Diltiazem CD 240mg Capsules (24 Hr)

Diltiazem is a non-dihydropyridine calcium channel blocker. It inhibits the influx of extracellular calcium ions across the myocardial and vascular smooth muscle cell membranes through voltage-gated L-type calcium channels. This leads to a reduction in myocardial contractility, slowing of sinoatrial (SA) and atrioventricular (AV) nodal conduction, and relaxation of vascular smooth muscle, resulting in peripheral and coronary vasodilation. These actions decrease myocardial oxygen demand and increase myocardial oxygen supply.

Important Side Effects to Report to Your Doctor Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, seek medical attention 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), characterized by:
+ 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, 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 may not experience any side effects or may only have mild ones. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Headache
* Feeling dizzy, tired, or weak

Reporting Side Effects

This is not a complete list of possible side effects. If you have questions or concerns about side effects, talk to 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:

Any allergies you have, including allergies to this medication, 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 for guidance.
Any of the following health conditions: fluid accumulation in the lungs, low blood pressure, or a recent heart attack.
If you are currently taking ivabradine or rifampin, as these medications interact with this drug.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.

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 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.

Depending on the specific product, you may need to avoid consuming alcohol while taking this medication. Consult your doctor or pharmacist to determine if alcohol consumption is safe for you.

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

• Ivabradine (increased risk of bradycardia and conduction disturbances)
• Dantrolene (IV) (risk of cardiovascular collapse)

• Beta-blockers (e.g., metoprolol, propranolol): Increased risk of bradycardia, AV block, and myocardial depression.
• Digoxin: Increased digoxin serum concentrations (monitor digoxin levels).
• 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, sinus arrest, AV block.
• Fentanyl: Increased fentanyl exposure (CYP3A4 inhibition).
• Midazolam, Triazolam: Increased benzodiazepine exposure (CYP3A4 inhibition).
• Cyclosporine, Tacrolimus, Sirolimus, Everolimus: Increased immunosuppressant levels (CYP3A4 inhibition).
• Alpha-blockers (e.g., prazosin, doxazosin): Increased risk of hypotension.
• Clonidine: Increased risk of bradycardia and AV block.
• Rifampin, Phenytoin, Carbamazepine, Phenobarbital: Decreased diltiazem levels (CYP3A4 induction).

• Other antihypertensives: Additive hypotensive effects.
• Grapefruit juice: May increase diltiazem levels (CYP3A4 inhibition).
• Cimetidine, Ranitidine: May increase diltiazem levels.
• Theophylline: May increase theophylline levels.
• Quinidine: May increase quinidine levels.

• NSAIDs: May reduce the antihypertensive effect of diltiazem.

• Dizziness
• Lightheadedness
• Fatigue
• Headache
• Swelling of ankles/feet (edema)
• Shortness of breath
• Chest pain (worsening angina)
• Palpitations
• Fainting (syncope)
• Yellowing of skin/eyes (jaundice)
• Dark urine
• Unusual bleeding/bruising

Diltiazem is classified as 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 at doses higher than human therapeutic doses.

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.

Safety and efficacy have not been established in pediatric patients. Use is generally not recommended outside of specific, carefully monitored situations (e.g., certain arrhythmias) where benefits clearly outweigh risks.

Geriatric patients may be more sensitive to the effects of diltiazem, particularly regarding hypotension and bradycardia. Start with lower doses and titrate slowly. Monitor closely for adverse effects, especially dizziness, falls, and changes in heart rate/rhythm. Renal and hepatic function may be impaired, requiring dose adjustments.

• Diltiazem CD is an extended-release formulation designed for once-daily dosing, providing 24-hour control of blood pressure or heart rate.
• As a non-dihydropyridine calcium channel blocker, diltiazem affects both vascular smooth muscle and cardiac conduction, making it effective for hypertension, angina, and rate control in atrial fibrillation/flutter.
• Unlike dihydropyridine CCBs (e.g., amlodipine), diltiazem can cause bradycardia and AV block, especially when combined with other AV nodal blocking agents (e.g., beta-blockers, digoxin). Close monitoring of heart rate and ECG is crucial.
• Patients should be advised not to crush, chew, or divide the extended-release capsules, as this can lead to rapid release of the drug and potentially dangerous overdose.
• Grapefruit juice can significantly increase diltiazem levels due to CYP3A4 inhibition; patients should be advised to avoid it.
• Peripheral edema is a common side effect, but it is typically less pronounced than with dihydropyridine CCBs.

• Other Calcium Channel Blockers (e.g., Amlodipine, Nifedipine for hypertension/angina)
• Beta-blockers (e.g., Metoprolol, Atenolol for hypertension, angina, rate control)
• ACE Inhibitors (e.g., Lisinopril, Enalapril for hypertension)
• Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan for hypertension)
• Diuretics (e.g., Hydrochlorothiazide, Furosemide for hypertension, edema)
• Nitrates (e.g., Isosorbide mononitrate, Nitroglycerin for angina)
• Antiarrhythmics (e.g., Amiodarone, Sotalol for atrial fibrillation)

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 medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.