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| Product NDC Code | 0264-9594 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Lidocaine hydrochloride and dextrose |
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| Type | Brand | ||||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | INTRAVENOUS | ||||||
| Dosage Form | INJECTION, SOLUTION | ||||||
| RxCUI drug identifier | 1737723, 1737742, 1737744 |
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| Application Number | NDA019830 | ||||||
| Labeler Name | B. Braun Medical Inc. | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Lidocaine Hydrochloride and Dextrose
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.OVERDOSAGE Overdosage results in systemic toxicity (see ADVERSE REACTIONS ).
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.ADVERSE REACTIONS Systemic reactions of the following types have been reported: Central Nervous System: Light-headedness; drowsiness; dizziness; apprehension; euphoria; tinnitus; blurred or double vision; nausea and vomiting; sensation of heat, cold or numbness; twitching; tremors; convulsions; unconsciousness; respiratory depression and arrest. Cardiovascular System: Hypotension; cardiovascular arrest; and bradycardia which may lead to cardiac arrest. Hematologic Effects: methemoglobinemia Allergic reactions, including anaphylactic reactions, may occur but are infrequent. There have been no reports of cross-sensitivity between lidocaine hydrochloride and procainamide or between lidocaine hydrochloride and quinidine.
Lidocaine Hydrochloride and Dextrose Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.Drug Interactions Lidocaine should be used with caution in patients with digitalis toxicity accompanied by atrioventricular block (see CONTRAINDICATIONS ). Coadministration of propranolol or cimetidine with lidocaine has been reported to reduce clearance from the plasma and may result in toxic accumulation of the drug (see CLINICAL PHARMACOLOGY ). When lidocaine is administered with other antiarrhythmic drugs such as phenytoin, procainamide, propranolol, amiodarone, or quinidine, the cardiac effects may be additive or antagonistic and toxic effects may be additive. Phenytoin may stimulate the hepatic metabolism of lidocaine, but the clinical significance of this effect is not known.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY Lidocaine hydrochloride exerts an antiarrhythmic effect by increasing the electric stimulation threshold of the ventricle during diastole. In usual therapeutic doses, lidocaine hydrochloride produces no change in myocardial contractility, in systemic arterial pressure, or in absolute refractory period. About 90% of an administered dose of the drug is metabolized in the liver. The remaining 10% is excreted unchanged via the kidneys. Lidocaine toxicity is related to systemic blood levels. The decreased clearance and longer half-life of lidocaine should be taken into consideration with prolonged (24 hour) infusions. Constant rate of infusion may result in toxic accumulation of lidocaine. Infusion should be reduced to approximately one-half to compensate for decreased rate of clearance and concomitant or prior administration of propranolol may further increase blood concentrations by as much as 30% in patients without cardiac or hepatic failure. In clinical studies, patients over 65 years showed decreased lidocaine clearance. This was partly due to the tendency of elderly patients to have lower body weight and the increased risk of cardiac failure in these patients. This solution provides approximately 170 calories per liter.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS Lidocaine hydrochloride is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type. Lidocaine should not be used in patients with Stokes-Adams syndrome, Wolff-Parkinson-White syndrome, or with severe degrees of sinoatrial, atrioventricular, or intraventricular block. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION Lidocaine Hydrochloride and 5% Dextrose Injection USP is a sterile, nonpyrogenic solution prepared from lidocaine hydrochloride and dextrose in water for injection. Lidocaine hydrochloride is designated chemically as 2-(Diethylamino)-2',6'-acetoxylidide monohydrochloride. The solution serves as a cardiac antiarrhythmic agent intended for intravenous use. Composition - Each 100 mL contains: Solution Lidocaine Hydrochloride Anhydrous USP Hydrous Dextrose USP pH Calculated Osmolarity mOsmol/liter 0.4% Lidocaine HCl and 5% Dextrose Injection USP 0.4 g 5 g 4.4 (3.0–7.0) 280 0.8% Lidocaine HCl and 5% Dextrose Injection USP 0.8 g 5 g 4.2 (3.0–7.0) 305 Water for Injection USP qs The formulas of the active ingredients are: Lidocaine Hydrochloride Anhydrous USP (M.W. 270.80) Hydrous Dextrose USP (M.W. 198.17) Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. The closure system has two ports; the one for the administration set has a tamper evident plastic protector. Refer to the Directions for Use of the container. Chemical Structure Chemical Structure
