Sauerland C, Engelking C, Wickham R, Corbi D. Vesicant extravasation part I: mechanisms, pathogenesis, and nursing care to reduce risk. These VPBs are transient, are typically considered to be benign, and appear to have no clinical significance. Hypotension: Vasopressors (e.g., dopamine or norepinephrine). Sterile 10 mL Single-Dose Vial, Rx only NDC 55150-426-10 Chicago (IL): University of Illinois College of Pharmac; c2020. Pain, edema, and ulcer do not appear, and symptoms disappear within 30 to 90 minutes. 10 mL Single-Dose Vials Unable to load your collection due to an error, Unable to load your delegates due to an error. Diltiazem may impair your thinking or reactions. 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. Do not stop taking this medication without first talking to your doctor. 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. Concepts in oncology therapeutics: a self-instructional course. The study suggested that diltiazem ointment was better than GTN at healing anal fissures in children (23 out of 28 using diltiazem were healed compared with 11 out of 28 using GTN). Discoloration and edema do not occur. 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. Dosage: The dose is 150 units (1 mL) given as five 0.2 mL injections into the extravasation site at the leading edge; change the needle after each injection. For the most part, blood does not backflow. 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. 0000029456 00000 n Medically reviewed by Drugs.com. In renal and cardiac transplant recipients, a reduction of cyclosporine dose ranging from 15% to 48% was necessary to maintain cyclosporine trough concentrations similar to those seen prior to the addition of diltiazem. Guideline for the management of extravasation of a cytotoxic agent or a monoclonal antibody used in the treatment of malignant disease: version 4.2. - Do not insert the cannula in the antecubital fossa area, where it is extremely difficult to detect extravasation. tiazac. 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. Available for Android and iOS devices. the contents by NLM or the National Institutes of Health. Antidotes, special drug management, drugs with high osmolarity, and drugs with pH are provided as supplement files (Supplements 14). Carcinogenesis, Mutagenesis, Impairment of Fertility Patients who have demonstrated hypersensitivity to the drug. Diltiazem hydrochloride injection is clear, colorless, sterile, nonpyrogenic solution and is supplied as follows: 0 Patients should be dosed on an individual basis and reference should be made to the respective manufacturer's package insert for information relative to dosage and administration. hb``d``f`c`P "@1vG(r8}C#7mcH`KfYtfnzv$@,BKK~x$3$shElVVp A_8{.>9UiiGK:&ALg>)tvNV-+>'(yqnSg@Em.P^''*.^. Mix thoroughly. . privacy practices. Direct Intravenous Single Injections (Bolus) Distributed by: 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. [cited 2020 Jul 10]. 1Department of Pharmacy, Kyung Hee University Hospital at Gangdong, Seoul, Korea, 2Department of Clinical Nursing, University of Ulsan, Seoul, Korea. 0000010698 00000 n E. Windsor, NJ 08520 - Small and fragile veins in infants, children, or elderly patients, - Cancer patients with hardened and thickened vessels due to frequent venipuncture, - Patients with vessels that move easily during venipuncture attempts, - Patients with excised lymph nodes, limb amputation, or closed vena cava, - Obesity in which peripheral venous access is more difficult, - Inadequate choice of equipment (peripheral catheter choice, size, or steel needle). For Direct Intravenous Bolus Injection and Patients may be unable to work for some time; quality of life must be compensated for if a patients occupation requires full physical mobility, and exposure of the disfigurement in public can cause a psychological impact. High blood pressure adds to the workload of the heart and arteries. Be careful if you drive or do anything that requires you to be alert. 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. Extravasation severity can range from benign lipid masses to florid skin necrosis. Enhanced effects and increased toxicity of buspirone may be possible during concomitant administration with diltiazem. Differences in volume were determined by magnetic resonance imaging (MRI) at three intervals postinfiltration. IV push by TSN or MD only (in non-emergent settings). To provide you with the most relevant and helpful information, and understand which The phase IV clinical study is created by eHealthMe based on reports from the FDA, and is updated regularly. Bethesda, MD 20894, Web Policies Cardiac Failure: Administer inotropic agents (isoproterenol, dopamine, or dobutamine) and diuretics. If these agents are to be administered concurrently, cyclosporine concentrations should be monitored, especially when diltiazem therapy is initiated, adjusted or discontinued. Pediatric Use Diltiazem (Oral Route) Your gift holds great power - donate today! When treatment for hypotension was required, it generally consisted of administration of saline or placing the patient in the Trendelenburg position. 