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Diltiazem CD 180mg Capsules (24hr)

Manufacturer INGENUS 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
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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 1991
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Diltiazem CD is a medication used to treat high blood pressure (hypertension) and chest pain (angina). It belongs to a class of drugs called calcium channel blockers. It works by relaxing blood vessels, which helps lower blood pressure, and by affecting the heart to reduce heart rate and improve blood flow to the heart muscle.
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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. It's crucial to check with your pharmacist to determine the best way to take your specific medication. In some cases, you may be able to open the medication and mix it with a spoonful of applesauce, but this is not always the case. Be sure to consult with your pharmacist to see if this is an option for your particular medication.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication, store it at room temperature, away from direct light and moisture. Keep it in a dry place, and avoid storing it in the bathroom. It's also essential to keep all medications out of the reach of children and pets.

When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Instead, throw them away in a safe and responsible manner. You can also check with your pharmacist to see if there are any drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose of your medication, 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 exactly as prescribed, usually once daily. Do not crush, chew, or divide the capsule.
  • Take with or without food, but consistently.
  • Avoid grapefruit and grapefruit juice, as it can increase the amount of diltiazem in your body.
  • Limit alcohol consumption, as it can worsen dizziness or lower blood pressure too much.
  • Maintain a healthy diet (e.g., low sodium, low fat).
  • Engage in regular physical activity as advised by your doctor.
  • Quit smoking.
  • Manage stress.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 180 mg orally once daily
Dose Range: 120 - 540 mg

Condition-Specific Dosing:

hypertension: Initial: 180-240 mg orally once daily; Titrate up to 540 mg/day as needed.
chronicstableangina: Initial: 180-240 mg orally once daily; Titrate up to 540 mg/day as needed.
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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, use with caution.
Moderate: No specific adjustment recommended, use with caution and monitor for adverse effects.
Severe: Use with caution, start at lower end of dosing range and titrate slowly. Monitor for adverse effects.
Dialysis: Not significantly dialyzable. Use with caution, monitor for adverse effects.

Hepatic Impairment:

Mild: No specific adjustment recommended, use with caution.
Moderate: Use with caution, start at lower end of dosing range and titrate slowly. Monitor for adverse effects.
Severe: Use with caution, start at lower end of dosing range and titrate slowly. Monitor for adverse effects.

Pharmacology

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Mechanism of Action

Diltiazem is a non-dihydropyridine calcium channel blocker. It 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 vasodilation and reduced systemic vascular resistance, thereby lowering blood pressure. In the heart, it decreases myocardial contractility, slows sinoatrial (SA) and atrioventricular (AV) nodal conduction, and prolongs AV nodal refractory period, which can reduce heart rate and treat certain arrhythmias.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 40-65% (due to extensive first-pass metabolism)
Tmax: 10-14 hours (for CD formulation)
FoodEffect: Food may slightly increase absorption, but generally not clinically significant; 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 CD formulation, apparent half-life can be longer due to extended release)
Clearance: Approximately 1.1 L/min
ExcretionRoute: Urine (35%), Feces (65%)
Unchanged: <4%
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Pharmacodynamics

OnsetOfAction: Within 2-3 hours (for blood pressure reduction with ER formulations)
PeakEffect: 6-14 hours (for CD formulation)
DurationOfAction: 24 hours

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
+ 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, 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

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 unusual symptoms, contact your doctor or seek medical attention:

 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.
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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)
  • Swelling in the ankles, feet, or hands (peripheral edema)
  • 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 new or worsening
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Before Using This Medicine

Before taking this medication, it is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the symptoms you experienced with the allergy.
 Certain types of abnormal heart rhythms, as this medication is not suitable for use with many types of irregular heartbeats. If you are unsure, consult your doctor or pharmacist for guidance.
Any of the following health conditions: fluid accumulation in the lungs, low blood pressure, or a recent heart attack.
 If you are currently taking ivabradine or rifampin, as these medications may interact with this drug.

It is crucial to note that this list is not exhaustive, and you should disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems to your doctor and pharmacist. This will enable them to assess potential interactions and ensure it is safe for you to take this medication. Never start, stop, or adjust the dosage of any medication without first 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 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 with this medication and at intervals 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. 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 are breastfeeding, inform your doctor. It is crucial 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
  • Dizziness
  • Fainting

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, vasopressors, or glucagon.

