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Diltiazem 60mg Tablets

Manufacturer TEVA PHARMACEUTICALS USA Active Ingredient Diltiazem 60 mg, 90 mg, and 120 mg Tablets(dil TYE a zem) Pronunciation dil TYE a zem
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
Antianginal, Antihypertensive, Antiarrhythmic
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Pharmacologic Class
Calcium Channel Blocker (Benzothiazepine)
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Pregnancy 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 can lower your blood pressure, reduce chest pain (angina), and help control certain irregular heartbeats. It works by blocking calcium from entering heart and blood vessel cells.
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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 take it as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. 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 better.

You can take this medication with or without food, and it may be swallowed whole, crushed, or chewed, depending on your preference or medical needs.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication, store it at room temperature, away from direct light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. Ensure that all medications are kept out of reach of children and pets to prevent accidental ingestion.

When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless specifically instructed to do so by your pharmacist or healthcare provider. Instead, check with your pharmacist for guidance on the best disposal method. Many communities have drug take-back programs that allow you to safely dispose of unwanted medications.

What to Do If You Miss a Dose

If you forget to take 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.
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Lifestyle & Tips

  • Take your medication exactly as prescribed, do not skip doses or stop taking it without consulting your doctor.
  • Do not crush, chew, or break extended-release tablets; swallow them whole.
  • Avoid grapefruit and grapefruit juice while taking this medication, as it can increase the amount of diltiazem in your body and lead to more side effects.
  • Limit alcohol consumption, as it can increase the blood pressure-lowering effect.
  • Maintain a healthy diet (low in sodium and saturated fats) and engage in regular physical activity as advised by your doctor.
  • Monitor your blood pressure and heart rate at home if advised by your doctor.
  • Report any swelling in your ankles or feet, dizziness, or slow heart rate to your doctor.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose for hypertension or angina: 30 mg four times daily (immediate-release) or 120-240 mg once daily (extended-release).
Dose Range: 30 - 540 mg

Condition-Specific Dosing:

angina_pectoris_immediate_release: 30 mg four times daily initially; titrate up to 180-360 mg/day in divided doses (e.g., 60-120 mg three to four times daily).
hypertension_extended_release: 180-240 mg once daily initially; titrate up to 360-540 mg once daily. Max 540 mg/day.
atrial_fibrillation_or_flutter_paroxysmal_supraventricular_tachycardia: Immediate-release: 30 mg four times daily initially; titrate up to 180-360 mg/day in divided doses.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (limited data for specific conditions, e.g., supraventricular tachycardia, but generally not recommended for routine use)
Adolescent: Not established (limited data, use with caution and only if benefits outweigh risks)
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: Use with caution; monitor for exaggerated effects. Consider lower initial doses and slower titration.
Moderate: Use with caution; monitor for exaggerated effects. Consider lower initial doses and slower titration.
Severe: Contraindicated in severe hepatic impairment due to extensive hepatic metabolism and potential for accumulation. Use with extreme caution or avoid.

Pharmacology

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Mechanism of Action

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-dependent L-type calcium channels. This leads to relaxation of vascular smooth muscle, resulting in peripheral and coronary vasodilation, decreased peripheral vascular resistance, and reduced blood pressure. In the heart, it decreases sinoatrial (SA) and atrioventricular (AV) nodal conduction, prolongs AV nodal refractory period, and reduces myocardial contractility and heart rate, thereby decreasing myocardial oxygen demand.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 40-65% (due to extensive first-pass metabolism)
Tmax: Immediate-release: 2-4 hours; Extended-release: 5-11 hours
FoodEffect: Food may increase bioavailability of some extended-release formulations and delay Tmax, but generally does not significantly alter overall absorption.

