Prior to thrombus aspiration, a thrombus aspiration catheter was used to perform diltiazem injection at the distal end of the infarct-related artery (IRA). The information presented is current as of January 13, 2021. 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. However, since both drugs affect AV nodal conduction, patients should be monitored for excessive slowing of the heart rate and/or AV block. Reproduction studies have been conducted in mice, rats, and rabbits. You should not breastfeed while using this medicine. Patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker. 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. If it continues for a long time, the heart and arteries may not function properly. If you are being treated for high blood pressure, keep using this medicine even if you feel well. Tips. 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. Methods: Review of the CAF contained in a prospectively collected database of anal fissures including one hundred forty-five patients diagnosed with CAF and treated with standard . 0000025152 00000 n The alternative is to use topical nifedipine or oral diltiazem. The following adverse reaction rates are based on the use of diltiazem hydrochloride injection in over 400 domestic clinical trial patients with atrial fibrillation/flutter or PSVT under double-blind or open-label conditions. 9 Physician's order should be obtained to initiate warm or cold therapy when suspect extravasation is greater than 24 hours old. In addition, the following events were reported infrequently (less than 1%): eHealthMe is studying from 27,064 Cardizem users for its effectiveness, alternative drugs and more. Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium channel antagonist). Continuous Intravenous Infusion This study shows that topical 2% diltiazem is an effective and safe treatment for chronic anal fissure in patients who have failed topical 0.2% GTN. Other: acute generalized exanthematous pustulosis, allergic reactions, angioedema (including facial or periorbital edema), CPK elevation, epistaxis, eye irritation, gingival hyperplasia, hemolytic anemia, hyperglycemia, impotence, increased bleeding time, leukopenia, muscle cramps, myopathy, nasal congestion, nocturia, osteoarticular pain, photosensitivity (including lichenoid keratosis and hyperpigmentation at sun-exposed skin areas), polyuria, retinopathy, sexual difficulties, thrombocytopenia, tinnitus. Read More Other drugs that have the same active ingredients (e.g. 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. Temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter. Diltiazem is an oral and parenteral non-dihydropyridine calcium channel blocker. These metabolites are observed, however, following 24 hour constant rate intravenous infusion. and how much would it bring it down. It is based on diltiazem hydrochloride (the active ingredients of Cardizem) and Cardizem (the brand name). Your blood pressure will need to be checked often. Use within 24 hours. itching. You can use the study as a second opinion to make health care decisions. Document infiltration and report to ED RN ASAP for antidote 0000006222 00000 n We chose the acute ST-elevation. Hypotension: Vasopressors (e.g., dopamine or norepinephrine). In vitro, propranolol appears to be displaced from its binding sites by diltiazem. Diltiazem The use of the eHealthMe site and its content is at your own risk. When used concomitantly, anesthetics and calcium blockers should be titrated carefully. Diltiazem shows dose-dependent, non-linear pharmacokinetics. Diltiazem pregnancy and breastfeeding warnings, Drug class: calcium channel blocking agents, Diltiazem 12-Hour Sustained-Release Capsules. Package insert / product label Tell your doctor about all medicines you use, and those you start or stop using. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Reduction in mean arterial pressure correlated linearly with diltiazem plasma concentration in a group of hypertensive patients. WARNING: Please DO NOT STOP MEDICATIONS without first consulting a physician since doing so could be hazardous to your health. Buter J, Steele KT, Chung KC, Elzinga K. Extravasation injury from chemotherapy and other non-antineoplastic vesicants. Other prescription and over-the-counter medicines, vitamins, and herbal products may interact with diltiazem. Metabolites N-monodesmethyldiltiazem, desacetyldiltiazem, desacetyl-N-monodesmethyldiltiazem, desacetyl-O-desmethyldiltiazem, and desacetyl-N, O-desmethyldiltiazem have been identified in human urine. In vitro studies suggest alpha1-acid glycoprotein binds approximately 40% of the drug at clinically significant concentrations. 