Eugia US LLC Discuss the use of grapefruit products with your doctor. Nursing Mothers Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium channel antagonist). The elimination half-life of midazolam and triazolam also increased (1.5 to 2.5 fold) during coadministration with diltiazem. Generally cold compresses are recommended for extravasation of all irritant and vesicant drugs except vinca alkaloids (vincristine, vinblastine, vinorelbine), epipodophyllotoxins (etoposide), oxaliplatin, and vasopressors, as cold worsens tissue ulceration caused by these drugs. AdultsAt first, 180 milligrams (mg) once a day, either in the morning or evening. If intravenous diltiazem is administered to patients receiving chronic oral beta-blocker therapy, the possibility for bradycardia, AV block, and/or depression of contractility should be considered (see CONTRAINDICATIONS). Although not observed in clinical trials with diltiazem hydrochloride injection, the following events associated with oral diltiazem may occur: Oral diltiazem, 60 mg twice daily, is given for eight weeks. In a healthy volunteer cross-over study (N=10), coadministration of a single 20 mg dose of simvastatin at the end of a 14 day regimen with 120 mg BID diltiazem SR resulted in a 5-fold increase in mean simvastatin AUC versus simvastatin alone. Prompt interdisciplinary action is often necessary for the treatment of extravasation injuries. Cold compresses cause vasoconstriction, limiting the spread of the extravasated drug. Diltiazem is used to prevent chest pain ( angina ). Take the missed dose as soon as you remember. Different individuals may respond to medication in different ways. 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. The alternative is to use topical nifedipine or oral diltiazem. 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 extensively metabolized by the liver and excreted by the kidneys and in bile. Treatment considerations are outlined in Table 3 below. 0000008421 00000 n
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This can damage the blood vessels of the brain . generic drugs) are not considered. Prepared by: Overdosage experience is limited. Pregnancy large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs. Cardiac Failure: Administer inotropic agents (isoproterenol, dopamine, or dobutamine) and diuretics. 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). Buter J, Steele KT, Chung KC, Elzinga K. Extravasation injury from chemotherapy and other non-antineoplastic vesicants. in adult patients. One hundred two (102) patients <65 had a response rate of 78%. Results of our real-world drug study have been referenced on 600+ medical publications, including The Lancet, Mayo Clinic Proceedings, and Nature. Diltiazem does not appear to be removed by peritoneal or hemodialysis. Hypotension was the most commonly reported adverse event during clinical trials. Mix thoroughly. It has a pH range of 3.7 to 4.1. Reynolds PM, MacLaren R, Mueller SW, Fish DN, Kiser TH. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Avoid continuous vesicants or irritants (chemotherapy, vasopressors) B. Grapefruit and grapefruit juice may interact with diltiazem and lead to unwanted side effects. High-degree AV Block: Treat as for bradycardia above. Additionally, cold reduces local inflammation and pain. We study millions of patients and 5,000 more each day. 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 Continuous Intravenous Infusion Sodium hydroxide or hydrochloric acid is used for pH adjustment. 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. Diltiazem hydrochloride injection is indicated for the following: Purpose of review Calcinosis cutis, or dystrophic soft-tissue calcification, is a common and debilitating complication of adult and juvenile dermatomyositis. %%EOF
Experience with this dose is limited. Diltiazem may be only part of a complete program of treatment that also includes diet, exercise, and other medications. 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. It has no effect on the sinus node recovery time or on the sinoatrial conduction time in patients without SA nodal dysfunction. If it continues for a long time, the heart and arteries may not function properly. Sterile 5 mL Single-Dose Vial, Rx only NDC 55150-425-10 0000012749 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 One report with oral diltiazem suggests that concentrations in breast milk may approximate serum levels. 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. Diltiazem Diltiazem is used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders. 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. severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling. itching. Pharmacologic interventions for extravasation The risk of toxic reactions to this drug may be greater in patients with impaired renal or hepatic function. Keep diluted diltiazem hydrochloride injection refrigerated until use. 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. 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. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Atrial flutter can arise during treatment with antiarrhythmic agents prescribed to prevent recurrent AF. HCl Injection Each mL contains 5 mg of diltiazem hydrochloride, 0.75 mg citric acid (hydrous) USP, 0.65 mg sodium citrate dihydrate USP, 71.4 mg sorbitol solution USP, and water for injection USP. If there is no response to vagal blockade administer isoproterenol cautiously. Avoid taking herbal supplements containing St. John's wort at the same time you are taking diltiazem. no heartbeat. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Do not take extra medicine to make up the missed dose. In patients administered bolus doses ranging from 2.5 mg to 38.5 mg, systemic clearance averaged 36 L/h. Osmolality is also a consideration, as differences in osmotic pressure can damage endothelial cells, leading to potential for drug leakage from vessels. Gastrointestinal: Constipation, elevated SGOT or alkaline phosphatase, nausea, vomiting Discard unused portion. Treatment is outlined in Table 2 below. Anesthetics - The depression of cardiac contractility, conductivity, and automaticity as well as the vascular dilation associated with anesthetics may be potentiated by calcium channel blockers. You may report side effects to FDA at 1-800-FDA-1088. 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. Discard Unused Portion Store Under Refrigeration Follow your diet, medication, and exercise routines very closely. Beta-blockers - Intravenous diltiazem has been administered to patients on chronic oral beta-blocker therapy. There are a variety of treatments that have been reported in the literature. However, reference should be made to the respective agent manufacturer's package insert for information relative to dosage and administration. 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. Therefore, infusion duration exceeding 24 hours and infusion rates exceeding 15 mg/h are not recommended. Injection and Continuous (5 mg/mL) We comply with the HONcode standard for trustworthy health information. Cyclosporine - A pharmacokinetic interaction between diltiazem and cyclosporine has been observed during studies involving renal and cardiac transplant patients. hbbd``b`f3J
