marcaine
Pharmaranks rates Marcaine 3.0/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Marcaine (Bupivacaine Hydrochloride) is an amide local anesthetic used to treat Postoperative Pain.
Bupivacaine Hydrochloride · by Hospira
Available as a generic: Bupivacaine Hydrochloride
⚠ FDA reports a current shortage of the injection form — availability differs between suppliers — see drug shortages →Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Bupivacaine Hydrochloride
- Drug class
- Amide Local Anesthetic
- Form
- Injectable
- Strength
- Bupivacaine Hydrochloride 0.75%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- postoperative pain
- Manufacturer
- Hospira
- What the pharmacy pays
- ~$0.06 per ml — not your price
- FDA application
- NDA018692
What is Marcaine?
From the FDA label:MARCAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is an amide-local anesthetic and sterile hyperbaric aqueous solution. The route of administration for MARCAINE SPINAL is by subarachnoid injection. MARCAINE SPINAL contains bupivacaine hydrochloride, as the active pharmaceutical ingredient and also contains Dextrose, as baricity agent. Bupivacaine Hydrochloride (monohydrate) chemical name 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. Bupivacaine Hydrochloride (monohydrate) has a molecular formula of C 18 H 28 N 2 O∙HCl∙H 2 O and molecular weight of 342.90 g/mol and has the following structural formula: Dextrose chemical name is D-glucopyranose. Dextrose (anhydrous) has a molecular formula of C 6 H 12 O 6 , molecular weight of 180.16 g/mol and has the following structural formula: MARCAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is a clear and colorless sterile hyperbaric solution. Each mL of MARCAINE SPINAL contains 7.5 mg bupivacaine hydrochloride (anhydrous) (equivalent to 7.9 mg of bupivacaine hydrochloride monohydrate), 82.5 mg dextrose (anhydrous) as baricity agent, and sodium hydroxide and hydrochloric acid as pH adjusters in water for injection. MARCAINE…
How to use
The dosage of MARCAINE SPINAL administered varies with the anesthetic procedure, 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. Administer the smallest dosage and concentration required to produce the desired result. The following are general dosage guidelines: • MARCAINE SPINAL 6 mg is generally adequate for vaginal delivery. ( 2.2 ) • MARCAINE SPINAL 7.5 mg is generally adequate for spinal anesthesia for lower extremity and perineal procedures. ( 2.2 ) • MARCAINE SPINAL 12 mg is generally adequate for lower abdominal procedures. ( 2.2 ) • MARCAINE SPINAL 7.5 mg to 10.5 mg is generally adequate for Cesarean section. ( 2.2 ) 2.1 Important Dosage and Administration Information • Visually inspect this product for particulate matter and discoloration prior to administration. MARCAINE SPINAL is a clear, colorless solution. Do not administer solutions which are discolored or contain particulate matter. • Mixing or the prior or intercurrent use of any other local anesthetic with MARCAINE SPINAL is not recommended because of insufficient data on the clinical use of such mixtures. • Discard unused portions of MARCAINE SPINAL following initial use. Administration Precautions • MARCAINE…
Side effects
The following clinically significant adverse reactions have been reported and described in other sections of the labeling: • Allergic-Type Reactions [see Contraindications (4) ] • Dose-Related Toxicity [see Warnings and Precautions (5.3) ] • Systemic Toxicities with Unintended Intravascular Injection [see Warnings and Precautions (5.4) ] • Methemoglobinemia [see Warnings and Precautions (5.5) ] • Cardiac Arrest in Obstetrical Anesthesia [see Warnings and Precautions (5.6) ] • Chondrolysis with Intra-Articular Infusion [see Warnings and Precautions (5.7) ] • Cardiac Arrest with Intravenous Regional Anesthesia Use [see Contraindications (4) , Warnings and Precautions (5.8) ] 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 MARCAINE SPINAL are characteristic of those associated with other amide-type local anesthetics. A major cause of adverse reactions to MARCAINE SPINAL is due to cephalad extension of the motor level of anesthesia and/or excessive plasma levels, which may be due to overdosage, unintentional intravascular injection, or slow metabolic degradation. The most commonly…
Warnings
Important safety information
Use of Spinal Anesthetics During Uterine Contractions : Spinal anesthetics, including MARCAINE SPINAL, should not be injected during uterine contractions because cerebrospinal fluid current may carry the drug further cephalad than desired, resulting in a high motor block. ( 5.1 ) • Patients with Hypertension : Sympathetic blockade due to spinal anesthesia may result in peripheral vasodilation and hypotension. Monitor blood pressure frequently. Hypotension may be controlled by administration of vasoconstrictor agents in titrated dosages depending on the severity of hypotension and response to treatment. Monitor the onset of adequate spinal anesthesia frequently. ( 5.2 ) • Dose-Related Toxicity : Monitor cardiovascular and respiratory vital signs and patient's state of