Diltiazem is a calcium channel blocker. 2838 0 obj <>stream 0000025152 00000 n Diltiazem hydrochloride injection is indicated for the following: Before 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. Available for Android and iOS devices. Diltiazem (Oral Route) Proper Use - Mayo Clinic The recommended application schedule for both warm and cold applications is 15 to 20 minutes, every 4 hours, for 24 to 48 hours. We comply with the HONcode standard for trustworthy health information. - 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). Symptomatic hypotension occurred in 3.2% of patients. National Center for Biotechnology Information Sterile 10 mL Single-Dose Vial, Rx only NDC 55150-426-10 Intravenous diltiazem and intravenous beta-blockers should not be administered together or in close proximity (within a few hours). Diltiazem may impair your thinking or reactions. To provide you with the most relevant and helpful information, and understand which In the perinatal/postnatal studies there was some reduction in early individual pup weights and survival rates. JFIF C C d[" 113. - Check for blood backflow before/during administration, and always rinse the catheter with a saline solution in between administrations. The prolongation of PR interval correlated significantly with plasma diltiazem concentration in normal volunteers using the Sigmoidal Emax model. 0000001363 00000 n Diltiazem - After the injection, make sure to run a saline solution through the catheter. If use of diltiazem hydrochloride is deemed essential, an alternative method of infant feeding should be instituted. If these agents are to be administered concurrently, cyclosporine concentrations should be monitored, especially when diltiazem therapy is initiated, adjusted or discontinued. 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%. 0000002809 00000 n Management of Extravasation Injuries: A Focused Evaluation of The infusion may be maintained for up to 24 hours. hbbd``b`f3J "-@ ?y "RD%qAaLL )' dJ Calcium gluconate has also been administered as a continuous infusion at a rate of 2 g per hour for 10 hours. After oral administration, diltiazem undergoes extensive metabolism in man by deacetylation, N-demethylation, and O-demethylation via cytochrome P-450 (oxidative metabolism) in addition to conjugation. 3. Transition to other antiarrhythmic agents following administration of diltiazem hydrochloride injection is generally safe. Regression of calcinosis associated with adult dermatomyositis following diltiazem therapy. 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. official website and that any information you provide is encrypted Diltiazem hydrochloride is extensively metabolized by the liver and excreted by the kidneys and in bile. Treatment suspension wastes time and other problems can occur due to delayed treatment. Diltiazem can pass into breast milk and may harm a nursing baby. In a limited number of studies of patients with compromised myocardium (severe congestive heart failure, acute myocardial infarction, hypertrophic cardiomyopathy), administration of intravenous diltiazem produced no significant effect on contractility, left ventricular end diastolic pressure, or pulmonary capillary wedge pressure. 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. You may report side effects to FDA at 1-800-FDA-1088. Infusions of calcium for 24 hours or more may be required. 0000030429 00000 n Avoid concomitant use of ivabradine and diltiazem. Other: Amblyopia, asthenia, dry mouth, dyspnea, edema, headache, hyperuricemia The site is secure. DO NOT apply pressure to the area 6. Heart rate reduction may last from 1 to 3 hours. PDF Memorial Medical Center Intravenous Medication Use Guidelines An extremely severe case of cutaneous calcinosis with juvenile dermatomyositis, and successful treatment with diltiazem. High-degree AV Block: Treat as for bradycardia above. In some cases intravenous calcium has been administered (1 g calcium chloride or 3 g calcium gluconate) over 5 minutes, and repeated every 10 to 20 minutes as necessary. Appendix A: Management of Extravasation: Chemotherapeutic and Non-chemotherapeutic Agents Figure 1: Workflow algorithm Stop infusion at first suspicion of extravasation. Rifampin - Coadministration of rifampin with diltiazem lowered the diltiazem plasma concentrations to undetectable levels. Upon discontinuation of infusion, heart rate reduction may last from 0.5 hours to more than 10 hours (median duration 7 hours). 