Vinen CS, Patel S, Bruckner FE. DO NOT apply pressure to the area 6. To make sure diltiazem is safe for you, tell your doctor if you have: if you also take digoxin, or a beta blocker (such as atenolol, carvedilol, metoprolol, propranolol, sotalol, and others). Manchester: The Christie NHS Foundation Trust; 2014. 5. Local cooling (ice packs) aids in vasoconstriction, theoretically limiting the drug dispersion. Antidotes for the care of the extravasation. 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. Distributed by: 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. PMC Differences in volume were determined by magnetic resonance imaging (MRI) at three intervals postinfiltration. Cardiovascular: AV block (third degree), bundle branch block, ECG abnormality, palpitations, syncope, tachycardia, ventricular extrasystoles Monitor heart rate in patients receiving concomitant diltiazem and clonidine. Vesicant extravasation:Leakage of a drug that causes pain, necrosis, or tissue sloughing. Subsequent dose adjustments may be necessary during coadministration, and should be based on clinical assessment. 0000012749 00000 n You may need to use blood pressure medicine for the rest of your life. You may report side effects to FDA at 1-800-FDA-1088. and transmitted securely. Manufactured by: Drug information handbook for oncology: a complete guide to combination chemotherapy regimens. Dermatologic: Pruritus, sweating 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. 0000029456 00000 n The recommended application schedule for both warm and cold applications is 15 to 20 minutes, every 4 hours, for 24 to 48 hours. An adjustment in the diltiazem dose may be warranted. Langer SW. Extravasation of chemotherapy. The heart rate reduction may last from 1 - 3 hours. privacy practices. %%EOF The leakage of the IV-administered fluids is clearly unintended, the condition being often presented as extravasation. For Direct Intravenous Bolus Injection and You may also need frequent blood tests. Accessibility 0000006002 00000 n To make swallowing easier, ask your doctor or pharmacist if you can open a diltiazem capsule and sprinkle the medicine into a spoonful of applesauce. Three solutions were used: 1/2 saline (154 mOsm), normal saline (308 mOsm), and 3% saline (1027 mOsm). (5 mg/mL) Version: 15.01. However, no guidelines can be perfect, and they need to be regularly updated. R7:@Io;X(^0)&c3EA$w `Yl RL`5w0$(22p9]8JIg4@ !v Liver cirrhosis was shown to reduce diltiazem's apparent oral clearance and prolong its half-life. Apply compresses for 20 to 60 minutes 3 or 4 times daily for the first 24 to 72 hours after extravasation occurs. Discard Unused Portion Store Under Refrigeration - Check if there is any local discomfort or swelling by running a saline solution through the catheter, and then inject the drug. Adapted from: Saint Francis Hospital Department of Pharmacy Services Protocol Diltiazem Injection Prescribing Information. Your doctor will adjust the dose and frequency of diltiazem to your needs. Rheumatology (Oxford) 2000; 39:333. Inject phentolamine 0.5 mg/mL by subcutaneous or intradermal route using a 25 gauge needle in 5 aliquots of 0.2 mL each into the area of the extravasation; change the needle after each injection Give immediately but may be used up to 12 hours after the extravasation occurs Occurs due to contraction of the vessel wall and usually happens as soon as the fluid injection begins. Sodium hydroxide or hydrochloric acid is used for pH adjustment. 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. India .,gzTwgV- *m ;vQt3 Y s::;:@4w00 fF=$:a [|E! K|+o|`meff;priV@ud`\e`t0 b0 2737 0 obj <> endobj - Initial physical symptoms usually appear immediately but also might appear several days or weeks later. - Be familiar with the extravasation management standard guidelines and prepare the extravasation kit. Available from: Lacy C, American Pharmaceutical Association . In severe cases, extravasation may cause tissue dysfunction or physical defects, resulting in a delay of attempted treatment, patients distrust, and numerous other issues. Related/similar drugs Please enable it to take advantage of the complete set of features! Diltiazem hydrochloride injection is clear, colorless, sterile, nonpyrogenic solution and is supplied as follows: Clipboard, Search History, and several other advanced features are temporarily unavailable. However, reference should be made to the respective agent manufacturer's package insert for information relative to dosage and administration. Elevation of the limb may aid in reabsorption of the infiltrate or extravasated vesicant by decreasing capillary hydrostatic pressure. Diltiazem may also be used for purposes not listed in this medication guide. 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. Local thermal treatments are used to decrease the site reaction and absorption of the infiltrate. Injection and Continuous Diltiazem (Cardizem, Tiazac, others) Felodipine; Isradipine; Nicardipine; Nifedipine (Procardia) Nisoldipine (Sular) Verapamil (Calan SR, Verelan) Sometimes, a doctor might prescribe a calcium channel blocker with other high blood pressure medications or with cholesterol-lowering drugs such as statins. Caution should be exercised when using the drug in such patients. 