Dilacor XR 240mg Capsules

Manufacturer ACTAVIS 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.
đŸˇī¸
Drug Class
Antihypertensive, Antianginal
đŸ§Ŧ
Pharmacologic Class
Calcium Channel Blocker, Non-dihydropyridine
🤰
Pregnancy Category
Category C
✅
FDA Approved
Sep 1992
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Diltiazem is a medication called a calcium channel blocker. It works by relaxing blood vessels, which helps lower blood pressure and reduce chest pain (angina). It also helps slow down your heart rate.
📋

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.

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.
💡

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 or sprinkle the contents of the capsule on a spoonful of soft food (like applesauce) and swallow immediately without chewing.
  • Avoid grapefruit juice as it can increase the levels of diltiazem in your body.
  • 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 help manage your blood pressure and heart health.
  • Limit alcohol consumption, as it can also lower blood pressure and increase dizziness.
💊

Available Forms & Alternatives

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: 120-240 mg orally once daily
Dose Range: 120 - 480 mg

Condition-Specific Dosing:

Hypertension: Initial: 180-240 mg orally once daily; adjust dose based on patient response, typically 120-480 mg once daily.
Chronic Stable Angina: Initial: 120-180 mg orally once daily; adjust dose based on patient response, typically 120-480 mg once daily.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, monitor closely.
Moderate: No specific adjustment recommended, monitor closely.
Severe: Use with caution, monitor for exaggerated effects. Dose reduction may be necessary.
Dialysis: Diltiazem is not significantly removed by hemodialysis. Use with caution, monitor for exaggerated effects.

Hepatic Impairment:

Mild: Use with caution, monitor for exaggerated effects.
Moderate: Use with caution, consider lower initial doses and careful titration due to extensive hepatic metabolism.
Severe: Use with caution, consider lower initial doses and careful titration due to extensive hepatic metabolism.
Confidence: Medium

Pharmacology

đŸ”Ŧ

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 and coronary vasodilation, resulting in decreased peripheral vascular resistance and reduced myocardial oxygen demand. It also slows conduction through the AV node, prolonging the PR interval and decreasing heart rate.
📊

Pharmacokinetics

Absorption:

Bioavailability: 40-65%
Tmax: 6-11 hours (for extended-release formulations)
FoodEffect: Food may slightly increase the rate and extent of absorption, but can be taken without regard to meals.

Distribution:

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

Elimination:

HalfLife: 5-10 hours (terminal half-life for extended-release formulations can be longer)
Clearance: Not available
ExcretionRoute: Urine (35-65%), Feces (35-65%)
Unchanged: Less than 4% (urine)
âąī¸

Pharmacodynamics

OnsetOfAction: Within hours (for extended-release formulations)
PeakEffect: 6-11 hours
DurationOfAction: 24 hours

Safety & Warnings

âš ī¸

Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when 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

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. However, 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.
🚨

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
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine or pale stools
  • Persistent nausea or vomiting
  • Severe headache that does not go away
📋

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 individuals with specific heart rhythm disorders. If you are unsure, consult your doctor or pharmacist for guidance.
Existing health conditions, including:
+ Fluid accumulation in the lungs
+ Low blood pressure
+ Recent heart attack
Current medications, particularly:
+ Ivabradine
+ Rifampin
* All other prescription and over-the-counter medications, natural products, and vitamins you are taking, as this medication may interact with them.

Please note that this is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to discuss all your medications and health conditions with your doctor and pharmacist. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm it is safe to do so.
âš ī¸

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, stand up slowly after sitting or lying down, 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 they will need to discuss the potential benefits and risks of this medication to both you and your baby.
🆘

Overdose Information

Overdose Symptoms:

  • Profound 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 your local emergency number. For poison control, call 1-800-222-1222.

