Cartia (diltiazem) 180mgxt Caps

Manufacturer ACTAVIS 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, 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
Jan 1970
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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 makes it easier for your heart to pump blood, which can lower your blood pressure, reduce chest pain (angina), and help control certain irregular heart rhythms.
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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 to feel better.

Some medications may need to be taken with food, while others should be taken on an empty stomach. Check with your pharmacist to determine the best way to take your specific medication. Additionally, some products can be opened and mixed with a spoonful of applesauce, while others must be swallowed whole. Consult with your pharmacist to see if your medication can be opened.

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 about potential 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.
  • Continue to monitor your blood pressure and heart rate as advised by your doctor.
  • Maintain a healthy lifestyle, including a balanced diet (low in sodium and saturated fats), regular exercise, and limiting alcohol intake.
  • Avoid grapefruit and grapefruit juice while taking this medication, as it can increase drug levels and side effects.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking.
  • Do not stop taking this medication suddenly without consulting your doctor, as it can worsen your condition.

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 up to 540 mg once daily based on response.
chronicStableAngina: Initial: 120-180 mg once daily; Titrate up to 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 (Safety and efficacy not established for hypertension or angina in pediatric patients.)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, monitor for exaggerated effects.
Moderate: No specific adjustment recommended, monitor for exaggerated effects.
Severe: Use with caution, monitor for exaggerated effects. Consider lower initial doses.
Dialysis: Diltiazem is not significantly removed by dialysis. No specific adjustment, but monitor closely.

Hepatic Impairment:

Mild: Use with caution, monitor for exaggerated effects.
Moderate: Use with caution, consider lower initial doses and careful titration due to extensive hepatic metabolism.
Severe: Contraindicated in severe hepatic impairment due to risk of accumulation and increased adverse effects.
Confidence: Medium

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 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 reduced myocardial oxygen demand.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 40-65% (due to first-pass metabolism)
Tmax: Approximately 10-14 hours (for extended-release capsules)
FoodEffect: Food may increase bioavailability slightly but generally does not significantly alter absorption of extended-release formulations.

Distribution:

Vd: Approximately 5.3 L/kg
ProteinBinding: 70-80%
CnssPenetration: Limited (low CNS penetration)

Elimination:

HalfLife: Approximately 5-10 hours (for extended-release formulations, terminal half-life can be longer)
Clearance: Approximately 1.1 L/min
ExcretionRoute: Mainly renal (60-65% as metabolites), fecal (35% as metabolites)
Unchanged: Less than 4% (renal)
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Pharmacodynamics

OnsetOfAction: Within 30-60 minutes (for blood pressure reduction with ER)
PeakEffect: Approximately 2-6 hours (for heart rate reduction), 10-14 hours (for blood pressure reduction with ER)
DurationOfAction: 24 hours (for extended-release formulations)
Confidence: Medium

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). Seek immediate medical attention if you experience:
+ Shortness of breath
+ Sudden 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 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

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you are bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:

Headache
* Feeling dizzy, tired, or weak

This is not an exhaustive list of potential 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 persistent nausea/vomiting (signs of liver problems)
  • Severe 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 symptoms you experienced.
Certain types of abnormal heart rhythms, as this medication is not suitable for individuals with specific heart rhythm disorders. If you are unsure, consult your doctor or pharmacist for guidance.
Existing health conditions, including:
+ Fluid accumulation in the lungs
+ Low blood pressure
+ Recent heart attack
Current medications, particularly:
+ 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 modifying the dose of any medication, always consult 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 your full attention, 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 exercise caution when navigating 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 at intervals 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, inform your doctor, as this may interact with your medication. Additionally, you may need to avoid consuming alcohol while taking this medication; consult your doctor or pharmacist to determine if this is necessary.

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, discuss the potential benefits and risks of this medication with your doctor to ensure the best outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Profound hypotension (very low blood pressure)
  • Severe bradycardia (very slow heart rate)
  • AV block (heart block)
  • Cardiogenic shock
  • Asystole (cardiac arrest)
  • Dizziness
  • Confusion
  • Nausea
  • Vomiting

What to Do:

Seek immediate medical attention or call 911. For poison control, call 1-800-222-1222. Treatment is supportive and may include IV fluids, vasopressors (e.g., norepinephrine), atropine, calcium gluconate, glucagon, and 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
  • Digoxin - increased digoxin levels, risk of toxicity
  • Amiodarone - increased risk of bradycardia, AV block, hypotension
  • Statins (e.g., simvastatin, lovastatin) - increased statin levels, risk of myopathy/rhabdomyolysis (diltiazem is a CYP3A4 inhibitor)
  • Fentanyl (CYP3A4 substrate) - increased fentanyl levels, respiratory depression
  • Immunosuppressants (e.g., cyclosporine, tacrolimus, sirolimus) - increased immunosuppressant levels, toxicity
  • Alpha-blockers (e.g., prazosin, doxazosin) - increased risk of hypotension
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Moderate Interactions

