Medically reviewed by Kaci Durbin, MD. Apply compresses for 20 to 60 minutes 3 or 4 times daily for the first 24 to 72 hours after extravasation occurs. 0 Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. In terms of cancer therapy, extravasation refers to the inadvertent infiltration of chemotherapeutic drugs in the tissues surrounding the IV site. FOIA Diltiazem has no significant electrophysiologic effects on tissues in the heart that are fast sodium channel dependent, e.g., His-Purkinje tissue, atrial and ventricular muscle, and extranodal accessory pathways. Adverse events reported in controlled and uncontrolled clinical trials were generally mild and transient. They should regularly check the extravasation kit, assess patients sensory changes, tingling or burning, and always pay attention to patients words. 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. show all 12 brands High blood pressure often has no symptoms. For prevention of extravasation, health professionals should be familiar with the extravasation management standard guidelines. Sodium hydroxide or hydrochloric acid is used for pH adjustment. These two medications are different than other calcium channel blockers because they have direct action on cardiac tissue at therapeutic levels. This is an open-access article distributed under the terms of the Creative Commons Attribution License (, GUID:367E9C1D-E270-4114-AA3D-21C537398B1B, GUID:D253D40D-77BC-48AC-A9B8-1814B76155B0, GUID:AD28B884-86A0-4E06-8641-E315D06B067F, GUID:3AC69EF7-5706-454E-AEA5-D87005B23EF4, GUID:D75BDE9D-DD6A-421F-A27E-A2A0FE0A12C1, GUID:6CED1AD4-FC08-4A32-B5E3-E0B71BFF0284, Extravasation, Antidotes, Intravenous injections, Patient care, Risk factors. Hemodynamics 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%. prolonged sedation) of both midazolam and triazolam. Diltiazem hydrochloride is extensively metabolized by the liver and excreted by the kidneys and in bile. Diltiazem prolongs the sinus cycle length. Effect of warm and cold applications on the resolution of i.v Prompt interdisciplinary action is often necessary for the treatment of extravasation injuries. Stopping suddenly may make your condition worse. %&'()*456789:CDEFGHIJSTUVWXYZcdefghijstuvwxyz Extravasation must be suspected if any of the following specific signs or symptoms are presented (Table 1). Sterile eugia 10 x 10 mL Single-Dose Vials, Rx only NDC 55150-427-01 hb``d``f`c`P "@1vG(r8}C#7mcH`KfYtfnzv$@,BKK~x$3$shElVVp A_8{.>9UiiGK:&ALg>)tvNV-+>'(yqnSg@Em.P^''*.^. Occurs due to contraction of the vessel wall and usually happens as soon as the fluid injection begins. 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. We comply with the HONcode standard for trustworthy health information. When treatment for hypotension was required, it generally consisted of administration of saline or placing the patient in the Trendelenburg position. Photographic documentation can be helpful for follow-up procedures. 50 mg per 10 mL * Irritant drugs can cause local pain and inflammation but rarely cause tissue destruction. Diltiazem may impair your thinking or reactions. (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 . All rights reserved. Similar ventricular complexes have been noted during cardioversion, other pharmacologic therapy, and during spontaneous conversion of PSVT to sinus rhythm. General This can damage the blood vessels of the brain . The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). The usual dose range of oral diltiazem for the treatment of hypertension is 180 to 360 mg daily. Avoid concomitant use of ivabradine and diltiazem. You should not use diltiazem if you are allergic to it, or if you have: a serious heart condition such as "sick sinus syndrome" or "second- or third-degree AV block" (unless you have a pacemaker); if you have recently had a heart attack and you have a build-up of fluid in your lungs. It also increases the supply of blood and oxygen to the heart. Diltiazem may also be used for purposes not listed in this medication guide. PEI can be very effective in the treatment of larger cysts that have one significant pocket of fluid (in contrast to multiple, small pockets of fluid) -- The cyst is drained then approx half of that volume in 95% ethanol is injected back into the . Related/similar drugs Common signs include inflammation, tightness of the skin, and pain around the IV site. If there is no response to vagal blockade administer isoproterenol cautiously. Caution should be exercised when using the drug in such patients. endstream endobj 513 0 obj <. If you are a Mayo Clinic patient, this could Injection and Continuous 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%. Intravenous Infusion In vitro studies suggest alpha1-acid glycoprotein binds approximately 40% of the drug at clinically significant concentrations. Blood backflow works well, and edema or ulcer do not occur. health information, we will treat all of that information as protected health In vitro, propranolol appears to be displaced from its binding sites by diltiazem. 