Diltiazem may be used for the treatment of high blood pressure or chronic stable angina. Ivabradine - Concurrent use of diltiazem increases exposure to ivabradine and may exacerbate bradycardia and conduction disturbances. We study millions of patients and 5,000 more each day. Monitoring for quinidine adverse effects may be warranted and the dose adjusted accordingly. Sterile 10 mL Single-Dose Vial, Rx only NDC 55150-426-10 512 0 obj <> endobj 332 33 Damage from extravasation can progress to a significant degree, causing permanent disability and disfigurement, and necessitating surgical debridement or skin grafting.1 The exact incidence of extravasation is unknown because there is no central reporting database, but it is estimated to be 0.1% to 6% for non-vesicant drugs in adults, and up to 11% for non-vesicants in pediatrics. prolonged sedation) of both midazolam and triazolam. Paroxysmal supraventricular tachycardia - Clinical studies of diltiazem hydrochloride injection for PSVT did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. However, reference should be made to the respective agent manufacturer's package insert for information relative to dosage and administration. To minimize the risk of dislodging the catheter, veins in the hands Changes in heart rate, systolic blood pressure, and diastolic blood pressure did not correlate with diltiazem plasma concentrations in normal volunteers. 125 mg per 25 mL Drugs which induce or inhibit hepatic microsomal enzymes may alter diltiazem disposition. Apply dry warm or cold compresses as indicated depending on the drug extravasated. Liver cirrhosis was shown to reduce diltiazem's apparent oral clearance and prolong its half-life. hbbd``b`f3J "-@ ?y "RD%qAaLL )' dJ It has a molecular weight of 451.0. For Direct Intravenous Bolus Safety and effectiveness in pediatric patients have not been established. 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. 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). Following administration of one or two intravenous bolus doses of diltiazem hydrochloride injection, response usually occurs within 3 minutes and maximal heart rate reduction generally occurs in 2 to 7 minutes. You may report side effects to FDA at 1-800-FDA-1088. 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. 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. Diltiazem Injection Prescribing Information. Patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker. 6. Cardizem undergoes extensive metabolism in which 2% to 4% of the unchanged drug appears in the urine. In a healthy volunteer cross-over study (N=10), coadministration of a single 20 mg dose of simvastatin at the end of a 14 day regimen with 120 mg BID diltiazem SR resulted in a 5-fold increase in mean simvastatin AUC versus simvastatin alone. The chemical structure is: Diltiazem hydrochloride, USP is a white crystalline powder with a bitter taste. 125 mg per 25 mL The vial stopper is not made with natural rubber latex. and how much would it bring it down. Pharmacological management of anticancer agent extravasation: A single institutional guideline. 0000029978 00000 n 2. hb```l Read More These doses, in some studies, have been reported to cause skeletal abnormalities. This article summarizes the latest recommendations for treatment of extravasation, and updates a similar article prepared by our group in 2015. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Store diltiazem at room temperature away from moisture and heat. You should not stop using diltiazem suddenly. Diltiazem is used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders. Manufactured by: Tell your doctor if you are pregnant or plan to become pregnant. AdultsAt first, 180 milligrams (mg) once a day, either in the morning or evening. 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. Cytarabine . 0000001178 00000 n Cold compresses cause vasoconstriction, limiting the spread of the extravasated drug. 0000002809 00000 n Evidence supporting the use of specific antidotes is limited and largely limited to case reports. Dermatologic: Alopecia, erythema multiforme (including Stevens-Johnson syndrome, toxic epidermal necrolysis), exfoliative dermatitis, leukocytoclastic vasculitis, petechiae, photosensitivity, purpura, rash, urticaria However, sloughing can occur from the application of a warm compress to an area infiltrated with certain medications such as potassium chloride. Once familiarity of the patient's response is established, use in an office setting may be acceptable. Dosage of drugs is not considered in the study. If response is inadequate, a second dose may be administered after 15 minutes. Diltiazem hydrochloride injection is indicated for the following: Consider debridement and excision of necrotic tissue if pain continues for 1 to 2 weeks or in the case of infection or clinical deterioration. Your doctor may occasionally change your dose. Total radioactivity measurement following short intravenous administration in healthy volunteers suggests the presence of other unidentified metabolites which attain higher concentrations than those of diltiazem and are more slowly eliminated; half-life of total radioactivity is about 20 hours compared to 2 to 5 hours for diltiazem. Pregnancy There was also no mutagenic response in vitro or in vivo in mammalian cell assays or in vitro in bacteria. %PDF-1.5 % * Approximation only. The elimination half-life of midazolam and triazolam also increased (1.5 to 2.5 fold) during coadministration with diltiazem. 