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Diltiazem SR 120mg 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.
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Drug Class
Antihypertensive, Antianginal, Antiarrhythmic (Class IV)
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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 1982
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Diltiazem SR is a medication that helps relax blood vessels and slow down your heart rate. This can lower your blood pressure, reduce chest pain (angina), and help control an irregular heartbeat. The 'SR' means 'sustained release,' so the capsule releases the medicine slowly over 12 hours, allowing you to take it once a day.
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How to Use This Medicine

Taking Your Medication Correctly

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

Take your medication as directed by your doctor, swallowing the tablets whole without chewing, breaking, or crushing them.
 Establish a routine by taking your medication at the same time every day.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling well.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication:

 Store it at room temperature, protected from light and moisture.
Keep it in a dry place, avoiding storage in bathrooms.
 Keep 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 or healthcare provider. Check with your pharmacist for guidance on the best disposal method, as there may be drug take-back programs available in your area.

What to Do If You Miss a Dose

If you miss a dose of your medication:

 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.
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Lifestyle & Tips

  • Follow a heart-healthy diet (low in sodium, saturated fats, and cholesterol).
  • Engage in regular physical activity as advised by your doctor.
  • Maintain a healthy weight.
  • Limit alcohol intake.
  • Avoid smoking.
  • Manage stress effectively.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 120 mg once daily (SR)
Dose Range: 120 - 480 mg

Condition-Specific Dosing:

hypertension: Initial 120-240 mg once daily; titrate up to 480 mg/day if needed.
chronicstableangina: Initial 120-240 mg once daily; titrate up to 480 mg/day if needed.
atrialfibrillation_ratecontrol: Initial 120-240 mg once daily; titrate based on heart rate response, up to 480 mg/day.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for hypertension/angina. Limited data for arrhythmias in specific conditions.
Adolescent: Not established for hypertension/angina. Limited data for arrhythmias in specific conditions.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment generally required, but monitor closely.
Moderate: Use with caution; consider lower initial doses and slower titration.
Severe: Use with caution; consider lower initial doses and slower titration. Monitor for exaggerated effects.
Dialysis: Diltiazem is not significantly removed by hemodialysis. Administer after dialysis if dose adjustment is needed.

Hepatic Impairment:

Mild: No specific adjustment generally required, but monitor closely.
Moderate: Use with caution; consider lower initial doses and slower titration due to extensive hepatic metabolism.
Severe: Contraindicated or use with extreme caution; significant dose reduction may be necessary. Monitor for exaggerated effects.
Confidence: Medium

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 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 afterload. In the heart, it decreases myocardial contractility, slows SA nodal automaticity, and prolongs AV nodal conduction, leading to a reduction in heart rate and myocardial oxygen demand.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 40-65% (due to extensive first-pass metabolism)
Tmax: 6-11 hours (for SR formulations)
FoodEffect: Food can slightly increase bioavailability and delay Tmax, but generally not clinically significant for SR formulations.

Distribution:

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

Elimination:

HalfLife: 5-9 hours (for SR formulations, can be longer due to sustained release)
Clearance: Approximately 1.5-2.5 L/min
ExcretionRoute: Mainly urine (metabolites, ~60-65%), feces (~35%)
Unchanged: <5%
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Pharmacodynamics

OnsetOfAction: 2-3 hours (oral SR)
PeakEffect: 6-11 hours (oral SR)
DurationOfAction: 12-24 hours (for SR formulations)
Confidence: Medium

Safety & Warnings

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Side Effects

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), 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:

 Headache
* Feeling dizzy, tired, or weak

Reporting Side Effects

If you have questions or concerns about side effects, don't hesitate to reach out 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or lightheadedness, especially when standing up.
  • Fainting spells.
  • Unusual or excessive swelling in your ankles, feet, or legs.
  • Severe fatigue or weakness.
  • Shortness of breath, especially with exertion or lying down.
  • Worsening chest pain or new onset of chest pain.
  • Very slow heart rate (feeling faint or dizzy).
  • Yellowing of the skin or eyes (jaundice), dark urine, or persistent nausea/vomiting (signs of liver problems).
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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. Be sure to describe the allergic reaction and its symptoms.
 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, such as:
+ Fluid accumulation in the lungs
+ Low blood pressure
+ Recent heart attack
 Current medications, including:
+ Ivabradine
+ Rifampin
* All other prescription and over-the-counter medications, natural products, and vitamins you are taking, as this is not an exhaustive list of potential interactions.

To ensure safe treatment, 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.
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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, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be cautious 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 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 supplements.

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.
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Overdose Information

Overdose Symptoms:

  • Severe bradycardia (very slow heart rate)
  • Profound hypotension (very low blood pressure)
  • Heart block (especially second or third-degree AV 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. Treatment may include gastric lavage, activated charcoal, IV fluids, atropine, calcium gluconate, vasopressors, and/or glucagon, depending on severity and symptoms.