0000008421 00000 n Most extravasations can be prevented with the systematic implementation of careful, standardized, and evidence-based administration techniques. HCl Injection Some patients may maintain response to an initial rate of 5 mg/h. 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. 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. In the perinatal/postnatal studies there was some reduction in early individual pup weights and survival rates. - Check for blood backflow before/during administration, and always rinse the catheter with a saline solution in between administrations. and transmitted securely. Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4-(5H)-one,3-(Acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(-4-methoxyphenyl)-, monohydrochloride, (+)-cis-. - After the injection, make sure to run a saline solution through the catheter. Ivabradine - Concurrent use of diltiazem increases exposure to ivabradine and may exacerbate bradycardia and conduction disturbances. endstream endobj 333 0 obj <. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Your doctor will tell you which of these are most important for you. 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. In severe cases, extravasation may cause tissue dysfunction or physical defects, resulting in a delay of attempted treatment, patients distrust, and numerous other issues. 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. The https:// ensures that you are connecting to the hb``e``= P30p %DeA@>;O2`8Te~0C;L5gla3a1fb+ fd`+ 2 n', tiazac. Bookshelf High-degree AV Block: Treat as for bradycardia above. 3. Grapefruit and grapefruit juice may interact with diltiazem and lead to unwanted side effects. High blood pressure may also increase the risk of heart attacks. Gastrointestinal: Anorexia, diarrhea, dysgeusia, dyspepsia, mild elevations of SGPT and LDH, thirst, weight increase Your blood pressure will need to be checked often. Diltiazem slows the ventricular rate in patients with a rapid ventricular response during atrial fibrillation or atrial flutter. 0000030429 00000 n Many drugs can interact with diltiazem, and your doctor may need to change your treatment plan if you use certain other medicines. It is important to remember that the degree of damage is dependent on the type of the drug, the drug concentration, the localization of the extravasation, and the length of time for which the drug develops its potential for damage. DO NOT apply pressure to the area 6. Supplement 1. 8600 Rockville Pike Keywords: Use within 24 hours. Available from: [place unknown]: [publisher unknown]; 2018. Fixed high-degree AV block should be treated with cardiac pacing. While the injury is usually minor and resolves spontaneously, some cases result in serious complications, including full-thickness skin loss and muscle and tendon necrosis requiring reconstructive surgery or even amputation, leading to longer hospital stays, increased morbidity, and increased costs. One report with oral diltiazem suggests that concentrations in breast milk may approximate serum levels. 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). Supplement 6. 5. 0000030705 00000 n The National Extravasation Information Service website [Internet] [cited 2020 Jul 10]. Mayo Clinic College of Medicine and Science, Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Graduate Medical Education, Mayo Clinic School of Continuous Professional Development, Mayo Clinic on Incontinence - Mayo Clinic Press, NEW Mayo Clinic on High Blood Pressure - Mayo Clinic Press, Mayo Clinic on Hearing and Balance - Mayo Clinic Press, FREE Mayo Clinic Diet Assessment - Mayo Clinic Press, Mayo Clinic Health Letter - FREE book - Mayo Clinic Press, Financial Assistance Documents Minnesota. Geriatric Use Three solutions were used: 1/2 saline (154 mOsm), normal saline (308 mOsm), and 3% saline (1027 mOsm). eugia, Rx only NDC 55150-427-10 8600 Rockville Pike There was an increased incidence of stillbirths at doses of 20 times the human oral antianginal dose or greater. official website and that any information you