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Diltiazem 100mg Inj, 1 Vial

Manufacturer HOSPIRA Active Ingredient Diltiazem Injection(dil TYE a zem) Pronunciation dil TYE a zem
It is used to treat certain types of abnormal heartbeats.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antiarrhythmic, Antihypertensive
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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 1981
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Diltiazem is a medicine given by injection, usually in a hospital setting, to help control your heart rate if it's beating too fast or irregularly. It works by relaxing blood vessels and slowing down the electrical signals in your heart.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Adhere to the dosage instructions provided by your healthcare team. This medication is administered intravenously over a specified period.

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the appropriate storage method.

In the event that you miss a dose, contact your doctor promptly to receive guidance on the next steps to take.
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Lifestyle & Tips

  • Report any dizziness, lightheadedness, or feeling faint immediately to your healthcare provider.
  • Inform your healthcare provider about all medications, supplements, and herbal products you are taking.
  • Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness.
  • Limit or avoid alcohol consumption as it can worsen dizziness and lower blood pressure.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Initial bolus: 0.25 mg/kg IV over 2 minutes. If response is inadequate after 15 minutes, a second bolus of 0.35 mg/kg IV over 2 minutes may be administered. Continuous infusion: 5 to 15 mg/hour, adjusted to heart rate response.
Dose Range: 0.25 - 0.35 mg

Condition-Specific Dosing:

atrialFibrillationFlutter: Initial bolus: 0.25 mg/kg IV over 2 minutes. If inadequate response, second bolus: 0.35 mg/kg IV over 2 minutes. Maintenance infusion: 5-15 mg/hour.
paroxysmalSupraventricularTachycardia: Initial bolus: 0.25 mg/kg IV over 2 minutes. If inadequate response, second bolus: 0.35 mg/kg IV over 2 minutes. Maintenance infusion: 5-15 mg/hour.
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Pediatric Dosing

Neonatal: Not established; use with extreme caution and expert consultation due to risk of severe bradycardia and hypotension.
Infant: Not established; use with extreme caution and expert consultation due to risk of severe bradycardia and hypotension.
Child: Not established; use with extreme caution and expert consultation due to risk of severe bradycardia and hypotension. Limited data for supraventricular tachycardia (SVT) in older children, typically 0.1-0.25 mg/kg IV over 2-5 minutes, max 10 mg.
Adolescent: Dosing similar to adult, but with caution and individualized based on weight and response.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required.
Moderate: No specific dose adjustment required.
Severe: Use with caution; monitor for exaggerated effects due to potential accumulation of active metabolites.
Dialysis: Not significantly dialyzable. Use with caution; monitor for exaggerated effects.

Hepatic Impairment:

Mild: Use with caution; monitor for exaggerated effects.
Moderate: Consider lower initial doses and slower titration; monitor closely for adverse effects due to impaired metabolism.
Severe: Contraindicated in severe hepatic impairment due to extensive hepatic metabolism and risk of accumulation.

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 membranes of myocardial and vascular smooth muscle cells, without changing serum calcium concentrations. This leads to a reduction in myocardial contractility, slowing of SA and AV nodal conduction (prolonging the AV nodal refractory period), and relaxation of vascular smooth muscle, resulting in peripheral and coronary vasodilation. These actions decrease heart rate, reduce blood pressure, and improve coronary blood flow.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV)
Tmax: 2-7 minutes (IV)
FoodEffect: Not applicable for IV formulation.

Distribution:

Vd: 1.7 L/kg
ProteinBinding: 70-85%
CnssPenetration: Limited

Elimination:

HalfLife: 2-5 hours (IV bolus), 5-8 hours (continuous infusion)
Clearance: 0.5-1.1 L/min
ExcretionRoute: Renal (35-65%), Fecal (35-65%)
Unchanged: <5% (urine)
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Pharmacodynamics

OnsetOfAction: 2-7 minutes (IV)
PeakEffect: 2-7 minutes (IV)
DurationOfAction: 1-3 hours (IV bolus), longer with continuous infusion

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
+ 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, which may be life-threatening
+ Signs of severe skin reactions include:
- Red, swollen, blistered, or peeling skin
- 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:

 Irritation at the injection site

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, don't hesitate to reach out to 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 lightheadedness
  • Fainting
  • Slow or irregular heartbeat
  • Shortness of breath
  • Chest pain
  • Swelling in your ankles or feet
  • Unusual fatigue or weakness
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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 signs and 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 potential interactions. To ensure safe treatment, it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. Before starting, stopping, or modifying the dose of any medication, consult your doctor to confirm that it is safe to do so in conjunction with this medication.
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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 treatment and during the course of therapy. Discuss any concerns or questions 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, plan to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Profound bradycardia (very slow heart rate)
  • Severe hypotension (very low blood pressure)
  • Asystole (cardiac arrest)
  • High-degree AV block
  • Cardiogenic shock
  • Metabolic acidosis
  • Hyperglycemia

What to Do:

Immediate medical attention is required. Treatment is supportive and may include atropine for bradycardia, vasopressors (e.g., norepinephrine, dopamine) for hypotension, intravenous calcium gluconate/chloride, glucagon, and potentially cardiac pacing. Dialysis is generally not effective. Call 1-800-222-1222 (Poison Control) or seek emergency medical care immediately.

