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Diltiazem ER 90mg 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
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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 is a medication that helps relax blood vessels and slow down your heart rate. This makes it easier for your heart to pump blood, which can lower your blood pressure and reduce chest pain (angina). It's often used to treat high blood pressure, chest pain, and certain heart rhythm problems.
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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, away from direct light.
Keep it in a dry place, avoiding storage in a 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 disposal method, and consider participating in local drug take-back programs.

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

  • Take the medication exactly as prescribed, usually once or twice daily. Do not chew, crush, or divide extended-release capsules.
  • Swallow the capsule whole.
  • Avoid grapefruit and grapefruit juice while taking this medication, as it can increase the levels of diltiazem in your body.
  • Maintain a healthy lifestyle, including a balanced diet (low in sodium and saturated fats), regular exercise (as advised by your doctor), and stress management.
  • Limit alcohol intake, as it can also lower blood pressure and cause dizziness.
  • Do not stop taking this medication suddenly without consulting your doctor, as it can worsen your condition.
  • Be aware of potential dizziness, especially when standing up quickly. Change positions slowly.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 120-240 mg once daily (for ER formulations), adjusted based on response. For 90mg ER 12hr, typical starting is 90-120mg twice daily.
Dose Range: 90 - 540 mg

Condition-Specific Dosing:

hypertension: 180-360 mg once daily (for once-daily ER), or 90-120 mg twice daily (for 12-hr ER)
chronicstableangina: 180-360 mg once daily (for once-daily ER), or 90-120 mg twice daily (for 12-hr ER)
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (limited data, generally not recommended for routine use)
Adolescent: Not established (limited data, generally not recommended for routine use)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment generally required.
Moderate: No specific adjustment generally required, monitor for exaggerated effects.
Severe: Use with caution, monitor closely for exaggerated effects. Consider lower starting doses.
Dialysis: Not significantly removed by dialysis. Use with caution, monitor closely.

Hepatic Impairment:

Mild: Use with caution, monitor for exaggerated effects.
Moderate: Use with caution, consider lower starting doses and careful titration due to prolonged half-life.
Severe: Contraindicated or use with extreme caution and significant dose reduction 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. This leads to relaxation of vascular smooth muscle, resulting in peripheral vasodilation and reduction in systemic vascular resistance, thereby lowering blood pressure. In the heart, it decreases myocardial contractility, slows sinoatrial (SA) node firing, and prolongs atrioventricular (AV) node conduction, leading to a reduction in heart rate and myocardial oxygen demand.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 40-65% (due to first-pass metabolism), varies with formulation.
Tmax: 3-6 hours (for ER formulations)
FoodEffect: Food may increase bioavailability and delay Tmax for some ER formulations, but generally can be taken with or without food.

Distribution:

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

Elimination:

HalfLife: 5-8 hours (for ER formulations, can be up to 10 hours)
Clearance: Approximately 1.1 L/min
ExcretionRoute: Mainly urine (60-65%), feces (35%)
Unchanged: Less than 4% (in urine)
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Pharmacodynamics

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

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. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

 Headache
* Feeling dizzy, tired, or weak

Reporting 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 fainting spells
  • Very slow heart rate (e.g., less than 50 beats per minute)
  • New or worsening swelling in your ankles, feet, or legs
  • Shortness of breath, especially with exertion or lying down
  • Unusual fatigue or weakness
  • Yellowing of skin or eyes (jaundice)
  • Dark urine or persistent nausea/vomiting (signs of liver problems)
  • Severe headache that is unusual or persistent
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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 these conditions. 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 disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. Your doctor and pharmacist need this information to ensure safe use and potential interactions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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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 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 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. You and your doctor will need 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 hypotension (very low blood pressure)
  • Profound bradycardia (extremely slow heart rate)
  • Second- or third-degree AV block
  • Asystole (cardiac arrest)
  • Cardiogenic shock
  • Heart failure
  • Dizziness
  • Confusion
  • Lethargy
  • Coma

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, atropine, calcium gluconate, vasopressors, glucagon, or cardiac pacing depending on severity.