provide is encrypted Diltiazem pregnancy and breastfeeding warnings, Drug class: calcium channel blocking agents, Diltiazem 12-Hour Sustained-Release Capsules. Unable to load your collection due to an error, Unable to load your delegates due to an error. PDF 3364-133-125 Treatment of Intravenous Non-Chemoterapeutic Extravasations Enhanced effects and increased toxicity of buspirone may be possible during concomitant administration with diltiazem. Chicago (IL): University of Illinois College of Pharmac; c2020. Metabolites N-monodesmethyldiltiazem, desacetyldiltiazem, desacetyl-N-monodesmethyldiltiazem, desacetyl-O-desmethyldiltiazem, and desacetyl-N, O-desmethyldiltiazem have been identified in human urine. The use of local warming is recommended for the extravasation of nonDNA-binding vesicants. May be stored at room temperature for up to 1 month. Bradycardia: Administer atropine (0.6 to 1.0 mg). Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician. Diltiazem Injection: Package Insert - Drugs.com Delayed extravasation:Symptoms occur 48 hours, or later, after drug administration. - Dilute stimulant drugs as much as possible and inject them at a proper rate. . An overdose of diltiazem can be fatal. The site is secure. If bone marrow function decreases, anticancer treatments may be delayed due to infection caused by leukopenia. The patient must be informed of the scope of the problem (Supplement 5). Diltiazem extravasation. High blood pressure adds to the workload of the heart and arteries. Manchester: The Christie NHS Foundation Trust; 2014. - 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. Continuous Intravenous Infusion Experience in the use of antiarrhythmic agents following maintenance infusion of diltiazem hydrochloride injection is limited. These pharmacokinetic effects seen during diltiazem coadministration can result in increased clinical effects (e.g. 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. Patients with low body weights should be dosed on a mg/kg basis. Rhinitis, headache, and constipation are commonly reported side effects. Some patients may respond to an initial dose of 0.15 mg/kg, although duration of action may be shorter. Eugia US LLC 125 mg per 25 mL (5 mg/mL) Paroxysmal Supraventricular Tachycardia Diltiazem hydrochloride injection rarely converts atrial fibrillation or atrial flutter to normal sinus rhythm. - Directions: apply hot fomentations for 20 to 30 minutes four to 6 times per day (for 1 day or more). Injection and Continuous The plasma elimination half-life is approximately 3.4 hours. 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. Use diltiazem regularly to get the most benefit. Continuous Intravenous Infusion Limited data suggest that plasmapheresis or charcoal hemoperfusion may hasten diltiazem elimination following overdose. Discuss the use of grapefruit products with your doctor. Liver cirrhosis was shown to reduce diltiazem's apparent oral clearance and prolong its half-life. 6. 0000019842 00000 n 0000022294 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. Drug information handbook. The toxic dose in man is not known. Impact of intravenous calcium with diltiazem for atrial fibrillation The infusion may be maintained for up to 24 hours. Although clear benefit has not been demonstrated with thermal applications, it remains a standard supportive care. 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. Review/update the hbbd```b``= "ro) "5" `LBT80yLHf) 8, EA! Maximal hemodynamic effects usually occurred within 2 to 5 minutes of an injection. Take diltiazem exactly as prescribed by your doctor. Eugia Pharma Specialities Limited For Direct Intravenous Bolus Inclusion in an NLM database does not imply endorsement of, or agreement with, If hypotension occurs, it is generally short-lived, but may last from 1 to 3 hours. 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. In patients administered bolus doses ranging from 2.5 mg to 38.5 mg, systemic clearance averaged 36 L/h. HCl Injection All rights reserved. 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. Local cooling (ice packs) aids in vasoconstriction, theoretically limiting the drug dispersion. Diltiazem is used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders. 0000010832 00000 n - For observation, do not cover the cannula area with opaque gauze. Unless otherwise contraindicated, appropriate vagal maneuvers should be attempted prior to administration of diltiazem hydrochloride injection. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. 