Drug Interactions

đŸšĢ

Contraindicated Interactions

  • Dantrolene (IV)
🔴

Major Interactions

  • Beta-blockers (e.g., propranolol, metoprolol) - risk of bradycardia, AV block, heart failure
  • Digoxin - increased digoxin levels
  • Amiodarone - risk of bradycardia, AV block, hypotension
  • Statins (e.g., simvastatin, lovastatin) - increased statin levels, risk of myopathy/rhabdomyolysis
  • Ivabradine - increased ivabradine exposure, risk of bradycardia
  • Fingolimod - increased risk of bradycardia
🟡

Moderate Interactions

  • CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir) - increased diltiazem levels
  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) - decreased diltiazem levels
  • Grapefruit juice - increased diltiazem levels
  • Alpha-blockers (e.g., prazosin, doxazosin) - increased risk of hypotension
  • Clonidine - increased risk of bradycardia, AV block
  • Fentanyl - increased fentanyl levels
  • Buspirone - increased buspirone levels
  • Cyclosporine - increased cyclosporine levels
  • Tacrolimus - increased tacrolimus levels
  • Theophylline - increased theophylline levels
đŸŸĸ

Minor Interactions

  • Cimetidine - increased diltiazem levels (minor effect)
  • Ranitidine - increased diltiazem levels (minor effect)

Monitoring

đŸ”Ŧ

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 risk.

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 (if clinically indicated)

Liver Function Tests (LFTs)

Rationale: Diltiazem is extensively metabolized by the liver; baseline assessment is prudent, especially in patients with hepatic impairment.

Timing: Prior to initiation (if clinically indicated)

Renal Function (SCr, BUN)

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

Timing: Prior to initiation (if clinically indicated)

📊

Routine Monitoring

Blood Pressure (BP)

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

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

Action Threshold: Persistent hypotension (<90/60 mmHg) or uncontrolled hypertension.

Heart Rate (HR)

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

Target: 50-90 bpm (or individualized target)

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

Electrocardiogram (ECG)

Frequency: Periodically, especially if symptoms of conduction abnormalities (e.g., dizziness, syncope) or if co-administered with other AV nodal blocking agents.

Target: Normal sinus rhythm, PR interval <0.20 seconds

Action Threshold: Significant PR prolongation (>0.24 seconds), new onset AV block, or other arrhythmias.

Liver Function Tests (LFTs)

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

Target: Within normal limits

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

Signs/Symptoms of Peripheral Edema

Frequency: At each visit

Target: Absence of significant edema

Action Threshold: New or worsening peripheral edema.

đŸ‘ī¸

Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Headache
  • Swelling of ankles/feet (peripheral edema)
  • Shortness of breath
  • Chest pain (angina)
  • Palpitations
  • Slow heart rate
  • Signs of liver dysfunction (e.g., yellowing of skin/eyes, dark urine, persistent nausea/vomiting)

Special Patient Groups

🤰

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 adverse developmental effects observed in animal studies; human data are limited.
Second Trimester: Limited human data; use with caution.
Third Trimester: Limited human data; use with caution. May affect uterine contractility.
🤱

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 bradycardia, hypotension, and sedation.

Infant Risk: L3 (Moderate risk) - Monitor infant for adverse effects such as bradycardia, hypotension, and sedation. Consider alternative if infant is premature or has underlying cardiac issues.
đŸ‘ļ

Pediatric Use

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

👴

Geriatric Use

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

Clinical Information

💎

Clinical Pearls

  • Diltiazem XR is a good option for patients with both hypertension and chronic stable angina.
  • Unlike beta-blockers, diltiazem can be used in patients with asthma or COPD, as it does not cause bronchoconstriction.
  • Extended-release formulations are designed for once-daily dosing, improving patient adherence.
  • Counsel patients not to crush or chew the extended-release capsules to avoid dose dumping and potential adverse effects.
  • Monitor for peripheral edema, a common side effect of calcium channel blockers, though generally less pronounced with diltiazem compared to dihydropyridine CCBs (e.g., amlodipine).
  • Be cautious when co-administering with other drugs that slow AV nodal conduction (e.g., beta-blockers, digoxin, amiodarone) due to increased risk of bradycardia and AV block.
🔄

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)
  • Thiazide Diuretics (e.g., Hydrochlorothiazide)
  • Beta-blockers (e.g., Metoprolol, Atenolol)
  • Nitrates (for angina) (e.g., Isosorbide mononitrate, Nitroglycerin)
💰

Cost & Coverage

Average Cost: $50 - $200 per 30 capsules (generic 240mg XR)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
📚

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 this 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 overdose, including the medication taken, the amount, and the time it occurred.