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Bupivacaine Hydrochloride 2.5 mg/mL Injection, Solution — NDC 71872-7217-1 (Billing 71872-7217-01)

by Medical Purchasing Solutions, LLC · 1 VIAL, MULTI-DOSE in 1 BAG / 50 mL in 1 VIAL, MULTI-DOSE

This is a package of Bupivacaine Hydrochloride 2.5 mg/mL Injection, Solution from Medical Purchasing Solutions, LLC, marketed since Apr 2005 and currently FDA-listed. It is this product's only package size.

NDC 71872-7217-01
🏷️ FDA NDC (as labeled) 71872-7217-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Bupivacaine Hydrochloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 2, 2026 — Lack of Assurance of Sterility (Huons Co., Ltd.) · FDA recall D-0530-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71872-7217-1
Product NDC 71872-7217
11-digit billing NDC 71872721701
RxCUI 1012396
UNII 7TQO7W3VT8
Application # ANDA070590
SPL Set ID ada6a9bf-f7cb-035a-e053-2a95a90a6a3d
Established class (EPC) Amide Local Anesthetic
Physiologic effect Local Anesthesia
Chemical class Amides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2005-04-30
Route INFILTRATION, PERINEURAL
Dosage form INJECTION, SOLUTION
Substance BUPIVACAINE HYDROCHLORIDE
TE code (Orange Book) AP · RLD · RS
Quick answers
  • RxCUI (RxNorm): 1012396
Why two NDCs? The FDA registers this code as 71872-7217-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 71872-7217-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Amide Local Anesthetic class.

Pharmacologic class Amide Local Anesthetic
Drug family (ATC) Amides
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • Bupivacaine is a local anesthetic — it numbs a specific area of your body so you don't feel pain during a procedure. Your doctor or anesthesiologist injects it near the nerves that...
  • What exactly is bupivacaine and why is my doctor using it?
  • The most common ones are nausea, vomiting, constipation, dizziness, and headache. You might also notice your heart beating a little faster or your blood pressure dropping temporari...
  • What side effects should I expect after getting bupivacaine?
📖 Read our full Bupivacaine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
71872-7217-01 You're viewing this Main listing 1 VIAL, MULTI-DOSE in 1 BAG / 50 mL in 1 VIAL, MULTI-DOSE 2020-07-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bupivacaine HCl 2.5 mg/mL 70594-0116-01 Xellia 50 ml $0.048 AP Availability likely —
bupivacaine hydrochloride 2.5 mg/mL 71288-0723-52 Meitheal 1 vial $0.048 — Availability likely —
Bupivacaine Hydrochloride 2.5 mg/mL 00143-9328-10 Hikma 10 vials — AP FDA listed —
Bupivacaine Hydrochloride 2.5 mg/mL 00404-9826-50 Henry 1 vial — AP FDA listed —
Sensorcaine 2.5 mg/mL 00404-9945-50 Henry 1 vial — AP FDA listed —
Bupivacaine Hydrochloride 2.5 mg/mL 00409-1160-01 Hospira, 25 vials — AP FDA listed —
Marcaine 2.5 mg/mL 00409-1587-50 Hospira, 1 vial — AP FDA listed —
Bupivacaine Hci 2.5 mg/mL 51662-1581-03 HF 25 pouches — AP FDA listed —
0.25% BUPIVACAINE HCl 2.5 mg/mL 51662-1606-03 HF 25 pouches — AP FDA listed —
Bupivacaine Hydrochloride 2.5 mg/mL 55150-0249-50 Eugia 25 vials — AP FDA listed —
Sensorcaine 2.5 mg/mL 63323-0465-57 Fresenius 25 vials — AP FDA listed —
Bupivacaine hydrochloride 2.5 mg/mL 70069-0752-25 Somerset 25 vials — AP FDA listed —
Bupivacaine Hydrochloride 2.5 mg/mL 71872-7133-01 Medical 1 vial — AP FDA listed —
Bupivacaine Hydrochloride 2.5 mg/mLthis 71872-7217-01 Medical 1 vial — AP FDA listed —
bupivacaine hydrochloride 2.5 mg/mL 72603-0279-25 Northstar 25 vials — — FDA listed —
Bupivacaine Hydrochloride 2.5 mg/mL 83270-0168-01 ONESOURCE 1 vial — AP FDA listed —
Bupivacaine Hydrochloride 2.5 mg/mL 84549-0259-02 ProPharma 30 ml — AP FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2005
On the market since
Apr 2005
📍
2026
Currently FDA-listed
21 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerMedical Purchasing Solutions, LLC
Application holderHOSPIRA INC
FDA applicationANDA070590 (ANDA)
Labeler code71872
First marketedApr 2005
Product typeHuman Prescription Drug
Portfolio250 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 161 words ▾

