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Diltiazem ER 300mg Capsules (24 Hr)

Manufacturer OCEANSIDE PHARMACEUTICALS 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
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 heartbeats. The ER (extended-release) form works over 24 hours, so you usually take it 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 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.
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Lifestyle & Tips

  • Take the medication at the same time each day, preferably with or without food, but consistently.
  • Swallow the capsule whole; do not chew, crush, or divide it.
  • Avoid grapefruit and grapefruit juice, as they can increase the amount of diltiazem in your body and lead to more side effects.
  • Monitor your blood pressure and heart rate regularly as advised by your doctor.
  • Maintain a healthy lifestyle, including a balanced diet (low in sodium), regular exercise, and stress management.
  • Limit alcohol consumption, as it can further lower blood pressure.
  • 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: 300 mg orally once daily
Dose Range: 120 - 540 mg

Condition-Specific Dosing:

hypertension: Initial: 180-240 mg once daily; adjust to maximum 540 mg once daily based on response.
chronicStableAngina: Initial: 120-180 mg once daily; adjust to maximum 540 mg once daily based on response.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, monitor for adverse effects.
Moderate: No specific adjustment recommended, monitor for adverse effects.
Severe: Use with caution; monitor for exaggerated effects (e.g., bradycardia, hypotension). Consider lower initial doses.
Dialysis: Diltiazem is not significantly removed by hemodialysis. Use with caution, monitor for adverse 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 and slower titration.
Severe: Contraindicated in severe hepatic impairment due to extensive hepatic metabolism. If used, extreme caution and significant dose reduction required.

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, leading to reduced blood pressure, relief of angina, and control of certain supraventricular arrhythmias.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 40-65% (variable due to first-pass metabolism); ER formulations have sustained absorption.
Tmax: For ER capsules, typically 10-14 hours.
FoodEffect: Food can increase the bioavailability of some ER formulations, but generally, it can be taken with or without food. Consistent administration relative to meals is recommended.

Distribution:

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

Elimination:

HalfLife: Extended-release formulations: 5-10 hours (terminal half-life can be longer due to sustained release)
Clearance: Approximately 0.6-1.3 L/min
ExcretionRoute: Primarily urine (60-65%) and feces (35%) as metabolites.
Unchanged: Less than 4% (urine)
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Pharmacodynamics

OnsetOfAction: Within 30-60 minutes (for immediate release); for ER, effects are gradual.
PeakEffect: For ER, typically 10-14 hours.
DurationOfAction: 24 hours (for 24-hour 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), 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 taking this medication do not experience severe side effects. However, some may encounter minor side effects. If you experience any of the following symptoms or if they persist or bother you, contact your doctor:

 Headache
* Feeling dizzy, tired, or weak

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 spells
  • Very slow heart rate (less than 50 beats per minute)
  • New or worsening swelling in your ankles, feet, or legs
  • Shortness of breath, especially with exertion or lying down
  • Unusual fatigue or weakness
  • Yellowing of the skin or eyes (jaundice), dark urine, or persistent nausea/vomiting (signs of liver problems)
  • Severe headache that is unusual or persistent
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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.
Any history of fluid accumulation in the lungs, low blood pressure, or a recent heart attack, as these conditions may affect the safety and efficacy of this medication.
 If you are currently taking ivabradine or rifampin, as these medications may interact with this drug.

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 ensure safe treatment and prevent potential interactions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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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 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. Consult with your doctor regarding the frequency of these checks.

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 to determine if this is necessary.

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 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:

  • Profound hypotension (very low blood pressure)
  • Severe bradycardia (very slow heart rate)
  • AV block (heart 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 gastric lavage, activated charcoal, IV fluids, atropine, calcium gluconate/chloride, vasopressors (e.g., dopamine, norepinephrine), glucagon, and cardiac pacing.

Drug Interactions

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Contraindicated Interactions

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

  • Beta-blockers (e.g., metoprolol, carvedilol): Additive negative chronotropic and inotropic effects, risk of severe bradycardia, AV block, heart failure.
  • Digoxin: Increased digoxin levels, risk of digoxin toxicity (bradycardia, arrhythmias).
  • Amiodarone: Increased risk of bradycardia, AV block, and myocardial depression.
  • Statins (e.g., simvastatin, lovastatin, atorvastatin): Increased statin levels due to CYP3A4 inhibition, leading to increased risk of myopathy/rhabdomyolysis.
  • Fentanyl: Increased fentanyl levels, risk of respiratory depression.
  • Midazolam, Triazolam: Increased benzodiazepine levels, prolonged sedation.
  • Cyclosporine, Tacrolimus, Sirolimus: Increased immunosuppressant levels, risk of toxicity.
  • Alpha-blockers (e.g., prazosin, doxazosin): Additive hypotensive effects, risk of orthostatic hypotension.
  • Clonidine: Risk of severe bradycardia and AV block.
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Moderate Interactions

  • Grapefruit juice: Can increase diltiazem levels due to CYP3A4 inhibition.
  • Carbamazepine, Phenytoin: Increased levels of these anticonvulsants.
  • Rifampin, Phenobarbital: Decreased diltiazem levels due to CYP3A4 induction.
  • Theophylline: Increased theophylline levels.
  • Cimetidine: Increased diltiazem levels.
  • Nitrates: Additive hypotensive effects.
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Minor Interactions

  • NSAIDs: May reduce the antihypertensive effect of diltiazem.

