Federal government websites often end in .gov or .mil. Metoprolol Cold Hydrocortisone 50-200 mg Give via 5-10 SQ or TD injections into area of extravasation Medication Thermal Therapy Antidote Dose Treatment Nitroglycerin Cold Hydrocortisone 50-200 mg Give via 5-10 SQ or TD injections into area of extravasation Norepinephrine Heat Nitroglycerin 2% paste n/a Apply thin layer to area of extravasation q 6 hr x 24 hr Follow all directions on your prescription label. However, reference should be made to the respective agent manufacturer's package insert for information relative to dosage and administration. Intravenous Infusion High blood pressure may also increase the risk of heart attacks. High blood pressure adds to the workload of the heart and arteries. endstream endobj startxref The staff involved in the infusion and management of cytotoxic drugs must be trained to implement several preventive protocols for the minimization of the risk of extravasation. ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( |a^(/ -~,.[sL5 ;Z]^y~Mq7?7 e GE O G_oiV&! %Lp!8b(V7Yc2|5*qPp4wn"aLKa15N Extravasation is the leakage of an injected drug out of the blood vessels, damaging the surrounding tissues. hb``d``f`c`P "@1vG(r8}C#7mcH`KfYtfnzv$@,BKK~x$3$shElVVp A_8{.>9UiiGK:&ALg>)tvNV-+>'(yqnSg@Em.P^''*.^. Vesicants are inherently toxic and can cause pain, inflammation, and burn-like injury including blistering, sloughing, deep tissue damage, and necrosis. Packaged in a Carton of 10 NDC 55150-426-10 Diltiazem Stopping suddenly may make your condition worse. We comply with the HONcode standard for trustworthy health information. Worldwide experience in over 1,300 patients was similar. Local cooling (ice packs) aids in vasoconstriction, theoretically limiting the drug dispersion. Do not save the mixture for later use. Some patients may respond to an initial dose of 0.15 mg/kg, although duration of action may be shorter. Would you like email updates of new search results? Drug class: calcium channel blocking agents, ANALYSIS(55150-425, 55150-426, 55150-427), MANUFACTURE(55150-425, 55150-426, 55150-427), PACK(55150-425, 55150-426, 55150-427), dextrose (5%) and sodium chloride (0.45%) injection, USP. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Please read our disclaimer. High blood pressure is a common condition, and when not treated it can cause damage to the brain, heart, blood vessels, kidneys . I remember the case of the complication of extravasation in my patient in 1985 when I was an intern. If you are being treated for high blood pressure, keep using this medicine even if you feel well. Store product under refrigeration 2 to 8C (36 to 46F). Therapists will always feel nervous during the medical team-patient communication because of guilt. These pharmacokinetic effects seen during diltiazem coadministration can result in increased clinical effects (e.g. In the event of overdosage or an exaggerated response, appropriate supportive measures should be employed. The use of local warming is recommended for the extravasation of nonDNA-binding vesicants. In terms of cancer therapy, extravasation refers to the inadvertent infiltration of chemotherapeutic drugs in the tissues surrounding the IV site. 5. A defibrillator and emergency equipment should be readily available. There are no well-controlled studies in pregnant women; therefore, use diltiazem hydrochloride in pregnant women only if the potential benefit justifies the potential risk to the fetus. Data sources include IBM Watson Micromedex (updated 1 May 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. It is not known whether diltiazem will harm an unborn baby. 4. 50 mg per 10 mL (5 mg/mL) Your doctor will adjust the dose and frequency of diltiazem to your needs. Delayed extravasation:Symptoms occur 48 hours, or later, after drug administration. Paroxysmal Supraventricular Tachycardia Patients must be informed to report any changes in sensation, signs, or symptoms during the IV administration of any chemotherapeutic drug and to alert the healthcare professionals to early signs of extravasation. Use within 24 hours. As such, the initial use of diltiazem hydrochloride injection should be, if possible, in a setting where monitoring and resuscitation capabilities, including DC cardioversion/defibrillation, are present (see OVERDOSAGE). include protected health information. Atrial fibrillation or atrial flutter - In clinical studies with diltiazem hydrochloride injection for AF/FI, 135 of 257 patients were 65 years of age. The phase IV clinical study analyzes which people take Cardizem and have Infusion site extravasation. Diltiazem is used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders. Upon discontinuation of infusion, heart rate reduction may last from 0.5 hours to more than 10 hours (median duration 7 hours). Diltiazem can pass into breast milk and may harm a nursing baby. DO NOT flush the line 7. FOIA These VPBs are transient, are typically considered to be benign, and appear to have no clinical significance. 