Diltiazem ER 60mg Capsules (12 Hr)

Manufacturer MYLAN Active Ingredient Diltiazem 12-Hour Sustained- Release Capsules(dil TYE a zem) Pronunciation dil TYE a zem
It is used to treat high blood pressure.It may be given to you for other reasons. Talk with the doctor.
đŸˇī¸
Drug Class
Antihypertensive, Antianginal, Antiarrhythmic
đŸ§Ŧ
Pharmacologic Class
Calcium Channel Blocker (Non-dihydropyridine)
🤰
Pregnancy Category
Category C
✅
FDA Approved
Sep 1982
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Diltiazem ER is a medication that belongs to a class of drugs called calcium channel blockers. It works by relaxing blood vessels, which helps to lower blood pressure and improve blood flow to the heart. It also helps to slow down your heart rate, which can be beneficial for certain heart conditions like angina (chest pain) or irregular heart rhythms.
📋

How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. When taking your medication:

Swallow the tablet whole without chewing, breaking, or crushing it.
Take your medication at the same time every day to establish a routine.
Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling well.

Storing and Disposing of Your Medication

To maintain the quality and safety of your medication:

Store it at room temperature, protected from light and moisture.
Keep it in a dry place, away from the bathroom.
Store all medications in a secure location, out of reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist for guidance on the best way to dispose of medications, and consider participating in local drug take-back programs.

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 open the extended-release capsule.
  • Swallow the capsule whole.
  • Do not stop taking this medication suddenly without consulting your doctor, as it can worsen your condition.
  • Monitor your blood pressure and heart rate regularly as advised by your doctor.
  • Avoid grapefruit and grapefruit juice while taking this medication, as it can increase the levels of diltiazem in your body.
  • Limit alcohol consumption, as it can increase the hypotensive effects.
  • Maintain a healthy diet, regular exercise, and manage stress to support cardiovascular health.
  • Report any new or worsening symptoms, especially swelling in the ankles/feet, dizziness, or very slow heart rate.
💊

Available Forms & Alternatives

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: Initial dose for Diltiazem ER is typically 120-240 mg once daily. 60mg ER is a very low starting dose, often used for titration or specific patient needs. Max dose up to 540 mg/day.
Dose Range: 60 - 540 mg

Condition-Specific Dosing:

hypertension: Initial: 180-240 mg once daily; titrate to response. Doses up to 540 mg/day.
chronicStableAngina: Initial: 120-180 mg once daily; titrate to response. Doses up to 540 mg/day.
atrialFibrillationFlutterRateControl: Initial: 120-240 mg once daily; titrate to achieve target heart rate. Doses up to 540 mg/day.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (Safety and efficacy not established for ER formulations)
Adolescent: Not established (Safety and efficacy not established for ER formulations)
âš•ī¸

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: Diltiazem is not significantly removed by hemodialysis. No specific supplemental dose needed, but monitor for exaggerated effects.

Hepatic Impairment:

Mild: Use with caution, monitor for exaggerated effects.
Moderate: Use with caution, consider lower initial doses and titrate slowly due to prolonged half-life.
Severe: Contraindicated in severe hepatic impairment due to extensive hepatic metabolism and risk of accumulation.

Pharmacology

đŸ”Ŧ

Mechanism of Action

Diltiazem is a non-dihydropyridine calcium channel blocker. It inhibits the influx of extracellular calcium ions across the membranes of myocardial and vascular smooth muscle cells. This leads to relaxation of vascular smooth muscle and coronary vasodilation, resulting in decreased peripheral vascular resistance and reduced blood pressure. In the heart, it decreases sinoatrial (SA) and atrioventricular (AV) nodal conduction, prolonging the effective refractory period and slowing heart rate, which reduces myocardial oxygen demand.
📊

Pharmacokinetics

Absorption:

Bioavailability: Approximately 40% (due to extensive first-pass metabolism)
Tmax: 3-6 hours (for ER formulations)
FoodEffect: Food may increase bioavailability and delay Tmax, but generally does not significantly alter overall exposure for ER formulations; can be taken with or without food.