8th ed. INTRODUCTION. eugia, Rx only NDC 55150-427-10 Ventricular Premature Beats (VPBs) - VPBs may be present on conversion of PSVT to sinus rhythm with diltiazem hydrochloride injection. Available for Android and iOS devices. Supplement 3. In controlled clinical trials, therapy with antiarrhythmic agents to maintain reduced heart rate in atrial fibrillation or atrial flutter or for prophylaxis of PSVT was generally started within 3 hours after bolus administration of diltiazem hydrochloride injection. Diltiazem shows dose-dependent, non-linear pharmacokinetics. Diltiazem hydrochloride injection was found to be physically compatible and chemically stable in the following parenteral solutions for at least 24 hours when stored in glass or polyvinylchloride (PVC) bags at controlled room temperature 15 to 30C (59 to 86F) or under refrigeration 2 to 8C (36 to 46F). The usual dose range of oral diltiazem for controlling chest pain is 120 to 480 mg daily. IV push by TSN or MD only (in non-emergent settings). Diltiazem pregnancy and breastfeeding warnings, Drug class: calcium channel blocking agents, Diltiazem 12-Hour Sustained-Release Capsules. Common signs include inflammation, tightness of the skin, and pain around the IV site. A 24 hour continuous infusion of diltiazem hydrochloride injection in the treatment of atrial fibrillation or atrial flutter maintained at least a 20% heart rate reduction during the infusion in 83% of patients. You may need to use blood pressure medicine for the rest of your life. High blood pressure often has no symptoms. It is not known whether diltiazem will harm an unborn baby. The risk of myopathy and rhabdomyolysis with statins metabolized by CYP3A4 may be increased with concomitant use of diltiazem. This relaxes the blood vessels, lowers blood pressure, and increases the supply of blood and oxygen to the heart while reducing its workload. Diltiazem is a calcium channel blocker. Diltiazem is in a class of medications called calcium-channel blockers. Patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker. Geriatric Use Dilution: To prepare diltiazem hydrochloride injection for continuous intravenous infusion, aseptically transfer the appropriate quantity (see chart) of diltiazem hydrochloride injection to the desired volume of either Normal Saline, D5W, or D5W/0.45% NaCl. The combination of the two drugs was generally well tolerated without serious adverse effects. If there is no response to vagal blockade administer isoproterenol cautiously. Avoid concomitant use of ivabradine and diltiazem. Ivabradine - Concurrent use of diltiazem increases exposure to ivabradine and may exacerbate bradycardia and conduction disturbances. (5 mg/mL) Diltiazem prolongs the sinus cycle length. 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 anticipated that these guidelines would help health professionals to prevent extravasation during IV and central vein injection and to promote patient safety should extravasation occur in any case. In the same study, there was no significant change in 20 mg single dose pravastatin AUC and Cmax during diltiazem coadministration. Although drugs can be administered by methods (e.g., micro-patch, micro-injection) other than IV injection, extravasation cannot be totally avoided because there are drugs that can only be administered through IV or central vein injection. Transition to other antiarrhythmic agents following administration of diltiazem hydrochloride injection is generally safe. Nursing standard for intravenous injection of Asan Medical Center. 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. Quinidine - Diltiazem significantly increases the AUC(0) of quinidine by 51%, T1/2 by 36% and decreases its CLoral, by 33%. Although clear benefit has not been demonstrated with thermal applications, it remains a standard supportive care. In terms of cancer therapy, extravasation refers to the inadvertent infiltration of chemotherapeutic drugs in the tissues surrounding the IV site. Bookshelf The combination of the two drugs was well tolerated without serious adverse effects. An extremely severe case of cutaneous calcinosis with juvenile dermatomyositis, and successful treatment with diltiazem. Swallow right away without chewing. Pediatric Use In the perinatal/postnatal studies there was some reduction in early individual pup weights and survival rates. sharing sensitive information, make sure youre on a federal E. Windsor, NJ 08520 The drug prevents the recurrence of life-threatening ventricular arrhythmias and. Your doctor may occasionally change your dose. IV infiltrations and extravasations occur when fluid leaks out of the vein into surrounding soft tissue. The medical teams continuous education on extravasation is essential. Common Questions and Answers about Diltiazem extravasation. Atrial fibrillation or atrial flutter - In clinical studies with diltiazem hydrochloride injection for AF/FI, 135 of 257 patients were 65 years of age. One hundred two (102) patients <65 had a response rate of 78%. Intravenous Infusion A defibrillator and emergency equipment should be readily available. - For observation, do not cover the cannula area with opaque gauze. government site. You'll soon start receiving the latest Mayo Clinic health information you requested in your inbox. Reproduction studies have been conducted in mice, rats, and rabbits. Available from: Lacy C, American Pharmaceutical Association . Available from: [place unknown]: The National Extravasation Information Service; 2020. Br J Dermatol 2001; 144:894. 