Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker or calcium channel antagonist). 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. Some patients may respond to an initial dose of 0.15 mg/kg, although duration of action may be shorter. Congestive Heart Failure - Although diltiazem has a negative inotropic effect in isolated animal tissue preparations, hemodynamic studies in humans with normal ventricular function and in patients with a compromised myocardium, such as severe CHF, acute MI, and hypertrophic cardiomyopathy, have not shown a reduction in cardiac index nor consistent negative effects on contractility (dp/dt). 5. Eugia US LLC If you are being treated for high blood pressure, keep using this medicine even if you feel well. 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. Diltiazem infiltration Common Questions and Answers about Diltiazem infiltration tiazac I am currently on 30 mg of diltiazem 3x day and i was wondering how effective is this dose at bring down your blood pressure. 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. Generic name: diltiazem [dil-TYE-a-zem] 25 mg per 5 mL In: Nelson LS, Howland MA, Lewin NA, Smith SW, Goldfrank LR, Hoffman RS, eds. 0000008421 00000 n 25 mg per 5 mL (5 mg/mL) 5 mL Single-Dose Vials 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. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. %%EOF The following are common drugs that interact with diltiazem; Not all possible interactions are listed in this medication guide. There was also no mutagenic response in vitro or in vivo in mammalian cell assays or in vitro in bacteria. In a ten-subject randomized, open label, 4-way crossover study, coadministration of diltiazem (120 mg bid, diltiazem SR for 2 weeks) with a single 20 mg dose of lovastatin resulted in a 3- to 4-fold increase in mean lovastatin AUC and Cmax versus lovastatin alone. Some patients may maintain response to an initial rate of 5 mg/h. Therefore, the potential for these dermatologic reactions exists following exposure to intravenous diltiazem. 0000012749 00000 n Diltiazem slows the ventricular rate in patients with a rapid ventricular response during atrial fibrillation or atrial flutter. Cytarabine . Overdose symptoms may include slow heartbeat, weakness, chest pain, shortness of breath, or fainting. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. The combination of the two drugs was well tolerated without serious adverse effects. show all 12 brands Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4-(5H)-one,3-(Acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(-4-methoxyphenyl)-, monohydrochloride, (+)-cis-. Blood and urine tests may be needed to check for unwanted effects. The toxic dose in man is not known. In addition, the following events were reported infrequently (less than 1%): Nursing Mothers unpredictable hypotension in some patients. Drugs which induce or inhibit hepatic microsomal enzymes may alter diltiazem disposition. . Immediately stop the IV push or infusion if the patient complains of pain or a burning sensation. An overdose of diltiazem can be fatal. hbbd``b`f3J "-@ ?y "RD%qAaLL )' dJ Sterile 5 mL Single-Dose Vial, Rx only NDC 55150-425-10 Among them, 22 people (0.08%) have Infusion site extravasation. 3. A. Descriptions. (5 mg/mL) Medications used to treat insulin resistance, hyperlipidemia, and obesity have been shown to improve transaminase levels, steatosis, and histologic findings. in adult patients. Cardizem, Cartia XT, Cardizem CD, Dilt-XR, +7 more. If possible, it is recommended that diltiazem hydrochloride injection not be co-infused in the same intravenous line. 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). These VPBs are transient, are typically considered to be benign, and appear to have no clinical significance. These metabolites are observed, however, following 24 hour constant rate intravenous infusion. 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. Manufactured by: 50-mg, 10-mL vialeach sterile vial contains 50 mg diltiazem hydrochloride, 7.5 mg citric acid USP, 6.5 mg sodium citrate dihydrate USP, 714 mg sorbitol solution USP, and water for injection USP up to 10 mL. If use of diltiazem hydrochloride is deemed essential, an alternative method of infant feeding should be instituted. Pharmacological management of anticancer agent extravasation: A single institutional guideline. endstream endobj 363 0 obj <>/Filter/FlateDecode/Index[10 322]/Length 34/Size 332/Type/XRef/W[1 1 1]>>stream 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. Coadministration of diltiazem with rifampin or any known CYP3A4 inducer should be avoided when possible, and alternative therapy considered. 