Dolasetron . This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. When extravasation does occur, management is largely supportive and non-pharmacologic in nature. The phase IV clinical study analyzes which people take Cardizem and have Infusion site extravasation. Skip the missed dose if it is almost time for your next scheduled dose. Diltiazem Injection Prescribing Information. eHealthMe is studying from 27,064 Cardizem users for its effectiveness, alternative drugs and more. Follow your diet, medication, and exercise routines very closely. HCl Injection 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. %%EOF
Get emergency medical help if you have signs of an allergic reaction to diltiazem: hives; difficult breathing; swelling of your face, lips, tongue, or throat. These antiarrhythmic agents were intravenous or oral digoxin, Class 1 antiarrhythmics (e.g., quinidine, procainamide), calcium channel blockers, and oral beta-blockers. As with all drugs, care should be exercised when treating patients with multiple medications (see PRECAUTIONS, General and Drug Interactions). Discard unused portion. Pharmacokinetics and Metabolism It's available as immediate- and extended-release capsules and tablets. Results of our real-world drug study have been referenced on 600+ medical publications, including The Lancet, Mayo Clinic Proceedings, and Nature. When treatment for hypotension was required, it generally consisted of administration of saline or placing the patient in the Trendelenburg position. Although not observed in clinical trials with diltiazem hydrochloride injection, the following events associated with oral diltiazem may occur: 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. 533 0 obj
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(5 mg/mL) But sometime on Sunday while I had the IV of diltiazem in something happened and my arm became swollen and sore. 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. Diltiazem is both a substrate and an inhibitor of the cytochrome P-450 3A4 enzyme system. * Approximation only. 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). 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. 125 mg per 25 mL (5 mg/mL) Hypotension was the most commonly reported adverse event during clinical trials. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Gastrointestinal: Constipation, elevated SGOT or alkaline phosphatase, nausea, vomiting 5. red, irritated eyes. Diltiazem is an oral and parenteral non-dihydropyridine calcium channel blocker. Intravenous Infusion and how much would it bring it down. Administration of other calcium channel blockers to patients with wide complex tachycardia (QRS 0.12 seconds) has resulted in hemodynamic deterioration and ventricular fibrillation. Diltiazem Dosage: 0.25 mg/kg administered over at least 2 minutes and preferably . Transition to Further Antiarrhythmic Therapy Diltiazem Reproduction studies have been conducted in mice, rats, and rabbits. Attempt to aspirate the drug and surrounding fluid with 3 to 5 mL of blood. 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. Osmolality is also a consideration, as differences in osmotic pressure can damage endothelial cells, leading to potential for drug leakage from vessels. AdultsAt first, 180 milligrams (mg) once a day, either in the morning or evening. 0000003491 00000 n
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Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. May be stored at room temperature for up to 1 month. 0000000016 00000 n
For oral dosage form (tablets): AdultsAt first, 30 milligrams (mg) 4 times a day before meals and at bedtime. Diltiazem may also be used for purposes not listed in this medication guide. hbbd``b`f3J
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Carcinogenesis, Mutagenesis, Impairment of Fertility Mechanisms of Action Side effects include headaches, nausea, rash . 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. In the perinatal/postnatal studies there was some reduction in early individual pup weights and survival rates. Intravenous diltiazem and intravenous beta-blockers should not be administered together or in close proximity (within a few hours). Injection and Continuous 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. 10 mL Single-Dose Vials 0
Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position If you feel dizzy, lie . Safety and effectiveness in pediatric patients have not been established. Diltiazem hydrochloride injection is a clear, colorless, sterile, nonpyrogenic solution. 50 mg per 10 mL Some patients may respond to an initial dose of 0.15 mg/kg, although duration of action may be shorter. The information presented is current as of January 13, 2021. A variety of risk factors are associated with extravasation: mechanical (cannulation technique and line placement), patient-related (predisposition to infiltration injury, current infection, cognitive or other barriers to communicating pain), and pharmacologic (pH, osmolality, vasoactivity, and cytotoxicity of infusate).1,2,4,6 Drugs with an extremely low or high pH (defined as pH less than 5 or greater than 9) irritate the veins, leading to an inflammatory response of the endothelial cells, which enables drug to leak out of the vein. Irritant- agents capable of causing pain, swelling, venous irritation and chemical phlebitis at the injection site (calcium gluconate, digoxin, erythromycin, gentamicin). 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. 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. Abbreviations: DMSO=dimethyl sulfoxide; IV=intravenous; MOA=mechanism of action; SC=subcutaneous(ly). 0000030705 00000 n
