These guidelines consist of following topics: basic knowledge about extravasation, extravasation management, and extravasation prevention. Injection site extravasation is found among people who take Cardizem, especially for people who are female, 60+ old, have been taking the drug for < 1 month. - 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). Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. 25 mL Single-Dose Vials Manufactured by: PMC Bradycardia: Administer atropine (0.6 to 1.0 mg). Carcinogenesis, Mutagenesis, Impairment of Fertility information submitted for this request. Related/similar drugs Pharmacologic interventions for extravasation Geriatric Use These pharmacokinetic effects seen during diltiazem coadministration can result in increased clinical effects (e.g. - Assess patients sensory changes, tingling or burning, and always pay attention to the words of patients. Methods: This was a multicenter, retrospective cohort study that evaluated adults admitted to the ED with documented AF or AFL, heart rate (HR) > 120 bpm, SBP 90 to 140 mmHg, and received treatment with IV diltiazem for rate control. If high-degree AV block occurs in sinus rhythm, intravenous diltiazem should be discontinued and appropriate supportive measures instituted (see OVERDOSAGE). 0000003340 00000 n
If you are being treated for high blood pressure, keep using this medicine even if you feel well. The elimination half-life of midazolam and triazolam also increased (1.5 to 2.5 fold) during coadministration with diltiazem. The effectiveness of intravenous calcium administration to reverse the pharmacological effects of diltiazem overdose has been inconsistent. Medically reviewed by Drugs.com. India 0000010698 00000 n
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Disconnect the IV tubing but DO NOT remove the catheter or needle. However, the study had only a small number of This medicine is available only with your doctor's prescription. - Directions: apply cold fomentations for 15 to 20 minutes four to 6 times per day (for 1 day or more). Spots or solid lines with blisters can be suddenly felt along the vessels injected with drugs. Discuss the use of grapefruit products with your doctor. include protected health information. Bethesda, MD 20894, Web Policies Br J Dermatol 2001; 144:894. hbbd```b``=
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"5" `LBT80yLHf) 8, EA! Diltiazem is in a class of medications called calcium-channel blockers. Photographic documentation can be helpful for follow-up procedures. In the same study, there was no significant change in 20 mg single dose pravastatin AUC and Cmax during diltiazem coadministration. These antiarrhythmic agents were intravenous or oral digoxin, Class 1 antiarrhythmics (e.g., quinidine, procainamide), calcium channel blockers, and oral beta-blockers. Before taking diltiazem, tell your doctor if you have kidney disease, liver disease, or congestive heart failure. endstream
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The National Extravasation Information Service website [Internet] [cited 2020 Jul 10]. Generic name: diltiazem [dil-TYE-a-zem] 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). If coadministration of simvastatin with diltiazem is required, limit the daily doses of simvastatin to 10 mg and diltiazem to 240 mg. If there is no response to vagal blockade administer isoproterenol cautiously. Diltiazem hydrochloride injection is for direct intravenous bolus injection and continuous intravenous infusion. health information, we will treat all of that information as protected health The patient must be informed of the scope of the problem (Supplement 5). If possible, it is recommended that diltiazem hydrochloride injection not be co-infused in the same intravenous line. government site. [cited 2020 Jul 10]. information highlighted below and resubmit the form. 0000001363 00000 n
Diltiazem Acute Hepatic Injury - In rare instances, significant elevations in enzymes such as alkaline phosphatase, LDH, SGOT, SGPT, and other phenomena consistent with acute hepatic injury have been noted following oral diltiazem. Mechanisms of Action Patients with low body weights should be dosed on a mg/kg basis. 0000002809 00000 n
5. Clonidine - Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concurrently with diltiazem. The guidelines described herein are based on the authors best practice for the management and prevention of the extravasation. For Direct Intravenous Bolus Injection and 125-mg, 25-mL vialeach sterile vial contains 125 mg diltiazem hydrochloride, 18.75 mg citric acid USP, 16.25 mg sodium citrate dihydrate USP, 1,785 mg sorbitol solution USP, and water for injection USP up to 25 mL. Adverse events reported in controlled and uncontrolled clinical trials were generally mild and transient. Diltiazem is used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders. Supplement 3. 0.5 - 1 mL over 1 minute. Following oral administration, 2% to 4% of the unchanged diltiazem appears in the urine. 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. xref
