Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Bupivacaine Hydrochloride in Dextrose Injection, USP solution may be autoclaved once at 15 pound pressure, 121°C (250°F) for 15 minutes. This product is clear and colorless. Do not use the solution if it is discolored or contains particulate matter. Single-dose ampules of 2 mL Bupivacaine Hydrochloride in Dextrose Injection, USP (15 mg bupivacaine hydrochloride with 165 mg dextrose) are supplied as follows: NDC Container Concentration Size Total (mg) 71351-022-10 Single Dose Ampule (Package of 10) 0.75% (7.5 mg/mL) 2mL 15 71351-022-50 Single Dose Ampule (Package of 50) 0.75% (7.5 mg/mL) 2mL 15 Discard the unused portion.; Principal Display Panel 2 mL (10 Ampules Unit Dose) Carton Label 10 x 2 mL Single-dose Ampules NDC 71351-022-10 STERILE HYPERBARIC SOLUTION FOR SPINAL ANESTHESIA Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP SPINAL 0.75% (15 mg/2 mL) (7.5 mg/mL) Distributed by: Brookfield Pharmaceuticals, LLC 2 mL (50 Ampules Unit Dose) Carton Label 50 x 2 mL Single-dose Ampules NDC 71351-022-50 STERILE HYPERBARIC SOLUTION FOR SPINAL ANESTHESIA Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP SPINAL 0.75% (15 mg/2 mL) (7.5 mg/mL) Distributed by: Brookfield Pharmaceuticals, LLC 2 mL Ampule Label 2 mL Ampule NDC 71351-022-02 EL6461-02 Rx only Bupivacaine HCl 0.75% in Dextrose 8.25% Injection, USP SPINAL Contains 7.5 mg bupivacaine HCl (anhydrous) and 82.5 mg dextrose (anhydrous) per mL. pH adjusted between 4.0 and 6.5 with NaOH or HCl. Distributed by: Brookfield Pharmaceuticals, LLC LOT NO. : XXXXXX EXP. DATE : YYYY/MM/DD EK6177-01 EK6147-02 EL6461-02
- 16 HOW SUPPLIED/STORAGE AND HANDLING Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Bupivacaine Hydrochloride in Dextrose Injection, USP solution may be autoclaved once at 15 pound pressure, 121°C (250°F) for 15 minutes. This product is clear and colorless. Do not use the solution if it is discolored or contains particulate matter. Single-dose ampules of 2 mL Bupivacaine Hydrochloride in Dextrose Injection, USP (15 mg bupivacaine hydrochloride with 165 mg dextrose) are supplied as follows: NDC Container Concentration Size Total (mg) 71351-022-10 Single Dose Ampule (Package of 10) 0.75% (7.5 mg/mL) 2mL 15 71351-022-50 Single Dose Ampule (Package of 50) 0.75% (7.5 mg/mL) 2mL 15 Discard the unused portion.
- Principal Display Panel 2 mL (10 Ampules Unit Dose) Carton Label 10 x 2 mL Single-dose Ampules NDC 71351-022-10 STERILE HYPERBARIC SOLUTION FOR SPINAL ANESTHESIA Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP SPINAL 0.75% (15 mg/2 mL) (7.5 mg/mL) Distributed by: Brookfield Pharmaceuticals, LLC 2 mL (50 Ampules Unit Dose) Carton Label 50 x 2 mL Single-dose Ampules NDC 71351-022-50 STERILE HYPERBARIC SOLUTION FOR SPINAL ANESTHESIA Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP SPINAL 0.75% (15 mg/2 mL) (7.5 mg/mL) Distributed by: Brookfield Pharmaceuticals, LLC 2 mL Ampule Label 2 mL Ampule NDC 71351-022-02 EL6461-02 Rx only Bupivacaine HCl 0.75% in Dextrose 8.25% Injection, USP SPINAL Contains 7.5 mg bupivacaine HCl (anhydrous) and 82.5 mg dextrose (anhydrous) per mL. pH adjusted between 4.0 and 6.5 with NaOH or HCl. Distributed by: Brookfield Pharmaceuticals, LLC LOT NO. : XXXXXX EXP. DATE : YYYY/MM/DD EK6177-01 EK6147-02 EL6461-02
Overview
Bupivacaine Hydrochloride in Dextrose Injection, USP is an amide-local anesthetic and sterile hyperbaric aqueous solution. The route of administration for Bupivacaine Hydrochloride in Dextrose Injection, USP is by subarachnoid injection. Bupivacaine Hydrochloride in Dextrose Injection, USP 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-(2,6dimethylphenyl)-, 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 C18H28N2O·HCl·H2O 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 C6H12O6, molecular weight of 180.16 g/mol and has the following structural formula: Bupivacaine Hydrochloride in Dextrose Injection, USP is a clear and colorless sterile hyperbaric solution. Each mL of Bupivacaine Hydrochloride in Dextrose Injection, USP 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. Bupivacaine Hydrochloride in Dextrose Injection, USP pH is between 4.0 and 6.5. The specific gravity of Bupivacaine Hydrochloride in Dextrose Injection, USP is between 1.030 and 1.035 at 25°C and 1.03 at 37°C. Bupivacaine Hydrochloride in Dextrose Injection, USP does not contain any preservatives. Bupivacaine Formula dextrose(anhydrous)-formula
