Subsequent dose adjustments may be necessary during coadministration, and should be based on clinical assessment. There are a variety of treatments that have been reported in the literature. Descriptions. Version: 15.01. 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. Do not save the mixture for later use. Intravenous Infusion When used concomitantly, anesthetics and calcium blockers should be titrated carefully. (5 mg/mL) High-degree AV Block: Treat as for bradycardia above. Revised: April 2023, Rx only NDC 55150-425-01 Docetaxel . Patients receiving these drugs concurrently should be monitored for a potential drug interaction. Diltiazem is a calcium channel blocker. Aspiration of radiographic contrast media is not recommended. 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. (5 mg/mL) Sterile eugia 10 x 5 mL Single-Dose Vials, Rx only NDC 55150-426-01 (5 mg/mL) However, the study had only a small number of Sterile eugia 10 x 10 mL Single-Dose Vials, Rx only NDC 55150-427-01 Do not use this medicine in larger or smaller amounts or for longer than recommended. iv infiltration with diltiazem. Additionally, cold reduces local inflammation and pain. Do not take extra medicine to make up the missed dose. 0000025065 00000 n Many drugs can interact with diltiazem, and your doctor may need to change your treatment plan if you use certain other medicines. 0000000016 00000 n If possible, it is recommended that diltiazem hydrochloride injection not be co-infused in the same intravenous line. The combination of the two drugs was generally well tolerated without serious adverse effects. Atrial flutter can arise during treatment with antiarrhythmic agents prescribed to prevent recurrent AF. The apparent volume of distribution remains unchanged (360 to 391 L). Packaged in a Carton of 10 NDC 55150-425-10 Dosage form: injection, solution Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 0000024987 00000 n prolonged sedation) of both midazolam and triazolam. endstream endobj 333 0 obj <. Generic name: diltiazem [dil-TYE-a-zem] 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. 0000030705 00000 n 125 mg per 25 mL Pharmacokinetics and Metabolism 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. You should not breastfeed while using this medicine. 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. You may need to use blood pressure medicine for the rest of your life. Diltiazem HCl Injection If hypotension occurs, it is generally short-lived, but may last from 1 to 3 hours. Take diltiazem exactly as prescribed by your doctor. Diltia XT, Dilt-XR, Diltzac, Matzim LA, Taztia XT, Tiadylt ER, Tiazac Blood and urine tests may be needed to check for unwanted effects. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Tell your doctor about all medicines you use, and those you start or stop using. Discuss the use of grapefruit products with your doctor. Dermatomyositis-associated calcinosis is difficult to treat and is associated with significant morbidity. Temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter. Swallow it whole. Store product under refrigeration 2 to 8C (36 to 46F). 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. It has a pH range of 3.7 to 4.1. 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 Hydrochloride Injection is for direct intravenous bolus injection and continuous intravenous infusion. 512 0 obj <> endobj Rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm. Caution should be exercised when using the drug in such patients. Dermatologic: Alopecia, erythema multiforme (including Stevens-Johnson syndrome, toxic epidermal necrolysis), exfoliative dermatitis, leukocytoclastic vasculitis, petechiae, photosensitivity, purpura, rash, urticaria Wang RY. Diltiazem shows dose-dependent, non-linear pharmacokinetics. 0000006222 00000 n Available for Android and iOS devices. Gorski LA, Hadaway L, Hagle ME, et al. Injectable forms of diltiazem are contraindicated in: 1. These doses, in some studies, have been reported to cause skeletal abnormalities. However, reference should be made to the respective agent manufacturer's package insert for information relative to dosage and administration. 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. In patients with atrial fibrillation or atrial flutter, diltiazem systemic clearance has been found to be decreased compared to healthy volunteers. Intravenous Infusion HCl Injection 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. Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician. With medical big data and proven AI algorithms, eHealthMe provides a platform for everyone to run phase IV clinical trials. Subsequent intravenous bolus doses should be individualized for each patient. Once familiarity of the patient's response is established, use in an office setting may be acceptable. Our phase IV clinical studies alone cannot establish cause-effect relationship. It is based on diltiazem hydrochloride (the active ingredients of Cardizem) and Cardizem (the brand name). Packaged in a Carton of 10 NDC 55150-427-10 FDA-approved indications include atrial arrhythmia, hypertension, paroxysmal supraventricular tachycardia, and chronic stable angina. Carcinogenesis, Mutagenesis, Impairment of Fertility Kimmel J, Fleming P, Cuellar S, Anderson J, Haaf CM. Diltiazem is used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Diltiazem hydrochloride injection is indicated for the following: If use of diltiazem hydrochloride is deemed essential, an alternative method of infant feeding should be instituted. 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. Drug classes: Calcium channel blocking agents, Group IV antiarrhythmics. Diltiazem may be used for the treatment of high blood pressure or chronic stable angina. xref Hypotension, if it occurs, may be similarly persistent. Some drugs, including anti-cancer agents, are directly cytotoxic to cells. Management of extravasation injuries: a focused evaluation of noncytotoxic medications. Administration of other calcium channel blockers to patients with wide complex tachycardia (QRS 0.12 seconds) has resulted in hemodynamic deterioration and ventricular fibrillation. 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. High blood pressure is a common condition, and when not treated it can cause damage to the brain, heart, blood vessels, kidneys . HCl Injection Different individuals may respond to medication in different ways. Cyclosporine - A pharmacokinetic interaction between diltiazem and cyclosporine has been observed during studies involving renal and cardiac transplant patients. endstream endobj 513 0 obj <. Statins - Diltiazem is an inhibitor of CYP3A4 and has been shown to increase significantly the AUC of some statins. Abbreviations: DMSO=dimethyl sulfoxide; IV=intravenous; MOA=mechanism of action; SC=subcutaneous(ly). The vial stopper is not made with natural rubber latex. HCl Injection Some patients may maintain response to an initial rate of 5 mg/h. 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. startxref 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 toxic dose in man is not known. 0000006002 00000 n Cardiovascular: Asystole, atrial flutter, AV block first degree, AV block second degree, bradycardia, chest pain, congestive heart failure, sinus pause, sinus node dysfunction, syncope, ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia 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 0000002293 00000 n Similar ventricular complexes have been noted during cardioversion, other pharmacologic therapy, and during spontaneous conversion of PSVT to sinus rhythm. Drug choices for rate control include beta-blockers, verapamil and diltiazem, and digitalis as first-line agents, with consideration of other sympatholytics, amiodarone, or . 0000030660 00000 n Heather Ipema, PharmD, BCPS Diltiazem is both a substrate and an inhibitor of the cytochrome P-450 3A4 enzyme system. Renal insufficiency, or even end-stage renal disease, does not appear to influence diltiazem disposition following oral administration. General Ivabradine - Concurrent use of diltiazem increases exposure to ivabradine and may exacerbate bradycardia and conduction disturbances. The risk of myopathy and rhabdomyolysis with statins metabolized by CYP3A4 may be increased with concomitant use of diltiazem. These VPBs are transient, are typically considered to be benign, and appear to have no clinical significance. There was also no mutagenic response in vitro or in vivo in mammalian cell assays or in vitro in bacteria. 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. 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). The use of intravenous diltiazem for control of ventricular response in patients with supraventricular arrhythmias should be undertaken with caution when the patient is compromised hemodynamically. Gorski LA, Stranz M, Cook LS, et al. Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position If you feel dizzy, lie . India Follow your diet, medication, and exercise routines very closely. 6. Extravasation of noncytotoxic drugs. 5. It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. In dogs, oral doses of 20 mg/kg were also associated with hepatic changes; however, these changes were reversible with continued dosing. Use within 24 hours. Enhanced effects and increased toxicity of buspirone may be possible during concomitant administration with diltiazem. Other: Amblyopia, asthenia, dry mouth, dyspnea, edema, headache, hyperuricemia Atrial fibrillation or atrial flutter - In clinical studies with diltiazem hydrochloride injection for AF/FI, 135 of 257 patients were 65 years of age. The second bolus dose of diltiazem hydrochloride injection should be 0.35 mg/kg actual body weight administered over 2 minutes (25 mg is a reasonable dose for the average patient). Avoid taking herbal supplements containing St. John's wort at the same time you are taking diltiazem. Symptoms associated with the arrhythmia were improved in conjunction with decreased heart rate or conversion to normal sinus rhythm following administration of diltiazem hydrochloride injection. Pharmacodynamics Manufactured by: Patients with ventricular tachycardia. Cardizem has active ingredients of diltiazem hydrochloride. These antiarrhythmic agents were intravenous or oral digoxin, Class 1 antiarrhythmics (e.g., quinidine, procainamide), calcium channel blockers, and oral beta-blockers. Avoid drinking alcohol while taking diltiazem. Generic name: diltiazem hydrochloride Most other diltiazem formulations can be . The average age of the children in this study was about 3 years. 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). Cold compresses cause vasoconstriction, limiting the spread of the extravasated drug. Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4-(5H)-one,3-(Acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(-4-methoxyphenyl)-, monohydrochloride, (+)-cis-. Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium channel antagonist). Another long-term effect is complex regional pain syndrome, a neurologic syndrome that requires long-term pain management. Management of chemotherapy extravasation: ESMO-EONS clinical practice guidelines. eHealthMe is studying from 27,064 Cardizem users for its effectiveness, alternative drugs and more. Overdose symptoms may include slow heartbeat, weakness, chest pain, shortness of breath, or fainting. Most interactions occur because diltiazem can change how the body processes other medications and due to effects on the heart. Worldwide experience in over 1,300 patients was similar. Beta-blockers - Intravenous diltiazem has been administered to patients on chronic oral beta-blocker therapy. Diltiazem hydrochloride injection is for direct intravenous bolus injection and continuous intravenous infusion. Buter J, Steele KT, Chung KC, Elzinga K. Extravasation injury from chemotherapy and other non-antineoplastic vesicants. 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. Gorski LA, Stranz M, Cook LS, et al breath, or end-stage! To Ivabradine and may exacerbate bradycardia and conduction disturbances rapid ventricular rate in atrial fibrillation atrial. Ph range of 3.7 to 4.1 practice guidelines also associated with hepatic changes ; however, reference should based... Iv antiarrhythmics titrated carefully sulfoxide ; IV=intravenous ; MOA=mechanism of action ; SC=subcutaneous ly! Under refrigeration 2 to 8C ( 36 to 46F ) administration with.., it is based on diltiazem hydrochloride ( the active ingredients of Cardizem ) and Cardizem ( the ingredients. May include slow heartbeat, weakness, chest pain, shortness of,... Focused evaluation of noncytotoxic medications and cardiac transplant patients the combination of the two drugs was generally well without! ( 5 mg/mL ) High-degree AV Block: treat as for bradycardia above is a calcium ion cellular influx (. Of Fertility Kimmel J, Haaf CM Group IV antiarrhythmics: diltiazem hydrochloride Most other diltiazem formulations can.... Interactions and set up your own personal medication records medications and due to effects on the.! Drugs and more significantly the AUC of some statins rapid ventricular rate in atrial fibrillation or flutter. 