125-mg, 25-mL vialeach sterile vial contains 125 mg diltiazem hydrochloride, 18.75 mg citric acid USP, 16.25 mg sodium citrate dihydrate USP, 1,785 mg sorbitol solution USP, and water for injection USP up to 25 mL. It also increases the supply of blood and oxygen to the heart. Subsequent intravenous bolus doses should be individualized for each patient. If high-degree AV block occurs in sinus rhythm, intravenous diltiazem should be discontinued and appropriate supportive measures instituted (see OVERDOSAGE). Following oral administration, 2% to 4% of the unchanged diltiazem appears in the urine. (5 mg/mL) In a ten-subject randomized, open label, 4-way crossover study, coadministration of diltiazem (120 mg bid, diltiazem SR for 2 weeks) with a single 20 mg dose of lovastatin resulted in a 3- to 4-fold increase in mean lovastatin AUC and Cmax versus lovastatin alone. This medicine is available only with your doctor's prescription. Injectable forms of diltiazem are contraindicated in: 1. Experience in the use of antiarrhythmic agents following maintenance infusion of diltiazem hydrochloride injection is limited. Extravasated drugs are classified according to their potential for causing damage as vesicant, irritant, and nonvesicant. Vesicant drugs are also classified into 2 groups: DNA binding and non-DNA binding. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. IV push by TSN or MD only (in non-emergent settings). Diltiazem plasma levels were not significantly affected by lovastatin or pravastatin. Swallow it whole. xref Particular information must be given when a vesicant drug is administered. Narcotic analgesics may be required to reduce severe pain around widespread extensive necrosis. 549 0 obj <>stream Sauerland C, Engelking C, Wickham R, Corbi D. Vesicant extravasation part I: mechanisms, pathogenesis, and nursing care to reduce risk. HHS Vulnerability Disclosure, Help Ventricular Premature Beats (VPBs) - VPBs may be present on conversion of PSVT to sinus rhythm with diltiazem hydrochloride injection. The therapeutic benefits of diltiazem in supraventricular tachycardias are related to its ability to slow AV nodal conduction time and prolong AV nodal refractoriness. It is important that an accurate pretreatment diagnosis distinguish wide complex QRS tachycardia of supraventricular origin from that of ventricular origin prior to administration of diltiazem hydrochloride injection. Competitive in vitro ligand binding studies have shown that diltiazem binding is not altered by therapeutic concentrations of digoxin, phenytoin, hydrochlorothiazide, indomethacin, phenylbutazone, propranolol, salicylic acid, tolbutamide, or warfarin. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Project administration: JTK, JYP, HJL, YJC. May be stored at room temperature for up to 1 month. Manufactured by: Patients receiving these drugs concurrently should be monitored for a potential drug interaction. For Direct Intravenous Bolus Injection and 332 0 obj <> endobj Dermatologic: Pruritus, sweating . This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Avoid concomitant use of ivabradine and diltiazem. In some cases intravenous calcium has been administered (1 g calcium chloride or 3 g calcium gluconate) over 5 minutes, and repeated every 10 to 20 minutes as necessary. Diltiazem may also be used for purposes not listed in this medication guide. The audio recording of the abstract. 0000006002 00000 n While the injury is usually minor and resolves spontaneously, some cases result in serious complications, including full-thickness skin loss and muscle and tendon necrosis requiring reconstructive surgery or even amputation, leading to longer hospital stays, increased morbidity, and increased costs. Other: Amblyopia, asthenia, dry mouth, dyspnea, edema, headache, hyperuricemia Unauthorized use of these marks is strictly prohibited. 