This site needs JavaScript to work properly. Keywords: Particular information must be given when a vesicant drug is administered. Diltiazem extravasation. Calcium channel blockers (CCBs) are among the most commonly used cardiovascular drugs in the adult population. severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling. 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. Follow all directions on your prescription label. Limited data suggest that plasmapheresis or charcoal hemoperfusion may hasten diltiazem elimination following overdose. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Other: Amblyopia, asthenia, dry mouth, dyspnea, edema, headache, hyperuricemia Patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker. The combination of the two drugs was well tolerated without serious adverse effects. Extravasation kit includes the following: 25G needle, 10-cc syringe, and 1-mL syringe; disinfection swabs, sterile gauze, and adhesive bandage; saline solution (1 ampule); sterile distilled water (1 ampule); dimethyl sulfoxide 99% solution; hyaluronidase 1,500 U/mL (refrigerated); hydrocortisone cream 1%; sodium thiosulfate 25% solution; and warm pack and an ice pack (frozen). Englewood (CO): Micromedex Inc; [date unknown]. Package insert / product label These doses, in some studies, have been reported to cause skeletal abnormalities. 0000030660 00000 n Antidotes; Extravasation; Intravenous injections; Patient care; Risk factors. Overdosage experience is limited. In some cases intravenous calcium has been administered (1 g calcium chloride or 3 g calcium gluconate) over 5 minutes, and repeated every 10 to 20 minutes as necessary. Common Questions and Answers about Diltiazem extravasation. $4%&'()*56789:CDEFGHIJSTUVWXYZcdefghijstuvwxyz ? Swallow it whole. This content does not have an English version. Three solutions were used: 1/2 saline (154 mOsm), normal saline (308 mOsm), and 3% saline (1027 mOsm). Available from: Lacy C, American Pharmaceutical Association . Local thermal treatments are used to decrease the site reaction and absorption of the infiltrate. 0000030204 00000 n 0000025065 00000 n - Initial physical symptoms usually appear immediately but also might appear several days or weeks later. Diltiazem hydrochloride is extensively metabolized by the liver and excreted by the kidneys and in bile. In renal and cardiac transplant recipients, a reduction of cyclosporine dose ranging from 15% to 48% was necessary to maintain cyclosporine trough concentrations similar to those seen prior to the addition of diltiazem. No potential conflict of interest relevant to this article was reported. Eugia US LLC The therapeutic benefits of diltiazem in supraventricular tachycardias are related to its ability to slow AV nodal conduction time and prolong AV nodal refractoriness. Carbamazepine - Concomitant administration of oral diltiazem with carbamazepine has been reported to result in elevated plasma levels of carbamazepine (by 40 to 72%), resulting in toxicity in some cases. - Once the needle is removed, apply pressure to the puncture site for about five minutes and elevate the limb. Diltia XT, Dilt-XR, Diltzac, Matzim LA, Taztia XT, Tiadylt ER, Tiazac Narcotic analgesics may be required to reduce severe pain around widespread extensive necrosis. Get your prescription refilled before you run out of medicine completely. Continuous Intravenous Infusion Diltiazem does not appear to be removed by peritoneal or hemodialysis. Metabolites N-monodesmethyldiltiazem, desacetyldiltiazem, desacetyl-N-monodesmethyldiltiazem, desacetyl-O-desmethyldiltiazem, and desacetyl-N, O-desmethyldiltiazem have been identified in human urine. Atrial Fibrillation or Atrial Flutter %PDF-1.5 % The best therapeutic agent for treatment of vasopressor extravasation is intradermal . Pain, tightening, and skin discoloration tend to worsen. IV infiltrations and extravasations occur when fluid leaks out of the vein into surrounding soft tissue. Portions of this document last updated: April 01, 2023. Diltiazem hydrochloride injection is clear, colorless, sterile, nonpyrogenic solution and is supplied as follows: 2838 0 obj <>stream The prolongation of PR interval correlated significantly with plasma diltiazem concentration in normal volunteers using the Sigmoidal Emax model. Hadaway L. Extravasation: Issues and Controversies. Patients should be monitored for signs of hypercalcemia. Concepts in oncology therapeutics: a self-instructional course. HCl Injection Mean plasma diltiazem concentrations of 130 ng/mL and 300 ng/mL were determined to produce reductions in heart rate of 30% and 40%. Avoid concomitant use of ivabradine and diltiazem. Quinidine - Diltiazem significantly increases the AUC(0) of quinidine by 51%, T1/2 by 36% and decreases its CLoral, by 33%. High blood pressure often has no symptoms. HCl Injection 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). @ 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. Worldwide experience in over 1,300 patients was similar. 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). Venous shock can occur when injecting very cold medication or when medication is injected at a rapid pace. The patient must be informed of the scope of the problem (Supplement 5). 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. 0000029456 00000 n Diltiazem slows the ventricular rate in patients with a rapid ventricular response during atrial fibrillation or atrial flutter. Donate. Physical Incompatibilities: Because of potential physical incompatibilities, it is recommended that diltiazem hydrochloride injection not be mixed with any other drugs in the same container. 