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. Do not save the mixture for later use. (5 mg/mL) It also increases the supply of blood and oxygen to the heart. Read More large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs. When treatment for hypotension was required, it generally consisted of administration of saline or placing the patient in the Trendelenburg position. .,gzTwgV- *m ;vQt3 Y s::;:@4w00 fF=$:a [|E! K|+o|`meff;priV@ud`\e`t0 b0 Diltiazem is excreted in human milk. But sometime on Sunday while I had the IV of diltiazem in something happened and my arm became swollen and sore. Prompt interdisciplinary action is often necessary for the treatment of extravasation injuries. Prepared by: Different individuals may respond to medication in different ways. Dosage form: injection, solution 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. Direct Intravenous Single Injections (Bolus) Cold compresses cause vasoconstriction, limiting the spread of the extravasated drug. Packaged in a Carton of 10 NDC 55150-426-10 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. Monitoring for quinidine adverse effects may be warranted and the dose adjusted accordingly. Hypotension: Vasopressors (e.g., dopamine or norepinephrine). 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). Before taking diltiazem, tell your doctor if you have kidney disease, liver disease, or congestive heart failure. Over this infusion range, as the dose is increased, systemic clearance decreases from 64 to 48 L/h while the plasma elimination half-life increases from 4.1 to 4.9 hours. Precautions. In dogs, oral doses of 20 mg/kg were also associated with hepatic changes; however, these changes were reversible with continued dosing. eHealthMe is studying from 27,064 Cardizem users for its effectiveness, alternative drugs and more. Le A, Patel S. Extravasation of noncytotoxic drugs: a review of the literature. The infusion rate may be increased in 5 mg/h increments up to 15 mg/h as needed, if further reduction in heart rate is required. Administration of other calcium channel blockers to patients with wide complex tachycardia (QRS 0.12 seconds) has resulted in hemodynamic deterioration and ventricular fibrillation. Every effort has been made to ensure that all information is accurate, up-to-date, and complete, but no guarantee is made to that effect. It works by relaxing the muscles of your heart and blood vessels. Do not stop taking this medication without first talking to your doctor. Metabolites N-monodesmethyldiltiazem, desacetyldiltiazem, desacetyl-N-monodesmethyldiltiazem, desacetyl-O-desmethyldiltiazem, and desacetyl-N, O-desmethyldiltiazem have been identified in human urine. Events such as myocardial infarction have been observed which are not readily distinguishable from the natural history of the disease for the patient. Gorski LA, Hadaway L, Hagle ME, et al. It is used in many clinical scenarios as an antihypertensive, anti-arrhythmic, and anti-anginal. Other drugs that have the same active ingredients (e.g. . HCl Injection Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. E. Windsor, NJ 08520 %%EOF Version: 15.01. 0000000956 00000 n 0000001363 00000 n Sterile 25 mL Single-Dose Vial Discard unused portion. The purpose of this review is to provide an update of treatment modalities for calcinosis in dermatomyositis based on published . Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. The following measures may be considered: Extravasation is a potentially serious unintended event associated with IV drug administration. 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. A defibrillator and emergency equipment should be readily available. Gastrointestinal: Constipation, elevated SGOT or alkaline phosphatase, nausea, vomiting Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Pregnancy No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. 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. <<893FCAAD4A261745BEDEB8B64953C410>]/Prev 46654/XRefStm 1178>> Disconnect IV tubing from IV device. iv infiltration with diltiazem. Other drugs that are specific substrates, inhibitors, or inducers of this enzyme system may have a significant impact on the efficacy and side effect profile of diltiazem. 0000025065 00000 n Cardiac Failure: Administer inotropic agents (isoproterenol, dopamine, or dobutamine) and diuretics. Digitalis - Intravenous diltiazem has been administered to patients receiving either intravenous or oral digitalis therapy. Patients with ventricular tachycardia. Evidence supporting the use of specific antidotes is limited and largely limited to case reports. Use within 24 hours. Some patients may respond to an initial dose of 0.15 mg/kg, although duration of action may be shorter. no heartbeat. For Direct Intravenous Bolus Injection and Results of our real-world drug study have been referenced on 600+ medical publications, including The Lancet, Mayo Clinic Proceedings, and Nature. Drugs which induce or inhibit hepatic microsomal enzymes may alter diltiazem disposition. Diltiazem Hydrochloride Injection is for direct intravenous bolus injection and continuous intravenous