Dosage of drugs is not considered in the study. Patients who have demonstrated hypersensitivity to the drug. Cytarabine, liposomal. Common diltiazem side effects may include: This is not a complete list of side effects and others may occur. In vitro, propranolol appears to be displaced from its binding sites by diltiazem. HCl Injection Irritant- agents capable of causing pain, swelling, venous irritation and chemical phlebitis at the injection site (calcium gluconate, digoxin, erythromycin, gentamicin). (5 mg/mL) 512 0 obj <> endobj 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. The phase IV clinical study analyzes which people take Cardizem and have Infusion site extravasation. Some patients may maintain response to an initial rate of 5 mg/h. Rhinitis, headache, and constipation are commonly reported side effects. Worldwide experience in over 1,300 patients was similar. A defibrillator and emergency equipment should be readily available. Cardiac Failure: Administer inotropic agents (isoproterenol, dopamine, or dobutamine) and diuretics. Purpose of review Calcinosis cutis, or dystrophic soft-tissue calcification, is a common and debilitating complication of adult and juvenile dermatomyositis. 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. 25 mg per 5 mL Management of chemotherapy extravasation: ESMO-EONS clinical practice guidelines. Disconnect IV tubing from IV device. FDA-approved indications include atrial arrhythmia, hypertension, paroxysmal supraventricular tachycardia, and chronic stable angina. However, since both drugs affect AV nodal conduction, patients should be monitored for excessive slowing of the heart rate and/or AV block. Sodium hydroxide or hydrochloric acid is used for pH adjustment. red, irritated eyes. Docetaxel . The infusion may be maintained for up to 24 hours. Administration of other calcium channel blockers to patients with wide complex tachycardia (QRS 0.12 seconds) has resulted in hemodynamic deterioration and ventricular fibrillation. Medically reviewed by Kaci Durbin, MD. Gastrointestinal: Anorexia, diarrhea, dysgeusia, dyspepsia, mild elevations of SGPT and LDH, thirst, weight increase Store product under refrigeration 2 to 8C (36 to 46F). Hudson, OH: Wolters Kluwer Health; 2021. http://onlinelexi.com. Diltiazem hydrochloride injection is for direct intravenous bolus injection and continuous intravenous infusion. Prompt interdisciplinary action is often necessary for the treatment of extravasation injuries. It also increases the supply of blood and oxygen to the heart. The drug should be used with caution in patients with impaired renal or hepatic function (see WARNINGS). (5 mg/mL) Your blood pressure will need to be checked often. Infiltration- inadvertent administration of non-vesicant medication or fluid into the surrounding tissues. 5. Other drugs that have the same active ingredients (e.g. However, reference should be made to the respective agent manufacturer's package insert for information relative to dosage and administration. Elevate the affected limb to minimize swelling and encourage resorption of the drug via the lymphatic system. Some patients may respond to an initial dose of 0.15 mg/kg, although duration of action may be shorter. Treatment should begin as soon as possible and no later than 6 hours after extravasation. In the same study, there was no significant change in 20 mg single dose pravastatin AUC and Cmax during diltiazem coadministration. 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). Diltiazem is in a class of medications called calcium-channel blockers. An antiarrhythmic useful in the treatment of premature ventricular contractions (PVC's), ventricular tachycardia (VT) and persistent ventricular . 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. 25 mL Single-Dose Vials No evidence of impaired fertility was observed in a study performed in male and female rats at oral dosages of up to 100 mg/kg/day. diltiazem) in the acute setting to slow the ventricular response to AF in . HCl Injection Diltiazem slows the ventricular rate in patients with a rapid ventricular response during atrial fibrillation or atrial flutter. Phase IV trials are used to detect adverse drug outcomes and monitor drug effectiveness in the real world. Diltiazem hydrochloride injection is clear, colorless, sterile, nonpyrogenic solution and is supplied as follows: show all 12 brands Extended-release diltiazem capsules should be taken on an empty stomach (this means one hour before food or two hours after food). "treatment" for extravasation reactions is prevention. 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. Blood and urine tests may be needed to check for unwanted effects. A 24-month study in rats at oral dosage levels of up to 100 mg/kg/day and a 21-month study in mice at oral dosage levels of up to 30 mg/kg/day showed no evidence of carcinogenicity. Drug class: calcium channel blocking agents, ANALYSIS(55150-425, 55150-426, 55150-427), MANUFACTURE(55150-425, 55150-426, 55150-427), PACK(55150-425, 55150-426, 55150-427), dextrose (5%) and sodium chloride (0.45%) injection, USP. 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. It has no effect on the sinus node recovery time or on the sinoatrial conduction time in patients without SA nodal dysfunction. As such, the initial use of diltiazem hydrochloride injection should be, if possible, in a setting where monitoring and resuscitation capabilities, including DC cardioversion/defibrillation, are present (see OVERDOSAGE). Packaged in a Carton of 10 NDC 55150-425-10 In the perinatal/postnatal studies there was some reduction in early individual pup weights and survival rates. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Patients with ventricular tachycardia. The effectiveness of intravenous calcium administration to reverse the pharmacological effects of diltiazem overdose has been inconsistent. Diltiazem does not appear to be removed by peritoneal or hemodialysis. 