In terms of cancer therapy, extravasation refers to the inadvertent infiltration of chemotherapeutic drugs in the tissues surrounding the IV site. eugia, Rx only NDC 55150-427-10 A defibrillator and emergency equipment should be readily available. 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. In subacute and chronic dog and rat studies designed to produce toxicity, high oral doses of diltiazem were associated with hepatic damage. Diltiazem (Oral Route) Your gift holds great power - donate today! 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. Seoul: BIT Druginfo; 2020. Digitalis - Intravenous diltiazem has been administered to patients receiving either intravenous or oral digitalis therapy. You may report side effects to FDA at 1-800-FDA-1088. 0000030705 00000 n
Calcium Cows Channel Blocked (V-rapper & Dill-tazer) Picmonic. The chemical structure is: Diltiazem hydrochloride, USP is a white crystalline powder with a bitter taste. Your doctor may occasionally change your dose. Liver cirrhosis was shown to reduce diltiazem's apparent oral clearance and prolong its half-life. Apply compresses for 20 to 60 minutes 3 or 4 times daily for the first 24 to 72 hours after extravasation occurs. The following measures may be considered: The use of local warming is recommended for the extravasation of nonDNA-binding vesicants. In the perinatal/postnatal studies there was some reduction in early individual pup weights and survival rates. Diltiazem Injection Prescribing Information. Pain, edema, and ulcer do not appear, and symptoms disappear within 30 to 90 minutes. Most extravasations can be prevented with the systematic implementation of careful, standardized, and evidence-based administration techniques. The heart rate reduction may last from 1 - 3 hours. Packaged in a Carton of 10 NDC 55150-425-10 Swallow right away without chewing. 4 Hyaluronidase has been successfully used in the treatment of TPN extravasations. Other: Amblyopia, asthenia, dry mouth, dyspnea, edema, headache, hyperuricemia 2737 0 obj
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privacy practices. hb```l - Dilute stimulant drugs as much as possible and inject them at a proper rate. All rights reserved. It is not known whether diltiazem will harm an unborn baby. 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. Antidotes for the care of the extravasation. Last updated on Apr 1, 2023. Intravenous diltiazem and intravenous beta-blockers should not be administered together or in close proximity (within a few hours). Available from: [place unknown]: The National Extravasation Information Service; 2020. 8600 Rockville Pike Once familiarity of the patient's response is established, use in an office setting may be acceptable. Diltiazem may also be used for purposes not listed in this medication guide. 512 0 obj
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The apparent volume of distribution remains unchanged (360 to 391 L). Available for Android and iOS devices. Knowledge of the mechanism of extravasation-induced tissue injury, agents for reversal, and appropriate nonpharmacologic treatment methods is essential. Portions of this document last updated: April 01, 2023. Occurs due to contraction of the vessel wall and usually happens as soon as the fluid injection begins. Do not crush, chew, break, or open an extended-release diltiazem tablet or capsule. The audio recording of the abstract. These metabolites are observed, however, following 24 hour constant rate intravenous infusion. For the most part, blood does not backflow. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The mean ejection fraction and cardiac output/index remained unchanged or increased. Generic name: diltiazem hydrochloride IV Push IV infusion . Calcium channel blockers (CCBs) are among the most commonly used cardiovascular drugs in the adult population. The T1/2 and Tmax of buspirone were not significantly affected by diltiazem. 6. The .gov means its official. 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 . Accessibility Policy for the management of extravasation of intravenous drugs [Internet] [cited 2020 Jul 10]. 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. %PDF-1.5
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Safety and effectiveness in pediatric patients have not been established. Cardizem, Cartia XT, Dilt-XR, Cardizem CD, +7 more. Drugs with high osmolarity. - Watch for edema, inflammation, and pain around the cannula during administration. %%EOF
In special subacute hepatic studies, oral doses of 125 mg/kg and higher in rats were associated with histological changes in the liver, which were reversible when the drug was discontinued. Avoid drinking alcohol while taking diltiazem. 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. (5 mg/mL) In vitro studies suggest alpha1-acid glycoprotein binds approximately 40% of the drug at clinically significant concentrations. 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 Donate. Supplement 1. * Irritant drugs can cause local pain and inflammation but rarely cause tissue destruction. Prompt interdisciplinary action is often necessary for the treatment of extravasation injuries. Drug information provided by: Merative, Micromedex. Administration of oral diltiazem in patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission is contraindicated. endstream