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%. Mechanisms of Action Diltiazem Uses, Dosage & Side Effects - Drugs.com General Do not save the mixture for later use. Injectable forms of diltiazem are contraindicated in: 1. Adverse events reported in controlled and uncontrolled clinical trials were generally mild and transient. This medicine is available only with your doctor's prescription. Pain, tightening, and skin discoloration tend to worsen. Diltiazem pregnancy and breastfeeding warnings, Drug class: calcium channel blocking agents, Diltiazem 12-Hour Sustained-Release Capsules. LD = 0.25 mg/kg over 2 min. Diltiazem is used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders. Manufactured by: The plasma elimination half-life is approximately 3.4 hours. (5 mg/mL) It will be our pleasure if these guidelines are used in the training of health professionals to promote patients safety. 2. Diltiazem: 7 things you should know - Drugs.com IV Push IVPB IVPB IVPB EXTRAVASATION PRECAUTION - May be Harmful. PDF Diltiazem (Cardizem) - Advocate Health 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. Limited data suggest that plasmapheresis or charcoal hemoperfusion may hasten diltiazem elimination following overdose. Patients must be informed to report any changes in sensation, signs, or symptoms during the IV administration of any chemotherapeutic drug and to alert the healthcare professionals to early signs of extravasation. With the practical use of these guidelines, it is expected to reduce the occurrence rate of extravasation and contribute to patient care improvement. endstream endobj 333 0 obj <. the unsubscribe link in the e-mail. Clonidine - Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concurrently with diltiazem. Although not observed in clinical trials with diltiazem hydrochloride injection, the following events associated with oral diltiazem may occur: Proceedings of the Infusion Nurses Society Annual Meeting; 1997 May; Salt Lake City, USA. prolonged sedation) of both midazolam and triazolam. The patient must be informed of the scope of the problem (Supplement 5). Common signs include inflammation, tightness of the skin, and pain around the IV site. Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4-(5H)-one,3-(Acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(-4-methoxyphenyl)-, monohydrochloride, (+)-cis-. Atrial Fibrillation or Atrial Flutter Revised: April 2023, Rx only NDC 55150-425-01 Vesicants are inherently toxic and can cause pain, inflammation, and burn-like injury including blistering, sloughing, deep tissue damage, and necrosis. Available from: [place unknown]: [publisher unknown]; 2018. The phase IV clinical study is created by eHealthMe based on reports from the FDA, and is updated regularly. 0000030204 00000 n However, if you have symptoms of low blood pressure (dizziness, fainting, weakness, or blurred vision), call your doctor and stop taking diltiazem. The .gov means its official. 0000001178 00000 n Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. In severe cases, extravasation may cause tissue dysfunction or physical defects, resulting in a delay of attempted treatment, patients distrust, and numerous other issues. 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. PDF Extravasation Management Reference Sheet - NACNS diltiazem extravasation - MedHelp 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. 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. An official website of the United States government. All rights reserved. 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 . The therapeutic benefits of diltiazem in supraventricular tachycardias are related to its ability to slow AV nodal conduction time and prolong AV nodal refractoriness. 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. Unable to load your collection due to an error, Unable to load your delegates due to an error. E. Windsor, NJ 08520 Keep diluted diltiazem hydrochloride injection refrigerated until use. Eugia Pharma Specialities Limited Intravenous Infusion health information, we will treat all of that information as protected health 0000008421 00000 n The primary outcome was the change in SBP 60 min (+/- 30 min) after initial IV diltiazem administration. Topical nitroglycerin for management of peripheral extravasation of 0000029248 00000 n 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. 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. