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Diltiazem ER 360mg Tablets (la 24h)

Manufacturer OCEANSIDE PHARMACEUTICALS 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
Non-dihydropyridine Calcium Channel Blocker
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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 makes it easier for your heart to pump blood, which can lower your blood pressure, reduce chest pain (angina), and help control certain irregular heart rhythms.
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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.
Keep it in a dry place, avoiding storage in a bathroom.
 Keep all medications in a secure location, out of the reach of children and pets.
* Dispose of 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 or healthcare provider. 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 this medication exactly as prescribed, usually once daily. Do not crush, chew, or divide the extended-release tablet; swallow it whole.
  • Take it at the same time each day to maintain consistent levels in your body.
  • Avoid consuming grapefruit or grapefruit juice while taking this medication, as it can increase the amount of diltiazem in your body and lead to side effects.
  • Limit alcohol consumption, as it can increase the blood pressure-lowering effects.
  • Maintain a healthy diet, regular exercise, and manage stress as part of your overall treatment plan for high blood pressure or heart conditions.
  • Do not stop taking this medication suddenly without consulting your doctor, as it can worsen your condition.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 360 mg orally once daily
Dose Range: 120 - 540 mg

Condition-Specific Dosing:

hypertension: 180-480 mg once daily, adjusted based on response
chronicStableAngina: 120-480 mg once daily, adjusted based on response
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for hypertension/angina; limited use for supraventricular tachycardia (off-label)
Adolescent: Not established for hypertension/angina; limited use for supraventricular tachycardia (off-label)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed
Moderate: No specific adjustment needed, monitor for adverse effects
Severe: Use with caution, monitor closely for adverse effects; consider lower starting dose
Dialysis: Not significantly removed by dialysis; use with caution, monitor closely

Hepatic Impairment:

Mild: Use with caution, monitor for adverse effects
Moderate: Consider lower starting dose and titrate slowly; monitor closely for adverse effects
Severe: Contraindicated in severe hepatic impairment due to extensive hepatic metabolism

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, resulting in peripheral and coronary vasodilation, 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 heart rate and myocardial contractility, thereby decreasing myocardial oxygen demand.
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Pharmacokinetics

Absorption:

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

Distribution:

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

Elimination:

HalfLife: 5-10 hours (for extended-release formulations, effective half-life is longer due to sustained release)
Clearance: Not available (highly variable)
ExcretionRoute: Renal (35-65%), Fecal (35-65%)
Unchanged: <4% (renal)
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Pharmacodynamics

OnsetOfAction: 30-60 minutes (for blood pressure reduction with ER)
PeakEffect: 2-3 weeks (for full antihypertensive effect with chronic dosing)
DurationOfAction: 24 hours (for extended-release 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 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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
 Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ 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, discuss this with your doctor). Seek immediate medical attention if you experience:
+ Shortness of breath
+ Sudden 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 life-threatening). 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

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:

 Headache
Dizziness
 Fatigue
* Weakness

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)
  • New or worsening swelling in your ankles, feet, or hands
  • Shortness of breath, especially with exertion or lying down
  • Unusual fatigue or weakness
  • Chest pain that worsens or does not go away
  • Signs of liver problems (e.g., yellowing of skin/eyes, dark urine, persistent nausea/vomiting)
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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, including:
+ Ivabradine
+ Rifampin
* All other prescription and over-the-counter medications, natural products, and vitamins you are taking, as this is not an exhaustive list of potential interactions.

To ensure safe treatment, it is crucial to discuss all your medications and health conditions with your doctor and pharmacist. 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, avoid driving and other activities that require alertness 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 be cautious 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 any concerns 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. 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, 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)
  • Second- or third-degree AV block
  • Asystole (cardiac arrest)
  • Cardiogenic shock
  • Congestive heart failure
  • Dizziness, confusion, stupor, 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 (e.g., norepinephrine), atropine, calcium gluconate, glucagon, and potentially cardiac pacing.