consciousness after injection of MARCAINE SPINAL. ( 5.3 ) • Risk of Systemic Toxicities with Unintended Intravascular Injection : Unintended intravascular injection may be associated with systemic toxicities, including CNS or cardiorespiratory depression and coma, progressing ultimately to respiratory arrest. Aspirate for blood and cerebrospinal fluid (where applicable) prior to each dose. ( 5.4 ) • Methemoglobinemia : Cases of methemoglobinemia have been reported in association with local anesthetic use. See full prescribing information for more detail on managing these risks. ( 5.5 ) • Risk of Cardiac Arrest with Use of Epidural Bupivacaine in Obstetrical Anesthesia : There have been reports of cardiac arrest during use of MARCAINE 0.75% solution for epidural anesthesia in obstetrical patients. MARCAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is recommended for spinal anesthesia in obstetrical patients. ( 5.6 ) • Chondrolysis with Intra-Articular Infusion : Intra-articular infusions of local anesthetics including bupivacaine following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions. ( 5.7 ) • 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). ( 5.8 ) 5.1 Use of Spinal Anesthetics During Uterine Contractions Spinal anesthetics including MARCAINE SPINAL should not be injected during uterine contractions because cerebrospinal fluid current may carry the drug further cephalad than desired, resulting in a high motor block. 5.2 Patients with Hypertension Sympathetic blockade due to spinal anesthesia may result in peripheral vasodilation and hypotension, the extent of which depends on the number of dermatomes blocked. Patients over 65 years, particularly those with hypertension, may be at increased risk for experiencing the hypotensive effects of MARCAINE SPINAL. Monitor blood pressure frequently, especially in the early phases of anesthesia. Hypotension may be controlled by administration of vasoconstrictor agents in titrated dosages depending on the severity of hypotension and response to treatment. Monitor the onset of adequate spinal anesthesia because it is not always possible to control the level of anesthesia after subarachnoid injection of MARCAINE SPINAL. 5.3 Dose-Related Toxicity The safety and effectiveness of MARCAINE SPINAL depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies. Careful and constant monitoring of cardiovascular and respiratory (adequacy of oxygenation and ventilation) vital signs and the patient's state of consciousness should be performed after injection of MARCAINE SPINAL solutions. 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. Delay in proper management of dose-related toxicity, hypoventilation from any cause, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest, and possibly death. The patient should have an indwelling intravenous catheter to assure adequate intravenous access. Use the lowest dosage of MARCAINE SPINAL that results in effective anesthesia to avoid serious adverse reactions. Avoid rapid injection of a large volume of MARCAINE SPINAL. Injection of repeated doses of MARCAINE SPINAL may cause significant increases in plasma bupivacaine 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. Reduced doses may be indicated in patients with increased intra-abdominal pressure (including obstetrical patients), if otherwise suitable for spinal anesthesia. 5.4 Risk of Systemic Toxicities with Unintended Intravascular Injection Unintended intravascular injection of MARCAINE SPINAL may be associated with systemic toxicities, including CNS or cardiorespiratory depression and coma, progressing ultimately to respiratory arrest [see Adverse Reactions (6) ] . Aspirate for blood and cerebrospinal fluid before injecting MARCAINE SPINAL, for both the initial dose and all subsequent doses (where applicable), to confirm entry into the subarachnoid space and to avoid intravascular injection. Aspiration of cerebrospinal fluid into a MARCAINE SPINAL-filled syringe will result in an identifiable swirl in the solution. A negative aspiration for blood does not ensure against an intravascular injection. 5.5 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 [see Drug Interactions (7.2) ] . 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 MARCAINE SPINAL 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. 5.6 Risk of Cardiac Arrest with Use of Epidural Bupivacaine in Obstetrical Anesthesia There have been reports of cardiac arrest with difficult resuscitation or death during use of MARCAINE for epidural anesthesia in obstetrical patients. In most cases, this has followed use of MARCAINE 0.75%, not MARCAINE SPINAL. The package insert for MARCAINE hydrochloride for epidural, nerve block, etc., has a more complete discussion of preparation for, and management of cardiac arrest following epidural administration. MARCAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is recommended for spinal anesthesia in obstetrical patients. 5.7 Chondrolysis with Intra-Articular Infusion Intra-articular infusions of local anesthetics including bupivacaine following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such…
