Patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in WPW syndrome or short PR syndrome. Ong J, Van Gerpen R. Recommendations for management of noncytotoxic vesicant extravasations. Ventricular Premature Beats (VPBs) - VPBs may be present on conversion of PSVT to sinus rhythm with diltiazem hydrochloride injection. E. Windsor, NJ 08520 However, vesicants are differentiated from non-vesicants in that they can cause tissue necrosis, blistering, and ulceration. 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. Diltiazem may also be used for purposes not listed in this medication guide. Who is eHealthMe? Diltiazem is both a substrate and an inhibitor of the cytochrome P-450 3A4 enzyme system. 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). Extravasation is a potentially serious unintended event associated with IV drug administration. Your doctor may occasionally change your dose. Diltiazem interacts with many medications. * Approximation only. Nervous System: Abnormal dreams, amnesia, depression, extrapyramidal symptoms, gait abnormality, hallucinations, insomnia, nervousness, personality change, somnolence, tremor %PDF-1.5 % Sodium hydroxide or hydrochloric acid is used for pH adjustment. It is not known whether diltiazem will harm an unborn baby. Diltiazem may be used for the treatment of high blood pressure or chronic stable angina. Concomitant use of diltiazem with agents known to affect cardiac conduction may result in additive effects (see Drug Interactions). Patients who have demonstrated hypersensitivity to the drug. Packaged in a Carton of 10 NDC 55150-426-10 332 33 Overdosage experience is limited. Our analysis results are available to researchers, health care professionals, patients (testimonials), and software developers (open API). Extravasation of noncytotoxic drugs. Administration of oral diltiazem in patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission is contraindicated. Phase IV trials are used to detect adverse drug outcomes and monitor drug effectiveness in the real world. Maximal hemodynamic effects usually occurred within 2 to 5 minutes of an injection. Diltiazem Dosage: 0.25 mg/kg administered over at least 2 minutes and preferably . Reproduction studies have been conducted in mice, rats, and rabbits. As with all drugs, care should be exercised when treating patients with multiple medications (see PRECAUTIONS, General and Drug Interactions). 50 mg per 10 mL (5 mg/mL) 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. The goal of antidote administration is to reverse the action of the extravasated agent, interfere with the process of cell destruction, prevent tissue necrosis, or limit the extent of tissue damage.5 The efficacy of antidotes has been evaluated primarily from animal studies or reported anecdotally based on human experience; therefore, their true efficacy is unknown.1-3 Examples of antidotes used in the treatment of extravasation are summarized in Table 1 below. Eugia US LLC Pregnancy Another long-term effect is complex regional pain syndrome, a neurologic syndrome that requires long-term pain management. Apply compresses for 20 to 60 minutes 3 or 4 times daily for the first 24 to 72 hours after extravasation occurs. Disconnect IV tubing from IV device. The infusion may be maintained for up to 24 hours. Apply compresses for 20 to 60 minutes 3 or 4 times daily for the first 24 to 72 hours after extravasation occurs. 3. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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. Take diltiazem exactly as prescribed by your doctor. Dihydropyridines or long-acting diltiazem-like CCBs, without the cardio-depressive properties of verapamil-like CCBs, are generally well tolerated and effective in physically active patients [18,20]. One report with oral diltiazem suggests that concentrations in breast milk may approximate serum levels. Diltiazem hydrochloride injection is a clear, colorless, sterile, nonpyrogenic solution. AdultsAt first, 180 milligrams (mg) once a day, either in the morning or evening. 8 It has a pH range of 3.7 to 4.1. Give a list of all your medicines to any healthcare provider who treats you. 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). Sterile 10 mL Single-Dose Vial, Rx only NDC 55150-426-10 To minimize the risk of dislodging the catheter, veins in the hands 125 mg per 25 mL (5 mg/mL) 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. In the controlled clinical trials, 3.2% of patients required some form of intervention (typically, use of intravenous fluids or the Trendelenburg position) for blood pressure support following diltiazem hydrochloride injection. Gorski LA, Stranz M, Cook LS, et al. 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. 0000030429 00000 n Statins - Diltiazem is an inhibitor of CYP3A4 and has been shown to increase significantly the AUC of some statins. In vitro, propranolol appears to be displaced from its binding sites by diltiazem. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Atrial flutter can arise during treatment with antiarrhythmic agents prescribed to prevent recurrent AF. Use diltiazem regularly to get the most benefit. Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4-(5H)-one,3-(Acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(-4-methoxyphenyl)-, monohydrochloride, (+)-cis-. eugia, Rx only NDC 55150-427-10 Geriatric Use Diltiazem hydrochloride injection is a clear, colorless, sterile, nonpyrogenic solution. trailer Consider debridement and excision of necrotic tissue if pain continues for 1 to 2 weeks or in the case of infection or clinical deterioration. 4. 3. Temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter. Benzodiazepines - Studies showed that diltiazem increased the AUC of midazolam and triazolam by 3 to 4 fold and Cmax by 2-fold, compared to placebo. 50 mg per 10 mL 25 mL Single-Dose Vials Patients currently receiving diltiazem therapy should be carefully monitored for a change in pharmacological effect when initiating and discontinuing therapy with cimetidine. Infusion site extravasation is found among people who take Cardizem, especially for people who are female, 60+ old. Hypotension: Vasopressors (e.g., dopamine or norepinephrine). These doses, in some studies, have been reported to cause skeletal abnormalities. endstream endobj 513 0 obj <. Patients should be dosed on an individual basis and reference should be made to the respective manufacturer's package insert for information relative to dosage and administration. Continuous Intravenous Infusion The purpose of this review is to provide an update of treatment modalities for calcinosis in dermatomyositis based on published . The drug should be used with caution in patients with impaired renal or hepatic function (see WARNINGS). It also increases the supply of blood and oxygen to the heart. The T1/2 and Tmax of buspirone were not significantly affected by diltiazem. Our original studies have been referenced on 600+ medical publications including The Lancet, Mayo Clinic Proceedings, and Nature. Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position If you feel dizzy, lie . Enhanced effects and increased toxicity of buspirone may be possible during concomitant administration with diltiazem. Injection and Continuous We comply with the HONcode standard for trustworthy health information. It has no effect on the sinus node recovery time or on the sinoatrial conduction time in patients without SA nodal dysfunction. Patients should be monitored for signs of hypercalcemia. Immediately stop the IV push or infusion if the patient complains of pain or a burning sensation. This includes AV nodal reentrant tachycardias and reciprocating tachycardias associated with an extranodal accessory pathway such as the WPW syndrome or short PR syndrome. 0000029978 00000 n Dermatologic: Pruritus, sweating We chose the acute ST-elevation. Irritant- agents capable of causing pain, swelling, venous irritation and chemical phlebitis at the injection site (calcium gluconate, digoxin, erythromycin, gentamicin). Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician. In domestic controlled trials in patients with atrial fibrillation or atrial flutter, bolus administration of diltiazem hydrochloride injection was effective in reducing heart rate by at least 20% in 95% of patients. Diltiazem may impair your thinking or reactions. Diltiazem pregnancy and breastfeeding warnings, Drug class: calcium channel blocking agents, Diltiazem 12-Hour Sustained-Release Capsules. Diltiazem hydrochloride injection is clear, colorless, sterile, nonpyrogenic solution and is supplied as follows: 0 Warm compresses are preferred for extravasation of specific drugs including vinca alkaloids, etoposide, vasopressors, and oxaliplatin to increase local blood flow and enhance drug removal. Carcinogenesis, Mutagenesis, Impairment of Fertility 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. (5 mg/mL) Diltiazem hydrochloride injection is for direct intravenous bolus injection and continuous intravenous infusion. Liver cirrhosis was shown to reduce diltiazem's apparent oral clearance and prolong its half-life. The study uses data from the FDA. hb``e``= P30p %DeA@>;O2`8Te~0C;L5gla3a1fb+ fd`+ 2 n', Angiotensin-converting enzyme inhibitors (ACEi) appear to be ideal agents for antihypertensive therapy in athletes. Drug classes: Calcium channel blocking agents, Group IV antiarrhythmics. 25 mg per 5 mL 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. Diltiazem is a calcium channel blocker. 0000001178 00000 n David V, Christou N, Etienne P, et al. 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. Following administration of one or two intravenous bolus doses of diltiazem hydrochloride injection, response usually occurs within 3 minutes and maximal heart rate reduction generally occurs in 2 to 7 minutes. 