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Diltiazem ER 240mg Capsules (24 Hr)

Manufacturer OCEANSIDE Active Ingredient Diltiazem Long-Acting Capsules(dil TYE a zem) Pronunciation dil TYE a zem
It is used to treat high blood pressure.It is used to treat some types of chest pain (angina).It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antihypertensive, Antianginal, Antiarrhythmic
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Pharmacologic Class
Calcium Channel Blocker, Non-dihydropyridine
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Pregnancy Category
Category C
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FDA Approved
Sep 1982
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Diltiazem is a medication that helps relax blood vessels and slow down your heart rate. This can lower your blood pressure, reduce chest pain (angina), and help control an irregular heartbeat. It's a type of medicine called a calcium channel blocker.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, it's essential to take it as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. Take your medication at the same time every day to establish a routine. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling better.

Some medications may need to be taken with food, while others should be taken on an empty stomach. Check with your pharmacist to determine the best way to take your specific medication. Additionally, some products can be opened and mixed with a spoonful of applesauce, while others must be swallowed whole. Consult with your pharmacist to see if your medication can be opened.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing your medication in a bathroom. Keep all medications in a secure location, out of the reach of children and pets. Dispose of any unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult with your pharmacist, who can also inform you about potential drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take the capsule whole; do not crush, chew, or divide it.
  • Take at the same time each day, preferably with or without food, but be consistent.
  • Avoid grapefruit and grapefruit juice while taking this medication, as it can increase the amount of diltiazem in your body.
  • Limit alcohol consumption, as it can increase the risk of dizziness and low blood pressure.
  • Maintain a healthy diet, regular exercise, and manage stress to support cardiovascular health.
  • Monitor your blood pressure and heart rate at home as advised by your doctor.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 240 mg orally once daily
Dose Range: 120 - 480 mg

Condition-Specific Dosing:

hypertension: Initial: 180-240 mg orally once daily; adjust dose based on blood pressure response, typically 1-2 weeks apart. Max: 540 mg/day.
chronicStableAngina: Initial: 120-180 mg orally once daily; adjust dose based on clinical response. Max: 540 mg/day.
atrialFibrillationFlutterRateControl: Initial: 120-240 mg orally once daily; adjust dose based on heart rate response. Max: 540 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for hypertension/angina. Off-label use for supraventricular tachycardia (SVT) may involve immediate-release formulations.
Adolescent: Not established for hypertension/angina. Off-label use for SVT may involve immediate-release formulations.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed, but monitor for exaggerated effects.
Severe: Use with caution; monitor for exaggerated effects. No specific dose reduction guidelines, but consider lower initial doses.
Dialysis: Diltiazem is not significantly removed by hemodialysis. Administer after dialysis if dose adjustment is needed.

Hepatic Impairment:

Mild: Use with caution; monitor for exaggerated effects.
Moderate: Reduced initial dose recommended (e.g., 50% of usual starting dose) due to extensive hepatic metabolism. Titrate carefully.
Severe: Contraindicated or use with extreme caution; significant dose reduction required. Monitor closely for adverse effects.

Pharmacology

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Mechanism of Action

Diltiazem is a non-dihydropyridine calcium channel blocker. It inhibits the influx of extracellular calcium ions across the membranes of myocardial and vascular smooth muscle cells by blocking voltage-gated L-type calcium channels. This action leads to a reduction in myocardial contractility, slowing of sinoatrial (SA) and atrioventricular (AV) nodal conduction, and relaxation of vascular smooth muscle, resulting in peripheral and coronary vasodilation. These effects contribute to decreased heart rate, reduced systemic vascular resistance, and improved coronary blood flow, leading to blood pressure reduction and antianginal effects.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 40-65% (due to extensive first-pass metabolism); ER formulations are designed for sustained release.
Tmax: 10-14 hours (for extended-release capsules)
FoodEffect: Food may increase bioavailability and delay Tmax for some ER formulations; generally recommended to take consistently with or without food.