Drug Interactions

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Contraindicated Interactions

  • Ivabradine (risk of severe bradycardia)
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Major Interactions

  • Beta-blockers (additive negative chronotropic and inotropic effects, risk of severe bradycardia, heart block, heart failure)
  • Digoxin (increased digoxin levels, risk of toxicity)
  • Amiodarone (risk of severe bradycardia, heart block, hypotension)
  • Statins (e.g., simvastatin, lovastatin; increased statin levels due to CYP3A4 inhibition, risk of myopathy/rhabdomyolysis)
  • Immunosuppressants (e.g., cyclosporine, tacrolimus, sirolimus; increased immunosuppressant levels)
  • Benzodiazepines (e.g., midazolam, triazolam; increased benzodiazepine levels)
  • Fentanyl (increased fentanyl levels, risk of respiratory depression)
  • Alpha-blockers (e.g., prazosin, doxazosin; increased risk of hypotension)
  • Dabigatran (increased dabigatran levels)
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Moderate Interactions

  • Grapefruit juice (increased diltiazem levels)
  • 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 reduce antihypertensive effect)

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and assess efficacy.

Timing: Prior to initiation

Heart Rate (HR)

Rationale: To establish baseline and assess risk of bradycardia.

Timing: Prior to initiation

Electrocardiogram (ECG)

Rationale: To assess baseline cardiac rhythm and conduction, especially PR interval.

Timing: Prior to initiation

Liver Function Tests (LFTs)

Rationale: Diltiazem is hepatically metabolized; to assess baseline hepatic function.

Timing: Prior to initiation

Renal Function (BUN, Creatinine)

Rationale: To assess baseline renal function, though primarily hepatically cleared.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly (e.g., daily at home, at each clinic visit)

Target: <130/80 mmHg (or individualized target)

Action Threshold: Hypotension (e.g., SBP <90 mmHg or symptomatic), or uncontrolled hypertension

Heart Rate (HR)

Frequency: Regularly (e.g., daily at home, at each clinic visit)

Target: 50-90 bpm (or individualized target for rate control)

Action Threshold: Bradycardia (<50 bpm or symptomatic), or tachycardia (uncontrolled rate)

Electrocardiogram (ECG)

Frequency: Periodically (e.g., annually or as clinically indicated), especially with dose changes or concomitant drugs affecting conduction

Target: Normal rhythm, PR interval <0.20 sec

Action Threshold: Significant bradycardia, AV block (2nd or 3rd degree), or other conduction abnormalities

Liver Function Tests (LFTs)

Frequency: Periodically (e.g., every 6-12 months or as clinically indicated), especially with long-term use or high doses

Target: Within normal limits

Action Threshold: Significant elevation (e.g., >3x ULN) of AST/ALT

Peripheral Edema

Frequency: At each clinic visit

Target: None to mild

Action Threshold: Significant or worsening edema

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fainting (syncope)
  • Fatigue
  • Shortness of breath
  • Swelling of ankles/feet (peripheral edema)
  • Chest pain (worsening or new onset)
  • Palpitations
  • Nausea
  • Headache

Special Patient Groups

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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:

First Trimester: Potential for teratogenicity observed in animal studies at high doses; human data are limited.
Second Trimester: Limited human data; generally avoided unless clearly needed.
Third Trimester: Potential for fetal bradycardia and hypotension; may inhibit labor. Generally avoided near term.
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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 signs of bradycardia, hypotension, or sedation.

Infant Risk: Low to moderate risk. Monitor for bradycardia, hypotension, and lethargy. Consider alternative if infant is premature or has cardiac issues.
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Pediatric Use

Safety and efficacy have not been established for most pediatric indications (e.g., hypertension, angina). Use in children is generally limited to specific cardiac arrhythmias under specialist supervision, and dosing is highly individualized.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Diltiazem SR capsules should be swallowed whole; do not crush, chew, or divide, as this will disrupt the sustained-release mechanism and could lead to rapid absorption and increased side effects.
  • Monitor heart rate closely, especially when initiating therapy or increasing dose, and when co-administered with other drugs that slow heart rate (e.g., beta-blockers, digoxin).
  • Peripheral edema is a common side effect, often dose-dependent. It is typically mild and can be managed with diuretics if bothersome.
  • Patients should be advised to avoid grapefruit juice as it can increase diltiazem levels.
  • Diltiazem is a substrate and inhibitor of CYP3A4, leading to numerous potential drug interactions. Always review concomitant medications.
  • While effective for rate control in atrial fibrillation, diltiazem is not indicated for rhythm control or in patients with Wolff-Parkinson-White (WPW) syndrome and atrial fibrillation due to risk of accelerated ventricular response.
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Alternative Therapies

  • Other calcium channel blockers (e.g., amlodipine, felodipine for hypertension/angina; verapamil for rate control/angina)
  • Beta-blockers (e.g., metoprolol, carvedilol for hypertension, angina, rate control)
  • ACE inhibitors (e.g., lisinopril, enalapril for hypertension)
  • Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan for hypertension)
  • Diuretics (e.g., hydrochlorothiazide, furosemide for hypertension, edema)
  • Nitrates (e.g., nitroglycerin, isosorbide for angina)
  • Ranolazine (for chronic angina)
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Cost & Coverage

Average Cost: Price range varies widely by pharmacy and formulation per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 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.