| Solution | Lidocaine Hydrochloride Anhydrous USP | Hydrous Dextrose USP | pH | Calculated Osmolarity mOsmol/liter |
|---|---|---|---|---|
| 0.4% Lidocaine HCl and 5% Dextrose Injection USP | 0.4 g | 5 g | 4.4 (3.0–7.0) | 280 |
| 0.8% Lidocaine HCl and 5% Dextrose Injection USP | 0.8 g | 5 g | 4.2 (3.0–7.0) | 305 |
| Water for Injection USP qs |
| | |
| Lidocaine Hydrochloride Anhydrous USP (M.W. 270.80) | Hydrous Dextrose USP (M.W. 198.17) |
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE AND ADMINISTRATION Therapy of ventricular arrhythmias is often initiated with a single IV bolus of 1 mg/kg of Lidocaine Hydrochloride Injection USP. Following acute treatment by bolus in patients in whom arrhythmias tend to recur and who are incapable of receiving oral antiarrhythmic agents, intravenous infusion of Lidocaine Hydrochloride and 5% Dextrose Injection USP is administered continuously. Rate of Administration Adults (20 to 50 mcg/kg/min): Average 70 kg adult mg/min mL/hr mL/min 0.4% Lidocaine Hydrochloride and 5% Dextrose Injection USP (4 mg lidocaine hydrochloride/mL) 1–4 15–60 0.25–1.0 0.8% Lidocaine Hydrochloride and 5% Dextrose Injection USP (8 mg lidocaine hydrochloride/mL) 1–4 7.5–30 0.12–0.5 Pediatric Patients (30 mcg/kg/min). Standards and Guidelines for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiac Care (ECC). American Heart Association, JAMA 244 (5):453–509, 1980. Pharmacokinetic data indicate reduced elimination of lidocaine after prolonged infusion (24 hours) with resultant prolongation of the half-life to approximately three times that seen following a single administration. Failure to adjust the rate of infusion in keeping with this altered ability to eliminate lidocaine may result in toxic accumulation of the drug in the patient's serum. LeLorier J, Grenon D, Latour Y, et al.: Pharmacokinetics of lidocaine after prolonged intravenous infusions in uncomplicated myocardial infarction. Ann Int Med 87:700–702, 1977. Intravenous infusions of lidocaine hydrochloride must be administered under constant ECG monitoring to avoid potential overdosage and toxicity. Intravenous infusion should be terminated as soon as the patient's basic cardiac rhythm appears to be stable or at the earliest signs of toxicity. It should rarely be necessary to continue intravenous infusions beyond 24 hours. As soon as possible and when indicated, patients should be changed to an oral antiarrhythmic agent for maintenance therapy. Caution: Concentrated solutions of lidocaine hydrochloride (greater than 0.2%) should be administered by carefully calibrated infusion devices. Pediatric Use Therapy should be initiated with a single IV bolus of 1 mg/kg of Lidocaine Hydrochloride Injection USP. A maintenance intravenous infusion of Lidocaine Hydrochloride and 5% Dextrose Injection USP administered at a recommended infusion rate of 30 mcg/kg/min may be given. Geriatric Use Patients with reduced hepatic function or diminished hepatic blood flow (as in heart failure and after cardiac surgery), or those over 70 years of age should receive half the usual loading dose and also should be given lower maintenance levels of intravenous lidocaine. Patients over 65 years may benefit from dosing based upon body weight (see CLINICAL PHARMACOLOGY and PRECAUTIONS, Geriatric Use ). Lidocaine hydrochloride should not be added to blood transfusion assemblies. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
| Average 70 kg adult | |||
|---|---|---|---|
| mg/min | mL/hr | mL/min | |
| 0.4% Lidocaine Hydrochloride and 5% Dextrose Injection USP (4 mg lidocaine hydrochloride/mL) | 1–4 | 15–60 | 0.25–1.0 |
| 0.8% Lidocaine Hydrochloride and 5% Dextrose Injection USP (8 mg lidocaine hydrochloride/mL) | 1–4 | 7.5–30 | 0.12–0.5 |
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS AND USAGE Lidocaine hydrochloride administered intravenously is specifically indicated in the acute management of (1) ventricular arrhythmias occurring during cardiac manipulations, such as cardiac surgery and (2) life-threatening arrhythmias which are ventricular in origin, such as occur during acute myocardial infarction.
