Diltiazem CD 180mg 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
Non-dihydropyridine Calcium Channel Blocker
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Pregnancy Category
Category C
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FDA Approved
Sep 1990
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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 can lower your blood pressure, reduce chest pain (angina), and help control an irregular heartbeat. It works by blocking calcium from entering certain cells in your heart and blood vessels.
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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. 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.

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 responsible manner. You can also check with your pharmacist 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 exactly as prescribed, usually once daily. Do not crush, chew, or divide the extended-release capsules.
  • Swallow the capsule whole. If you have difficulty swallowing, some capsules can be opened and the contents sprinkled on a spoonful of applesauce and swallowed immediately without chewing.
  • Avoid consuming grapefruit or grapefruit juice while taking this medication, as it can increase the levels of diltiazem in your body and lead to side effects.
  • Maintain a healthy lifestyle, including a balanced diet (low in sodium and saturated fats), regular exercise (as advised by your doctor), and stress management.
  • Limit alcohol intake, as it can also lower blood pressure and increase dizziness.
  • Do not stop taking this medication suddenly without consulting your doctor, as it can worsen your condition.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 180 mg orally once daily
Dose Range: 120 - 480 mg

Condition-Specific Dosing:

hypertension: Initial: 180-240 mg orally once daily; Titrate up to 360-480 mg/day if needed.
chronic stable angina: Initial: 120-180 mg orally once daily; Titrate up to 480 mg/day if needed.
atrial fibrillation/flutter (rate control): Initial: 120-240 mg orally once daily; Titrate based on heart rate response.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for hypertension/angina; limited use for supraventricular tachycardia (off-label, IV formulation more common).
Adolescent: Not established for hypertension/angina; limited use for supraventricular tachycardia (off-label, IV formulation more common).
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed, monitor for exaggerated effects.
Moderate: No specific adjustment needed, monitor for exaggerated effects.
Severe: Use with caution, monitor for exaggerated effects. Consider lower initial doses.
Dialysis: Not significantly dialyzable. Use with caution, monitor for exaggerated effects.

Hepatic Impairment:

Mild: No specific adjustment needed, monitor for exaggerated effects.
Moderate: Use with caution, consider lower initial doses and slower titration due to extensive hepatic metabolism.
Severe: Contraindicated in severe hepatic impairment or use with extreme caution and significant dose reduction.

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 relaxation of vascular smooth muscle, resulting in peripheral and coronary vasodilation, and a reduction in systemic vascular resistance and blood pressure. In the heart, it decreases sinoatrial (SA) and atrioventricular (AV) nodal conduction, prolonging the effective refractory period and slowing heart rate, particularly in conditions like atrial fibrillation/flutter. It also reduces myocardial oxygen demand.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 40-65% (oral, variable due to first-pass metabolism); extended-release formulations may have different absorption profiles.
Tmax: 10-14 hours (for CD formulation)
FoodEffect: Food may slightly increase bioavailability but generally does not significantly affect absorption of extended-release formulations; can be taken with or without food.

Distribution:

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

Elimination:

HalfLife: 5-8 hours (for extended-release formulations, can be longer with chronic dosing)
Clearance: Approximately 0.9-1.2 L/min
ExcretionRoute: Primarily renal (60-65% as metabolites, <5% as unchanged drug), also fecal (35% as metabolites)
Unchanged: <5%
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Pharmacodynamics

OnsetOfAction: Within 30-60 minutes (oral, for initial effect)
PeakEffect: 6-11 hours (for CD formulation)
DurationOfAction: 24 hours (for CD formulation)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

Although rare, some individuals may experience severe and potentially life-threatening side effects while taking this medication. If you exhibit 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, 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

As with any medication, you may experience side effects. While many people have no side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor or seek medical help:

Headache
* Feeling dizzy, tired, or weak

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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
  • Signs of liver problems (e.g., yellowing of skin or eyes, dark urine, persistent nausea/vomiting, severe stomach pain)
  • Severe headache that is unusual or persistent
  • Chest pain that worsens or does not go away
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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 use of this medication:

Any allergies you have, including allergies to this drug, 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 use with many types of irregular heartbeats. If you are unsure, consult your doctor or pharmacist.
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 problems to your doctor and pharmacist. This will help determine whether it is safe to take this medication with your existing treatments and health conditions. 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 and avoid driving or engaging in activities that require your full attention 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 be careful 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 consume grapefruit juice or eat grapefruit regularly, discuss this with your doctor, as it may interact with your medication.

Some products may require you to avoid alcohol consumption. Consult your doctor or pharmacist to determine if you should avoid drinking alcohol while taking this medication.

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. You and your doctor will need to discuss the potential benefits and risks of this medication to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypotension (very low blood pressure)
  • Profound bradycardia (extremely slow heart rate)
  • Heart block (especially AV block)
  • Asystole (cardiac arrest)
  • Cardiogenic shock
  • Dizziness, lightheadedness, fainting
  • Confusion
  • Lethargy

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 for bradycardia, calcium gluconate/chloride, vasopressors, and glucagon.