0000003491 00000 n Tell your doctor if you are pregnant or plan to become pregnant. Extravasation must be suspected if any of the following specific signs or symptoms are presented (Table 1). In subgroup analysis following a two-dose procedure in double-blind and open-label studies, 104 patients 65 years of age and 95 patients <65 both had a 95% response rate. sharing sensitive information, make sure youre on a federal Available from: Le A, Patel S. Extravasation of noncytotoxic drugs: a review of the literature. Use diltiazem as a continuous IV infusion for rate control in supraventricular tachycardiain patients without concomitant LV systolic dysfunction.33-35 (Class II, Level B) 14.2. Diltiazem may impair your thinking or reactions. Administration of oral doses ranging from five to ten times greater (on a mg/kg basis) than the daily recommended oral antianginal therapeutic dose has resulted in embryo and fetal lethality. To prevent extravasation, a clinical specialist should perform the venipuncture or injection, who with relevant skills and management ability understands the properties of the injected drug. Common diltiazem side effects may include: This is not a complete list of side effects and others may occur. Bookshelf The .gov means its official. The medical teams continuous education on extravasation is essential. Experience in the use of antiarrhythmic agents following maintenance infusion of diltiazem hydrochloride injection is limited. In patients administered bolus doses ranging from 2.5 mg to 38.5 mg, systemic clearance averaged 36 L/h. This document is only valid for the day on which it is accessed. Oral administration of diltiazem with propranolol in five normal volunteers resulted in increased propranolol levels in all subjects and bioavailability of propranolol was increased approximately 50%. NHS. FOIA Subsequent dose adjustments may be necessary during coadministration, and should be based on clinical assessment. Sterile eugia 10 x 10 mL Single-Dose Vials, Rx only NDC 55150-427-01 In the event of overdosage or an exaggerated response, appropriate supportive measures should be employed. Adverse events reported in controlled and uncontrolled clinical trials were generally mild and transient. HCl Injection Extravasation:Unintentional leakage of fluid out of a blood vessel into surrounding tissue. Dermatologic: Alopecia, erythema multiforme (including Stevens-Johnson syndrome, toxic epidermal necrolysis), exfoliative dermatitis, leukocytoclastic vasculitis, petechiae, photosensitivity, purpura, rash, urticaria High blood pressure often has no symptoms. 0000002293 00000 n Patients with low body weights should be dosed on a mg/kg basis. Follow your diet, medication, and exercise routines very closely. Carcinogenesis, Mutagenesis, Impairment of Fertility Asymptomatic hypotension occurred in 4.3% of patients. Copyright 1996-2023 Cerner Multum, Inc. Nervous System: Abnormal dreams, amnesia, depression, extrapyramidal symptoms, gait abnormality, hallucinations, insomnia, nervousness, personality change, somnolence, tremor Generic name: diltiazem [dil-TYE-a-zem] Pain or tightening occurs along the vein, and it is caused mainly by drugs such as vinorelbine and dacarbazine. 0000029248 00000 n Medically reviewed by Kaci Durbin, MD. Discuss the use of grapefruit products with your doctor. Hypotension was the most commonly reported adverse event during clinical trials. Drug classes: Calcium channel blocking agents, Group IV antiarrhythmics. Cyclosporine - A pharmacokinetic interaction between diltiazem and cyclosporine has been observed during studies involving renal and cardiac transplant patients. hb``d``f`c`P "@1vG(r8}C#7mcH`KfYtfnzv$@,BKK~x$3$shElVVp A_8{.>9UiiGK:&ALg>)tvNV-+>'(yqnSg@Em.P^''*.^. Vinen CS, Patel S, Bruckner FE. and transmitted securely. Disclaimer. 50 mg per 10 mL For Direct Intravenous Bolus Injection and For Direct Intravenous Bolus Do not stop taking this medication without first talking to your doctor. 4. 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. Gastrointestinal: Anorexia, diarrhea, dysgeusia, dyspepsia, mild elevations of SGPT and LDH, thirst, weight increase 0000022294 00000 n Reynolds PM, MacLaren R, Mueller SW, Fish DN, Kiser TH. The frequency of extravasation in adults is reported to be between 0.1% and 6%. - Watch for edema, inflammation, and pain around the cannula during administration. Concomitant use of diltiazem with agents known to affect cardiac conduction may result in additive effects (see Drug Interactions). 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. Rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm. 0000000016 00000 n - Dilute stimulant drugs as much as possible and inject them at a proper rate. 50 mg per 10 mL (5 mg/mL) Federal government websites often end in .gov or .mil. DO NOT flush the line 7. Single-dose vials. These contents are derived from authors experiences and the references [1-21]. 0000030705 00000 n Project administration: JTK, JYP, HJL, YJC. 332 33 1). Carcinogenesis, Mutagenesis, Impairment of Fertility, Paroxysmal supraventricular tachycardia -, Direct Intravenous Single Injections (Bolus), Quantity of Diltiazem hydrochloride injection, Transition to Further Antiarrhythmic Therapy, diltiazem hydrochloride injection, solution. Following oral administration, 2% to 4% of the unchanged diltiazem appears in the urine.
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