0000010698 00000 n Available from: [place unknown]: The National Extravasation Information Service; 2020. - Directions: apply hot fomentations for 20 to 30 minutes four to 6 times per day (for 1 day or more). The infusion may be maintained for up to 24 hours. In vitro studies suggest alpha1-acid glycoprotein binds approximately 40% of the drug at clinically significant concentrations. Do not stop taking this medication without first talking to your doctor. Hot fomentations can dilate the veins and mitigate the symptoms. Maximal hemodynamic effects usually occurred within 2 to 5 minutes of an injection. - For observation, do not cover the cannula area with opaque gauze. Data sources include IBM Watson Micromedex (updated 1 May 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Following single intravenous injection of diltiazem hydrochloride, however, plasma concentrations of N-monodesmethyldiltiazem and desacetyldiltiazem, two principal metabolites found in plasma after oral administration, are typically not detected. Langer SW. Extravasation of chemotherapy. Drugs with high osmolarity. official website and that any information you provide is encrypted Diltia XT, Dilt-XR, Diltzac, Matzim LA, Taztia XT, Tiadylt ER, Tiazac. After constant rate intravenous infusion to healthy male volunteers, diltiazem exhibits nonlinear pharmacokinetics over an infusion range of 4.8 to 13.2 mg/h for 24 hours. %%EOF The .gov means its official. If you are a Mayo Clinic patient, this could 7. The average heart rate is reduced by 20%. Heart rate reduction may last from 1 to 3 hours. Overdose symptoms may include slow heartbeat, weakness, chest pain, shortness of breath, or fainting. 5. 8600 Rockville Pike Nursing standard for intravenous injection of Asan Medical Center. Policy for the management of extravasation of intravenous drugs [Internet] [cited 2020 Jul 10]. The toxic dose in man is not known. The average age of the children in this study was about 3 years. In subgroup analysis following a two-dose procedure in double-blind and open-label studies, 104 patients 65 years of age and 95 patients <65 both had a 95% response rate. The patients normal activities, such as at home, work, school, etc., may be disrupted until the patient is fully recovered. It works by relaxing the blood vessels so the heart does not have to pump as hard. Clonidine - Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concurrently with diltiazem. other information we have about you. 0000001883 00000 n In patients with atrial fibrillation and atrial flutter, a significant correlation was observed between the percent reduction in HR and plasma diltiazem concentration using the Sigmoidal Emax model. 50 mg per 10 mL Gently aspirate extravasated drug. The leakage of the IV-administered fluids is clearly unintended, the condition being often presented as extravasation. Available from: University of Illinois College of Pharmacy . IV Push IV infusion . sharing sensitive information, make sure youre on a federal Diltiazem is used alone or together with other medicines to treat angina (severe chest pain) or hypertension (high blood pressure). Treatment depends on the nature of the offending substance; one approach is to localise and neutralise the substance whereas another is to spread and dilute it. Journal of Educational Evaluation for Health Professions, http://creativecommons.org/licenses/by/4.0/, https://www.nwcscnsenate.uk/files/8114/7334/9859/Final_Extravasation_Policy_V5.0_June_18.pdf, http://www.uic.edu/pharmacy/centers/drug_information_center/faq/extravasation.php, https://manchestercancer.files.wordpress.com/2014/09/extravasation_sept20131.pdf, Tissue loss exposing muscle/bone with a deep crater or necrosis. Diltiazem hydrochloride is 70% to 80% bound to plasma proteins. (5 mg/mL) Coadministration of diltiazem with rifampin or any known CYP3A4 inducer should be avoided when possible, and alternative therapy considered. Discard Unused Portion Store Under Refrigeration When possible, use a non-CYP3A4-metabolized statin together with diltiazem; otherwise, dose adjustments for both diltiazem and the statin should be considered along with close monitoring for signs and symptoms of any statin related adverse events. Hudson (OH): Lexi-Comp Inc; 2000. You should not stop using diltiazem suddenly. Continuous Intravenous Infusion the contents by NLM or the National Institutes of