bupivacaine hydrochloride
Bupivacaine Hydrochloride is an amide local anesthetic used to treat Postoperative Pain.
Amide Local Anesthetic · by Onesource Specialty
Generic of Marcaine
⚠ FDA reports a current shortage of the injection form — availability differs between suppliers — see drug shortages →Key facts
- Active ingredient
- Bupivacaine Hydrochloride
- Drug class
- Amide Local Anesthetic
- Form
- Injectable
- Strength
- Bupivacaine Hydrochloride 0.25% · Bupivacaine Hydrochloride 0.5%
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- postoperative pain
- Manufacturer
- Onesource Specialty
- What the pharmacy pays
- ~$0.06 per ml — not your price
- FDA application
- ANDA091503
- FDA boxed warning
- Yes — see the boxed warning
What is Bupivacaine Hydrochloride?
From the FDA label:Bupivacaine hydrochloride injection, USP contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for bupivacaine hydrochloride injection, USP is by injection, for infiltration, perineural use.[ s ee Warnings and Precautions (5.4) ]. Bupivacaine hydrochloride is 2-piperidinecarboxamide, 1-butyl- N -(2,6-dimethylphenyl)-, monohydrochloride, monohydrate. It is 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: Bupivacaine hydrochloride injection, USP is a clear and colorless sterile isotonic solution. Each mL of multiple-dose vial contains 2.5 mg, 5 mg of bupivacaine hydrochloride (equivalent to 2.22 mg, 4.44 mg of bupivacaine, respectively), sodium chloride for isotonicity, sodium hydroxide or hydrochloric acid to adjust the pH between 4 and 6.5 in water for injection. For the Multiple-dose vials, each mL also contains 1 mg methylparaben as preservative. image description
How to use
Not for intrathecal use. (2.1) • Avoid use of solutions containing antimicrobial preservatives (i.e., multiple-dose vials) for epidural or caudal anesthesia. (2.1, 5.4) • See full prescribing information for: - Recommended concentrations and dosages of bupivacaine hydrochloride injection according to type of block. (2.2)
Side effects
The following clinically significant adverse reactions have been reported and described in the Warnings and Precautions section of the labeling: • Cardiac Arrest in Obstetrical Anesthesia [ see Warnings and Precautions (5.1) ] • Dose-Related Toxicity [ see Warnings and Precautions (5.2) ] • Methemoglobinemia [ see Warnings and Precautions (5.3) ] • Chondrolysis with Intra-Articular Infusion [ see Warnings and Precautions (5.5) ] • Cardiac Arrest with Intravenous Regional Anesthesia Use [ see Contraindications (4), Warnings and Precautions (5.7) ] • Systemic Toxicities with Unintended Intravascular or Intrathecal Injection [ see Warnings and Precautions (5.9) ] The following adverse reactions from voluntary reports or clinical studies have been reported with bupivacaine. 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. Adverse reactions to bupivacaine hydrochloride injection 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 reactions that demand immediate…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
There have been reports of cardiac arrest with diffcult resuscitation or death during use of bupivacaine hydrochloride injection for epidural anesthesia in obstetrical patients. In most cases, this has followed use of the 0.75% (7.5 mg/mL) concentration. Resuscitation has been diffcult 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% (7.5 mg/mL) concentration of bupivacaine hydrochloride injection is not recommended for obstetrical anesthesia and should be reserved for surgical procedures where a high degree of muscle relaxation and prolonged effect are necessary (5.1). WARNING: RISK OF CARDIAC ARREST WITH USE OF BUPIVACAINE HYDROCHLORIDE INJECTION IN OBSTETRICAL ANESTHESIA See full prescribing information for complete boxed warning. There have been reports of cardiac arrest with diffcult resuscitation or death during use of bupivacaine hydrochloride injection for epidural anesthesia in obstetrical patients. In most cases, this has followed use of the 0.75% (7.5 mg/mL) concentration. Resuscitation has been diffcult 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% (7.5 mg/mL) concentration of bupivacaine hydrochloride injection is not recommended for obstetrical anesthesia and should be reserved for surgical procedures where a high degree of muscle relaxation and prolonged effect are necessary (5.1).
