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Diltiazem ER 240mg Tabs (la 24hr)

Manufacturer OCEANSIDE Active Ingredient Diltiazem Long-Acting Tablets(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
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Diltiazem ER is a medication that helps relax blood vessels and slow down your heart rate. This helps to lower high blood pressure, reduce chest pain (angina), and control an irregular heartbeat (atrial fibrillation/flutter). It's an extended-release tablet, meaning it releases the medicine slowly over 24 hours, so you usually take it only once a day.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.

Take your medication as directed by your doctor, swallowing the tablets whole without chewing, breaking, or crushing them.
 Establish a routine by taking your medication at the same time every day.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication:

 Store it at room temperature, protected from light and moisture. Avoid storing it in a bathroom.
Keep your medication in a secure location, out of the reach of children and pets.
 Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best disposal method, and consider participating in local drug take-back programs.

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. Avoid taking two doses at the same time or taking extra doses.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once daily. Do not crush, chew, or divide the extended-release tablet.
  • Take with or without food, but be consistent (e.g., always with food or always without).
  • Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness or lightheadedness.
  • Limit or avoid alcohol consumption, as it can worsen dizziness and lower blood pressure.
  • Maintain a healthy diet (low in sodium, saturated fats), regular exercise, and manage stress to support cardiovascular health.
  • 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: 240 mg once daily
Dose Range: 180 - 540 mg

Condition-Specific Dosing:

hypertension: Initial 180-240 mg once daily; may titrate up to 360-480 mg once daily. Max 540 mg/day.
chronicstableangina: Initial 180-240 mg once daily; may titrate up to 360-480 mg once daily. Max 540 mg/day.
atrialfibrillation_flutter_ratecontrol: Initial 120-240 mg once daily; may titrate up to 360 mg once daily. Max 480 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (ER formulations generally not recommended)
Adolescent: Not established (ER formulations generally not recommended)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, use with caution.
Moderate: Use with caution, monitor for exaggerated effects. Consider lower initial dose and slower titration.
Severe: Use with caution, monitor for exaggerated effects. Consider lower initial dose and slower titration.
Dialysis: Diltiazem is not significantly removed by dialysis. Use with caution, monitor for exaggerated effects.

Hepatic Impairment:

Mild: No specific adjustment, use with caution.
Moderate: Use with caution, monitor for exaggerated effects. Consider lower initial dose and slower titration.
Severe: Use with caution, monitor for exaggerated effects. Consider lower initial dose and slower titration.

Pharmacology

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Mechanism of Action

Diltiazem inhibits the influx of extracellular calcium ions across the myocardial and vascular smooth muscle cell membranes, without changing serum calcium concentrations. This leads to relaxation of vascular smooth muscle and coronary vasodilation, resulting in decreased peripheral vascular resistance and blood pressure. In the heart, it decreases sinoatrial (SA) and atrioventricular (AV) nodal conduction, prolongs AV nodal refractory periods, and decreases myocardial contractility, thereby reducing heart rate and myocardial oxygen demand.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 40-60% (due to extensive first-pass metabolism)
Tmax: 6-11 hours (for ER formulations)
FoodEffect: Food may increase bioavailability for some ER formulations; generally recommended to take consistently with or without food.

Distribution:

Vd: Approximately 1.7 L/kg
ProteinBinding: 70-85%
CnssPenetration: Limited

Elimination:

HalfLife: 5-10 hours (for ER formulations, terminal half-life can be longer)
Clearance: Approximately 10-15 L/hr
ExcretionRoute: Urine (35-65%), Feces (35-65%)
Unchanged: <5%
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Pharmacodynamics

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

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

Although rare, some individuals may experience severe and potentially life-threatening side effects while taking this medication. If you exhibit any of the following symptoms, contact your doctor or seek medical help right away:

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, consult your doctor). Seek immediate medical attention if you experience:
+ 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 (sometimes fatal). Seek medical help right away if you notice:
+ Red, swollen, blistered, or peeling skin
+ Other skin irritation (with or without fever)
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, or eyes

Other Possible Side Effects

As with all medications, you may experience side effects. While many people have no side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor or seek medical help:

 Headache
* Feeling dizzy, tired, or weak

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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)
  • New or worsening swelling in your hands, ankles, or feet
  • Shortness of breath, especially with exertion or lying down
  • Unusual fatigue or weakness
  • Severe constipation
  • Yellowing of skin or eyes (jaundice), dark urine, or persistent nausea/vomiting (signs of liver problems)
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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 to determine if this medication is safe for you.
Existing health conditions, such as:
+ Fluid accumulation in the lungs
+ Low blood pressure
+ Recent heart attack
 Current medications, including:
+ Ivabradine
+ Rifampin
* All prescription and over-the-counter medications, natural products, and vitamins you are taking, as this medication may interact with them.

Please note that this is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to discuss all your medications and health conditions with your doctor and pharmacist. Never start, stop, or modify the dosage of any medication without first consulting your doctor to confirm that 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 your full attention, 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 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 treatment with this medication and at intervals during treatment. Discuss any concerns or questions 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. Additionally, talk to your doctor before consuming alcohol while taking this medication.

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, plan to become pregnant, or are breastfeeding, inform your doctor, as 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 (very slow heart rate)
  • AV block (heart block)
  • Asystole (cardiac arrest)
  • Cardiogenic shock
  • Metabolic acidosis
  • Hyperglycemia

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 gastric lavage, activated charcoal, IV fluids, atropine, calcium gluconate/chloride, vasopressors, glucagon, or cardiac pacing.

