If hypotension occurs, it is generally short-lived, but may last from 1 to 3 hours. 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. Subjects with increased average steady-state exposures of diltiazem showed a greater fold increase in simvastatin exposure. Patients receiving these drugs concurrently should be monitored for a potential drug interaction. Diltiazem hydrochloride injection rarely converts atrial fibrillation or atrial flutter to normal sinus rhythm. Do NOT flush the line with normal saline or dextrose No evidence of impaired fertility was observed in a study performed in male and female rats at oral dosages of up to 100 mg/kg/day. 0000003340 00000 n Rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm. Continuous Intravenous Infusion Subsequent dose adjustments may be necessary during coadministration, and should be based on clinical assessment. [cited 2020 Jul 10]. Cardiac Conduction - Diltiazem prolongs AV nodal conduction and refractoriness that may rarely result in second- or third-degree AV block in sinus rhythm. In vitro studies suggest alpha1-acid glycoprotein binds approximately 40% of the drug at clinically significant concentrations. Hypotension was the most commonly reported adverse event during clinical trials. 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. India $4%&'()*56789:CDEFGHIJSTUVWXYZcdefghijstuvwxyz ? 0000002293 00000 n Some patients may maintain response to an initial rate of 5 mg/h. severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling. - If in doubt, re-insert the cannula and administer the drug. Clipboard, Search History, and several other advanced features are temporarily unavailable. %%EOF Distributed by: The site is secure. Quinidine - Diltiazem significantly increases the AUC(0) of quinidine by 51%, T1/2 by 36% and decreases its CLoral, by 33%. Diltiazem prolongs the sinus cycle length. 8600 Rockville Pike Appendix A: Management of Extravasation: Chemotherapeutic and Non-chemotherapeutic Agents Figure 1: Workflow algorithm Stop infusion at first suspicion of extravasation. Special drug management for care of the extravasation. Physical Incompatibilities: Because of potential physical incompatibilities, it is recommended that diltiazem hydrochloride injection not be mixed with any other drugs in the same container. BIT Druginfo website [Internet] [cited 2020 Jul 10]. Discard unused portion. The effectiveness of intravenous calcium administration to reverse the pharmacological effects of diltiazem overdose has been inconsistent. hb``e``= P30p %DeA@>;O2`8Te~0C;L5gla3a1fb+ fd`+ 2 n', Torralba TP, Li-Yu J, Navarra ST. Spots or solid lines with blisters can be suddenly felt along the vessels injected with drugs. Local cooling (ice packs) aids in vasoconstriction, theoretically limiting the drug dispersion. High blood pressure often has no symptoms. 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. official website and that any information you provide is encrypted The best therapeutic agent for treatment of vasopressor extravasation is intradermal . Your blood pressure will need to be checked often. Available from: University of Illinois College of Pharmacy . 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. For Direct Intravenous Bolus High blood pressure often has no symptoms. IV infiltration is a common complication of intravenous (IV) therapy. If there is no response to vagal blockade administer isoproterenol cautiously. * Irritant drugs can cause local pain and inflammation but rarely cause tissue destruction. The heart rate reduction may last from 1 - 3 hours. If you are being treated for high blood pressure, keep using this medicine even if you feel well. Digitalis - Intravenous diltiazem has been administered to patients receiving either intravenous or oral digitalis therapy. 0000015118 00000 n However, since both drugs affect AV nodal conduction, patients should be monitored for excessive slowing of the heart rate and/or AV block. Common diltiazem side effects may include: This is not a complete list of side effects and others may occur. Knowledge of the mechanism of extravasation-induced tissue injury, agents for reversal, and appropriate nonpharmacologic treatment methods is essential. This includes AV nodal reentrant tachycardias and reciprocating tachycardias associated with an extranodal accessory pathway such as the WPW syndrome or short PR syndrome. Rheumatology (Oxford) 2000; 39:333. The therapeutic benefits of diltiazem in supraventricular tachycardias are related to its ability to slow AV nodal conduction time and prolong AV nodal refractoriness. 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. 2. 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. Sterile eugia 10 x 10 mL Single-Dose Vials, Rx only NDC 55150-427-01 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. 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. 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. - Assess patients sensory changes, tingling or burning, and always pay attention to the words of patients. 0000029978 00000 n 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. Cold application is recommended for extravasation of DNA-binding vesicants except for mechlorethamine (nitrogen mustard), contrast media, and hyperosmolar fluids. 