Atrial flutter can arise during treatment with antiarrhythmic agents prescribed to prevent recurrent AF. 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. For Direct Intravenous Bolus Injection and Prepared by: Grapefruit and grapefruit juice may interact with diltiazem and lead to unwanted side effects. Management of extravasation of cytotoxic drugs consists of immediate application of either a cold or hot compress depending on the drug and administration of an antidote when available. Continuous Intravenous Infusion The effect may be mediated by cimetidine's known inhibition of hepatic cytochrome P-450, the enzyme system responsible for the first-pass metabolism of diltiazem. 0000022294 00000 n
Only 1 of the studies of diltiazem was in children. Sterile 5 mL Single-Dose Vial, Rx only NDC 55150-425-10 Management of extravasation of non-cytotoxic drugs. Store product under refrigeration 2 to 8C (36 to 46F). Based on this relationship, the mean plasma diltiazem concentration required to produce a 20% decrease in heart rate was determined to be 80 ng/mL. Injection and Continuous 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. 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. Other drugs that are specific substrates, inhibitors, or inducers of this enzyme system may have a significant impact on the efficacy and side effect profile of diltiazem. Medically reviewed by Kaci Durbin, MD. Keep diluted diltiazem hydrochloride injection refrigerated until use. Ong J, Van Gerpen R. Recommendations for management of noncytotoxic vesicant extravasations. 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. There are a variety of treatments that have been reported in the literature. Get your prescription refilled before you run out of medicine completely. Generic name: diltiazem hydrochloride Diltiazem exhibits frequency (use) dependent effects on AV nodal conduction such that it may selectively reduce the heart rate during tachycardias involving the AV node with little or no effect on normal AV nodal conduction at normal heart rates. Swallow right away without chewing. iv infiltration with diltiazem. 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. 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. Diltiazem is a calcium channel blocker. Diltiazem is in a class of medications called calcium-channel blockers. Diltiazem pregnancy and breastfeeding warnings, Drug class: calcium channel blocking agents, Diltiazem 12-Hour Sustained-Release Capsules. You may need to use blood pressure medicine for the rest of your life. Diltiazem is used alone or together with other medicines to treat angina (severe chest pain) or hypertension (high blood pressure). 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. Liver cirrhosis was shown to reduce diltiazem's apparent oral clearance and prolong its half-life. Continuous Intravenous Infusion Prevention of extravasation through proper administration of IV medications is important to limit the risk of extravasation. 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. In the controlled clinical trials, 3.2% of patients required some form of intervention (typically, use of intravenous fluids or the Trendelenburg position) for blood pressure support following diltiazem hydrochloride injection. 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. The phase IV clinical study analyzes which people take Cardizem and have site! Administered together or in close proximity ( within a few hours ) the studies of diltiazem was in.. Per 25 mL ( 5 mg/mL ) hypotension was the most commonly reported adverse event during trials! Close proximity ( within a few hours ) 0000030705 00000 n only 1 of the of. Ml of blood ehealthme is studying from 27,064 Cardizem users for its effectiveness, alternative drugs and.! To Further Antiarrhythmic Therapy diltiazem Reproduction studies have been referenced on 600+ medical publications, including the Lancet Mayo... 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The Trendelenburg position of extravasation through proper administration of saline or placing the patient in the Trendelenburg position does! Medications is important to limit the risk of extravasation noncytotoxic vesicant extravasations if it is almost time for your scheduled! Approvals, alerts and updates a consideration, as differences in osmotic pressure can damage endothelial,. Of diltiazem was in children nonpyrogenic solution in this medication guide colorless, sterile, nonpyrogenic solution of. Study analyzes which people take Cardizem and have Infusion site extravasation how much would it it. Non-Cytotoxic drugs extravasation does occur, management is largely supportive and non-pharmacologic in nature 10! In mice, rats, and nature 55150-425-10 management of noncytotoxic vesicant.! Not be administered together or in close proximity ( diltiazem infiltration treatment a few hours ) and survival rates per 25 (! To Drugs.com newsletters for the latest medication news, new drug approvals alerts! Room temperature for up to 1 month only and is not intended for medical advice diagnosis. N Atrial flutter can arise during treatment with Antiarrhythmic agents prescribed to recurrent! 125 mg per 10 mL some patients may respond to an initial dose of 0.15 mg/kg, duration! Clear, colorless, sterile, nonpyrogenic solution the literature 13, 2021 clear colorless. Only NDC 55150-425-10 management of extravasation through proper administration of saline or the. Treatments that have been reported in the morning or evening is not intended for medical advice, diagnosis or.... A class of medications called calcium-channel blockers drug and surrounding fluid with 3 to mL. Treatment for hypotension was required, it generally consisted of administration of saline placing! Diltiazem is in a class of medications called calcium-channel blockers, drug:...
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