Spl product data elements
Usually a list of ingredients in a drug product.Lidocaine Hydrochloride and Dextrose LIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATE LIDOCAINE HYDROCHLORIDE ANHYDROUS LIDOCAINE DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE WATER Lidocaine Hydrochloride and Dextrose LIDOCAINE HYDROCHLORIDE ANHYDROUS and DEXTROSE MONOHYDRATE LIDOCAINE HYDROCHLORIDE ANHYDROUS LIDOCAINE DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE WATER
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.Carcinogenesis, Mutagenesis, Impairment of Fertility Long term animal studies have not been performed to evaluate carcinogenic potential of lidocaine; nor have studies been conducted to assess the mutagenic potential of lidocaine or its potential to affect fertility.
Laboratory tests
Information on laboratory tests helpful in following the patient’s response to the drug or in identifying possible adverse reactions. If appropriate, information may be provided on such factors as the range of normal and abnormal values expected in the particular situation and the recommended frequency with which tests should be performed before, during, and after therapy.Laboratory Tests Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 500 mL Container Label Lidocaine HCl and 5% Dextrose Injection USP REF P5941 NDC 0264-9594-10 500 mL EXCEL ® CONTAINER Lidocaine 2 g (4 mg/mL) Y94-003-343 LD-261-4 Each 100 mL contains: Lidocaine Hydrochloride USP 0.4 g; Hydrous Dextrose USP 5 g; Water for Injection USP qs pH: 4.4 (3.0-7.0); Calc. Osmolarity: 280 mOsmol/liter WARNING: Do not admix with other drugs. Do not administer simultaneously with blood. Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y94-003-293 LD-121-4 EXP LOT P5941 Other symbol P5941
PRINCIPAL DISPLAY PANEL - 250 mL Container Label Lidocaine HCl and 5% Dextrose Injection USP REF P5942 NDC 0264-9594-20 250 mL EXCEL ® CONTAINER Lidocaine 1 g (4 mg/mL) Y94-003-298 LD-270-3 Each 100 mL contains: Lidocaine Hydrochloride USP 0.4 g; Hydrous Dextrose USP 5 g; Water for Injection USP qs pH: 4.4 (3.0-7.0) Calc. Osmolarity: 280 mOsmol/liter WARNING: Do not admix with other drugs. Do not administer simultaneously with blood. Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Not made with natural rubber latex, PVC or DEHP. Excel is a registered trademark of B. Braun Medical Inc. Rx only B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y94-003-297 LD-119-4 EXP LOT P5942 Other symbol P5942
PRINCIPAL DISPLAY PANEL - 250 mL Container Label Lidocaine HCl and 5% Dextrose Injection USP REF P5982 NDC 0264-9598-20 250 mL EXCEL ® CONTAINER Lidocaine 2 g (8 mg/mL) Y94-003-296 LD-343-2 Each 100 mL contains: Lidocaine Hydrochloride USP 0.8 g; Hydrous Dextrose USP 5 g; Water for Injection USP qs pH: 4.2 (3.0-7.0) Calc. Osmolarity: 305 mOsmol/liter WARNING: Do not admix with other drugs. Do not administer simultaneously with blood. Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Not made with natural rubber latex, PVC or DEHP. Excel is a registered trademark of B. Braun Medical Inc. Rx only B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y94-003-295 LD-120-4 EXP LOT P5982 Other symbol P5982
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Do not admix with other drugs.
Rx only Revised: November 2019 EXCEL is a registered trademark of B. Braun Medical Inc.
