Revised: April 2023, Rx only NDC 55150-425-01 Local thermal treatments are used to decrease the site reaction and absorption of the infiltrate. official website and that any information you provide is encrypted 7. Last updated on Apr 1, 2023. Hypotension - Decreases in blood pressure associated with diltiazem hydrochloride injection therapy may occasionally result in symptomatic hypotension (3.2%). Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. [cited 2020 Jul 10]. Diltiazem is not intended to convert atrial fib or flutter to NSR but to slow the heart rate down. Stopping suddenly may make your condition worse. Torralba TP, Li-Yu J, Navarra ST. When used concomitantly, anesthetics and calcium blockers should be titrated carefully. If there is no response to vagal blockade administer isoproterenol cautiously. Review/update the Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Intravenous diltiazem and intravenous beta-blockers should not be administered together or in close proximity (within a few hours). Common diltiazem side effects may include: This is not a complete list of side effects and others may occur. other information we have about you. High blood pressure may also increase the risk of heart attacks. Sterile eugia 10 x 25 mL Single-Dose Vials, Cardizem, Cartia XT, Dilt-XR, Cardizem CD, +6 more, amlodipine, lisinopril, aspirin, metoprolol, losartan, furosemide, carvedilol, hydrochlorothiazide, spironolactone, propranolol. If coadministration of simvastatin with diltiazem is required, limit the daily doses of simvastatin to 10 mg and diltiazem to 240 mg. 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. the unsubscribe link in the e-mail. Get your prescription refilled before you run out of medicine completely. National Library of Medicine Hudson (OH): Lexi-Comp Inc; 2000. The usual dose range of oral diltiazem for the treatment of hypertension is 180 to 360 mg daily. This guideline will enable health professions to manage the patients extravasation appropriately. General %&'()*456789:CDEFGHIJSTUVWXYZcdefghijstuvwxyz Verapamil belongs to the Phenylalkylamines class of calcium channel blockers and Diltiazem belongs to a class called the Benzothiazepines. Before Although drugs can be administered by methods (e.g., micro-patch, micro-injection) other than IV injection, extravasation cannot be totally avoided because there are drugs that can only be administered through IV or central vein injection. Manufactured by: Diltiazem hydrochloride is extensively metabolized by the liver and excreted by the kidneys and in bile. Swallow right away without chewing. We comply with the HONcode standard for trustworthy health information. 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. Federal government websites often end in .gov or .mil. (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 . 0000010832 00000 n The mean ejection fraction and cardiac output/index remained unchanged or increased. You may need to use blood pressure medicine for the rest of your life. } !1AQa"q2#BR$3br In vitro studies suggest alpha1-acid glycoprotein binds approximately 40% of the drug at clinically significant concentrations. Sterile 5 mL Single-Dose Vial, Rx only NDC 55150-425-10 In subacute and chronic dog and rat studies designed to produce toxicity, high oral doses of diltiazem were associated with hepatic damage. 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). Adverse events reported in controlled and uncontrolled clinical trials were generally mild and transient. 125 mg per 25 mL HCl Injection The second bolus dose of diltiazem hydrochloride injection should be 0.35 mg/kg actual body weight administered over 2 minutes (25 mg is a reasonable dose for the average patient). Disconnect the IV tubing but DO NOT remove the catheter or needle. HHS Vulnerability Disclosure, Help Experience in the use of antiarrhythmic agents following maintenance infusion of diltiazem hydrochloride injection is limited. Treatment suspension wastes time and other problems can occur due to delayed treatment. In dogs, oral doses of 20 mg/kg were also associated with hepatic changes; however, these changes were reversible with continued dosing. Swallow it whole. 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. 