0000001178 00000 n Acute Hepatic Injury - In rare instances, significant elevations in enzymes such as alkaline phosphatase, LDH, SGOT, SGPT, and other phenomena consistent with acute hepatic injury have been noted following oral diltiazem. It has a molecular weight of 451.0. Prez Fidalgo JA, Garca Fabregat L, Cervantes A, et al. The vial stopper is not made with natural rubber latex. Atrial fibrillation or atrial flutter - In clinical studies with diltiazem hydrochloride injection for AF/FI, 135 of 257 patients were 65 years of age. In subacute and chronic dog and rat studies designed to produce toxicity, high oral doses of diltiazem were associated with hepatic damage. * Approximation only. Package insert / product label Packaged in a Carton of 10 NDC 55150-425-10 Treatment should begin as soon as possible and no later than 6 hours after extravasation. Do not remove the IV device or noncoring port needle. Pharmacodynamics 5. Nervous System: Dizziness, paresthesia Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position If you feel dizzy, lie . Following single intravenous injection of diltiazem hydrochloride, however, plasma concentrations of N-monodesmethyldiltiazem and desacetyldiltiazem, two principal metabolites found in plasma after oral administration, are typically not detected. Upon discontinuation of infusion, heart rate reduction may last from 0.5 hours to more than 10 hours (median duration 7 hours). 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. Cardiovascular: AV block (third degree), bundle branch block, ECG abnormality, palpitations, syncope, tachycardia, ventricular extrasystoles %PDF-1.5 % 0 Our analysis results are available to researchers, health care professionals, patients (testimonials), and software developers (open API). Diltiazem hydrochloride injection is clear, colorless, sterile, nonpyrogenic solution and is supplied as follows: Mean plasma diltiazem concentrations of 130 ng/mL and 300 ng/mL were determined to produce reductions in heart rate of 30% and 40%. Gorski LA, Hadaway L, Hagle ME, et al. (5 mg/mL) Renal insufficiency, or even end-stage renal disease, does not appear to influence diltiazem disposition following oral administration. Discard Unused Portion Store Under Refrigeration Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. When possible, use a non-CYP3A4-metabolized statin together with diltiazem; otherwise, dose adjustments for both diltiazem and the statin should be considered along with close monitoring for signs and symptoms of any statin related adverse events. diltiazem) in the acute setting to slow the ventricular response to AF in . If it continues for a long time, the heart and arteries may not function properly. This article summarizes the latest recommendations for treatment of extravasation, and updates a similar article prepared by our group in 2015. Knowledge of the mechanism of extravasation-induced tissue injury, agents for reversal, and appropriate nonpharmacologic treatment methods is essential. Diltiazem may impair your thinking or reactions. It should not be used in patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in Wolff-Parkinson-White (WPW) syndrome or short PR syndrome. High-degree AV Block: Treat as for bradycardia above. Competitive in vitro ligand binding studies have shown that diltiazem binding is not altered by therapeutic concentrations of digoxin, phenytoin, hydrochlorothiazide, indomethacin, phenylbutazone, propranolol, salicylic acid, tolbutamide, or warfarin. All information is observation-only. 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]. Keep diluted diltiazem hydrochloride injection refrigerated until use. Diltiazem may be used for the treatment of high blood pressure or chronic stable angina. Unless otherwise contraindicated, appropriate vagal maneuvers should be attempted prior to administration of diltiazem hydrochloride injection. 4. startxref Patients taking other drugs that are substrates of CYP450 3A4, especially patients with renal and/or hepatic impairment, may require dosage adjustment when starting or stopping concomitantly administered diltiazem in order to maintain optimum therapeutic blood levels. Last updated on Apr 1, 2023. Discard unused portion. In the same study, there was no significant change in 20 mg single dose pravastatin AUC and Cmax during diltiazem coadministration. 0000022294 00000 n HCl Injection Once familiarity of the patient's response is established, use in an office setting may be acceptable. An antiarrhythmic useful in the treatment of premature ventricular contractions (PVC's), ventricular tachycardia (VT) and persistent ventricular . Patients receiving these drugs concurrently should be monitored for a potential drug interaction. Available for Android and iOS devices. Disconnect IV tubing from IV device. Diltiazem is a potent coronary but a mild arterial vasodilator, producing . May be stored at room temperature for up to 1 month. , et al pravastatin AUC and Cmax during diltiazem coadministration and Cmax during diltiazem coadministration and rat studies to! Call the Poison Help line at 1-800-222-1222 any known CYP3A4 inducer should be attempted prior to administration of with... 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