Dilacor XR 180mg Capsules

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, decreased peripheral vascular resistance, and reduced afterload. In the heart, it decreases myocardial contractility, slows sinoatrial (SA) node automaticity, and prolongs atrioventricular (AV) node conduction, leading to a reduction in heart rate and myocardial oxygen demand.

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). Be aware of:
+ 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 help if you experience:
+ Red, swollen, blistered, or peeling skin
+ 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 can cause side effects. Many people may not experience any side effects or only minor ones. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical help:

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.

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 treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including the symptoms that occurred.
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, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you are experiencing. Your doctor and pharmacist need this information to assess potential interactions and ensure safe treatment. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.

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.

Follow your doctor's instructions for monitoring 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 regularly 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 with 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, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of this medication to both you and your baby.

• Ivabradine (risk of severe bradycardia)
• Dantrolene (IV) (risk of severe cardiovascular depression)

• Beta-blockers (e.g., metoprolol, carvedilol) - increased risk of bradycardia, AV block, heart failure
• Digoxin - increased digoxin levels, risk of toxicity
• Amiodarone - increased risk of bradycardia, AV block, hypotension
• Statins (e.g., simvastatin, lovastatin) - increased statin levels, risk of myopathy/rhabdomyolysis
• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) - increased diltiazem levels
• Strong CYP3A4 inducers (e.g., rifampin, phenytoin) - decreased diltiazem levels
• Fentanyl (IV) - increased fentanyl levels, risk of respiratory depression
• Midazolam/Triazolam - increased benzodiazepine levels, prolonged sedation

• Alpha-blockers (e.g., prazosin, tamsulosin) - additive hypotensive effects
• Other antihypertensives (e.g., ACE inhibitors, ARBs, diuretics) - additive hypotensive effects
• Clonidine - increased risk of bradycardia, AV block
• Carbamazepine - increased carbamazepine levels, risk of toxicity
• Cyclosporine - increased cyclosporine levels, risk of nephrotoxicity
• Tacrolimus - increased tacrolimus levels, risk of nephrotoxicity
• Theophylline - increased theophylline levels
• Grapefruit juice - may increase diltiazem levels

• NSAIDs - may reduce antihypertensive effect
• Cimetidine - may increase diltiazem levels (minor effect)

• Peripheral edema (especially ankles)
• Dizziness or lightheadedness
• Fatigue or weakness
• Bradycardia (slow heart rate)
• Shortness of breath
• Chest pain (angina, if applicable)
• Headache
• Nausea
• Constipation

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.

Diltiazem is excreted in human breast milk. The American Academy of Pediatrics considers diltiazem to be compatible with breastfeeding, but caution is advised. Monitor the infant for potential adverse effects such as bradycardia, hypotension, or sedation.

Safety and efficacy of extended-release diltiazem formulations have not been established in pediatric patients. Use is generally not recommended.

Geriatric 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 hypotension, bradycardia, and constipation. Renal and hepatic function should be considered.

• Dilacor XR capsules should be swallowed whole; they should not be chewed, crushed, or divided, as this will alter the extended-release properties and may lead to rapid absorption and increased side effects.
• Diltiazem is a potent CYP3A4 inhibitor, leading to significant drug-drug interactions with many commonly prescribed medications (e.g., statins, immunosuppressants, certain benzodiazepines). Always review concomitant medications.
• While generally well-tolerated, common side effects include peripheral edema, headache, dizziness, bradycardia, and constipation.
• Patients should be advised to avoid grapefruit juice due to its potential to increase diltiazem levels.
• Monitor heart rate and blood pressure regularly, especially during dose titration, to avoid excessive bradycardia or hypotension.

• Other non-dihydropyridine calcium channel blockers (e.g., verapamil)
• Dihydropyridine calcium channel blockers (e.g., amlodipine, nifedipine)
• ACE inhibitors (e.g., lisinopril, enalapril)
• Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan)
• Beta-blockers (e.g., metoprolol, atenolol)
• Thiazide diuretics (e.g., hydrochlorothiazide)
• Loop diuretics (e.g., furosemide)
• Alpha-1 blockers (e.g., prazosin, doxazosin)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. 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 discuss them with 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.