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Diltiazem 30mg Tablets

Manufacturer TEVA PHARMACEUTICALS USA Active Ingredient Diltiazem 30 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
Calcium Channel Blocker, Antiarrhythmic, Antihypertensive
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Pharmacologic Class
Benzothiazepine 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 works by blocking calcium from entering heart and blood vessel cells.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication at the same time every day. Continue taking it as directed by your doctor or healthcare provider, even if you're feeling well. You can swallow the tablet whole, crush it, or chew it, but do not split or break it.

Storing and Disposing of Your Medication

Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. Keep all medications out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, check with your pharmacist for guidance on the best disposal method or look into local drug take-back programs.

Missing 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 dose, skip the missed dose and resume your regular 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 with or without food. Do not crush, chew, or break extended-release tablets.
  • Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness or lightheadedness.
  • Limit or avoid alcohol consumption, as it can worsen dizziness and lower blood pressure.
  • Maintain a healthy diet (low in sodium and saturated fats) and engage in regular exercise as advised by your doctor.
  • Monitor your blood pressure and heart rate regularly at home if instructed by your doctor.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking, especially grapefruit juice, as they can interact with diltiazem.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 30 mg four times daily (QID) for immediate-release tablets, or 60 mg three times daily (TID)
Dose Range: 30 - 360 mg

Condition-Specific Dosing:

angina: Initial: 30 mg QID. Titrate gradually to 180-360 mg/day in divided doses.
hypertension: Initial: 30 mg QID. Titrate gradually based on response, typically 180-360 mg/day in divided doses. (Note: ER formulations are more common for hypertension).
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for routine use; limited data for specific conditions like supraventricular tachycardia (SVT) in older children, but generally not recommended due to risk of adverse effects.
Adolescent: Not established for routine use; limited data for specific conditions.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment usually required.
Moderate: No specific adjustment usually 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 dose adjustment needed, but monitor clinical response.

Hepatic Impairment:

Mild: Use with caution; monitor for exaggerated effects.
Moderate: Significant reduction in dosage may be necessary. Start with lower doses and titrate slowly with careful monitoring of heart rate, blood pressure, and ECG.
Severe: Contraindicated or use with extreme caution; significant reduction in dosage is required. Monitor closely for adverse effects.

Pharmacology

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Mechanism of Action

Diltiazem is a benzothiazepine 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 coronary vasodilation and peripheral vasodilation, which decreases systemic vascular resistance and blood pressure. In the heart, it decreases sinoatrial (SA) and atrioventricular (AV) nodal conduction, prolongs AV nodal refractory period, and reduces myocardial contractility, leading to decreased heart rate and improved myocardial oxygen supply.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 40% (due to extensive first-pass metabolism) for immediate-release formulations.
Tmax: 2-3 hours for immediate-release tablets.
FoodEffect: Food may increase bioavailability slightly but generally does not significantly alter absorption; can be taken with or without food.

Distribution:

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

Elimination:

HalfLife: 3.5-6 hours for immediate-release tablets (may be prolonged with chronic dosing).
Clearance: Approximately 0.8 L/hr/kg.
ExcretionRoute: Primarily renal (60-65% as metabolites, 2-4% as unchanged drug) and fecal (35% as metabolites).
Unchanged: 2-4%
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Pharmacodynamics

OnsetOfAction: 30-60 minutes (oral immediate-release).
PeakEffect: 2-4 hours (oral immediate-release).
DurationOfAction: 4-8 hours (oral immediate-release).

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
+ 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. 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
  • Severe headache that is unusual
  • Yellowing of the skin or eyes (jaundice), dark urine, or persistent nausea/vomiting (signs of liver problems)
  • Chest pain that worsens or does not go away
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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.
 Certain types of abnormal heart rhythms, as this medication is not suitable for use with some types. 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 safe use of this medication with your other treatments 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 exercise caution 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 treatment and periodically while taking this medication. Discuss any concerns with your doctor.

If you have high blood pressure, 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 regularly consume grapefruit juice or eat grapefruit, 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, planning to become pregnant, or breastfeeding, inform your doctor. You 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 (very slow heart rate)
  • Second- or third-degree AV block (heart block)
  • Asystole (cardiac arrest)
  • Cardiogenic shock
  • Congestive heart failure
  • 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 gastric lavage, activated charcoal, IV fluids, atropine for bradycardia, calcium gluconate/chloride, vasopressors, and potentially glucagon or cardiac pacing.

