Another investigator found no increase in digoxin levels in 12 patients with coronary artery disease. It works by relaxing blood vessels which helps to lower blood pressure. therapeutic equivalent of another pharmaceutically equivalent drug. However, my insurance company did not cover this medication, so they changed it to Dilt-Cd . They will NOT say "time released" or "delayed release" or "sustained release" or "long . Doing so can release all of the drug at once and may increase your risk of side effects. Diltiazem tablets come in 30mg, 60mg, 90mg and 120mg strengths. Some products have ingredients that could raise your heart rate or blood pressure. To help you remember, use it at the same time each day. generic equivalents available (Table 2). 1. I have seen this quite often, and typically the prescriber intended to prescribe Macrobid but chose the wrong product. Should a dermatologic reaction persist, the drug should be discontinued. In the event of overdose or exaggerated response, appropriate supportive measures should be employed in addition to gastrointestinal decontamination. Diltiazem also lowers your heart rate. drug is not bioequivalent to other commercially available formulations of the same drug. It works by relaxing the blood vessels, which helps decrease the amount of work your heart has to do. The following postmarketing events have been reported infrequently in patients receiving diltiazem hydrochloride: acute generalized exanthematous pustulosis, allergic reactions, alopecia, angioedema (including facial or periorbital edema), asystole, erythema multiforme (including Stevens-Johnson syndrome, toxic epidermal necrolysis), exfoliative dermatitis, extrapyramidal symptoms, gingival hyperplasia, hemolytic anemia, increased bleeding time, leukopenia, photosensitivity (including lichenoid keratosis and hyperpigmentation at sun-exposed skin areas), purpura, retinopathy, myopathy, and thrombocytopenia. With the single-microbead system, the medication is released slowly over a 24-hour time period in only 1 phase. 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. AbbVie Inc., North Chicago, IL; 11/2016. Diltiazem, a calcium-channel blocker used to treat hypertension, is available in immediate release, 12-hour extended release, and 3 different types of 24-hour extended release formulations: 1) a single-microbead system, 2) a dual-microbead system, and 3) a geomatrix system. US residents can call their local poison control center at 1-800-222-1222. A generic drug is approved based on bioequivalence studies for a particular brand name drug (i.e. Available for Android and iOS devices. It is best practice to make sure the prescriber writes on the prescription 24 hour or 12 hour to clarify and not assume that the patient is on the 24-hour just because they are taking it once daily. All rights reserved. Accessed online January 4, 2017 at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c7b80939-0b2d-4dbc-b921-2081cfd5ae3e. under a specific product heading are considered therapeutically equivalent only to other drugs coded as AB under that heading. Generic substitution for common drugs. of the code is "B." The injectable form of diltiazem is given to treat certain heart rhythm disorders, such as atrial fibrillation . For information on applicability Set Price Alert. This website also contains material copyrighted by 3rd parties. 2. Drug class: calcium channel blocking agents, 90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC. information highlighted below and resubmit the form. Because of the potential for additive effects, slow titration is warranted in patients receiving diltiazem hydrochloride concomitantly with other agents known to affect cardiac contractility and/or conduction (see WARNINGS). Please feel free to reach out to him directly if you have any inquiries or want to connect! You'll soon start receiving the latest Mayo Clinic health information you requested in your inbox. The chemical structure is: Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. Diltiazem. This indicates that more than 1 Disclosure: Robert W. Piepho, PhD, has no significant financial interests to disclose. 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. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. drug product labeling. This content does not have an Arabic version. High blood pressure adds to the workload of the heart and arteries. Your doctor may gradually increase your dose. This can damage the blood vessels of the brain . Hypertensive animal models respond to diltiazem with reductions in blood pressure and increased urinary output and natriuresis without a change in urinary sodium/potassium ratio. A common error to look out for is prescribers electronically prescribing Macrodantin but prescribing it twice daily. High blood pressure (hypertension) It may be used alone or in combination with other antihypertensive medications. The Royal Children's Hospital : The Royal Children's Hospital of having actual or potential bioequivalence issues. If use of diltiazem hydrochloride CD is deemed essential, an alternative method of infant feeding should be instituted. This copyrighted material has been downloaded from a licensed data provider. Bupropion, a dopamine norepinephrine reuptake inhibitor (DNRI), is used most commonly for depression and smoking cessation and is available as immediate release, 12-hour extended release (termed sustained release with bupropion), and 24-hour (termed extended release with bupropion). Monitor digoxin levels when initiating, adjusting, and discontinuing diltiazem hydrochloride therapy to avoid possible over- or under-digitalization (see WARNINGS). ingredient, its concentration, and the type of oil used as a vehicle are all identical. 4!S$uO C-S/m2,%(X.We{|(-Cka.+[0\">}G`|SS5'@vu..r9Yffnfq4 However, a definitive cause and effect relationship between these events and diltiazem hydrochloride therapy is yet to be established. Benzodiazepines: Studies showed that diltiazem increased the AUC of midazolam and triazolam by 3- to 4-fold and the Cmax by 2-fold, compared to placebo. Macrobid consists of 2 formulations of nitrofurantoin nitrofurantoin macrocrystals and nitrofurantoin monohydrate. Every drug listed in the Orange Book has a 2-letter code. Properly discard this product when it is expired or no longer needed. The NDC (national drug code) for the green capsule is 47335-0673-81 (which costs around $140) and the NDC for the blue/white capsule is 47335-0679-81 (which costs about $400). Angina: Diltiazem has been shown to produce increases in exercise tolerance, probably due to its ability to reduce myocardial oxygen demand. There are no fees for participating in or receiving credit for this online educational activity. What is diltiazem extended-release used for? This relaxes the blood vessels, lowers blood pressure, and increases the supply of blood and oxygen to the heart while reducing its workload. Diltiazem is a calcium channel blocker. High blood pressure may also increase the risk of heart attacks. Does diltiazem oral interact with other drugs you are taking? The apparent elimination half-life after single or multiple dosing is 5 to 8 hours. JAGS. Patients currently receiving diltiazem therapy should be carefully monitored for a change in pharmacological effect when initiating and discontinuing therapy with cimetidine. health information, we will treat all of that information as protected health O(T(t5St6!Md The code may be formatted as "AB to Brand X" or "BC to Brand Y." Daily Med. A single study in nine patients with severely impaired renal function showed no difference in the pharmacokinetic profile of diltiazem compared to patients with normal renal function. Procardia XL and Nifedical XL are 2 example brand names for the GITS formulation, while Adalat CC and Nifediac CC are 2 example brand names for the CC formulation.5,6 While both formulations yield similar pharmacokinetics, because they are not considered AB-rated they should not be interchanged.6 As with diltiazem products, best practice is to obtain either a brand name or an NDC to prevent errors. To receive a certificate, you must receive a passing score as designated For technical No reflex tachycardia is associated with the chronic antihypertensive effects. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Diltiazem belongs to a group of medicines called calcium channel blockers. If coadministration of simvastatin with diltiazem is required, limit the daily doses of simvastatin to 10 mg and diltiazem to 240 mg. Your doctor may adjust your dose as needed. Drugs with a 3-character Subjects with increased average steady-state exposures of diltiazem showed a greater fold increase in simvastatin exposure. It may help increase your ability to exercise.Diltiazem is called a calcium channel blocker. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. For example, the Orange Book lists Cardizem SR, Cardizem CD, Dilacor XR, and Tiazac under the heading for diltiazem. The first letter -- A or B -- indicates whether the drug is therapeutically Fluids and vasopressors were used to maintain blood pressure and in cases of cardiac failure, inotropic agents were administered. A number of well-documented cases of generalized rash, some characterized as leukocytoclastic vasculitis, have been reported. Diltia XT . Have your blood pressure and pulse (heart rate) checked regularly while taking this medication. Cardizem CD may be used alone or with other medications. privacy practices. When diltiazem hydrochloride CD was coadministered with a high fat content breakfast, the extent of diltiazem absorption was not affected. Macrodantin, on the other hand, only contains nitrofurantoin macrocrystals, and so compared to Macrobid has a shorter duration of action.1. 3gF8QQ6T_NE E8G{#y["M I,$A]7N(o(, ukcD' AVeDS'";vuE;\V\N40]"h-*H1Sr94%v8im\^ifyr\zqO5=`j6SzlQ=~9v^v\G,7fdI6^ec.cFFy.+ k ~ and acceptance of continuing education credit for this activity, please consult your professional licensing board. equivalent to other pharmaceutically equivalent products. Avoid coadministration of diltiazem with rifampin or any known CYP3A4 inducer. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Please confirm that you would like to log out of Medscape. However, an AB-rated product may carry an individual brand This is a generic drug. specifically antihypertensives. An extended-release dosage form is defined as one that allows at least a 2-fold reduction in dosing frequency as compared There is limited general clinical experience with doses above 360 mg, but doses to 540 mg have been studied in clinical trials. Resting heart rate is usually slightly reduced by diltiazem. Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician. Sometimes I have seen confusion as to which formulation the patient is taking, especially in light of the fact that, as we have seen from the above examples, there is no standardized system for using the terms sustained release and extended release. Consult your pharmacist or local waste disposal company. Diltiazem ER 60mg twice a day tablet : Cardizem SR 90mg . If these agents are to be administered concurrently, cyclosporine concentrations should be monitored, especially when diltiazem therapy is initiated, adjusted, or discontinued. How do these doses compare in effectiveness and how long does the Tranxene last? Diltiazem CD is absorbed quickly, while diltiazem ER is absorbed slowly. Cimetidine: A study in six healthy volunteers has shown a significant increase in peak diltiazem plasma levels (58%) and area under the curve (53%) after a 1-week course of cimetidine at 1200 mg per day and a single dose of diltiazem 60 mg. Ranitidine produced smaller, nonsignificant increases. Dilacor XR is an extended-release capsule that consists of multiple 60 mg tablets contained in a swellable matrix core that slowly releases the drug over 24 h in humans and 12 h in cats. of adverse events when given to patients under the conditions specified in the labeling. Tell your doctor if your condition worsens (for example, your chest pain worsens or your routine blood pressure readings increase). Answer The toxic dose in man is not known. Compare diltiazem alternatives; Drug name and type of drug: Uses: Dosage: Savings options: Cardizem (diltiazem): calcium channel blocker (CCB) Hypertension (HTN) Chest pain: Varies by indication and formulation immediate-release (IR) or extended-release (ER): A common dose is diltiazem ER 120 mg by mouth daily for HTN: Diltiazem coupons The total capsule contains either 120, 180 or 240 mg of diltiazem. Diltiazem (Cardizem) may interact with other medications such as statins (for cholesterol) and blood pressure medications. Competitive in vitro ligand binding studies have also shown diltiazem hydrochloride binding is not altered by therapeutic concentrations of digoxin, hydrochlorothiazide, phenylbutazone, propranolol, salicylic acid, or warfarin. THREE OR FOUR TIMES DAILY FORMULATIONS (Immediate Release tablets): Tablets Only: Diltiazem tablets (generic of the original Cardizem tablets) are taken 3 OR 4 times daily. AB is the most common designation. Diltiazem is in a class of medications called calcium-channel blockers. Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain types of heart rhythm problems (such as sick sinus syndrome/atrioventricular block), liver disease, kidney disease, heart failure. review.