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Diltiazem ER 120mg 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
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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 1990
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Diltiazem ER is a medication that belongs to a group of drugs called calcium channel blockers. It works by relaxing blood vessels and slowing your heart rate, which helps to lower blood pressure and reduce chest pain (angina). The 'ER' means extended-release, so it works over 24 hours and is usually taken once a day.
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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 follow your doctor's instructions 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 directed by your doctor or healthcare provider, even if you start to feel better. Some medications may need to be taken with food, while others can be taken on an empty stomach. Check with your pharmacist to determine the best way to take your specific medication.

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 or mixed with food.

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.

When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to explore local 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 a missed one.
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Lifestyle & Tips

  • Take the medication exactly as prescribed, usually once daily. Do not crush, chew, or divide the extended-release capsule.
  • Swallow the capsule whole.
  • Do not stop taking this medication suddenly without consulting your doctor, as it can worsen your condition.
  • Monitor your blood pressure and heart rate at home as advised by your doctor.
  • Avoid grapefruit and grapefruit juice while taking this medication, as it can increase the levels of diltiazem in your body.
  • Limit alcohol consumption, as it can increase the blood pressure-lowering effects.
  • Maintain a healthy diet (e.g., low sodium, low fat), regular exercise, and manage stress to help control blood pressure and angina.
  • Inform your doctor or dentist that you are taking diltiazem before any surgery or dental procedures.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

hypertension: Initial: 120-240 mg orally once daily; adjust dose based on response, typically 120-480 mg once daily. Max: 540 mg/day for some formulations.
chronic_stable_angina: Initial: 120-240 mg orally once daily; adjust dose based on response, typically 120-480 mg once daily. Max: 540 mg/day for some formulations.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for hypertension; limited data for other uses, generally not recommended.
Adolescent: Not established for hypertension; limited data for other uses, generally not recommended.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment generally needed, monitor for exaggerated effects.
Moderate: No specific adjustment generally needed, monitor for exaggerated effects.
Severe: Use with caution, monitor for exaggerated effects. Consider lower initial doses.
Dialysis: Diltiazem is not significantly removed by dialysis. Use with caution, monitor for exaggerated effects.

Hepatic Impairment:

Mild: Use with caution, monitor for exaggerated effects. Consider lower initial doses.
Moderate: Use with caution, monitor for exaggerated effects. Consider lower initial doses.
Severe: Contraindicated in severe hepatic impairment due to extensive hepatic metabolism. Use with extreme caution or avoid.

Pharmacology

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Mechanism of Action

Diltiazem is a non-dihydropyridine calcium channel blocker that inhibits the influx of extracellular calcium ions across the myocardial and vascular smooth muscle cell membranes. This leads to relaxation of vascular smooth muscle and coronary vasodilation, resulting in decreased peripheral vascular resistance and reduced blood pressure. In the heart, it decreases sinoatrial (SA) and atrioventricular (AV) nodal conduction, prolongs AV nodal refractory period, and reduces myocardial contractility, leading to decreased heart rate and improved myocardial oxygen supply/demand balance.
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Pharmacokinetics

Absorption:

Bioavailability: 40-65%
Tmax: 6-11 hours (for ER formulations)
FoodEffect: Food may increase bioavailability and delay Tmax, but generally does not significantly alter overall exposure for ER formulations; can be taken with or without food.

Distribution:

Vd: 5.3 L/kg
ProteinBinding: 70-85%
CnssPenetration: Limited

Elimination:

HalfLife: 5-8 hours (parent drug); 9-12 hours (desacetyl diltiazem)
Clearance: Not available (highly variable due to first-pass)
ExcretionRoute: Urine (35-65%, primarily metabolites), Feces (35-65%, primarily metabolites)
Unchanged: Less than 4% (urine)
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Pharmacodynamics

OnsetOfAction: 30-60 minutes (for immediate release); prolonged for ER
PeakEffect: 6-11 hours (for ER formulations)
DurationOfAction: 24 hours (for ER formulations)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate 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
Abnormal heartbeat (new or worsening)
 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

Most people experience few or no side effects when taking this medication. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:

 Headache
* Feeling dizzy, tired, or weak

Reporting Side Effects

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 (less than 50 beats per minute)
  • Swelling in your ankles, feet, or hands
  • Shortness of breath, especially with exertion or lying down
  • Unusual fatigue or weakness
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine or pale stools
  • Persistent nausea or vomiting
  • Severe headache that doesn't go away
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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 specific heart rhythm disorders. If you are unsure, consult your doctor or pharmacist for guidance.
Existing health conditions, such as:
+ Fluid accumulation in the lungs
+ Low blood pressure
+ Recent heart attack
 Current medications, particularly:
+ Ivabradine
+ Rifampin

Please note that this is not an exhaustive list of potential interactions. To ensure safe treatment, it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. Before starting, stopping, or adjusting the dosage of any medication, consult your doctor to confirm that it is safe to do so in conjunction with this medication.
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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, get up slowly from a sitting or lying down position, and exercise caution when climbing stairs.

As directed by your doctor, regularly monitor your blood pressure and heart rate. You may need to undergo an electrocardiogram (ECG) before initiating this medication and during treatment. Discuss this with your doctor.

If you have high blood pressure and are taking this medication, 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.

Depending on the specific product, you may need to avoid consuming alcohol while taking this medication. Consult your doctor or pharmacist to determine if alcohol consumption is safe for you.

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. You 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:

  • Severe hypotension (very low blood pressure)
  • Profound bradycardia (extremely slow heart rate)
  • AV block (heart block)
  • Asystole (cardiac arrest)
  • Cardiogenic shock
  • Dizziness
  • Confusion
  • Slurred speech
  • Coma

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment may involve supportive care, IV fluids, vasopressors, atropine, calcium gluconate, glucagon, or cardiac pacing.

