Diltiazem ER 180mg Capsules (24 Hr)

Manufacturer OCEANSIDE PHARMACEUTICALS 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
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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 used to treat high blood pressure (hypertension) and chest pain (angina). It works by relaxing blood vessels and slowing down your heart rate, which helps blood flow more easily and reduces the heart's workload.
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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 medication 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. Some medications must be taken with food, while others should be taken on an empty stomach. If you're unsure, consult with your pharmacist for guidance on the best way to take your medication.

Some products can be opened and mixed with a spoonful of applesauce, while others must be swallowed whole. Check with your pharmacist to see if your medication can be opened and mixed with food.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing your medication in a bathroom. Keep all medications in a secure location, out of the reach of children and pets.

When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Instead, throw them away in a responsible manner. You can also check with your pharmacist to see if there are any drug take-back programs in your area.

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. 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 daily. Do not crush, chew, or divide extended-release capsules.
  • Swallow the capsule whole. Some capsules may be opened and sprinkled on soft food (like applesauce) if swallowing is difficult, but check specific product instructions.
  • 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.
  • Monitor your blood pressure and heart rate regularly as advised by your doctor.
  • Do not stop taking this medication suddenly without consulting your doctor, as it can worsen your condition.
  • Limit alcohol consumption, as it can increase the blood pressure-lowering effect.
  • Maintain a healthy diet (e.g., low sodium, low fat), regular exercise, and manage stress to help control blood pressure and angina.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 180 mg once daily
Dose Range: 120 - 480 mg

Condition-Specific Dosing:

hypertension: Initial 180-240 mg once daily; may titrate up to 360-480 mg once daily based on response.
chronicStableAngina: Initial 120-180 mg once daily; may titrate up to 360-480 mg once daily based on response.
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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 generally required, but monitor closely.
Moderate: Use with caution; monitor for exaggerated effects. Dose reduction may be necessary.
Severe: Use with caution; significant dose reduction may be necessary. Monitor closely for adverse effects.
Dialysis: Diltiazem is not significantly removed by dialysis. Administer after dialysis if dose adjustment is needed.

Hepatic Impairment:

Mild: Use with caution; monitor for exaggerated effects.
Moderate: Use with caution; consider lower initial doses and careful titration. Monitor for adverse effects.
Severe: Contraindicated in severe hepatic impairment due to extensive hepatic metabolism. If used, significant dose reduction and close monitoring are essential.

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 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: 10-14 hours (for extended-release formulations)
FoodEffect: Food may increase bioavailability and delay Tmax, but overall effect on AUC is minimal for some ER formulations. Should be taken consistently with or without food.

Distribution:

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

Elimination:

HalfLife: 5-9 hours (parent drug, for ER formulations can be effectively longer due to sustained release)
Clearance: Approximately 1.1 L/min
ExcretionRoute: Mainly urine (60-65% as metabolites), feces (35% as metabolites)
Unchanged: <4% (in urine)
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Pharmacodynamics

OnsetOfAction: Within 30-60 minutes (for immediate release); longer for ER formulations (effects seen within hours)
PeakEffect: Approximately 2-3 hours (for immediate release); 10-14 hours (for ER formulations)
DurationOfAction: 24 hours (for 24-hour extended-release formulations)

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), characterized by:
+ 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 may be life-threatening
+ Signs of severe skin reactions include:
- Red, swollen, blistered, or peeling skin
- Other 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. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

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 fainting
  • Very slow heart rate (e.g., less than 50 beats per minute)
  • Shortness of breath, especially with swelling in the ankles or feet (signs of heart failure)
  • New or worsening chest pain
  • Yellowing of the skin or eyes (jaundice), dark urine, or persistent nausea/vomiting (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. Be sure to describe the allergic reaction and its symptoms.
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 existing health conditions, including:
+ Fluid accumulation in the lungs
+ Low blood pressure
+ Recent heart attack
If you are currently taking any of the following medications:
+ 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 with 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, 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, get up slowly from a sitting or lying down position, and be careful when climbing stairs.

Follow your doctor's instructions for monitoring 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, consult your doctor before taking 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 regularly consume grapefruit juice or eat grapefruit, 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.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypotension (very low blood pressure)
  • Profound bradycardia (extremely slow heart rate)
  • Heart block (impaired electrical conduction in the heart)
  • Cardiogenic shock
  • Asystole (cardiac arrest)
  • Dizziness
  • Confusion
  • Slurred speech

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 supportive care, IV fluids, atropine, calcium gluconate, vasopressors, or glucagon.

