Store diltiazem at room temperature away from moisture and heat. 2023 eHealthMe.com. Read More Copyright 1996-2023 Cerner Multum, Inc. 0000012749 00000 n Fibrosis or fatty infiltration can also affect the sinus node and might be a reaction to inflammatory or degenerative processes that are difficult to detect. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Compatibility: Diltiazem hydrochloride injection was tested for compatibility with three commonly used intravenous fluids at a maximal concentration of 1 mg diltiazem hydrochloride per milliliter. In: Nelson LS, Howland MA, Lewin NA, Smith SW, Goldfrank LR, Hoffman RS, eds. It is based on diltiazem hydrochloride (the active ingredients of Cardizem) and Cardizem (the brand name). Treatment is outlined in Table 2 below. Diltiazem may also be used for purposes not listed in this medication guide. With medical big data and AI algorithms, eHealthMe is running millions of phase IV trials and makes the results available to the public. Overdose symptoms may include slow heartbeat, weakness, chest pain, shortness of breath, or fainting. unpredictable hypotension in some patients. These antiarrhythmic agents were intravenous or oral digoxin, Class 1 antiarrhythmics (e.g., quinidine, procainamide), calcium channel blockers, and oral beta-blockers. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. 0000025065 00000 n To make swallowing easier, ask your doctor or pharmacist if you can open a diltiazem capsule and sprinkle the medicine into a spoonful of applesauce. For Direct Intravenous Bolus trailer Cardizem has active ingredients of diltiazem hydrochloride. There was an increased incidence of stillbirths at doses of 20 times the human oral antianginal dose or greater. Dosage of drugs is not considered in the study. Diltiazem may also be used for purposes not listed in this medication guide. Injectable forms of diltiazem are contraindicated in: 1. Drug classes: Calcium channel blocking agents, Group IV antiarrhythmics. Dermatologic: Pruritus, sweating Diltiazem slows the ventricular rate in patients with a rapid ventricular response during atrial fibrillation or atrial flutter. These metabolites are observed, however, following 24 hour constant rate intravenous infusion. Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium channel antagonist). The best therapeutic agent for treatment of vasopressor extravasation is intradermal phentolamine. 0000001883 00000 n 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 Prez Fidalgo JA, Garca Fabregat L, Cervantes A, et al. Worldwide experience in over 1,300 patients was similar. Infusion Therapy Standards of Practice, 8th edition. When considering therapy for atrial fibrillation (AF), the dominant issues are rate control, anticoagulation, rhythm control, and treatment of any underlying disorder. Injection and Continuous Leave the catheter or needle in place initially to attempt to aspirate fluid from the extravasated area. To minimize the risk of dislodging the catheter, veins in the hands Diltiazem is a calcium channel blocker. Avoid taking herbal supplements containing St. John's wort at the same time you are taking diltiazem. The risk of myopathy and rhabdomyolysis with statins metabolized by CYP3A4 may be increased with concomitant use of diltiazem. Diltiazem Hydrochloride Injection is for direct intravenous bolus injection and continuous intravenous infusion. Fixed high-degree AV block should be treated with cardiac pacing. Prompt interdisciplinary action is often necessary for the treatment of extravasation injuries. Be careful if you drive or do anything that requires you to be alert. Apply dry warm or cold compresses as indicated depending on the drug extravasated. An antiarrhythmic useful in the treatment of premature ventricular contractions (PVC's), ventricular tachycardia (VT) and persistent ventricular . Extended-release diltiazem capsules should be taken on an empty stomach (this means one hour before food or two hours after food). 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. Monitoring for quinidine adverse effects may be warranted and the dose adjusted accordingly. 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). Continuous Intravenous Infusion Stopping suddenly may make your condition worse. Dolasetron . 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. One hundred two (102) patients <65 had a response rate of 78%. 512 0 obj <> endobj Statins - Diltiazem is an inhibitor of CYP3A4 and has been shown to increase significantly the AUC of some statins. Quinidine - Diltiazem significantly increases the AUC(0) of quinidine by 51%, T1/2 by 36% and decreases its CLoral, by 33%. 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. 6. When extravasation does occur, management is largely supportive and non-pharmacologic in nature. Sterile 25 mL Single-Dose Vial You may also need frequent blood tests. It has a pH range of 3.7 to 4.1. The alternative is to use topical nifedipine or oral diltiazem. Le A, Patel S. Extravasation of noncytotoxic drugs: a review of the literature. If there is no response to vagal blockade administer isoproterenol cautiously. Floxuridine . Dermatologic events progressing to erythema multiforme and/or exfoliative dermatitis have been infrequently reported following oral diltiazem. You may need to use blood pressure medicine for the rest of your life. It has no effect on the sinus node recovery time or on the sinoatrial conduction time in patients without SA nodal dysfunction. Cardizem undergoes extensive metabolism in which 2% to 4% of the unchanged drug appears in the urine. Management of drug extravasations. 0000008421 00000 n Administration of oral diltiazem in patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission is contraindicated. The combination of the two drugs was well tolerated without serious adverse effects. However, the study had only a small number of However, if you have symptoms of low blood pressure (dizziness, fainting, weakness, or blurred vision), call your doctor and stop taking diltiazem. Rifampin - Coadministration of rifampin with diltiazem lowered the diltiazem plasma concentrations to undetectable levels. 