4. It has a molecular weight of 451.0. startxref 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. To provide you with the most relevant and helpful information, and understand which Diltiazem is excreted in human milk. In addition, the following events were reported infrequently (less than 1%): In severe cases, extravasation may cause tissue dysfunction or physical defects, resulting in a delay of attempted treatment, patients distrust, and numerous other issues. Continuous Intravenous Infusion Clinical studies of diltiazem did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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. Diltiazem is both a substrate and an inhibitor of the cytochrome P-450 3A4 enzyme system. Proceedings of the Infusion Nurses Society Annual Meeting; 1997 May; Salt Lake City, USA. This medicine is available only with your doctor's prescription. Maximal hemodynamic effects usually occurred within 2 to 5 minutes of an injection. Based on the results of pharmacokinetic studies in healthy volunteers administered different oral diltiazem hydrochloride formulations, constant rate intravenous infusions of diltiazem hydrochloride at 3, 5, 7, and 11 mg/h are predicted to produce steady-state plasma diltiazem concentrations equivalent to 120-, 180-, 240-, and 360-mg total daily oral doses of diltiazem hydrochloride tablets or diltiazem hydrochloride extended-release capsules. For Direct Intravenous Bolus Hadaway L. Extravasation: Issues and Controversies. It is soluble in water, methanol, and chloroform. Extravasation severity can range from benign lipid masses to florid skin necrosis. National Library of Medicine Unable to load your collection due to an error, Unable to load your delegates due to an error. 0.5 - 1 mL over 1 minute. The use of vasopressor medications is the mainstay in management of patients with distributive shock in intensive care unit (ICU). Visualization: JTK, JYP, HJL, YJC. Available from: [place unknown]: [publisher unknown]; 2018. Safety and effectiveness in pediatric patients have not been established. Diltiazem inhibits the influx of calcium (Ca2+) ions during membrane depolarization of cardiac and vascular smooth muscle. Carcinogenesis, Mutagenesis, Impairment of Fertility, Paroxysmal supraventricular tachycardia -, Direct Intravenous Single Injections (Bolus), Quantity of Diltiazem hydrochloride injection, Transition to Further Antiarrhythmic Therapy, diltiazem hydrochloride injection, solution. 3. 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. hbbd```b``= "ro) "5" `LBT80yLHf) 8, EA! Appendix A: Management of Extravasation: Chemotherapeutic and Non-chemotherapeutic Agents Figure 1: Workflow algorithm Stop infusion at first suspicion of extravasation. Diltiazem is a calcium channel blocker. - Veins on the back of the hand can be used, and in some cases, observation is easier. 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. Drugs which induce or inhibit hepatic microsomal enzymes may alter diltiazem disposition. 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. eugia, Rx only NDC 55150-427-10 Prompt interdisciplinary action is often necessary for the treatment of extravasation injuries. Use diltiazem cautiously in treatment of patients with concomitant LV systolic dysfunction because the negative inotropic effect can cause hypotension. 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 Some patients may respond to an initial dose of 0.15 mg/kg, although duration of action may be shorter. It has no effect on the sinus node recovery time or on the sinoatrial conduction time in patients without SA nodal dysfunction. IV infiltration is a common complication of intravenous (IV) therapy. For Direct Intravenous Bolus Injection and and transmitted securely. Manchester: The Christie NHS Foundation Trust; 2014. 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. I remember the case of the complication of extravasation in my patient in 1985 when I was an intern. Diltiazem hydrochloride injection is indicated for the following: 0000001178 00000 n Available for Android and iOS devices. 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). Drug classes: Calcium channel blocking agents, Group IV antiarrhythmics. 5. Disclaimer. An official website of the United States government. Discoloration and edema do not occur. Related/similar drugs 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 . Available from: [place unknown]: [publisher unknown]; 2018. Diltiazem may also be used for purposes not listed in this medication guide. Diltiazem may impair your thinking or reactions. The therapeutic benefits of diltiazem in supraventricular tachycardias are related to its ability to slow AV nodal conduction time and prolong AV nodal refractoriness. 0000029456 00000 n 6. Transition to other antiarrhythmic agents following administration of diltiazem hydrochloride injection is generally safe. 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. Ivabradine - Concurrent use of diltiazem increases exposure to ivabradine and may exacerbate bradycardia and conduction disturbances. They should regularly check the extravasation kit, assess patients sensory changes, tingling or burning, and always pay attention to patients words. Do not take extra medicine to make up the missed dose. The drug prevents the recurrence of life-threatening ventricular arrhythmias and. 