Distribution:

Vd: Approximately 5.3 L/kg
ProteinBinding: 70-80%
CnssPenetration: Limited (low concentrations in CSF, but can cause CNS effects)

Elimination:

HalfLife: Immediate-release: 3-4.5 hours; Extended-release: 5-10 hours (can be longer with chronic dosing)
Clearance: Approximately 0.9-1.2 L/min
ExcretionRoute: Mainly renal (60-65% as metabolites), fecal (35% as metabolites)
Unchanged: Less than 4% (renal)
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Pharmacodynamics

OnsetOfAction: Immediate-release: 30-60 minutes; Extended-release: 2-3 hours
PeakEffect: Immediate-release: 2-4 hours; Extended-release: 5-11 hours
DurationOfAction: Immediate-release: 6-8 hours; Extended-release: 12-24 hours

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

Although rare, some individuals may experience severe and potentially life-threatening side effects while taking this medication. If you encounter 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

As with any medication, you may experience side effects. While many people have no 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 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, 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or lightheadedness
  • Fainting spells
  • Very slow heart rate (e.g., less than 50 beats per minute)
  • New or worsening swelling in your hands, ankles, or feet
  • Shortness of breath, especially with exertion or lying down
  • Severe fatigue or weakness
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine or pale stools (signs of liver problems)
  • Severe skin rash or allergic reaction
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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 allergic reaction you experienced, including any symptoms that occurred.
 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 may 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 it is safe for you to take this medication with your other medications and health conditions. 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, 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 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 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. 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 hypotension (very low blood pressure)
  • Profound bradycardia (very slow heart rate)
  • AV block (heart block)
  • Asystole (cardiac arrest)
  • Cardiogenic shock
  • Metabolic acidosis
  • Hyperglycemia
  • Nausea, vomiting
  • Dizziness, confusion, stupor, 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 include gastric lavage, activated charcoal, IV fluids, atropine for bradycardia, calcium gluconate/chloride, vasopressors (e.g., dopamine, norepinephrine), glucagon, and potentially cardiac pacing.

Drug Interactions

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Contraindicated Interactions

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

  • Beta-blockers (e.g., metoprolol, propranolol): Increased risk of bradycardia, AV block, heart failure, hypotension.
  • Digoxin: Increased digoxin levels, leading to toxicity (bradycardia, arrhythmias).
  • Amiodarone: Increased risk of bradycardia, AV block, hypotension.
  • Statins (e.g., simvastatin, lovastatin): Increased statin levels, leading to increased risk of myopathy/rhabdomyolysis (diltiazem is a CYP3A4 inhibitor).
  • Fentanyl: Increased fentanyl levels (CYP3A4 inhibition), leading to increased respiratory depression.
  • Immunosuppressants (e.g., cyclosporine, tacrolimus, sirolimus): Increased immunosuppressant levels (CYP3A4 inhibition), leading to increased toxicity.
  • Alpha-blockers (e.g., prazosin, doxazosin): Increased risk of hypotension.
  • Other antihypertensives: Additive hypotensive effects.
  • CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, grapefruit juice): Increased diltiazem levels.
  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): Decreased diltiazem levels.
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Moderate Interactions

  • Benzodiazepines (e.g., midazolam, triazolam): Increased benzodiazepine levels (CYP3A4 inhibition).
  • Carbamazepine: Increased carbamazepine levels.
  • Theophylline: Increased theophylline levels.
  • Cimetidine: Increased diltiazem levels.
  • Ranitidine: Increased diltiazem levels.
  • Grapefruit juice: May increase diltiazem levels.
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Minor Interactions

  • Acetaminophen: Minor interaction, unlikely to be clinically significant.
  • NSAIDs: May slightly reduce 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 risk.

Timing: Prior to initiation

Electrocardiogram (ECG)

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

Timing: Prior to initiation, especially if history of cardiac conduction issues

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, if clinically indicated

Renal Function (SCr, BUN)

Rationale: To assess baseline kidney function, though dose adjustment is not typically required for mild-moderate impairment, caution is warranted in severe impairment.

Timing: Prior to initiation, if clinically indicated

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly (e.g., weekly initially, then monthly or every 3-6 months once stable)

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

Action Threshold: If persistently high, consider dose increase; if too low (<90/60 mmHg or symptomatic), consider dose reduction.