Distribution:

Vd: 3-13 L/kg
ProteinBinding: 70-80%
CnssPenetration: Limited

Elimination:

HalfLife: 5-8 hours (for ER formulations, can be longer with chronic dosing)
Clearance: Not available (highly variable due to first-pass metabolism)
ExcretionRoute: Mainly urine (35-65%) and feces (35-65%)
Unchanged: <4% (urine)
âąī¸

Pharmacodynamics

OnsetOfAction: Within 30-60 minutes (for ER formulations)
PeakEffect: 3-6 hours (for ER formulations)
DurationOfAction: 12-24 hours (for ER formulations)

Safety & Warnings

âš ī¸

Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

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 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, which can be life-threatening. 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

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 possible 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.
🚨

Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting
  • Very slow heart rate (e.g., less than 50 beats per minute)
  • Shortness of breath, especially with exertion or lying down
  • Significant swelling in the ankles, feet, or legs
  • New or worsening chest pain
  • Signs of liver problems (e.g., yellowing of skin/eyes, dark urine, persistent nausea/vomiting, severe stomach pain)
  • Severe constipation
📋

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 allergic reaction you experienced, including any symptoms that occurred.
Certain types of abnormal heart rhythms, as this medication is not suitable for individuals with these conditions. If you are unsure about your specific heart rhythm, 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 may interact with this drug.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if 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.
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, get up slowly from a sitting or lying down position, and exercise caution 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 treatment and during the course of therapy. Discuss any concerns or questions with your doctor.

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. Additionally, talk to your doctor before consuming 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, plan to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby.
🆘

Overdose Information

Overdose Symptoms:

  • Severe hypotension (very low blood pressure)
  • Profound bradycardia (extremely slow heart rate)
  • AV block (heart block)
  • Cardiogenic shock
  • Asystole (cardiac arrest)
  • Dizziness
  • Confusion
  • Lethargy
  • Nausea
  • Vomiting

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, vasopressors (e.g., norepinephrine), atropine, calcium gluconate, glucagon, or cardiac pacing.

Drug Interactions

đŸšĢ

Contraindicated Interactions

  • Ivabradine (risk of severe bradycardia)
  • Dantrolene (IV) (risk of hyperkalemia and myocardial depression)
  • Ranolazine (increased ranolazine levels)
🔴

Major Interactions

  • Beta-blockers (additive negative chronotropic and inotropic effects, risk of severe bradycardia, AV block, heart failure)
  • Digoxin (increased digoxin levels, risk of toxicity)
  • Statins (e.g., simvastatin, lovastatin) (increased statin levels, risk of myopathy/rhabdomyolysis due to CYP3A4 inhibition)
  • Amiodarone (risk of severe bradycardia, AV block)
  • Fentanyl (increased fentanyl levels, risk of respiratory depression)
  • Immunosuppressants (e.g., cyclosporine, tacrolimus, sirolimus, everolimus) (increased immunosuppressant levels)
  • Alpha-blockers (e.g., prazosin, doxazosin) (additive hypotensive effects)
  • Other CYP3A4 substrates with narrow therapeutic index (e.g., carbamazepine, quinidine, midazolam, triazolam)
🟡

Moderate Interactions

  • Clonidine (additive bradycardia)
  • Phenytoin (increased phenytoin levels)
  • Theophylline (increased theophylline levels)
  • Cimetidine (increased diltiazem levels)
  • Rifampin (decreased diltiazem levels)
  • Grapefruit juice (increased diltiazem levels)
  • Nitrates (additive hypotensive effects)
đŸŸĸ

Minor Interactions

  • NSAIDs (may reduce antihypertensive effect)
  • Antacids (may reduce diltiazem absorption)

Monitoring

đŸ”Ŧ

Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and assess efficacy for hypertension.

Timing: Prior to initiation

Heart Rate (HR)

Rationale: To establish baseline and assess for bradycardia, especially if used for rate control or with other rate-lowering agents.

Timing: Prior to initiation

Electrocardiogram (ECG)

Rationale: To assess for pre-existing conduction abnormalities (e.g., sick sinus syndrome, AV block) which are contraindications.

Timing: Prior to initiation (especially if cardiac history)

Liver Function Tests (LFTs)

Rationale: To assess baseline hepatic function due to extensive hepatic metabolism.