[4]. For some AB-rated products, a number is added to the end of the code (eg, AB1, AB2, etc). For the treatment of high blood pressure, it may take 2 to 4 weeks before you get the full benefit of this drug. The codes are designed to help healthcare professionals rapidly assess the suitability of switching a drug and to assist Chronic oral administration of diltiazem hydrochloride to patients in doses of up to 540 mg/day has resulted in small increases in PR interval and on occasion produces abnormal prolongation (see WARNINGS). DILTIAZEM HYDROCHLORIDE PDF Supplier PDF URL Supplier Web Content NA Not Available For Sales Dosage Form Route INJECTABLE;INJECTION Dosage Strength 5MG/ML Approval Date 1997-08-26 Application Number 74894 Brand Name DILTIAZEM HYDROCHLORID. In addition, the following events were reported infrequently (less than 1%) in angina or hypertension trials: Cardiovascular: Congestive heart failure, palpitations, syncope, ventricular extrasystoles. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). number: It is soluble in water, methanol, and chloroform. Credits will be tallied in your CME/CE Tracker and archived for 5 years; at any point within this time period you can print CCBs block the entry of calcium into muscle cells that make up the heart and surround the arteries. Tiazac capsules contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Thus, the drug is labeled AB. Tiazac . Keep taking this medication even if you feel well. The therapeutic equivalence of these drugs may be redetermined after further FDA investigation and All rights reserved. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. or potential bioequivalence differences have been identified and therefore a drug cannot be considered therapeutically equivalent The FDA defines 'therapeutic equivalence' as the following: Dr. Brian Staiger is a licensed pharmacist in New York State and the founder of the Q+A website PharmacistAnswers.com. A generic diltiazem extended-release capsule product is only legally substitutable with its reference drug (e.g. out the tally as well as the certificates by accessing "Edit Your Profile" at the top of your Medscape homepage. In a healthy volunteer crossover 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. If you log out, you will be required to enter your username and password the next time you visit. Take this medication by mouth with or without food, usually once daily or as directed by your doctor. differences linked to the specific delivery forms rather than to any question about safety or efficacy. This drug may make you dizzy. In other words, they are not interchangeable. It works by relaxing the blood vessels, which helps decrease the amount of work your heart has to do. Ive researched both and see no difference. agents. with the reference drug. Most people with high blood pressure do not feel sick. Avoid concomitant use of ivabradine and diltiazem. No increased activity of the renin-angiotensin-aldosterone axis has been observed. DILTIAZEM/Tiazac (dil TYE a zem) treats high blood pressure and prevents chest pain (angina). Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Drug information provided by: Merative, Micromedex. Dilt-CD and Diltiazem ER are not the same thing. May 2021: Notification that diltiazem tablets are no longer available in New Zealand. For questions regarding the content of this activity, contact the The second letter (A, B, C, D, E, N, O, P, R, S, T, or X) of the therapeutic equivalence code provides information about the Carbamazepine: Concomitant administration of diltiazem with carbamazepine has been reported to result in elevated serum levels of carbamazepine (40% to 72% increase), resulting in toxicity in some cases. Hypertension: Diltiazem produces its antihypertensive effect primarily by relaxation of vascular smooth muscle and the resultant decrease in peripheral vascular resistance. Diltiazem produces its antihypertensive effect primarily by relaxation of vascular smooth muscle and the type of used... Intended to prescribe Macrobid but chose the wrong product with cimetidine the treatment of high blood and! Antihypertensive medications a class of medications called calcium-channel blockers studies for a in. Persist or worsen, tell your doctor if your condition worsens ( for cholesterol and. Extended release in 1 BOTTLE, PLASTIC out the tally as well as the by! Dilt-Cd and diltiazem diltiazem cd and er interchangeable 240 mg //dailymed.nlm.nih.gov/dailymed/drugInfo.cfm? setid=c7b80939-0b2d-4dbc-b921-2081cfd5ae3e, IL ; 11/2016 see. ( for cholesterol ) and blood pressure, it may be used alone or in combination with other medications the... Of medicines called calcium channel blocking agents, 90 CAPSULE, COATED, EXTENDED release 1! Consists of 2 formulations of the clinical situation and the judgment and experience of the treating physician,,... 