infusion. %%EOF Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Check whether Infusion site extravasation is associated with a drug or a condition, Infusion site extravasation and drugs with ingredients of diltiazem hydrochloride, Atrial fibrillation/flutter (atrial fibrillation and flutter are abnormal heart rhythms in which the atria, or upper chambers of the heart, are out of sync with the ventricles), Infusion site extravasation in Moderna COVID Vaccine, Infusion site extravasation in Pfizer BioNTech Covid Vaccine, Infusion site extravasation in Johnson and Johnson Covid Vaccine, Fatigue (feeling of tiredness): 5 people, 22.73%, Infusion Site Swelling: 4 people, 18.18%, Urinary Tract Infection: 4 people, 18.18%, Fluid Overload (too much fluid in the blood): 3 people, 13.64%, Immunodeficiency Common Variable: 12 people, 54.55%, Primary Immunodeficiency Syndrome: 3 people, 13.64%, Colorectal Cancer Metastatic (cancer of colon and rectal spreads to other parts): 2 people, 9.09%, Rheumatoid Arthritis (a chronic progressive disease causing inflammation in the joints): 1 person, 4.55%, Osteoporosis (bones weak and more likely to break): 1 person, 4.55%, Metastatic Gastric Cancer (cancer types can spread to the stomach from other place): 1 person, 4.55%. When used concomitantly, anesthetics and calcium blockers should be titrated carefully. It may help to increase your ability to exercise and decrease how often you may get angina attacks. Revised: April 2023, Rx only NDC 55150-425-01 Coadministration of diltiazem with rifampin or any known CYP3A4 inducer should be avoided when possible, and alternative therapy considered. 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. The T1/2 and Tmax of buspirone were not significantly affected by diltiazem. Most interactions occur because diltiazem can change how the body processes other medications and due to effects on the heart. 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. For Direct Intravenous Bolus University of Illinois at Chicago College of Pharmacy. Diltiazem This article summarizes the latest recommendations for treatment of extravasation, and updates a similar article prepared by our group in 2015. Diltiazem Dosage: 0.25 mg/kg administered over at least 2 minutes and preferably . Dermatologic: Pruritus, sweating Changes in heart rate, systolic blood pressure, and diastolic blood pressure did not correlate with diltiazem plasma concentrations in normal volunteers. Mix thoroughly. As such, the initial use of diltiazem hydrochloride injection should be, if possible, in a setting where monitoring and resuscitation capabilities, including DC cardioversion/defibrillation, are present (see OVERDOSAGE). 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. Diltiazem plasma levels were not significantly affected by lovastatin or pravastatin. "treatment" for extravasation reactions is prevention. One hundred two (102) patients <65 had a response rate of 78%. It works by relaxing the muscles of your heart and blood vessels. Diltiazem is used alone or together with other medicines to treat angina (severe chest pain) or hypertension (high blood pressure). red, irritated eyes. The average age of the children in this study was about 3 years. Eugia Pharma Specialities Limited 3. 0000001178 00000 n Package insert / product label Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician. 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. itching. red skin lesions, often with a purple center. 0000010832 00000 n 2. In addition, the following events were reported infrequently (less than 1%): Diltiazem is an oral and parenteral non-dihydropyridine calcium channel blocker. 4. However, sloughing can occur from the application of a warm compress to an area infiltrated with certain medications such as potassium chloride. Mean plasma diltiazem concentrations of 130 ng/mL and 300 ng/mL were determined to produce reductions in heart rate of 30% and 40%. The following are common drugs that interact with diltiazem; Not all possible interactions are listed in this medication guide. Nervous System: Dizziness, paresthesia 125 mg per 25 mL (5 mg/mL) Ivabradine - Concurrent use of diltiazem increases exposure to ivabradine and may exacerbate bradycardia and conduction disturbances. Extravasation of noncytotoxic drugs. Diltiazem hydrochloride injection is a clear, colorless, sterile, nonpyrogenic solution. ACR Manual on Contrast Media 2020. Immediately following bolus administration of 20 mg (0.25 mg/kg) or 25 mg (0.35 mg/kg) diltiazem hydrochloride injection and reduction of heart rate, begin an intravenous infusion of diltiazem hydrochloride injection. unpredictable hypotension in some patients. Available for Android and iOS devices. Swallow it whole. Diltiazem is used to prevent chest pain ( angina ). Sodium hydroxide or hydrochloric acid is used for pH adjustment. Related/similar drugs 50 mg per 10 mL Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. 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. 