Drug Interactions

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Contraindicated Interactions

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

  • Beta-blockers (e.g., metoprolol, carvedilol, propranolol) - increased risk of bradycardia, AV block, heart failure
  • Digoxin - increased digoxin levels, risk of bradycardia, AV block
  • Amiodarone - increased risk of bradycardia, AV block, myocardial depression
  • Statins (e.g., simvastatin, lovastatin, atorvastatin) - increased statin levels, risk of myopathy/rhabdomyolysis (diltiazem is a CYP3A4 inhibitor)
  • Fentanyl (CYP3A4 substrate) - increased fentanyl levels, respiratory depression
  • Immunosuppressants (e.g., cyclosporine, tacrolimus, sirolimus) - increased immunosuppressant levels, toxicity
  • Alpha-1 blockers (e.g., prazosin, doxazosin) - increased risk of hypotension
  • Other antihypertensives - additive hypotensive effects
  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) - increased diltiazem levels
  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital) - decreased diltiazem levels
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Moderate Interactions

  • Benzodiazepines (e.g., midazolam, triazolam) - increased benzodiazepine levels
  • Buspirone - increased buspirone levels
  • Carbamazepine - increased carbamazepine levels
  • Theophylline - increased theophylline levels
  • Cimetidine - increased diltiazem levels
  • Grapefruit juice - increased diltiazem levels
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Minor Interactions

  • Acetaminophen - minor interaction, no dose adjustment typically needed

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 for bradycardia risk.

Timing: Prior to initiation

Electrocardiogram (ECG) - PR interval

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

Timing: Prior to initiation, especially if co-morbidities or co-medications affecting conduction

Liver Function Tests (LFTs)

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

Timing: Prior to initiation, especially in patients with suspected hepatic impairment

Renal Function (SCr, eGFR)

Rationale: To assess baseline renal function, though renal excretion of parent drug is minimal.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, at each clinic visit or as clinically indicated

Target: Individualized, e.g., <130/80 mmHg for hypertension

Action Threshold: Persistent hypotension or inadequate BP control

Heart Rate (HR)

Frequency: Regularly, at each clinic visit or as clinically indicated

Target: 50-90 bpm (unless otherwise indicated for specific conditions)

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

Electrocardiogram (ECG) - PR interval

Frequency: Periodically, or if symptoms of conduction abnormalities occur

Target: Normal PR interval (<0.20 seconds)

Action Threshold: Significant PR prolongation or development of AV block

Liver Function Tests (LFTs)

Frequency: Periodically, or if symptoms of hepatic dysfunction occur (e.g., jaundice, fatigue)

Target: Within normal limits

Action Threshold: Significant elevation of liver enzymes (e.g., >3x ULN)

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Headache
  • Peripheral edema (swelling of ankles/feet)
  • Bradycardia (slow heart rate)
  • Palpitations
  • Shortness of breath
  • Chest pain (worsening angina)
  • Signs of heart failure (e.g., worsening dyspnea, weight gain, edema)
  • Signs of liver injury (e.g., jaundice, dark urine, persistent nausea/vomiting)

Special Patient Groups

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Pregnancy

Use in pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Diltiazem crosses the placenta. Animal studies have shown adverse effects on the fetus at high doses.

Trimester-Specific Risks:

First Trimester: Limited human data; animal studies suggest potential for developmental toxicity at high doses.
Second Trimester: Limited human data; continued monitoring for fetal growth and well-being.
Third Trimester: Limited human data; potential for neonatal bradycardia or hypotension if used close to delivery.
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Lactation

Diltiazem is excreted into breast milk. The American Academy of Pediatrics considers diltiazem to be compatible with breastfeeding. Monitor breastfed infants for bradycardia, hypotension, or sedation.

Infant Risk: Low to Moderate (L3 - Moderately Safe)
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Pediatric Use

Safety and efficacy have not been established in pediatric patients. Use is generally not recommended.

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Geriatric Use

Start with lower doses and titrate slowly due to increased sensitivity to the hypotensive and bradycardic effects, and potential for decreased hepatic and renal function. Monitor closely for adverse effects such as dizziness, orthostatic hypotension, and bradycardia.

Clinical Information

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Clinical Pearls

  • Diltiazem ER is a once-daily formulation; emphasize not to crush or chew the capsules.
  • Monitor heart rate and blood pressure closely, especially during initiation and dose titration.
  • Caution when co-administering with beta-blockers or digoxin due to additive negative chronotropic and dromotropic effects; consider ECG monitoring.
  • Advise patients to avoid grapefruit juice due to potential for increased diltiazem levels.
  • Peripheral edema is a common side effect, often dose-dependent. It is typically mild and can sometimes be managed by dose reduction or adding a diuretic.
  • Patients with pre-existing sick sinus syndrome or second/third-degree AV block without a pacemaker should generally avoid diltiazem.
  • Liver function tests should be monitored periodically, especially if symptoms of hepatic dysfunction develop.
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Alternative Therapies

  • Other calcium channel blockers (e.g., amlodipine, nifedipine, verapamil)
  • Beta-blockers (e.g., metoprolol, carvedilol)
  • ACE inhibitors (e.g., lisinopril, enalapril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan)
  • Diuretics (e.g., hydrochlorothiazide, furosemide)
  • Nitrates (for angina) (e.g., isosorbide mononitrate, nitroglycerin)
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Cost & Coverage

Average Cost: $30 - $150 per 30 capsules (120mg ER)
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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.