cardizem la
Cardizem La (Diltiazem Hydrochloride) is a calcium channel blocker used to treat Variant Angina Pectoris, Atrial Fibrillation, Atrial Flutter, Hypertension.
Diltiazem Hydrochloride · by Bausch
Available as a generic: Diltiazem Hydrochloride
Key facts
- Active ingredient
- Diltiazem Hydrochloride
- Drug class
- Calcium Channel Blocker
- Form
- Tablet, extended release
- Strength
- Diltiazem Hydrochloride 120MG · Diltiazem Hydrochloride 180MG · Diltiazem Hydrochloride 240MG · Diltiazem Hydrochloride 300MG · Diltiazem Hydrochloride 360MG · Diltiazem Hydrochloride 420MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Bausch
- Half-life
- about 3 to 4.5 hours (how long it stays in your system)
- What the pharmacy pays
- ~$9.18 for 30 — not your price
- FDA application
- NDA021392
What is Cardizem La?
From the FDA label:CARDIZEM ® LA (diltiazem hydrochloride) is a nondihydropyridine calcium channel blocker (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride is 1,5-benzothiazepin-4(5 H )-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)- cis -. The structural formula is: Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform. It has a molecular weight of 450.98. CARDIZEM LA is formulated as a once-a-day extended-release tablet for oral administration containing 120 mg, 180 mg, 240 mg, 300 mg, 360 mg or 420 mg of diltiazem hydrochloride. Tablets also contain: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, ethyl acrylate and methyl methacrylate copolymer dispersion, hydrogenated vegetable oil, hypromellose, magnesium stearate, microcrystalline cellulose, paraffin wax, polydextrose, polyethylene glycol, polysorbate, povidone, pregelatinized starch, simethicone, sodium starch glycolate, sucrose stearate, talc, and titanium dioxide. Chemical structure
How to use
Take CARDIZEM LA once a day at approximately the same time. Do not chew or crush the tablet. • Tablet should be swallowed whole and not chewed or crushed. ( 2 ) • Hypertension: Initial adult dose is 180 to 240 mg once daily. Adjust dose according to blood pressure response to a maximum of 540 mg daily. ( 2.1 ) • Angina: Initial adult dose is 180 mg once daily. Adjust dose according to response to a maximum of 360 mg. ( 2.2 ) • Switching to CARDIZEM LA: Patients may be switched to the nearest equivalent total daily diltiazem dose. ( 2.3 ) 2.1 Hypertension Initiate dosing at 180 to 240 mg once daily, although some patients may respond to lower doses. Titrate according to blood pressure to a maximum of 540 mg daily. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy. 2.2 Angina Initiate dosing at 180 mg once daily and increase dose at intervals of 7 to 14 days if adequate response is not obtained, to a maximum of 360 mg. 2.3 Switching to CARDIZEM LA Tablets Patients controlled on diltiazem alone or in combination with other medications may be switched to CARDIZEM LA once a day at the nearest equivalent total daily dose. Higher doses of CARDIZEM LA may be needed in some patients based on clinical response.
