marcaine hydrochloride w/ epinephrine preservative free
Pharmaranks rates Marcaine Hydrochloride W/ Epinephrine Preservative Free 2.2/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Marcaine Hydrochloride W/ Epinephrine Preservative Free is a combination medicine containing Bupivacaine Hydrochloride and Epinephrine Bitartrate.
Bupivacaine Hydrochloride and Epinephrine Bitartrate · by Hospira
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 and Epinephrine Bitartrate
- Form
- Injectable
- Strength
- Bupivacaine Hydrochloride 0.25%; Epinephrine Bitartrate 0.0091MG/ML · Bupivacaine Hydrochloride 0.5%; Epinephrine Bitartrate 0.0091MG/ML · Bupivacaine Hydrochloride 0.75%; Epinephrine Bitartrate 0.0091MG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Hospira
- What the pharmacy pays
- ~$0.06 per ml — not your price
- FDA application
- NDA016964
What is Marcaine Hydrochloride W/ Epinephrine Preservative Free?
From the FDA label:MARCAINE / MARCAINE WITH EPINEPHRINE contains bupivacaine hydrochloride, an amide local anesthetic, as the active pharmaceutical ingredient. The route of administration for MARCAINE (without epinephrine) is by injection, for infiltration, perineural, caudal, epidural, or retrobulbar use. The route of administration for MARCAINE WITH EPINEPHRINE is by injection, for infiltration, perineural, caudal, or epidural use. Multiple-dose vials contain methylparaben [see 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: MARCAINE with 1:200,000 epinephrine, contains bupivacaine hydrochloride and epinephrine bitartrate (an alpha and beta-adrenergic agonist) as active pharmaceutical ingredients. This product is for injection via local infiltration, peripheral nerve block, and caudal and lumbar epidural blocks. Multiple dose vials contain methylparaben and they should not be used for caudal and lumbar epidural blocks. Epinephrine bitartrate is (–) - 3,4-Dihydroxy-α-[(methylamino)methyl] benzyl alcohol (+)-tartrate (1:1) salt. Epinephrine is a vasoconstrictor. It has the following structural formula: MARCAINE…
How to use
2.1 Important Dosage and Administration Information •MARCAINE / MARCAINE WITH EPINEPHRINE is not for intrathecal use. •Avoid use of MARCAINE / MARCAINE WITH EPINEPHRINE solutions containing antimicrobial preservatives (i.e., multiple-dose vials) for epidural or caudal anesthesia [see Warnings and Precautions (5.4)]. •Discard unused portions of solution not containing preservatives, i.e., those supplied in single-dose vials, following initial use. •Visually inspect this product for particulate matter and discoloration prior to administration whenever solution and container permit. MARCAINE / MARCAINE WITH EPINEPHRINE are clear, colorless solutions. 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 / MARCAINE WITH EPINEPHRINE is not recommended because of insufficient data on the clinical use of such mixtures. Administration Precautions •MARCAINE / MARCAINE WITH EPINEPHRINE are to be administered in carefully adjusted dosages by or under the supervision of experienced clinicians who are well versed in the diagnosis and management of dose-related toxicity and other acute emergencies which might arise from the block to be employed. •Use MARCAINE / MARCAINE WITH EPINEPHRINE only if the following are immediately available: oxygen, cardiopulmonary resuscitative equipment…
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)] •Severe, Persistent Hypertension, Cerebrovascular Accidents, and Bradycardia Due to Drug Interactions [see Warnings and Precautions (5.6)] •Cardiac Arrest with Intravenous Regional Anesthesia Use [see Contraindications (4), Warnings and Precautions (5.7)] •Allergic-Type Reactions [see Warnings and Precautions (5.8)] •Systemic Toxicities with Unintended Intravascular or Intrathecal Injection [see Warnings and Precautions (5.9)] •Respiratory Arrest Following Retrobulbar Block [see Warnings and Precautions (5.15)] The following adverse reactions from voluntary reports or clinical studies have been reported with bupivacaine or bupivacaine and epinephrine. 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 / MARCAINE WITH EPINEPHRINE are characteristic of those associated with other…
Warnings
Important safety information
WARNING: RISK OF CARDIAC ARREST WITH USE OF MARCAINE 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 the 0.75% (7.5 mg/mL) 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% (7.5 mg/mL) concentration of MARCAINE 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 [see Warnings and Precautions (5.1)]. WARNING: RISK OF CARDIAC ARREST WITH USE OF MARCAINE IN OBSTETRICAL ANESTHESIA See full prescribing information for complete boxed warning. 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 the 0.75% (7.5 mg/mL) 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% (7.5 mg/mL) concentration of MARCAINE 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). 