diltiazem extravasation treatment

0000025065 00000 n Your doctor will adjust the dose and frequency of diltiazem to your needs. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. We comply with the HONcode standard for trustworthy health information. Pain or tightening occurs along the vein, and it is caused mainly by drugs such as vinorelbine and dacarbazine. 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. If coadministration of simvastatin with diltiazem is required, limit the daily doses of simvastatin to 10 mg and diltiazem to 240 mg. The audio recording of the abstract. Acute Hepatic Injury - In rare instances, significant elevations in enzymes such as alkaline phosphatase, LDH, SGOT, SGPT, and other phenomena consistent with acute hepatic injury have been noted following oral diltiazem. Total radioactivity measurement following short intravenous administration in healthy volunteers suggests the presence of other unidentified metabolites which attain higher concentrations than those of diltiazem and are more slowly eliminated; half-life of total radioactivity is about 20 hours compared to 2 to 5 hours for diltiazem. Diltiazem Cardiovascular: Asystole, atrial flutter, AV block first degree, AV block second degree, bradycardia, chest pain, congestive heart failure, sinus pause, sinus node dysfunction, syncope, ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia Diltiazem hydrochloride is extensively metabolized by the liver and excreted by the kidneys and in bile. Common symptoms and signs of extravasation include pain, stinging or burning sensations, and edema around the intravenous (IV) injection site. 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. Maximal hemodynamic effects usually occurred within 2 to 5 minutes of an injection. The primary outcome was the change in SBP 60 min (+/- 30 min) after initial IV diltiazem administration. Elevate the affected extremity The drug should be used with caution in patients with impaired renal or hepatic function (see WARNINGS). - Once the needle is removed, apply pressure to the puncture site for about five minutes and elevate the limb. JFIF C C d[" Nursing standard for intravenous injection of Asan Medical Center. Single-dose vials. Injection and Continuous HCl Injection 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. Do not save the mixture for later use. Administration of other calcium channel blockers to patients with wide complex tachycardia (QRS 0.12 seconds) has resulted in hemodynamic deterioration and ventricular fibrillation. Drug information handbook. Cardiovascular: AV block (third degree), bundle branch block, ECG abnormality, palpitations, syncope, tachycardia, ventricular extrasystoles Pain, edema, and ulcer do not appear, and symptoms disappear within 30 to 90 minutes. In severe cases, extravasation may cause tissue dysfunction or physical defects, resulting in a delay of attempted treatment, patients distrust, and numerous other issues. The chemical structure is: Diltiazem hydrochloride, USP is a white crystalline powder with a bitter taste. Physical incompatibilities (precipitate formation or cloudiness) were observed when diltiazem hydrochloride injection was infused in the same intravenous line with the following drugs: acetazolamide, acyclovir, aminophylline, ampicillin, ampicillin sodium/sulbactam sodium, cefamandole, cefoperazone, diazepam, furosemide, hydrocortisone sodium succinate, insulin (regular: 100 units/mL), methylprednisolone sodium succinate, mezlocillin, nafcillin, phenytoin, rifampin, and sodium bicarbonate. However, in rare instances, worsening of congestive heart failure has been reported in patients with preexisting impaired ventricular function. Discuss the use of grapefruit products with your doctor. <<893FCAAD4A261745BEDEB8B64953C410>]/Prev 46654/XRefStm 1178>> Diltiazem hydrochloride is extensively metabolized by the liver and excreted by the kidneys and in bile. Diltiazem extravasation. Atrial Fibrillation or Atrial Flutter To prevent extravasation, a clinical specialist should perform the venipuncture or injection, who with relevant skills and management ability understands the properties of the injected drug. Other: Amblyopia, asthenia, dry mouth, dyspnea, edema, headache, hyperuricemia Prompt interdisciplinary action is often necessary for the treatment of extravasation injuries. Appendix A: Management of Extravasation: Chemotherapeutic and Non-chemotherapeutic Agents Figure 1: Workflow algorithm Stop infusion at first suspicion of extravasation. Patients with low body weights should be dosed on a mg/kg basis. This includes AV nodal reentrant tachycardias and reciprocating tachycardias associated with an extranodal accessory pathway such as the WPW syndrome or short PR syndrome. 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). official website and that any information you provide is encrypted An official website of the United States government. Drug Information Group [Internet] [cited 2020 Jul 10]. High blood pressure may also increase the risk of heart attacks. Unauthorized use of these marks is strictly prohibited. Local thermal treatments are used to decrease the site reaction and absorption of the infiltrate. 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. 0.5 - 1 mL over 1 minute. privacy practices. These problems may be less likely to occur if blood pressure is controlled. Only 1 of the studies of diltiazem was in children. 