B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Y36-003-016 LD-236-8
Spl patient package insert
Information necessary for patients to use the drug safely and effectively.Directions for Use of EXCEL® Container Do not admix with other drugs. Caution: Do not use plastic containers in series connection. To Open Tear overwrap down at notch and remove solution container. Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired. NOTE: Before use, perform the following checks: Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date. Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container which is suspect should not be used. Use only if solution is clear and container and seals are intact. Preparation for Administration Remove plastic protector from sterile set port at bottom of container. Attach administration set. Refer to complete directions accompanying set.
Geriatric use
Information about any limitations on any geriatric indications, needs for specific monitoring, hazards associated with use of the drug in the geriatric population.Geriatric Use Lidocaine is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION ).
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Lidocaine Hydrochloride and 5% Dextrose Injection USP is administered to a nursing woman.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.Pediatric Use The safety and effectiveness of lidocaine has not been established in pediatric patients (neonates to adolescents). (see WARNINGS and DOSAGE AND ADMINISTRATION .)
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)Pregnancy Teratogenic Effects Reproduction studies have been performed in rats at doses up to 5 times the human dose and have revealed no evidence of harm to the fetus due to lidocaine hydrochloride. There are, however, no adequate well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Teratogenic effects
Pregnancy category A: Adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in the first trimester of pregnancy, and there is no evidence of a risk in later trimesters. Pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus, there are no adequate and well-controlled studies in humans, and the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks. Pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks (for example, if the drug is needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective). Pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities or there is positive evidence of fetal risk based on adverse reaction reports from investigational or marketing experience, or both, and the risk of the use of the drug in a pregnant woman clearly outweighs any possible benefit (for example, safer drugs or other forms of therapy are available).Teratogenic Effects Reproduction studies have been performed in rats at doses up to 5 times the human dose and have revealed no evidence of harm to the fetus due to lidocaine hydrochloride. There are, however, no adequate well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED Lidocaine Hydrochloride and 5% Dextrose Injection USP is supplied sterile and nonpyrogenic in Full Fill 500 mL and 250 mL EXCEL® Containers packaged 24 per case. Fill NDC REF Solution 2 g Lidocaine Hydrochloride: 500 mL 0264-9594-10 P5941 0.4% Lidocaine Hydrochloride and 5% Dextrose Injection USP 250 mL 0264-9598-20 P5982 0.8% Lidocaine Hydrochloride and 5% Dextrose Injection USP 1 g Lidocaine Hydrochloride: 250 mL 0264-9594-20 P5942 0.4% Lidocaine Hydrochloride and 5% Dextrose Injection USP Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.
| Fill | NDC | REF | Solution |
|---|---|---|---|
| | |||
| 500 mL | 0264-9594-10 | P5941 | 0.4% Lidocaine Hydrochloride |
| and 5% Dextrose Injection USP | |||
| 250 mL | 0264-9598-20 | P5982 | 0.8% Lidocaine Hydrochloride |
| and 5% Dextrose Injection USP | |||
| | |||
| 250 mL | 0264-9594-20 | P5942 | 0.4% Lidocaine Hydrochloride |
| and 5% Dextrose Injection USP | |||
Storage and handling
Information about safe storage and handling of the drug product.Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.
General precautions
Information about any special care to be exercised for safe and effective use of the drug.General Caution should be employed in the repeated use of lidocaine hydrochloride in patients with severe liver or renal disease because accumulation may occur and lead to toxic phenomena, since lidocaine hydrochloride is metabolized mainly in the liver and excreted by the kidneys. The drug should also be used with caution in patients with hypovolemia and shock, and in all forms of heart block (see CONTRAINDICATIONS and WARNINGS ). In patients with sinus bradycardia or incomplete heart block, the administration of lidocaine hydrochloride intravenously for the elimination of ventricular ectopic beats without prior acceleration in heart rate ( e.g., by isoproterenol or by electric pacing) may promote more frequent and serious ventricular arrhythmias or complete heart block (see CONTRAINDICATIONS ). Most potent anesthetic agents, local anesthetics of the amide type which includes lidocaine, and muscle relaxants of both depolarizing and nondepolarizing types have been associated with malignant hyperthermia. Care should be taken in the administration of intravenous fluids in patients with compromised myocardial function to avoid fluid overload or disturbances of serum electrolyte concentrations which might interfere with cardiac conduction or result in congestive heart failure. Do not use plastic containers in series connection. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container. These solutions are intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. Use only if solution is clear and container and seals are intact.
