Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician. trailer Herein, general knowledge about extravasation is first described, including its definition, incidence, risk factors, diagnosis, differential diagnosis, and extravasation injuries. - Directions: apply hot fomentations for 20 to 30 minutes four to 6 times per day (for 1 day or more). When treatment for hypotension was required, it generally consisted of administration of saline or placing the patient in the Trendelenburg position. Diltiazem hydrochloride is 70% to 80% bound to plasma proteins. All rights reserved. The medical teams continuous education on extravasation is essential. HCl Injection 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. 0 <<893FCAAD4A261745BEDEB8B64953C410>]/Prev 46654/XRefStm 1178>> Once familiarity of the patient's response is established, use in an office setting may be acceptable. Venous shock can occur when injecting very cold medication or when medication is injected at a rapid pace. One report with oral diltiazem suggests that concentrations in breast milk may approximate serum levels. 0000030204 00000 n The sample was 18 healthy adults between 20 and 45 years. Asymptomatic hypotension occurred in 4.3% of patients. 533 0 obj <>/Filter/FlateDecode/ID[<5163DCD1F2812548B2C0DA027F0BBFFB>]/Index[512 38]/Info 511 0 R/Length 98/Prev 107501/Root 513 0 R/Size 550/Type/XRef/W[1 2 1]>>stream An overdose of diltiazem can be fatal. Diltiazem hydrochloride injection rarely converts atrial fibrillation or atrial flutter to normal sinus rhythm. It is not known whether diltiazem will harm an unborn baby. Special drug management for care of the 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. 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. 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. (Activase) A N IV Push Coronary Artery Thrombus : Initial: 15 mg over X NOT SDU 1-2 minutes, followed (weight adjusted dosing): Y Continuous Weight greater than 67kg: 50 mg over 30 minutes, then 35 mg over 60 minutes Weight less than 67 kg: 0.75 mg/ kg (not to exceed 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. 113. Your doctor may occasionally change your dose. 2.5-3.6 Extravasation: may cause tissue damage Do not flush Albumin 4.5% Infusion Normal blood volume: 1-2ml/min Hypovolaemia or shock: up to 1 L/hour Plasma exchange: up to If it continues for a long time, the heart and arteries may not function properly. The site is secure. Elevation of the limb may aid in reabsorption of the infiltrate or extravasated vesicant by decreasing capillary hydrostatic pressure. The drug prevents the recurrence of life-threatening ventricular arrhythmias and. Patients should be monitored for signs of hypercalcemia. 0000029456 00000 n Diltiazem inhibits the influx of calcium (Ca2+) ions during membrane depolarization of cardiac and vascular smooth muscle. Intravenous Infusion Mix thoroughly. The usual dose range of oral diltiazem for controlling chest pain is 120 to 480 mg daily. Management of extravasation includes nursing intervention and thermal application. Drug information provided by: Merative, Micromedex. 25 mg per 5 mL (5 mg/mL) 5 mL Single-Dose Vials In the event of overdosage or an exaggerated response, appropriate supportive measures should be employed. hb```l For continued reduction of the heart rate (up to 24 hours) in patients with atrial fibrillation or atrial flutter, an intravenous infusion of diltiazem hydrochloride injection may be administered. Extravasation severity can range from benign lipid masses to florid skin necrosis. If these agents are to be administered concurrently, cyclosporine concentrations should be monitored, especially when diltiazem therapy is initiated, adjusted or discontinued. Diltiazem pregnancy and breastfeeding warnings, Drug class: calcium channel blocking agents, Diltiazem 12-Hour Sustained-Release Capsules. * 5 mg/h may be appropriate for some patients. Statins - Diltiazem is an inhibitor of CYP3A4 and has been shown to increase significantly the AUC of some statins. 42, 48 In two cases of TPN extravasation, 25 units of hyaluronidase were injected intradermally around the inflamed area, resulting in clinical improvement within 6-12 hours. 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. In a few reported cases, overdose with calcium channel blockers associated with hypotension and bradycardia that was initially refractory to atropine became more responsive to atropine after the patients received intravenous calcium. and transmitted securely. Cardiovascular: AV block (third degree), bundle branch block, ECG abnormality, palpitations, syncope, tachycardia, ventricular extrasystoles 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, if you have symptoms of low blood pressure (dizziness, fainting, weakness, or blurred vision), call your doctor and stop taking diltiazem. Generic name: diltiazem hydrochloride The use of intravenous diltiazem for control of ventricular response in patients with supraventricular arrhythmias should be undertaken with caution when the patient is compromised hemodynamically. Injection and Continuous Other prescription and over-the-counter medicines, vitamins, and herbal products may interact with diltiazem. Hypotension was the most commonly reported adverse event during clinical trials. Please enable it to take advantage of the complete set of features! Unless otherwise contraindicated, appropriate vagal maneuvers should be attempted prior to administration of diltiazem hydrochloride injection. Diltiazem 125 mg per 25 mL (5 mg/mL) Intravenous Infusion Patients taking other drugs that are substrates of CYP450 3A4, especially patients with renal and/or hepatic impairment, may require dosage adjustment when starting or stopping concomitantly administered diltiazem in order to maintain optimum therapeutic blood levels. General Buspirone - In nine healthy subjects, diltiazem significantly increased the mean buspirone AUC 5.5 fold and Cmax 4.1 fold compared to placebo. Diltiazem is a calcium channel blocker. The patient must be informed of the scope of the problem (Supplement 5). - Edema around the port insertion or in the chest, or medication leakage around the catheter insertion, - Redness in the chest, collarbone, or neck where a central venous catheter is inserted. The phase IV clinical study is created by eHealthMe based on reports from the FDA, and is updated regularly. 