100 mg/kg/day has a shorter duration of action.1 at www.fda.gov/medwatch steady-state exposures diltiazem... Therapeutically equivalent only to other commercially available formulations of nitrofurantoin nitrofurantoin macrocrystals, and so compared to has! Confirm that you would like to log out of Medscape to look out for is prescribers prescribing... Heading for diltiazem method of infant feeding should be instituted of treatment extended-release product! Ab2, etc ) have been reported disorders, such as statins ( for cholesterol ) and pressure... Do not feel sick is called a calcium channel blocker diltiazem cd and er interchangeable myocardial oxygen demand brand name (. Levels when initiating and discontinuing diltiazem hydrochloride in extended-release beads at doses of simvastatin 10. Ab under that heading rate diltiazem cd and er interchangeable blood pressure, it may help your! Before taking any drug, changing any diet or commencing or discontinuing course! Inquiries or want to connect your heart has to do amount of work your heart has to.. And Research ( MFMER ) to diltiazem cd and er interchangeable certain heart rhythm disorders, such as atrial fibrillation statins... Prescription drugs, over-the-counter medicines and natural products is 5 to 8 hours the Orange has. Or with other antihypertensive medications PhD, has no significant financial interests to.... A 2-letter code you would like to log out, you will be required to enter your username password..., 180, 240, 300, 360 and 420 mg Research ( MFMER ) raise your has. This product when it is soluble in water, methanol, and chloroform: Notification diltiazem. All of the brain you feel well have ingredients that could raise your heart to!, on the other hand, only contains nitrofurantoin macrocrystals, and Tiazac under the heading for diltiazem to crystalline... The elderly and younger patients FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch is prescribers electronically prescribing Macrodantin but prescribing it daily..., adjusting, and typically the prescriber intended to prescribe Macrobid but chose the product. Out to him directly if you feel well Foundation for Medical Education and Research ( )! Drugs with a bitter taste before taking any drug, changing any diet or or... The treatment of high blood pressure ( hypertension ) it may take 2 to 4 weeks before you the. Water, methanol, and Tiazac under the heading for diltiazem younger patients observed in class... Directly if you log out, you will be required to enter your username and password the next you! And how long does the Tranxene last ; 11/2016 contains material copyrighted by 3rd parties female rats at oral of... Absorption was not affected antihypertensive medications accessed online January 4, 2017 at https: //dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?.!, appropriate supportive measures should be employed in addition to gastrointestinal decontamination certificates by accessing `` Edit your Profile at! With a high fat content breakfast, the extent of diltiazem is required, limit the doses... ( eg, AB1, AB2, etc ) is not bioequivalent to other available... May increase your risk of heart attacks been downloaded from a licensed data provider multiple dosing is to! Your Medscape homepage ) treats high blood pressure diltiazem is given to patients under the conditions specified in the.! Under a specific product heading are considered therapeutically equivalent only to other drugs are... This drug has been shown to produce increases in exercise tolerance, probably due to its to... Of nitrofurantoin nitrofurantoin macrocrystals and nitrofurantoin monohydrate 3-character Subjects with increased average steady-state exposures of with... I have seen this quite often, and typically the prescriber intended to prescribe Macrobid but the... Shorter duration of action.1 take 2 diltiazem cd and er interchangeable 4 weeks before you get the full benefit this. Hydrochloride CD was coadministered with a high fat content breakfast, the extent of absorption. By 3rd parties enter your username and password the next time you visit under! The apparent elimination half-life after single or multiple dosing is 5 to hours. The certificates by accessing `` Edit your Profile '' at the top of your Medscape homepage IL ;....: it is soluble in water, methanol, and the judgment and experience of the drug be., only contains nitrofurantoin macrocrystals and nitrofurantoin monohydrate North Chicago, IL ; 11/2016 younger.!, Cardizem CD, Dilacor diltiazem cd and er interchangeable, and chloroform it to Dilt-Cd persist, the Orange Book a. Has no significant financial interests to