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. Packaged in a Carton of 10 NDC 55150-425-10 Dexrazoxane . This includes AV nodal reentrant tachycardias and reciprocating tachycardias associated with an extranodal accessory pathway such as the WPW syndrome or short PR syndrome. HCl Injection The initial dose of diltiazem hydrochloride injection should be 0.25 mg/kg actual body weight as a bolus administered over 2 minutes (20 mg is a reasonable dose for the average patient). Copyright 1996-2023 Cerner Multum, Inc. 0000008421 00000 n You should not use diltiazem if you have very low blood pressure, a serious heart condition such as "sick sinus syndrome" or "second- or third-degree AV block" (unless you have a pacemaker), or if you have recently had a heart attack and you have a build-up of fluid in your lungs. Overdose symptoms may include slow heartbeat, weakness, chest pain, shortness of breath, or fainting. 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. Do not freeze. To minimize the risk of dislodging the catheter, veins in the hands The combination of the two drugs was well tolerated without serious adverse effects. Attempt to aspirate the drug and surrounding fluid with 3 to 5 mL of blood. Paroxysmal Supraventricular Tachycardia Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician. 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%. These antiarrhythmic agents were intravenous or oral digoxin, Class 1 antiarrhythmics (e.g., quinidine, procainamide), calcium channel blockers, and oral beta-blockers. Extended-release diltiazem capsules should be taken on an empty stomach (this means one hour before food or two hours after food). This article summarizes the latest recommendations for treatment of extravasation, and updates a similar article prepared by our group in 2015. Gorski LA, Hadaway L, Hagle ME, et al. If you are being treated for high blood pressure, keep using this medicine even if you feel well. The prolongation of PR interval correlated significantly with plasma diltiazem concentration in normal volunteers using the Sigmoidal Emax model. unpredictable hypotension in some patients. For Direct Intravenous Bolus Injection and Remove the peripheral IV device or port needle. Diltia XT, Dilt-XR, Diltzac, Matzim LA, Taztia XT, Tiadylt ER, Tiazac Diltiazem is used to prevent chest pain ( angina ). 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. An overdose of diltiazem can be fatal. 0000029978 00000 n 0000006002 00000 n Pharmacodynamics (5 mg/mL) 0000010698 00000 n %%EOF Therefore, the potential for these dermatologic reactions exists following exposure to intravenous diltiazem. Diltiazem is excreted in human milk. hb```l 0000015118 00000 n 6. Diltiazem may also be used for purposes not listed in this medication guide. Consider debridement and excision of necrotic tissue if pain continues for 1 to 2 weeks or in the case of infection or clinical deterioration. Distributed by: Treatment should begin as soon as possible and no later than 6 hours after extravasation. Available for Android and iOS devices. Both infiltration and extravasation can have serious consequences: the patient may need surgical intervention resulting in large scars, experience limitation of function, or even require amputation. Patients with severe hypotension or cardiogenic shock. 0000019842 00000 n The best therapeutic agent for treatment of vasopressor extravasation is intradermal phentolamine. Cytarabine . 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. prolonged sedation) of both midazolam and triazolam. Extravasation of xenobiotics. 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. Subsequent intravenous bolus doses should be individualized for each patient. The need for sphincterotomy can be avoided in up to 70% of cases. for i am hoping to come off of this medicine. Prepared by: Diltiazem hydrochloride is extensively metabolized by the liver and excreted by the kidneys and in bile. Prompt interdisciplinary action is often necessary for the treatment of extravasation injuries. Store diltiazem at room temperature away from moisture and heat. An adjustment in the diltiazem dose may be warranted. It has a pH range of 3.7 to 4.1. 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. Descriptions. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. It is not known whether diltiazem will harm an unborn baby. 125 mg per 25 mL a rough estimate would be great. Rhinitis, headache, and constipation are commonly reported side effects. Sterile eugia 10 x 25 mL Single-Dose Vials, Cardizem, Cartia XT, Cardizem CD, Dilt-XR, +6 more, amlodipine, lisinopril, aspirin, metoprolol, losartan, furosemide, carvedilol, hydrochlorothiazide, propranolol, spironolactone. * Approximation only. You can discuss the study with your doctor, to ensure that all drug risks and benefits are fully discussed and understood. Do not crush, chew, break, or open an extended-release diltiazem tablet or capsule. Last updated on Apr 1, 2023. High-degree AV Block: Treat as for bradycardia above. Hypotension - Decreases in blood pressure associated with diltiazem hydrochloride injection therapy may occasionally result in symptomatic hypotension (3.2%). Hemodynamics Transition to other antiarrhythmic agents following administration of diltiazem hydrochloride injection is generally safe. 0000030204 00000 n Therefore, infusion duration exceeding 24 hours and infusion rates exceeding 15 mg/h are not recommended. Statins - Diltiazem is an inhibitor of CYP3A4 and has been shown to increase significantly the AUC of some statins. 1. Keep diluted diltiazem hydrochloride injection refrigerated until use. Diltiazem may be only part of a complete program of treatment that also includes diet, exercise, and other medications. Do not take extra medicine to make up the missed dose. Administration of oral diltiazem in patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission is contraindicated. eugia, Rx only NDC 55150-427-10 Atrial fibrillation or atrial flutter - In clinical studies with diltiazem hydrochloride injection for AF/FI, 135 of 257 patients were 65 years of age. 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. What are current recommendations for treatment of drug extravasation? Some patients may respond to an initial dose of 0.15 mg/kg, although duration of action may be shorter. Immediately stop the IV push or infusion if the patient complains of pain or a burning sensation. Phase IV trials are used to detect adverse drug outcomes and monitor drug effectiveness in the real world. A. Hypotension, if it occurs, may be similarly persistent. Dosage form: injection, solution Ong J, Van Gerpen R. Recommendations for management of noncytotoxic vesicant extravasations. Diltiazem Results of our real-world drug study have been referenced on 600+ medical publications, including The Lancet, Mayo Clinic Proceedings, and Nature. 2023 eHealthMe.com. Diltiazem hydrochloride injection rarely converts atrial fibrillation or atrial flutter to normal sinus rhythm. Upon discontinuation of infusion, heart rate reduction may last from 0.5 hours to more than 10 hours (median duration 7 hours). Dilution: To prepare diltiazem hydrochloride injection for continuous intravenous infusion, aseptically transfer the appropriate quantity (see chart) of diltiazem hydrochloride injection to the desired volume of either Normal Saline, D5W, or D5W/0.45% NaCl. Patients with low body weights should be dosed on a mg/kg basis. 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. Ivabradine - Concurrent use of diltiazem increases exposure to ivabradine and may exacerbate bradycardia and conduction disturbances. Only 1 of the studies of diltiazem was in children. Prez Fidalgo JA, Garca Fabregat L, Cervantes A, et al. Direct Intravenous Single Injections (Bolus) HCl Injection Hudson, OH: Wolters Kluwer Health; 2021. http://onlinelexi.com. General In: Nelson LS, Howland MA, Lewin NA, Smith SW, Goldfrank LR, Hoffman RS, eds. Pharmacological management of anticancer agent extravasation: A single institutional guideline. 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. 0000030660 00000 n Changes in heart rate, systolic blood pressure, and diastolic blood pressure did not correlate with diltiazem plasma concentrations in normal volunteers. 332 33 Some side effects may occur that usually do not need medical attention. Cardizem undergoes extensive metabolism in which 2% to 4% of the unchanged drug appears in the urine. hbbbd`b``3 Tell your doctor if you are pregnant or plan to become pregnant. Take diltiazem exactly as prescribed by your doctor. Infiltration- inadvertent administration of non-vesicant medication or fluid into the surrounding tissues. Diltiazem is a calcium channel blocker. 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. Nervous System: Dizziness, paresthesia Diltiazem hydrochloride injection is for direct intravenous bolus injection and continuous intravenous infusion. 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. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 0000017632 00000 n The elimination half-life of midazolam and triazolam also increased (1.5 to 2.5 fold) during coadministration with diltiazem. 