Timing: Prior to initiation (especially if hepatic impairment suspected)

Renal Function Tests (RFTs)

Rationale: To assess baseline renal function.

Timing: Prior to initiation (especially if renal impairment suspected)

📊

Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, as clinically indicated (e.g., weekly during titration, then monthly/quarterly)

Target: Individualized (e.g., <130/80 mmHg for hypertension)

Action Threshold: Persistent hypotension, inadequate BP control

Heart Rate (HR)

Frequency: Regularly, as clinically indicated (e.g., weekly during titration, then monthly/quarterly)

Target: Individualized (e.g., 60-100 bpm for general use, 80-100 bpm for rate control in AF)

Action Threshold: Bradycardia (<50 bpm), symptomatic bradycardia, or inadequate rate control

ECG (PR interval)

Frequency: Periodically, especially during dose titration or with concomitant AV nodal blocking agents

Target: Normal PR interval (<0.20 seconds)

Action Threshold: Significant PR prolongation, new or worsening AV block

Peripheral Edema

Frequency: Regularly, at each visit

Target: Absence of significant edema

Action Threshold: New or worsening lower extremity edema

Liver Function Tests (LFTs)

Frequency: Periodically, especially with long-term therapy or symptoms of hepatic dysfunction

Target: Within normal limits

Action Threshold: Significant elevation of transaminases

đŸ‘ī¸

Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Headache
  • Constipation
  • Swelling in ankles/feet
  • Shortness of breath
  • Chest pain
  • Palpitations
  • Fainting spells

Special Patient Groups

🤰

Pregnancy

Category C. Diltiazem should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity observed in animal studies at high doses. Human data limited.
Second Trimester: Risk of fetal bradycardia or hypotension, though human data is limited.
Third Trimester: Risk of fetal bradycardia or hypotension, and potential for prolonged labor due to uterine relaxation. Human data limited.
🤱

Lactation

L3 (Moderately Safe). Diltiazem is excreted into breast milk. While the amount is small, monitor breastfed infants for signs of bradycardia, hypotension, or sedation. Use with caution, or consider an alternative drug, especially in preterm or neonates.

Infant Risk: Low to moderate risk. Potential for bradycardia, hypotension, or sedation in the infant. Monitor infant for adverse effects.
đŸ‘ļ

Pediatric Use

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

👴

Geriatric Use

Geriatric patients may be more sensitive to the hypotensive and bradycardic effects of diltiazem due to age-related decreases in renal and hepatic function, and increased sensitivity of the cardiovascular system. Start with lower doses and titrate slowly, monitoring closely for adverse effects.

Clinical Information

💎

Clinical Pearls

  • Diltiazem ER is typically dosed once daily. Ensure patients understand not to crush or chew the extended-release capsules.
  • It is a non-dihydropyridine CCB, meaning it affects both vascular smooth muscle and cardiac conduction (SA/AV nodes), unlike dihydropyridines (e.g., amlodipine) which are primarily vasodilators.
  • Caution is advised when co-administering with beta-blockers or digoxin due to additive effects on heart rate and AV conduction, increasing risk of bradycardia and AV block.
  • Diltiazem is a moderate CYP3A4 inhibitor, leading to significant drug interactions with substrates like statins (simvastatin, lovastatin), immunosuppressants, and certain benzodiazepines.
  • Peripheral edema is a common side effect, but it is typically less pronounced than with dihydropyridine CCBs.
  • Constipation is a frequent side effect, especially at higher doses. Advise patients on dietary fiber and hydration.
  • Monitor for signs of heart failure exacerbation in patients with pre-existing left ventricular dysfunction.
🔄

Alternative Therapies

  • Other Calcium Channel Blockers (e.g., Verapamil for rate control/angina, Amlodipine/Nifedipine for hypertension/angina)
  • Beta-blockers (e.g., Metoprolol, Atenolol for hypertension, angina, rate control)
  • ACE Inhibitors/ARBs (for hypertension, heart failure)
  • Diuretics (for hypertension)
  • Nitrates (for angina)
  • Antiarrhythmics (e.g., Amiodarone, Sotalol for rate/rhythm control in AF)
💰

Cost & Coverage

Average Cost: $10 - $50 per 30 capsules (for generic 60mg ER)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
📚

General Drug Facts

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