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. 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. Herein, general knowledge about extravasation is first described, including its definition, incidence, risk factors, diagnosis, differential diagnosis, and extravasation injuries. 5. 50-mg, 10-mL vialeach sterile vial contains 50 mg diltiazem hydrochloride, 7.5 mg citric acid USP, 6.5 mg sodium citrate dihydrate USP, 714 mg sorbitol solution USP, and water for injection USP up to 10 mL. This content does not have an Arabic version. endstream endobj 363 0 obj <>/Filter/FlateDecode/Index[10 322]/Length 34/Size 332/Type/XRef/W[1 1 1]>>stream government site. In dogs, oral doses of 20 mg/kg were also associated with hepatic changes; however, these changes were reversible with continued dosing. Appendix A: Management of Extravasation: Chemotherapeutic and Non-chemotherapeutic Agents Figure 1: Workflow algorithm Stop infusion at first suspicion of extravasation. Before Local cooling (ice packs) aids in vasoconstriction, theoretically limiting the drug dispersion. Data files are available from Harvard Dataverse: https://doi.org/10.7910/DVN/NUWZML. If we combine this information with your protected 279 Princeton-Hightstown Rd. The vial stopper is not made with natural rubber latex. An overdose of diltiazem can be fatal. Venous shock can occur when injecting very cold medication or when medication is injected at a rapid pace. Immediately following bolus administration of 20 mg (0.25 mg/kg) or 25 mg (0.35 mg/kg) diltiazem hydrochloride injection and reduction of heart rate, begin an intravenous infusion of diltiazem hydrochloride injection. 2. NHS. National Library of Medicine Available from: [place unknown]: The National Extravasation Information Service; 2020. Avoid drinking alcohol while taking diltiazem. Digitalis - Intravenous diltiazem has been administered to patients receiving either intravenous or oral digitalis therapy. Diltiazem inhibits the influx of calcium (Ca2+) ions during membrane depolarization of cardiac and vascular smooth muscle. 0000002293 00000 n Gastrointestinal: Constipation, elevated SGOT or alkaline phosphatase, nausea, vomiting Supplement 5. Do not save the mixture for later use. Diltiazem converts paroxysmal supraventricular tachycardia (PSVT) to normal sinus rhythm by interrupting the reentry circuit in AV nodal reentrant tachycardias and reciprocating tachycardias, e.g., Wolff- Parkinson-White syndrome (WPW). Subsequent intravenous bolus doses should be individualized for each patient. Barton-Burke M, Wilkes GM, Ingwersen KC, Bean CK, Berg D. Cancer chemotherapy: a nursing process approach. FOIA These problems may be less likely to occur if blood pressure is controlled. Statins - Diltiazem is an inhibitor of CYP3A4 and has been shown to increase significantly the AUC of some statins. Drug Information Group [Internet] [cited 2020 Jul 10]. Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician. These doses, in some studies, have been reported to cause skeletal abnormalities. Hypotension was the most commonly reported adverse event during clinical trials. Like other calcium channel antagonists, because of its effect on vascular smooth muscle, diltiazem decreases total peripheral resistance resulting in a decrease in both systolic and diastolic blood pressure. In patients administered bolus doses ranging from 2.5 mg to 38.5 mg, systemic clearance averaged 36 L/h. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Discard unused portion. Cardiac Failure: Administer inotropic agents (isoproterenol, dopamine, or dobutamine) and diuretics. 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). The patient must be informed of the scope of the problem (Supplement 5). Fixed high-degree AV block should be treated with cardiac pacing. 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. HCl Injection Narcotic analgesics may be required to reduce severe pain around widespread extensive necrosis. IV infiltration is a common complication of intravenous (IV) therapy. Duration of infusion longer than 24 hours and infusion rates greater than 15 mg/h have not been studied. High blood pressure often has no symptoms. The therapeutic benefits of diltiazem in supraventricular tachycardias are related to its ability to slow AV nodal conduction time and prolong AV nodal refractoriness. Drug information provided by: Merative, Micromedex. These pharmacokinetic effects seen during diltiazem coadministration can result in increased clinical effects (e.g. Diltiazem hydrochloride is extensively metabolized by the liver and excreted by the kidneys and in bile. 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 a calcium ion cellular influx inhibitor (slow channel blocker or calcium channel antagonist). HCl Injection 6. show all 12 brands May be stored at room temperature for up to 1 month. Diltiazem Torralba TP, Li-Yu J, Navarra ST. Keep diluted diltiazem hydrochloride injection refrigerated until use. 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.
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