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. It works by relaxing the muscles of your heart and blood vessels. Diltiazem 0000015118 00000 n 0.5 - 1 mL over 1 minute. Dermatologic: Pruritus, sweating For prevention of extravasation, health professionals should be familiar with the extravasation management standard guidelines. Local cooling (ice packs) aids in vasoconstriction, theoretically limiting the drug dispersion. Local thermal treatments are used to decrease the site reaction and absorption of the infiltrate. Particular information must be given when a vesicant drug is administered. Most extravasations can be prevented with the systematic implementation of careful, standardized, and evidence-based administration techniques. In the event of overdosage or an exaggerated response, appropriate supportive measures should be employed. However, no guidelines can be perfect, and they need to be regularly updated. Supplement 6. Journal of Educational Evaluation for Health Professions, http://creativecommons.org/licenses/by/4.0/, https://www.nwcscnsenate.uk/files/8114/7334/9859/Final_Extravasation_Policy_V5.0_June_18.pdf, http://www.uic.edu/pharmacy/centers/drug_information_center/faq/extravasation.php, https://manchestercancer.files.wordpress.com/2014/09/extravasation_sept20131.pdf, Tissue loss exposing muscle/bone with a deep crater or necrosis. Diltiazem Injection Prescribing Information. HCl Injection The therapeutic benefits of diltiazem in supraventricular tachycardias are related to its ability to slow AV nodal conduction time and prolong AV nodal refractoriness. Cardizem and Infusion site extravasation - eHealthMe and transmitted securely. Hyderabad 500032 512 0 obj <> endobj Copyright: Merative US L.P. 1973, 2023. 0000019842 00000 n 0000001883 00000 n 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). and transmitted securely. Data curation: JTK, JYP, HJL, YJC. Available from: De Wit M, Ortner P, Lipp HP, Sehouli J, Untch M, Ruhnke M, Mayer-Steinacker R, Bokemeyer C, Jordan K. Management of cytotoxic extravasation: ASORS expert opinion for diagnosis, prevention and treatment. Follow all directions on your prescription label. Unless otherwise contraindicated, appropriate vagal maneuvers should be attempted prior to administration of diltiazem hydrochloride 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. Dermatologic events progressing to erythema multiforme and/or exfoliative dermatitis have been infrequently reported following oral diltiazem. Subjects with increased average steady-state exposures of diltiazem showed a greater fold increase in simvastatin exposure. 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. National Library of Medicine 50 mg per 10 mL (5 mg/mL) The best therapeutic agent for treatment of vasopressor extravasation is intradermal . Diltia XT, Dilt-XR, Diltzac, Matzim LA, Taztia XT, Tiadylt ER, Tiazac The National Extravasation Information Service website [Internet] [cited 2020 Jul 10]. 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. Data files are available from Harvard Dataverse: https://doi.org/10.7910/DVN/NUWZML. For prevention of extravasation, health professionals should be familiar with the extravasation management standard guidelines. tiazac. Management of Extravasation Injuries: A Focused Evaluation of information submitted for this request. 8600 Rockville Pike Last updated on Mar 22, 2023. Cardiac Conduction - Diltiazem prolongs AV nodal conduction and refractoriness that may rarely result in second- or third-degree AV block in sinus rhythm. Do NOT flush the line with normal saline or dextrose 332 0 obj <> endobj What are current recommendations for treatment of drug extravasation Diltiazem may also be used for purposes not listed in this medication guide. PDF Extravasation/Infiltration Management Chart - Johns Hopkins University Store diltiazem at room temperature away from moisture and heat. Congestive Heart Failure - Although diltiazem has a negative inotropic effect in isolated animal tissue preparations, hemodynamic studies in humans with normal ventricular function and in patients with a compromised myocardium, such as severe CHF, acute MI, and hypertrophic cardiomyopathy, have not shown a reduction in cardiac index nor consistent negative effects on contractility (dp/dt). 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. 113. These metabolites are observed, however, following 24 hour constant rate intravenous infusion. Experience in the use of antiarrhythmic agents following maintenance infusion of diltiazem hydrochloride injection is limited. Common symptoms and signs of extravasation include pain, stinging or burning sensations, and edema around the intravenous (IV) injection site. For Direct Intravenous Bolus Injection and Use diltiazem regularly to get the most benefit. Hudson (OH): Lexi-Comp Inc; 2000. Available from: Le A, Patel S. Extravasation of noncytotoxic drugs: a review of the literature. Review/update the Antidotes; Extravasation; Intravenous injections; Patient care; Risk factors. - It causes contraction of blood vessels, minimizing the spread of drugs to other tissues and reducing topical infections and pain. Avoid drinking alcohol while taking diltiazem. Please enable it to take advantage of the complete set of features! Direct Intravenous Single Injections (Bolus) - Be familiar with the extravasation management standard guidelines and prepare the extravasation kit. Pregnancy Patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker. 