Diltiazem ER 360mg Capsules (24 Hr)
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.
Drug Class
Antihypertensive, Antianginal
Pharmacologic Class
Calcium Channel Blocker (Non-dihydropyridine)
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Diltiazem ER is a medication used to treat high blood pressure and chest pain (angina). It works by relaxing blood vessels and slowing down your heart rate, which helps your heart pump blood more easily and reduces its workload. This is an extended-release capsule, meaning it releases the medicine slowly over 24 hours, so you only need to take it once a day.
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.
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.
Lifestyle & Tips
- Take the capsule whole; do not crush, chew, or divide it.
- Take at approximately the same time each day.
- Do not stop taking this medication suddenly without consulting your doctor.
- Avoid grapefruit and grapefruit juice while on this medication, as it can increase drug levels.
- Limit alcohol intake, as it can increase the risk of dizziness and low blood pressure.
- Maintain a healthy diet, regular exercise, and manage stress to support blood pressure control.
- Monitor your blood pressure and heart rate regularly as advised by your doctor.
Available Forms & Alternatives
Available Strengths:
- Diltiazem SR 120mg Capsules (12 Hr)
- Diltiazem ER 90mg Capsules (12 Hr)
- Diltiazem ER 60mg Capsules (12 Hr)
- Diltiazem XR 120mg Capsules (24 Hr)
- Diltiazem 30mg Tablets
- Diltiazem 120mg Tablets
- Diltiazem 90mg Tablets
- Diltiazem XR 240mg Capsules (24 Hr)
- Diltiazem 60mg Tablets
- Diltiazem ER 180mg Caps (xr-24h)
- Diltiazem ER 360mg Capsules (24 Hr)
- Diltiazem ER 360mg (24 Hr/cd) Caps
- Diltiazem ER 420mg Tablets
- Diltiazem ER 180mg Capsules (24 Hr)
- Diltiazem ER 240mg Capsules (24 Hr)
- Diltiazem ER 420mg Capsules (24 Hr)
- Diltiazem ER 240mg Tabs (la 24hr)
- Diltiazem ER 120mg Capsules (24 Hr)
- Diltiazem ER 300mg Capsules (24 Hr)
- Diltiazem Hcl ER 180mg Tablets
- Diltiazem ER 300mg Capsules (24 Hr)
- Diltiazem ER 360mg Tablets (la 24h)
- Diltiazem ER 180mg Capsules
- Diltiazem ER 360mg Capsules (24 Hr)
- Diltiazem Hcl ER 180mg Tablets
- Diltiazem ER 360mg Tablets (la 24h)
- Diltiazem ER 300mg Tablets (la 24h)
- Diltiazem CD 240mg Capsules (24 Hr)
- Diltiazem CD 300mg Capsules (24 Hr)
- Diltiazem CD 180mg Capsules (24 Hr)
- Diltiazem ER 360mg (24 Hr/cd) Caps
- Diltiazem CD 120mg Capsules (24 Hr)
- Diltiazem CD 240mg Capsules (24 Hr)
- Diltiazem CD 180mg Capsules (24 Hr)
- Diltiazem CD 120mg Capsules (24 Hr)
- Diltiazem ER 360mg (24 Hr/cd) Caps
- Diltiazem CD 300mg Capsules (24 Hr)
- Diltiazem CD 180mg Capsules (24hr)
- Diltiazem ER 120mg Tablets (la 24h)
- Diltiazem ER 120mg Tablets (la 24h)
- Diltiazem 5mg/ml Inj, 5ml
- Diltiazem 125mg/25ml Inj, 25ml
- Diltiazem 50mg/10ml Inj, 10ml
- Diltiazem 100mg Inj, 1 Vial
Dosing & Administration
Adult Dosing
Standard Dose:
360 mg orally once daily
Dose Range:
120 - 540 mg
Condition-Specific Dosing:
hypertension:
Initial: 180-240 mg once daily; titrate up to 360-480 mg once daily based on response. Max: 540 mg/day.
chronicStableAngina:
Initial: 120-180 mg once daily; titrate up to 360-480 mg once daily based on response. Max: 540 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment generally required, but monitor closely.