Side effects
The following adverse reactions are described in greater detail, in other sections: • Bradycardia and AV block [see Warnings and Precautions ( 5.1 )] • Heart failure [see Warnings and Precautions ( 5.2 )] • Acute hepatic injury [see Warnings and Precautions ( 5.3 )] • Severe skin reactions [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (>2%) are lower limb edema, sinus congestion and rash in patients treated for hypertension, and lower limb edema, headache, dizziness, fatigue, bradycardia, first-degree AV block and cough in patients treated for angina. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. For the hypertension studies, the following table presents adverse reactions more common on diltiazem than on placebo (but excluding events with no plausible relationship to treatment), as reported in placebo-controlled hypertension trials in patients receiving a diltiazem hydrochloride extended-release formulation (once-a-day dosing) up to 540 mg. Placebo Diltiazem…
Warnings
Important safety information
Bradycardia, second- or third-degree AV block: Monitor heart rate and rhythm. ( 5.1 ) • Heart failure: Monitor for signs and symptoms. ( 5.2 ) • Increased liver enzymes and acute hepatic injury. ( 5.3 ) • Severe skin reactions. ( 5.4 ) 5.1 Bradycardia or AV Block CARDIZEM LA may cause abnormally slow heart rates or second- or third-degree AV block. Patients with sick sinus syndrome are at increased risk of bradycardia. Concomitant use of diltiazem with beta-blockers or digitalis may result in additive effects on cardiac conduction. A patient with Prinzmetal’s angina developed periods of asystole (2 to 5 seconds) after a single dose of 60 mg of diltiazem [see Adverse Reactions ( 6 )] . Monitor for effects on heart rate and cardiac conduction. 5.2 Heart Failure Worsening of heart failure has been reported in patients with impairment of ventricular function. Experience with the use of diltiazem in combination with beta-blockers in patients with impaired ventricular function is limited. 5.3 Acute Hepatic Injury Significant elevations in liver enzymes such as alkaline phosphatase, LDH, AST (SGOT), ALT (SGPT) and signs of acute hepatic injury have been reported with diltiazem therapy. These reactions tended to occur early after therapy initiation (1 to 8 weeks) and have been reversible upon discontinuation of drug therapy. Mild elevations of transaminases with and without concomitant elevation in alkaline phosphatase and bilirubin have also been observed. Such elevations were usually transient and frequently resolved even with continued diltiazem treatment. 5.4 Severe Skin Reactions Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme and/or exfoliative dermatitis have been reported.
Who should not take Cardizem La
CARDIZEM LA is contraindicated in: • Patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker. • Patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker. • Patients with hypotension (less than 90 mm Hg systolic). • Patients who have demonstrated hypersensitivity to the drug. • Patients with acute myocardial infarction and pulmonary. • Sick sinus syndrome except in the presence of a functioning ventricular pacemaker. ( 4 ) • Second- or third-degree AV block except in the presence of a functioning ventricular pacemaker. ( 4 ) • Hypotension (less than 90 mm Hg systolic). ( 4 ) • Hypersensitivity to the drug. ( 4 ) • Acute myocardial infarction and pulmonary. ( 4 )
Overdose — what happens if you take too much
The oral LD 50 is 415 to 740 mg/kg in mice and 560 to 810 mg/kg in rats. The intravenous LD 50 is 60 mg/kg in mice and 38 mg/kg in rats. The oral LD 50 in dogs is considered to be in excess of 50 mg/kg, while lethality was seen in monkeys at 360 mg/kg. The toxic dose in man is not known. Blood levels after a standard dose of diltiazem can vary over tenfold, limiting the usefulness of blood levels in overdose cases. There have been 29 reports of diltiazem overdose in doses ranging from less than 1 g to 18 g. Sixteen of these reports involved multiple drug ingestions. Twenty-two reports indicated patients had recovered from diltiazem overdose ranging from less than 1 g to 10.8 g. There were seven reports with a fatal outcome; although the amount of diltiazem ingested was unknown, multiple drug ingestions were confirmed in six of the seven reports. Events observed following diltiazem overdose included bradycardia, hypotension, heart block, and cardiac failure. Most reports of overdose described some supportive medical measure and/or drug treatment. Bradycardia frequently responded favorably to atropine as did heart block, although cardiac pacing was also frequently utilized to treat heart block. Fluids and vasopressors were used to maintain blood pressure and in cases of cardiac failure, inotropic agents were administered. In addition, some patients received treatment with…
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Beta-blockers, digitalis, and other agents known to impair cardiac contractility and conduction may increase risk for hypotension, bradycardia, and heart failure. ( 7.1 ) • CYP450 3A4: Diltiazem is both a substrate and inhibitor of CYP450 3A4. CYP450 3A4 substrates may require dosage adjustment. ( 7.2 ) 7.1 Agents Known to Impair Cardiac Contractility and Conduction Using other agents known to affect cardiac conduction or contractility with diltiazem may increase the risk of bradycardia, AV block, and heart failure [see Warnings and Precautions ( 5.1 , 5.2 )] . Ivabradine: Concurrent use of diltiazem increases exposure to ivabradine and may exacerbate bradycardia and conduction disturbances. Avoid concomitant use of ivabradine and diltiazem. 7.2 P-glycoprotein (P-gp) and Cytochrome P450 3A4 Mediated Drug Interactions Diltiazem is both a substrate and an inhibitor of the Pg-p and cytochrome P450 3A4 enzyme system which may affect exposure to diltiazem and concomitant drugs metabolized by those pathways. Patients with renal and/or hepatic impairment may be particularly at risk of exposure changes [see Clinical Pharmacology ( 12.3 )] .