Drug Interactions

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Contraindicated Interactions

  • Ivabradine (risk of severe bradycardia)
  • Dantrolene (IV) (risk of cardiovascular collapse)
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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)
  • Amiodarone (risk of severe bradycardia, AV block, hypotension)
  • Statins (e.g., simvastatin, lovastatin - increased statin levels due to CYP3A4 inhibition, risk of myopathy/rhabdomyolysis)
  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir - increased diltiazem levels)
  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin - decreased diltiazem levels)
  • Fentanyl (risk of severe hypotension, bradycardia)
  • Midazolam, Triazolam (increased benzodiazepine levels)
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Moderate Interactions

  • Alpha-blockers (e.g., prazosin, doxazosin - additive hypotensive effects)
  • Other antihypertensives (additive hypotensive effects)
  • Grapefruit juice (may increase diltiazem levels)
  • Theophylline (increased theophylline levels)
  • Cyclosporine, Tacrolimus, Sirolimus (increased immunosuppressant levels)
  • Carbamazepine (increased carbamazepine levels)
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Minor Interactions

  • Cimetidine (may increase diltiazem levels slightly)
  • Ranitidine (no significant interaction)

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing.

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 for pre-existing conduction abnormalities (e.g., AV block) that may be exacerbated.

Timing: Prior to initiation, especially in patients with cardiac history.

Liver Function Tests (LFTs)

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

Timing: Prior to initiation.

Renal Function (SCr, BUN)

Rationale: To assess baseline kidney function, though renal elimination is minor, severe impairment may affect overall health.

Timing: Prior to initiation.

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially during dose titration and periodically thereafter (e.g., weekly during titration, then monthly/quarterly).

Target: Individualized based on target BP (e.g., <130/80 mmHg for most adults).

Action Threshold: If BP remains uncontrolled or drops excessively (e.g., symptomatic hypotension).

Heart Rate (HR)

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

Target: Typically >50-60 bpm (unless otherwise clinically indicated).

Action Threshold: If HR <50 bpm or symptomatic bradycardia occurs.

Signs/Symptoms of Heart Failure

Frequency: Periodically, especially in patients with pre-existing left ventricular dysfunction.

Target: Absence of new or worsening symptoms.

Action Threshold: New or worsening dyspnea, edema, fatigue.

Liver Function Tests (LFTs)

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

Target: Within normal limits.

Action Threshold: Significant elevation of liver enzymes.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Headache
  • Peripheral edema (swelling of ankles/feet)
  • Bradycardia (slow heart rate)
  • Palpitations
  • Shortness of breath
  • Chest pain (worsening angina)
  • Signs of heart failure (e.g., dyspnea, weight gain, edema)
  • 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. 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.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity observed in animal studies (e.g., skeletal abnormalities, embryolethality at high doses). Human data are limited.
Second Trimester: Risk of fetal bradycardia or other cardiovascular effects, though data are limited.
Third Trimester: Risk of fetal bradycardia or other cardiovascular effects, though data are limited. May inhibit labor.
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Lactation

Diltiazem is excreted in human 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. Potential for bradycardia, hypotension, or sedation in the infant, especially in neonates or premature infants. Monitor infant for adverse effects.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients. Use is generally not recommended for routine management of hypertension or angina in children. Limited data exist for specific conditions like supraventricular tachycardia, but typically under specialist supervision.

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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 hepatic and renal function. Lower starting doses and careful titration are recommended. Monitor closely for adverse effects such as dizziness, falls, and excessive bradycardia.

Clinical Information

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Clinical Pearls

  • Diltiazem ER capsules should be swallowed whole; do not crush, chew, or divide, as this can lead to rapid release of the drug and potential toxicity.
  • Patients should be advised to avoid grapefruit juice due to its potential to increase diltiazem levels.
  • Monitor heart rate and blood pressure closely, especially during initiation and dose titration, due to the risk of bradycardia and hypotension.
  • Caution is advised when co-administering with beta-blockers or digoxin due to additive negative chronotropic and dromotropic effects.
  • Peripheral edema is a common side effect, often dose-dependent, and may be managed by dose reduction or addition of a diuretic.
  • Diltiazem is a substrate and inhibitor of CYP3A4, leading to numerous potential drug interactions with other CYP3A4 substrates (e.g., statins, immunosuppressants) or inhibitors/inducers.
  • Patients with pre-existing second- or third-degree AV block or sick sinus syndrome (without a pacemaker) should not use diltiazem.
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Alternative Therapies

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

Average Cost: $15 - $50 per 30 capsules (90mg ER)
Generic Available: Yes
Insurance Coverage: Tier 1 or 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 it's a good idea to check with your pharmacist. 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 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.