Indications & Usage
Bupivacaine Hydrochloride in Dextrose Injection, USP is indicated for subarachnoid injection in adults for the production of subarachnoid block (spinal anesthesia).
Dosage & Administration
2.1 Important Dosage and Administration Information Visually inspect this product for particulate matter and discoloration prior to administration. Bupivacaine Hydrochloride in Dextrose Injection, USP 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 Bupivacaine Hydrochloride in Dextrose Injection, USP is not recommended because of insufficient data on the clinical use of such mixtures. Discard unused portions of Bupivacaine Hydrochloride in Dextrose Injection, USP following initial use. Administration Precautions Bupivacaine Hydrochloride in Dextrose Injection, USP is 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 Bupivacaine Hydrochloride in Dextrose Injection, USP only if the following are immediately available: oxygen, cardiopulmonary resuscitative equipment and drugs, and the personnel resources needed for proper management of toxic reactions and related emergencies [ see Warnings and Precautions (5.3) , Adverse Reactions (6) , Overdosage (10) ]. The toxic effects of local anesthetics are additive. Monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity when additional local anesthetics are administered with Bupivacaine Hydrochloride in Dextrose Injection, USP [ see Warnings and Precautions (5.3) , Drug Interactions (7.1) , Overdosage (10) ]. Aspirate for blood and cerebrospinal fluid prior to injecting Bupivacaine Hydrochloride in Dextrose Injection, USP, for both the initial dose and all subsequent doses (where applicable), to avoid intravascular injection and to confirm entry into the subarachnoid space. Aspiration of cerebrospinal fluid into a Bupivacaine Hydrochloride in Dextrose Injection, USP-filled syringe will result in an identifiable swirl in the solution. A negative aspiration for blood does not ensure against an intravascular injection [ see Warnings and Precautions (5.4) ]. Avoid rapid injection of Bupivacaine Hydrochloride in Dextrose Injection, USP. The patient should have an indwelling intravenous catheter to assure adequate intravenous access. The lowest dosage of Bupivacaine Hydrochloride in Dextrose Injection, USP that results in effective spinal anesthesia should be used to avoid a high motor block and serious adverse reactions. Perform careful and constant monitoring of cardiovascular and respiratory (adequacy of oxygenation and ventilation) vital signs and the patient’s level of consciousness during spinal anesthesia. Conditions Which May Preclude Use of Spinal Anesthesia The following conditions may preclude the use of spinal anesthesia, depending upon the physician’s evaluation of the patient: Pre-existing diseases of the central nervous system (CNS), such as those attributable to pernicious anemia, poliomyelitis, syphilis, or tumor. Hematological disorders predisposing to coagulopathies or patients on anticoagulant therapy. Trauma to a blood vessel during the conduct of spinal anesthesia may, in some instances, result in uncontrollable CNS hemorrhage, soft tissue hemorrhage, or development of a hematoma. Chronic backache and preoperative headache. Hypotension and hypertension. Technical problems (persistent paresthesias, persistent bloody tap). Arthritis or spinal deformity. Extremes of age. Psychosis, dementia, or other illnesses resulting in poor patient cooperation. 2.2 Recommended Dosages of Bupivacaine Hydrochloride in Dextrose Injection, USP The dosage of Bupivacaine Hydrochloride in Dextrose Injection, USP 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 extent and degree of spinal anesthesia depend upon several factors including dosage, baricity of the anesthetic solution, volume of solution, force of injection, level of puncture, and position of the patient during and immediately after injection. In recommended doses, Bupivacaine Hydrochloride in Dextrose Injection, USP produces complete motor and sensory block. The following table summarizes general dosage guidelines for adult patients for the procedures described: PROCEDURES DOSAGE GUIDELINES Vaginal Delivery Starting dose, 6 mg (0.8 mL) Lower Extremity and Perineal Procedures, such as: transurethral resection of the prostate (TURP) vaginal hysterectomy 7.5 mg (1 mL) Lower Abdominal Procedures, such as: abdominal hysterectomy tubal ligation appendectomy 12 mg (1.6 mL) Cesarean Section 7.5 mg to 10.5 mg (1 mL to 1.4 mL)