Distribution:

Vd: Approximately 5.3 L/kg
ProteinBinding: 70-80%
CnssPenetration: Limited

Elimination:

HalfLife: 5-10 hours (terminal half-life for ER formulations can be longer due to sustained release)
Clearance: Approximately 1.1 L/min
ExcretionRoute: Primarily urine (35%) and feces (65%)
Unchanged: <4% (urine)
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Pharmacodynamics

OnsetOfAction: Within 2-3 hours (for ER formulations)
PeakEffect: 6-11 hours (for ER formulations)
DurationOfAction: 24 hours (for 24-hour ER formulations)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
 Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Severe dizziness or fainting
 Slow heartbeat
New or worsening abnormal heartbeat
 Worsening heart failure (if you have a history of heart failure), characterized by:
+ Shortness of breath
+ Significant weight gain
+ Swelling in the arms or legs
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other severe skin reactions, which may be life-threatening
+ Signs of severe skin reactions include:
- Red, swollen, blistered, or peeling skin
- Skin irritation (with or without fever)
- Red or irritated eyes
- Sores in the mouth, throat, nose, or eyes

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

 Headache
* Feeling dizzy, tired, or weak

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting
  • Very slow heart rate (e.g., less than 50 beats per minute)
  • New or worsening swelling in your ankles, feet, or legs
  • Shortness of breath, especially with exertion or lying down
  • Unusual fatigue or weakness
  • Yellowing of skin or eyes (jaundice)
  • Dark urine or light-colored stools
  • Persistent nausea, vomiting, or loss of appetite
  • Severe constipation
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
 Certain types of abnormal heart rhythms, as this medication is not suitable for individuals with these conditions. If you are unsure, consult your doctor or pharmacist for guidance.
Any of the following health conditions: fluid accumulation in the lungs, low blood pressure, or a recent heart attack.
 If you are currently taking ivabradine or rifampin, as these medications may interact with this drug.

This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems. Your doctor and pharmacist need this information to ensure safe treatment. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

When starting this medication, be cautious when performing tasks that require alertness, such as driving, until you understand how it affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when navigating stairs.

As directed by your doctor, regularly monitor your blood pressure and heart rate. You may need to undergo an electrocardiogram (ECG) before initiating treatment and periodically while taking this medication. Consult with your doctor regarding the frequency of these checks.

If you have high blood pressure, consult your doctor before using over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.

If you consume grapefruit juice or eat grapefruit regularly, discuss this with your doctor, as it may interact with your medication. Additionally, you may need to avoid consuming alcohol while taking this medication; consult your doctor or pharmacist to determine if this is necessary.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Profound hypotension (very low blood pressure)
  • Severe bradycardia (very slow heart rate)
  • AV block (heart block)
  • Cardiogenic shock
  • Asystole (cardiac arrest)
  • Metabolic acidosis
  • Hyperglycemia

What to Do:

Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Treatment may involve gastric lavage, activated charcoal, IV fluids, atropine, calcium gluconate, vasopressors, glucagon, and/or cardiac pacing.

Drug Interactions

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Contraindicated Interactions

  • Ivabradine (increased risk of bradycardia)
  • Dantrolene (IV) (risk of hyperkalemia and myocardial depression)
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Major Interactions

  • Beta-blockers (e.g., metoprolol, carvedilol): Increased risk of bradycardia, AV block, and heart failure.
  • Digoxin: Increased digoxin serum concentrations (monitor digoxin levels).
  • Statins (e.g., simvastatin, lovastatin): Increased statin exposure due to CYP3A4 inhibition (consider lower statin doses or alternative statins).
  • Amiodarone: Increased risk of bradycardia, AV block, and myocardial depression.
  • Fentanyl: Increased fentanyl exposure (monitor for respiratory depression).
  • Cyclosporine, Tacrolimus, Sirolimus: Increased immunosuppressant levels (monitor levels and adjust dose).
  • Carbamazepine, Phenytoin: Increased levels of these anticonvulsants.
  • Rifampin: Decreased diltiazem levels (CYP3A4 induction).
  • Grapefruit juice: Increased diltiazem exposure (avoid or limit consumption).
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Moderate Interactions

  • Alpha-blockers (e.g., prazosin): Additive hypotensive effects.
  • Clonidine: Additive bradycardia and AV block.
  • Cimetidine: Increased diltiazem levels.
  • Theophylline: Increased theophylline levels.
  • Buspirone: Increased buspirone levels.
  • Midazolam, Triazolam: Increased benzodiazepine levels.
  • Quinidine: Increased quinidine levels.
  • Other antihypertensives: Additive hypotensive effects.
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Minor Interactions

  • NSAIDs: May reduce the antihypertensive effect of diltiazem.