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<. 42 . Delayed extravasation:Symptoms occur 48 hours, or later, after drug administration. 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. Avoid taking herbal supplements containing St. John's wort at the same time you are taking diltiazem. Sterile 5 mL Single-Dose Vial, Rx only NDC 55150-425-10 8th ed. You'll soon start receiving the latest Mayo Clinic health information you requested in your inbox. Atrial fibrillation or atrial flutter - In clinical studies with diltiazem hydrochloride injection for AF/FI, 135 of 257 patients were 65 years of age. Continuous Intravenous Infusion Blood backflow works well, and edema or ulcer do not occur. An adjustment in the diltiazem dose may be warranted. In dogs, oral doses of 20 mg/kg were also associated with hepatic changes; however, these changes were reversible with continued dosing. JFIF C C d[" Data sources include IBM Watson Micromedex (updated 1 May 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Data sources include IBM Watson Micromedex (updated 1 May 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. 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. Unauthorized use of these marks is strictly prohibited. Common symptoms and signs of extravasation include pain, stinging or burning sensations, and edema around the intravenous (IV) injection site. Experience in the use of antiarrhythmic agents following maintenance infusion of diltiazem hydrochloride injection is limited. Many drugs can interact with diltiazem, and your doctor may need to change your treatment plan if you use certain other medicines. This includes AV nodal reentrant tachycardias and reciprocating tachycardias associated with an extranodal accessory pathway such as the WPW syndrome or short PR syndrome. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Diltiazem extravasation. An incident of extravasation must be correctly documented and reported. 0000012749 00000 n
The .gov means its official. You should not stop using diltiazem suddenly. Conceptualization: JTK, JYP, HJL, YJC. Diltiazem hydrochloride injection is clear, colorless, sterile, nonpyrogenic solution and is supplied as follows: Descriptions. Amiodarone is a potent antiarrhythmic agent that is used to treat ventricular arrhythmias and atrial fibrillation. Diltiazem does not appear to be removed by peritoneal or hemodialysis. The effect may be mediated by cimetidine's known inhibition of hepatic cytochrome P-450, the enzyme system responsible for the first-pass metabolism of diltiazem. 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. prolonged sedation) of both midazolam and triazolam. 125 mg per 25 mL (5 mg/mL) High blood pressure may also increase the risk of heart attacks. 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. Drug information handbook for oncology: a complete guide to combination chemotherapy regimens. 2. - Veins on the back of the hand can be used, and in some cases, observation is easier. This content does not have an English version. 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. 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. Gastrointestinal: Constipation, elevated SGOT or alkaline phosphatase, nausea, vomiting %%EOF
Hypotension: Vasopressors (e.g., dopamine or norepinephrine). 7. 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. But it must be done carefully because this area can suffer a more severe injury due to extravasation. Some patients may maintain response to an initial rate of 5 mg/h. Chicago (IL): University of Illinois College of Pharmac; c2020. 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. 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. Follow your diet, medication, and exercise routines very closely. Diltiazem hydrochloride is extensively metabolized by the liver and excreted by the kidneys and in bile. Subsequent intravenous bolus doses should be individualized for each patient. High-degree AV Block: Treat as for bradycardia above. w !1AQaq"2B #3Rbr 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. other information we have about you. 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. Store diltiazem at room temperature away from moisture and heat. Upon discontinuation of infusion, heart rate reduction may last from 0.5 hours to more than 10 hours (median duration 7 hours). HCl Injection 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. 0000015118 00000 n
Diltiazem (Cardizem ) IV Push IV infusion . 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. 0000019842 00000 n
