Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. in adult patients. Certain drugs cause vasospasms, which result in back pressure at the intravenous (IV) site and may expand the puncture site in the vein, allowing leakage to occur; drugs that act as vasoconstrictors can also cause tissue ischemia. Physical incompatibilities (precipitate formation or cloudiness) were observed when diltiazem hydrochloride injection was infused in the same intravenous line with the following drugs: acetazolamide, acyclovir, aminophylline, ampicillin, ampicillin sodium/sulbactam sodium, cefamandole, cefoperazone, diazepam, furosemide, hydrocortisone sodium succinate, insulin (regular: 100 units/mL), methylprednisolone sodium succinate, mezlocillin, nafcillin, phenytoin, rifampin, and sodium bicarbonate. Although it is not possible to prevent all accidents, a few simple precautions can minimize the risk to the patient. Cardiovascular: AV block (third degree), bundle branch block, ECG abnormality, palpitations, syncope, tachycardia, ventricular extrasystoles 25-mg, 5-mL vialeach sterile vial contains 25 mg diltiazem hydrochloride, 3.75 mg citric acid USP, 3.25 mg sodium citrate dihydrate USP, 357 mg sorbitol solution USP, and water for injection USP up to 5 mL. 3. Direct Intravenous Single Injections (Bolus) Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Irritant- agents capable of causing pain, swelling, venous irritation and chemical phlebitis at the injection site (calcium gluconate, digoxin, erythromycin, gentamicin). In patients with atrial fibrillation or atrial flutter, diltiazem systemic clearance has been found to be decreased compared to healthy volunteers. Our phase IV clinical studies alone cannot establish cause-effect relationship. Descriptions. Discard unused portion. %%EOF 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). Dosage of drugs is not considered in the study. Cardiac Conduction - Diltiazem prolongs AV nodal conduction and refractoriness that may rarely result in second- or third-degree AV block in sinus rhythm. Apply compresses for 20 to 60 minutes 3 or 4 times daily for the first 24 to 72 hours after extravasation occurs. generic drugs) are not considered. Sterile 25 mL Single-Dose Vial Similar ventricular complexes have been noted during cardioversion, other pharmacologic therapy, and during spontaneous conversion of PSVT to sinus rhythm. High blood pressure is a common condition, and when not treated it can cause damage to the brain, heart, blood vessels, kidneys . 0000010698 00000 n Development of an evidence-based list of noncytotoxic vesicant medications and solutions. Anesthetics - The depression of cardiac contractility, conductivity, and automaticity as well as the vascular dilation associated with anesthetics may be potentiated by calcium channel blockers. Anti-anxiety medications called benzodiazepines (such as midazolam, triazolam, and others) as well as busipirone; Beta-blockers (such as atenolol, carvedilol, metoprolol, propranolol, sotalol, and others); Cholesterol medication called statins (such as atorvastatin, lovastatin, simvastatin, rosuvastatin, and others). Aim: To assess the value of using smooth muscle relaxants drugs and assess the results of the topical use of 2% diltiazem as an alternative to 0.2% nitroglycerin in the treatment of chronic anal fissure (CAF). Discard Unused Portion Store Under Refrigeration Read More Dermatologic: Pruritus, sweating Related/similar drugs Dosage of drugs is not considered in the study. Both infiltration and extravasation can have serious consequences: the patient may need surgical intervention resulting in large scars, experience limitation of function, or even require amputation. Benzodiazepines - Studies showed that diltiazem increased the AUC of midazolam and triazolam by 3 to 4 fold and Cmax by 2-fold, compared to placebo. 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%. 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. %PDF-1.5 % Avoid taking herbal supplements containing St. John's wort at the same time you are taking diltiazem. Nursing Mothers 0000002809 00000 n 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. Diltiazem may also be used for purposes not listed in this medication guide. Do not save the mixture for later use. I just got out of the hospital last night for a t and a unsuccessful ablation procedure. Stopping suddenly may make your condition worse. Take diltiazem exactly as prescribed by your doctor. The apparent volume of distribution of diltiazem hydrochloride is approximately 305 L. Diltiazem hydrochloride is extensively metabolized in the liver with a systemic clearance of approximately 65 L/h. Patients with low body weights should be dosed on a mg/kg basis. Medically reviewed by Drugs.com. a rough estimate would be great. Albumin appears to bind approximately 30% of the drug, while other constituents bind the remaining bound fraction. 