Drug Interactions

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Contraindicated Interactions

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

  • Beta-blockers (e.g., metoprolol, carvedilol): Increased risk of bradycardia, AV block, and myocardial depression.
  • Digoxin: Increased digoxin levels, leading to toxicity (nausea, vomiting, arrhythmias).
  • Amiodarone: Increased risk of bradycardia, AV block, and hypotension.
  • Statins (e.g., simvastatin, lovastatin, atorvastatin): Increased statin levels due to CYP3A4 inhibition, leading to increased risk of myopathy/rhabdomyolysis.
  • Fentanyl: Increased fentanyl levels (CYP3A4 inhibition).
  • Midazolam, Triazolam: Increased benzodiazepine levels (CYP3A4 inhibition).
  • Cyclosporine, Tacrolimus, Sirolimus: Increased immunosuppressant levels (CYP3A4 inhibition).
  • Alpha-blockers (e.g., prazosin, doxazosin): Increased risk of hypotension.
  • Grapefruit juice: Increased diltiazem levels due to CYP3A4 inhibition.
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Moderate Interactions

  • Clonidine: Additive bradycardia/hypotension.
  • Phenytoin: Increased phenytoin levels.
  • Carbamazepine: Increased carbamazepine levels.
  • Rifampin, Phenobarbital (CYP3A4 inducers): Decreased diltiazem levels.
  • Cimetidine, Ranitidine: May increase diltiazem levels.
  • Theophylline: Increased theophylline levels.
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Minor Interactions

  • NSAIDs: May reduce antihypertensive effect.

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 risk of bradycardia, especially with co-administered drugs.

Timing: Prior to initiation

Electrocardiogram (ECG)

Rationale: To assess baseline cardiac rhythm, PR interval, and identify pre-existing conduction abnormalities.

Timing: Prior to initiation, especially if pre-existing cardiac conditions

Liver Function Tests (LFTs)

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

Timing: Prior to initiation, especially in patients with suspected hepatic impairment

Renal Function (BUN, Creatinine)

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

Timing: Prior to initiation, especially in patients with suspected renal impairment

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, e.g., weekly during titration, then monthly/quarterly once stable.

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

Action Threshold: Persistent BP above target, or symptomatic hypotension.

Heart Rate (HR)

Frequency: Regularly, e.g., weekly during titration, then monthly/quarterly once stable.

Target: 50-90 bpm (or individualized target, e.g., 60-80 bpm for angina/rate control)

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

Electrocardiogram (ECG)

Frequency: Periodically, or if symptoms of bradycardia, AV block, or new arrhythmias develop.

Target: Normal sinus rhythm, PR interval <0.20 sec

Action Threshold: Significant PR prolongation, second- or third-degree AV block.

Symptoms of peripheral edema

Frequency: At each visit

Target: Absence of significant edema

Action Threshold: New or worsening lower extremity edema.

Liver Function Tests (LFTs)

Frequency: Periodically, or if symptoms of hepatic dysfunction (e.g., jaundice, fatigue) develop.

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
  • Bradycardia (slow heart rate)
  • Palpitations
  • Shortness of breath
  • Swelling in ankles/feet (edema)
  • Chest pain (angina, monitor for improvement or worsening)
  • Signs of liver dysfunction (e.g., yellowing of skin/eyes, dark urine, persistent nausea/vomiting)

Special Patient Groups

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Pregnancy

Diltiazem is Pregnancy Category C. Studies in animals have shown adverse effects on the fetus, but 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 developmental abnormalities observed in animal studies at high doses. Use only if clearly needed.
Second Trimester: Limited human data. Use with caution, monitoring fetal well-being.
Third Trimester: Limited human data. Use with caution, monitoring fetal well-being and potential for neonatal bradycardia/hypotension if used close to delivery.
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Lactation

Diltiazem is excreted in human breast milk. While the amount is generally small, caution is advised. The American Academy of Pediatrics considers diltiazem to be compatible with breastfeeding. Monitor the infant for signs of bradycardia, hypotension, or sedation.

Infant Risk: Low to moderate risk. Monitor for bradycardia, hypotension, and sedation. Consider alternative if infant is premature or has underlying cardiac conditions.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients for hypertension or angina. Limited off-label use for supraventricular tachycardia, typically with IV formulation and under close supervision.

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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 dizziness, bradycardia, and hypotension.

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 or heart rate.
  • Do not crush, chew, or divide the extended-release capsules. If a patient cannot swallow the capsule whole, some formulations allow for opening and sprinkling contents on applesauce (check specific product instructions).
  • Monitor heart rate and blood pressure regularly, especially during initiation and dose titration, due to the risk of bradycardia and hypotension.
  • Caution is advised when co-administering with beta-blockers or digoxin due to additive effects on heart rate and AV conduction.
  • Educate patients about avoiding grapefruit and grapefruit juice due to potential for increased diltiazem levels and side effects.
  • Peripheral edema is a common side effect, often dose-dependent. It is typically mild and can be managed with diuretics or by adjusting the dose.
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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, Atenolol) for hypertension, angina, rate control
  • ACE inhibitors (e.g., Lisinopril, Ramipril) for hypertension
  • ARBs (e.g., Valsartan, Losartan) for hypertension
  • Diuretics (e.g., Hydrochlorothiazide, Furosemide) for hypertension
  • Other antiarrhythmics (e.g., Amiodarone, Sotalol) for rate/rhythm control in atrial fibrillation/flutter
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Cost & Coverage

Average Cost: $10 - $50 per 30 capsules (generic 180mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic formulations)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. 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. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.