Warnings & Precautions
5.1 Use of Spinal Anesthetics During Uterine Contractions Spinal anesthetics including Bupivacaine Hydrochloride in Dextrose Injection, USP 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 Bupivacaine Hydrochloride in Dextrose Injection, USP. 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 Bupivacaine Hydrochloride in Dextrose Injection, USP. 5.3 Dose-Related Toxicity The safety and effectiveness of Bupivacaine Hydrochloride in Dextrose Injection, USP 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 Bupivacaine Hydrochloride in Dextrose Injection, USP 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 Bupivacaine Hydrochloride in Dextrose Injection, USP that results in effective anesthesia to avoid serious adverse reactions. Avoid rapid injection of a large volume of Bupivacaine Hydrochloride in Dextrose Injection, USP. Injection of repeated doses of Bupivacaine Hydrochloride in Dextrose Injection, USP 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 Bupivacaine Hydrochloride in Dextrose Injection, USP 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 Bupivacaine Hydrochloride in Dextrose Injection, USP, 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 Bupivacaine Hydrochloride in Dextrose Injection, USP-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 Bupivacaine Hydrochloride in Dextrose Injection, USP 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 Bupivacaine Hydrochloride Injection, USP for epidural anesthesia in obstetrical patients. In most cases, this has followed use of Bupivacaine Hydrochloride Injection, USP 0.75%, not Bupivacaine Hydrochloride in Dextrose Injection, USP. The package insert for Bupivacaine Hydrochloride Injection, USP for epidural, nerve block, etc., has a more complete discussion of preparation for, and management of cardiac arrest following epidural administration. Bupivacaine Hydrochloride in Dextrose Injection, USP 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 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 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. 5.8 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). Information on safe dosages and techniques of administration of Bupivacaine Hydrochloride in Dextrose Injection, USP in this procedure is lacking. Therefore, Bupivacaine Hydrochloride in Dextrose Injection, USP is contraindicated for use with this technique [ see Contraindications (4) ]. 5.9 Patients with Severe Disturbances of Cardiac Rhythm, Shock, or Heart Block Consider alternate anesthetic techniques in patients with severe disturbances of cardiac rhythm, shock, or heart block [ see Contraindications (4) ]. 5.10 Risk of Toxicity in Patients with Hepatic Impairment Because amide-type local anesthetics such as bupivacaine are metabolized by the liver, consider reduced dosing and increased monitoring for bupivacaine systemic toxicity in patients with moderate to severe hepatic impairment who are treated with Bupivacaine Hydrochloride in Dextrose Injection, USP [ see Use in Specific Populations (8.6) ]. Most information regarding dose-related hepatic impairment is based on larger dosages of bupivacaine administered for other neuraxial, peripheral nerve, or fascial plane blocks. 5.11 Risk of Use in Patients with Impaired Cardiovascular Function Bupivacaine Hydrochloride in Dextrose Injection, USP should be given in reduced doses in patients with impaired cardiovascular function (e.g., hypotension, heartblock, valvular abnormalities) because they may be less able to compensate for functional changes associated with the sympathetic blockade observed after subarachnoid administration of Bupivacaine Hydrochloride in Dextrose Injection, USP and the prolongation of AV conduction produced by the drug. Monitor patients closely for blood pressure, heart rate, and ECG changes.