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. Apply sterile dressing over the area of extravasation, regularly assess the extravasation site during every shift, and take medical photographs and consult the department of cosmetic surgery if necessary. LD = 0.25 mg/kg over 2 min. Langer SW. Extravasation of chemotherapy. Mayo Clinic does not endorse companies or products. Accessibility For Direct Intravenous Bolus Injection and This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 0000003491 00000 n BIT Druginfo website [Internet] [cited 2020 Jul 10]. 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. Reynolds PM, MacLaren R, Mueller SW, Fish DN, Kiser TH. Extravasation:Unintentional leakage of fluid out of a blood vessel into surrounding tissue. 0000001178 00000 n 7. The primary outcome was the change in SBP 60 min (+/- 30 min) after initial IV diltiazem administration. Store diltiazem at room temperature away from moisture and heat. The audio recording of the abstract. Intravenous Infusion In the event of overdosage or an exaggerated response, appropriate supportive measures should be employed. 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 0000000016 00000 n Therefore, the potential for these dermatologic reactions exists following exposure to intravenous diltiazem. The effect of cyclosporine on diltiazem plasma concentrations has not been evaluated. Alteplase Adult Assess for hemorrhage during first hour of treatment. These metabolites are observed, however, following 24 hour constant rate intravenous infusion. Common symptoms and signs of extravasation include pain, stinging or burning sensations, and edema around the intravenous (IV) injection site. Common diltiazem side effects may include: This is not a complete list of side effects and others may occur. Diltiazem hydrochloride injection is for direct intravenous bolus injection and continuous intravenous infusion. PDF Diltiazem (Cardizem) - Advocate Health 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. An extremely severe case of cutaneous calcinosis with juvenile dermatomyositis, and successful treatment with diltiazem. Amiodarone: Guidelines for Use and Monitoring | AAFP This guideline will enable health professions to manage the patients extravasation appropriately. National Center for Biotechnology Information Diltiazem shows dose-dependent, non-linear pharmacokinetics. With the practical use of these guidelines, it is expected to reduce the occurrence rate of extravasation and contribute to patient care improvement. HCl Injection Diltiazem is used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders. Sauerland C, Engelking C, Wickham R, Corbi D. Vesicant extravasation part I: mechanisms, pathogenesis, and nursing care to reduce risk. .,gzTwgV- *m ;vQt3 Y s::;:@4w00 fF=$:a [|E! K|+o|`meff;priV@ud`\e`t0 b0 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. Antidotes, special drug management, drugs with high osmolarity, and drugs with pH are provided as supplement files (Supplements 14). You may also need frequent blood tests. (5 mg/mL) 0000001883 00000 n If these agents are to be administered concurrently, cyclosporine concentrations should be monitored, especially when diltiazem therapy is initiated, adjusted or discontinued. - Do not insert the cannula in the antecubital fossa area, where it is extremely difficult to detect extravasation. 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. Available for Android and iOS devices. Diltiazem is a calcium channel blocker. Should a dermatologic reaction persist, the drug should be discontinued. Elevate the affected extremity 332 0 obj <> endobj 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). - 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). Extravasation severity can range from benign lipid masses to florid skin necrosis. Manufactured by: 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). This content does not have an Arabic version. The risk of toxic reactions to this drug may be greater in patients with impaired renal or hepatic function. %%EOF 1997. %PDF-1.4 % Hadaway L. Extravasation: Issues and Controversies. Extravasation is the leakage of an injected drug out of the blood vessels, damaging the surrounding tissues. - Initial physical symptoms usually appear immediately but also might appear several days or weeks later. Changes in heart rate, systolic blood pressure, and diastolic blood pressure did not correlate with diltiazem plasma concentrations in normal volunteers. 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.
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