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Diltiazem ER 180mg Capsules

Manufacturer SUN PHARMACEUTICAL 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 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, 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're feeling well.

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 medication exactly as prescribed, usually once daily. Do not crush, chew, or divide extended-release capsules.
  • Continue to follow a heart-healthy diet (low in sodium and saturated fats).
  • Engage in regular physical activity as advised by your doctor.
  • Limit alcohol intake, as it can worsen dizziness or lower blood pressure too much.
  • Avoid grapefruit juice, as it can increase diltiazem levels and side effects.
  • Monitor your blood pressure and heart rate at home if advised by your doctor.
  • 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: 180 mg once daily
Dose Range: 120 - 540 mg

Condition-Specific Dosing:

hypertension: Initial: 180-240 mg once daily; Titrate up to 540 mg once daily based on response.
chronic stable angina: Initial: 120-180 mg once daily; Titrate up to 480 mg once daily based on response.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for ER formulations; limited data for immediate-release in specific conditions (e.g., supraventricular tachycardia).
Adolescent: Not established for ER formulations; limited data for immediate-release in specific conditions.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment generally needed.
Moderate: No specific adjustment generally needed, but monitor for exaggerated effects.
Severe: Use with caution; monitor for exaggerated effects. Consider lower starting doses and careful titration.
Dialysis: Diltiazem is not significantly removed by dialysis. No specific supplemental dose needed, but monitor for effects.

Hepatic Impairment:

Mild: Use with caution; monitor for exaggerated effects.
Moderate: Use with caution; consider lower starting doses and careful titration due to extensive hepatic metabolism.
Severe: Contraindicated in severe hepatic impairment or used with extreme caution and significant dose reduction. Monitor closely for adverse effects.

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 a reduction in myocardial contractility, slowing of AV nodal conduction, and peripheral and coronary vasodilation. These actions result in decreased heart rate, decreased systemic vascular resistance, and increased coronary blood flow, thereby reducing myocardial oxygen demand and improving oxygen supply.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 40-65% (variable due to extensive first-pass metabolism)
Tmax: 5-9 hours (for extended-release 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: Approximately 5.3 L/kg
ProteinBinding: 70-80%
CnssPenetration: Limited

Elimination:

HalfLife: 5-10 hours (for extended-release formulations)
Clearance: Approximately 0.8-1.2 L/min
ExcretionRoute: Mainly renal (approximately 60-65% as metabolites, <5% as unchanged drug), fecal (approximately 35% as metabolites).
Unchanged: Less than 5%
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Pharmacodynamics

OnsetOfAction: Within 30-60 minutes (for blood pressure reduction with ER)
PeakEffect: 5-9 hours (for extended-release formulations)
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
+ 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

Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:

 Headache
* Feeling dizzy, tired, or weak

This is not an exhaustive list of potential 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 or feet
  • Shortness of breath, especially with exertion or lying down
  • Unusual fatigue or weakness
  • Signs of liver problems (e.g., yellowing of skin/eyes, dark urine, persistent nausea/vomiting, severe stomach pain)
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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 conditions to ensure safe treatment:

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 all types. If you are unsure, consult your doctor or pharmacist for guidance.
Specific health conditions, including:
+ Fluid accumulation in the lungs
+ Low blood pressure
+ Recent heart attack
 Concurrent use of certain medications, such as:
+ Ivabradine
+ Rifampin

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 assess potential interactions and ensure safe treatment. Never start, stop, or modify the dosage of any medication without consulting your doctor.
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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 frequently consume grapefruit juice or eat grapefruit, 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, plan to become pregnant, or are breastfeeding, inform your doctor. You and your doctor 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)
  • Bradycardia (very slow heart rate)
  • AV block (heart block)
  • Asystole (cardiac arrest)
  • Cardiogenic shock
  • Dizziness
  • Confusion
  • Lethargy

What to Do:

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

Drug Interactions

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Contraindicated Interactions