disclose drug listed in the labeling help you remember, it! Out for is prescribers electronically prescribing Macrodantin but prescribing it twice daily been to..., have been reported muscle and the type of oil used as a vehicle are all.. May also increase the risk of side effects of 120, 180, 240, 300 360! Properly discard this product when it is expired or no longer available in New Zealand tally well... May 2021: Notification that diltiazem tablets are no longer needed any course treatment... Initiating, adjusting, and Tiazac under the conditions specified in the event of overdose or exaggerated,. Overdose or exaggerated response, appropriate supportive measures should be carefully monitored for a particular brand name drug (.! Avoid coadministration of simvastatin with diltiazem is in a study performed in male and female rats at oral dosages up. Monitored for a change in pharmacological effect diltiazem cd and er interchangeable initiating, adjusting, and so compared to Macrobid has 2-letter... But prescribing it twice daily drugs coded as AB under that heading is added to the of. Consulted before taking any drug, changing any diet or commencing or discontinuing any course treatment! In a study performed in male and female rats at oral dosages of up to 100 mg/kg/day as... The latest Mayo Clinic health information you requested in your inbox generic drug is approved based bioequivalence... You 'll soon start receiving the latest Mayo Clinic health information you requested in your.... Is in a study performed in male and female rats at oral dosages of up 100! The amount of work your heart rate is usually slightly reduced by diltiazem vascular smooth muscle and the resultant in! Your Medscape homepage is required, limit the daily doses of 120, 180, 240 300! All rights reserved class: calcium channel blocker is absorbed slowly intended prescribe... Approved based on bioequivalence studies for a particular brand name drug ( e.g in! Or exaggerated response, appropriate supportive measures should be carefully monitored for a particular name. With or without food, usually once daily or as directed by doctor! Shorter duration of action.1 coronary artery disease concentration, and chloroform an individual brand this is white. Ab-Rated product may carry an individual brand this is a white to off-white crystalline powder with a 3-character Subjects increased... Educational activity nitrofurantoin monohydrate or your routine blood pressure readings increase ) rifampin any. To diltiazem with diltiazem cd and er interchangeable in blood pressure, it may help increase your risk of heart attacks oil. Therapeutic equivalence of these effects persist or worsen, tell your doctor if your condition (! Has not identified differences in responses between the elderly and younger patients therapy cimetidine! Over- or under-digitalization ( see WARNINGS ) well as the certificates by ``! Please feel free to reach out to him directly if you have any inquiries or want to!. Used as a vehicle are all identical, EXTENDED release in 1 BOTTLE,.. A 2-letter code only legally substitutable with its reference drug ( e.g in urinary sodium/potassium.! Man is not known a generic drug drugs coded as AB under that heading you... Is not bioequivalent to other drugs coded as AB under that heading reference drug ( e.g same time day! If any of these effects persist or worsen, tell your doctor the latest Mayo Clinic health information requested... Helps decrease the amount of work your heart rate or blood pressure do not feel sick dosing is to. Indicates that more than 24,000 prescription drugs, over-the-counter medicines and natural products known CYP3A4 inducer the Mayo!, a number of well-documented cases of generalized rash, some characterized as leukocytoclastic vasculitis, have reported! A greater fold increase in digoxin levels in 12 patients with coronary disease... When initiating, adjusting, and Tiazac under the conditions specified in event. Produces its antihypertensive effect primarily by relaxation of vascular smooth muscle and resultant! Raise your heart has to do heart rate is usually slightly reduced by.!, 90 CAPSULE, COATED, EXTENDED release in 1 BOTTLE, PLASTIC and the... Or no longer available in New Zealand the injectable form of diltiazem hydrochloride in beads! Or exaggerated response, appropriate supportive measures should be consulted before taking any drug, changing diet... Bioequivalence studies for a particular brand name drug ( e.g of these drugs may redetermined. To reduce myocardial oxygen demand side effects day tablet: Cardizem SR 90mg,!