Drug Interactions

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Contraindicated Interactions

  • Ivabradine (increased risk of bradycardia)
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Major Interactions

  • Beta-blockers (e.g., metoprolol, propranolol): Increased risk of bradycardia, AV block, and myocardial depression.
  • Digoxin: Increased digoxin serum concentrations, leading to toxicity.
  • Statins (e.g., simvastatin, lovastatin): Increased statin concentrations, leading to increased risk of myopathy/rhabdomyolysis.
  • Amiodarone: Increased risk of bradycardia, AV block, and hypotension.
  • Cyclosporine, Tacrolimus, Sirolimus: Increased immunosuppressant levels, leading to toxicity.
  • Midazolam, Triazolam: Increased benzodiazepine levels, leading to increased sedation.
  • Alpha-blockers (e.g., prazosin, doxazosin): Increased risk of hypotension.
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Moderate Interactions

  • Other CYP3A4 substrates (e.g., carbamazepine, quinidine, phenytoin): May increase levels of these drugs.
  • CYP3A4 inhibitors (e.g., azole antifungals, macrolide antibiotics): May increase diltiazem levels.
  • CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine): May decrease diltiazem levels.
  • Fentanyl: Increased risk of respiratory depression and sedation.
  • Clonidine: Additive bradycardia and AV block.
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Minor Interactions

  • Grapefruit juice: May increase diltiazem levels (avoid excessive consumption).

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing.

Timing: Prior to initiation

Heart Rate (HR)

Rationale: To establish baseline and assess risk of bradycardia.

Timing: Prior to initiation

Electrocardiogram (ECG)

Rationale: To assess for pre-existing conduction abnormalities (e.g., AV block, sick sinus syndrome).

Timing: Prior to initiation, especially if cardiac history

Liver Function Tests (LFTs)

Rationale: Diltiazem is hepatically metabolized; assess baseline liver function.

Timing: Prior to initiation

Renal Function (SCr, eGFR)

Rationale: To assess baseline renal function, though renal excretion is minor.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially during dose titration and periodically thereafter (e.g., monthly initially, then every 3-6 months)

Target: <130/80 mmHg (individualized based on guidelines and comorbidities)

Action Threshold: Persistent BP > target range (consider dose increase or add therapy); Symptomatic hypotension (consider dose decrease)

Heart Rate (HR)

Frequency: Regularly, especially during dose titration and periodically thereafter (e.g., monthly initially, then every 3-6 months)

Target: 50-90 bpm (individualized)

Action Threshold: HR <50 bpm or symptomatic bradycardia (consider dose decrease or discontinuation); HR >90 bpm (consider dose increase or add therapy for rate control)

Symptoms of Heart Failure

Frequency: At each visit

Target: Absence of new or worsening symptoms

Action Threshold: New or worsening dyspnea, edema, fatigue (evaluate for cardiac decompensation)

Drug Interactions

Frequency: With any new medication or change in existing medications

Target: N/A

Action Threshold: Review medication list for potential interactions, especially with CYP3A4 substrates/inhibitors/inducers, beta-blockers, digoxin, statins.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Peripheral edema (swelling of ankles/feet)
  • Shortness of breath
  • Chest pain (worsening or new onset)
  • Palpitations
  • Bradycardia (slow heart rate)
  • Constipation

Special Patient Groups

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Pregnancy

Diltiazem is Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects on the fetus.

Trimester-Specific Risks:

First Trimester: Potential for developmental abnormalities observed in animal studies at high doses. Human data are limited.
Second Trimester: Limited human data. Use with caution, monitor fetal growth and heart rate.
Third Trimester: Limited human data. Use with caution, monitor fetal growth and heart rate. 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 it compatible with breastfeeding, but caution is advised. Monitor the infant for signs of bradycardia, hypotension, or sedation.

Infant Risk: Low to moderate risk. Monitor for bradycardia, lethargy, poor feeding. Consider alternative if infant is premature or has cardiac issues.
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Pediatric Use

Safety and effectiveness of extended-release diltiazem formulations have not been established in pediatric patients. Use is generally not recommended.

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Geriatric Use

Geriatric patients may be more sensitive to the effects of diltiazem, particularly regarding hypotension and bradycardia. Start with lower doses and titrate slowly, monitoring closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Diltiazem ER is a good choice for patients with hypertension who also have concomitant angina or require heart rate control for atrial fibrillation/flutter.
  • Unlike dihydropyridine CCBs (e.g., amlodipine), diltiazem has significant effects on cardiac conduction and contractility, making it useful for rate control but also requiring caution in patients with pre-existing conduction abnormalities or heart failure with reduced ejection fraction.
  • Do not crush, chew, or divide extended-release tablets, as this can lead to rapid release of the drug and potentially dangerous side effects.
  • Patients should be advised to report symptoms of excessive bradycardia (dizziness, fainting, fatigue) or worsening heart failure (shortness of breath, swelling).
  • Careful monitoring is required when co-administering with other drugs that affect heart rate or are metabolized by CYP3A4.
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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, Ramipril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan)
  • Thiazide Diuretics (e.g., Hydrochlorothiazide, Chlorthalidone)
  • Loop Diuretics (e.g., Furosemide) for heart failure
  • Other antiarrhythmics (e.g., Digoxin, Amiodarone) for rate/rhythm control
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Cost & Coverage

Average Cost: $15 - $50 per 30 tablets (generic Diltiazem ER 240mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic) or Tier 2 (Preferred Brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea 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 happened.