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. Maximal hemodynamic effects usually occurred within 2 to 5 minutes of an injection. A defibrillator and emergency equipment should be readily available. 279 Princeton-Hightstown Rd. 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. Discard Unused Portion Store Under Refrigeration Many drugs can interact with diltiazem, and your doctor may need to change your treatment plan if you use certain other medicines. Direct Intravenous Single Injections (Bolus) Clinical studies of diltiazem did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. "treatment" for extravasation reactions is prevention. In vitro, propranolol appears to be displaced from its binding sites by diltiazem. 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]. Oral diltiazem, 60 mg twice daily, is given for eight weeks. Heather Ipema, PharmD, BCPS The vial stopper is not made with natural rubber latex. Pharmacokinetics and Metabolism You may need to use blood pressure medicine for the rest of your life. Pregnancy Other drugs that have the same active ingredients (e.g. Although it is not possible to prevent all accidents, a few simple precautions can minimize the risk to the patient. Apply compresses for 20 to 60 minutes 3 or 4 times daily for the first 24 to 72 hours after extravasation occurs. Other prescription and over-the-counter medicines, vitamins, and herbal products may interact with diltiazem. Eugia US LLC Diltiazem slows the ventricular rate in patients with a rapid ventricular response during atrial fibrillation or atrial flutter. Discard Unused Portion Store Under Refrigeration Cardizem, Cartia XT, Cardizem CD, Dilt-XR, +7 more. Drug Interactions Your blood pressure will need to be checked often. The information presented is current as of January 13, 2021. Diltiazem Injection Prescribing Information. Some reports may have incomplete information. India 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. 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. Mechanisms of Action eHealthMe is studying from 27,064 Cardizem users for its effectiveness, alternative drugs and more. 0000008421 00000 n 0000030705 00000 n Diltiazem is an oral and parenteral non-dihydropyridine calcium channel blocker. Medically reviewed by Kaci Durbin, MD. Grapefruit and grapefruit juice may interact with diltiazem and lead to unwanted side effects. An antiarrhythmic useful in the treatment of premature ventricular contractions (PVC's), ventricular tachycardia (VT) and persistent ventricular . Osmolality is also a consideration, as differences in osmotic pressure can damage endothelial cells, leading to potential for drug leakage from vessels. Heart rate reduction may last from 1 to 3 hours. Results of our real-world drug study have been referenced on 600+ medical publications, including The Lancet, Mayo Clinic Proceedings, and Nature. The vein used should be a large, intact vessel with good blood flow. 0000000016 00000 n Treatment considerations are outlined in Table 3 below. Gorski LA, Hadaway L, Hagle ME, et al. Medications used to treat insulin resistance, hyperlipidemia, and obesity have been shown to improve transaminase levels, steatosis, and histologic findings. Get your prescription refilled before you run out of medicine completely. 125 mg per 25 mL (5 mg/mL) AdultsAt first, 180 milligrams (mg) once a day, either in the morning or evening. The mean ejection fraction and cardiac output/index remained unchanged or increased. However, no treatments have been shown. The use of the eHealthMe site and its content is at your own risk. In the perinatal/postnatal studies there was some reduction in early individual pup weights and survival rates. 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). 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). Most other diltiazem formulations can be . Diltiazem interacts with many medications. 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. These antiarrhythmic agents were intravenous or oral digoxin, Class 1 antiarrhythmics (e.g., quinidine, procainamide), calcium channel blockers, and oral beta-blockers. 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. Wang RY. Diltiazem 332 0 obj <> endobj Tell your doctor about all medicines you use, and those you start or stop using. 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. The phase IV clinical study analyzes which people take Cardizem and have Infusion site extravasation. 0000002293 00000 n You should not breastfeed while using this medicine. The combination of the two drugs was well tolerated without serious adverse effects. Diltiazem hydrochloride injection was found to be physically compatible and chemically stable in the following parenteral solutions for at least 24 hours when stored in glass or polyvinylchloride (PVC) bags at controlled room temperature 15 to 30C (59 to 86F) or under refrigeration 2 to 8C (36 to 46F). Abbreviations: DMSO=dimethyl sulfoxide; IV=intravenous; MOA=mechanism of action; SC=subcutaneous(ly). Digitalis - Intravenous diltiazem has been administered to patients receiving either intravenous or oral digitalis therapy. Cytarabine . HCl Injection Gastrointestinal: Anorexia, diarrhea, dysgeusia, dyspepsia, mild elevations of SGPT and LDH, thirst, weight increase The effect may be mediated by cimetidine's known inhibition of hepatic cytochrome P-450, the enzyme system responsible for the first-pass metabolism of diltiazem. 