Cartia (diltiazem) 120mgxt 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
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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 used to treat high blood pressure (hypertension) and chest pain (angina). It works by relaxing blood vessels and slowing your heart rate, which helps your heart pump blood more easily and reduces the workload on your heart.
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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. In some cases, you may be able to open the medication and sprinkle it on a spoonful of applesauce, but be sure to check with your pharmacist first to see if this is acceptable for your particular medication. Other medications must be swallowed whole.

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 medication exactly as prescribed, usually once daily. Do not crush, chew, or divide extended-release capsules.
  • Swallow the capsule whole or sprinkle the contents of the capsule on a spoonful of applesauce and swallow immediately without chewing.
  • Avoid grapefruit juice as it can increase the amount of diltiazem in your body.
  • Monitor your blood pressure and heart rate regularly as advised by your doctor.
  • Maintain a healthy lifestyle including a balanced diet, regular exercise, and limiting sodium intake.
  • Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness or lightheadedness.
  • Limit alcohol consumption as it can worsen dizziness and lower blood pressure.

Dosing & Administration

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Adult Dosing

Standard Dose: 120 mg once daily (extended-release capsule)
Dose Range: 120 - 480 mg

Condition-Specific Dosing:

hypertension: Initial 180-240 mg once daily; titrate up to 360-480 mg once daily based on response.
chronic_stable_angina: 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 (safety and efficacy not established)
Adolescent: Not established (safety and efficacy not established)
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment generally required, but monitor closely.
Moderate: No specific dose adjustment generally required, but monitor closely.
Severe: Use with caution; monitor for exaggerated effects. Dose reduction may be necessary.
Dialysis: Diltiazem is not significantly removed by dialysis. Administer after dialysis; 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: Use with caution; consider lower initial doses and careful titration due to extensive hepatic metabolism. Monitor for exaggerated 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 a reduction in myocardial contractility, slowing of SA and AV nodal conduction, and relaxation of vascular smooth muscle, resulting in peripheral and coronary vasodilation. These actions decrease myocardial oxygen demand and increase myocardial oxygen supply.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 40-65% (due to extensive first-pass metabolism)
Tmax: Extended-release capsules: 6-11 hours
FoodEffect: Food may increase the rate and extent of absorption for some extended-release formulations; generally recommended to take consistently with or without food.

Distribution:

Vd: Approximately 5.3 L/kg
ProteinBinding: 70-85%
CnssPenetration: Limited

Elimination:

HalfLife: Extended-release: 5-10 hours
Clearance: Approximately 1.1 L/min
ExcretionRoute: Urine (35-65%), Feces (35-65%)
Unchanged: Less than 4% (in urine)
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Pharmacodynamics

OnsetOfAction: Extended-release: Hours (for full therapeutic effect)
PeakEffect: Extended-release: 6-11 hours
DurationOfAction: Extended-release: 24 hours

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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ 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
+ 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 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

Reporting Side Effects

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, feet, or legs
  • Shortness of breath, especially with exertion or lying down
  • Unusual fatigue or weakness
  • Severe headache that doesn't go away
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine or pale stools
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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. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain types of abnormal heart rhythms, as this medication is not suitable for use with some types of irregular heartbeats. If you are unsure, consult your doctor or pharmacist to determine if this medication is safe for you.
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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help you determine if it is safe to take 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, 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, stand up slowly after sitting or lying down, 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 periodically while taking this medication. Consult with your doctor regarding the frequency of these checks.

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, as it may interact with your medication. Additionally, you may need to avoid consuming alcohol while taking this medication; consult with 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, inform your doctor, as 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)
  • Bradycardia (very slow heart rate)
  • AV block (heart block)
  • Asystole (cardiac arrest)
  • Cardiogenic shock
  • Congestive heart failure
  • Dizziness
  • Confusion
  • Nausea
  • Vomiting

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, glucagon, or cardiac pacing depending on severity.