10 mL Single-Dose Vials 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. %PDF-1.5 % Diltiazem (Cardizem ) IV Push IV infusion . - Regularly check the extravasation kit and refill any used medications. Sodium hydroxide or hydrochloric acid is used for pH adjustment. Maximal hemodynamic effects usually occurred within 2 to 5 minutes of an injection. - After the injection, make sure to run a saline solution through the catheter. INTRODUCTION. 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. 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. Packaged in a Carton of 10 NDC 55150-426-10 The phase IV clinical study analyzes which people take Cardizem and have Infusion site extravasation. %&'()*456789:CDEFGHIJSTUVWXYZcdefghijstuvwxyz Adverse events reported in controlled and uncontrolled clinical trials were generally mild and transient. hbbd``b`f3J "-@ ?y "RD%qAaLL )' dJ The toxic dose in man is not known. Events such as myocardial infarction have been observed which are not readily distinguishable from the natural history of the disease for the patient. 2838 0 obj <>stream This content does not have an English version. If I understood the guidelines for extravasation management, it might be possible to prevent the necrosis of her arm skin. 0 50 mg per 10 mL Accessibility eugia, Rx only NDC 55150-427-10 Available from: [place unknown]: The National Extravasation Information Service; 2020. 25 mg per 5 mL PMC 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. It works by relaxing the muscles of your heart and blood vessels. Gastrointestinal: Anorexia, diarrhea, dysgeusia, dyspepsia, mild elevations of SGPT and LDH, thirst, weight increase You may report side effects to FDA at 1-800-FDA-1088. Seoul: BIT Druginfo; 2020. Diltiazem is in a class of medications called calcium-channel blockers. They are used to treat a broad array of clinical conditions, including hypertension, supraventricular tachycardia, vasospasm, and migraine headaches. Version: 15.01. tiazac. Patients should be dosed on an individual basis and reference should be made to the respective manufacturer's package insert for information relative to dosage and administration. 0000025152 00000 n 4 Hyaluronidase has been successfully used in the treatment of TPN extravasations. JFIF C C d[" LD = 0.25 mg/kg over 2 min. Anti-anxiety medications called benzodiazepines (such as midazolam, triazolam, and others) as well as busipirone; Beta-blockers (such as atenolol, carvedilol, metoprolol, propranolol, sotalol, and others); Cholesterol medication called statins (such as atorvastatin, lovastatin, simvastatin, rosuvastatin, and others). Writingoriginal draft: JTK, JYP, HJL, YJC. In addition, the following events were reported infrequently (less than 1%): Drugs which induce or inhibit hepatic microsomal enzymes may alter diltiazem disposition. Compatibility: Diltiazem hydrochloride injection was tested for compatibility with three commonly used intravenous fluids at a maximal concentration of 1 mg diltiazem hydrochloride per milliliter. Duration of infusion longer than 24 hours and infusion rates greater than 15 mg/h have not been studied. 25-mg, 5-mL vialeach sterile vial contains 25 mg diltiazem hydrochloride, 3.75 mg citric acid USP, 3.25 mg sodium citrate dihydrate USP, 357 mg sorbitol solution USP, and water for injection USP up to 5 mL. Dermatologic: Alopecia, erythema multiforme (including Stevens-Johnson syndrome, toxic epidermal necrolysis), exfoliative dermatitis, leukocytoclastic vasculitis, petechiae, photosensitivity, purpura, rash, urticaria Hyderabad 500032 4. Sterile eugia 10 x 5 mL Single-Dose Vials, Rx only NDC 55150-426-01 High blood pressure is a common condition, and when not treated it can cause damage to the brain, heart, blood vessels, kidneys . Dosage form: injection, solution and transmitted securely. Carcinogenesis, Mutagenesis, Impairment of Fertility Visualization: JTK, JYP, HJL, YJC. Copyright 1996-2023 Cerner Multum, Inc. - Watch for edema, inflammation, and pain around the cannula during administration. Available for Android and iOS devices. Seoul: BIT Druginfo; 2020. Intravenous Infusion 113. Administration of oral diltiazem in patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission is contraindicated. @ w !1AQaq"2B #3Rbr 2783 0 obj <>/Filter/FlateDecode/ID[<6BD6636305F82045A9925B53BB86E57F><9F492AA58F605D44ADB81D4034C4D4D8>]/Index[2737 102]/Info 2736 0 R/Length 173/Prev 1462405/Root 2738 0 R/Size 2839/Type/XRef/W[1 3 1]>>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. information submitted for this request. injury. Management of extravasation includes nursing intervention and thermal application. 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. Phase IV trials are used to detect adverse drug outcomes and monitor drug effectiveness in the real world. 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. Diltiazem The recommended initial infusion rate of diltiazem hydrochloride injection is 10 mg/h. 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 elimination half-life of midazolam and triazolam also increased (1.5 to 2.5 fold) during coadministration with diltiazem. If response is inadequate, a second dose may be administered after 15 minutes. (5 mg/mL) Communication and trust between patients and nurses can be interfered due to extravasation. 