125-mg, 25-mL vialeach sterile vial contains 125 mg diltiazem hydrochloride, 18.75 mg citric acid USP, 16.25 mg sodium citrate dihydrate USP, 1,785 mg sorbitol solution USP, and water for injection USP up to 25 mL. iv infiltration with diltiazem. Avoid continuous vesicants or irritants (chemotherapy, vasopressors) B. Drug classes: Calcium channel blocking agents, Group IV antiarrhythmics. An adjustment in the diltiazem dose may be warranted. Warm compresses are preferred for extravasation of specific drugs including vinca alkaloids, etoposide, vasopressors, and oxaliplatin to increase local blood flow and enhance drug removal. Diltiazem is well absorbed from the gastrointestinal tract and is subject to an extensive first-pass effect, giving an absolute bioavailability (compared to intravenous dosing) of about 40%. HCl Injection 0000006002 00000 n If hypotension occurs, it is generally short-lived, but may last from 1 to 3 hours. Available for Android and iOS devices. 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. HCl Injection High blood pressure often has no symptoms. 50 mg per 10 mL Experience in the use of antiarrhythmic agents following maintenance infusion of diltiazem hydrochloride injection is limited. Diltiazem shows dose-dependent, non-linear pharmacokinetics. May be stored at room temperature for up to 1 month. 0000022294 00000 n Infusion site extravasation (flow of (blood or lymph) from infusion site) is found to be associated with 1,007 drugs and 478 conditions by eHealthMe. The information presented is current as of January 13, 2021. Most other diltiazem formulations can be . The apparent volume of distribution remains unchanged (360 to 391 L). Heather Ipema, PharmD, BCPS 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. Dosage form: injection, solution Patients with low body weights should be dosed on a mg/kg basis. Patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Brand names: Cardizem (and Cardizem CD, LA and XR), Cartia XT, Dilacor XR, Dilt-CD, Temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter. generic drugs) are not considered. Events such as myocardial infarction have been observed which are not readily distinguishable from the natural history of the disease for the patient. In: Nelson LS, Howland MA, Lewin NA, Smith SW, Goldfrank LR, Hoffman RS, eds. Diltiazem You may need to use blood pressure medicine for the rest of your life. Follow all directions on your prescription label. Paroxysmal supraventricular tachycardia - Clinical studies of diltiazem hydrochloride injection for PSVT did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. 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. In patients administered bolus doses ranging from 2.5 mg to 38.5 mg, systemic clearance averaged 36 L/h. Different individuals may respond to medication in different ways. It may help to increase your ability to exercise and decrease how often you may get angina attacks. Direct Intravenous Single Injections (Bolus) 0000010832 00000 n endstream endobj startxref Experience with this dose is limited. Should a dermatologic reaction persist, the drug should be discontinued. WARNING: Please DO NOT STOP MEDICATIONS without first consulting a physician since doing so could be hazardous to your health. hbbbd`b``3 Atrial flutter can arise during treatment with antiarrhythmic agents prescribed to prevent recurrent AF. Do not freeze. 10 mL Single-Dose Vials Statins - Diltiazem is an inhibitor of CYP3A4 and has been shown to increase significantly the AUC of some statins. An overdose of diltiazem can be fatal. As with other agents which slow AV nodal conduction and do not prolong the refractoriness of the accessory pathway (e.g., verapamil, digoxin), in rare instances patients in atrial fibrillation or atrial flutter associated with an accessory bypass tract may experience a potentially life-threatening increase in heart rate accompanied by hypotension when treated with diltiazem hydrochloride injection. Sodium hydroxide or hydrochloric acid is used for pH adjustment. The average age of the children in this study was about 3 years. Read More Your doctor may occasionally change your dose. Diltiazem Dosage of drugs is not considered in the study. The alternative is to use topical nifedipine or oral diltiazem. Grapefruit and grapefruit juice may interact with diltiazem and lead to unwanted side effects. The T1/2 and Tmax of buspirone were not significantly affected by diltiazem. Diltiazem can pass into breast milk and may harm a nursing baby. 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). 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. Infusion Therapy Standards of Practice, 8th edition. However, the study had only a small number of 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. This information is intended as an educational piece and should not be used as the sole source for clinical decision-making. In addition, caution should be used in patients taking other drugs that decrease peripheral resistance, intravascular volume, myocardial contractility or conduction. In subacute and chronic dog and rat studies designed to produce toxicity, high oral doses of diltiazem were associated with hepatic damage. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Asymptomatic hypotension occurred in 4.3% of patients. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. The combination of the two drugs was generally well tolerated without serious adverse effects. 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. Take the missed dose as soon as you remember. Dolasetron . Our original studies have been referenced on 600+ medical publications including The Lancet, Mayo Clinic Proceedings, and Nature. This includes AV nodal reentrant tachycardias and reciprocating tachycardias associated with an extranodal accessory pathway such as the WPW syndrome or short PR syndrome. 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. Follow your diet, medication, and exercise routines very closely. This article summarizes the latest recommendations for treatment of extravasation, and updates a similar article prepared by our group in 2015. 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High blood pressure often has no effect on the sinoatrial conduction time in patients taking drugs! 10 NDC 55150-425-10 in the acute setting to slow the ventricular rate in with! The respective agent manufacturer 's package insert for information relative to dosage and administration observed are...