We comply with the HONcode standard for trustworthy health information. Diltiazem Swallow it whole. In the perinatal/postnatal studies there was some reduction in early individual pup weights and survival rates. 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. You should not breastfeed while using this medicine. Generally speaking, if the infiltration solution was isotonic, a warm compress is used to alleviate discomfort and help absorb the infiltration by increasing circulation to the affected area. 125 mg per 25 mL 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%. If high-degree AV block occurs in sinus rhythm, intravenous diltiazem should be discontinued and appropriate supportive measures instituted (see OVERDOSAGE). Mean plasma diltiazem concentrations of 130 ng/mL and 300 ng/mL were determined to produce reductions in heart rate of 30% and 40%. 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. 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. Enhanced effects and increased toxicity of buspirone may be possible during concomitant administration with diltiazem. 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). It is often used in high blood pressure. Hypotension: Vasopressors (e.g., dopamine or norepinephrine). WARNING: Please DO NOT STOP MEDICATIONS without first consulting a physician since doing so could be hazardous to your health. 50 mg per 10 mL Pharmacologic interventions for extravasation Patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in WPW syndrome or short PR syndrome. For Direct Intravenous Bolus Injection and Different individuals may respond to medication in different ways. 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. Last updated on Apr 1, 2023. Cardizem undergoes extensive metabolism in which 2% to 4% of the unchanged drug appears in the urine. Cardizem, Cartia XT, Cardizem CD, Dilt-XR, +7 more. 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. (5 mg/mL) Other: Amblyopia, asthenia, dry mouth, dyspnea, edema, headache, hyperuricemia 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. Asymptomatic hypotension occurred in 4.3% of patients. Version: 15.01. Distributed by: Use of this site constitutes acceptance of eHealthMe.com's terms of service and privacy policy. generic drugs) are not considered. Our phase IV clinical studies alone cannot establish cause-effect relationship. Avoid continuous vesicants or irritants (chemotherapy, vasopressors) B. Infusion Therapy Standards of Practice, 8th edition. The vein used should be a large, intact vessel with good blood flow. You may report side effects to FDA at 1-800-FDA-1088. 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. Sterile eugia 10 x 10 mL Single-Dose Vials, Rx only NDC 55150-427-01 Blood and urine tests may be needed to check for unwanted effects. Generic name: diltiazem hydrochloride and how much would it bring it down. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Among them, 22 people (0.08%) have Infusion site extravasation. Changes in heart rate, systolic blood pressure, and diastolic blood pressure did not correlate with diltiazem plasma concentrations in normal volunteers. However, sloughing can occur from the application of a warm compress to an area infiltrated with certain medications such as potassium chloride. 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. Following oral administration, 2% to 4% of the unchanged diltiazem appears in the urine. 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. 0000030204 00000 n Diltiazem plasma levels were not significantly affected by lovastatin or pravastatin. Cyclosporine - A pharmacokinetic interaction between diltiazem and cyclosporine has been observed during studies involving renal and cardiac transplant patients. Diltia XT, Dilt-XR, Diltzac, Matzim LA, Taztia XT, Tiadylt ER, Tiazac. Descriptions. Metabolites N-monodesmethyldiltiazem, desacetyldiltiazem, desacetyl-N-monodesmethyldiltiazem, desacetyl-O-desmethyldiltiazem, and desacetyl-N, O-desmethyldiltiazem have been identified in human urine. It is based on diltiazem hydrochloride (the active ingredients of Cardizem) and Cardizem (the brand name). %%EOF Subsequent dose adjustments may be necessary during coadministration, and should be based on clinical assessment. 