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, and myocardial depression.
  • Digoxin: Increased digoxin levels, leading to toxicity (bradycardia, arrhythmias).
  • Amiodarone: Increased risk of bradycardia, AV block, and hypotension.
  • Statins (e.g., simvastatin, lovastatin, atorvastatin): Increased statin levels due to CYP3A4 inhibition, leading to increased risk of myopathy/rhabdomyolysis.
  • Cyclosporine, Tacrolimus, Sirolimus: Increased immunosuppressant levels, leading to toxicity.
  • Midazolam, Triazolam: Increased benzodiazepine levels, leading to prolonged sedation.
  • Fentanyl: Increased fentanyl levels, leading to respiratory depression.
  • Alpha-blockers (e.g., prazosin, doxazosin): Increased risk of hypotension.
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Moderate Interactions

  • Other antihypertensives: Additive hypotensive effects.
  • CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, grapefruit juice): Increased diltiazem levels.
  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): Decreased diltiazem levels.
  • Clonidine: Increased risk of bradycardia and AV block.
  • Theophylline: Increased theophylline levels.
  • Carbamazepine: Increased carbamazepine levels.
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Minor Interactions

  • NSAIDs: May reduce antihypertensive effect.
  • Cimetidine: May increase diltiazem levels slightly.

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and assess efficacy for hypertension/angina.

Timing: Prior to initiation.

Heart Rate (HR)

Rationale: To establish baseline and monitor for bradycardia.

Timing: Prior to initiation.

Electrocardiogram (ECG)

Rationale: To assess baseline cardiac rhythm and PR interval, especially important for patients with pre-existing conduction abnormalities.

Timing: Prior to initiation.

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 (BUN, Creatinine)

Rationale: To assess baseline renal function, though renal excretion of unchanged drug is minimal, metabolites are renally cleared.

Timing: Prior to initiation.

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Routine Monitoring

Blood Pressure (BP)

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

Target: Individualized based on condition (e.g., <130/80 mmHg for hypertension).

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

Heart Rate (HR)

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

Target: Typically 50-90 bpm (unless target for rate control is lower).

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

Electrocardiogram (ECG)

Frequency: Periodically, especially with dose increases or in patients with pre-existing conduction abnormalities or concomitant use of other AV nodal blocking agents.

Target: Normal sinus rhythm, PR interval <0.20 seconds.

Action Threshold: Significant PR prolongation, AV block (second or third degree), or new arrhythmias.

Signs/Symptoms of Peripheral Edema

Frequency: Regularly.

Target: Absence of significant edema.

Action Threshold: Development of new or worsening peripheral edema.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Headache
  • Nausea
  • Constipation
  • Peripheral edema (swelling of ankles/feet)
  • Shortness of breath
  • Chest pain (worsening angina)
  • Palpitations
  • Fainting spells

Special Patient Groups

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Pregnancy

Category C. Diltiazem 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, but there are no adequate and well-controlled studies in pregnant women.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity observed in animal studies 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, hypotension, or other cardiovascular effects; may inhibit labor. Use with caution 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 bradycardia, hypotension, and sedation.

Infant Risk: L3 (Moderate risk) - Monitor infant for adverse effects such as bradycardia, hypotension, and sedation. Consider alternative if possible, especially in preterm or neonates.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients for most indications. Use is generally not recommended outside of specific, severe conditions (e.g., SVT) where benefits outweigh risks, and under close specialist supervision. Dosing is highly individualized and based on limited data.

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Geriatric Use

Elderly patients may be more sensitive to the effects of diltiazem, particularly regarding blood pressure lowering and heart rate effects. Start with lower doses and titrate slowly, monitoring closely for adverse effects such as bradycardia, hypotension, and peripheral edema. Renal and hepatic function may be impaired, necessitating dose adjustments.

Clinical Information

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Clinical Pearls

  • Diltiazem immediate-release (IR) 30mg tablets are typically used for initial titration or for patients requiring frequent dosing intervals. Extended-release (ER) formulations are generally preferred for once-daily or twice-daily dosing for hypertension and chronic stable angina.
  • Patients should be educated on the difference between IR and ER formulations and instructed not to crush or chew ER tablets.
  • Diltiazem is a potent inhibitor of CYP3A4, leading to numerous significant drug interactions. Always review concomitant medications.
  • Monitor heart rate and blood pressure closely, especially during initiation and dose adjustments, and when co-administered with other negative chronotropic or inotropic agents (e.g., beta-blockers, digoxin).
  • Peripheral edema is a common side effect, often dose-dependent, and may be managed with dose reduction or addition of a diuretic.
  • Constipation is a common gastrointestinal side effect; advise patients on adequate fluid intake and fiber.
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Alternative Therapies

  • Other Calcium Channel Blockers (e.g., Verapamil, Amlodipine, Felodipine, Nifedipine)
  • 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)
  • Other Antiarrhythmics (e.g., Amiodarone, Sotalol, Digoxin for rate control)
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets (30mg IR generic)
Generic Available: Yes
Insurance Coverage: Tier 1 (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 is a good idea to check with your pharmacist. If you have any questions or concerns about this medication, do not 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 medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.