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. The .gov means its official. 2.5-3.6 Extravasation: may cause tissue damage Do not flush Albumin 4.5% Infusion Normal blood volume: 1-2ml/min Hypovolaemia or shock: up to 1 L/hour Plasma exchange: up to 0000030660 00000 n Your doctor will adjust the dose and frequency of diltiazem to your needs. This medicine is available only with your doctor's prescription. Due to concern of potential extravasation and local tissue injury, central venous catheter (CVC) is the preferred route for vasopressor administration [].Despite this concern, vasopressors are administered via peripheral lines, often in resource . Packaged in a Carton of 10 NDC 55150-427-10 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). 1Department of Pharmacy, Kyung Hee University Hospital at Gangdong, Seoul, Korea, 2Department of Clinical Nursing, University of Ulsan, Seoul, Korea. Sodium hydroxide or hydrochloric acid is used for pH adjustment. Diltiazem (Oral Route) Your gift holds great power - donate today! Atrial Fibrillation or Atrial Flutter Intravenous Infusion Patients with severe hypotension or cardiogenic shock. Diltiazem hydrochloride is extensively metabolized by the liver and excreted by the kidneys and in bile. IV push over 10 minutes or IVPB as directed. Diltiazem slows the ventricular rate in patients with a rapid ventricular response during atrial fibrillation or atrial flutter. Therefore, the potential for acute hepatic injury exists following administration of intravenous diltiazem. The medical teams continuous education on extravasation is essential. Manchester: The Christie NHS Foundation Trust; 2014. Gently aspirate extravasated drug. Therefore, infusion duration exceeding 24 hours and infusion rates exceeding 15 mg/h are not recommended. No potential conflict of interest relevant to this article was reported. Most extravasations can be prevented with the systematic implementation of careful, standardized, and evidence-based administration techniques. Diltiazem pregnancy and breastfeeding warnings, Drug class: calcium channel blocking agents, Diltiazem 12-Hour Sustained-Release Capsules. 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. 0 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. Paroxysmal supraventricular tachycardia - Clinical studies of diltiazem hydrochloride injection for PSVT did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. These two medications are different than other calcium channel blockers because they have direct action on cardiac tissue at therapeutic levels. The phase IV clinical study analyzes which people take Cardizem and have Injection site extravasation. FOIA It should not be used in patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in Wolff-Parkinson-White (WPW) syndrome or short PR syndrome. The vial stopper is not made with natural rubber latex. 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. These pharmacokinetic effects seen during diltiazem coadministration can result in increased clinical effects (e.g. Your doctor may occasionally change your dose. Hot fomentations can dilate the veins and mitigate the symptoms. 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 The recommended application schedule for both warm and cold applications is 15 to 20 minutes, every 4 hours, for 24 to 48 hours. Drug Interactions MeSH Therapists will always feel nervous during the medical team-patient communication because of guilt. A 24-month study in rats at oral dosage levels of up to 100 mg/kg/day and a 21-month study in mice at oral dosage levels of up to 30 mg/kg/day showed no evidence of carcinogenicity. Metabolites N-monodesmethyldiltiazem, desacetyldiltiazem, desacetyl-N-monodesmethyldiltiazem, desacetyl-O-desmethyldiltiazem, and desacetyl-N, O-desmethyldiltiazem have been identified in human urine. The therapeutic benefits of diltiazem in supraventricular tachycardias are related to its ability to slow AV nodal conduction time and prolong AV nodal refractoriness. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. The following are common drugs that interact with diltiazem; Not all possible interactions are listed in this medication guide. Similar ventricular complexes have been noted during cardioversion, other pharmacologic therapy, and during spontaneous conversion of PSVT to sinus rhythm. In addition, caution should be used in patients taking other drugs that decrease peripheral resistance, intravascular volume, myocardial contractility or conduction. Make your tax-deductible gift and be a part of the cutting-edge research and care that's changing medicine. Swallow right away without chewing. 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%. Three solutions were used: 1/2 saline (154 mOsm), normal saline (308 mOsm), and 3% saline (1027 mOsm). As with other agents which slow AV nodal conduction and do not prolong the refractoriness of the accessory pathway (e.g., verapamil, digoxin), in rare instances patients in atrial fibrillation or atrial flutter associated with an accessory bypass tract may experience a potentially life-threatening increase in heart rate accompanied by hypotension when treated with diltiazem hydrochloride injection. Fixed high-degree AV block should be treated with cardiac pacing. Common Questions and Answers about Diltiazem extravasation.