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.
  • Amiodarone: Increased risk of bradycardia, sinus arrest, AV block.
  • Statins (e.g., simvastatin, lovastatin): Increased statin concentrations due to CYP3A4 inhibition, leading to increased risk of myopathy/rhabdomyolysis.
  • Immunosuppressants (e.g., cyclosporine, tacrolimus, sirolimus): Increased immunosuppressant concentrations.
  • Benzodiazepines (e.g., midazolam, triazolam): Increased benzodiazepine concentrations.
  • Alpha-blockers (e.g., prazosin, doxazosin): Additive hypotensive effects.
  • Fentanyl: Increased fentanyl concentrations.
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Moderate Interactions

  • Grapefruit juice: May increase diltiazem plasma concentrations.
  • Other antihypertensives: Additive hypotensive effects.
  • Cimetidine: May increase diltiazem levels.
  • Rifampin: May decrease 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 assess efficacy for hypertension/angina.

Timing: Prior to initiation

Heart Rate (HR)

Rationale: To establish baseline and monitor for bradycardia.

Timing: Prior to initiation

Electrocardiogram (ECG)

Rationale: To assess cardiac rhythm and conduction, especially in patients with pre-existing cardiac conditions.

Timing: Prior to initiation (consider if cardiac history)

Liver Function Tests (LFTs)

Rationale: Diltiazem is metabolized hepatically; monitor for potential hepatic impairment.

Timing: Prior to initiation (consider if hepatic history)

Renal Function (SCr, BUN)

Rationale: To assess baseline renal function, as elimination is partly renal.

Timing: Prior to initiation (consider if renal history)

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly (e.g., weekly initially, then monthly or as clinically indicated)

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

Action Threshold: If BP remains uncontrolled or drops excessively (e.g., symptomatic hypotension).

Heart Rate (HR)

Frequency: Regularly (e.g., weekly initially, then monthly or as clinically indicated)

Target: 50-90 bpm (or individualized target)

Action Threshold: If HR <50 bpm or symptomatic bradycardia occurs.

Electrocardiogram (ECG)

Frequency: Periodically (e.g., annually or as clinically indicated, especially with dose changes or co-administration of other AV nodal blocking agents)

Target: Normal sinus rhythm, PR interval <0.20 sec

Action Threshold: Development of new arrhythmias, significant bradycardia, or AV block.

Liver Function Tests (LFTs)

Frequency: Periodically (e.g., every 6-12 months or as clinically indicated, especially if symptoms of hepatic dysfunction occur)

Target: Within normal limits

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

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Peripheral edema (swelling of ankles/feet)
  • Headache
  • Bradycardia (slow heart rate)
  • Shortness of breath
  • Chest pain (worsening or new onset)
  • Signs of heart failure (e.g., weight gain, increasing edema, dyspnea)

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 fetal harm, though human data are limited. Avoid if possible.
Second Trimester: Use with caution, monitor fetal growth and well-being.
Third Trimester: Use with caution, monitor for potential effects on the neonate (e.g., bradycardia, 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 signs of adverse effects.

Infant Risk: L3 (Moderate risk). Potential for bradycardia, hypotension, or other cardiovascular effects in the infant. Monitor infant for signs of adverse effects.
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established for hypertension or angina. Use is generally not recommended.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Diltiazem CD is an extended-release formulation designed for once-daily dosing, providing 24-hour control of blood pressure and angina.
  • It is a non-dihydropyridine calcium channel blocker, meaning it affects both vascular smooth muscle and cardiac conduction (SA and AV nodes). This distinguishes it from dihydropyridines (e.g., amlodipine) which primarily affect vasculature.
  • Caution is advised in patients with pre-existing bradycardia, sick sinus syndrome (without a pacemaker), second- or third-degree AV block (without a pacemaker), or severe left ventricular dysfunction/heart failure with reduced ejection fraction, as it can worsen these conditions.
  • Due to its CYP3A4 inhibitory properties, significant drug interactions can occur, requiring dose adjustments or alternative therapies for co-administered medications (e.g., statins, immunosuppressants, digoxin).
  • Patients should be instructed not to crush, chew, or open the capsules, as this will alter the extended-release properties and could lead to rapid absorption and increased risk of adverse effects.
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Alternative Therapies

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

Average Cost: Varies widely, typically $10-$50 for 30 capsules (generic) per 30 capsules
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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.