Moderate:
Use with caution; monitor for exaggerated effects. Dose reduction may be considered.
Severe:
Use with caution; monitor for exaggerated effects. Dose reduction may be considered.
Dialysis:
Not significantly removed by dialysis. Administer usual dose with caution and monitor.
Hepatic Impairment:
Mild:
Use with caution; monitor for exaggerated effects.
Moderate:
Significant dose reduction may be required (e.g., 50% of usual dose). Monitor closely for adverse effects.
Severe:
Contraindicated or not recommended due to extensive hepatic metabolism and risk of accumulation.
Pharmacology
Mechanism of Action
Diltiazem is a non-dihydropyridine calcium channel blocker that inhibits the influx of extracellular calcium ions across the membranes of myocardial and vascular smooth muscle cells. This leads to relaxation of vascular smooth muscle, resulting in peripheral and coronary vasodilation, and a reduction in myocardial contractility and heart rate. These actions decrease myocardial oxygen demand and increase myocardial oxygen supply, leading to antianginal effects, and reduce peripheral vascular resistance, leading to antihypertensive effects.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 40-65% (due to first-pass metabolism), varies with ER formulations.
Tmax:
10-14 hours (for extended-release formulations)
FoodEffect:
Food can increase bioavailability 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:
5-8 hours (parent drug); 9-12 hours (extended-release formulations)
Clearance:
Approximately 1.1 L/min
ExcretionRoute:
Urine (35-65%), Feces (35-65%)
Unchanged:
Less than 4% (in urine)
Pharmacodynamics
OnsetOfAction:
Within hours (for ER formulations)
PeakEffect:
10-14 hours (for ER formulations)
DurationOfAction:
24 hours
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 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), 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
- Other 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 or seek medical help:
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.
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 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), 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
- Other 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 or seek medical help:
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.
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 or feet
- Shortness of breath, especially with exertion or lying down
- Unusual fatigue or weakness
- Yellowing of skin or eyes (jaundice)
- Dark urine or pale stools (signs of liver problems)
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, such as foods or drugs. Be sure to describe the symptoms you experienced.
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, including:
+ 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 all potential interactions. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use. Before starting, stopping, or adjusting the dose of any medication, always consult your doctor to verify the safety of combining it with this medication and your individual health conditions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
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, including:
+ 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 all potential interactions. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use. Before starting, stopping, or adjusting the dose of any medication, always consult your doctor to verify the safety of combining it with this medication and your individual health conditions.
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 position, 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. Discuss any concerns or questions with your doctor.
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 for guidance.
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.
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 position, 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. Discuss any concerns or questions with your doctor.
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 for guidance.
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.
Overdose Information
Overdose Symptoms:
- Severe hypotension (very low blood pressure)
- Profound bradycardia (very slow heart rate)
- Heart block (impaired electrical conduction in the heart)
- Cardiogenic shock
- Asystole (cardiac arrest)
- Dizziness, confusion, lethargy
- Metabolic acidosis
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Ivabradine (risk of severe bradycardia)
Major Interactions
- Beta-blockers (e.g., metoprolol, carvedilol): Increased risk of bradycardia, AV block, heart failure.
- Digoxin: Increased digoxin serum concentrations.
- Statins (e.g., simvastatin, lovastatin): Increased statin exposure due to CYP3A4 inhibition, leading to increased risk of myopathy/rhabdomyolysis.
- Amiodarone: Increased risk of bradycardia, AV block, and myocardial depression.
- Cyclosporine, Tacrolimus, Sirolimus: Increased immunosuppressant levels.
- Midazolam, Triazolam: Increased benzodiazepine levels.
- Fentanyl: Increased fentanyl exposure (CYP3A4 inhibition).
Moderate Interactions
- Alpha-blockers (e.g., prazosin, doxazosin): Increased risk of hypotension.
- Other antihypertensives: Additive hypotensive effects.