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 0000008421 00000 n Risk factors can be classified under patient-related, procedure-related, and product or product-related factors. Inject phentolamine 0.5 mg/mL by subcutaneous or intradermal route using a 25 gauge needle in 5 aliquots of 0.2 mL each into the area of the extravasation; change the needle after each injection Give immediately but may be used up to 12 hours after the extravasation occurs Would you like email updates of new search results? - Assess patients sensory changes, tingling or burning, and always pay attention to the words of patients. Supplement 1. The vial stopper is not made with natural rubber latex. Data sources include IBM Watson Micromedex (updated 1 May 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Tell your doctor about all medicines you use, and those you start or stop using. 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. High blood pressure often has no symptoms. hbbd``b`f3J "-@ ?y "RD%qAaLL )' dJ Blood backflow works well, and edema or ulcer do not occur. In the same study, there was no significant change in 20 mg single dose pravastatin AUC and Cmax during diltiazem coadministration. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. As with all drugs, care should be exercised when treating patients with multiple medications (see PRECAUTIONS, General and Drug Interactions). (5 mg/mL) HCl Injection The staff involved in the infusion and management of cytotoxic drugs must be trained to implement several preventive protocols for the minimization of the risk of extravasation. Click here for an email preview. High blood pressure often has no symptoms. ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( ( |a^(/ -~,.[sL5 ;Z]^y~Mq7?7 e GE O G_oiV&! %Lp!8b(V7Yc2|5*qPp4wn"aLKa15N Herein, general knowledge about extravasation is first described, including its definition, incidence, risk factors, diagnosis, differential diagnosis, and extravasation injuries. %PDF-1.4 % The National Extravasation Information Service website [Internet] [cited 2020 Jul 10]. Medically reviewed by Kaci Durbin, MD. For the most part, blood does not backflow. HCl Injection 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. It is the brilliant info like a diamond that is useful for the training of the interns, nurses, and medical laboratory technicians who routinely work for the vascular injection. 0000019842 00000 n The toxic dose in man is not known. The average heart rate is reduced by 20%. 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. Photographic documentation can be helpful for follow-up procedures. The elimination half-life of midazolam and triazolam also increased (1.5 to 2.5 fold) during coadministration with diltiazem. Extravasation is a serious complication during patient care. 4. Unless otherwise contraindicated, appropriate vagal maneuvers should be attempted prior to administration of diltiazem hydrochloride injection. Federal government websites often end in .gov or .mil. Diltiazem can pass into breast milk and may harm a nursing baby. In patients with atrial fibrillation and atrial flutter, a significant correlation was observed between the percent reduction in HR and plasma diltiazem concentration using the Sigmoidal Emax model. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. 50 mg per 10 mL This content does not have an English version. 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). 2. 0000024987 00000 n Generic name: diltiazem [dil-TYE-a-zem] Pregnancy 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. 0000000956 00000 n 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. Destroy after 1 month at room temperature. Buspirone - In nine healthy subjects, diltiazem significantly increased the mean buspirone AUC 5.5 fold and Cmax 4.1 fold compared to placebo. Only 1 of the studies of diltiazem was in children. Photographic documentation of extravasation case. Take diltiazem exactly as prescribed by your doctor. Drug information handbook. The chemical structure is: Diltiazem hydrochloride, USP is a white crystalline powder with a bitter taste. 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. Diltiazem Carbamazepine - Concomitant administration of oral diltiazem with carbamazepine has been reported to result in elevated plasma levels of carbamazepine (by 40 to 72%), resulting in toxicity in some cases. Definition The IV infiltration can be defined as a complication of the intravenous therapy, with the administered medication infiltrating into the surrounding tissues. 0000002809 00000 n Following administration of one or two intravenous bolus doses of diltiazem hydrochloride injection, response usually occurs within 3 minutes and maximal heart rate reduction generally occurs in 2 to 7 minutes. 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 %. include protected health information. 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. 0 In a healthy volunteer cross-over study (N=10), coadministration of a single 20 mg dose of simvastatin at the end of a 14 day regimen with 120 mg BID diltiazem SR resulted in a 5-fold increase in mean simvastatin AUC versus simvastatin alone. endstream endobj 363 0 obj <>/Filter/FlateDecode/Index[10 322]/Length 34/Size 332/Type/XRef/W[1 1 1]>>stream
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