0000000956 00000 n 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. 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. High blood pressure is a common condition, and when not treated it can cause damage to the brain, heart, blood vessels, kidneys . 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. Diltiazem Diltiazem hydrochloride is extensively metabolized by the liver and excreted by the kidneys and in bile. @ 0.5 - 1 mL over 1 minute. 4 Hyaluronidase has been successfully used in the treatment of TPN extravasations. Fixed high-degree AV block should be treated with cardiac pacing. Asymptomatic hypotension occurred in 4.3% of patients. The .gov means its official. Before taking diltiazem, tell your doctor if you have kidney disease, liver disease, or congestive heart failure. Communication and trust between patients and nurses can be interfered due to extravasation. Supplement 1. Quinidine - Diltiazem significantly increases the AUC(0) of quinidine by 51%, T1/2 by 36% and decreases its CLoral, by 33%. Keywords: Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 0000017632 00000 n Therefore, the potential for these dermatologic reactions exists following exposure to intravenous diltiazem. Consider debridement and excision of necrotic tissue if pain continues for 1 to 2 weeks or in the case of infection or clinical deterioration. The use of local warming is recommended for the extravasation of nonDNA-binding vesicants. Vinen CS, Patel S, Bruckner FE. However, since both drugs affect AV nodal conduction, patients should be monitored for excessive slowing of the heart rate and/or AV block. Supplement 6. Diltiazem may be used for the treatment of high blood pressure or chronic stable angina. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Local cooling (ice packs) aids in vasoconstriction, theoretically limiting the drug dispersion. If intravenous diltiazem is administered to patients receiving chronic oral beta-blocker therapy, the possibility for bradycardia, AV block, and/or depression of contractility should be considered (see CONTRAINDICATIONS). Review/update the The initial dose of diltiazem hydrochloride injection should be 0.25 mg/kg actual body weight as a bolus administered over 2 minutes (20 mg is a reasonable dose for the average patient). The drug prevents the recurrence of life-threatening ventricular arrhythmias and. It works by relaxing the muscles of your heart and blood vessels. However, no guidelines can be perfect, and they need to be regularly updated. Drug information handbook for oncology: a complete guide to combination chemotherapy regimens. Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4-(5H)-one,3-(Acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(-4-methoxyphenyl)-, monohydrochloride, (+)-cis-. Injection and Continuous IV: intravenous. Diltiazem may also be used for purposes not listed in this medication guide. 0000030429 00000 n hbbd```b``= "ro) "5" `LBT80yLHf) 8, EA! Get emergency medical help if you have signs of an allergic reaction to diltiazem: hives; difficult breathing; swelling of your face, lips, tongue, or throat. In the perinatal/postnatal studies there was some reduction in early individual pup weights and survival rates. Patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker. It works by relaxing the blood vessels so the heart does not have to pump as hard. 2. 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. At the first sign of extravasation, the following steps are recommended: (1) stop administration of IV fluids immediately, (2) disconnect the IV tube from the cannula, (3) aspirate any residual drug from the cannula, (4) administer a drug-specific antidote, and (5) notify the physician (Fig. Sterile 25 mL Single-Dose Vial Available from: Le A, Patel S. Extravasation of noncytotoxic drugs: a review of the literature. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 2. Avoid taking herbal supplements containing St. John's wort at the same time you are taking diltiazem. 