Drug Interactions

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Contraindicated Interactions

  • Ivabradine (risk of severe bradycardia)
  • Dantrolene (IV) (risk of cardiovascular collapse)
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Major Interactions

  • Beta-blockers (e.g., Metoprolol, Propranolol): Increased risk of bradycardia, AV block, heart failure
  • Digoxin: Increased digoxin levels, leading to toxicity (bradycardia, arrhythmias)
  • Amiodarone: Increased risk of bradycardia, AV block, hypotension
  • Statins (e.g., Simvastatin, Lovastatin, Atorvastatin): Increased statin levels due to CYP3A4 inhibition, leading to myopathy/rhabdomyolysis
  • Strong CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole, Ritonavir, Clarithromycin): Increased diltiazem levels
  • Strong CYP3A4 inducers (e.g., Rifampin, Phenytoin, Carbamazepine, St. John's Wort): Decreased diltiazem levels
  • Fentanyl: Increased fentanyl levels (CYP3A4 inhibition)
  • Midazolam/Triazolam: Increased benzodiazepine levels (CYP3A4 inhibition)
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Moderate Interactions

  • Alpha-blockers (e.g., Prazosin, Doxazosin): Additive hypotensive effects
  • Other antihypertensives: Additive hypotensive effects
  • Grapefruit juice: May increase diltiazem levels
  • Cimetidine: May increase diltiazem levels
  • Theophylline: Increased theophylline levels
  • Cyclosporine/Tacrolimus/Sirolimus: Increased immunosuppressant levels
  • Carbamazepine: Increased carbamazepine levels
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Minor Interactions

  • Not available

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, especially with co-administration of other rate-lowering agents.

Timing: Prior to initiation

Electrocardiogram (ECG)

Rationale: To assess for pre-existing conduction abnormalities (e.g., AV block) and establish baseline rhythm.

Timing: Prior to initiation (especially if history of cardiac disease)

Liver Function Tests (LFTs)

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

Timing: Prior to initiation

Renal Function (SCr, BUN)

Rationale: To assess baseline renal function, although minimal renal excretion of unchanged drug.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

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

Target: <130/80 mmHg (or individualized target)

Action Threshold: Persistent BP above target, or symptomatic hypotension

Heart Rate (HR)

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

Target: 50-90 bpm (or individualized target)

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

ECG (PR interval)

Frequency: Periodically, especially if signs of conduction disturbance or co-administered with other AV nodal blocking agents

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: At each visit

Target: Absence of significant edema

Action Threshold: Development of new or worsening peripheral edema

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Headache
  • Swelling of ankles/feet (peripheral edema)
  • Shortness of breath
  • Chest pain (worsening angina)
  • Palpitations
  • Bradycardia (slow heart rate)

Special Patient Groups

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Pregnancy

Diltiazem is Pregnancy Category C. Studies in animals have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity observed in animal studies at high doses; human data limited.
Second Trimester: Limited human data; generally avoided unless clearly needed.
Third Trimester: Limited human data; generally avoided unless clearly needed; potential for fetal bradycardia or hypotension.
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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 bradycardia, hypotension, and sedation.

Infant Risk: L3 (Moderate risk) - Monitor infant for adverse effects such as bradycardia, hypotension, and lethargy. Consider alternative agents if possible, especially in preterm or unstable infants.
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Pediatric Use

Safety and efficacy have not been established for hypertension or angina in pediatric patients. Limited off-label use for supraventricular tachycardia in specific cases, with careful monitoring and specialized dosing.

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Geriatric Use

Geriatric patients may be more sensitive to the effects of diltiazem, particularly hypotensive and bradycardic effects. A lower starting dose and slower titration may be appropriate. Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Diltiazem ER formulations are designed for once-daily dosing and should be swallowed whole; do not crush, chew, or divide.
  • Different extended-release formulations (e.g., CD, XT, LA) may have different pharmacokinetic profiles and are not always interchangeable; ensure the correct formulation is dispensed.
  • Avoid abrupt discontinuation, especially in patients with angina, as it can lead to rebound angina or myocardial infarction.
  • Patients should be advised to avoid grapefruit juice due to potential for increased diltiazem levels and adverse effects.
  • Monitor heart rate and blood pressure regularly, especially when initiating therapy or titrating dose, and when co-administering with other rate-lowering agents (e.g., beta-blockers, digoxin).
  • Peripheral edema is a common side effect, often dose-dependent, and may be managed by dose reduction or addition of a diuretic.
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Alternative Therapies

  • Other Calcium Channel Blockers (e.g., Amlodipine, Felodipine, Verapamil)
  • ACE Inhibitors (e.g., Lisinopril, Ramipril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan)
  • Beta-blockers (e.g., Metoprolol, Carvedilol)
  • Thiazide Diuretics (e.g., Hydrochlorothiazide)
  • Loop Diuretics (e.g., Furosemide)
  • Nitrates (for angina)
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Cost & Coverage

Average Cost: $30 - $150 per 30 tablets (generic 360mg ER)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for 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 occurred.