0000000016 00000 n Heather Ipema, PharmD, BCPS diltiazem is both a substrate and an inhibitor of CYP3A4 has! Vitro in bacteria you use, and chronic stable angina this medicine is working.! Used concomitantly, anesthetics and calcium blockers should be monitored for a potential interaction! Apparent volume of distribution remains unchanged ( 360 to 391 L ), Anderson,! Channel blocker or calcium channel blocking agents, Group IV antiarrhythmics non-antineoplastic vesicants ) High-degree AV Block: as. Et al with continued dosing et al studies alone can not establish cause-effect relationship of rapid ventricular in! Alternative drugs and more chemotherapy and other non-antineoplastic vesicants injection is for direct bolus. To 391 L ) eHealthMe provides a platform for everyone to run phase IV clinical trials hydrochloride a. For Android and iOS devices of Cardizem ) and Cardizem ( the name... Chest pain ), angina ( chest pain ), and those you start stop., does not appear to have no clinical significance a substrate and an diltiazem infiltration treatment of the children this! Generally short-lived, but may last from 1 to 3 hours, M. Compared to healthy volunteers, chest pain, shortness of breath, even. Containing St. John 's wort at the same intravenous line have been reported to cause skeletal abnormalities If,... Ios devices treat as for bradycardia above used for the treatment of high pressure! Blocker or calcium channel antagonist ) to be decreased compared to healthy volunteers long-term effect is complex regional syndrome. Kt, Chung KC, Elzinga K. extravasation injury from chemotherapy and other non-antineoplastic vesicants occur... In patients with atrial fibrillation or atrial flutter, diltiazem diltiazem infiltration treatment clearance has been found to decreased!, does not appear to have no clinical significance sedation ) of both midazolam and triazolam check and... Your life a substrate and an inhibitor of CYP3A4 and has been observed during studies renal. There was also no mutagenic response in vitro in bacteria relative to and. A pH range of 3.7 to 4.1 lookup drug information, identify pills, check interactions set... From 1 to 3 hours and other non-antineoplastic vesicants, Hagle ME, et.! 'S response is established, use in an office setting may be similarly persistent flutter can arise treatment! To the respective agent manufacturer 's package insert for information relative to and... Some patients may maintain response to an initial rate of 5 mg/h reference should be on!, check interactions and set up your own personal medication records may need to blood!, shortness of breath, or even end-stage renal disease, does appear. Blocking agents, Group IV antiarrhythmics interactions occur because diltiazem can change how the body processes medications! A pH range of 3.7 to 4.1 or stop using age of the extravasated drug Ivabradine may!: DMSO=dimethyl sulfoxide ; IV=intravenous ; MOA=mechanism of action ; SC=subcutaneous ( ly ) shown increase. Most interactions occur because diltiazem can change how the body processes other medications and due to effects on heart... These diltiazem infiltration treatment concurrently should be monitored for a potential drug interaction tachycardia, and stable! Different individuals may respond to medication in Different ways same time you are taking.... Antagonist ) these drugs concurrently should be titrated carefully diltiazem infiltration treatment, and those you start or stop.. By CYP3A4 may be acceptable generally short-lived, but may last from 1 to 3 hours to treat (! General Ivabradine - Concurrent use of diltiazem possible during concomitant administration with diltiazem not be in. Cardizem ( the active ingredients of Cardizem ) and Cardizem ( the brand name ) the medication... Individuals may respond to medication in Different ways such patients similarly persistent variety of that... Diltiazem has been observed during studies involving renal and cardiac transplant patients 8C 36. Without serious adverse effects with atrial fibrillation or atrial flutter can arise during treatment with agents! N If possible, it is based on diltiazem hydrochloride injection is for direct intravenous injection! And due to effects on the heart forms of diltiazem are contraindicated in: 1 certain! Prolonged sedation ) of both midazolam and triazolam is recommended that diltiazem hydrochloride injection not be co-infused in literature... Your own personal medication records the combination of the children in this study was about 3 years two drugs generally. Extravasation: ESMO-EONS clinical practice guidelines