- Grapefruit juice: May increase diltiazem levels.
- Carbamazepine: Increased carbamazepine levels.
- Phenytoin: Increased phenytoin levels.
- Theophylline: Increased theophylline levels.
Minor Interactions
- Cimetidine: May increase diltiazem levels slightly.
- Rifampin: May decrease diltiazem levels.
Monitoring
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 for bradycardia risk.
Timing: Prior to initiation
Electrocardiogram (ECG)
Rationale: To assess PR interval and rule out pre-existing conduction abnormalities.
Timing: Prior to initiation, especially in patients with cardiac history
Liver Function Tests (LFTs)
Rationale: To assess hepatic function due to extensive metabolism.
Timing: Prior to initiation, especially in patients with suspected hepatic impairment
Renal Function Tests (RFTs)
Rationale: To assess renal function.
Timing: Prior to initiation
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly (e.g., weekly during titration, then monthly or quarterly)
Target: <130/80 mmHg (or individualized target)
Action Threshold: Persistent hypotension (<90/60 mmHg) or uncontrolled hypertension
Heart Rate (HR)
Frequency: Regularly (e.g., weekly during titration, then monthly or quarterly)
Target: 50-90 bpm
Action Threshold: Persistent bradycardia (<50 bpm) or symptomatic bradycardia
ECG (PR interval)
Frequency: Periodically, especially during dose titration or with concomitant medications affecting conduction
Target: Normal PR interval (<0.20 seconds)
Action Threshold: Significant prolongation of PR interval (>0.24 seconds) or development of AV block
Peripheral Edema
Frequency: Regularly (e.g., monthly)
Target: Absence or minimal
Action Threshold: Significant or bothersome peripheral edema
Symptom Monitoring
- Dizziness
- Lightheadedness
- Fatigue
- Headache
- Swelling in ankles/feet
- Shortness of breath
- Chest pain (worsening or new)
- Palpitations
- Fainting spells
Special Patient Groups
Pregnancy
Diltiazem is classified as 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 based on animal data; human data limited.
Second Trimester:
Limited human data; use with caution.
Third Trimester:
Limited human data; use with caution. Potential for fetal bradycardia or hypotension.
Lactation
Diltiazem is excreted into breast milk. The American Academy of Pediatrics considers diltiazem to be 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.
Pediatric Use
Safety and efficacy have not been established in pediatric patients for hypertension or angina. Use is generally not recommended for extended-release formulations in this population.
Geriatric Use
Elderly patients may be more sensitive to the hypotensive and bradycardic effects of diltiazem. Start with lower doses and titrate slowly, monitoring closely for adverse effects such as dizziness, falls, and bradycardia. Renal and hepatic function may be impaired in the elderly, requiring dose adjustments.
Clinical Information
Clinical Pearls
- Diltiazem ER is a once-daily formulation, crucial for patient adherence. Emphasize taking it at the same time each day.
- Peripheral edema is a common side effect, often dose-dependent. Differentiating it from heart failure exacerbation is important.
- Monitor heart rate and PR interval, especially when co-administered with other negative chronotropes or dromotropes (e.g., beta-blockers, digoxin).
- Patients should be advised not to crush or chew the extended-release capsules, as this can lead to rapid release and potential overdose.
- Grapefruit juice can significantly increase diltiazem levels due to CYP3A4 inhibition; advise patients to avoid it.
Alternative Therapies
- Other Calcium Channel Blockers (e.g., Amlodipine, Felodipine, Verapamil ER)
- ACE Inhibitors (e.g., Lisinopril, Ramipril)
- Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan)
- Beta-blockers (e.g., Metoprolol ER, Atenolol)
- Thiazide Diuretics (e.g., Hydrochlorothiazide)
- Nitrates (for angina, e.g., Isosorbide mononitrate ER)
Cost & Coverage
Average Cost:
$15 - $50 per 30 capsules (generic 360mg ER)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
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 details. If you have any questions or concerns about this 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 information about the medication taken, the amount, and the time it happened.