0000002293 00000 n Alteplase Adult Assess for hemorrhage during first hour of treatment. It will be our pleasure if these guidelines are used in the training of health professionals to promote patients safety. Diltiazem can pass into breast milk and may harm a nursing baby. Some patients may respond to an initial dose of 0.15 mg/kg, although duration of action may be shorter. Based on this relationship, the mean plasma diltiazem concentration required to produce a 20% decrease in heart rate was determined to be 80 ng/mL. Eugia Pharma Specialities Limited In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. The effectiveness of intravenous calcium administration to reverse the pharmacological effects of diltiazem overdose has been inconsistent. Careers, Unable to load your collection due to an error. Venous shock can occur when injecting very cold medication or when medication is injected at a rapid pace. Following oral administration, 2% to 4% of the unchanged diltiazem appears in the urine. Appendix A: Management of Extravasation: Chemotherapeutic and Non-chemotherapeutic Agents Figure 1: Workflow algorithm Stop infusion at first suspicion of extravasation. The medical teams continuous education on extravasation is essential. The use of diltiazem hydrochloride injection should be undertaken with caution when the patient is compromised hemodynamically or is taking other drugs that decrease any or all of the following: peripheral resistance, myocardial filling, myocardial contractility, or electrical impulse propagation in the myocardium. In a limited number of studies of patients with compromised myocardium (severe congestive heart failure, acute myocardial infarction, hypertrophic cardiomyopathy), administration of intravenous diltiazem produced no significant effect on contractility, left ventricular end diastolic pressure, or pulmonary capillary wedge pressure. However, the study had only a small number of I remember the case of the complication of extravasation in my patient in 1985 when I was an intern. 0000003491 00000 n Amiodarone is a potent antiarrhythmic agent that is used to treat ventricular arrhythmias and atrial fibrillation. Sterile eugia 10 x 25 mL Single-Dose Vials, Cardizem, Cartia XT, Dilt-XR, Cardizem CD, +6 more, amlodipine, lisinopril, aspirin, metoprolol, losartan, furosemide, carvedilol, hydrochlorothiazide, spironolactone, propranolol. Other: Amblyopia, asthenia, dry mouth, dyspnea, edema, headache, hyperuricemia 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. 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. - Be familiar with the extravasation management standard guidelines and prepare the extravasation kit. - Check for blood backflow before injection to ensure that the catheter is positioned in the vein. Avoid drinking alcohol while taking diltiazem. If there is no response to vagal blockade administer isoproterenol cautiously. 6. 0000003528 00000 n Bethesda, MD 20894, Web Policies 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. At the first sign of extravasation, nursing intervention with following steps is recommended: stop administration of IV fluids immediately, disconnect the IV tube from the cannula, aspirate any remaining drug from the cannula, administer drug-specific antidote, and notify the physician. JFIF C C d[" Do not save the mixture for later use. Physical Incompatibilities: Because of potential physical incompatibilities, it is recommended that diltiazem hydrochloride injection not be mixed with any other drugs in the same container. Limited data suggest that plasmapheresis or charcoal hemoperfusion may hasten diltiazem elimination following overdose. Data sources include IBM Watson Micromedex (updated 1 May 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. sharing sensitive information, make sure youre on a federal It should not be used in patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in Wolff-Parkinson-White (WPW) syndrome or short PR syndrome. - Directions: apply cold fomentations for 15 to 20 minutes four to 6 times per day (for 1 day or more). Transition to Further Antiarrhythmic Therapy Do not take extra medicine to make up the missed dose. Ventricular Premature Beats (VPBs) - VPBs may be present on conversion of PSVT to sinus rhythm with diltiazem hydrochloride injection. The use of local warming therapy (dry heat) is based on the theory that it enhances vasodilation, thus enhancing the dispersion of the vesicant agent and decreasing drug accumulation in the local tissue. Local thermal treatments are used to decrease the site reaction and absorption of the infiltrate. Clonidine - Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concurrently with diltiazem. 332 33 Swallow right away without chewing. Diltiazem does not appear to be removed by peritoneal or hemodialysis. Patients with low body weights should be dosed on a mg/kg basis.
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