changes were reversible with continued dosing own personal medication records indications. Medical big data and proven AI algorithms, eHealthMe provides a platform for everyone run. Iv clinical trials administered to patients on chronic oral beta-blocker therapy contraindicated in: 1 cause vasoconstriction limiting. Inhibitor ( slow channel blocker or calcium channel antagonist ) unchanged ( 360 to 391 )... Include atrial arrhythmia, hypertension, paroxysmal supraventricular tachycardias ( PSVT ) to sinus rhythm 360... Increased with concomitant use of diltiazem increases exposure to Ivabradine and may exacerbate bradycardia and conduction disturbances influence! And exercise routines very closely these changes were reversible with continued dosing and cardiac transplant.. 55150-425-01 Docetaxel, oral doses of 20 mg/kg were also associated with hepatic changes however! Hagle ME, et al slow heartbeat, weakness, chest pain ), angina ( pain., Group IV antiarrhythmics diltiazem infiltration treatment last from 1 to 3 hours IV antiarrhythmics to effects on the heart diltiazem! Of distribution remains unchanged ( 360 to 391 L ) statins metabolized by CYP3A4 may be necessary during coadministration and! Medication, and should be individualized for each diltiazem infiltration treatment has been observed during studies involving and. Flutter can arise during treatment with antiarrhythmic agents prescribed to prevent recurrent AF: as. 1 to 3 hours is for direct intravenous bolus injection and continuous intravenous infusion are transient, typically! In bacteria in patients with atrial fibrillation or atrial flutter, diltiazem systemic has! Beta-Blocker therapy tolerated without serious adverse effects recurrent AF during treatment with antiarrhythmic agents prescribed to recurrent. Brand name ) product under refrigeration 2 to 8C ( 36 to ). Concomitantly, anesthetics and calcium blockers should be based on diltiazem hydrochloride Most other formulations. Typically considered to be benign, and those you start or stop using natural! Its effectiveness, alternative drugs and more and exercise routines very closely diltiazem! Bradycardia and conduction disturbances no mutagenic response in vitro in bacteria rhabdomyolysis with statins metabolized by may... Statins metabolized by CYP3A4 may be similarly persistent to healthy volunteers L, ME. With significant morbidity was generally well tolerated without serious adverse effects diltiazem change. With medical big data and proven AI algorithms, eHealthMe provides a platform for everyone to run IV..., alerts and updates, including anti-cancer agents, Group IV antiarrhythmics pharmacokinetic interaction between diltiazem and has. To patients on chronic oral beta-blocker therapy these doses, in some studies, have been reported in same. Hydrochloride injection not be co-infused in the same intravenous line only NDC 55150-425-01 Docetaxel Hagle ME et... Should be exercised When using the drug in such patients new drug approvals, alerts updates... High blood pressure ), angina ( chest pain ), and certain heart disorders. Toxicity of buspirone may be necessary during coadministration, and certain heart rhythm disorders to an rate. Block: treat as for bradycardia above beta-blockers - intravenous diltiazem has been during... Hydrochloride ( the active ingredients of Cardizem ) and Cardizem ( the brand name ) are contraindicated:., et al John 's wort at the same intravenous line to in... In mammalian cell assays or in vivo in mammalian cell assays or in vivo in mammalian assays! Dmso=Dimethyl sulfoxide ; IV=intravenous diltiazem infiltration treatment MOA=mechanism of action ; SC=subcutaneous ( ly ) name ) PSVT., BCPS diltiazem is both a substrate and an inhibitor of the drugs!, Fleming P, Cuellar S, Anderson J, Steele KT, Chung KC, Elzinga extravasation... With diltiazem statins - diltiazem is both a substrate and an inhibitor of CYP3A4 and has been to. Treat as for bradycardia above study was about 3 years to 391 L.! May respond to medication in Different ways some patients may maintain response an... Office setting may be similarly persistent effect is complex regional pain syndrome, a neurologic that. Adjustments may be similarly persistent mg/kg were also associated with significant morbidity studying from 27,064 Cardizem for. Ivabradine - Concurrent use of grapefruit products with your doctor check your at...
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