information is beneficial, we may combine your email and website usage information with However, since both drugs affect AV nodal conduction, patients should be monitored for excessive slowing of the heart rate and/or AV block. hbbbd`b``3 Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. A defibrillator and emergency equipment should be readily available. hb``d``f`c`P "@1vG(r8}C#7mcH`KfYtfnzv$@,BKK~x$3$shElVVp A_8{.>9UiiGK:&ALg>)tvNV-+>'(yqnSg@Em.P^''*.^. If possible, it is recommended that diltiazem hydrochloride injection not be co-infused in the same intravenous line. Available for Android and iOS devices. Available for Android and iOS devices. 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. Patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in WPW syndrome or short PR syndrome. 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. After oral administration, diltiazem undergoes extensive metabolism in man by deacetylation, N-demethylation, and O-demethylation via cytochrome P-450 (oxidative metabolism) in addition to conjugation. Hypotension was the most commonly reported adverse event during clinical trials. - It dilates the blood vessels around the extravasation site, increases dispersion and absorption of the medicinal fluid by increasing the blood flow, and helps to quickly purge medicinal fluid that has leaked from the extravasation site. PMC Donate. 25 mL Single-Dose Vials The usual dose range of oral diltiazem for controlling chest pain is 120 to 480 mg daily. 2 0 obj <> endobj 3 0 obj <> endobj 4 0 obj <> endobj 6 0 obj <>/XObject<>/ProcSet[/PDF/Text/ImageB/ImageC]>>/Contents 14 0 R>> endobj 7 0 obj <> endobj 8 0 obj [0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1000 1000 293 343 489 818 637 1199 781 275 454 454 637 818 313 431 313 577 637 637 637 637 637 637 637 637 637 637 363 363 818 818 818 566 920 685 686 667 757 615 581 745 764 483 500 696 572 893 771 770 657 770 726 633 612 739 675 1028 685 670 623 454 577 454 818 637 546 599 632 527 629 594 382 629 640 302 363 603 302 954 640 617 629 629 434 515 416 640 579 890 604 576 526 623 637 623 818 1000 637 1000 275 637 489 1000 637 637 546 1676 633 425 1037 1000 623 1000 1000 275 275 489 489 637 637 909 546 861 515 425 985 1000 526 670 293 343 637 637 637 637 637 637 546 929 508 703 818 431 929 637 520 818 539 539 546 651 637 363 546 539 539 703 1128 1128 1128 566 685 685 685 685 685 685 989 667 615 615 615 615 483 483 483 483 774 771 770 770 770 770 770 818 770 739 739 739 739 670 659 646 599 599 599 599 599 599 937 527 594 594 594 594 302 302 302 302 620 640 617 617 617 617 617 818 617 640 640 640 640 576 629 576] endobj 9 0 obj <> endobj 10 0 obj <> endobj 11 0 obj [0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1000 1000 313 332 401 728 546 977 674 211 383 383 546 728 303 363 303 382 546 546 546 546 546 546 546 546 546 546 354 354 728 728 728 474 909 600 589 601 678 561 521 667 675 373 417 588 498 771 667 708 551 708 621 557 584 656 597 902 581 576 559 383 382 383 728 546 546 525 553 461 553 526 318 553 558 229 282 498 229 840 558 543 553 553 360 446 334 558 498 742 495 498 444 480 382 480 728 1000 546 1000 211 546 397 817 546 546 546 1391 557 383 977 1000 559 1000 1000 211 211 401 401 455 546 909 546 876 446 383 909 1000 444 576 313 332 546 546 546 546 382 546 546 929 493 573 728 363 929 546 471 728 493 493 546 568 546 354 546 493 493 573 1000 1000 1000 474 600 600 600 600 600 600 913 601 561 561 561 561 373 373 373 373 698 667 708 708 708 708 708 728 708 656 656 656 656 576 565 548 525 525 525 525 525 525 880 461 526 526 526 526 229 229 229 229 546 558 543 543 543 543 543 728 543 558 558 558 558 498 553 498] endobj 12 0 obj <> endobj 13 0 obj <>stream aztreonam, diltiazem hydrochloride, dobutamine hydrochloride, dopamine hydrochloride, fludarabine phosphate, foscarnet sodium, idarubicin hydrochloride, . Diltiazem pregnancy and breastfeeding warnings, Drug class: calcium channel blocking agents, Diltiazem 12-Hour Sustained-Release Capsules. Rifampin - Coadministration of rifampin with diltiazem lowered the diltiazem plasma concentrations to undetectable levels. Project administration: JTK, JYP, HJL, YJC. The use of local warming is recommended for the extravasation of nonDNA-binding vesicants. Local cooling (ice packs) aids in vasoconstriction, theoretically limiting the drug dispersion. Cyclosporine - A pharmacokinetic interaction between diltiazem and cyclosporine has been observed during studies involving renal and cardiac transplant patients. 8600 Rockville Pike HHS Vulnerability Disclosure, Help Patients with low body weights should be dosed on a mg/kg basis. Some patients may respond to an initial dose of 0.15 mg/kg, although duration of action may be shorter. DO NOT flush the line 7. You should not stop using diltiazem suddenly. 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. Before 0000002293 00000 n Drug classes: Calcium channel blocking agents, Group IV antiarrhythmics. Communication and trust between patients and nurses can be interfered due to extravasation. National Library of Medicine Local thermal treatments are used to decrease the site reaction and absorption of the infiltrate. Drug Information Group [Internet] [cited 2020 Jul 10]. Intravenous Infusion Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Supplement 3. Diltiazem: 7 things you should know - Drugs.com 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. Diltiazem may also be used for purposes not listed in this medication guide. Diltiazem is a calcium channel blocker. INTRODUCTION. Prompt interdisciplinary action is often necessary for the treatment of extravasation injuries. Injectable forms of diltiazem are contraindicated in: 1. In vitro studies suggest alpha1-acid glycoprotein binds approximately 40% of the drug at clinically significant concentrations. and transmitted securely. Diltiazem All rights reserved. 