Avoid continuous vesicants or irritants (chemotherapy, vasopressors) B. Reynolds PM, MacLaren R, Mueller SW, Fish DN, Kiser TH. Available for Android and iOS devices. Eugia Pharma Specialities Limited 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. Some side effects may occur that usually do not need medical attention. This information is intended as an educational piece and should not be used as the sole source for clinical decision-making. 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. In subgroup analysis of double-blind and open-label trials following first-dose response, 116 patients 65 years of age had a response rate of 84%. 0000024987 00000 n If response is inadequate, a second dose may be administered after 15 minutes. The vial stopper is not made with natural rubber latex. Adverse events reported in controlled and uncontrolled clinical trials were generally mild and transient. Diltiazem may also be used for purposes not listed in this medication guide. Continuous Intravenous Infusion There was also no mutagenic response in vitro or in vivo in mammalian cell assays or in vitro in bacteria. The toxic dose in man is not known. It works by relaxing the blood vessels so the heart does not have to pump as hard. Concomitant use of diltiazem with agents known to affect cardiac conduction may result in additive effects (see Drug Interactions). However, sloughing can occur from the application of a warm compress to an area infiltrated with certain medications such as potassium chloride. These pharmacokinetic effects seen during diltiazem coadministration can result in increased clinical effects (e.g. Other drugs that have the same active ingredients (e.g. 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. Diltiazem can pass into breast milk and may harm a nursing baby. Diltiazem may impair your thinking or reactions. Patients with ventricular tachycardia. Skip the missed dose if it is almost time for your next scheduled dose. hb```l 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. endstream endobj 363 0 obj <>/Filter/FlateDecode/Index[10 322]/Length 34/Size 332/Type/XRef/W[1 1 1]>>stream 5. It is soluble in water, methanol, and chloroform. Hyderabad 500032 red skin lesions, often with a purple center. Sterile eugia 10 x 5 mL Single-Dose Vials, Rx only NDC 55150-426-01 Additionally, cold reduces local inflammation and pain. Distributed by: Most other diltiazem formulations can be . (5 mg/mL) Maximal hemodynamic effects usually occurred within 2 to 5 minutes of an injection. In the event of overdosage or an exaggerated response, appropriate supportive measures should be employed. The elimination half-life of midazolam and triazolam also increased (1.5 to 2.5 fold) during coadministration with diltiazem. Pregnancy 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. 25 mg per 5 mL Avoid taking herbal supplements containing St. John's wort at the same time you are taking diltiazem. Sodium hydroxide or hydrochloric acid is used for pH adjustment. It has a pH range of 3.7 to 4.1. In patients administered bolus doses ranging from 2.5 mg to 38.5 mg, systemic clearance averaged 36 L/h. Following a single intravenous injection in healthy male volunteers, diltiazem hydrochloride appears to obey linear pharmacokinetics over a dose range of 10.5 to 21.0 mg. 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. All information is observation-only. Patients currently receiving diltiazem therapy should be carefully monitored for a change in pharmacological effect when initiating and discontinuing therapy with cimetidine. The purpose of this review is to provide an update of treatment modalities for calcinosis in dermatomyositis based on published . Do not take extra medicine to make up the missed dose. Patients with low body weights should be dosed on a mg/kg basis. 125 mg per 25 mL We comply with the HONcode standard for trustworthy health information. Prepared by: 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. Keep diluted diltiazem hydrochloride injection refrigerated until use. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 0 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. Atrial flutter can arise during treatment with antiarrhythmic agents prescribed to prevent recurrent AF. 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. 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. Diltiazem is both a substrate and an inhibitor of the cytochrome P-450 3A4 enzyme system. Before taking diltiazem, tell your doctor if you have kidney disease, liver disease, or congestive heart failure. The same or an alternative antidote should be given if no response is observed within 30 to 60 minutes of the initial antidote.6, Management of extravasation of cytotoxic drugs. 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. no heartbeat. 1. Extravasation is a potentially serious unintended event associated with IV drug administration. Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position If you feel dizzy, lie . Another long-term effect is complex regional pain syndrome, a neurologic syndrome that requires long-term pain management. As with all drugs, care should be exercised when treating patients with multiple medications. However, vesicants are differentiated from non-vesicants in that they can cause tissue necrosis, blistering, and ulceration. Patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker. Diltiazem hydrochloride injection is for direct intravenous bolus injection and continuous intravenous infusion. 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. Nervous System: Abnormal dreams, amnesia, depression, extrapyramidal symptoms, gait abnormality, hallucinations, insomnia, nervousness, personality change, somnolence, tremor Diltiazem hydrochloride injection is a clear, colorless, sterile, nonpyrogenic solution. Nervous System: Dizziness, paresthesia Heart rate reduction may last from 1 to 3 hours. The goal of antidote administration is to reverse the action of the extravasated agent, interfere with the process of cell destruction, prevent tissue necrosis, or limit the extent of tissue damage.5 The efficacy of antidotes has been evaluated primarily from animal studies or reported anecdotally based on human experience; therefore, their true efficacy is unknown.1-3 Examples of antidotes used in the treatment of extravasation are summarized in Table 1 below. 0000001883 00000 n 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. Metabolites N-monodesmethyldiltiazem, desacetyldiltiazem, desacetyl-N-monodesmethyldiltiazem, desacetyl-O-desmethyldiltiazem, and desacetyl-N, O-desmethyldiltiazem have been identified in human urine. 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. For Direct Intravenous Bolus "treatment" for extravasation reactions is prevention. You should not stop using diltiazem suddenly. When considering therapy for atrial fibrillation (AF), the dominant issues are rate control, anticoagulation, rhythm control, and treatment of any underlying disorder. 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%. Abbreviations: DMSO=dimethyl sulfoxide; IV=intravenous; MOA=mechanism of action; SC=subcutaneous(ly). High blood pressure often has no symptoms. Tell your doctor if you are pregnant or plan to become pregnant. Descriptions. Diltiazem is used to prevent chest pain ( angina ). 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. Duration of infusion longer than 24 hours and infusion rates greater than 15 mg/h have not been studied. An overdose of diltiazem can be fatal. Patients who have demonstrated hypersensitivity to the drug. <<893FCAAD4A261745BEDEB8B64953C410>]/Prev 46654/XRefStm 1178>> Phase IV trials are used to detect adverse drug outcomes and monitor drug effectiveness in the real world. In vitro studies suggest alpha1-acid glycoprotein binds approximately 40% of the drug at clinically significant concentrations. 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. Do not freeze. Events such as myocardial infarction have been observed which are not readily distinguishable from the natural history of the disease for the patient. The infusion rate may be increased in 5 mg/h increments up to 15 mg/h as needed, if further reduction in heart rate is required. Upon discontinuation of infusion, heart rate reduction may last from 0.5 hours to more than 10 hours (median duration 7 hours). 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. 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. Medically reviewed by Drugs.com. Diltiazem does not appear to be removed by peritoneal or hemodialysis. Our phase IV clinical studies alone cannot establish cause-effect relationship. Worldwide experience in over 1,300 patients was similar. Should a dermatologic reaction persist, the drug should be discontinued. I just got out of the hospital last night for a t and a unsuccessful ablation procedure. Swallow it whole. 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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