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 (e.g., metoprolol, propranolol) - 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, hypotension
  • Statins (e.g., simvastatin, lovastatin) - increased statin levels, increased risk of myopathy/rhabdomyolysis
  • Fentanyl (CYP3A4 substrate) - increased fentanyl levels, increased respiratory depression
  • Immunosuppressants (e.g., cyclosporine, tacrolimus, sirolimus) - increased immunosuppressant levels
  • Alpha-blockers (e.g., prazosin, doxazosin) - increased risk of hypotension
  • Clonidine - increased risk of bradycardia, AV block
  • Quinidine - increased quinidine levels, increased risk of QT prolongation
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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
  • Benzodiazepines (e.g., midazolam, triazolam) - increased benzodiazepine levels
  • Erythromycin, Clarithromycin - increased diltiazem levels
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Minor Interactions

  • NSAIDs - may reduce antihypertensive effect
  • Alcohol - may enhance hypotensive 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 risk of bradycardia.

Timing: Prior to initiation

Electrocardiogram (ECG)

Rationale: To assess baseline cardiac rhythm and PR interval, especially if pre-existing conduction abnormalities.

Timing: Prior to initiation (if clinically indicated)

Liver Function Tests (LFTs)

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

Timing: Prior to initiation

Renal Function (SCr, BUN)

Rationale: To assess baseline renal function, as metabolites are renally excreted.

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: Persistent hypotension (e.g., systolic <90 mmHg or symptomatic hypotension); inadequate BP control

Heart Rate (HR)

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

Target: Typically 50-90 bpm (unless target bradycardia for specific conditions)

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

Electrocardiogram (ECG) - PR interval

Frequency: Periodically, especially if dose increased or with concomitant AV nodal blocking agents; or if symptoms of conduction disturbance occur.

Target: Normal PR interval (<0.20 seconds)

Action Threshold: Significant PR prolongation (>0.24 seconds) or development of higher-degree AV block

Liver Function Tests (LFTs)

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

Target: Within normal limits

Action Threshold: Significant elevation of transaminases (>3x ULN)

Signs/Symptoms of Peripheral Edema

Frequency: At each visit

Target: Absence of significant edema

Action Threshold: Development of new or worsening peripheral edema

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Headache
  • Swelling in ankles/feet (edema)
  • Shortness of breath
  • Chest pain (if angina not controlled)
  • Palpitations
  • Slow heart rate (bradycardia)

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 developmental abnormalities observed in animal studies at high doses.
Second Trimester: Limited human data; use with caution.
Third Trimester: Limited human data; use with caution. Potential for effects on fetal heart rate and uterine contractility.
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Lactation

Diltiazem is excreted in human milk. The American Academy of Pediatrics considers it compatible with breastfeeding. However, monitor breastfed infants for bradycardia, hypotension, and sedation. Use with caution, especially in preterm or neonates.

Infant Risk: Low to Moderate (L3 - Moderately Safe)
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended.

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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. Lower initial doses and careful titration are recommended. Monitor closely for bradycardia, hypotension, and constipation.

Clinical Information

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Clinical Pearls

  • Extended-release diltiazem capsules should be swallowed whole; do not crush, chew, or divide, as this can lead to rapid release of the drug and potential overdose.
  • Some ER formulations allow for opening the capsule and sprinkling the contents on soft food (e.g., applesauce) for patients with swallowing difficulties; always check the specific product's instructions.
  • Diltiazem is a potent CYP3A4 inhibitor, leading to significant drug-drug interactions with many commonly used medications (e.g., statins, immunosuppressants, other cardiovascular drugs). Review patient's medication list carefully.
  • Monitor heart rate and blood pressure regularly, especially during dose titration, to avoid symptomatic bradycardia or hypotension.
  • Patients should be advised to avoid grapefruit and grapefruit juice due to the potential for increased diltiazem levels and adverse effects.
  • While generally well-tolerated, common side effects include headache, dizziness, edema, and bradycardia.
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Alternative Therapies

  • Other non-dihydropyridine calcium channel blockers (e.g., verapamil)
  • Dihydropyridine calcium channel blockers (e.g., amlodipine, nifedipine) for hypertension/angina (less effect on heart rate/conduction)
  • Beta-blockers (e.g., metoprolol, atenolol) for hypertension/angina (especially with co-existing conditions like migraine or tremor)
  • 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
  • Nitrates (e.g., isosorbide mononitrate, nitroglycerin) for angina
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Cost & Coverage

Average Cost: $20 - $100 per 30 capsules (180mg 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 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 information about the medication taken, the amount, and the time it happened.