  • Other antihypertensives - additive hypotensive effects
  • Grapefruit juice - increased diltiazem levels
  • Carbamazepine - increased carbamazepine levels
  • Phenytoin - increased phenytoin levels
  • Rifampin (CYP3A4 inducer) - decreased diltiazem levels
  • Benzodiazepines (e.g., midazolam, triazolam) - increased benzodiazepine levels
  • Theophylline - increased theophylline levels
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Minor Interactions

  • Cimetidine - increased diltiazem levels (minor effect)
  • Ranitidine - no significant interaction

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, especially important due to diltiazem's negative chronotropic effects.

Timing: Prior to initiation.

Electrocardiogram (ECG)

Rationale: To assess baseline cardiac rhythm and PR interval, especially important due to diltiazem's effects on AV nodal conduction.

Timing: Prior to initiation.

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, as metabolites are renally excreted.

Timing: Prior to initiation, if clinically indicated.

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly (e.g., weekly after initiation/dose change, then monthly or quarterly)

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

Action Threshold: Persistent BP outside target range, or symptomatic hypotension.

Heart Rate (HR)

Frequency: Regularly (e.g., weekly after initiation/dose change, then monthly or quarterly)

Target: 50-90 bpm (or individualized target)

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

Electrocardiogram (ECG)

Frequency: Periodically, or if symptoms of bradycardia, AV block, or arrhythmia develop.

Target: Normal sinus rhythm, PR interval <0.20 seconds (unless pre-existing conduction abnormality)

Action Threshold: Significant prolongation of PR interval, new onset AV block, or other conduction disturbances.

Signs/Symptoms of Peripheral Edema

Frequency: At each visit

Target: Absence of significant edema

Action Threshold: Development of significant or bothersome lower extremity edema.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Headache
  • Nausea
  • Constipation
  • Swelling of ankles/feet (peripheral edema)
  • Shortness of breath
  • Chest pain (angina symptoms)
  • Palpitations
  • Slow heart rate

Special Patient Groups

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Pregnancy

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Diltiazem has shown teratogenic and embryotoxic effects in animal studies at doses higher than human therapeutic doses.

Trimester-Specific Risks:

First Trimester: Potential for teratogenic effects based on animal data; human data are limited.
Second Trimester: Limited human data; generally avoided unless clearly needed.
Third Trimester: Limited human data; generally avoided unless clearly needed. Potential for fetal bradycardia or hypotension.
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Lactation

Diltiazem is excreted into breast milk. While the amount is generally small, monitor breastfed infants for signs of bradycardia, hypotension, or sedation. Use with caution, or consider an alternative drug, especially in preterm or neonates.

Infant Risk: Low to moderate risk; potential for bradycardia, hypotension, or sedation in infant. L3 (Moderately Safe) per LactMed.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients. Use is generally not recommended for hypertension or angina in this population. Off-label use for certain arrhythmias may occur in specialized settings with careful monitoring.

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Geriatric Use

Elderly patients may have increased sensitivity 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

  • Extended-release formulations of diltiazem (like Cartia XT) are designed for once-daily dosing and should not be crushed, chewed, or divided, as this can lead to rapid release and increased risk of adverse effects.
  • Diltiazem is a potent negative chronotrope and dromotrope; use with extreme caution or avoid in patients with sick sinus syndrome, second- or third-degree AV block without a pacemaker, or severe bradycardia.
  • Monitor for peripheral edema, a common side effect of calcium channel blockers, which is often dose-dependent.
  • Due to its CYP3A4 inhibitory properties, diltiazem can significantly increase levels of many co-administered drugs, necessitating dose adjustments for the interacting drug (e.g., statins, immunosuppressants, digoxin).
  • Patients should be advised to avoid grapefruit juice due to its potential to increase diltiazem plasma concentrations.
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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 HR/AV conduction)
  • Beta-blockers (e.g., metoprolol, atenolol) for hypertension, angina, or rate control in arrhythmias
  • ACE inhibitors (e.g., lisinopril, enalapril) for hypertension
  • Angiotensin Receptor Blockers (ARBs) (e.g., valsartan, losartan) for hypertension
  • Diuretics (e.g., hydrochlorothiazide, furosemide) for hypertension
  • Nitrates (e.g., isosorbide mononitrate, nitroglycerin) for angina
  • Antiarrhythmics (e.g., amiodarone, flecainide) for specific arrhythmias
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Cost & Coverage

Average Cost: $50 - $300+ per 30 capsules (180mg ER)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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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.