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. Your doctor will adjust the dose and frequency of diltiazem to your needs. endstream endobj startxref Diltiazem hydrochloride injection is clear, colorless, sterile, nonpyrogenic solution and is supplied as follows: Calcium channel blockers - Mayo Clinic Conceptualization: JTK, JYP, HJL, YJC. %&'()*456789:CDEFGHIJSTUVWXYZcdefghijstuvwxyz Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Prompt interdisciplinary action is often necessary for the treatment of extravasation injuries. Diltiazem is a calcium channel blocker. Distributed by: Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 0000010698 00000 n The usual dose range of oral diltiazem for the treatment of hypertension is 180 to 360 mg daily. The risk of toxic reactions to this drug may be greater in patients with impaired renal or hepatic function. The primary purpose of these guidelines is to minimize the side-effects of IV injection, by suggesting proper and prompt emergency measures for extravasation and the appropriate treatments corresponding to the properties of the injected drug. The use of diltiazem hydrochloride injection should be undertaken with caution when the patient is compromised hemodynamically or is taking other drugs that decrease any or all of the following: peripheral resistance, myocardial filling, myocardial contractility, or electrical impulse propagation in the myocardium. Diltiazem may also be used for purposes not listed in this medication guide. BIT Druginfo website [Internet] [cited 2020 Jul 10]. There are no well-controlled studies in pregnant women; therefore, use diltiazem hydrochloride in pregnant women only if the potential benefit justifies the potential risk to the fetus. The sample was 18 healthy adults between 20 and 45 years. Occurs due to contraction of the vessel wall and usually happens as soon as the fluid injection begins. Careers, Unable to load your collection due to an error. An incident of extravasation must be correctly documented and reported. High blood pressure adds to the workload of the heart and arteries. HCl Injection An official website of the United States government. 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. For continued reduction of the heart rate (up to 24 hours) in patients with atrial fibrillation or atrial flutter, an intravenous infusion of diltiazem hydrochloride injection may be administered. - 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. Diltiazem is both a substrate and an inhibitor of the cytochrome P-450 3A4 enzyme system. Cardiac Failure: Administer inotropic agents (isoproterenol, dopamine, or dobutamine) and diuretics. Visualization: JTK, JYP, HJL, YJC. 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). Unauthorized use of these marks is strictly prohibited. endstream endobj 363 0 obj <>/Filter/FlateDecode/Index[10 322]/Length 34/Size 332/Type/XRef/W[1 1 1]>>stream Monitoring for quinidine adverse effects may be warranted and the dose adjusted accordingly. Tell your doctor if you are pregnant or plan to become pregnant. In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Diltiazem (Oral Route) Your gift holds great power - donate today! hbbbd`b``3 Buspirone - In nine healthy subjects, diltiazem significantly increased the mean buspirone AUC 5.5 fold and Cmax 4.1 fold compared to placebo. Vesicant extravasation:Leakage of a drug that causes pain, necrosis, or tissue sloughing. 0000003528 00000 n 0000006222 00000 n The https:// ensures that you are connecting to the 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. 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. Elevation of the limb may aid in reabsorption of the infiltrate or extravasated vesicant by decreasing capillary hydrostatic pressure. Cardizem and Injection site extravasation - a phase IV clinical study We comply with the HONcode standard for trustworthy health information. Only 1 of the studies of diltiazem was in children. Rheumatology (Oxford) 2000; 39:333. 3. They are used to treat a broad array of clinical conditions, including hypertension, supraventricular tachycardia, vasospasm, and migraine headaches. 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.
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