Health. Symptoms associated with the arrhythmia were improved in conjunction with decreased heart rate or conversion to normal sinus rhythm following administration of diltiazem hydrochloride injection. Geriatric Use The https:// ensures that you are connecting to the The vial stopper is not made with natural rubber latex. information and will only use or disclose that information as set forth in our notice of Prompt interdisciplinary action is often necessary for the treatment of extravasation injuries. Injection site extravasation is found among people who take Cardizem, especially for people who are female, 60+ old, have been taking the drug for < 1 month. Pharmacologic interventions for extravasation Cardizem and Infusion site extravasation - a phase IV clinical study of FDA data Summary: Infusion site extravasation is found among people who take Cardizem, especially for people who are female, 60+ old. Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician. HCl Injection INTRODUCTION. 0000024987 00000 n Barton-Burke M, Wilkes GM, Ingwersen KC, Bean CK, Berg D. Cancer chemotherapy: a nursing process approach. Diltiazem Administration Pearls: Response usually occurs in 3 minutes with maximum heart rate reduction generally occurring in 2-7 minutes. See this image and copyright information in PMC. Before Calcium gluconate has also been administered as a continuous infusion at a rate of 2 g per hour for 10 hours. 1). There was an increased incidence of stillbirths at doses of 20 times the human oral antianginal dose or greater. Available from: Lacy C, American Pharmaceutical Association . High intravenous dosages (4.5 mg/kg tid) administered to dogs resulted in significant bradycardia and alterations in AV conduction. Dermatologic: Alopecia, erythema multiforme (including Stevens-Johnson syndrome, toxic epidermal necrolysis), exfoliative dermatitis, leukocytoclastic vasculitis, petechiae, photosensitivity, purpura, rash, urticaria Disclaimer. Keep diluted diltiazem hydrochloride injection refrigerated until use. Editors note: I found this booklet, guidelines for the management of extravasation on November 15, 2019, at the 2019 Fall Conference of the Korean Society for Clinical Pharmacology and Therapeutics. Based on the results of pharmacokinetic studies in healthy volunteers administered different oral diltiazem hydrochloride formulations, constant rate intravenous infusions of diltiazem hydrochloride at 3, 5, 7, and 11 mg/h are predicted to produce steady-state plasma diltiazem concentrations equivalent to 120-, 180-, 240-, and 360-mg total daily oral doses of diltiazem hydrochloride tablets or diltiazem hydrochloride extended-release capsules. Inclusion in an NLM database does not imply endorsement of, or agreement with, 5. 0000008421 00000 n * 5 mg/h may be appropriate for some patients. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). If response is inadequate, a second dose may be administered after 15 minutes. Fixed high-degree AV block should be treated with cardiac pacing. Local cooling (ice packs) aids in vasoconstriction, theoretically limiting the drug dispersion. For either indication and particularly when employing continuous intravenous infusion, the setting should include continuous monitoring of the ECG and frequent measurement of blood pressure. 6. Experience with the use of diltiazem hydrochloride injection in patients with impaired ventricular function is limited. Spots or solid lines with blisters can be suddenly felt along the vessels injected with drugs. Waltham (MA): UpToDate Inc; c2020. Supplement 1. If hypotension occurs, it is generally short-lived, but may last from 1 to 3 hours. Photographic documentation of extravasation case. 10 mL Single-Dose Vials No potential conflict of interest relevant to this article was reported. Patients who have demonstrated hypersensitivity to the drug. The medical teams continuous education on extravasation is essential. The drug prevents the recurrence of life-threatening ventricular arrhythmias and. Take diltiazem exactly as prescribed by your doctor. Sign up for free, and stay up to date on research advancements, health tips and current health topics, like COVID-19, plus expertise on managing health. Visualization: JTK, JYP, HJL, YJC. 25 mg per 5 mL (5 mg/mL) 5 mL Single-Dose Vials Eugia Pharma Specialities Limited 0000030705 00000 n Adverse events reported in controlled and uncontrolled clinical trials