Therefore, infusion duration exceeding 24 hours and infusion rates exceeding 15 mg/h are not recommended. Management of extravasation of non-cytotoxic drugs. If you stop taking diltiazem suddenly, your condition may become worse. Liver cirrhosis was shown to reduce diltiazem's apparent oral clearance and prolong its half-life. Docetaxel . The combination of the two drugs was well tolerated without serious adverse effects. 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. Be careful if you drive or do anything that requires you to be alert. 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. It is often used in high blood pressure. 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. red skin lesions, often with a purple center. 4. As such, the initial use of diltiazem hydrochloride injection should be, if possible, in a setting where monitoring and resuscitation capabilities, including DC cardioversion/defibrillation, are present (see OVERDOSAGE). ChildrenUse and dose must be determined by your doctor. 364 0 obj <>stream no heartbeat. In patients administered bolus doses ranging from 2.5 mg to 38.5 mg, systemic clearance averaged 36 L/h. Diltiazem is a calcium channel blocker. If these agents are to be administered concurrently, cyclosporine concentrations should be monitored, especially when diltiazem therapy is initiated, adjusted or discontinued. 0000010832 00000 n Abbreviations: DMSO=dimethyl sulfoxide; IV=intravenous; MOA=mechanism of action; SC=subcutaneous(ly). Our phase IV clinical studies alone cannot establish cause-effect relationship. Diltiazem Dosage: 0.25 mg/kg administered over at least 2 minutes and preferably . In addition, caution should be used in patients taking other drugs that decrease peripheral resistance, intravascular volume, myocardial contractility or conduction. Experience with the use of diltiazem hydrochloride injection in patients with impaired ventricular function is limited. 0000030705 00000 n Treatment should begin as soon as possible and no later than 6 hours after extravasation. Intravenous Infusion One hundred two (102) patients <65 had a response rate of 78%. 0000012749 00000 n Your doctor may adjust your dose as needed. 5. Therefore, the potential for acute hepatic injury exists following administration of intravenous diltiazem. The need for sphincterotomy can be avoided in up to 70% of cases. Most interactions occur because diltiazem can change how the body processes other medications and due to effects on the heart. Last updated on Apr 1, 2023. 0000003528 00000 n Cytotoxic agents can be further subdivided into DNA-binding and nonDNA-binding agents. 25 mg per 5 mL (5 mg/mL) 5 mL Single-Dose Vials There was also no mutagenic response in vitro or in vivo in mammalian cell assays or in vitro in bacteria. 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. Do not freeze. Patients with ventricular tachycardia. Precautions. Some drugs, including anti-cancer agents, are directly cytotoxic to cells. Mechanisms of Action 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. Take the missed dose as soon as you remember. 7. in adult patients. hbbd``b`f3J "-@ ?y "RD%qAaLL )' dJ The infusion may be maintained for up to 24 hours. It is used in many clinical scenarios as an antihypertensive, anti-arrhythmic, and anti-anginal. Heart rate reduction may last from 1 to 3 hours. 0000029248 00000 n The vial stopper is not made with natural rubber latex. Events such as myocardial infarction have been observed which are not readily distinguishable from the natural history of the disease for the patient. Knowledge of the mechanism of extravasation-induced tissue injury, agents for reversal, and appropriate nonpharmacologic treatment methods is essential. Discharged 7pm 8/1/22. Diltiazem is excreted in human milk. However, if you have symptoms of low blood pressure (dizziness, fainting, weakness, or blurred vision), call your doctor and stop taking 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. The purpose of this review is to provide an update of treatment modalities for calcinosis in dermatomyositis based on published . Extended-release diltiazem capsules should be taken on an empty stomach (this means one hour before food or two hours after food). Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Document infiltration and report to ED RN ASAP for antidote Diltiazem slows the ventricular rate in patients with a rapid ventricular response during atrial fibrillation or atrial flutter. Drug classes: Calcium channel blocking agents, Group IV antiarrhythmics. Rifampin - Coadministration of rifampin with diltiazem lowered the diltiazem plasma concentrations to undetectable levels. Extravasation of xenobiotics. Diltiazem is called a calcium channel . hbbbd`b``3 In a ten-subject randomized, open label, 4-way crossover study, coadministration of diltiazem (120 mg bid, diltiazem SR for 2 weeks) with a single 20 mg dose of lovastatin resulted in a 3- to 4-fold increase in mean lovastatin AUC and Cmax versus lovastatin alone. 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. The management of non-cytotoxic drugs is largely supportive and non-pharmacological, except where antidotes exist, such as for vasopressors. Blood and urine tests may be needed to check for unwanted effects. startxref Competitive in vitro ligand binding studies have shown that diltiazem binding is not altered by therapeutic concentrations of digoxin, phenytoin, hydrochlorothiazide, indomethacin, phenylbutazone, propranolol, salicylic acid, tolbutamide, or warfarin. With medical big data and proven AI algorithms, eHealthMe provides a platform for everyone to run phase IV clinical trials. Assess the site of extravasation and the symptoms of the patient. Nervous System: Dizziness, paresthesia Drug choices for rate control include beta-blockers, verapamil and diltiazem, and digitalis as first-line agents, with consideration of other sympatholytics, amiodarone, or . Patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker. 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. 2. You can use the study as a second opinion to make health care decisions. Sodium hydroxide or hydrochloric acid is used for pH adjustment. In the perinatal/postnatal studies there was some reduction in early individual pup weights and survival rates. 0 High-degree AV Block: Treat as for bradycardia above. Overdosage experience is limited. The intravenous LD50's in mice and rats were 60 and 38 mg/kg, respectively. Infusion site extravasation is found among people who take Cardizem, especially for people who are female, 60+ old. 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. Diltiazem hydrochloride is extensively metabolized by the liver and excreted by the kidneys and in bile. 0000022294 00000 n Intravenous Infusion Apply compresses for 20 to 60 minutes 3 or 4 times daily for the first 24 to 72 hours after extravasation occurs. Coadministration of diltiazem with rifampin or any known CYP3A4 inducer should be avoided when possible, and alternative therapy considered. 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. Hemodynamics 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). Transition to other antiarrhythmic agents following administration of diltiazem hydrochloride injection is generally safe. 41 male, non smoker, USA , new York , Caucasian, 229lbs, asthma, iritis, hla-b27 gene , svt. It also increases the supply of blood and oxygen to the heart. Packaged in a Carton of 10 NDC 55150-425-10 If you are being treated for high blood pressure, keep using this medicine even if you feel well. Generic name: diltiazem hydrochloride 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. Store product under refrigeration 2 to 8C (36 to 46F). Although not observed in clinical trials with diltiazem hydrochloride injection, the following events associated with oral diltiazem may occur: 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). 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