INDICATIONS AND USAGE Bupivacaine Hydrochloride is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (See WARNINGS ). Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of Bupivacaine Hydrochloride in these patients.

Bupivacaine Hydrochloride is not recommended for intravenous regional anesthesia (Bier Block) (See WARNINGS ). The routes of administration and indicated Bupivacaine Hydrochloride concentrations are: •local infiltration 0.25% •peripheral nerve block 0.25% and 0.5% •retrobulbar block 0.75% •sympathetic block 0.25% •lumbar epidural 0.25%, 0.5%, and 0.75% (0.75% not for obstetrical anesthesia) •caudal 0.25% and 0.5% •epidural test dose 0.5% with epinephrine 1:200,000 •dental blocks 0.5% with epinephrine 1:200,000 (See DOSAGE AND ADMINISTRATION for additional information.) Standard textbooks should be consulted to determine the accepted procedures and techniques for the administration of Bupivacaine Hydrochloride.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION The dose of any local anesthetic administered varies with the anesthetic procedure, the area to be anesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked, the depth of anesthesia and degree of muscle relaxation required, the duration of anesthesia desired, individual tolerance, and the physical condition of the patient. The smallest dose and concentration required to produce the desired result should be administered. Dosages of Bupivacaine Hydrochloride should be reduced for elderly and/or debilitated patients and patients with cardiac and/or liver disease.

The rapid injection of a large volume of local anesthetic solution should be avoided and fractional (incremental) doses should be used when feasible. For specific techniques and procedures, refer to standard textbooks. There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures.

Bupivacaine Hydrochloride is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION ). In recommended doses, Bupivacaine Hydrochloride produces complete sensory block, but the effect on motor function differs among the three concentrations. 0.25% ─ when used for caudal, epidural, or peripheral nerve block, produces incomplete motor block.

Should be used for operations in which muscle relaxation is not important, or when another means of providing muscle relaxation is used concurrently. Onset of action may be slower than with the 0.5% or 0.75% solutions. 0.5% ─ provides motor blockade for caudal, epidural, or nerve block, but muscle relaxation may be inadequate for operations in which complete muscle relaxation is essential.

0.75% ─ produces complete motor block. Most useful for epidural block in abdominal operations requiring complete muscle relaxation, and for retrobulbar anesthesia. Not for obstetrical anesthesia.

The duration of anesthesia with Bupivacaine Hydrochloride is such that for most indications, a single dose is sufficient. Maximum dosage limit must be individualized in each case after evaluating the size and physical status of the patient, as well as the usual rate of systemic absorption from a particular injection site. Most experience to date is with single doses of Bupivacaine Hydrochloride up to 225 mg with epinephrine 1:200,000 and 175 mg without epinephrine; more or less drug may be used depending on individualization of each case.

These doses may be repeated up to once every three hours. In clinical studies to date, total daily doses have been up to 400 mg. Until further experience is gained, this dose should not be exceeded in 24 hours.

The duration of anesthetic effect may be prolonged by the addition of epinephrine. The dosages in Table 1 have generally proved satisfactory and are recommended as a guide for use in the average adult. These dosages should be reduced for elderly or debilitated patients.

Until further experience is gained, Bupivacaine Hydrochloride is not recommended for pediatric patients younger than 12 years. Bupivacaine Hydrochloride is contraindicated for obstetrical paracervical blocks, and is not recommended for intravenous regional anesthesia (Bier Block). Use in Epidural Anesthesia: During epidural administration of Bupivacaine Hydrochloride, 0.5% and 0.75% solutions should be administered in incremental doses of 3 mL to 5 mL with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection.