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 other rate-lowering drugs.

Timing: Prior to initiation

Electrocardiogram (ECG)

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

Timing: Prior to initiation (especially if cardiac history)

Liver Function Tests (LFTs)

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

Timing: Prior to initiation (especially if hepatic impairment suspected)

Renal Function Tests (RFTs)

Rationale: To assess baseline renal function, as metabolites are renally excreted.

Timing: Prior to initiation (especially if renal impairment suspected)

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially during dose titration and periodically thereafter (e.g., weekly during titration, then monthly/quarterly)

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

Action Threshold: Systolic BP <90 mmHg or symptomatic hypotension; BP consistently above target.

Heart Rate (HR)

Frequency: Regularly, especially during dose titration and periodically thereafter (e.g., weekly during titration, then monthly/quarterly)

Target: 50-90 bpm (or individualized target)

Action Threshold: HR <50 bpm or symptomatic bradycardia; new onset of AV block.

Symptoms of Edema

Frequency: At each visit

Target: Absence of significant peripheral edema

Action Threshold: Development of new or worsening peripheral edema.

Symptoms of Heart Failure

Frequency: At each visit

Target: Absence of new or worsening signs/symptoms (e.g., dyspnea, fatigue)

Action Threshold: Development of new or worsening heart failure symptoms.

Liver Function Tests (LFTs)

Frequency: Periodically, especially if signs of hepatic dysfunction or on high doses; or if co-administered with other hepatotoxic drugs.

Target: Within normal limits

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

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Symptom Monitoring

  • Dizziness or lightheadedness (especially upon standing)
  • Fatigue or weakness
  • Headache
  • Swelling in ankles, feet, or lower legs (peripheral edema)
  • Shortness of breath or difficulty breathing
  • Chest pain (if angina not controlled)
  • Palpitations or irregular heartbeat
  • Nausea or constipation

Special Patient Groups

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Pregnancy

Diltiazem is classified as Pregnancy Category C. Animal studies have shown adverse effects on the fetus (e.g., skeletal abnormalities, embryolethality) at doses higher than human therapeutic doses. 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, though human data are limited.
Second Trimester: Limited human data; continued monitoring for fetal growth and well-being.
Third Trimester: Potential for effects on fetal heart rate and uterine contractility. Risk of neonatal bradycardia or hypotension if used close to term.
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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. Potential for bradycardia, hypotension, or sedation in the infant, especially in neonates or if the mother is on high doses. Monitor infant closely.
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Pediatric Use

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

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Geriatric Use

Elderly patients may be more sensitive to the effects of diltiazem, particularly regarding blood pressure lowering and heart rate effects. Start with lower doses and titrate slowly, monitoring closely for adverse effects such as bradycardia, hypotension, and peripheral edema. Renal and hepatic function may be decreased in the elderly, requiring careful dose consideration.

Clinical Information

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Clinical Pearls

  • Diltiazem ER is a once-daily formulation; emphasize consistent timing of administration.
  • Counsel patients to swallow capsules whole; opening or crushing can lead to dose dumping and increased side effects.
  • Monitor heart rate closely, especially when co-administered with other AV nodal blocking agents (e.g., beta-blockers, digoxin).
  • Peripheral edema is a common side effect, often dose-dependent. It is due to arterial vasodilation and not fluid retention, so diuretics are generally not effective.
  • Caution with patients who have sick sinus syndrome, second- or third-degree AV block without a pacemaker, or severe left ventricular dysfunction.
  • Grapefruit juice interaction is significant; advise patients to avoid it completely.
  • Liver function should be monitored periodically, especially in patients with pre-existing hepatic impairment or those on long-term therapy.
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Alternative Therapies

  • Other non-dihydropyridine calcium channel blockers (e.g., verapamil ER)
  • Dihydropyridine calcium channel blockers (e.g., amlodipine, nifedipine ER, felodipine) for hypertension/angina
  • Beta-blockers (e.g., metoprolol ER, carvedilol) for hypertension/angina/rate control
  • ACE inhibitors (e.g., lisinopril) or ARBs (e.g., losartan) for hypertension
  • Nitrates (e.g., isosorbide mononitrate ER) for angina
  • Ranolazine for chronic angina
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Cost & Coverage

Average Cost: $30 - $150 per 30 tablets
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'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 happened.