5 Warnings and Precautions 5.1 Risk of Cardiac Arrest with Use of MARCAINE 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 the 0.75% (7.5 mg/mL) 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% (7.5 mg/mL) concentration of MARCAINE 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. 5.2 Dose-Related Toxicity The safety and effectiveness of MARCAINE / MARCAINE WITH EPINEPHRINE depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies. Careful and constant monitoring of cardiovascular and respiratory (adequacy of ventilation) vital signs and the patient's state of consciousness should be performed after injection of MARCAINE / MARCAINE WITH EPINEPHRINE 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, underventilation from any cause, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest, and, possibly, death. During major regional nerve blocks, such as those of the brachial plexus or lower extremity, the patient should have an indwelling intravenous catheter to assure adequate intravenous access. Use the lowest dosage of MARCAINE / MARCAINE WITH EPINEPHRINE that results in effective anesthesia to avoid high plasma levels and serious adverse effects. Avoid rapid injection of a large volume of MARCAINE / MARCAINE WITH EPINEPHRINE solution and administer fractional (incremental) doses when feasible. Injection of repeated doses of MARCAINE / MARCAINE WITH EPINEPHRINE 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. 5.3 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 (7.5)]. 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 / MARCAINE WITH EPINEPHRINE 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. 5.4 Antimicrobial Preservatives in Multiple-Dose Vials Avoid use of MARCAINE / MARCAINE WITH EPINEPHRINE solutions containing antimicrobial preservatives, i.e., those supplied in multiple-dose vials, for epidural or caudal anesthesia because safety has not been established with such use. 5.5 Chondrolysis with Intra-Articular Infusion Intra-articular infusions of local anesthetics including MARCAINE 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 associated with chondrolysis. 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 2 nd month after surgery. Currently, there is no effective treatment for chondrolysis; patients who experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement. 5.6 Risk of Adverse Reactions Due to Drug Interactions with MARCAINE WITH EPINEPHRINE Risk of Severe, Persistent Hypertension Due to Drug Interactions Between MARCAINE WITH EPINEPHRINE and Monoamine Oxidase Inhibitors and Tricyclic Antidepressants Administration of MARCAINE WITH EPINEPHRINE (containing a vasoconstrictor) in patients receiving monoamine oxidase inhibitors (MAOI) or tricyclic antidepressants may result in severe, prolonged hypertension. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful monitoring of the patient's hemodynamic status is essential [see Drug Interactions (7.2)]. Risk of Severe, Persistent Hypertension or Cerebrovascular Accidents Due to Drug Interactions Between MARCAINE WITH EPINEPHRINE and Ergot-Type Oxytocic Drugs Concurrent administration of MARCAINE WITH EPINEPHRINE and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents. Avoid use of…
Who should not take Marcaine Hydrochloride W/ Epinephrine Preservative Free
MARCAINE / MARCAINE WITH EPINEPHRINE 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 MARCAINE / MARCAINE WITH EPINEPHRINE. 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 MARCAINE / MARCAINE WITH EPINEPHRINE. (4)
Overdose — what happens if you take too much
Clinical Presentation Acute emergencies from use of MARCAINE / MARCAINE WITH EPINEPHRINE 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 MARCAINE / MARCAINE WITH EPINEPHRINE 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 MARCAINE / MARCAINE WITH EPINEPHRINE, 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…
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
7.1 Local Anesthetics The toxic effects of local anesthetics are additive. If coadministration of other local anesthetics with MARCAINE / MARCAINE WITH EPINEPHRINE 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 (5.2)]. 7.2 Monoamine Oxidase Inhibitors and Tricyclic Antidepressants The administration of MARCAINE WITH EPINEPHRINE to patients receiving monoamine oxidase inhibitors, or tricyclic antidepressants may produce severe, prolonged hypertension. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful monitoring of the patient's hemodynamic status is essential [see Warnings and Precautions (5.6)]. 7.3 Ergot-Type Oxytocic Drugs Concurrent administration of MARCAINE WITH EPINEPHRINE and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents. Avoid use of MARCAINE WITH EPINEPHRINE concomitantly with ergot-type oxytocic drugs [see Warnings and Precautions (5.6)]. 7.4 Nonselective Beta-Adrenergic Antagonists Administration of MARCAINE WITH EPINEPHRINE (containing a vasoconstrictor) in patients receiving nonselective beta-adrenergic antagonists may cause severe hypertension and bradycardia. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful monitoring of the patient's blood pressure and heart rate is essential [see Warnings and Precautions (5.6)]. 7.5 Drugs Associated with Methemoglobinemia Patients who are administered MARCAINE / MARCAINE WITH EPINEPHRINE are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics [see Warnings and Precautions (5.3)]. 7.6 Potent Inhalation Anesthetics Serious dose-related cardiac arrhythmias may occur if preparations containing a vasoconstrictor such as epinephrine (e.g., MARCAINE WITH EPINEPHRINE) are used in patients during or following the administration of potent inhalation anesthetics [see Warnings and Precautions (5.13)]. 7.7 Phenothiazines and Butyrophenones Phenothiazines and butyrophenones may reduce or reverse the pressor effect of epinephrine. Concurrent use of MARCAINE WITH EPINEPHRINE and these agents should generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential. • Local Anesthetics : The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects when additional local anesthetics are administered. (7.1) • Monoamine Oxidase Inhibitors and Tricyclic Antidepressants : Administration of MARCAINE WITH EPINEPHRINE to patients receiving monoamine oxidase inhibitors or tricyclic antidepressants may produce severe, prolonged hypertension. Concurrent use of these agents should generally be avoided. (5.6, 7.2) • Ergot-Type Oxytocic Drugs : Concurrent administration of MARCAINE WITH EPINEPHRINE and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents. (5.6, 7.3) • Nonselective Beta-Adrenergic Antagonists : Administration of MARCAINE WITH EPINEPHRINE (containing a vasoconstrictor) in patients receiving nonselective beta-adrenergic antagonists may cause severe hypertension and bradycardia. Concurrent use of these agents should generally be avoided. (5.6, 7.4) • 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) • Potent Inhalation Anesthetics : Serious dose-related cardiac arrhythmias may occur if preparations containing a vasoconstrictor such as epinephrine are used in patients during or following the administration of potent inhalation anesthetics. (5.13, 7.6) Image5.jpg
Dosage forms
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The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- How is Marcaine Hydrochloride W/ Epinephrine Preservative Free rated?
- pharmaranks gives Marcaine Hydrochloride W/ Epinephrine Preservative Free a composite score of 2.2 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 Hydrochloride W/ Epinephrine Preservative Free 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 Hydrochloride W/ Epinephrine Preservative Free?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Marcaine Hydrochloride W/ Epinephrine Preservative Free. 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 Hydrochloride W/ Epinephrine Preservative Free?
- Marcaine Hydrochloride W/ Epinephrine Preservative Free is marketed by Hospira. You can see Hospira's full profile, rating, and other products on pharmaranks.
- Is Marcaine Hydrochloride W/ Epinephrine Preservative Free a brand-name or generic drug?
- Marcaine Hydrochloride W/ Epinephrine Preservative Free is a brand-name product with the active ingredient Bupivacaine Hydrochloride and Epinephrine Bitartrate.
- Is Marcaine Hydrochloride W/ Epinephrine Preservative Free available over the counter?
- No. Marcaine Hydrochloride W/ Epinephrine Preservative Free 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 Hydrochloride W/ Epinephrine Preservative Free come in?
- Marcaine Hydrochloride W/ Epinephrine Preservative Free is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Marcaine Hydrochloride W/ Epinephrine Preservative Free FDA-registered?
- Marcaine Hydrochloride W/ Epinephrine Preservative Free is on record with the U.S. FDA under application number NDA016964. You can verify this on its official FDA label.
- Has Marcaine Hydrochloride W/ Epinephrine Preservative Free been recalled by the FDA?
- Yes. Marcaine Hydrochloride W/ Epinephrine Preservative Free has 4 recorded FDA recall events in the openFDA enforcement database. A recall removes specific lots from the market — usually for manufacturing, contamination, potency, or labeling issues — and does not mean the drug is unsafe to take; your specific lot was almost certainly never affected. This recall history is factored into its safety score above. Always check the FDA recall database or your pharmacist for current alerts.
- Is Marcaine Hydrochloride W/ Epinephrine Preservative Free safe?
- There's no single safe-or-not verdict. pharmaranks gives Marcaine Hydrochloride W/ Epinephrine Preservative Free a recall-safety score of 44/100, based on its FDA recall history (4 recorded recall events) — 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 Hydrochloride W/ Epinephrine Preservative Free?
- Marcaine Hydrochloride W/ Epinephrine Preservative Free'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)] •Methemoglobinem… 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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