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. Be careful if you drive or do anything that requires you to be alert. - Initial physical symptoms usually appear immediately but also might appear several days or weeks later. Give a list of all your medicines to any healthcare provider who treats you. Discard Unused Portion Store Under Refrigeration Data sources include IBM Watson Micromedex (updated 1 May 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. 125 mg per 25 mL Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use diltiazem only for the indication prescribed. This medicine is available only with your doctor's prescription. Local thermal treatments are used to decrease the site reaction and absorption of the infiltrate. Review/update the For prevention of extravasation, health professionals should be familiar with the extravasation management standard guidelines. The site is secure. - Veins on the back of the hand can be used, and in some cases, observation is easier. Pharmacologic interventions for extravasation Discard unused portion. (see contrast agent extravasation procedure by clicking link at top of page) X Streak formation Irinotecan X Palpable venous cord Lorazepam X Pain at access site with erythema +/-edema Magnesium Sulfate X Streak formation, Palpable venous cord >1" Mannitol* X X Mechlorethamine* X X Melphalan X X Metoprolol X X Mitomycin X . Patients currently receiving diltiazem therapy should be carefully monitored for a change in pharmacological effect when initiating and discontinuing therapy with cimetidine. - Directions: apply hot fomentations for 20 to 30 minutes four to 6 times per day (for 1 day or more). You may report side effects to FDA at 1-800-FDA-1088. 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. Stopping suddenly may make your condition worse. 50 mg per 10 mL 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. HCl Injection 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. For the most part, blood does not backflow. Therefore, the potential for these dermatologic reactions exists following exposure to intravenous diltiazem. For Direct Intravenous Bolus Injection and The leakage of the IV-administered fluids is clearly unintended, the condition being often presented as extravasation. - 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). Diltiazem may impair your thinking or reactions. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. - Check for blood backflow before injection to ensure that the catheter is positioned in the vein. Vesicants are inherently toxic and can cause pain, inflammation, and burn-like injury including blistering, sloughing, deep tissue damage, and necrosis. The elimination half-life of midazolam and triazolam also increased (1.5 to 2.5 fold) during coadministration with diltiazem. Tell your doctor if you are pregnant or plan to become pregnant. Clinical studies of diltiazem did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Descriptions. Drugs with high osmolarity. Regression of calcinosis associated with adult dermatomyositis following diltiazem therapy. Proceedings of the Infusion Nurses Society Annual Meeting; 1997 May; Salt Lake City, USA. Overdose symptoms may include slow heartbeat, weakness, chest pain, shortness of breath, or fainting. Alteplase Adult Assess for hemorrhage during first hour of treatment. 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. Available from: De Wit M, Ortner P, Lipp HP, Sehouli J, Untch M, Ruhnke M, Mayer-Steinacker R, Bokemeyer C, Jordan K. Management of cytotoxic extravasation: ASORS expert opinion for diagnosis, prevention and treatment. The average heart rate is reduced by 20%. The effect of cyclosporine on diltiazem plasma concentrations has not been evaluated. Bethesda, MD 20894, Web Policies Careers, Unable to load your collection due to an error. hb``e``= P30p %DeA@>;O2`8Te~0C;L5gla3a1fb+ fd`+ 2 n', 5. Nervous System: Abnormal dreams, amnesia, depression, extrapyramidal symptoms, gait abnormality, hallucinations, insomnia, nervousness, personality change, somnolence, tremor Congestive Heart Failure - Although diltiazem has a negative inotropic effect in isolated animal tissue preparations, hemodynamic studies in humans with normal ventricular function and in patients with a compromised myocardium, such as severe CHF, acute MI, and hypertrophic cardiomyopathy, have not shown a reduction in cardiac index nor consistent negative effects on contractility (dp/dt). Atrial fibrillation or atrial flutter - In clinical studies with diltiazem hydrochloride injection for AF/FI, 135 of 257 patients were 65 years of age. Supplement 6. } !1AQa"q2#BR$3br High-degree AV Block: Treat as for bradycardia above. other information we have about you. Drug information provided by: Merative, Micromedex. Infusions of calcium for 24 hours or more may be required. Received 2020 Jul 16; Accepted 2020 Jul 16. There was an increased incidence of stillbirths at doses of 20 times the human oral antianginal dose or greater. Intravenous diltiazem and intravenous beta-blockers should not be administered together or in close proximity (within a few hours). 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. Swallow right away without chewing. Reproduction studies have been conducted in mice, rats, and rabbits. Follow all directions on your prescription label. Unless otherwise contraindicated, appropriate vagal maneuvers should be attempted prior to administration of diltiazem hydrochloride injection. May repeat with 2. nd the contents by NLM or the National Institutes of Health. Use diltiazem cautiously in treatment of patients with concomitant LV systolic dysfunction because the negative inotropic effect can cause hypotension. The toxic dose in man is not known. Discard Unused Portion Store Under Refrigeration Administration of oral diltiazem in patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission is contraindicated. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. The recommended initial infusion rate of diltiazem hydrochloride injection is 10 mg/h. 0000030660 00000 n information and will only use or disclose that information as set forth in our notice of Sterile 5 mL Single-Dose Vial, Rx only NDC 55150-425-10 Communication and trust between patients and nurses can be interfered due to extravasation. 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. Common non-antineoplastic drugs that can act as vesicants or irritants [Internet] [cited 2020 Jul 10]. 549 0 obj <>stream Last updated on Apr 1, 2023. Bookshelf government site. Hot fomentations can be applied to the dilated veins to mitigate the symptoms. 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. Renal insufficiency, or even end-stage renal disease, does not appear to influence diltiazem disposition following oral administration. Make your tax-deductible gift and be a part of the cutting-edge research and care that's changing medicine. - Even if there is an existing IV route, secure a new route when administering vesicant drugs. This content does not have an Arabic version. Heart rate reduction may last from 1 to 3 hours. Accessibility Although not observed in clinical trials with diltiazem hydrochloride injection, the following events associated with oral diltiazem may occur: It works by relaxing the muscles of your heart and blood vessels. If it continues for a long time, the heart and arteries may not function properly. Diltiazem may be only part of a complete program of treatment that also includes diet, exercise, and other medications. MeSH - For observation, do not cover the cannula area with opaque gauze. Injection and Continuous 0000006002 00000 n Would you like email updates of new search results? - After the injection, make sure to run a saline solution through the catheter. The apparent volume of distribution of diltiazem hydrochloride is approximately 305 L. Diltiazem hydrochloride is extensively metabolized in the liver with a systemic clearance of approximately 65 L/h. This document is only valid for the day on which it is accessed. 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. %PDF-1.4 % One report with oral diltiazem suggests that concentrations in breast milk may approximate serum levels. Diltiazem is a calcium channel blocker. Diltiazem does not appear to be removed by peritoneal or hemodialysis. 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. Discard Unused Portion Store Under Refrigeration INTRODUCTION. Extravasation may occur if the administration of the drug is too quick, the medication is very acidic or basic, or there is an obstruction in the . Diltiazem hydrochloride injection is clear, colorless, sterile, nonpyrogenic solution and is supplied as follows: Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician. 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 unsubscribe link in the e-mail. IV Push IV infusion . 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. You may need to use blood pressure medicine for the rest of your life. Experience with this dose is limited. Sodium hydroxide or hydrochloric acid is used for pH adjustment. health information, we will treat all of that information as protected health Your doctor may occasionally change your dose. Drug information: Clinical Computerized Information System: vol. Englewood (CO): Micromedex Inc; [date unknown]. Brand names: Cardizem (and Cardizem CD, LA and XR), Cartia XT, Dilacor XR, Dilt-CD, 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. E. Windsor, NJ 08520 Available for Android and iOS devices. %%EOF 8600 Rockville Pike information highlighted below and resubmit the form. Writingoriginal draft: JTK, JYP, HJL, YJC. In subgroup analysis of double-blind and open-label trials following first-dose response, 116 patients 65 years of age had a response rate of 84%. The plasma elimination half-life is approximately 3.4 hours. Local cooling (ice packs) aids in vasoconstriction, theoretically limiting the drug dispersion. Data curation: JTK, JYP, HJL, YJC. Click here for an email preview. Other events reported in at least 1% of the diltiazem-treated patients were injection site reactions (e.g., itching, burning) 3.9%, vasodilation (flushing) 1.7%, and arrhythmia (junctional rhythm or isorhythmic dissociation) 1.0 %. tiazac. Because errors associated with IV administration can result in fatal or life-threatening outcomes, administration of IV fluids and medications can be a high-risk, with adverse outcomes potentially leading to malpractice claims. Waltham (MA): UpToDate Inc; c2020. Diltiazem hydrochloride injection is a clear, colorless, sterile, nonpyrogenic solution. Dosage form: injection, solution In the event of overdosage or an exaggerated response, appropriate supportive measures should be employed. 