Heart Rate (HR)

Frequency: Regularly (e.g., weekly initially, then monthly or every 3-6 months once stable)

Target: 50-90 bpm (or individualized target)

Action Threshold: If <50 bpm or symptomatic bradycardia, consider dose reduction or discontinuation.

Electrocardiogram (ECG)

Frequency: Periodically, especially if dose increased or new symptoms of conduction disturbance (e.g., dizziness, syncope)

Target: Normal sinus rhythm, PR interval <0.20 sec

Action Threshold: New or worsening AV block (e.g., 2nd or 3rd degree), significant bradycardia.

Liver Function Tests (LFTs)

Frequency: Periodically, if long-term use or symptoms of hepatic dysfunction develop.

Target: Within normal limits

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

Peripheral Edema

Frequency: Regularly (patient self-monitoring and clinical assessment)

Target: Absence of significant edema

Action Threshold: New or worsening lower extremity edema; consider dose adjustment or diuretic.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fainting (syncope)
  • Shortness of breath
  • Swelling of ankles/feet (edema)
  • Chest pain (worsening or new onset)
  • Palpitations
  • Unusual fatigue
  • Yellowing of skin/eyes (jaundice)
  • Dark urine
  • Nausea/vomiting

Special Patient Groups

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Pregnancy

Diltiazem is 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 cardiac effects, though data are limited.
Third Trimester: Risk of fetal bradycardia, hypotension, or other cardiac effects. May affect uterine contractility. Use with caution near term.
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Lactation

Diltiazem is excreted in human milk. The American Academy of Pediatrics considers it compatible with breastfeeding, but caution is advised. Monitor the infant for bradycardia, hypotension, and sedation.

Infant Risk: L3 (Moderately Safe) - There are no controlled studies in breastfeeding women. Monitor for potential adverse effects such as bradycardia, hypotension, or sedation in the infant. Consider alternative agents if possible, especially in preterm or unstable infants.
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended due to lack of data and potential for serious adverse effects, especially in neonates and infants. Limited use in specific conditions (e.g., supraventricular tachycardia) has been reported, but only under expert supervision.

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Geriatric Use

Elderly patients may be more sensitive to the effects of diltiazem, particularly the hypotensive and bradycardic effects, due to age-related decreases in renal and hepatic function. Lower initial doses and slower titration are recommended. Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Diltiazem is available in various formulations (immediate-release, extended-release, once-daily, twice-daily). Ensure the patient understands which formulation they are taking and how to take it (e.g., swallow whole, do not crush).
  • Extended-release formulations are preferred for hypertension and chronic angina due to once-daily dosing and smoother blood pressure control.
  • Patients should be advised to avoid grapefruit and grapefruit juice due to potential for increased diltiazem levels and side effects.
  • Caution is advised when combining diltiazem with beta-blockers or digoxin due to additive effects on heart rate and AV conduction; close monitoring is essential.
  • Peripheral edema, particularly in the ankles, is a common side effect, often dose-dependent. It is due to arterial vasodilation and not fluid retention, so diuretics may not be fully effective.
  • Diltiazem can cause gingival hyperplasia with long-term use; good oral hygiene is important.
  • Withdrawal of diltiazem should be gradual, especially in patients with angina, to avoid rebound angina.
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Alternative Therapies

  • Other Calcium Channel Blockers (e.g., Amlodipine, Felodipine, Nifedipine - dihydropyridines for hypertension/angina; Verapamil - non-dihydropyridine for arrhythmias/angina/hypertension)
  • Beta-blockers (e.g., Metoprolol, Atenolol, Carvedilol, Propranolol)
  • ACE Inhibitors (e.g., Lisinopril, Enalapril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan)
  • Diuretics (e.g., Hydrochlorothiazide, Furosemide)
  • Nitrates (for angina)
  • Antiarrhythmics (e.g., Amiodarone, Sotalol, Flecainide for arrhythmias)
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Cost & Coverage

Average Cost: $10 - $100+ per 30 tablets (generic, depending on strength/formulation)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (most generic formulations)
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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 information. 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 seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.