In obstetrics, only the 0.5% and 0.25% concentrations should be used; incremental doses of 3 mL to 5 mL of the 0.5% solution not exceeding 50 mg to 100 mg at any dosing interval are recommended. Repeat doses should be preceded by a test dose containing epinephrine if not contraindicated. Use only the single-use ampuls and single-dose vials for caudal or epidural anesthesia; the multiple-use vials contain a preservative and… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 51 words ▾

CONTRAINDICATIONS Bupivacaine Hydrochloride is contraindicated in obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death. Bupivacaine Hydrochloride 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 Hydrochloride solutions.

⚠️ Warnings ~3 min read ▾

WARNINGS THE 0.75% CONCENTRATION OF BUPIVACAINE HYDROCHLORIDE IS NOT RECOMMENDED FOR OBSTETRICAL ANESTHESIA. THERE HAVE BEEN REPORTS OF CARDIAC ARREST WITH DIFFICULT RESUSCITATION OR DEATH DURING USE OF BUPIVACAINE HYDROCHLORIDE FOR EPIDURAL ANESTHESIA IN OBSTETRICAL PATIENTS. IN MOST CASES, THIS HAS FOLLOWED USE OF THE 0.75% CONCENTRATION.

RESUSCITATION HAS BEEN DIFFICULT OR IMPOSSIBLE DESPITE APPARENTLY ADEQUATE PREPARATION AND APPROPRIATE MANAGEMENT. CARDIAC ARREST HAS OCCURRED AFTER CONVULSIONS RESULTING FROM SYSTEMIC TOXICITY, PRESUMABLY FOLLOWING UNINTENTIONAL INTRAVASCULAR INJECTION. THE 0.75% CONCENTRATION SHOULD BE RESERVED FOR SURGICAL PROCEDURES WHERE A HIGH DEGREE OF MUSCLE RELAXATION AND PROLONGED EFFECT ARE NECESSARY.

LOCAL ANESTHETICS SHOULD ONLY BE EMPLOYED 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 , PRECAUTIONS , and OVERDOSAGE ). 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.

Methemoglobinemia Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate 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. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.

Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure, and are characterized by a cyanotic skin discoloration and/or abnormal coloration of the blood. 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. Discontinue Bupivacaine Hydrochloride and any other oxidizing agents.

Depending on the severity of the signs and symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. A more severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen. Local anesthetic solutions containing antimicrobial preservatives, i.e., those supplied in multiple-dose vials, should not be used for epidural or caudal anesthesia because safety has not been established with regard to intrathecal injection, either intentionally or unintentionally, of such preservatives.

Intra-articular infusions of local anesthetics 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 not associated with these findings.

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 2nd month after surgery. Currently, there is no effective treatment for chondrolysis; patients who experienced chondrolysis have required additional diagnostic and therapeutic procedures and som… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

ADVERSE REACTIONS Reactions to Bupivacaine Hydrochloride 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, unintentional intravascular injection, or slow metabolic degradation. The most commonly encountered acute adverse experiences which demand immediate counter-measures are related to the CNS and the cardiovascular system.

These adverse experiences are generally dose related and due to high plasma levels which may result from overdosage, rapid absorption from the injection site, diminished tolerance, or from unintentional intravascular injection of the local anesthetic solution. In addition to systemic dose-related toxicity, unintentional subarachnoid injection of drug during the intended performance of caudal or lumbar epidural block or nerve blocks near the vertebral column (especially in the head and neck region) may result in underventilation or apnea ("Total or High Spinal").

Also, hypotension due to loss of sympathetic tone and respiratory paralysis or underventilation due to cephalad extension of the motor level of anesthesia may occur. This may lead to secondary cardiac arrest if untreated. Patients over 65 years, particularly those with hypertension, may be at increased risk for experiencing the hypotensive effects of Bupivacaine Hydrochloride.

Factors influencing plasma protein binding, such as acidosis, systemic diseases which alter protein production, or competition of other drugs for protein binding sites, may diminish individual tolerance. CNS Reactions: These are characterized by excitation and/or depression. Restlessness, anxiety, dizziness, tinnitus, blurred vision, or tremors may occur, possibly proceeding to convulsions.