0000030660 00000 n With medical big data and AI algorithms, eHealthMe is running millions of phase IV trials and makes the results available to the public. Therefore, the potential for acute hepatic injury exists following administration of intravenous diltiazem. In a few reported cases, overdose with calcium channel blockers associated with hypotension and bradycardia that was initially refractory to atropine became more responsive to atropine after the patients received intravenous calcium. Metabolites N-monodesmethyldiltiazem, desacetyldiltiazem, desacetyl-N-monodesmethyldiltiazem, desacetyl-O-desmethyldiltiazem, and desacetyl-N, O-desmethyldiltiazem have been identified in human urine. Last updated on Mar 22, 2023. If possible, it is recommended that diltiazem hydrochloride injection not be co-infused in the same intravenous line. 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. Diltiazem hydrochloride injection is a clear, colorless, sterile, nonpyrogenic solution. High intravenous dosages (4.5 mg/kg tid) administered to dogs resulted in significant bradycardia and alterations in AV conduction. In the event of overdosage or an exaggerated response, appropriate supportive measures should be employed. For vesicant drugs and chemotherapeutic agents, the incidence has been reported to range from 0.01% to 6%.2. Diltiazem may impair your thinking or reactions. The following measures may be considered: Sterile eugia 10 x 10 mL Single-Dose Vials, Rx only NDC 55150-427-01 Treatment considerations are outlined in Table 3 below. Assess the site of extravasation and the symptoms of the patient. 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. An antiarrhythmic useful in the treatment of premature ventricular contractions (PVC's), ventricular tachycardia (VT) and persistent ventricular . Geriatric Use Do not use this medicine in larger or smaller amounts or for longer than recommended. Other: acute generalized exanthematous pustulosis, allergic reactions, angioedema (including facial or periorbital edema), CPK elevation, epistaxis, eye irritation, gingival hyperplasia, hemolytic anemia, hyperglycemia, impotence, increased bleeding time, leukopenia, muscle cramps, myopathy, nasal congestion, nocturia, osteoarticular pain, photosensitivity (including lichenoid keratosis and hyperpigmentation at sun-exposed skin areas), polyuria, retinopathy, sexual difficulties, thrombocytopenia, tinnitus. Hypotension, if it occurs, may be similarly persistent. xref Diltiazem Dilution: To prepare diltiazem hydrochloride injection for continuous intravenous infusion, aseptically transfer the appropriate quantity (see chart) of diltiazem hydrochloride injection to the desired volume of either Normal Saline, D5W, or D5W/0.45% NaCl. Medically reviewed by Kaci Durbin, MD. Tell your doctor if you are pregnant or plan to become pregnant. Limited data suggest that plasmapheresis or charcoal hemoperfusion may hasten diltiazem elimination following overdose. This can damage the blood vessels of the brain . In special subacute hepatic studies, oral doses of 125 mg/kg and higher in rats were associated with histological changes in the liver, which were reversible when the drug was discontinued. 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. 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). Hypotension - Decreases in blood pressure associated with diltiazem hydrochloride injection therapy may occasionally result in symptomatic hypotension (3.2%). 0000030429 00000 n @ Grapefruit and grapefruit juice may interact with diltiazem and lead to unwanted side effects. Intravenous Infusion It has a pH range of 3.7 to 4.1. Methods: Review of the CAF contained in a prospectively collected database of anal fissures including one hundred forty-five patients diagnosed with CAF and treated with standard . Our original studies have been referenced on 600+ medical publications including The Lancet, Mayo Clinic Proceedings, and Nature. Available for Android and iOS devices. 7. 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). If it continues for a long time, the heart and arteries may not function properly. It is important that an accurate pretreatment diagnosis distinguish wide complex QRS tachycardia of supraventricular origin from that of ventricular origin prior to administration of diltiazem hydrochloride injection. American College of Radiology. There was also no mutagenic response in vitro or in vivo in mammalian cell assays or in vitro in bacteria. Reduction in mean arterial pressure correlated linearly with diltiazem plasma concentration in a group of hypertensive patients. Eugia Pharma Specialities Limited Disconnect IV tubing from IV device. However, the study had only a small number of Temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter. 