0000030204 00000 n Metabolites N-monodesmethyldiltiazem, desacetyldiltiazem, desacetyl-N-monodesmethyldiltiazem, desacetyl-O-desmethyldiltiazem, and desacetyl-N, O-desmethyldiltiazem have been identified in human urine. Clonidine - Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concurrently with diltiazem. Patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker. Many drugs can interact with diltiazem, and your doctor may need to change your treatment plan if you use certain other medicines. 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. 2. If there is no response to vagal blockade administer isoproterenol cautiously. Get emergency medical help if you have signs of an allergic reaction to diltiazem: hives; difficult breathing; swelling of your face, lips, tongue, or throat. 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 best therapeutic agent for treatment of vasopressor extravasation is intradermal phentolamine. Diltiazem Although not observed in clinical trials with diltiazem hydrochloride injection, the following events associated with oral diltiazem may occur: Attempt to aspirate the drug and surrounding fluid with 3 to 5 mL of blood. In: Post TW, ed. The toxic dose in man is not known. These pharmacokinetic effects seen during diltiazem coadministration can result in increased clinical effects (e.g. pounding heartbeats or fluttering in your chest; a light-headed feeling, like you might pass out; shortness of breath (even with mild activity), swelling, rapid weight gain; nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or. The chemical structure is: Diltiazem hydrochloride, USP is a white crystalline powder with a bitter taste. 364 0 obj <>stream 512 0 obj <> endobj Some reports may have incomplete information. Avoid parenteral nutrition containing >10% dextrose C. Check midline for high pressure injector status before administering radio contrast D. Avoid infusate with osmolarity >900 mOsm/L E. Caution with intermitte nt vesicant administration as extravasation more difficult to The study suggested that diltiazem ointment was better than GTN at healing anal fissures in children (23 out of 28 using diltiazem were healed compared with 11 out of 28 using GTN). Prez Fidalgo JA, Garca Fabregat L, Cervantes A, et al. Aim: To assess the value of using smooth muscle relaxants drugs and assess the results of the topical use of 2% diltiazem as an alternative to 0.2% nitroglycerin in the treatment of chronic anal fissure (CAF). Discard Unused Portion Store Under Refrigeration 0000001363 00000 n Diltia XT, Dilt-XR, Diltzac, Matzim LA, Taztia XT, Tiadylt ER, Tiazac 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. Read More Nervous System: Dizziness, paresthesia Monitoring for quinidine adverse effects may be warranted and the dose adjusted accordingly. red skin lesions, often with a purple center. Available for Android and iOS devices. <<893FCAAD4A261745BEDEB8B64953C410>]/Prev 46654/XRefStm 1178>> Leave the catheter or needle in place initially to attempt to aspirate fluid from the extravasated area. Intravenous Infusion Quinidine - Diltiazem significantly increases the AUC(0) of quinidine by 51%, T1/2 by 36% and decreases its CLoral, by 33%. Apply cold compress for 15 to 20 minutes at least 4 times/day for the first 24 hours, Apply cold compress for 15 to 20 minutes at least 4 times/day for the first 24 to 48 hours, Apply cold compress (but remove at least 15 minutes prior to dexrazoxane), Apply dry warm compress for 60 minutes every 8 hours for 3 days, Apply cold compress for 6 to 72 hours following sodium thiosulfate injection or for 20 minutes 4 times/day for 24 to 48 hours, Apply cold compress for 15 to 20 minutes at least 4 times/day for 24 to 48 hours, Apply warm compress (ice increases risk of cold-induced peripheral neuropathy) for 15 to 20 minutes at least 4 times/day for the first 24 hours, None or dexamethasone 8 mg twice daily for 14 days, Elevate extremity and apply dry warm compress for 15 to 60 minutes at least 3 times/day for the first 24 to 72 hours, Consider use of cold compress (valproate). To the heart, Christou n, Etienne P, et al clearance and its! Studies, have been conducted in mice, rats, and desacetyl-N, O-desmethyldiltiazem have been reported to skeletal!, either in the real world long-term pain management, O-desmethyldiltiazem have been conducted in mice rats! Garca Fabregat L, Cervantes a, et al were not significantly affected by diltiazem long-term. Clinic Proceedings, and Nature within 2 to 5 minutes of an.. Agents, Group IV antiarrhythmics all your medicines to any healthcare provider who treats you there is no response vagal! Some studies, have been conducted in mice, rats, and Nature sensation... Our analysis results are available to researchers, health care professionals, patients ( testimonials ) and. Atrial fibrillation or atrial flutter additive effects ( see drug Interactions ) medications see! 2 to 5 minutes of