833 S. Wood St., Suite B12, College of Pharmacy, (MC 886), Chicago, IL 60612, 2023 The Board of Trustees of the University of Illinois, UI Health is UICs academic health enterprise. Similar ventricular complexes have been noted during cardioversion, other pharmacologic therapy, and during spontaneous conversion of PSVT to sinus rhythm. Atrial Fibrillation or Atrial Flutter Different individuals may respond to medication in different ways. In patients administered continuous infusions at 10 mg/h or 15 mg/h for 24 hours, diltiazem systemic clearance averaged 42 L/h and 31 L/h, respectively. Once familiarity of the patient's response is established, use in an office setting may be acceptable. HCl Injection 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. Injection and Continuous Among them, 22 people (0.08%) have Infusion site extravasation. 549 0 obj <>stream 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. Use of this site constitutes acceptance of eHealthMe.com's terms of service and privacy policy. Diltiazem is used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders. Diltiazem One hundred two (102) patients <65 had a response rate of 78%. 0000025065 00000 n 0000030705 00000 n Diltiazem (Cardizem) is a medication used to treat high blood pressure and chest pain. Diltiazem hydrochloride injection is indicated for the following: Swallow it whole. Diltiazem does not appear to be removed by peritoneal or hemodialysis. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs. 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. 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). Certain drugs cause vasospasms, which result in back pressure at the intravenous (IV) site and may expand the puncture site in the vein, allowing leakage to occur; drugs that act as vasoconstrictors can also cause tissue ischemia. Experience in the use of antiarrhythmic agents following maintenance infusion of diltiazem hydrochloride injection is limited. Apply compresses for 20 to 60 minutes 3 or 4 times daily for the first 24 to 72 hours after extravasation occurs. .,gzTwgV- *m ;vQt3 Y s::;:@4w00 fF=$:a [|E! K|+o|`meff;priV@ud`\e`t0 b0 sores, ulcers, or white spots in the mouth or on the lips. 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. Quinidine - Diltiazem significantly increases the AUC(0) of quinidine by 51%, T1/2 by 36% and decreases its CLoral, by 33%. Overdosage experience is limited. E. Windsor, NJ 08520 High blood pressure often has no symptoms. 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. (5 mg/mL) India Who is eHealthMe? 279 Princeton-Hightstown Rd. 0000001883 00000 n Atrial flutter can arise during treatment with antiarrhythmic agents prescribed to prevent recurrent AF. 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). 2. When extravasation does occur, management is largely supportive and non-pharmacologic in nature. Brand names: Cardizem (and Cardizem CD, LA and XR), Cartia XT, Dilacor XR, Dilt-CD, Single-dose vials. 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. hb``e``= P30p %DeA@>;O2`8Te~0C;L5gla3a1fb+ fd`+ 2 n', Cardizem, Cartia XT, Cardizem CD, Dilt-XR, +7 more. In renal and cardiac transplant recipients, a reduction of cyclosporine dose ranging from 15% to 48% was necessary to maintain cyclosporine trough concentrations similar to those seen prior to the addition of diltiazem. Version: 15.01. This can damage the blood vessels of the brain . Be careful if you drive or do anything that requires you to be alert. If possible, it is recommended that diltiazem hydrochloride injection not be co-infused in the same intravenous line. 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. You may report side effects to FDA at 1-800-FDA-1088. Avoid taking herbal supplements containing St. John's wort at the same time you are taking diltiazem. Cyclosporine - A pharmacokinetic interaction between diltiazem and cyclosporine has been observed during studies involving renal and cardiac transplant patients. 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. :: ;: @ 4w00 fF= $: a [ |E for excessive slowing of the eHealthMe site its... Of blood., gzTwgV- * m ; vQt3 Y s:: ; @. This means one hour before food or two hours after extravasation: Cardizem ( and Cardizem CD, and. Following 24 hour constant rate intravenous infusion in this medication guide liver and excreted by the kidneys in... Of January 13, 2021 hypotension, if it continues for 1 to 2 weeks in... Flutter Different individuals may respond to medication in Different ways hundred two ( 102 )