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing for hypertension/angina.

Timing: Prior to initiation

Heart Rate (HR)

Rationale: To establish baseline and assess risk of bradycardia, especially with co-administered drugs.

Timing: Prior to initiation

Electrocardiogram (ECG) - PR interval

Rationale: To assess baseline cardiac conduction and identify pre-existing AV block.

Timing: Prior to initiation

Liver Function Tests (LFTs)

Rationale: Diltiazem is extensively metabolized by the liver; assess baseline hepatic function.

Timing: Prior to initiation

Renal Function Tests (RFTs)

Rationale: To assess baseline renal function, although renal excretion is minor, severe impairment may affect drug elimination.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially during dose titration and periodically thereafter (e.g., weekly during titration, then monthly/quarterly)

Target: <130/80 mmHg (for hypertension, individualized)

Action Threshold: Persistent hypotension (<90/60 mmHg) or inadequate BP control

Heart Rate (HR)

Frequency: Regularly, especially during dose titration and periodically thereafter (e.g., weekly during titration, then monthly/quarterly)

Target: 50-90 bpm (for rate control in AFib, individualized)

Action Threshold: Bradycardia (<50 bpm) or symptomatic bradycardia

Electrocardiogram (ECG) - PR interval

Frequency: Periodically, especially with dose increases or co-administration of other AV nodal blocking agents (e.g., beta-blockers, digoxin)

Target: Normal PR interval (<0.20 seconds)

Action Threshold: Significant PR prolongation or development of higher-degree AV block

Signs/Symptoms of Peripheral Edema

Frequency: Regularly

Target: Absence of significant edema

Action Threshold: Development of new or worsening peripheral edema

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Headache
  • Constipation
  • Peripheral edema (swelling of ankles/feet)
  • Shortness of breath
  • Chest pain (worsening angina)
  • Palpitations
  • Signs of liver dysfunction (e.g., jaundice, dark urine, persistent nausea/vomiting)

Special Patient Groups

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Pregnancy

Diltiazem is Pregnancy Category C. Animal studies have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity observed in animal studies (e.g., skeletal abnormalities, embryolethality at high doses).
Second Trimester: Limited human data; potential for fetal bradycardia or other cardiac effects.
Third Trimester: Potential for fetal bradycardia, hypotension, and other adverse effects on the neonate if used close to term.
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Lactation

Diltiazem is excreted into breast milk. The American Academy of Pediatrics considers it compatible with breastfeeding. Monitor the infant for signs of bradycardia, hypotension, or sedation.

Infant Risk: Low to moderate risk. Monitor for bradycardia, hypotension, and lethargy in the infant. Consider alternative agents if infant is premature or has underlying cardiac conditions.
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Pediatric Use

Safety and efficacy have not been established for hypertension or angina in pediatric patients. Immediate-release formulations are used off-label for certain supraventricular tachyarrhythmias in children under close supervision.

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Geriatric Use

Start with lower doses and titrate slowly due to increased sensitivity to hypotensive and bradycardic effects, and potential for reduced hepatic clearance. Monitor closely for adverse effects such as dizziness, falls, and edema.

Clinical Information

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Clinical Pearls

  • Diltiazem ER capsules should be swallowed whole and not crushed, chewed, or divided, as this can lead to rapid release of the drug and potential overdose.
  • Peripheral edema is a common side effect, often dose-dependent, and may not respond well to diuretics.
  • Constipation is a frequent gastrointestinal side effect; advise patients on adequate fluid intake and fiber.
  • Caution is advised when combining diltiazem with beta-blockers or digoxin due to additive effects on heart rate and AV conduction; close monitoring is essential.
  • Grapefruit juice can significantly increase diltiazem levels; patients should be advised to avoid it.
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Alternative Therapies

  • Other calcium channel blockers (e.g., amlodipine, verapamil)
  • Beta-blockers (e.g., metoprolol, carvedilol)
  • ACE inhibitors (e.g., lisinopril, enalapril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan)
  • Thiazide diuretics (e.g., hydrochlorothiazide)
  • Loop diuretics (e.g., furosemide) for edema management
  • Nitrates (for angina)
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Cost & Coverage

Average Cost: $15 - $50 per 30 capsules (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.