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. Supplement 3. Packaged in a Carton of 10 NDC 55150-426-10 Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Disclaimer. Drugs which induce or inhibit hepatic microsomal enzymes may alter diltiazem disposition. Diltiazem If there is no response to vagal blockade administer isoproterenol cautiously. Management of extravasation includes nursing intervention and thermal application. High blood pressure often has no symptoms. Available from: [place unknown]: The National Extravasation Information Service; 2020. Should a dermatologic reaction persist, the drug should be discontinued. Destroy after 1 month at room temperature. Photographic documentation of extravasation case. startxref Extravasation refers to the leakage of injected drugs from blood vessels causing damage to the surrounding tissues. Keep diluted diltiazem hydrochloride injection refrigerated until use. Hypotension was the most commonly reported adverse event during clinical trials. In addition, caution should be used in patients taking other drugs that decrease peripheral resistance, intravascular volume, myocardial contractility or conduction. The National Extravasation Information Service website [Internet] [cited 2020 Jul 10]. Cyclosporine - A pharmacokinetic interaction between diltiazem and cyclosporine has been observed during studies involving renal and cardiac transplant patients. Patients with severe hypotension or cardiogenic shock. The https:// ensures that you are connecting to the Diltiazem shows dose-dependent, non-linear pharmacokinetics. 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. Continuous Intravenous Infusion . government site. Use diltiazem regularly to get the most benefit. Extravasation kit includes the following: 25G needle, 10-cc syringe, and 1-mL syringe; disinfection swabs, sterile gauze, and adhesive bandage; saline solution (1 ampule); sterile distilled water (1 ampule); dimethyl sulfoxide 99% solution; hyaluronidase 1,500 U/mL (refrigerated); hydrocortisone cream 1%; sodium thiosulfate 25% solution; and warm pack and an ice pack (frozen). Unable to load your collection due to an error, Unable to load your delegates due to an error. As a library, NLM provides access to scientific literature. ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( |a^(/ -~,.[sL5 ;Z]^y~Mq7?7 e GE O G_oiV&! %Lp!8b(V7Yc2|5*qPp4wn"aLKa15N Extravasation:Unintentional leakage of fluid out of a blood vessel into surrounding tissue. HHS Vulnerability Disclosure, Help In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). endstream endobj startxref Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Metabolites N-monodesmethyldiltiazem, desacetyldiltiazem, desacetyl-N-monodesmethyldiltiazem, desacetyl-O-desmethyldiltiazem, and desacetyl-N, O-desmethyldiltiazem have been identified in human urine. This content does not have an English version. FOIA Diltiazem inhibits the influx of calcium (Ca 2+) ions during membrane depolarization of cardiac and vascular smooth muscle. Diltiazem may also be used for purposes not listed in this medication guide. Federal government websites often end in .gov or .mil. Enhanced effects and increased toxicity of buspirone may be possible during concomitant administration with diltiazem. IV infiltrations and extravasations occur when fluid leaks out of the vein into surrounding soft tissue. Langer SW. Extravasation of chemotherapy. endstream endobj 513 0 obj <. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. hb```l 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. For Direct Intravenous Bolus Particular information must be given when a vesicant drug is administered. The apparent volume of distribution remains unchanged (360 to 391 L). Diltiazem is used alone or together with other medicines to treat angina (severe chest pain) or hypertension (high blood pressure). Cimetidine - A study in six healthy volunteers has shown a significant increase in peak diltiazem plasma levels (58%) and area-under-the-curve (53%) after a 1-week course of cimetidine at 1,200 mg per day and a single dose of diltiazem 60 mg. Ranitidine produced smaller, nonsignificant increases. 2838 0 obj <>stream Oral administration of diltiazem with propranolol in five normal volunteers resulted in increased propranolol levels in all subjects and bioavailability of propranolol was increased approximately 50%. For Direct Intravenous Bolus Injection and - Watch for edema, inflammation, and pain around the cannula during administration. Mean plasma diltiazem concentrations of 130 ng/mL and 300 ng/mL were determined to produce reductions in heart rate of 30% and 40%. Nervous System: Dizziness, paresthesia Diltiazem plasma levels were not significantly affected by lovastatin or pravastatin. Delayed extravasation:Symptoms occur 48 hours, or later, after drug administration. 0 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. Nursing Department, Asan Medical Center . Herein, general knowledge about extravasation is first described, including its definition, incidence, risk factors, diagnosis, differential diagnosis, and extravasation injuries. 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. 0000008421 00000 n 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. Although clear benefit has not been demonstrated with thermal applications, it remains a standard supportive care, and the recommended application schedule for both warm and cold applications is 15 to 20 minutes, every 4 hours, for 24 to 48 hours. The patient must be informed of the scope of the problem (Supplement 5). Before Intravenous Infusion hbbd```b``= "ro) "5" `LBT80yLHf) 8, EA! The therapeutic benefits of diltiazem in supraventricular tachycardias are related to its ability to slow AV nodal conduction time and prolong AV nodal refractoriness. Some patients may respond to an initial dose of 0.15 mg/kg, although duration of action may be shorter. In vitro studies suggest alpha1-acid glycoprotein binds approximately 40% of the drug at clinically significant concentrations. sharing sensitive information, make sure youre on a federal Intravenous Infusion The following are common drugs that interact with diltiazem; Not all possible interactions are listed in this medication guide. information submitted for this request. Vesicant extravasation:Leakage of a drug that causes pain, necrosis, or tissue sloughing.

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