364 0 obj <>stream 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. 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. Local thermal treatments are used to decrease the site reaction and absorption of the infiltrate. Overdose symptoms may include slow heartbeat, weakness, chest pain, shortness of breath, or fainting. Diltiazem shows dose-dependent, non-linear pharmacokinetics. endstream endobj 363 0 obj <>/Filter/FlateDecode/Index[10 322]/Length 34/Size 332/Type/XRef/W[1 1 1]>>stream Give a list of all your medicines to any healthcare provider who treats you. E. Windsor, NJ 08520 Store product under refrigeration 2 to 8C (36 to 46F). The guidelines described herein are based on the authors best practice for the management and prevention of the extravasation. It works by affecting the movement of calcium into the cells of the heart and blood vessels. Seoul: BIT Druginfo; 2020. No potential conflict of interest relevant to this article was reported. If I understood the guidelines for extravasation management, it might be possible to prevent the necrosis of her arm skin. 25 mg per 5 mL The phase IV clinical study is created by eHealthMe based on reports from the FDA, and is updated regularly. You should not stop using diltiazem suddenly. Distributed by: The medical teams continuous education on extravasation is essential. For prevention of extravasation, health professionals should be familiar with the extravasation management standard guidelines. Delayed extravasation:Symptoms occur 48 hours, or later, after drug administration. %PDF-1.5 % Take the missed dose as soon as you remember. If hypotension occurs, it is generally short-lived, but may last from 1 to 3 hours. Reproduction studies have been conducted in mice, rats, and rabbits. The recommended application schedule for both warm and cold applications is 15 to 20 minutes, every 4 hours, for 24 to 48 hours. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. IV push over 10 minutes or IVPB as directed. Disclaimer. 0000010698 00000 n Cold application is recommended for extravasation of DNA-binding vesicants except for mechlorethamine (nitrogen mustard), contrast media, and hyperosmolar fluids. Skip the missed dose if it is almost time for your next scheduled dose. 4. As with all drugs, care should be exercised when treating patients with multiple medications (see PRECAUTIONS, General and Drug Interactions). Available from: [place unknown]: [publisher unknown]; 2018. Diltiazem Injection Prescribing Information. Drugs with high osmolarity. hbbd```b``= "ro) "5" `LBT80yLHf) 8, EA! Diltiazem - Check for blood backflow before/during administration, and always rinse the catheter with a saline solution in between administrations. endstream endobj 333 0 obj <. 0000010832 00000 n 1997. Patients receiving these drugs concurrently should be monitored for a potential drug interaction. Diltiazem hydrochloride is extensively metabolized by the liver and excreted by the kidneys and in bile. Patients currently receiving diltiazem therapy should be carefully monitored for a change in pharmacological effect when initiating and discontinuing therapy with cimetidine. DO NOT apply pressure to the area 6. 0.5 - 1 mL over 1 minute. Supplement 5. hbbbd`b``3 Proceedings of the Infusion Nurses Society Annual Meeting; 1997 May; Salt Lake City, USA. Be careful if you drive or do anything that requires you to be alert. Package insert / product label High blood pressure is a common condition, and when not treated it can cause damage to the brain, heart, blood vessels, kidneys . Vinen CS, Patel S, Bruckner FE. The .gov means its official. Drug information: Clinical Computerized Information System: vol. Drug classes: Calcium channel blocking agents, Group IV antiarrhythmics. 50 mg per 10 mL - Regularly check the extravasation kit and refill any used medications. Inclusion in an NLM database does not imply endorsement of, or agreement with, In vitro, propranolol appears to be displaced from its binding sites by diltiazem. 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. (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 The toxic dose in man is not known. 0 High blood pressure often has no symptoms. - For observation, do not cover the cannula area with opaque gauze. Most extravasations can be prevented with the systematic implementation of careful, standardized, and evidence-based administration techniques. National Library of Medicine Diltiazem may be used for the treatment of high blood pressure or chronic stable angina. Should a dermatologic reaction persist, the drug should be discontinued. General (5 mg/mL) Verapamil belongs to the Phenylalkylamines class of calcium channel blockers and Diltiazem belongs to a class called the Benzothiazepines. Data sources include IBM Watson Micromedex (updated 1 May 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Nervous System: Dizziness, paresthesia Version: 15.01. Paroxysmal Supraventricular Tachycardia Tell your doctor if you are pregnant or plan to become pregnant. The drug prevents the recurrence of life-threatening ventricular arrhythmias and. FOIA We comply with the HONcode standard for trustworthy health information. health information, we will treat all of that information as protected health privacy practices. Renal insufficiency, or even end-stage renal disease, does not appear to influence diltiazem disposition following oral administration. @ 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. Do not stop taking this medication without first talking to your doctor. It works by relaxing the muscles of your heart and blood vessels. Patients who have demonstrated hypersensitivity to the drug. official website and that any information you provide is encrypted (5 mg/mL) - After the injection, make sure to run a saline solution through the catheter. Follow your diet, medication, and exercise routines very closely. HHS Vulnerability Disclosure, Help Before Local thermal treatments are used to decrease the site reaction and absorption of the infiltrate. MeSH Sodium hydroxide or hydrochloric acid is used for pH adjustment. Reynolds PM, MacLaren R, Mueller SW, Fish DN, Kiser TH. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. In patients with cardiovascular disease, diltiazem hydrochloride injection administered intravenously in single bolus doses, followed in some cases by a continuous infusion, reduced blood pressure, systemic vascular resistance, the rate-pressure product, and coronary vascular resistance and increased coronary blood flow. Cleanse the extravasation site gently with an alcohol sponge, insert the needle of the TB syringe into the subcutaneous tissue around the site and gently aspirate as much of the solution as possible Avoid friction or pressure to the affected area 5. hb``d``f`c`P "@1vG(r8}C#7mcH`KfYtfnzv$@,BKK~x$3$shElVVp A_8{.