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Diltiazem Hcl ER 180mg Tablets

Manufacturer OCEANSIDE Active Ingredient Diltiazem Long-Acting Tablets(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
Calcium Channel Blocker, Antiarrhythmic, Antihypertensive
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Pharmacologic Class
Non-dihydropyridine Calcium Channel Blocker
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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 can lower your blood pressure, reduce chest pain (angina), and help control certain irregular heart rhythms. It's a long-acting tablet, so you usually 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. Avoid storing it in a bathroom.
Keep your medication in a safe and secure location, out of the reach of children and pets.
 Dispose of unused or expired medication responsibly. Do not flush it down the toilet or pour it 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, 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. Avoid taking two doses at the same time or taking extra doses to make up for a missed one.
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Lifestyle & Tips

  • Take the medication exactly as prescribed, usually once daily. Do not crush, chew, or divide extended-release tablets.
  • Do not stop taking the medication suddenly without consulting your doctor, as this can worsen your condition.
  • Avoid grapefruit and grapefruit juice while taking this medication, as it can increase the drug's levels in your body.
  • Maintain a healthy lifestyle, including a balanced diet (low in sodium and saturated fats), regular exercise, and stress management, to support blood pressure control.
  • Limit alcohol consumption, as it can also lower blood pressure and increase dizziness.
  • Monitor your blood pressure and heart rate regularly at home if advised by your doctor.
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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; titrate to maximum 540 mg once daily based on response.
Chronic Stable Angina: Initial 120-180 mg once daily; titrate to maximum 540 mg once daily based on response.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for routine use in hypertension or angina; limited data for specific cardiac conditions.
Adolescent: Not established for routine use in hypertension or angina; limited data for specific cardiac conditions.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment generally required, monitor for exaggerated effects.
Moderate: No specific dose adjustment generally required, 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 closely.

Hepatic Impairment:

Mild: Use with caution, monitor for exaggerated effects. Consider lower initial doses.
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. If used, extreme caution and significant dose reduction required.

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 reduced systemic vascular resistance, thereby lowering blood pressure. In the heart, it decreases myocardial contractility, slows sinoatrial (SA) node automaticity, and prolongs atrioventricular (AV) node conduction, leading to a reduction in heart rate and myocardial oxygen demand.
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Pharmacokinetics

Absorption:

Bioavailability: 35-90% (highly variable due to extensive first-pass metabolism)
Tmax: 10-14 hours (for extended-release formulations)
FoodEffect: Food may increase bioavailability and delay Tmax for some ER formulations, but generally can be taken with or without food.

Distribution:

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

Elimination:

HalfLife: 5-10 hours (for extended-release formulations)
Clearance: Not available (highly variable due to first-pass)
ExcretionRoute: Renal (60-65% as metabolites), Fecal (35% as metabolites)
Unchanged: < 4% (renal)
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Pharmacodynamics

OnsetOfAction: Within 30-60 minutes (for immediate release); longer for ER formulations
PeakEffect: 6-11 hours (for extended-release formulations)
DurationOfAction: 24 hours (for extended-release formulations)

Safety & Warnings

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Side Effects

Important Side Effects to Report to Your Doctor Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, seek medical attention 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
Abnormal heartbeat that is new or worsening
 Worsening heart failure, characterized by:
+ Shortness of breath
+ Significant weight gain
+ Swelling in the arms or legs (if you have a history of heart failure, discuss this with your doctor)
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 experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

 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.
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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, especially with exertion or lying down.
  • Very slow heart rate (e.g., less than 50 beats per minute) or irregular heartbeat.
  • New or worsening chest pain.
  • Signs of liver problems: yellowing of skin or eyes (jaundice), dark urine, persistent nausea/vomiting, severe stomach pain.
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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 conditions to ensure safe use of this medication:

Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
 Certain types of abnormal heart rhythms, as this medication may not be suitable for use in these conditions. If you are unsure, consult your doctor or pharmacist for guidance.
Presence of any of the following health issues: fluid accumulation in the lungs, low blood pressure, or a recent heart attack.
 Current use of 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 existing health problems. Your doctor and pharmacist need this information to assess potential interactions and ensure safe use of this medication. 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 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 this medication and during treatment. Discuss this 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.

It is crucial to inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. 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 bradycardia (very slow heart rate)
  • Profound hypotension (very low blood pressure)
  • Heart block (impaired electrical conduction in the heart)
  • Asystole (cardiac arrest)
  • Cardiogenic shock
  • Congestive heart failure
  • 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 involve gastric lavage, activated charcoal, IV fluids, atropine, calcium gluconate, vasopressors, and/or cardiac pacing depending on the severity and symptoms.

