Dilacor XR 240mg Capsules
Overview
What is this medicine?
How to Use This Medicine
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
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
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
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.
Precautions & Cautions
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
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
Minor Interactions
- Cimetidine - increased diltiazem levels (minor effect)
- Ranitidine - increased diltiazem levels (minor effect)
Monitoring
Baseline Monitoring
Rationale: To establish baseline and guide initial dosing for hypertension/angina.
Timing: Prior to initiation
Rationale: To establish baseline and assess for bradycardia risk.
Timing: Prior to initiation
Rationale: To assess baseline cardiac rhythm and PR interval, especially in patients with pre-existing conduction abnormalities.
Timing: Prior to initiation (if clinically indicated)
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)
Rationale: To assess baseline kidney function, as elimination is partly renal.
Timing: Prior to initiation (if clinically indicated)
Routine Monitoring
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.
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.
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.
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).
Frequency: At each visit
Target: Absence of significant edema
Action Threshold: New or worsening peripheral edema.
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:
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.
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)