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. HHS Vulnerability Disclosure, Help The https:// ensures that you are connecting to the The dose may be increased slowly over time until treatment goals are achieved. Buspirone - In nine healthy subjects, diltiazem significantly increased the mean buspirone AUC 5.5 fold and Cmax 4.1 fold compared to placebo. Beta-blockers - Intravenous diltiazem has been administered to patients on chronic oral beta-blocker therapy. The phase IV clinical study is created by eHealthMe based on reports from the FDA, and is updated regularly. 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. The primary outcome was the change in SBP 60 min (+/- 30 min) after initial IV diltiazem administration. Give a list of all your medicines to any healthcare provider who treats you. Local cooling (ice packs) aids in vasoconstriction, theoretically limiting the drug dispersion. Tips Extended-release diltiazem capsules should be taken on an empty stomach (this means one hour before food or two hours after food). show all 12 brands As with all drugs, care should be exercised when treating patients with multiple medications. Stopping suddenly may make your condition worse. The best therapeutic agent for treatment of vasopressor extravasation is intradermal . 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. and transmitted securely. 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. However, no guidelines can be perfect, and they need to be regularly updated. The recommended initial infusion rate of diltiazem hydrochloride injection is 10 mg/h. 0000030429 00000 n
The site is secure. (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 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. 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. R7:@Io;X(^0)&c3EA$w
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Cardiovascular: AV block (third degree), bundle branch block, ECG abnormality, palpitations, syncope, tachycardia, ventricular extrasystoles Worldwide experience in over 1,300 patients was similar. Medically reviewed by Kaci Durbin, MD. Although clear benefit has not been demonstrated with thermal applications, it remains a standard supportive care. Cold application is recommended for extravasation of DNA-binding vesicants except for mechlorethamine (nitrogen mustard), contrast media, and hyperosmolar fluids. For Direct Intravenous Bolus It has a molecular weight of 451.0. Proceedings of the Infusion Nurses Society Annual Meeting; 1997 May; Salt Lake City, USA. Single-dose vials. The effect of cyclosporine on diltiazem plasma concentrations has not been evaluated. The first method may be appropriate following extravasation of vesicant drugs and involves administration of an antidote (if available) and the application of cold compresses 3-4 . Patients who have demonstrated hypersensitivity to the drug. Asymptomatic hypotension occurred in 4.3% of patients. We comply with the HONcode standard for trustworthy health information. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. Subjects with increased average steady-state exposures of diltiazem showed a greater fold increase in simvastatin exposure. IV Push IV infusion . You may also need frequent blood tests. Do not stop taking this medication without first talking to your doctor. Local cooling (ice packs) aids in vasoconstriction, theoretically limiting the drug dispersion. Received 2020 Jul 16; Accepted 2020 Jul 16. Therefore, the potential for acute hepatic injury exists following administration of intravenous diltiazem. The drug prevents the recurrence of life-threatening ventricular arrhythmias and. They should regularly check the extravasation kit, assess patients sensory changes, tingling or burning, and always pay attention to patients words. Careers, Unable to load your collection due to an error. HHS Vulnerability Disclosure, Help - Edema around the port insertion or in the chest, or medication leakage around the catheter insertion, - Redness in the chest, collarbone, or neck where a central venous catheter is inserted. Torralba TP, Li-Yu J, Navarra ST. Extravasation may occur if the administration of the drug is too quick, the medication is very acidic or basic, or there is an obstruction in the . injury. Hypotension - Decreases in blood pressure associated with diltiazem hydrochloride injection therapy may occasionally result in symptomatic hypotension (3.2%). Make your tax-deductible gift and be a part of the cutting-edge research and care that's changing medicine. Available from: University of Illinois College of Pharmacy . Hadaway L. Extravasation: Issues and Controversies. However, reference should be made to the respective agent manufacturer's package insert for information relative to dosage and administration. Cimetidine - A study in six healthy volunteers has shown a significant increase in peak diltiazem plasma levels (58%) and area-under-the-curve (53%) after a 1-week course of cimetidine at 1,200 mg per day and a single dose of diltiazem 60 mg. Ranitidine produced smaller, nonsignificant increases. 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. . (5 mg/mL) You may opt-out of email communications at any time by clicking on
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