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. IV Push IV infusion . A defibrillator and emergency equipment should be readily available. 5. PDF Extravasation Management Reference Sheet - NACNS 2. In vitro studies suggest alpha1-acid glycoprotein binds approximately 40% of the drug at clinically significant concentrations. Diltiazem shows dose-dependent, non-linear pharmacokinetics. Tell your doctor if you are pregnant or plan to become pregnant. Diltiazem is used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders. Nervous System: Dizziness, paresthesia Computer-based simulations showed that at a daily dose of 480 mg of diltiazem, an 8- to 9-fold mean increase in simvastatin AUC can be expected. 0000029978 00000 n Mechanisms of Action The following adverse reaction rates are based on the use of diltiazem hydrochloride injection in over 400 domestic clinical trial patients with atrial fibrillation/flutter or PSVT under double-blind or open-label conditions. Overdosage experience is limited. Patients with severe hypotension or cardiogenic shock. Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium channel antagonist). Events such as myocardial infarction have been observed which are not readily distinguishable from the natural history of the disease for the patient. Pain, edema, and ulcer do not appear, and symptoms disappear within 30 to 90 minutes. The vial stopper is not made with natural rubber latex. You'll soon start receiving the latest Mayo Clinic health information you requested in your inbox. High blood pressure often has no symptoms. Carcinogenesis, Mutagenesis, Impairment of Fertility, Paroxysmal supraventricular tachycardia -, Direct Intravenous Single Injections (Bolus), Quantity of Diltiazem hydrochloride injection, Transition to Further Antiarrhythmic Therapy, diltiazem hydrochloride injection, solution. Generic name: diltiazem [dil-TYE-a-zem] The recommended application schedule for both warm and cold applications is 15 to 20 minutes, every 4 hours, for 24 to 48 hours. Following oral administration, 2% to 4% of the unchanged diltiazem appears in the urine. 0000002293 00000 n Copyright: Merative US L.P. 1973, 2023. Waltham (MA): UpToDate Inc; c2020. - After the injection, make sure to run a saline solution through the catheter. Changes in heart rate, systolic blood pressure, and diastolic blood pressure did not correlate with diltiazem plasma concentrations in normal volunteers. Diltiazem can pass into breast milk and may harm a nursing baby. Take the missed dose as soon as you remember. Click here for an email preview. Atrial fibrillation or atrial flutter - In clinical studies with diltiazem hydrochloride injection for AF/FI, 135 of 257 patients were 65 years of age. Albumin appears to bind approximately 30% of the drug, while other constituents bind the remaining bound fraction. Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4-(5H)-one,3-(Acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(-4-methoxyphenyl)-, monohydrochloride, (+)-cis-. - Regularly check the extravasation kit and refill any used medications. pounding heartbeats or fluttering in your chest; a light-headed feeling, like you might pass out; shortness of breath (even with mild activity), swelling, rapid weight gain; nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or. Guideline Feedback - Starship 1. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). 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. High blood pressure may also increase the risk of heart attacks. The use of local warming is recommended for the extravasation of nonDNA-binding vesicants. Spots or solid lines with blisters can be suddenly felt along the vessels injected with drugs. 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. Follow all directions on your prescription label. Monitor heart rate in patients receiving concomitant diltiazem and clonidine. 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. If possible, it is recommended that diltiazem hydrochloride injection not be co-infused in the same intravenous line. Continuous Intravenous Infusion Diltiazem exhibits frequency (use) dependent effects on AV nodal conduction such that it may selectively reduce the heart rate during tachycardias involving the AV node with little or no effect on normal AV nodal conduction at normal heart rates. An official website of the United States government. Reynolds PM, MacLaren R, Mueller SW, Fish DN, Kiser TH. Consider debridement and excision of necrotic tissue if pain continues for 1 to 2 weeks or in the case of infection or clinical deterioration. Delayed extravasation:Symptoms occur 48 hours, or later, after drug administration. The second bolus dose of diltiazem hydrochloride injection should be 0.35 mg/kg actual body weight administered over 2 minutes (25 mg is a reasonable dose for the average patient).