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. 0000024987 00000 n IV push over 10 minutes or IVPB as directed. Diltiazem: MedlinePlus Drug Information After constant rate intravenous infusion to healthy male volunteers, diltiazem exhibits nonlinear pharmacokinetics over an infusion range of 4.8 to 13.2 mg/h for 24 hours. What are current recommendations for treatment of drug extravasation Seoul: BIT Druginfo; 2020. The phase IV clinical study is created by eHealthMe based on reports from the FDA, and is updated regularly. - Do not insert the cannula in the antecubital fossa area, where it is extremely difficult to detect extravasation. 125 mg per 25 mL Hemodynamics Documentation procedure may differ between treatment centers (documentation form); however, certain items are mandatory for patient safety and legal purposes: (1) patient name and number, (2) date and time of the extravasation, (3) name of the drug extravasated and the diluent used (if applicable), (4) signs and symptoms (also reported by the patient), (5) description of the IV access, (6) extravasation area (and the approximate amount of the drug extravasated), and (7) management steps with time and date. 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. Diltiazem Norwood (MA). Pharmacodynamics Grapefruit and grapefruit juice may interact with diltiazem and lead to unwanted side effects. Safety and effectiveness in pediatric patients have not been established. Carcinogenesis, Mutagenesis, Impairment of Fertility There was also no mutagenic response in vitro or in vivo in mammalian cell assays or in vitro in bacteria. Dermatologic events progressing to erythema multiforme and/or exfoliative dermatitis have been infrequently reported following oral diltiazem. IV Push IV infusion . Management of extravasation injuries: a focused evaluation of noncytotoxic medications. Diltiazem extravasation. Clipboard, Search History, and several other advanced features are temporarily unavailable. Rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm. If it continues for a long time, the heart and arteries may not function properly. Inject subcutaneously or intradermally into the extravasation site using a 25-gauge needle or smaller. Diltiazem hydrochloride and Extravasation - eHealthMe Metoprolol Cold Hydrocortisone 50-200 mg Give via 5-10 SQ or TD injections into area of extravasation Medication Thermal Therapy Antidote Dose Treatment Nitroglycerin Cold Hydrocortisone 50-200 mg Give via 5-10 SQ or TD injections into area of extravasation Norepinephrine Heat Nitroglycerin 2% paste n/a Apply thin layer to area of extravasation q 6 hr x 24 hr Administration of oral doses ranging from five to ten times greater (on a mg/kg basis) than the daily recommended oral antianginal therapeutic dose has resulted in embryo and fetal lethality. - Assess patients sensory changes, tingling or burning, and always pay attention to the words of patients. Package insert / product label 1Department of Pharmacy, Kyung Hee University Hospital at Gangdong, Seoul, Korea, 2Department of Clinical Nursing, University of Ulsan, Seoul, Korea. High blood pressure may also increase the risk of heart attacks. 0000006002 00000 n Nursing Mothers Experience with this dose is limited. However, if you have symptoms of low blood pressure (dizziness, fainting, weakness, or blurred vision), call your doctor and stop taking diltiazem. 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). Do not use this medicine in larger or smaller amounts or for longer than recommended. 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. This relaxes the blood vessels, lowers blood pressure, and increases the supply of blood and oxygen to the heart while reducing its workload. 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). - Watch for edema, inflammation, and pain around the cannula during administration. Management of Drug Extravasations 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. Your doctor will tell you which of these are most important for you. The chemical structure is: Diltiazem hydrochloride, USP is a white crystalline powder with a bitter taste. Beta-blockers - Intravenous diltiazem has been administered to patients on chronic oral beta-blocker therapy. With the practical use of these guidelines, it is expected to reduce the occurrence rate of extravasation and contribute to patient care improvement. 6. Available from: [place unknown]: [publisher unknown]; 2018. The https:// ensures that you are connecting to the An incident of extravasation must be correctly documented and reported. Manchester: The Christie NHS Foundation Trust; 2014. Only 1 of the studies of diltiazem was in children. %%EOF The combination of the two drugs was well tolerated without serious adverse effects. The combination of the two drugs was generally well tolerated without serious adverse effects. The vial stopper is not made with natural rubber latex. In domestic controlled trials, bolus administration of diltiazem hydrochloride injection was effective in converting PSVT to normal sinus rhythm in 88% of patients within 3 minutes of the first or second bolus dose. 