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS General Caution should be employed in the repeated use of lidocaine hydrochloride in patients with severe liver or renal disease because accumulation may occur and lead to toxic phenomena, since lidocaine hydrochloride is metabolized mainly in the liver and excreted by the kidneys. The drug should also be used with caution in patients with hypovolemia and shock, and in all forms of heart block (see CONTRAINDICATIONS and WARNINGS ). In patients with sinus bradycardia or incomplete heart block, the administration of lidocaine hydrochloride intravenously for the elimination of ventricular ectopic beats without prior acceleration in heart rate ( e.g., by isoproterenol or by electric pacing) may promote more frequent and serious ventricular arrhythmias or complete heart block (see CONTRAINDICATIONS ). Most potent anesthetic agents, local anesthetics of the amide type which includes lidocaine, and muscle relaxants of both depolarizing and nondepolarizing types have been associated with malignant hyperthermia. Care should be taken in the administration of intravenous fluids in patients with compromised myocardial function to avoid fluid overload or disturbances of serum electrolyte concentrations which might interfere with cardiac conduction or result in congestive heart failure. Do not use plastic containers in series connection. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. If administration is not controlled by a pumping device, refrain from applying excessive pressure (>300mmHg) causing distortion to the container such as wringing or twisting. Such handling could result in breakage of the container. These solutions are intended for intravenous administration using sterile equipment. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. Use only if solution is clear and container and seals are intact. Laboratory Tests Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Drug Interactions Lidocaine should be used with caution in patients with digitalis toxicity accompanied by atrioventricular block (see CONTRAINDICATIONS ). Coadministration of propranolol or cimetidine with lidocaine has been reported to reduce clearance from the plasma and may result in toxic accumulation of the drug (see CLINICAL PHARMACOLOGY ). When lidocaine is administered with other antiarrhythmic drugs such as phenytoin, procainamide, propranolol, amiodarone, or quinidine, the cardiac effects may be additive or antagonistic and toxic effects may be additive. Phenytoin may stimulate the hepatic metabolism of lidocaine, but the clinical significance of this effect is not known. Carcinogenesis, Mutagenesis, Impairment of Fertility Long term animal studies have not been performed to evaluate carcinogenic potential of lidocaine; nor have studies been conducted to assess the mutagenic potential of lidocaine or its potential to affect fertility. Pregnancy Teratogenic Effects Reproduction studies have been performed in rats at doses up to 5 times the human dose and have revealed no evidence of harm to the fetus due to lidocaine hydrochloride. There are, however, no adequate well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Lidocaine Hydrochloride and 5% Dextrose Injection USP is administered to a nursing woman. Pediatric Use The safety and effectiveness of lidocaine has not been established in pediatric patients (neonates to adolescents). (see WARNINGS and DOSAGE AND ADMINISTRATION .) Geriatric Use Lidocaine is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION ).
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS Constant monitoring with an electrocardiograph is essential to the proper administration of lidocaine hydrochloride intravenously. Signs of excessive depression of cardiac conductivity, such as prolongation of the PR interval, widening of the QRS interval or the appearance or aggravation of arrhythmias, should be followed by prompt cessation of the intravenous infusion of this agent. It is mandatory to have emergency resuscitative equipment and drugs immediately available to manage adverse reactions involving cardiovascular, respiratory, or central nervous systems. Occasional acceleration of ventricular rate may occur when lidocaine hydrochloride is administered to patients with atrial fibrillation. Evidence for proper usage in pediatric patients is limited. Anaphylactic reactions may occur following administration of lidocaine hydrochloride. In the case of severe reaction, discontinue the use of the drug. Because dosages of this drug are titrated to response (see DOSAGE AND ADMINISTRATION ), no additives should be made to Lidocaine Hydrochloride and 5% Dextrose Injection USP .
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API