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Diltiazem CD 120mg Capsules (24 Hr)

Manufacturer TWI 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
Calcium Channel Blocker (Non-dihydropyridine)
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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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, chest pain (angina), and to control heart rate in certain irregular heart rhythms. It works by relaxing blood vessels and slowing down the heart, which helps blood flow more easily and reduces the heart's workload.
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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. It's crucial to 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. Your pharmacist can advise you on whether your medication can be opened or if it needs to be taken as is.

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, as the humidity and temperature fluctuations can affect its potency. Keep all medications in a secure location, 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, check with your pharmacist for guidance on the best disposal method. You may also want to explore local 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 exactly as prescribed, usually once daily. Do not crush, chew, or divide the capsule; swallow it whole.
  • Do not stop taking this medication suddenly without consulting your doctor, as it can worsen your condition.
  • Avoid grapefruit and grapefruit juice while taking this medication, as it can increase the drug's effects.
  • Monitor your blood pressure and heart rate regularly as advised by your doctor.
  • Maintain a healthy lifestyle, including a balanced diet, regular exercise, and limiting sodium intake, to support blood pressure control.
  • Limit alcohol consumption, as it can worsen dizziness or lower blood pressure too much.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 120 mg once daily (for hypertension/angina, extended-release formulations)
Dose Range: 120 - 480 mg

Condition-Specific Dosing:

hypertension: Initial: 180-240 mg once daily; Titration: May increase to 360-480 mg once daily based on response.
chronicStableAngina: Initial: 120-180 mg once daily; Titration: May increase to 480 mg once daily based on response.
atrialFibrillationFlutterRateControl: Initial: 120-240 mg once daily; Titration: May increase to 360-480 mg once daily based on heart rate control.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (Safety and efficacy not established for most indications)
Adolescent: Not established (Safety and efficacy not established for most indications)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, monitor closely.
Moderate: Use with caution, monitor for exaggerated effects. Dose adjustment may be necessary.
Severe: Use with caution, monitor for exaggerated effects. Dose adjustment may be necessary, consider lower starting doses.
Dialysis: Diltiazem is not significantly removed by dialysis. Administer after dialysis if dose adjustment is needed.

Hepatic Impairment:

Mild: No specific adjustment recommended, monitor closely.
Moderate: Use with caution, monitor for exaggerated effects. Consider lower starting doses and slower titration.
Severe: Use with caution, monitor for exaggerated effects. Consider lower starting doses and slower titration.

Pharmacology

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Mechanism of Action

Diltiazem inhibits the influx of extracellular calcium ions across the membranes of myocardial and vascular smooth muscle cells, as well as nodal tissue (SA and AV nodes). This action leads to a reduction in myocardial contractility, slowing of SA and AV nodal conduction, and relaxation of vascular smooth muscle, resulting in peripheral and coronary vasodilation. These effects contribute to decreased heart rate, reduced systemic vascular resistance, and improved coronary blood flow, leading to blood pressure reduction and antianginal effects.
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Pharmacokinetics

Absorption:

Bioavailability: 40-65% (due to extensive first-pass metabolism)
Tmax: 10-14 hours (for CD extended-release formulations)
FoodEffect: Food may slightly increase absorption or have no significant effect depending on the specific extended-release formulation. Generally, can be taken with or without food.

Distribution:

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

Elimination:

HalfLife: 5-10 hours (parent drug, for CD formulations, effective half-life for 24-hour dosing is longer)
Clearance: Not available
ExcretionRoute: Urine (35-65%), Feces (35-65%)
Unchanged: <5%
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Pharmacodynamics

OnsetOfAction: Within hours (for extended-release formulations)
PeakEffect: 10-14 hours (for CD extended-release formulations)
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, consult 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 may cause side effects. Many people experience no side effects or only 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 (e.g., 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
  • 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, 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 use with many types of irregular heartbeats. 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 (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. This will enable them to verify the safety of taking this medication in conjunction with your other treatments and health conditions. Never initiate, terminate, 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 and periodically while taking this medication. Discuss the details 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, 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, as you will need to discuss the potential benefits and risks to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypotension (very low blood pressure)
  • Profound bradycardia (very slow heart rate)
  • Heart block (abnormal heart rhythm)
  • Cardiogenic shock
  • Asystole (cardiac arrest)
  • 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, vasopressors, atropine, calcium gluconate, glucagon, or cardiac pacing.