0000030204 00000 n Extravasation is defined as the leakage or inadvertent administration of a vesicant drug or solution from a vein into the extravascular space.1 Infiltration, often used in reference to extravasation, refers to leakage of a non-vesicant drug or solution.2,3 Initial symptoms of extravasation are similar to infiltration and include persistent pain, burning, stinging, swelling, and either blanching or erythema at the site of injection or along the course of the vein. Metabolites N-monodesmethyldiltiazem, desacetyldiltiazem, desacetyl-N-monodesmethyldiltiazem, desacetyl-O-desmethyldiltiazem, and desacetyl-N, O-desmethyldiltiazem have been identified in human urine. The following adverse reaction rates are based on the use of diltiazem hydrochloride injection in over 400 domestic clinical trial patients with atrial fibrillation/flutter or PSVT under double-blind or open-label conditions. Our analysis results are available to researchers, health care professionals, patients (testimonials), and software developers (open API). Computer-based simulations showed that at a daily dose of 480 mg of diltiazem, an 8- to 9-fold mean increase in simvastatin AUC can be expected. eugia, Rx only NDC 55150-427-10 xref 4. Sterile 5 mL Single-Dose Vial, Rx only NDC 55150-425-10 You may need to use blood pressure medicine for the rest of your life. Discard Unused Portion Store Under Refrigeration Beta-blockers - Intravenous diltiazem has been administered to patients on chronic oral beta-blocker therapy. It works by relaxing the blood vessels so the heart does not have to pump as hard. Additionally, cold reduces local inflammation and pain. For Direct Intravenous Bolus Injection and Experience with this dose is limited. This article summarizes the latest recommendations for treatment of extravasation, and updates a similar article prepared by our group in 2015. Infiltration- inadvertent administration of non-vesicant medication or fluid into the surrounding tissues. 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. 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. Transition to other antiarrhythmic agents following administration of diltiazem hydrochloride injection is generally safe. 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. The average age of the children in this study was about 3 years. For either indication and particularly when employing continuous intravenous infusion, the setting should include continuous monitoring of the ECG and frequent measurement of blood pressure. red skin lesions, often with a purple center. Reproduction studies have been conducted in mice, rats, and rabbits. Subsequent dose adjustments may be necessary during coadministration, and should be based on clinical assessment. Document infiltration and report to ED RN ASAP for antidote Liver cirrhosis was shown to reduce diltiazem's apparent oral clearance and prolong its half-life. Eugia Pharma Specialities Limited 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. 0000010832 00000 n Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker. 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. Other: acute generalized exanthematous pustulosis, allergic reactions, angioedema (including facial or periorbital edema), CPK elevation, epistaxis, eye irritation, gingival hyperplasia, hemolytic anemia, hyperglycemia, impotence, increased bleeding time, leukopenia, muscle cramps, myopathy, nasal congestion, nocturia, osteoarticular pain, photosensitivity (including lichenoid keratosis and hyperpigmentation at sun-exposed skin areas), polyuria, retinopathy, sexual difficulties, thrombocytopenia, tinnitus. In patients with atrial fibrillation or atrial flutter, diltiazem systemic clearance has been found to be decreased compared to healthy volunteers. You can use the study as a second opinion to make health care decisions. Certain drugs cause vasospasms, which result in back pressure at the intravenous (IV) site and may expand the puncture site in the vein, allowing leakage to occur; drugs that act as vasoconstrictors can also cause tissue ischemia. Injection and Continuous Diltiazem is called a calcium channel . Management of extravasation injuries: a focused evaluation of noncytotoxic medications. 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. 0000030660 00000 n Discard Unused Portion Store Under Refrigeration 0000025152 00000 n In addition, caution should be used in patients taking other drugs that decrease peripheral resistance, intravascular volume, myocardial contractility or conduction. If coadministration of simvastatin with diltiazem is required, limit the daily doses of simvastatin to 10 mg and diltiazem to 240 mg. @ HCl Injection 3. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. When used concomitantly, anesthetics and calcium blockers should be titrated carefully. Diltiazem Injection Prescribing Information. Diltiazem shows dose-dependent, non-linear pharmacokinetics. 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%. Hyderabad 500032 Treatment should begin as soon as possible and no later than 6 hours after extravasation. Hudson, OH: Wolters Kluwer Health; 2021. http://onlinelexi.com. Following oral administration, 2% to 4% of the unchanged diltiazem appears in the urine. These doses, in some studies, have been reported to cause skeletal abnormalities. You should not use diltiazem if you are allergic to it, or if you have: a serious heart condition such as "sick sinus syndrome" or "second- or third-degree AV block" (unless you have a pacemaker); if you have recently had a heart attack and you have a build-up of fluid in your lungs. 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Diltiazem hydrochloride injection is for Direct Intravenous Bolus injection and Continuous Intravenous infusion applies to your personal circumstances SW Goldfrank!, and updates a similar article prepared by our Group in 2015 apply dry warm or cold as. Displayed on this page applies to your personal circumstances appears in the hands diltiazem is a channel. Concomitantly, anesthetics and calcium blockers should be treated with cardiac pacing ventricular pacemaker observed,,... With diltiazem lowered the diltiazem plasma concentrations to undetectable levels heart does have. Patients with atrial fibrillation or atrial flutter, diltiazem systemic clearance has been found to be compared. Constant rate Intravenous infusion, Goldfrank LR, Hoffman RS, eds,! Rs, eds atrial fibrillation or atrial flutter, diltiazem systemic clearance been! Requires you to be decreased compared to healthy volunteers occur, management largely. Concomitant use of diltiazem are contraindicated in: 1 use of diltiazem algorithms, eHealthMe is millions... To the public ) patients < 65 had a response rate of 78 % the displayed... Your life frequent blood tests antiarrhythmic agents following administration of diltiazem hydrochloride your.... In some studies, have been reported to cause skeletal abnormalities testimonials ), and rabbits unchanged... Between the elderly and younger patients and rhabdomyolysis with statins metabolized by CYP3A4 may be necessary during,..., patients ( testimonials ), and rabbits in: Nelson LS, Howland,...