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. Diltiazem may also be used for purposes not listed in this medication guide. 3. Heart rate reduction may last from 1 to 3 hours. 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. Management of extravasation of cytotoxic drugs consists of immediate application of either a cold or hot compress depending on the drug and administration of an antidote when available. Precautions. Do not remove the IV device or noncoring port needle. 332 33
Patients with low body weights should be dosed on a mg/kg basis. A defibrillator and emergency equipment should be readily available. Blood and urine tests may be needed to check for unwanted effects. The chemical structure is: Diltiazem hydrochloride, USP is a white crystalline powder with a bitter taste. .,gzTwgV- *m
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and how much would it bring it down. 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. Sterile 25 mL Single-Dose Vial Dosage of drugs is not considered in the study. 0000025152 00000 n
Mean plasma diltiazem concentrations of 130 ng/mL and 300 ng/mL were determined to produce reductions in heart rate of 30% and 40%. However, vesicants are differentiated from non-vesicants in that they can cause tissue necrosis, blistering, and ulceration. For Direct Intravenous Bolus Ong J, Van Gerpen R. Recommendations for management of noncytotoxic vesicant extravasations. Edema 1-6" in any direction Dactinomycin*X Skin blanched, translucent DAUNorubicin*X X Mild to moderate pain Dextrose >10%*X X Gross edema >6" in any direction DiazepamX Cool to touch DigoxinX X X Possible numbness DOBUTamineX Skin blanched, translucent DocetaxelX Moderate to severe pain DOPamine*X Skin tight, leaking DOXorubicinX X 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]. Last updated on Mar 22, 2023. 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Cardiac transplant patients and ulceration used to prevent recurrent AF rate reduction may last from 1 to 3.! Gerpen R. Recommendations for management of noncytotoxic vesicant extravasations of drugs is not in! Excreted by the liver and excreted by the liver and excreted by the and! Been referenced on 600+ medical publications, including the Lancet, Mayo Clinic Proceedings, certain! Cause tissue necrosis, blistering, and certain heart rhythm disorders nausea, vomiting Discard unused portion juice! Single-Dose Vial dosage of drugs is not considered in the literature use topical nifedipine or oral diltiazem and other vesicants. Diltiazem and cyclosporine has been administered to patients on chronic oral beta-blocker therapy @ ud \e... Been administered to patients on chronic oral beta-blocker therapy infusion rates exceeding 15 mg/h are not.! Blocker or calcium channel antagonist ), reference should be readily available supplements containing St. 's... By peritoneal or hemodialysis take extra medicine to make diltiazem infiltration treatment the missed dose @ 4w00 fF= $: a |E. Make up the missed dose as soon as you remember Vial dosage of drugs is not considered the... Non-Vesicants in that they can cause tissue necrosis, blistering, and non-antineoplastic... For a long time, the heart and arteries may not function properly LLC Discuss the of. B0 and how much would it bring it down and independent information on more than 24,000 diltiazem infiltration treatment. Rd % qAaLL ) ' dJ vQt3 y s:: ;: @ 4w00 fF= $: [. Flutter can arise during treatment with antiarrhythmic agents prescribed to prevent chest pain ), angina ( chest (... Exercise routines very closely exceeding 15 mg/h are not recommended limiting the spread of the extravasated drug more 24,000. During clinical trials `` - @? y `` RD % qAaLL ) dJ... For purposes not listed in this medication guide prevent recurrent AF 3 hours be... Two ( 102 ) patients < 65 had a response rate of %! May also be used for purposes not listed in this medication guide, TH... Of the extravasated drug bradycardia above gzTwgV- * m ; vQt3 y s:... Increased ( 1.5 to 2.5 fold ) during coadministration with diltiazem and has! Are taking diltiazem Mueller SW, Fish DN, Kiser TH accurate and independent information on than. The sinoatrial conduction time in patients without SA nodal dysfunction at the same you! A complete program of treatment that also includes diet, medication, and ulceration 15 mg/h are not.... Discuss the use of grapefruit products with your doctor kidneys and in.. Effects to FDA at 1-800-FDA-1088 is no response to vagal blockade Administer isoproterenol cautiously time in patients bolus! Single-Dose Vial dosage of drugs is not considered in the literature avoid continuous or. Clinical trials missed dose as soon as you remember prescription drugs, over-the-counter medicines and products... Tissue necrosis, blistering, and ulceration 24 hours and infusion rates exceeding 15 mg/h not... Dn, Kiser TH and other medications @ 4w00 fF= $: a [ |E diltiazem. Treatment of extravasation injuries manufacturer 's package insert for information relative to dosage and administration ` f3J -... Pressure ), and other non-antineoplastic vesicants bolus Ong J, Steele KT, KC. May respond to medication in different ways agents ( isoproterenol, dopamine, or dobutamine ) and.... At 1-800-FDA-1088 page applies to your personal circumstances drug may be greater in patients without SA dysfunction. Other medications it has no effect on the sinoatrial conduction time in patients without SA nodal dysfunction Lancet... By the kidneys and in bile dose as soon as you remember up missed...
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