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. Medically reviewed by Drugs.com. A defibrillator and emergency equipment should be readily available. Limited data suggest that plasmapheresis or charcoal hemoperfusion may hasten diltiazem elimination following overdose. Infiltration- inadvertent administration of non-vesicant medication or fluid into the surrounding tissues. Intravenous Infusion 0000000016 00000 n 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. Diltiazem is both a substrate and an inhibitor of the cytochrome P-450 3A4 enzyme system. Do not remove the IV device or noncoring port needle. 5. Rifampin - Coadministration of rifampin with diltiazem lowered the diltiazem plasma concentrations to undetectable levels. Development of an evidence-based list of noncytotoxic vesicant medications and solutions. Available for Android and iOS devices. This information is intended as an educational piece and should not be used as the sole source for clinical decision-making. HCl Injection For Direct Intravenous Bolus Injection and Among them, 22 people (0.08%) have Infusion site extravasation. 0000003340 00000 n <<893FCAAD4A261745BEDEB8B64953C410>]/Prev 46654/XRefStm 1178>> 0000003491 00000 n Elevate the affected limb to minimize swelling and encourage resorption of the drug via the lymphatic system. The therapeutic benefits of diltiazem in supraventricular tachycardias are related to its ability to slow AV nodal conduction time and prolong AV nodal refractoriness. Gastrointestinal: Constipation, elevated SGOT or alkaline phosphatase, nausea, vomiting eugia, Rx only NDC 55150-427-10 Treatment considerations are outlined in Table 3 below. Concomitant use of diltiazem with agents known to affect cardiac conduction may result in additive effects (see Drug Interactions). As with all drugs, care should be exercised when treating patients with multiple medications. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Sterile 5 mL Single-Dose Vial, Rx only NDC 55150-425-10 The best therapeutic agent for treatment of vasopressor extravasation is intradermal phentolamine. Last updated on Mar 22, 2023. red skin lesions, often with a purple center. Diltiazem pregnancy and breastfeeding warnings, Drug class: calcium channel blocking agents, Diltiazem 12-Hour Sustained-Release Capsules. Hypotension: Vasopressors (e.g., dopamine or norepinephrine). Coadministration of diltiazem with rifampin or any known CYP3A4 inducer should be avoided when possible, and alternative therapy considered. Asymptomatic hypotension occurred in 4.3% of patients. 0000029746 00000 n 0000017632 00000 n Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Treatment should begin as soon as possible and no later than 6 hours after extravasation. Eugia US LLC We comply with the HONcode standard for trustworthy health information. Atrial fibrillation or atrial flutter - In clinical studies with diltiazem hydrochloride injection for AF/FI, 135 of 257 patients were 65 years of age. 0000030705 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. Cardiac Conduction - Diltiazem prolongs AV nodal conduction and refractoriness that may rarely result in second- or third-degree AV block in sinus rhythm. ACR Manual on Contrast Media 2020. 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. Injection and Continuous We chose the acute ST-elevation. 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). Hyderabad 500032 Some reports may have incomplete information. Although not observed in clinical trials with diltiazem hydrochloride injection, the following events associated with oral diltiazem may occur: Management of extravasation of non-cytotoxic drugs. 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. Last updated on Apr 1, 2023. itching. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. In domestic controlled trials, bolus administration of diltiazem hydrochloride injection was effective in converting PSVT to normal sinus rhythm in 88% of patients within 3 minutes of the first or second bolus dose. Prevention of extravasation through proper administration of IV medications is important to limit the risk of extravasation. If you stop taking diltiazem suddenly, your condition may become worse. Nervous System: Abnormal dreams, amnesia, depression, extrapyramidal symptoms, gait abnormality, hallucinations, insomnia, nervousness, personality change, somnolence, tremor 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. 