5. Diltiazem is called a calcium channel . Asymptomatic hypotension occurred in 4.3% of patients. Additionally, administration factors, including the experience of personnel administering the injection, the injection technique, and the number of venipuncture attempts to establish a line, contribute to the risk of extravasation, as does the fragility of the patients veins. Dosage of drugs is not considered in the study. 0000029248 00000 n xref For Direct Intravenous Bolus Some side effects may occur that usually do not need medical attention. Worldwide experience in over 1,300 patients was similar. Rifampin - Coadministration of rifampin with diltiazem lowered the diltiazem plasma concentrations to undetectable levels. 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. Patients who have demonstrated hypersensitivity to the drug. It is created by eHealthMe based on reports of 26,148 people who have side effects when taking Cardizem from the FDA, and is updated regularly. 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. Brand names: Cardizem (and Cardizem CD, LA and XR), Cartia XT, Dilacor XR, Dilt-CD, endstream endobj startxref Diltiazem does not appear to be removed by peritoneal or hemodialysis. 0000003491 00000 n The risk of toxic reactions to this drug may be greater in patients with impaired renal or hepatic function. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use diltiazem only for the indication prescribed. These VPBs are transient, are typically considered to be benign, and appear to have no clinical significance. Adverse events reported in controlled and uncontrolled clinical trials were generally mild and transient. Pediatric Use Therefore, the potential for acute hepatic injury exists following administration of intravenous diltiazem. 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. Infusion site extravasation is found among people who take Cardizem, especially for people who are female, 60+ old. In subgroup analysis following a two-dose procedure in double-blind and open-label studies, 104 patients 65 years of age and 95 patients <65 both had a 95% response rate. Grapefruit and grapefruit juice may interact with diltiazem and lead to unwanted side effects. When considering therapy for atrial fibrillation (AF), the dominant issues are rate control, anticoagulation, rhythm control, and treatment of any underlying disorder. Dermatologic events progressing to erythema multiforme and/or exfoliative dermatitis have been infrequently reported following oral diltiazem. Upon discontinuation of infusion, heart rate reduction may last from 0.5 hours to more than 10 hours (median duration 7 hours). 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). Diltiazem is well absorbed from the gastrointestinal tract and is subject to an extensive first-pass effect, giving an absolute bioavailability (compared to intravenous dosing) of about 40%. India Hudson, OH: Wolters Kluwer Health; 2021. http://onlinelexi.com. Diltiazem interacts with many medications. FDA-approved indications include atrial arrhythmia, hypertension, paroxysmal supraventricular tachycardia, and chronic stable angina. Cardiovascular: AV block (third degree), bundle branch block, ECG abnormality, palpitations, syncope, tachycardia, ventricular extrasystoles hb```l In the event of overdosage or an exaggerated response, appropriate supportive measures should be employed. Temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter. Subjects with increased average steady-state exposures of diltiazem showed a greater fold increase in simvastatin exposure. Although it is not possible to prevent all accidents, a few simple precautions can minimize the risk to the patient. Renal insufficiency, or even end-stage renal disease, does not appear to influence diltiazem disposition following oral administration. To minimize the risk of dislodging the catheter, veins in the hands 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. The need for sphincterotomy can be avoided in up to 70% of cases. trailer 4. Store diltiazem at room temperature away from moisture and heat. 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. 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. Knowledge of the mechanism of extravasation-induced tissue injury, agents for reversal, and appropriate nonpharmacologic treatment methods is essential. Pharmacodynamics Manufactured by: a rough estimate would be great. Continuous Intravenous Infusion Do not remove the IV device or noncoring port needle. However, if you have symptoms of low blood pressure (dizziness, fainting, weakness, or blurred vision), call your doctor and stop taking diltiazem. 0000029456 00000 n Diltiazem is a calcium channel blocker. Diltiazem may be used for the treatment of high blood pressure or chronic stable angina. 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. ChildrenUse and dose must be determined by your doctor. 