Contraindications
Bupivacaine Hydrochloride in Dextrose Injection, USP 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 Bupivacaine Hydrochloride in Dextrose Injection, USP. patients with local infection at the site of proposed lumbar puncture.
Adverse Reactions
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 Bupivacaine Hydrochloride in Dextrose Injection, USP are characteristic of those associated with other amide-type local anesthetics. A major cause of adverse reactions to Bupivacaine Hydrochloride in Dextrose Injection, USP 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 encountered acute adverse reactions that demand immediate counter-measures following the administration of spinal anesthesia were hypotension due to loss of sympathetic tone and respiratory paralysis or underventilation due to cephalad extension of the motor level of anesthesia. These have led to cardiac arrest if untreated. In addition, dose-related convulsions and cardiovascular collapse have resulted from diminished tolerance, rapid absorption from the injection site, or from unintentional intravascular injection of a local anesthetic solution. Respiratory System : Respiratory paralysis or underventilation have been noted as a result of cephalad spread of spinal anesthesia and has led to secondary hypoxic cardiac arrest when untreated. Preanesthetic medication, intraoperative anesthetics, analgesics, and sedatives, as well as surgical manipulation, may contribute to underventilation. This has usually been noted within minutes of the injection of spinal anesthetic solution, but because of differing maximal onset times, differing intercurrent drug usage, and differing surgical manipulation, it may occur at any time during surgery or the immediate recovery period. Cardiac Disorders : Hypotension due to loss of sympathetic tone has been commonly encountered following spinal anesthesia. This has been more commonly observed in elderly patients, particularly those with hypertension, and patients with reduced blood volume, reduced interstitial fluid volume, cephalad spread of the local anesthetic, and/or mechanical obstruction of venous return. Nausea and vomiting have been frequently associated with hypotensive episodes following the administration of spinal anesthesia. High doses, or inadvertent intravascular injection, have led to high plasma levels and related depression of the myocardium, decreased cardiac output, bradycardia, heart block, ventricular arrhythmias, and cardiac arrest [ see Warnings and Precautions (5.4) ]. Nervous System Disorders : Respiratory paralysis or underventilation secondary to cephalad spread of the level of spinal anesthesia (see Respiratory System ) and hypotension for the same reason (see Cardiac Disorders ) have been the two most commonly encountered CNS-related adverse observations which demand immediate counter-measures. High doses or inadvertent intravascular injection have led to high plasma levels and related CNS toxicity. Adverse reactions were characterized by excitation and/or depression of the CNS and included restlessness, anxiety, dizziness, tinnitus, blurred vision, tremors, convulsions, drowsiness, unconsciousness, and respiratory arrest. 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. Convulsions : Incidence varied 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. 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. Neurologic effects following spinal anesthesia have included loss of perineal sensation and sexual function; persistent anesthesia, paresthesia, weakness and paralysis of the lower extremities, and loss of sphincter control with slow, incomplete, or no recovery; hypotension, high or total spinal block; urinary retention; headache; backache; septic meningitis, meningismus; arachnoiditis; slowing of labor; increased incidence of forceps delivery; shivering; cranial nerve palsies due to traction on nerves from loss of cerebrospinal fluid; and fecal and urinary incontinence. Immune System Disorders : Allergic-type reactions have occurred as a result of sensitivity to bupivacaine. These reactions were characterized by signs such as urticaria, pruritus, erythema, angioneurotic edema (including laryngeal edema), tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive sweating, elevated temperature, and severe hypotension. Cross sensitivity among members of the amide-type local anesthetic group has been reported.
Drug Interactions
DRUG INERACTIONS 7.1 Local Anesthetics The toxic effects of local anesthetics are additive. If coadministration of other local anesthetics with Bupivacaine Hydrochloride in Dextrose Injection, USP 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 Bupivacaine Hydrochloride in Dextrose Injection, USP 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
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