Drug Interactions

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Contraindicated Interactions

  • Ivabradine (increased risk of bradycardia and conduction disturbances)
  • Dantrolene (intravenous) (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).
  • Statins (e.g., simvastatin, lovastatin): Increased statin exposure due to CYP3A4 inhibition (dose reduction of statin may be needed).
  • Amiodarone: Increased risk of bradycardia, sinus arrest, AV block.
  • Fentanyl: Increased risk of hypotension and bradycardia.
  • Clonidine: Increased risk of bradycardia and AV block.
  • Quinidine: Increased risk of hypotension and bradycardia.
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Moderate Interactions

  • Cyclosporine, Tacrolimus, Sirolimus: Increased immunosuppressant levels (monitor levels).
  • Carbamazepine, Phenytoin: Increased anticonvulsant levels.
  • Alpha-blockers (e.g., prazosin, doxazosin): Increased risk of orthostatic hypotension.
  • Benzodiazepines (e.g., midazolam, triazolam): Increased benzodiazepine levels.
  • Theophylline: Increased theophylline levels.
  • Rifampin: Decreased diltiazem levels (CYP3A4 induction).
  • Grapefruit juice: May increase diltiazem exposure (avoid large amounts).
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Minor Interactions

  • Cimetidine: May increase diltiazem levels (minor 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 for bradycardia, a common side effect.

Timing: Prior to initiation

Electrocardiogram (ECG)

Rationale: To assess for pre-existing conduction abnormalities (e.g., AV block, sick sinus syndrome) which are contraindications or require caution.

Timing: Prior to initiation (especially if cardiac history)

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 kidney function, as dose adjustments may be needed in severe renal 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 indication (e.g., <130/80 mmHg for hypertension)

Action Threshold: Hypotension (e.g., systolic <90 mmHg or symptomatic), or 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 >50-60 bpm (unless otherwise clinically indicated)

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

Electrocardiogram (ECG) - PR interval

Frequency: Periodically, especially with dose increases or concomitant use of other AV nodal blocking agents (e.g., beta-blockers, digoxin)

Target: Normal PR interval (<0.20 seconds)

Action Threshold: Significant PR prolongation or development of AV block

Signs/Symptoms of Heart Failure

Frequency: Regularly (e.g., at each clinic visit)

Target: Absence of new or worsening symptoms (e.g., dyspnea, edema, fatigue)

Action Threshold: Development or worsening of heart failure symptoms

Peripheral Edema

Frequency: Regularly (e.g., at each clinic visit)

Target: Absence or minimal edema

Action Threshold: Significant or bothersome peripheral edema

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Shortness of breath
  • Swelling in ankles/feet (edema)
  • Chest pain (worsening or new onset)
  • Palpitations
  • Slow heart rate
  • Constipation
  • Headache

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, 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 limited.
Second Trimester: Limited human data; generally considered safer than first trimester, but still Category C.
Third Trimester: Potential for fetal bradycardia or other cardiovascular effects; use with caution.
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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 signs of bradycardia, hypotension, or sedation.

Infant Risk: Low to moderate risk. Monitor for bradycardia, lethargy, poor feeding. Consider alternative if infant is premature or has cardiac issues.
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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 be more sensitive to the effects of diltiazem, particularly regarding hypotension and bradycardia. Start with lower doses and titrate slowly. Monitor blood pressure, heart rate, and renal/hepatic function closely.

Clinical Information

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Clinical Pearls

  • Diltiazem ER is a once-daily formulation, improving patient adherence.
  • It is a good choice for patients with both hypertension and angina due to its dual effects.
  • Unlike dihydropyridine CCBs (e.g., amlodipine), diltiazem has significant effects on cardiac conduction and contractility, making it useful for rate control in atrial fibrillation/flutter (off-label for ER formulations, more common for IV/IR).
  • Can cause constipation, which may require dietary modifications or laxatives.
  • Patients should be advised to avoid grapefruit juice due to potential for increased diltiazem levels and adverse effects.
  • Caution is advised when combining with beta-blockers or digoxin due to additive effects on heart rate and AV conduction.
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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, carvedilol)
  • ACE inhibitors (e.g., lisinopril, enalapril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan)
  • Thiazide diuretics (e.g., hydrochlorothiazide)
  • Nitrates (for angina)
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Cost & Coverage

Average Cost: $30 - $300+ per 30 capsules (generic vs. brand)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 or 4 (brand)
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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 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.