How long does Diltiazem Hydrochloride stay in your body?
The elimination half-life of diltiazem hydrochloride is about 3 to 4.5 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the plasma elimination half-life of diltiazem itself after single or repeated dosing, in adults with normal organ function. The label elsewhere quotes a slightly wider 2-to-5-hour range for the drug. Three things change that number. (1) Extended-release forms: the label reports an apparent elimination half-life of 5 to 8 hours for the extended-release capsule. That is the slow release of the formulation, not a change in how fast the body clears the drug. (2) An active metabolite: desacetyldiltiazem circulates at 10% to 20% of parent levels and is 25% to 50% as potent a coronary vasodilator as diltiazem, so some activity outlasts the parent drug's numbers. The label does not state a half-life for desacetyldiltiazem, so none is given here. The label does note that metabolites are eliminated more slowly than the parent, with a total-radioactivity half-life of about 20 hours. (3) Dose: kinetics are not linear, and the label says half-life is slightly increased at higher doses. By population, the label says liver disease matters and kidney disease does not: in cirrhosis, half-life was increased and bioavailability rose 69%; in nine patients with severely impaired renal function, the pharmacokinetic profile did not differ from normal. The Geriatric Use section states nothing about half-life in older adults. Diltiazem is not a prodrug. These figures describe how long the drug stays in plasma; they are not a drug-test detection window (metabolites are detectable far longer) and are not dosing guidance.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: DailyMed - DILTIAZEM HYDROCHLORIDE capsule, extended release (Clinical Pharmacology - Pharmacokinetics and Metabolism).
Drug class
How this class works, per Calcium Channel Blockers - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
- variant angina pectoris
- atrial fibrillation
- atrial flutter
- hypertension
- myocardial infarction
- supraventricular tachycardia
See how Cardizem La ranks — best-rated calcium channel blocker for:
Dosage forms
Tablet, extended release
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- What does Cardizem La treat?
- Cardizem La (Diltiazem Hydrochloride) may be used to treat variant angina pectoris, atrial fibrillation, atrial flutter, hypertension, myocardial infarction, supraventricular tachycardia, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Cardizem La work?
- Cardizem La is a calcium channel blocker. Calcium channel blockers slow the flow of calcium into the muscle cells of the heart and blood vessels. With less calcium, blood vessels relax and widen and the heart pumps with less force, which lowers blood pressure and eases chest pain.
- How much does Cardizem La cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $9.18 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Amlodipine Besylate — about $0.33 on the same basis.
- Is there a coupon or discount for Cardizem La?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Cardizem La. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Cardizem La?
- Cardizem La is marketed by Bausch. You can see Bausch's full profile, rating, and other products on pharmaranks.
- Is Cardizem La a brand-name or generic drug?
- Cardizem La is a brand-name product with the active ingredient Diltiazem Hydrochloride. Lower-cost generic equivalents containing Diltiazem Hydrochloride are available — ask your pharmacist.
- Is Cardizem La available over the counter?
- No. Cardizem La is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Cardizem La come in?
- Cardizem La is currently marketed as tablet, extended release, per the FDA's National Drug Code Directory.
- What class of drug is Cardizem La?
- Cardizem La is classified as calcium channel blocker, per the FDA's Established Pharmacologic Class.
- Is Cardizem La FDA-registered?
- Cardizem La is on record with the U.S. FDA under application number NDA021392. You can verify this on its official FDA label.
- Is Cardizem La safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Cardizem La. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Cardizem La?
- Cardizem La's side effects are taken directly from its FDA label. From the label: The following adverse reactions are described in greater detail, in other sections: • Bradycardia and AV block [see Warnings and Precautions ( 5.1 )] • Heart failure [see Warnings and Precautions ( 5.2 )] • Acute hepatic injury [see Warnings and Precautions ( 5.3 )] • Severe skin reactions [see Warn… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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