Diltiazem 90mg 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
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 used to treat high blood pressure, chest pain (angina), and certain types of irregular heartbeats. It works by relaxing blood vessels and slowing down your heart rate, which helps your heart pump blood more easily.
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How to Use This Medicine

Taking Your Medication

To get the most benefit from your medication, follow these steps:

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
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 to feel better.

You can take your medication by swallowing it whole, crushing it, or chewing it.

Storing and Disposing of Your Medication

To keep your medication safe and effective:

Store it at room temperature, away from light and moisture.
Keep it in a dry place, such as a closet or drawer.
Do not store your medication in a bathroom.
Keep all medications out of the 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 disposing of medications, and consider participating in a drug take-back program in your area.

What to Do If You Miss a Dose

If you miss a dose of your medication:

Take it as soon as you remember.
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 a missed one.
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Lifestyle & Tips

  • Take medication exactly as prescribed, do not stop abruptly without consulting your doctor.
  • Do not crush, chew, or break extended-release tablets/capsules (if applicable for other strengths/forms). Immediate-release tablets can be split if scored.
  • Avoid grapefruit and grapefruit juice, 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 sodium, low fat) and engage in regular exercise as advised by your doctor.
  • Monitor your blood pressure and heart rate at home if instructed by your doctor.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: For Angina: 30 mg four times daily (QID). For Hypertension: 30 mg four times daily (QID).
Dose Range: 30 - 360 mg

Condition-Specific Dosing:

angina: Initial: 30 mg QID. Titrate gradually to 180-360 mg/day in divided doses (e.g., 90 mg QID).
hypertension: Initial: 30 mg QID. Titrate gradually to 180-360 mg/day in divided doses (e.g., 90 mg QID).
atrialFibrillation/Flutter (rate control): Initial: 30 mg QID. Titrate based on heart rate response, typically 120-360 mg/day in divided doses.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for routine use in hypertension or angina. Limited use for supraventricular tachycardia (SVT) in specific cases, dose highly individualized and typically IV.
Adolescent: Not established for routine use in hypertension or angina. Limited use for SVT in specific cases, dose highly individualized.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: Use with caution. Consider lower initial doses and careful titration.
Moderate: Use with caution. Consider lower initial doses and careful titration. Monitor for signs of toxicity due to reduced metabolism.
Severe: Contraindicated or use with extreme caution. Significant dose reduction may be necessary. Monitor closely for adverse effects.

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-gated L-type calcium channels. This leads to relaxation of vascular smooth muscle, resulting in peripheral and coronary vasodilation, which reduces 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 a decrease in heart rate and myocardial oxygen demand.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 40% (due to extensive first-pass metabolism)
Tmax: 2-3 hours (for immediate-release tablets)
FoodEffect: Food may slightly increase bioavailability and delay Tmax, but generally not clinically significant for IR forms. Administering with food may reduce GI upset.

Distribution:

Vd: Approximately 1.7 L/kg
ProteinBinding: 70-80%
CnssPenetration: Limited

Elimination:

HalfLife: 3-4.5 hours (for immediate-release tablets)
Clearance: Approximately 1.1 L/min
ExcretionRoute: Mainly renal (urine, ~60-65%) and fecal (bile, ~35%)
Unchanged: Less than 4% (renal)
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Pharmacodynamics

OnsetOfAction: 30-60 minutes (oral)
PeakEffect: 2-4 hours (oral)
DurationOfAction: 6-8 hours (for immediate-release tablets)

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, consult your doctor). Be aware of symptoms such as:
+ 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 (sometimes fatal). Seek help if you experience:
- Red, swollen, blistered, or peeling skin
- Skin irritation (with or without fever)
- Red or irritated eyes
- Sores in your mouth, throat, nose, or eyes

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only mild ones. If you are bothered by any of the following side effects or if they persist, 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)
  • New or worsening swelling in your ankles or feet
  • Shortness of breath, especially with exertion or lying down
  • Unusual fatigue or weakness
  • Yellowing of skin or eyes (jaundice), dark urine, or severe stomach pain (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 conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms.
Certain types of abnormal heart rhythms, as this medication may not be suitable for you. If you are unsure, consult your doctor or pharmacist for guidance.
Specific health conditions, such as:
+ Fluid accumulation in the lungs
+ Low blood pressure
+ Recent heart attack
Concurrent use of certain medications, including:
+ Ivabradine
+ Rifampin

Please note that this is not an exhaustive list of potential interactions. To guarantee your safety, it is crucial to disclose all of your:

Prescription and over-the-counter medications
Natural products
Vitamins
Health problems

Your doctor and pharmacist need this information to assess the safety of taking this medication with your existing 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 be cautious 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 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 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, plan to become pregnant, or are 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 (extremely slow heart rate)
  • Asystole (cardiac arrest)
  • High-degree AV block
  • Cardiogenic shock
  • Metabolic acidosis
  • Hyperglycemia
  • Confusion, stupor, coma

