochloride and epinephrine injection, USP) is contraindicated in patients with a known hypersensitivity to it or to any local anesthetic agent of the amide type or to other components of bupivacaine solutions.

Drug Interactions

Drug Interactions See WARNINGS concerning solutions containing a vasoconstrictor. 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. Vivacaine® (bupivacaine hydrochloride and epinephrine injection, USP) should be used cautiously in persons with known drug allergies or sensitivities, particularly to the amide-type local anesthetics. 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.

Adverse Reactions

ADVERSE REACTIONS Reactions to Vivacaine® (bupivacaine hydrochloride and epinephrine injection, USP) are characteristic of those associated with other amide-type local anesthetics. A major cause of adverse reactions to this group of drugs is excessive plasma levels, which may be due to overdosage, inadvertent intravascular injection or slow metabolic degradation. Excessive plasma levels of the amide-type local anesthetics cause systemic reactions involving the central nervous system and the cardiovascular system. The central nervous system effects are characterized by excitation or depression. The first manifestation may be nervousness, dizziness, blurred vision, or tremors, followed by drowsiness, convulsions, unconsciousness, and possibly respiratory arrest. Since excitement may be transient or absent, the first manifestation may be drowsiness, sometimes merging into unconsciousness and respiratory arrest. Other central nervous system effects may be nausea, vomiting, chills, constriction of the pupils, or tinnitus. The cardiovascular manifestations of excessive plasma levels may include depression of the myocardium, blood pressure changes (usually hypotension), and cardiac arrest…

Frequently Asked Questions

What is Vivacaine used for?

Vivacaine contains bupivacaine hydrochloride and epinephrine bitartrate. It is a injection, solution taken submucosal. Consult your doctor for specific uses.

Is Vivacaine a controlled substance?

Vivacaine is not classified as a controlled substance by the DEA.

What is the generic name for Vivacaine?

The generic name for Vivacaine is bupivacaine hydrochloride and epinephrine bitartrate. There are 11 other brand versions of bupivacaine hydrochloride and epinephrine bitartrate.

What is the NDC code for Vivacaine 5 mg/mL?

The NDC (National Drug Code) for Vivacaine 5 mg/mL is 0362-9011, listed by Septodont, Inc..

Product NDC

0362-9011

Package NDC

0362-9011-50

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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