Warnings
Important safety information
Dose-Related Toxicity : Monitor cardiovascular and respiratory vital signs and patient’s state of consciousness after injection of bupivacaine hydrochloride injection. (5.2) • Methemoglobinemia : Cases of methemoglobinemia have been reported in association with local anesthetic use. See full prescribing information for more detail on managing these risks. (5.3) • Chondrolysis with Intra-Articular Infusion : Intra-articular infusions of local anesthetics including bupivacaine hydrochloride injection following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions. (5.5) • Risk of Cardiac Arrest with Intravenous Regional Anesthesia Use (Bier Block) : There have been reports of cardiac arrest and death during the use of bupivacaine for intravenous regional anesthesia (Bier Block). (5.7) • Risk of Systemic Toxicities with Unintended Intravascular or Intrathecal Injection : Unintended intravascular or intrathecal injection may be associated with systemic toxicities, including CNS or cardiorespiratory depression and coma, progressing ultimately to respiratory arrest. Aspirate for blood or cerebrospinal fluid (where applicable) prior to each dose. (5.9)
Who should not take Bupivacaine Hydrochloride
Bupivacaine hydrochloride injection is contraindicated in: obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death. intravenous regional anesthesia (Bier Block) [see Warnings and Precautions (5.7)]. patients with a known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of bupivacaine hydrochloride injection. Obstetrical paracervical block anesthesia. Its use in this technique has resulted in fetal bradycardia and death. (4) Intravenous regional anesthesia (Bier Block).(4) Known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of bupivacaine hydrochloride injection. (4)
Overdose — what happens if you take too much
Clinical Presentation Acute emergencies from use of bupivacaine hydrochloride injection are generally related to high plasma levels encountered during therapeutic use or to unintended intrathecal injection [ see Warnings and Precautions (5.2, 5.9), Adverse Reactions (6) ]. If not treated immediately, convulsions with simultaneous hypoxia, hypercarbia, and acidosis plus myocardial depression from the direct effects of bupivacaine may result in cardiac arrhythmias, bradycardia, asystole, ventricular fibrillation, or cardiac arrest. Respiratory abnormalities, including apnea, may occur. Hypoventilation or apnea due to unintentional intrathecal injection of bupivacaine hydrochloride injection 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. Management The first step in the management of systemic toxic reactions, as well as hypoventilation or apnea due to unintentional intrathecal injection of bupivacaine hydrochloride injection, 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. Endotracheal intubation, using drugs and techniques familiar to the…
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Local Anesthetics : The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects when additional local anesthetics are administered. (7.1) • Drugs Associated with Methemoglobinemia : Patients are at increased risk of developing methemoglobinemia when concurrently exposed to nitrates, nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants, and other drugs. (7.5)
Drug class
How this class works, per Topical, Local, and Regional Anesthesia and Anesthetics - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Bupivacaine Hydrochloride ranks — best-rated amide local anesthetic for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- What does Bupivacaine Hydrochloride treat?
- Bupivacaine Hydrochloride (Bupivacaine Hydrochloride) may be used to treat postoperative pain, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Bupivacaine Hydrochloride work?
- Bupivacaine Hydrochloride is a amide local anesthetic. Amide local anesthetics temporarily block the sodium channels that nerves use to fire, so the treated nerves can't send signals. This numbs pain in the area, and because the block reverses as the drug wears off, sensation returns afterward.
- How much does Bupivacaine Hydrochloride cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.06 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Bupivacaine Hydrochloride?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Bupivacaine Hydrochloride. To pay less, Bupivacaine Hydrochloride is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Bupivacaine Hydrochloride?
- Bupivacaine Hydrochloride is marketed by Onesource Specialty. You can see Onesource Specialty's full profile, rating, and other products on pharmaranks.
- Is Bupivacaine Hydrochloride a brand-name or generic drug?
- Bupivacaine Hydrochloride is a generic medication; its active ingredient is Bupivacaine Hydrochloride. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Bupivacaine Hydrochloride available over the counter?
- No. Bupivacaine Hydrochloride is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Bupivacaine Hydrochloride come in?
- Bupivacaine Hydrochloride is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Bupivacaine Hydrochloride?
- Bupivacaine Hydrochloride is classified as amide local anesthetic, per the FDA's Established Pharmacologic Class.
- Is Bupivacaine Hydrochloride FDA-registered?
- Bupivacaine Hydrochloride is on record with the U.S. FDA under application number ANDA091503. You can verify this on its official FDA label.
- Is Bupivacaine Hydrochloride safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Bupivacaine Hydrochloride. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Bupivacaine Hydrochloride?
- Bupivacaine Hydrochloride's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions have been reported and described in the Warnings and Precautions section of the labeling: • Cardiac Arrest in Obstetrical Anesthesia [ see Warnings and Precautions (5.1) ] • Dose-Related Toxicity [ see Warnings and Precautions (5.2) ] • Methemog… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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