Drug Interactions

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Contraindicated Interactions

  • Ivabradine (risk of severe bradycardia)
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Major Interactions

  • Beta-blockers (e.g., metoprolol, propranolol): Increased risk of bradycardia, AV block, and heart failure.
  • Digoxin: Increased digoxin serum concentrations.
  • Statins (e.g., simvastatin, lovastatin, atorvastatin): Increased statin concentrations due to CYP3A4 inhibition, leading to increased risk of myopathy/rhabdomyolysis.
  • Amiodarone: Increased risk of bradycardia, AV block, and hypotension.
  • Fentanyl: Increased fentanyl concentrations due to CYP3A4 inhibition.
  • Midazolam, Triazolam: Increased benzodiazepine concentrations due to CYP3A4 inhibition.
  • Cyclosporine, Tacrolimus, Sirolimus, Everolimus: Increased immunosuppressant concentrations.
  • Alpha-blockers (e.g., prazosin, doxazosin): Increased risk of hypotension.
  • Clonidine: Increased risk of bradycardia and AV block.
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Moderate Interactions

  • Grapefruit juice: May increase diltiazem plasma concentrations.
  • Cimetidine: May increase diltiazem plasma concentrations.
  • Rifampin, Phenytoin, Carbamazepine, Phenobarbital: May decrease diltiazem plasma concentrations (CYP3A4 induction).
  • Other antihypertensives: Additive hypotensive effects.
  • Nitrates: Additive hypotensive effects.
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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 assess risk of bradycardia.

Timing: Prior to initiation

Electrocardiogram (ECG)

Rationale: To assess baseline cardiac rhythm and PR interval, especially in patients with pre-existing conduction abnormalities.

Timing: Prior to initiation

Liver Function Tests (LFTs)

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

Timing: Prior to initiation

Renal Function (SCr, BUN)

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

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially during dose titration and periodically thereafter.

Target: Individualized, typically <130/80 mmHg for hypertension.

Action Threshold: Persistent hypotension (e.g., SBP <90 mmHg) or inadequate BP control.

Heart Rate (HR)

Frequency: Regularly, especially during dose titration and periodically thereafter.

Target: Typically 50-90 bpm (unless specific rate control target for AFib).

Action Threshold: Bradycardia (<50 bpm) or symptomatic bradycardia.

Electrocardiogram (ECG) - PR interval

Frequency: Periodically, especially with higher doses or concomitant use of other AV nodal blocking agents.

Target: Normal PR interval (<0.20 seconds).

Action Threshold: Significant PR prolongation or development of AV block.

Signs/Symptoms of Peripheral Edema

Frequency: Regularly

Target: Absence of significant edema.

Action Threshold: Development of new or worsening peripheral edema.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Shortness of breath
  • Swelling in ankles/feet
  • Chest pain (worsening or new onset)
  • Palpitations
  • Fainting spells

Special Patient Groups

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Pregnancy

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

Trimester-Specific Risks:

First Trimester: Potential for developmental toxicity observed in animal studies.
Second Trimester: Not well studied, but generally avoided unless clearly needed.
Third Trimester: Not well studied, but generally avoided unless clearly needed. 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 risk. Monitor for bradycardia, hypotension, and lethargy in the infant.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients for most indications. Use is generally not recommended.

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Geriatric Use

Use with caution in elderly patients. They may be more sensitive to the hypotensive and bradycardic effects of diltiazem due to age-related decreases in renal and hepatic function, and potential for polypharmacy. Start with lower doses and titrate slowly.

Clinical Information

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Clinical Pearls

  • Diltiazem CD (extended-release) formulations are not interchangeable with other diltiazem formulations (e.g., immediate-release, other extended-release brands) due to different pharmacokinetic profiles. Always ensure the correct formulation is dispensed.
  • Peripheral edema is a common side effect, often dose-dependent. It is typically mild and can be managed with lifestyle modifications or diuretics if severe.
  • Patients should be advised to swallow the capsule whole and not to crush, chew, or divide it, as this can lead to rapid release of the drug and potential overdose.
  • Diltiazem is a moderate inhibitor of CYP3A4, leading to significant drug interactions with many commonly used medications, particularly statins (simvastatin, lovastatin), immunosuppressants, and certain benzodiazepines. Review concomitant medications carefully.
  • While effective for rate control in atrial fibrillation/flutter, diltiazem is contraindicated in patients with Wolff-Parkinson-White (WPW) syndrome or short PR syndrome with atrial fibrillation/flutter due to the risk of accelerating conduction down the accessory pathway, leading to ventricular fibrillation.
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Alternative Therapies

  • Other Calcium Channel Blockers (e.g., Amlodipine, Verapamil, Nifedipine)
  • ACE Inhibitors (e.g., Lisinopril, Enalapril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan)
  • Beta-blockers (e.g., Metoprolol, Atenolol)
  • Diuretics (e.g., Hydrochlorothiazide, Furosemide)
  • Other antiarrhythmics (e.g., Digoxin, Amiodarone for rate/rhythm control)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 capsules (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.