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. ACR Manual on Contrast Media 2020. It is based on diltiazem hydrochloride (the active ingredients of Cardizem) and Cardizem (the brand name). 0000030429 00000 n For Direct Intravenous Bolus Injection and Diltia XT, Dilt-XR, Diltzac, Matzim LA, Taztia XT, Tiadylt ER, Tiazac. There was also no mutagenic response in vitro or in vivo in mammalian cell assays or in vitro in bacteria. We comply with the HONcode standard for trustworthy health information. HCl Injection Diltiazem is a calcium channel blocker. This can damage the blood vessels of the brain . The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. It has no effect on the sinus node recovery time or on the sinoatrial conduction time in patients without SA nodal dysfunction. Discuss the use of grapefruit products with your doctor. Calcium gluconate has also been administered as a continuous infusion at a rate of 2 g per hour for 10 hours. 0000006222 00000 n Subsequent dose adjustments may be necessary during coadministration, and should be based on clinical assessment. HCl Injection It has a pH range of 3.7 to 4.1. Rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm. With medical big data and AI algorithms, eHealthMe is running millions of phase IV trials and makes the results available to the public. High-degree AV Block: Treat as for bradycardia above. Consider debridement and excision of necrotic tissue if pain continues for 1 to 2 weeks or in the case of infection or clinical deterioration. Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4-(5H)-one,3-(Acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(-4-methoxyphenyl)-, monohydrochloride, (+)-cis-. An adjustment in the diltiazem dose may be warranted. 2. 26,148 people reported to have side effects when taking Cardizem. In vitro studies suggest alpha1-acid glycoprotein binds approximately 40% of the drug at clinically significant concentrations. Dermatologic events progressing to erythema multiforme and/or exfoliative dermatitis have been infrequently reported following oral diltiazem. Transition to other antiarrhythmic agents following administration of diltiazem hydrochloride injection is generally safe. However, the study had only a small number of Other events reported in at least 1% of the diltiazem-treated patients were injection site reactions (e.g., itching, burning) 3.9%, vasodilation (flushing) 1.7%, and arrhythmia (junctional rhythm or isorhythmic dissociation) 1.0 %. Diltiazem shows dose-dependent, non-linear pharmacokinetics. Sterile 25 mL Single-Dose Vial Duration of infusion longer than 24 hours and infusion rates greater than 15 mg/h have not been studied. Nursing Mothers Diltiazem To minimize the risk of dislodging the catheter, veins in the hands However, since both drugs affect AV nodal conduction, patients should be monitored for excessive slowing of the heart rate and/or AV block. Patients with severe hypotension or cardiogenic shock. 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. Patients should be monitored for signs of hypercalcemia. 7. When treatment for hypotension was required, it generally consisted of administration of saline or placing the patient in the Trendelenburg position. The risk of toxic reactions to this drug may be greater in patients with impaired renal or hepatic function. Eugia Pharma Specialities Limited Diltiazem can pass into breast milk and may harm a nursing baby. Diltiazem hydrochloride injection is for direct intravenous bolus injection and continuous intravenous infusion. %PDF-1.5 % Atrial flutter can arise during treatment with antiarrhythmic agents prescribed to prevent recurrent AF. %%EOF 0 Ventricular Premature Beats (VPBs) - VPBs may be present on conversion of PSVT to sinus rhythm with diltiazem hydrochloride injection. Discard unused portion. 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. 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Outlined in Table 3 below Hadaway L, Hagle ME, et al pup weights and survival rates simple... Dose adjustments may be necessary during coadministration, and should be readily available remained unchanged or increased lead to side! Accidents, a few simple precautions can minimize the risk of toxic reactions to this drug may warranted! No mutagenic response in vitro in bacteria extravasation reactions is prevention can arise during treatment with agents!, a few simple precautions can minimize the risk of toxic reactions to this drug may be greater patients... Or placing the patient in the diltiazem dose may be greater in patients with impaired renal or hepatic.. Greater in patients without SA nodal dysfunction suggest alpha1-acid glycoprotein binds approximately 40 % the. Cardizem ) and Cardizem ( the brand name ) over-the-counter medicines, vitamins, Nature... Necrotic tissue if pain continues for 1 to 2 weeks or in vitro in bacteria, Hadaway,!