364 0 obj <>stream 0 Sterile 5 mL Single-Dose Vial, Rx only NDC 55150-425-10 549 0 obj <>stream Diltiazem is used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders. 0000030204 00000 n Damage from extravasation can progress to a significant degree, causing permanent disability and disfigurement, and necessitating surgical debridement or skin grafting.1 The exact incidence of extravasation is unknown because there is no central reporting database, but it is estimated to be 0.1% to 6% for non-vesicant drugs in adults, and up to 11% for non-vesicants in pediatrics. Sterile 10 mL Single-Dose Vial, Rx only NDC 55150-426-10 Competitive in vitro ligand binding studies have shown that diltiazem binding is not altered by therapeutic concentrations of digoxin, phenytoin, hydrochlorothiazide, indomethacin, phenylbutazone, propranolol, salicylic acid, tolbutamide, or warfarin. These metabolites are observed, however, following 24 hour constant rate intravenous infusion. There are a variety of treatments that have been reported in the literature. Tell your doctor about all medicines you use, and those you start or stop using. This can damage the blood vessels of the brain . Extravasation of xenobiotics. 0000015118 00000 n Diltiazem may impair your thinking or reactions. Patients should be monitored for signs of hypercalcemia. Last updated on Mar 22, 2023. Reproduction studies have been conducted in mice, rats, and rabbits. Quinidine - Diltiazem significantly increases the AUC(0) of quinidine by 51%, T1/2 by 36% and decreases its CLoral, by 33%. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Management of extravasation of non-cytotoxic drugs. Buter J, Steele KT, Chung KC, Elzinga K. Extravasation injury from chemotherapy and other non-antineoplastic vesicants. 512 0 obj <> endobj Other drugs that have the same active ingredients (e.g. https://www.acr.org/Clinical-Resources/Contrast-Manual, Each vial of dexrazoxane must be mixed with the supplied diluent to a concentration of 10 mg/mL, Withhold cold compress 15 minutes prior to infusion, Vial contains 150 units per 1 mL or 200 units per 1 mL depending on manufacturer, Inject from 15 to 150 units of the hyaluronidase solution as 5 separate injections, each containing 0.2 mL to 1 mL hyaluronidase, Use 2 mL of the prepared solution for each 1 mg drug extravasated, 50% solution (99% solution reported in literature, but not available in US), Apply topically to site for 7 to 14 days and allow to dry, 5 to 10 mg in 10 to 20 mL of 0.9% sodium chloride, Use a 25-gauge needle to inject at multiple sites within the affected area (change needle with each injection), 1-inch strip applied to site of ischemia, can redose every 8 hours as necessary, Use a 25-gauge needle to inject locally across symptomatic sites (change needle with each injection). It is often used in high blood pressure. Duration of infusion longer than 24 hours and infusion rates greater than 15 mg/h have not been studied. For vesicant drugs and chemotherapeutic agents, the incidence has been reported to range from 0.01% to 6%.2. 2023 eHealthMe.com. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. 0000017632 00000 n Generic name: diltiazem hydrochloride Diltiazem Apply compresses for 20 to 60 minutes 3 or 4 times daily for the first 24 to 72 hours after extravasation occurs. It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Intravenous Infusion Diltiazem hydrochloride is extensively metabolized by the liver and excreted by the kidneys and in bile. 8 Hyderabad 500032 UIC's seven health sciences colleges and health care delivery enterprise. Floxuridine . Subsequent intravenous bolus doses should be individualized for each patient. Treatment should begin as soon as possible and no later than 6 hours after extravasation. * 5 mg/h may be appropriate for some patients. However, no treatments have been shown. Diltiazem hydrochloride injection is for direct intravenous bolus injection and continuous intravenous infusion. 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. 0000000016 00000 n American College of Radiology. Accessed January 13, 2021. 0000006002 00000 n 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. Once familiarity of the patient's response is established, use in an office setting may be acceptable. 9 Physician's order should be obtained to initiate warm or cold therapy when suspect extravasation is greater than 24 hours old. 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. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. The best approach to extravasation injury is prevention.3-6 Preventive measures include appropriate dilution of medication, infusion of medication via the appropriate rate of administration, ensuring patency of the vascular access device, careful monitoring of infusions during administration, use of clear tape or dressings to allow for visual inspection of the infusion site, and immobilization of the extremity with the IV cannula. Diltiazem may be only part of a complete program of treatment that also includes diet, exercise, and other medications. Atrial fibrillation or atrial flutter - In clinical studies with diltiazem hydrochloride injection for AF/FI, 135 of 257 patients were 65 years of age. hb``e``= P30p %DeA@>;O2`8Te~0C;L5gla3a1fb+ fd`+ 2 n', 125 mg per 25 mL Packaged in a Carton of 10 NDC 55150-427-10 Another long-term effect is complex regional pain syndrome, a neurologic syndrome that requires long-term pain management. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products.

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