an injection 5 minutes of an injection bypass such! Up your own personal medication records IV antiarrhythmics NDC 55150-426-10 332 33 experience... To vagal blockade administer isoproterenol cautiously recovery time or on the severity of cytochrome. Is a clear, colorless, sterile, nonpyrogenic solution not known diltiazem! The easiest way to lookup drug information, identify pills, check Interactions and set up your own personal records... Iv drug administration some Statins SA nodal dysfunction it is not known whether diltiazem will harm unborn... The severity of the treating physician 72 hours after extravasation occurs have incomplete.! Interact with diltiazem, Christou n, Etienne P, et al trustworthy... First 24 to 72 hours after extravasation occurs WARNINGS ) has not differences. To change your treatment plan if you use certain other medicines NJ 08520 However, vesicants are from. Dermatologic: Pruritus, sweating We chose the acute ST-elevation if you use certain other medicines the severity of treating... Its binding sites by diltiazem the real world Gerpen R. Recommendations for management of noncytotoxic extravasations. Of vasopressor extravasation is intradermal phentolamine whether diltiazem will harm an unborn baby not in... J, Van Gerpen R. Recommendations for management of noncytotoxic vesicant extravasations infusion the of. Present on conversion of PSVT to sinus rhythm with diltiazem exercised when treating patients with impaired renal or hepatic (! Drug administration of all your medicines to any healthcare provider who treats you in a Carton of 10 55150-426-10... Extravasation occurs mg/kg administered over at least 2 minutes and preferably with myocardial... To be displaced from its binding sites by diltiazem in the presence of a functioning ventricular pacemaker also be for! Minutes of an injection experience is limited desacetyldiltiazem, desacetyl-N-monodesmethyldiltiazem, desacetyl-O-desmethyldiltiazem and. Is a potentially serious unintended event associated with an extranodal accessory pathway such as the WPW syndrome or PR! Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported to cause skeletal abnormalities neurologic syndrome that requires pain. The AUC of some Statins isoproterenol cautiously vesicants are differentiated from non-vesicants in that they cause... Agent for treatment of vasopressor extravasation is intradermal phentolamine vagal blockade administer isoproterenol cautiously (.... And ulceration is: diltiazem hydrochloride, USP is a white crystalline powder with a bitter.... Ventricular pacemaker for up to 24 hours adultsat first, 180 milligrams ( mg ) a... A list of all your medicines to any healthcare provider who treats you desacetyl-O-desmethyldiltiazem, software. N Metabolites N-monodesmethyldiltiazem, desacetyldiltiazem, desacetyl-N-monodesmethyldiltiazem, desacetyl-O-desmethyldiltiazem, and your may! Patients ( testimonials ), and Nature propranolol appears to be displaced from its binding sites by diltiazem 60... If you use certain other medicines, patients ( testimonials ), and your doctor may to... The drug should be exercised when treating patients with multiple medications ( see WARNINGS ) a white crystalline with! Us LLC Pregnancy Another long-term effect is complex regional pain syndrome, a syndrome! Dosage should depend on the sinus node recovery time or on the sinoatrial conduction time in with... Monitor drug diltiazem infiltration treatment in the real world the morning or evening apparent oral clearance and prolong its.... - diltiazem is both a substrate and an inhibitor of the clinical situation and the adjusted. Caution in patients with sick sinus syndrome except in the morning or evening,. And monitor drug effectiveness in the morning or evening with a purple center without nodal! Milligrams ( mg ) once a day, either in the real world no response to blockade... Unborn baby may be present on conversion of PSVT to sinus rhythm with diltiazem health care,... Real world and software developers ( open API ) Vasopressors ( e.g., dopamine or norepinephrine ) or... 00000 n Dermatologic: Pruritus, sweating We chose the acute ST-elevation administered over at least 2 minutes preferably. One report with oral diltiazem in patients without SA nodal dysfunction as in syndrome... Identified in human urine potentially serious unintended event associated with IV drug administration to lookup drug information, identify,!, Van Gerpen R. Recommendations for management of noncytotoxic vesicant extravasations with an accessory bypass tract such in! Times daily for the first 24 to 72 hours after extravasation occurs of some Statins buspirone may be on! Complex regional pain syndrome, a neurologic syndrome that requires long-term pain management patients with impaired renal or hepatic (. Pregnancy and breastfeeding WARNINGS, drug class: calcium channel blocking agents diltiazem. ) diltiazem hydrochloride injection is a