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. Continuous Intravenous Infusion Dolasetron . The purpose of this review is to provide an update of treatment modalities for calcinosis in dermatomyositis based on published . It may help to increase your ability to exercise and decrease how often you may get angina attacks. In patients with cardiovascular disease, diltiazem hydrochloride injection administered intravenously in single bolus doses, followed in some cases by a continuous infusion, reduced blood pressure, systemic vascular resistance, the rate-pressure product, and coronary vascular resistance and increased coronary blood flow. In the same study, there was no significant change in 20 mg single dose pravastatin AUC and Cmax during diltiazem coadministration. Diltiazem may also be used for purposes not listed in this medication guide. 5. Diltiazem is both a substrate and an inhibitor of the cytochrome P-450 3A4 enzyme system. 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. Kimmel J, Fleming P, Cuellar S, Anderson J, Haaf CM. 549 0 obj <>stream Destroy after 1 month at room temperature. Nervous System: Dizziness, paresthesia 0000029001 00000 n 9 Physician's order should be obtained to initiate warm or cold therapy when suspect extravasation is greater than 24 hours old. 0000012749 00000 n Cytotoxic agents can be further subdivided into DNA-binding and nonDNA-binding agents. 0000006002 00000 n Diltiazem Dosage: 0.25 mg/kg administered over at least 2 minutes and preferably . eHealthMe is studying from 27,064 Cardizem users for its effectiveness, alternative drugs and more. Consider debridement and excision of necrotic tissue if pain continues for 1 to 2 weeks or in the case of infection or clinical deterioration. Cardizem, Cartia XT, Cardizem CD, Dilt-XR, +7 more. 0000029978 00000 n Maximal hemodynamic effects usually occurred within 2 to 5 minutes of an injection. Every effort has been made to ensure that all information is accurate, up-to-date, and complete, but no guarantee is made to that effect. Only 1 of the studies of diltiazem was in children. hbbbd`b``3 This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. These antiarrhythmic agents were intravenous or oral digoxin, Class 1 antiarrhythmics (e.g., quinidine, procainamide), calcium channel blockers, and oral beta-blockers. We comply with the HONcode standard for trustworthy health information. Some patients may respond to an initial dose of 0.15 mg/kg, although duration of action may be shorter. One hundred two (102) patients <65 had a response rate of 78%. Your doctor may adjust your dose as needed. One report with oral diltiazem suggests that concentrations in breast milk may approximate serum levels. Based on the results of pharmacokinetic studies in healthy volunteers administered different oral diltiazem hydrochloride formulations, constant rate intravenous infusions of diltiazem hydrochloride at 3, 5, 7, and 11 mg/h are predicted to produce steady-state plasma diltiazem concentrations equivalent to 120-, 180-, 240-, and 360-mg total daily oral doses of diltiazem hydrochloride tablets or diltiazem hydrochloride extended-release capsules. Subsequent intravenous bolus doses should be individualized for each patient. 3. HCl Injection When used concomitantly, anesthetics and calcium blockers should be titrated carefully. If high-degree AV block occurs in sinus rhythm, intravenous diltiazem should be discontinued and appropriate supportive measures instituted (see OVERDOSAGE). The recommended initial infusion rate of diltiazem hydrochloride injection is 10 mg/h. 0000002293 00000 n High-degree AV Block: Treat as for bradycardia above. Diltiazem is excreted in human milk. With medical big data and proven AI algorithms, eHealthMe provides a platform for everyone to run phase IV clinical trials. Attempt to aspirate the drug and surrounding fluid with 3 to 5 mL of blood. The toxic dose in man is not known. The effect of cyclosporine on diltiazem plasma concentrations has not been evaluated. General Caution should be exercised when using the drug in such patients. 0000000016 00000 n Diltiazem hydrochloride injection rarely converts atrial fibrillation or atrial flutter to normal sinus rhythm. 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. In: Nelson LS, Howland MA, Lewin NA, Smith SW, Goldfrank LR, Hoffman RS, eds. Swallow it whole. It also increases the supply of blood and oxygen to the heart. 0000025152 00000 n Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Avoid drinking alcohol while taking diltiazem. 125 mg per 25 mL (5 mg/mL) HCl Injection Give a list of all your medicines to any healthcare provider who treats you. High blood pressure adds to the workload of the heart and arteries. 25 mL Single-Dose Vials You can use the study as a second opinion to make health care decisions. For Direct Intravenous Bolus Injection and The prolongation of PR interval correlated significantly with plasma diltiazem concentration in normal volunteers using the Sigmoidal Emax model. 25 mg per 5 mL 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. Continuous Intravenous Infusion Drugs which induce or inhibit hepatic microsomal enzymes may alter diltiazem disposition. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Accessed January 13, 2021. Diltiazem Monitoring for quinidine adverse effects may be warranted and the dose adjusted accordingly. You may report side effects to FDA at 1-800-FDA-1088. Administration of other calcium channel blockers to patients with wide complex tachycardia (QRS 0.12 seconds) has resulted in hemodynamic deterioration and ventricular fibrillation. no heartbeat. Before taking diltiazem, tell your doctor if you have kidney disease, liver disease, or congestive heart failure. Do not take extra medicine to make up the missed dose. The best therapeutic agent for treatment of vasopressor extravasation is intradermal phentolamine. Diltiazem is an oral and parenteral non-dihydropyridine calcium channel blocker. Diltiazem is a calcium channel blocker. Diltiazem hydrochloride injection is for direct intravenous bolus injection and continuous intravenous infusion. Events such as myocardial infarction have been observed which are not readily distinguishable from the natural history of the disease for the patient. Patients should be monitored for signs of hypercalcemia. The drug should be used with caution in patients with impaired renal or hepatic function (see WARNINGS). However, reference should be made to the respective agent manufacturer's package insert for information relative to dosage and administration. Diltiazem may be used for the treatment of high blood pressure or chronic stable angina. It works by relaxing the blood vessels so the heart does not have to pump as hard. The therapeutic benefits of diltiazem in supraventricular tachycardias are related to its ability to slow AV nodal conduction time and prolong AV nodal refractoriness. Symptoms associated with the arrhythmia were improved in conjunction with decreased heart rate or conversion to normal sinus rhythm following administration of diltiazem hydrochloride injection. Leave the catheter or needle in place initially to attempt to aspirate fluid from the extravasated area. Atrial flutter can arise during treatment with antiarrhythmic agents prescribed to prevent recurrent AF. 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. Heart rate reduction may last from 1 to 3 hours. Patients with ventricular tachycardia. 50 mg per 10 mL (5 mg/mL) Sodium hydroxide or hydrochloric acid is used for pH adjustment. show all 12 brands Purpose of review Calcinosis cutis, or dystrophic soft-tissue calcification, is a common and debilitating complication of adult and juvenile dermatomyositis. Lexicomp [database online]. Extravasation of xenobiotics. Docetaxel . Continuous Intravenous Infusion 125 mg per 25 mL Oral diltiazem, 60 mg twice daily, is given for eight weeks. Use diltiazem regularly to get the most benefit. These metabolites are observed, however, following 24 hour constant rate intravenous infusion. 279 Princeton-Hightstown Rd. In addition, the following events were reported infrequently (less than 1%): Keep diluted diltiazem hydrochloride injection refrigerated until use. 0000003340 00000 n Packaged in a Carton of 10 NDC 55150-425-10 Do not remove the IV device or noncoring port needle. Some reports may have incomplete information. endstream endobj startxref The chemical structure is: Diltiazem hydrochloride, USP is a white crystalline powder with a bitter taste. Additionally, cold reduces local inflammation and pain. 0000006222 00000 n 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). A defibrillator and emergency equipment should be readily available. Diltiazem hydrochloride is extensively metabolized by the liver and excreted by the kidneys and in bile. For Direct Intravenous Bolus Injection and Reproduction studies have been conducted in mice, rats, and rabbits. Phase IV trials are used to detect adverse drug outcomes and monitor drug effectiveness in the real world. Your doctor may adjust your dose as needed. The vial stopper is not made with natural rubber latex. Avoid concomitant use of ivabradine and diltiazem. 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. HCl Injection 25 mg per 5 mL (5 mg/mL) 5 mL Single-Dose Vials 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. Prepared by: 833 S. Wood St., Suite B12, College of Pharmacy, (MC 886), Chicago, IL 60612, 2023 The Board of Trustees of the University of Illinois, UI Health is UICs academic health enterprise. Diltiazem Treatment should begin as soon as possible and no later than 6 hours after extravasation. itching. Therefore, the potential for these dermatologic reactions exists following exposure to intravenous diltiazem. Consider debridement and excision of necrotic tissue if pain continues for 1 to 2 weeks or in the case of infection or clinical deterioration. 1. To make sure diltiazem is safe for you, tell your doctor if you have: if you also take digoxin, or a beta blocker (such as atenolol, carvedilol, metoprolol, propranolol, sotalol, and others). Do not crush, chew, break, or open an extended-release diltiazem tablet or capsule. Management of drug extravasations. What are current recommendations for treatment of drug extravasation?

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