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Diltiazem ER 180mg Caps (xr-24h)

Manufacturer APOTEX 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.
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Drug Class
Antihypertensive, Antianginal, Antiarrhythmic
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Pharmacologic Class
Calcium Channel Blocker (Non-dihydropyridine)
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Pregnancy Category
Category C
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FDA Approved
Sep 1990
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Diltiazem is a medication that helps relax blood vessels and slow down your heart rate. This can lower your blood pressure, help with chest pain (angina), and control a fast or irregular heartbeat. It works by blocking calcium from entering certain cells in your heart and blood vessels.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow these guidelines:

Take your medication exactly as directed by your doctor.
 Read all the information provided with your medication and follow the instructions carefully.
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 well.

Special Instructions for Taking Your Medication

Some medications may need to be taken with food or on an empty stomach. Check with your pharmacist to determine the best way to take your 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 ensure the safety and effectiveness of your medication:

Store it at room temperature, protected from light.
 Keep it in a dry place, away from the bathroom.
Store all medications in a secure location, out of the 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 your medication, and consider participating in a local drug take-back program.

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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take the medication at the same time each day, preferably in the morning.
  • Swallow the extended-release capsules whole; do not crush, chew, or divide them.
  • Avoid grapefruit and grapefruit juice while taking this medication, as it can increase the amount of diltiazem in your body.
  • Maintain a healthy diet, low in sodium, and engage in regular physical activity as advised by your doctor.
  • Limit alcohol consumption, as it can further lower blood pressure.
  • Do not stop taking this medication suddenly without consulting your doctor, as it can worsen your condition.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 180 mg once daily
Dose Range: 120 - 540 mg

Condition-Specific Dosing:

hypertension: Initial 180-240 mg once daily; may titrate up to 540 mg once daily.
chronic_stable_angina: Initial 120-180 mg once daily; may titrate up to 540 mg once daily.
atrial_fibrillation_flutter_rate_control: Initial 120-240 mg once daily; may titrate up to 360 mg once daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment usually required.
Moderate: No specific adjustment usually required.
Severe: Use with caution; monitor for exaggerated effects. Consider lower initial doses.
Dialysis: Diltiazem is not significantly removed by dialysis. Use with caution, monitor for effects.

Hepatic Impairment:

Mild: Use with caution; monitor for exaggerated effects.
Moderate: Consider a 50% reduction in initial dose and titrate slowly with careful monitoring.
Severe: Contraindicated in severe hepatic impairment due to extensive hepatic metabolism.

Pharmacology

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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 through voltage-gated L-type calcium channels. This leads to relaxation of vascular smooth muscle, resulting in peripheral vasodilation and reduced systemic vascular resistance, and also reduces myocardial contractility and slows conduction through the AV node, leading to decreased heart rate.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 40% (due to extensive first-pass metabolism)
Tmax: 10-14 hours (for extended-release formulations)
FoodEffect: Food increases the rate and extent of absorption for some ER formulations.

Distribution:

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

Elimination:

HalfLife: 5-10 hours (parent drug, extended-release); 7-12 hours (desacetyl diltiazem)
Clearance: Approximately 1.1 L/min
ExcretionRoute: Urine (35-65%), Feces (35-65%)
Unchanged: <4% (in urine)
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Pharmacodynamics

OnsetOfAction: 2-3 hours (for extended-release formulations)
PeakEffect: 10-14 hours (for extended-release formulations)
DurationOfAction: 24 hours

Safety & Warnings

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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, discuss this with 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 may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:

 Headache
* Feeling dizzy, tired, or weak

Reporting Side Effects

This list is not exhaustive, and you may experience other 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or lightheadedness, especially when standing up.
  • Fainting spells.
  • Unusual swelling in your ankles, feet, or hands.
  • Difficulty breathing or shortness of breath.
  • Very slow heart rate (e.g., feeling your pulse is unusually slow or irregular).
  • New or worsening chest pain.
  • Signs of liver problems (e.g., yellowing of skin/eyes, dark urine, persistent nausea/vomiting, unusual tiredness).
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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

Please note that this is not an exhaustive list of all potential interactions. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist to ensure safe use. Before starting, stopping, or adjusting the dose of any medication, always consult your doctor to verify the safety of combining it with this medication and your individual health profile.
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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. Discuss any concerns 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. Additionally, you may need to avoid consuming alcohol while taking this medication; consult your doctor or pharmacist for guidance.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

It is crucial to inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Your doctor will help you weigh the benefits and risks of taking this medication to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypotension (very low blood pressure)
  • Bradycardia (very slow heart rate)
  • AV block (heart conduction problems)
  • Asystole (cardiac arrest)
  • Heart failure
  • Dizziness
  • Fainting

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment is supportive and may include IV fluids, vasopressors, atropine, calcium gluconate, glucagon, or cardiac pacing.