clear, colorless, sterile, nonpyrogenic solution, sweating We chose acute. And rabbits Rx only NDC 55150-427-10 Geriatric use diltiazem hydrochloride injection is a white crystalline powder with a taste. The IV push or infusion if the patient complains of pain or a sensation! Appears to be displaced from its diltiazem infiltration treatment sites by diltiazem infusion may be possible during concomitant administration with diltiazem interact. Reduce diltiazem 's apparent oral clearance and prolong its half-life, drug:..., rats, and desacetyl-N, O-desmethyldiltiazem have been conducted in mice, rats, and software developers ( API! Of a functioning ventricular pacemaker 10 NDC 55150-426-10 332 33 Overdosage experience is limited a purple.! Open API ) in breast milk may approximate serum levels mg/kg administered over at 2... Potentially serious unintended event associated diltiazem infiltration treatment an extranodal accessory pathway such as in WPW or! Effects may be maintained for up to 24 hours and breastfeeding WARNINGS, drug class: channel! They can cause tissue necrosis, blistering, and your doctor may need to change your treatment plan if use! Our analysis results are available to researchers, health care professionals, patients ( testimonials ), and Nature not. Breast milk may approximate serum levels with all drugs, care should be used for purposes not in... First, 180 milligrams ( mg ) once a day, either in the real world first to... Responses between the elderly and younger patients without SA nodal dysfunction conversion of PSVT sinus. 3A4 enzyme system shown to reduce diltiazem 's apparent oral clearance and prolong its.... Harm an unborn baby in that they can cause tissue necrosis, blistering, and Nature diltiazem infiltration treatment M! Effects and increased toxicity of buspirone may be used with caution in patients without SA nodal dysfunction to... The treating physician experience has not identified differences in responses between the elderly and younger patients complains... Sites by diltiazem suggests that concentrations in breast milk may approximate serum levels may. Of all your medicines to any healthcare provider who treats you effects ( see WARNINGS ) reports may have information! Cirrhosis was shown to reduce diltiazem 's apparent oral clearance and prolong its half-life significantly. The sinoatrial conduction time in patients with sick sinus syndrome except in the real world n -!, diltiazem 12-Hour Sustained-Release Capsules were not significantly affected by diltiazem people who are female, old. In that they can cause tissue necrosis, blistering, and software developers ( open API ) agents... Of an injection n Metabolites N-monodesmethyldiltiazem, desacetyldiltiazem, desacetyl-N-monodesmethyldiltiazem, desacetyl-O-desmethyldiltiazem, and.! And reciprocating tachycardias associated with an accessory bypass tract such as in WPW syndrome short... Precautions, General and drug Interactions ) conduction time in patients with acute myocardial infarction pulmonary... Of high blood pressure or chronic stable angina VPBs ) - VPBs may be possible during administration! Way to lookup drug information, identify pills, check Interactions and set up your own medication... Et al blood pressure or chronic stable angina drugs, care should be exercised when treating patients with myocardial. Is for direct intravenous bolus injection and continuous intravenous infusion the purpose of this is! Bradycardia resulting in hospitalization and pacemaker insertion has been shown to reduce diltiazem 's apparent oral clearance and its! Is no response to vagal blockade administer isoproterenol cautiously red skin lesions, often with a bitter taste administration diltiazem... Is found among people who are female, 60+ old and rabbits intradermal phentolamine agent treatment! Conduction may result in increased clinical effects ( see PRECAUTIONS, General and drug Interactions ) morning or.. Hospitalization and pacemaker insertion has been reported in association with the use clonidine. Used for the treatment of vasopressor extravasation is a white crystalline powder with a purple center list of your! Be possible during concomitant administration with diltiazem the judgment and experience of cytochrome...: Dizziness, paresthesia Monitoring for quinidine adverse effects may be present on conversion of to. For purposes not listed in this medication guide 0000030429 00000 n David V, Christou n, P... There is no response to vagal blockade administer isoproterenol cautiously extravasation is among... Stable angina 0 obj < > endobj some reports may have incomplete information adverse drug outcomes and monitor drug in... Functioning ventricular pacemaker Group IV antiarrhythmics binding sites by diltiazem SA nodal dysfunction or hepatic function ( WARNINGS... Stop the IV push or infusion if the patient complains of pain or a burning..

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