However, excitement may be transient or absent, with depression being the first manifestation of an adverse reaction. This may quickly be followed by drowsiness merging into unconsciousness and respiratory arrest. Other CNS effects may be nausea, vomiting, chills, and constriction of the pupils.

The incidence of convulsions associated with the use of local anesthetics varies with the procedure used and the total dose administered. In a survey of studies of epidural anesthesia, overt toxicity progressing to convulsions occurred in approximately 0.1% of local anesthetic administrations. Cardiovascular System Reactions: High doses or unintentional intravascular injection may lead to high plasma levels and related depression of the myocardium, decreased cardiac output, heartblock, hypotension, bradycardia, ventricular arrhythmias, including ventricular tachycardia and ventricular fibrillation, and cardiac arrest (See WARNINGS , PRECAUTIONS , and OVERDOSAGE ).

Allergic: Allergic-type reactions are rare and may occur as a result of sensitivity to the local anesthetic or to other formulation ingredients, such as the antimicrobial preservative methylparaben contained in multiple-use vials or sulfites in epinephrine-containing solutions. These reactions are characterized by signs such as urticaria, pruritus, erythema, angioneurotic edema (including laryngeal edema), tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive sweating, elevated temperature, and possibly, anaphylactoid-like symptomatology (including severe hypotension).

Cross sensitivity among members of the amide-type local anesthetic group has been reported. The usefulness of screening for sensitivity has not been definitely established. Neurologic: The incidences of adverse neurologic reactions associated with the use of local anesthetics may be related to the total dose of local anesthetic administered and are also dependent upon the particular drug used, the route of administration, and the physical status of the patient.

Many of these effects may be related to local anesthetic techniques, with or without a contribution from the drug. In the practice of caudal or lumbar ep… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage ~3 min read ▾

OVERDOSAGE Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics or to unintended subarachnoid injection of local anesthetic solution (See ADVERSE REACTIONS , WARNINGS , and PRECAUTIONS ). Management of Local Anesthetic Emergencies: The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness after each local anesthetic injection.

At the first sign of change, oxygen should be administered. The first step in the management of systemic toxic reactions, as well as underventilation or apnea due to unintentional subarachnoid injection of drug solution, consists of immediate attention to the establishment and maintenance of a patent airway and effective assisted or controlled ventilation with 100% oxygen with a delivery system capable of permitting immediate positive airway pressure by mask. This may prevent convulsions if they have not already occurred.

If necessary, use drugs to control the convulsions. A 50 mg to 100 mg bolus intravenous injection of succinylcholine will paralyze the patient without depressing the central nervous or cardiovascular systems and facilitate ventilation. A bolus intravenous dose of 5 mg to 10 mg of diazepam or 50 mg to 100 mg of thiopental will permit ventilation and counteract CNS stimulation, but these drugs also depress CNS, respiratory, and cardiac function, add to postictal depression and may result in apnea.

Intravenous barbiturates, anticonvulsant agents, or muscle relaxants should only be administered by those familiar with their use. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated. Supportive treatment of circulatory depression may require administration of intravenous fluids, and when appropriate, a vasopressor dictated by the clinical situation (such as ephedrine or epinephrine to enhance myocardial contractile force).

Endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated after initial administration of oxygen by mask if difficulty is encountered in the maintenance of a patent airway, or if prolonged ventilatory support (assisted or controlled) is indicated. Recent clinical data from patients experiencing local anesthetic-induced convulsions demonstrated rapid development of hypoxia, hypercarbia, and acidosis with bupivacaine within a minute of the onset of convulsions. These observations suggest that oxygen consumption and carbon dioxide production are greatly increased during local anesthetic convulsions and emphasize the importance of immediate and effective ventilation with oxygen which may avoid cardiac arrest.

If not treated immediately, convulsions with simultaneous hypoxia, hypercarbia, and acidosis plus myocardial depression from the direct effects of the local anesthetic may result in cardiac arrhythmias, bradycardia, asystole, ventricular fibrillation, or cardiac arrest. Respiratory abnormalities, including apnea, may occur. Underventilation or apnea due to unintentional subarachnoid injection of local anesthetic solution may produce these same signs and also lead to cardiac arrest if ventilatory support is not instituted.