Who should not take Marcaine
MARCAINE SPINAL is contraindicated in: • intravenous regional anesthesia (Bier Block) [see Warnings and Precautions (5.8) ] . • patients with septicemia. • patients with severe hemorrhage, severe hypotension or shock, due to a reduced cardiac output. • patients with clinically significant arrhythmias, such as complete heartblock, due a reduced cardiac output. • patients with a known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of MARCAINE SPINAL. o patients with local infection at the site of proposed lumbar puncture. • Intravenous regional anesthesia (Bier Block). ( 4 ) • Septicemia. ( 4 ) • Severe hemorrhage, severe hypotension or shock, and arrhythmias, such as complete heartblock, which severely reduce cardiac output. ( 4 ) • Known hypersensitivity to bupivacaine or to any local anesthetic agent of the amide-type or to other components of MARCAINE SPINAL. ( 4 ) • Local infection at the site of proposed lumbar puncture. ( 4 )
Overdose — what happens if you take too much
Clinical Presentation Acute emergencies from MARCAINE SPINAL are generally related to hypoventilation (and perhaps apnea) secondary to upward extension of spinal anesthesia or high plasma levels encountered during therapeutic use [see Warnings and Precautions (5.3) , Adverse Reactions (6) ] . Hypotension is commonly encountered during the conduct of spinal anesthesia due to loss of sympathetic tone, and sometimes, contributory mechanical obstruction of venous return due to the gravid uterus exerting pressure on the great vessels [see Warnings and Precautions (5.2) , Adverse Reactions (6) ] . 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. Hypoventilation or apnea due to a high or total spinal 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 a high or total spinal, consists of immediate attention to the establishment and maintenance of a patent…
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. ( 7.2 ) 7.1 Local Anesthetics The toxic effects of local anesthetics are additive. If coadministration of other local anesthetics with MARCAINE SPINAL cannot be avoided, monitor patients for neurologic and cardiovascular effects related to local anesthetic systemic toxicity [see Dosage and Administration (2.1) , Warnings and Precautions (5.3) ] . 7.2 Drugs Associated with Methemoglobinemia Patients who are administered MARCAINE SPINAL are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics [see Warnings and Precautions (5.5) ] . Examples of Drugs Associated with Methemoglobinemia: Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic agents cyclophosphamide, flutamide, hydroxyurea, isofamide, rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants phenobarbital, phenytoin, sodium valproate Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine
Drug class
How this class works, per Topical, Local, and Regional Anesthesia and Anesthetics - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Marcaine 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
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Use copay cards
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Frequently asked questions
- What does Marcaine treat?
- Marcaine (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 Marcaine work?
- Marcaine 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 is Marcaine rated?
- pharmaranks gives Marcaine a composite score of 3.0 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Marcaine 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 Marcaine?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Marcaine. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Marcaine?
- Marcaine is marketed by Hospira. You can see Hospira's full profile, rating, and other products on pharmaranks.
- Is Marcaine a brand-name or generic drug?
- Marcaine is a brand-name product with the active ingredient Bupivacaine Hydrochloride. Lower-cost generic equivalents containing Bupivacaine Hydrochloride are available — ask your pharmacist.
- Is Marcaine available over the counter?
- No. Marcaine 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 Marcaine come in?
- Marcaine is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Marcaine?
- Marcaine is classified as amide local anesthetic, per the FDA's Established Pharmacologic Class.
- Is Marcaine FDA-registered?
- Marcaine is on record with the U.S. FDA under application number NDA018692. You can verify this on its official FDA label.
- Has Marcaine been recalled by the FDA?
- Marcaine has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Marcaine safe?
- There's no single safe-or-not verdict. pharmaranks gives Marcaine a recall-safety score of 60/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Marcaine?
- Marcaine'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 other sections of the labeling: • Allergic-Type Reactions [see Contraindications (4) ] • Dose-Related Toxicity [see Warnings and Precautions (5.3) ] • Systemic Toxicities with Unintended Intravascular Injectio… 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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marcaine
60/100