>9UiiGK:&ALg>)tvNV-+>'(yqnSg@Em.P^''*.^. (5 mg/mL) Extravasation is the leakage of an injected drug out of the blood vessels, damaging the surrounding tissues. 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). BIT Druginfo website [Internet] [cited 2020 Jul 10]. Diltiazem Clipboard, Search History, and several other advanced features are temporarily unavailable. 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. Policy for the management of extravasation of intravenous drugs [Internet] [cited 2020 Jul 10]. If you stop taking diltiazem suddenly, your condition may become worse. However, no guidelines can be perfect, and they need to be regularly updated. Albumin appears to bind approximately 30% of the drug, while other constituents bind the remaining bound fraction. 8600 Rockville Pike Diltiazem may also be used for purposes not listed in this medication guide. 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). Antidotes for the care of the extravasation. 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. Injectable forms of diltiazem are contraindicated in: 1. Mayo Clinic does not endorse companies or products. Subsequent intravenous bolus doses should be individualized for each patient. Duration of infusion longer than 24 hours and infusion rates greater than 15 mg/h have not been studied. hb``e``= P30p %DeA@>;O2`8Te~0C;L5gla3a1fb+ fd`+ 2 n', Treatment suspension wastes time and other problems can occur due to delayed treatment. Do not use this medicine in larger or smaller amounts or for longer than recommended. 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. Your doctor will adjust the dose and frequency of diltiazem to your needs. HCl Injection 0000030705 00000 n Occurs due to contraction of the vessel wall and usually happens as soon as the fluid injection begins. 6. Tell your doctor about all medicines you use, and those you start or stop using. 3. Drug information handbook for oncology: a complete guide to combination chemotherapy regimens. Although clear benefit has not been demonstrated with thermal applications, it remains a standard supportive care. include protected health information. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Single-dose vials. Diltiazem may also be used for purposes not listed in this medication guide. Local cooling (ice packs) aids in vasoconstriction, theoretically limiting the drug dispersion. Call your doctor for medical advice about side effects. Descriptions. NHS. This medicine is available only with your doctor's prescription. Dermatologic events progressing to erythema multiforme and/or exfoliative dermatitis have been infrequently reported following oral diltiazem. Following oral administration, 2% to 4% of the unchanged diltiazem appears in the urine. 2838 0 obj <>stream 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. %%EOF the contents by NLM or the National Institutes of Health. - Possibly no initial symptoms of extravasation, - Redness, pruritus, and edema around the injection site, - Fluid injection rate slows down or stops, - Blood backflow does not work well or there is leakage of medication around the needle, - A complaint of discomfort or pain and occasional expression of searing pain or numbness. Waltham (MA): UpToDate Inc; c2020. For Direct Intravenous Bolus Injection and These metabolites are observed, however, following 24 hour constant rate intravenous infusion. Spots or solid lines with blisters can be suddenly felt along the vessels injected with drugs. Do not freeze. 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. Hypotension, if it occurs, may be similarly persistent. 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. Diltiazem is excreted in human milk. Diltiazem is both a substrate and an inhibitor of the cytochrome P-450 3A4 enzyme system. and transmitted securely. They should regularly check the extravasation kit, assess patients sensory changes, tingling or burning, and always pay attention to patients words. Federal government websites often end in .gov or .mil. You may report side effects to FDA at 1-800-FDA-1088. w !1AQaq"2B #3Rbr 0000030204 00000 n You may also need frequent blood tests. Sterile 10 mL Single-Dose Vial, Rx only NDC 55150-426-10 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). An adjustment in the diltiazem dose may be warranted. Diltiazem The average age of the children in this study was about 3 years. This content does not have an English version. 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. Diltiazem hydrochloride injection rarely converts atrial fibrillation or atrial flutter to normal sinus rhythm. This can damage the blood vessels of the brain . Available from: University of Illinois College of Pharmacy . IV Push IVPB IVPB IVPB EXTRAVASATION PRECAUTION - May be Harmful. Diltiazem inhibits the influx of calcium (Ca 2+) ions during membrane depolarization of cardiac and vascular smooth muscle. Before taking diltiazem, tell your doctor if you have kidney disease, liver disease, or congestive heart failure. . Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. However, the study had only a small number of The risk of toxic reactions to this drug may be greater in patients with impaired renal or hepatic function. Destroy after 1 month at room temperature. High blood pressure may also increase the risk of heart attacks. Differences in volume were determined by magnetic resonance imaging (MRI) at three intervals postinfiltration. Sterile eugia 10 x 5 mL Single-Dose Vials, Rx only NDC 55150-426-01 In addition, the following events were reported infrequently (less than 1%): prolonged sedation) of both midazolam and triazolam. 0000003340 00000 n One report with oral diltiazem suggests that concentrations in breast milk may approximate serum levels. Cardiac Failure: Administer inotropic agents (isoproterenol, dopamine, or dobutamine) and diuretics. sharing sensitive information, make sure youre on a federal Discoloration and edema do not occur. These VPBs are transient, are typically considered to be benign, and appear to have no clinical significance. The mean ejection fraction and cardiac output/index remained unchanged or increased. India If high-degree AV block occurs in sinus rhythm, intravenous diltiazem should be discontinued and appropriate supportive measures instituted (see OVERDOSAGE). Extravasation is a serious complication during patient care. A defibrillator and emergency equipment should be readily available. Manufactured by: If we combine this information with your protected
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