Drug Interactions

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Contraindicated Interactions

  • Intravenous beta-blockers (concurrently or within a few hours due to risk of severe bradycardia, AV block, and heart failure)
  • Patients with sick sinus syndrome or second- or third-degree AV block (unless a functional ventricular pacemaker is present)
  • Severe hypotension (systolic BP <90 mmHg)
  • Cardiogenic shock
  • Acute myocardial infarction and pulmonary congestion
  • Ivabradine (concurrent use)
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Major Interactions

  • Digoxin (increases digoxin levels, risk of bradycardia)
  • Amiodarone (increased risk of bradycardia, AV block, and hypotension)
  • Statins (e.g., simvastatin, lovastatin - increased statin levels due to CYP3A4 inhibition, leading to increased risk of myopathy/rhabdomyolysis)
  • Fentanyl (increased risk of bradycardia and hypotension)
  • Other antiarrhythmics (e.g., quinidine, procainamide - additive effects on cardiac conduction)
  • Dantrolene (risk of hyperkalemia and myocardial depression)
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Moderate Interactions

  • Other antihypertensives (additive hypotensive effects)
  • CYP3A4 inhibitors (e.g., azole antifungals, macrolide antibiotics - increased diltiazem levels)
  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin - decreased diltiazem levels)
  • Benzodiazepines (e.g., midazolam, triazolam - increased benzodiazepine levels)
  • Cyclosporine, tacrolimus, sirolimus (increased immunosuppressant levels)
  • Alpha-blockers (e.g., prazosin - increased risk of orthostatic hypotension)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Electrocardiogram (ECG)

Rationale: To assess baseline cardiac rhythm, PR interval, QRS duration, and QT interval, and to rule out contraindications like high-degree AV block.

Timing: Prior to initiation of IV bolus and continuous infusion.

Blood Pressure (BP)

Rationale: To establish baseline and identify pre-existing hypotension.

Timing: Prior to initiation.

Heart Rate (HR)

Rationale: To establish baseline and identify pre-existing bradycardia.

Timing: Prior to initiation.

Renal Function (BUN, Creatinine)

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

Timing: Prior to initiation, especially in patients with known renal impairment.

Hepatic Function (ALT, AST, Bilirubin)

Rationale: To assess liver function, as diltiazem is extensively metabolized by the liver.

Timing: Prior to initiation, especially in patients with known hepatic impairment.

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Routine Monitoring

Continuous ECG Monitoring

Frequency: Continuously during IV bolus and infusion.

Target: Maintain heart rate within target range (e.g., <100 bpm for AFib/flutter), PR interval <0.20 seconds.

Action Threshold: Bradycardia (HR <50 bpm), significant PR prolongation (>0.24 seconds), development of AV block (2nd or 3rd degree), or new arrhythmias. Hypotension (systolic BP <90 mmHg or symptomatic drop).

Blood Pressure (BP)

Frequency: Every 5-15 minutes during bolus and initial infusion titration, then hourly or as clinically indicated during maintenance.

Target: Maintain systolic BP >90 mmHg or within patient's acceptable range.

Action Threshold: Systolic BP <90 mmHg or symptomatic hypotension.

Heart Rate (HR)

Frequency: Continuously via ECG monitor.

Target: As per treatment goal (e.g., 60-100 bpm for rate control).

Action Threshold: HR <50 bpm or symptomatic bradycardia.

Fluid Balance/Edema

Frequency: Daily or as clinically indicated.

Target: Not applicable.

Action Threshold: Development of peripheral edema or signs of fluid overload.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fainting
  • Chest pain
  • Shortness of breath
  • Palpitations
  • Swelling of ankles/feet
  • Unusual fatigue
  • Nausea
  • 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 on the fetus.

Trimester-Specific Risks:

First Trimester: Potential for teratogenic effects observed in animal studies (skeletal abnormalities, embryo-lethality at high doses). Human data are limited.
Second Trimester: Limited human data. Use with caution, monitoring fetal heart rate and growth.
Third Trimester: Limited human data. May cause fetal bradycardia or hypotension. Use with caution, especially near term.
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Lactation

Diltiazem is excreted in 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, hypotension, and lethargy in the infant. Consider alternative agents if possible, especially in preterm or unstable infants.
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Pediatric Use

Not routinely recommended for IV use in children, especially neonates and infants, due to limited safety and efficacy data and a higher risk of severe adverse cardiovascular effects (bradycardia, hypotension, AV block). Use only in critical care settings with expert consultation and continuous monitoring, if at all.

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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, and increased sensitivity of the cardiovascular system. Start with lower doses and titrate slowly, monitoring closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Diltiazem IV is highly effective for rapid rate control in atrial fibrillation/flutter and for terminating PSVT.
  • Always administer IV diltiazem with continuous ECG and blood pressure monitoring.
  • Avoid concurrent IV beta-blocker administration due to the risk of profound bradycardia and AV block.
  • Ensure patient is not in wide complex tachycardia (e.g., ventricular tachycardia) before administering, as diltiazem can worsen outcomes in these arrhythmias.
  • Calcium chloride or gluconate can be used as an antidote for severe diltiazem overdose, along with atropine and vasopressors.
  • Titrate infusion rate based on heart rate response and blood pressure tolerance.
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Alternative Therapies

  • Beta-blockers (e.g., metoprolol, esmolol) for rate control in AFib/flutter or PSVT.
  • Adenosine for termination of PSVT.
  • Digoxin for chronic rate control in AFib/flutter (slower onset).
  • Amiodarone for rate and rhythm control in AFib/flutter (different mechanism, more side effects).
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Cost & Coverage

Average Cost: Varies, typically $10-$50 per 100mg vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed otherwise, do not flush medications down the toilet or pour them down the drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek medical attention. Be prepared to provide information about the medication taken, the amount, and the time of ingestion.