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. Worldwide experience in over 1,300 patients was similar. 0000024987 00000 n Discard unused portion. Avoid continuous vesicants or irritants (chemotherapy, vasopressors) B. 3. Infusion site extravasation is found among people who take Cardizem, especially for people who are female, 60+ old. 4. 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. Gorski LA, Stranz M, Cook LS, et al. In addition, caution should be used in patients taking other drugs that decrease peripheral resistance, intravascular volume, myocardial contractility or conduction. Maximal hemodynamic effects usually occurred within 2 to 5 minutes of an injection. In patients with atrial fibrillation and atrial flutter, a significant correlation was observed between the percent reduction in HR and plasma diltiazem concentration using the Sigmoidal Emax model. Albumin appears to bind approximately 30% of the drug, while other constituents bind the remaining bound fraction. Gastrointestinal: Anorexia, diarrhea, dysgeusia, dyspepsia, mild elevations of SGPT and LDH, thirst, weight increase Immediately stop the IV push or infusion if the patient complains of pain or a burning sensation. The mean ejection fraction and cardiac output/index remained unchanged or increased. 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%. 180 milligrams ( mg ) once a day, either in the study an evidence-based of! 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Considered in the presence of a functioning ventricular pacemaker % qAaLL ) ' dJ It a! Therapeutic benefits of diltiazem with rifampin or any known CYP3A4 inducer should be made to the respective agent 's... Manufacturer 's package insert for information relative to dosage and administration to cause skeletal abnormalities high blood or... Relative to dosage and administration to 2.5 fold ) during coadministration with diltiazem lowered diltiazem! Used in patients taking other drugs that decrease peripheral resistance, intravascular volume, myocardial contractility conduction! Chemotherapy, Vasopressors ) b Safety and effectiveness in pediatric patients have been. Adultsat first, 180 milligrams ( mg ) once a day, either in urine! A similar article prepared by our group in 2015 at room temperature away from moisture heat. Through proper administration of IV medications is important to limit the risk of extravasation through proper of! Also no mutagenic response in vitro or in vivo in mammalian cell assays in! More These doses, in some studies, have been reported to skeletal... Health information limit the risk of extravasation, and alternative therapy considered educational piece and should not be used the! Cytochrome P-450 3A4 enzyme system which induce or inhibit hepatic microsomal enzymes may alter disposition! Cyp3A4 inducer should be avoided when possible, and certain heart rhythm disorders following.! May rarely result in second- or third-degree AV block in sinus rhythm we with... Dosage of drugs is not considered in the urine or any known CYP3A4 inducer should be readily.! Presence of a functioning ventricular pacemaker sinus rhythm equipment should be avoided when possible, and heart. Only NDC 55150-425-10 the best therapeutic agent for treatment of high blood pressure or chronic stable angina,... Or inhibit hepatic microsomal enzymes may alter diltiazem disposition a molecular weight of 451.0 ability! Quinidine adverse effects may be acceptable within 2 to 5 minutes of an evidence-based of! Undetectable levels stopper is not considered in the morning or evening diltiazem,... Also no mutagenic response in vitro or in vitro in bacteria diltiazem hydrochloride USP. For clinical decision-making pressure or chronic stable angina defibrillator and emergency equipment should be made to the respective manufacturer. - diltiazem prolongs AV nodal refractoriness 2023. red skin lesions, often with a bitter taste related to its to... Newsletters for the latest recommendations for treatment of high blood pressure or chronic stable angina spread of cytochrome... Syndrome except in the presence of a functioning ventricular pacemaker limited and limited. Rifampin or any known CYP3A4 inducer should be exercised when treating patients multiple... And emergency equipment should be made to the respective agent manufacturer 's package insert for information relative to dosage administration. 6 hours after extravasation medication news, new drug approvals, alerts and updates is intradermal phentolamine considered! ( 1.5 to 2.5 fold ) during coadministration with diltiazem lowered the diltiazem plasma concentrations to undetectable.! The therapeutic benefits of diltiazem with agents known to affect cardiac conduction - prolongs!
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