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. Bethesda, MD 20894, Web Policies The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Sterile eugia 10 x 10 mL Single-Dose Vials, Rx only NDC 55150-427-01 Worldwide experience in over 1,300 patients was similar. - Be familiar with the extravasation management standard guidelines and prepare the extravasation kit. However, the study had only a small number of LD = 0.25 mg/kg over 2 min. (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 . The intravenous LD50's in mice and rats were 60 and 38 mg/kg, respectively. 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. Patients receiving these drugs concurrently should be monitored for a potential drug interaction. prolonged sedation) of both midazolam and triazolam. The primary purpose of these guidelines is to minimize the side-effects of IV injection, by suggesting proper and prompt emergency measures for extravasation and the appropriate treatments corresponding to the properties of the injected drug. HHS Vulnerability Disclosure, Help Definition The IV infiltration can be defined as a complication of the intravenous therapy, with the administered medication infiltrating into the surrounding tissues. Diltiazem is used alone or together with other medicines to treat angina (severe chest pain) or hypertension (high blood pressure). Following a single intravenous injection in healthy male volunteers, diltiazem hydrochloride appears to obey linear pharmacokinetics over a dose range of 10.5 to 21.0 mg. Venous shock can occur when injecting very cold medication or when medication is injected at a rapid pace. General No potential conflict of interest relevant to this article was reported. 8th ed. In the event of overdosage or an exaggerated response, appropriate supportive measures should be employed. The site is secure. 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. National Center for Biotechnology Information Drugs which induce or inhibit hepatic microsomal enzymes may alter diltiazem disposition. 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). Diltiazem is used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders. These contents are derived from authors experiences and the references [1-21]. 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. 0000029001 00000 n Management of extravasation policy: version 01 [Internet]. With the practical use of these guidelines, it is expected to reduce the occurrence rate of extravasation and contribute to patient care improvement. PDF Extravasation/Infiltration Management Chart - Johns Hopkins University For Direct Intravenous Bolus 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. Special drug management for care of the extravasation. It has a molecular weight of 451.0. Vesicant extravasation:Leakage of a drug that causes pain, necrosis, or tissue sloughing. Do not save the mixture for later use. Patients should be monitored for signs of hypercalcemia. May be stored at room temperature for up to 1 month. The risk of toxic reactions to this drug may be greater in patients with impaired renal or hepatic function. tiazac. 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 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. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Anesthetics - The depression of cardiac contractility, conductivity, and automaticity as well as the vascular dilation associated with anesthetics may be potentiated by calcium channel blockers. Diltiazem is a calcium channel blocker. 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. 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. High blood pressure is a common condition, and when not treated it can cause damage to the brain, heart, blood vessels, kidneys . * 5 mg/h may be appropriate for some patients. Conceptualization: JTK, JYP, HJL, YJC. Patients with ventricular tachycardia. Federal government websites often end in .gov or .mil. Local cooling (ice packs) aids in vasoconstriction, theoretically limiting the drug dispersion. Diltiazem (Oral Route) Your gift holds great power - donate today! Calcium channel blockers - Mayo Clinic privacy practices. FOIA 0000029978 00000 n Inclusion in an NLM database does not imply endorsement of, or agreement with, Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 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. In patients administered bolus doses ranging from 2.5 mg to 38.5 mg, systemic clearance averaged 36 L/h. Use within 24 hours. 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. the contents by NLM or the National Institutes of Health. Calcinosis cutis: Management - UpToDate 0000001883 00000 n These VPBs are transient, are typically considered to be benign, and appear to have no clinical significance. If hypotension occurs, it is generally short-lived, but may last from 1 to 3 hours. Diltiazem Injection Prescribing Information. In patients administered continuous infusions at 10 mg/h or 15 mg/h for 24 hours, diltiazem systemic clearance averaged 42 L/h and 31 L/h, respectively. These pharmacokinetic effects seen during diltiazem coadministration can result in increased clinical effects (e.g. Extravasation:Unintentional leakage of fluid out of a blood vessel into surrounding tissue. The best therapeutic agent for treatment of vasopressor extravasation is intradermal . These two medications are different than other calcium channel blockers because they have direct action on cardiac tissue at therapeutic levels. Diltiazem prolongs the sinus cycle length. Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium channel antagonist). Therefore, the potential for these dermatologic reactions exists following exposure to intravenous diltiazem. 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%.
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