If cardiac arrest should occur, successful outcome may require prolonged resuscitative efforts. The supine position is dangerous in pregnant women at term because of aortocaval compression by the gravid uterus. Therefore during treatment of systemic toxicity, maternal hypotension or fetal bradycardia following regional block, the parturient should be maintained in the left lateral decubitus position if possible, or manual displacement of the uterus off the great vessels be accomplished.

The mean seizure dosage of bupivacaine in rhesus monkeys was found to be 4.4 mg/kg with mean arterial plasma concentration of 4.5 mcg/mL. The intravenous and subcu… [Excerpted — this section continues on DailyMed.]

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Local anesthetics block the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential. In general, the progression of anesthesia is related to the diameter, myelination, and conduction velocity of affected nerve fibers. Clinically, the order of loss of nerve function is as follows: (1) pain, (2) temperature, (3) touch, (4) proprioception, and (5) skeletal muscle tone.

Systemic absorption of local anesthetics produces effects on the cardiovascular and central nervous systems (CNS). At blood concentrations achieved with normal therapeutic doses, changes in cardiac conduction, excitability, refractoriness, contractility, and peripheral vascular resistance are minimal. However, toxic blood concentrations depress cardiac conduction and excitability, which may lead to atrioventricular block, ventricular arrhythmias, and cardiac arrest, sometimes resulting in fatalities.

In addition, myocardial contractility is depressed and peripheral vasodilation occurs, leading to decreased cardiac output and arterial blood pressure. Recent clinical reports and animal research suggest that these cardiovascular changes are more likely to occur after unintended intravascular injection of bupivacaine. Therefore, incremental dosing is necessary.

Following systemic absorption, local anesthetics can produce CNS stimulation, depression, or both. Apparent central stimulation is manifested as restlessness, tremors and shivering progressing to convulsions, followed by depression and coma progressing ultimately to respiratory arrest. However, the local anesthetics have a primary depressant effect on the medulla and on higher centers.

The depressed stage may occur without a prior excited state. Pharmacokinetics: The rate of systemic absorption of local anesthetics is dependent upon the total dose and concentration of drug administered, the route of administration, the vascularity of the administration site, and the presence or absence of epinephrine in the anesthetic solution. A dilute concentration of epinephrine (1:200,000 or 5 mcg/mL) usually reduces the rate of absorption and peak plasma concentration of Bupivacaine Hydrochloride, permitting the use of moderately larger total doses and sometimes prolonging the duration of action.

The onset of action with Bupivacaine Hydrochloride is rapid and anesthesia is long lasting. The duration of anesthesia is significantly longer with Bupivacaine Hydrochloride than with any other commonly used local anesthetic. It has also been noted that there is a period of analgesia that persists after the return of sensation, during which time the need for strong analgesics is reduced.

The onset of action following dental injections is usually 2 to 10 minutes and anesthesia may last two or three times longer than lidocaine and mepivacaine for dental use, in many patients up to 7 hours. The duration of anesthetic effect is prolonged by the addition of epinephrine 1:200,000. Local anesthetics are bound to plasma proteins in varying degrees.

Generally, the lower the plasma concentration of drug the higher the percentage of drug bound to plasma proteins. Local anesthetics appear to cross the placenta by passive diffusion. The rate and degree of diffusion is governed by (1) the degree of plasma protein binding, (2) the degree of ionization, and (3) the degree of lipid solubility.

Fetal/maternal ratios of local anesthetics appear to be inversely related to the degree of plasma protein binding, because only the free, unbound drug is available for placental transfer. Bupivacaine Hydrochloride with a high protein binding capacity (95%) has a low fetal/maternal ratio (0.2 to 0.4). The extent of placental transfer is also determined by the degree of ionization and lipid solubility of the drug.

Lipid soluble, nonionized drugs readily enter the f… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling ~2 min read ▾

HOW SUPPLIED These solutions are not for spinal anesthesia. Store at 20 to 25°C (68 to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Bupivacaine Hydrochloride ─ Solutions of Bupivacaine Hydrochloride that do not contain epinephrine may be autoclaved. Autoclave at 15-pound pressure, 121°C (250°F) for 15 minutes.