9 Physician's order should be obtained to initiate warm or cold therapy when suspect extravasation is greater than 24 hours old. Sodium hydroxide or hydrochloric acid is used for pH adjustment. Medically reviewed by Drugs.com. Avoid parenteral nutrition containing >10% dextrose C. Check midline for high pressure injector status before administering radio contrast D. Avoid infusate with osmolarity >900 mOsm/L E. Caution with intermitte nt vesicant administration as extravasation more difficult to Subjects with increased average steady-state exposures of diltiazem showed a greater fold increase in simvastatin exposure. Last updated on Mar 22, 2023. Reproduction studies have been conducted in mice, rats, and rabbits. Package insert / product label Development of an evidence-based list of noncytotoxic vesicant medications and solutions. For continued reduction of the heart rate (up to 24 hours) in patients with atrial fibrillation or atrial flutter, an intravenous infusion of diltiazem hydrochloride injection may be administered. Discharged 7pm 8/1/22. 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. We study millions of patients and 5,000 more each day. In patients administered continuous infusions at 10 mg/h or 15 mg/h for 24 hours, diltiazem systemic clearance averaged 42 L/h and 31 L/h, respectively. Paroxysmal Supraventricular Tachycardia Nervous System: Abnormal dreams, amnesia, depression, extrapyramidal symptoms, gait abnormality, hallucinations, insomnia, nervousness, personality change, somnolence, tremor <<893FCAAD4A261745BEDEB8B64953C410>]/Prev 46654/XRefStm 1178>> Clonidine - Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concurrently with diltiazem. The therapeutic benefits of diltiazem in supraventricular tachycardias are related to its ability to slow AV nodal conduction time and prolong AV nodal refractoriness. 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. startxref Patients should be dosed on an individual basis and reference should be made to the respective manufacturer's package insert for information relative to dosage and administration. Sterile 10 mL Single-Dose Vial, Rx only NDC 55150-426-10 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. Monitoring for quinidine adverse effects may be warranted and the dose adjusted accordingly. Diltiazem (Cardizem) is a medication used to treat high blood pressure and chest pain. There was also no mutagenic response in vitro or in vivo in mammalian cell assays or in vitro in bacteria. In controlled clinical trials, therapy with antiarrhythmic agents to maintain reduced heart rate in atrial fibrillation or atrial flutter or for prophylaxis of PSVT was generally started within 3 hours after bolus administration of diltiazem hydrochloride injection. trailer Diltiazem interacts with many medications. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter. It has a molecular weight of 451.0. in adult patients. 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. Apply compresses for 20 to 60 minutes 3 or 4 times daily for the first 24 to 72 hours after extravasation occurs. Patients currently receiving diltiazem therapy should be carefully monitored for a change in pharmacological effect when initiating and discontinuing therapy with cimetidine. 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. Diltiazem Injection Prescribing Information. . Do not crush, chew, break, or open an extended-release diltiazem tablet or capsule. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. hbbd``b`f3J "-@ ?y "RD%qAaLL )' dJ Hyderabad 500032 4. Avoid taking herbal supplements containing St. John's wort at the same time you are taking diltiazem. Injectable forms of diltiazem are contraindicated in: 1. Drug Interactions But sometime on Sunday while I had the IV of diltiazem in something happened and my arm became swollen and sore. 533 0 obj <>/Filter/FlateDecode/ID[<5163DCD1F2812548B2C0DA027F0BBFFB>]/Index[512 38]/Info 511 0 R/Length 98/Prev 107501/Root 513 0 R/Size 550/Type/XRef/W[1 2 1]>>stream Tell your doctor about all medicines you use, and those you start or stop using. Mechanisms of Action 0000001363 00000 n Diltiazem can pass into breast milk and may harm a nursing baby. 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). @ It has a pH range of 3.7 to 4.1. Once familiarity of the patient's response is established, use in an office setting may be acceptable. The drug should be used with caution in patients with impaired renal or hepatic function (see WARNINGS). 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Ingredients of Cardizem ) and Cardizem ( the brand name ) adult patients 24 72... Certain medications such as potassium chloride, identify pills, check interactions and up... Patients and 5,000 more each day brand name ) been observed during studies involving renal cardiac! Report side effects to FDA at 1-800-FDA-1088 OVERDOSAGE ) vitro or in vitro or in vitro in!