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

  • Beta-blockers (e.g., metoprolol, propranolol) - increased risk of bradycardia, AV block, heart failure
  • Digoxin - increased digoxin levels, increased risk of bradycardia, AV block
  • Amiodarone - increased risk of bradycardia, AV block, hypotension
  • Statins (e.g., simvastatin, lovastatin, atorvastatin) - increased statin levels, increased risk of myopathy/rhabdomyolysis
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) - increased diltiazem levels
  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort) - decreased diltiazem levels
  • Fentanyl (risk of severe bradycardia and hypotension)
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Moderate Interactions

  • Alpha-blockers (e.g., prazosin, doxazosin) - increased risk of hypotension
  • Other antihypertensives - additive hypotensive effects
  • Cyclosporine - increased cyclosporine levels
  • Tacrolimus - increased tacrolimus levels
  • Buspirone - increased buspirone levels
  • Midazolam, Triazolam - increased benzodiazepine levels
  • Theophylline - increased theophylline levels
  • Cimetidine - increased diltiazem 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 important due to diltiazem's negative chronotropic effects.

Timing: Prior to initiation

Electrocardiogram (ECG)

Rationale: To assess for pre-existing conduction abnormalities (e.g., AV block) that may be exacerbated by diltiazem.

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

Liver Function Tests (LFTs)

Rationale: Diltiazem is extensively metabolized by the liver; baseline LFTs are important, especially in patients with suspected hepatic impairment.

Timing: Prior to initiation (if clinically indicated)

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially during dose titration and periodically thereafter (e.g., every 2-4 weeks during titration, then every 3-6 months)

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

Action Threshold: Persistent BP outside target range; symptomatic hypotension

Heart Rate (HR)

Frequency: Regularly, especially during dose titration and periodically thereafter (e.g., every 2-4 weeks during titration, then every 3-6 months)

Target: 50-90 bpm (or individualized target)

Action Threshold: HR <50 bpm or symptomatic bradycardia

Signs/Symptoms of Edema

Frequency: At each clinical visit

Target: Absence of significant peripheral edema

Action Threshold: Development of new or worsening peripheral edema

Liver Function Tests (LFTs)

Frequency: Periodically, especially if symptoms of hepatic dysfunction develop or in patients with pre-existing hepatic impairment.

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)
  • Shortness of breath
  • Chest pain (worsening angina)
  • Palpitations
  • Signs of bradycardia (slow pulse, fainting)

Special Patient Groups

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Pregnancy

Diltiazem is Pregnancy Category C. Animal studies have shown adverse effects on the fetus. There are no adequate and well-controlled studies in pregnant women. Use 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 (skeletal abnormalities, embryolethality at high doses).
Second Trimester: Limited human data; potential for fetal bradycardia or hypotension.
Third Trimester: Potential for fetal bradycardia or hypotension; may inhibit labor.
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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 breastfed infants for bradycardia, hypotension, and sedation.

Infant Risk: L3 (Moderately safe) - Potential for mild adverse effects in the infant (e.g., bradycardia, sedation), especially in neonates or if the mother is on high doses. Monitor infant for signs of adverse effects.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients for extended-release formulations. Use in children is generally off-label and requires careful consideration and monitoring, typically for specific cardiac conditions.

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Geriatric Use

Elderly patients may be more sensitive to the hypotensive and bradycardic effects of diltiazem due to age-related decreases in renal and hepatic function. Start with lower doses and titrate slowly, monitoring closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Diltiazem ER should be swallowed whole; do not crush, chew, or divide the capsules, as this can lead to rapid release of the drug and potential overdose.
  • Avoid grapefruit juice while on diltiazem, as it can significantly increase drug levels and side effects.
  • Patients should be advised to report symptoms of bradycardia (e.g., dizziness, fainting, slow pulse) or peripheral edema.
  • When switching from immediate-release to extended-release diltiazem, the total daily dose may need adjustment.
  • Diltiazem is a potent negative chronotrope and dromotrope; use with extreme caution or avoid in patients with sick sinus syndrome, second- or third-degree AV block without a pacemaker, or severe left ventricular dysfunction.
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Alternative Therapies

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

Average Cost: Varies widely, typically $20-$100+ per 30 capsules (180mg ER)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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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 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 it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 overdose, including the medication taken, the amount, and the time it occurred.