Unit of Sale Concentration NDC 0409-1159-01 Tray of 25 Single-dose Teartop Vials 0.25% 25 mg/10 mL (2.5 mg/mL) pH: 4.0 to

6.5NDC 0409-1159-02 Tray of 25 Single-dose Teartop Vials 0.25% 75 mg/30 mL (2.5 mg/mL) pH: 4.0 to

6.5NDC 0409-1160-01 Tray of 25 Multiple-dose Fliptop Vials 0.25% 125 mg/50 mL (2.5 mg/mL) pH: 4.0 to

6.5NDC 0409-1163-01 Tray of 25 Multiple-dose Fliptop Vials 0.5% 250 mg/50 mL (5 mg/mL) pH: 4.0 to

6.5NDC 0409-1162-01 Tray of 25 Single-dose Teartop Vials 0.5% 50 mg/10 mL (5 mg/mL) pH: 4.0 to

6.5NDC 0409-1162-02 Tray of 25 Single-dose Teartop Vials 0.5% 150 mg/30 mL (5 mg/mL) pH: 4.0 to

6.5NDC 0409-1165-01 Tray of 25 Single-dose Teartop Vials 0.75% 75 mg/10 mL (7.5 mg/mL) pH: 4.0 to

6.5NDC 0409-1165-02 Tray of 25 Single-dose Teartop Vials 0.75% 225 mg/30 mL (7.5 mg/mL) pH: 4.0 to

6.5Bupivacaine Hydrochloride with epinephrine 1:200,000 (as bitartrate) ─ Solutions of Bupivacaine Hydrochloride that contain epinephrine should not be autoclaved and should be protected from light. Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate. Unit of Sale Concentration NDC 0409-9042-01 Carton of 10 Single-dose Teartop Vials 0.25% 25 mg/10 mL (2.5 mg/mL) pH: 3.3 to

5.5NDC 0409-9042-17 Tray of 25 Single-dose Teartop Vials 0.25% 75 mg/30 mL (2.5 mg/mL) pH: 3.3 to

5.5NDC 0409-9043-01 Case of 25 individually packaged Multiple-dose Fliptop Vials 0.25% 125 mg/50 mL (2.5 mg/mL) pH: 3.3 to

5.5NDC 0409-9045-01 Carton of 10 Single-dose Teartop Vials 0.5% 50 mg/10 mL (5 mg/mL) pH: 3.3 to

5.5NDC 0409-9045-17 Tray of 25 Single-dose Teartop Vials 0.5% 150 mg/30 mL (5 mg/mL) pH: 3.3 to

5.5NDC 0409-9046-01 Case of 25 individually packaged Multiple-dose Fliptop Vials 0.5% 250 mg/50 mL (5 mg/mL) pH: 3.3 to

5.5For single-dose ampuls and vials: Discard the unused portion. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1176-2.0 Revised: 12/2018 Hospira Logo

📋 Description ~2 min read ▾

DESCRIPTION Bupivacaine Hydrochloride is 2-Piperidinecarboxamide, 1-butyl- N -(2,6-dimethylphenyl)-, 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: Epinephrine is (-)-3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol. It has the following structural formula: Bupivacaine Hydrochloride is available in sterile isotonic solutions with and without epinephrine (as bitartrate) 1:200,000 for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks.

Solutions of Bupivacaine Hydrochloride may be autoclaved if they do not contain epinephrine. Solutions are clear and colorless. 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.

Bupivacaine Hydrochloride Injection, USP is available in sterile, isotonic solutions containing bupivacaine hydrochloride in water for injection with characteristics as follows: Bupivacaine Hydrochloride Injection, USP (without epinephrine) Concentration Bupivacaine Hydrochloride mg/mL Sodium Chloride mg/mL 0.25% 2.5 8.6 0.5% 5 8.1 0.75% 7.5

7.6May contain sodium hydroxide and/or hydrochloric acid for pH adjustment (See HOW SUPPLIED section for pH information). Multiple-dose vials contain methylparaben 1 mg/mL added as a preservative. Bupivacaine and Epinephrine Injection, USP is available in sterile, isotonic solutions containing bupivacaine hydrochloride and epinephrine 1:200,000 with characteristics as follows: Bupivacaine and Epinephrine Injection, USP Concentration (Bupivacaine HCl) Bupivacaine Hydrochloride (mg/mL) Epinephrine 1:200,000 (mcg/mL) Sodium Chloride (mg/mL) 0.25% 2.5 5 8.5 0.5% 5 5 8.5 0.75% 7.5 5

8.5Sodium metabisulfite 0.1 mg/mL added as antioxidant and edetate calcium disodium, anhydrous 0.1 mg/mL added as stabilizer. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment (See HOW SUPPLIED section for pH information). Multiple-dose vials contain methylparaben 1 mg/mL added as a preservative.