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For advice, call a poison control center at 1-800-222-1222. Treatment may include IV fluids, vasopressors (e.g., norepinephrine), atropine, calcium gluconate/chloride, glucagon, and 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/heart failure.
  • Digoxin: Increased digoxin serum concentrations (monitor digoxin levels).
  • Amiodarone: Increased risk of bradycardia, sinus arrest, and AV block.
  • Statins (e.g., simvastatin, lovastatin, atorvastatin): Increased statin concentrations due to CYP3A4 inhibition, leading to increased risk of myopathy/rhabdomyolysis.
  • Fentanyl: Increased fentanyl exposure (CYP3A4 inhibition).
  • Midazolam/Triazolam: Increased benzodiazepine exposure (CYP3A4 inhibition).
  • Cyclosporine/Tacrolimus/Sirolimus: Increased immunosuppressant levels (CYP3A4 inhibition).
  • Quinidine: Increased quinidine levels and risk of adverse cardiac effects.
  • Rifampin/Phenytoin/Carbamazepine: Decreased diltiazem levels (CYP3A4 induction).
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Moderate Interactions

  • Alpha-blockers (e.g., prazosin, tamsulosin): Additive hypotensive effects.
  • Other antihypertensives: Additive hypotensive effects.
  • Grapefruit juice: May increase diltiazem levels (CYP3A4 inhibition).
  • Cimetidine: May increase diltiazem levels.
  • Theophylline: May increase theophylline levels.
  • Buspirone: Increased buspirone levels.
  • Alfentanil: Increased alfentanil exposure.
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Minor Interactions

  • Acetaminophen: Minor effect on diltiazem metabolism.
  • NSAIDs: May reduce the antihypertensive effect of diltiazem.

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 assess risk of bradycardia.

Timing: Prior to initiation

Electrocardiogram (ECG) - PR interval

Rationale: To assess baseline cardiac conduction and risk of AV block.

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 (BUN, Creatinine)

Rationale: To assess baseline renal function, especially in patients with pre-existing impairment.

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 condition (e.g., <130/80 mmHg for hypertension)

Action Threshold: Hypotension (e.g., systolic <90 mmHg or symptomatic), or inadequate control (e.g., BP consistently above target)

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 treating tachycardia)

Action Threshold: Bradycardia (<50 bpm or symptomatic), or significant changes from baseline

Electrocardiogram (ECG) - PR interval

Frequency: Periodically, especially with dose increases or in patients with conduction abnormalities or on concomitant AV nodal blocking agents.

Target: Normal PR interval (0.12-0.20 seconds)

Action Threshold: Significant PR prolongation (>0.20 seconds) or development of higher-degree AV block

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
  • Constipation
  • Swelling in ankles/feet (peripheral edema)
  • Shortness of breath
  • Chest pain (angina control)
  • Palpitations (rate control)

Special Patient Groups

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Pregnancy

Diltiazem is Pregnancy Category C. It 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.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though human data are limited and conflicting. Avoid if possible.
Second Trimester: Risk of fetal bradycardia or other cardiac effects. Use with caution.
Third Trimester: Risk of fetal bradycardia, hypotension, or other cardiac effects. May inhibit labor. Use with caution.
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Lactation

Diltiazem is excreted into breast milk. While the amount is generally small, caution is advised. Monitor the infant for bradycardia, hypotension, or sedation. The American Academy of Pediatrics considers diltiazem to be compatible with breastfeeding, but individual risk-benefit should be assessed.

Infant Risk: Low to moderate risk. Potential for bradycardia, hypotension, or sedation in the infant. Monitor infant closely.
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Pediatric Use

Safety and efficacy have not been established for routine use in pediatric patients for hypertension or angina. Use in children is generally limited to specific cardiac arrhythmias (e.g., SVT) under specialist supervision, often via IV route, with highly individualized dosing and close monitoring.

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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 renal and hepatic function. Start with lower doses and titrate slowly, monitoring closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Diltiazem IR (immediate-release) is typically dosed multiple times a day (e.g., QID) due to its short half-life. Ensure patients understand the dosing frequency.
  • Peripheral edema is a common side effect, particularly in the ankles. It's often dose-dependent and can be managed by dose reduction or adding a diuretic.
  • Always check heart rate and blood pressure before administering diltiazem, especially in patients prone to bradycardia or hypotension.
  • Be cautious when combining diltiazem with other medications that slow AV nodal conduction (e.g., beta-blockers, digoxin, amiodarone) due to increased risk of severe bradycardia or AV block.
  • Diltiazem is a potent CYP3A4 inhibitor; significant drug interactions can occur with substrates of this enzyme (e.g., statins, immunosuppressants).
  • For patients with adherence issues or those preferring once-daily dosing, consider switching to an extended-release formulation of diltiazem (e.g., Cardizem CD, Tiazac, Cartia XT) if appropriate for their condition.
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Alternative Therapies

  • Other non-dihydropyridine calcium channel blockers (e.g., Verapamil)
  • Dihydropyridine calcium channel blockers (e.g., Amlodipine, Nifedipine)
  • Beta-blockers (e.g., Metoprolol, Atenolol)
  • 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)
  • Ranolazine (for chronic angina)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (generic 90mg IR)
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 for more information. 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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.