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, and heart failure.
  • Digoxin: Increased digoxin serum concentrations (monitor levels).
  • Statins (e.g., simvastatin, lovastatin, atorvastatin): Increased statin exposure due to CYP3A4 inhibition (reduce statin dose).
  • Amiodarone: Increased risk of bradycardia, sinus arrest, AV block.
  • Fentanyl: Increased fentanyl exposure (CYP3A4 inhibition).
  • Midazolam, Triazolam: Increased benzodiazepine exposure (CYP3A4 inhibition).
  • Cyclosporine, Tacrolimus, Sirolimus: Increased immunosuppressant levels (CYP3A4 inhibition, monitor levels).
  • Quinidine, Procainamide: Increased risk of QT prolongation and arrhythmias.
  • Phenytoin, Carbamazepine: Increased levels of these anticonvulsants.
  • Rifampin, Phenobarbital: Decreased diltiazem levels (CYP3A4 induction).
  • Cimetidine: Increased diltiazem levels (CYP3A4 inhibition).
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Moderate Interactions

  • Alpha-blockers (e.g., prazosin, doxazosin): Additive hypotensive effects.
  • Nitrates: Additive hypotensive effects.
  • Clonidine: Additive bradycardia and AV block.
  • Grapefruit juice: May increase diltiazem levels (CYP3A4 inhibition).
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Minor Interactions

  • NSAIDs: May reduce the antihypertensive effect of diltiazem.

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing for hypertension.

Timing: Prior to initiation

Heart Rate (HR)

Rationale: To establish baseline and assess for bradycardia, especially in patients with pre-existing bradycardia or on other rate-lowering drugs.

Timing: Prior to initiation

Electrocardiogram (ECG)

Rationale: To assess for pre-existing conduction abnormalities (e.g., AV block) and establish baseline PR interval.

Timing: Prior to initiation

Liver Function Tests (LFTs)

Rationale: Diltiazem is extensively metabolized by the liver; to assess baseline hepatic function.

Timing: Prior to initiation

Renal Function (SCr, BUN)

Rationale: To assess baseline renal function, although dose adjustment is less critical than for hepatic impairment.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

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

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

Action Threshold: Persistent hypotension (e.g., SBP <90 mmHg) or inadequate BP control.

Heart Rate (HR)

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

Target: 50-90 bpm (or individualized target)

Action Threshold: Persistent bradycardia (<50 bpm) or symptomatic bradycardia.

Electrocardiogram (ECG) - PR interval

Frequency: Periodically, especially with dose increases or concomitant use of other AV nodal blocking agents.

Target: Normal PR interval (<0.20 seconds)

Action Threshold: Significant PR prolongation or development of higher-degree AV block.

Signs/Symptoms of Heart Failure

Frequency: Regularly

Target: Absence of new or worsening symptoms

Action Threshold: Development of dyspnea, peripheral edema, weight gain, or other signs of heart failure.

Liver Function Tests (LFTs)

Frequency: Periodically, especially if symptoms of hepatic dysfunction develop.

Target: Within normal limits

Action Threshold: Significant elevation of liver enzymes (e.g., >3x ULN).

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Peripheral edema (swelling of ankles/feet)
  • Shortness of breath
  • Chest pain (angina, monitor for improvement or worsening)
  • Palpitations
  • Headache
  • Nausea

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: Limited human data. Use only if clearly needed.
Third Trimester: Limited human data. Potential for effects on fetal heart rate and uterine contractility. Use with caution.
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Lactation

Diltiazem is excreted in human breast milk. The American Academy of Pediatrics considers diltiazem to be compatible with breastfeeding, but caution is advised. Monitor the infant for potential adverse effects such as bradycardia, hypotension, or sedation.

Infant Risk: Low to moderate risk. Monitor for bradycardia, hypotension, and lethargy in the infant. Consider alternative agents if possible, especially in preterm or unstable infants.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients for hypertension or angina. Use is generally not recommended outside of specific, limited indications (e.g., certain arrhythmias) where benefits outweigh risks, and under specialist supervision.

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Geriatric Use

Elderly patients may have increased sensitivity to the effects of diltiazem due to age-related decreases in hepatic and renal function, and potential for polypharmacy. Start with lower doses and titrate slowly, monitoring closely for adverse effects such as bradycardia, hypotension, and constipation.

Clinical Information

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Clinical Pearls

  • Diltiazem ER formulations are not interchangeable; different brands may have different pharmacokinetic profiles and should not be substituted without physician approval.
  • Instruct patients not to crush, chew, or divide extended-release tablets, as this can lead to rapid release of the drug and potential overdose.
  • Monitor for signs of heart failure, especially in patients with pre-existing left ventricular dysfunction.
  • Be aware of significant drug interactions, particularly with CYP3A4 substrates/inhibitors and other agents that affect heart rate or AV conduction.
  • Patients may notice a 'ghost tablet' in their stool, which is the inert matrix of the extended-release tablet and is normal.
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Alternative Therapies

  • Other Calcium Channel Blockers (e.g., Amlodipine, Verapamil, Felodipine)
  • 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)
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Cost & Coverage

Average Cost: $20 - $100+ per 30 tablets (generic 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 is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 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 emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.