Drug Interactions

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Contraindicated Interactions

  • Ivabradine (risk of severe bradycardia and conduction disturbances)
  • Dantrolene (IV, risk of hyperkalemia and myocardial depression)
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Major Interactions

  • Beta-blockers (additive negative chronotropic and inotropic effects, increased risk of bradycardia, AV block, heart failure)
  • Digoxin (increased digoxin levels, increased risk of bradycardia, AV block)
  • Amiodarone (increased risk of bradycardia, AV block, and myocardial depression)
  • Statins (e.g., Simvastatin, Lovastatin - increased statin levels due to CYP3A4 inhibition, increased risk of myopathy/rhabdomyolysis)
  • Immunosuppressants (e.g., Cyclosporine, Tacrolimus, Sirolimus - increased immunosuppressant levels due to CYP3A4 inhibition)
  • Alpha-blockers (e.g., Prazosin, Doxazosin - additive hypotensive effects)
  • Fentanyl (increased fentanyl levels, increased risk of respiratory depression)
  • Midazolam, Triazolam (increased benzodiazepine levels, prolonged sedation)
  • Grapefruit juice (increased diltiazem levels)
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Moderate Interactions

  • Other antihypertensives (additive hypotensive effects)
  • Cimetidine (increased diltiazem levels)
  • Rifampin (decreased diltiazem levels)
  • Carbamazepine (increased carbamazepine levels)
  • Phenytoin (increased phenytoin levels)
  • Theophylline (increased theophylline levels)
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Minor Interactions

  • NSAIDs (may attenuate antihypertensive effect)

Monitoring

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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, especially with AV nodal blocking effects.

Timing: Prior to initiation

Electrocardiogram (ECG)

Rationale: To assess baseline cardiac rhythm and PR interval, especially important for patients with pre-existing conduction abnormalities or those at risk for AV block.

Timing: Prior to initiation

Liver Function Tests (LFTs)

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

Timing: Prior to initiation

Renal Function (SCr, BUN)

Rationale: To assess baseline kidney function, though renal elimination is minor, severe impairment may alter drug clearance.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

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

Target: Individualized, typically <130/80 mmHg for hypertension.

Action Threshold: Hypotension (e.g., systolic <90 mmHg or symptomatic), or inadequate BP control.

Heart Rate (HR)

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

Target: Typically 50-90 bpm (unless specific rate control target for AFib).

Action Threshold: Bradycardia (<50 bpm or symptomatic), or inadequate rate control for AFib.

Electrocardiogram (ECG)

Frequency: Periodically, especially with dose changes, symptoms of conduction abnormalities, or concomitant use of other AV nodal blocking agents.

Target: Normal sinus rhythm, PR interval <0.20 seconds.

Action Threshold: Significant PR prolongation, AV block (2nd or 3rd degree), or other arrhythmias.

Peripheral Edema

Frequency: Regularly, during clinical visits.

Target: Absence of significant edema.

Action Threshold: Development of new or worsening peripheral edema.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Headache
  • Peripheral edema (swelling of ankles/feet)
  • Shortness of breath
  • Chest pain (worsening or new onset)
  • Bradycardia symptoms (e.g., fainting, severe fatigue)
  • Signs of liver dysfunction (e.g., jaundice, dark urine, persistent nausea/vomiting)

Special Patient Groups

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Pregnancy

Diltiazem is classified as Pregnancy Category C. Animal studies 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.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity observed in animal studies at high doses; human data limited.
Second Trimester: Risk of fetal bradycardia and hypotension; monitor fetal heart rate.
Third Trimester: Risk of fetal bradycardia and hypotension; monitor fetal heart rate and maternal blood pressure closely.
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Lactation

Diltiazem is excreted into breast milk. While the amount is generally small, potential for adverse effects on the infant (e.g., bradycardia, hypotension) exists. Use with caution; monitor breastfed infant for signs of bradycardia or other adverse effects. Consider alternative agents or temporary discontinuation of breastfeeding if concerns arise.

Infant Risk: Low to moderate risk; monitor for bradycardia, hypotension, sedation.
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Pediatric Use

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

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Geriatric Use

Geriatric patients may have increased sensitivity to the hypotensive and bradycardic effects of diltiazem due to age-related decreases in renal and hepatic function, and potential for polypharmacy. Initiate therapy with lower doses and titrate slowly with careful monitoring of blood pressure and heart rate.

Clinical Information

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Clinical Pearls

  • Diltiazem ER capsules should be swallowed whole and not crushed, chewed, or divided, as this can lead to rapid release of the drug and potential overdose.
  • Advise patients to avoid grapefruit and grapefruit juice due to potential for increased diltiazem levels and adverse effects.
  • Monitor for peripheral edema, a common side effect, especially in the lower extremities.
  • Caution is advised when co-administering with beta-blockers or digoxin due to additive effects on heart rate and AV conduction.
  • Patients should be advised to report any symptoms of severe dizziness, fainting, or significant swelling to their healthcare provider immediately.
  • Diltiazem is a potent CYP3A4 inhibitor; review all concomitant medications for potential interactions, especially statins (simvastatin, lovastatin) and immunosuppressants.
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Alternative Therapies

  • Other Calcium Channel Blockers (e.g., Amlodipine, Felodipine, Verapamil)
  • Beta-blockers (e.g., Metoprolol, Atenolol)
  • ACE Inhibitors (e.g., Lisinopril, Enalapril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan)
  • Diuretics (e.g., Hydrochlorothiazide, Furosemide)
  • Nitrates (for angina)
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Cost & Coverage

Average Cost: Varies widely by manufacturer and pharmacy; typically $30-$150 per 30 capsules (180mg ER)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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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 details. If you have any questions or concerns about your 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 medical attention. When reporting the incident, be prepared to provide information about the medication taken, the amount, and the time it occurred.