Single-use solutions contain no added bacteriostat or anti-microbial agent and unused portions should be discarded after use. structural formula bupivacaine hydrochloride structural formula epinephrine

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General: The safety and effectiveness of local anesthetics depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies. Resuscitative equipment, oxygen, and other resuscitative drugs should be available for immediate use (See WARNINGS , ADVERSE REACTIONS , and OVERDOSAGE ). During major regional nerve blocks, the patient should have intravenous fluids running via an indwelling catheter to assure a functioning intravenous pathway.

The lowest dosage of local anesthetic that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects. The rapid injection of a large volume of local anesthetic solution should be avoided and fractional (incremental) doses should be used when feasible. Epidural Anesthesia: During epidural administration of Bupivacaine Hydrochloride, 0.5% and 0.75% solutions should be administered in incremental doses of 3 mL to 5 mL with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection.

Injections should be made slowly, with frequent aspirations before and during the injection to avoid intravascular injection. Syringe aspirations should also be performed before and during each supplemental injection in continuous (intermittent) catheter techniques. An intravascular injection is still possible even if aspirations for blood are negative.

During the administration of epidural anesthesia, it is recommended that a test dose be administered initially and the effects monitored before the full dose is given. When using a "continuous" catheter technique, test doses should be given prior to both the original and all reinforcing doses, because plastic tubing in the epidural space can migrate into a blood vessel or through the dura. When clinical conditions permit, the test dose should contain epinephrine (10 mcg to 15 mcg has been suggested) to serve as a warning of unintended intravascular injection.

If injected into a blood vessel, this amount of epinephrine is likely to produce a transient "epinephrine response" within 45 seconds, consisting of an increase in heart rate and/or systolic blood pressure, circumoral pallor, palpitations, and nervousness in the unsedated patient. The sedated patient may exhibit only a pulse rate increase of 20 or more beats per minute for 15 or more seconds. Therefore, following the test dose, the heart rate should be monitored for a heart rate increase.

Patients on beta-blockers may not manifest changes in heart rate, but blood pressure monitoring can detect a transient rise in systolic blood pressure. The test dose should also contain 10 mg to 15 mg of Bupivacaine Hydrochloride or an equivalent amount of another local anesthetic to detect an unintended intrathecal administration. This will be evidenced within a few minutes by signs of spinal block (e.g., decreased sensation of the buttocks, paresis of the legs, or, in the sedated patient, absent knee jerk).

The Test Dose formulation of Bupivacaine Hydrochloride contains 15 mg of bupivacaine and 15 mcg of epinephrine in a volume of 3 mL. An intravascular or subarachnoid 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 epinephrine-induced cardiovascular effects.

Injection of repeated doses of local anesthetics may cause significant increases in plasma levels with each repeated dose due to slow accumulation of the drug or its metabolites, or to slow metabolic degradation. 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.

Local anesthetics should also be used with caution in patients with hypotension or heartblock. Careful and constant monitoring of cardiovascular and respiratory (adequacy of ventilation) vital signs and the patient's sta… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 74 words ▾

PRINCIPAL DISPLAY PANEL - VIAL LABEL 50 mL Multiple-dose Fliptop Vial 0.25% Bupivacaine Hydrochloride Injection, USP 125 mg/50 mL (2.5 mg/mL) For INFILTRATION and NERVE BLOCK. Not for caudal, epidural or spinal anesthesia. bupivial

PRINCIPAL DISPLAY PANEL - OUTER PACKAGE NDC 71872-7217-1 1 X 50 mL Multiple-dose Fliptop Vial Rx only 0.25% Bupivacaine Hydrochloride Injection, USP 125 mg/50 mL (2.5 mg/mL) For INFILTRATION and NERVE BLOCK. Not for caudal, epidural or spinal anesthesia. bupilabel

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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