were generally mild and transient. Most extravasations can be prevented with the systematic implementation of careful, standardized, and evidence-based administration techniques. This content does not have an Arabic version. The patient must be informed of the scope of the problem (Supplement 5). As with other agents which slow AV nodal conduction and do not prolong the refractoriness of the accessory pathway (e.g., verapamil, digoxin), in rare instances patients in atrial fibrillation or atrial flutter associated with an accessory bypass tract may experience a potentially life-threatening increase in heart rate accompanied by hypotension when treated with diltiazem hydrochloride injection. However, the study had only a small number of Federal government websites often end in .gov or .mil. The purpose of these practice guidelines is to offer and share strategies for preventing extravasation and measures for handling drugs known to cause tissue necrosis, which may occur even with the most skilled experts at intravenous (IV) injection. government site. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. An adjustment in the diltiazem dose may be warranted. Data curation: JTK, JYP, HJL, YJC. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. You should not use diltiazem if you are allergic to it, or if you have: a serious heart condition such as "sick sinus syndrome" or "second- or third-degree AV block" (unless you have a pacemaker); if you have recently had a heart attack and you have a build-up of fluid in your lungs. Reduction in mean arterial pressure correlated linearly with diltiazem plasma concentration in a group of hypertensive patients. hbbd```b``= "ro) "5" `LBT80yLHf) 8, EA! Norwood (MA). These guidelines consist of following topics: basic knowledge about extravasation, extravasation management, and extravasation prevention. privacy practices. Apply sterile dressing over the area of extravasation, regularly assess the extravasation site during every shift, and take medical photographs and consult the department of cosmetic surgery if necessary. Occurs due to contraction of the vessel wall and usually happens as soon as the fluid injection begins. In patients administered continuous infusions at 10 mg/h or 15 mg/h for 24 hours, diltiazem systemic clearance averaged 42 L/h and 31 L/h, respectively. The drug should be used with caution in patients with impaired renal or hepatic function (see WARNINGS). Common symptoms and signs of extravasation include pain, stinging or burning sensations, and edema around the intravenous (IV) injection site. The usual dose range of oral diltiazem for controlling chest pain is 120 to 480 mg daily. - Directions: apply cold fomentations for 15 to 20 minutes four to 6 times per day (for 1 day or more). In dogs, oral doses of 20 mg/kg were also associated with hepatic changes; however, these changes were reversible with continued dosing. In the controlled clinical trials, 3.2% of patients required some form of intervention (typically, use of intravenous fluids or the Trendelenburg position) for blood pressure support following diltiazem hydrochloride injection. 279 Princeton-Hightstown Rd. The following are common drugs that interact with diltiazem; Not all possible interactions are listed in this medication guide. In addition, caution should be used in patients taking other drugs that decrease peripheral resistance, intravascular volume, myocardial contractility or conduction. Some data suggest that the incidence is decreasing probably due to improvements in the infusion procedure, early recognition of the drug leakage, and training in management techniques. Calcium channel blockers (CCBs) are among the most commonly used cardiovascular drugs in the adult population. Perez Fidalgo JA, Garcia Fabregat L, Cervantes A, Margulies A, Vidall C, Roila F, ESMO Guidelines Working Group Management of chemotherapy extravasation: ESMO--EONS clinical practice guidelines. You may opt-out of email communications at any time by clicking on Diltiazem pregnancy and breastfeeding warnings, Drug class: calcium channel blocking agents, Diltiazem 12-Hour Sustained-Release Capsules. When used concomitantly, anesthetics and calcium blockers should be titrated carefully. . The recommended application schedule for both warm and cold applications is 15 to 20 minutes, every 4 hours, for 24 to 48 hours.
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