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Diltiazem 5mg/ml Inj, 5ml

Manufacturer HIKMA PHARMACEUTICALS USA 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
Jan 1970
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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. It works by relaxing blood vessels and slowing down your heart rate. This helps to lower high blood pressure and control certain fast or irregular heart rhythms.
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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. Take this medication exactly as directed, and adhere to all guidelines provided. This drug 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 proper storage procedure.

In the event that you miss a dose, contact your doctor immediately to receive guidance on the appropriate course of action.
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Lifestyle & Tips

  • Since this is an injectable medication given in a hospital, lifestyle changes are generally not directly applicable during acute treatment. However, for underlying conditions, patients should follow their doctor's advice on diet, exercise, and smoking cessation.
  • Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness or lightheadedness, especially after initial dosing.
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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 inadequate after 15 minutes, a second bolus of 0.35 mg/kg IV over 2 minutes may be administered. Maintenance infusion: 5 to 15 mg/hour IV, titrated to heart rate or blood pressure response.
Dose Range: 0.25 - 15 mg

Condition-Specific Dosing:

PSVT: Initial bolus 0.25 mg/kg IV over 2 min; if needed, 0.35 mg/kg IV over 2 min after 15 min. Maintenance infusion 5-15 mg/hr.
Atrial Fibrillation/Flutter with RVR: Initial bolus 0.25 mg/kg IV over 2 min; if needed, 0.35 mg/kg IV over 2 min after 15 min. Maintenance infusion 5-15 mg/hr.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (limited data, generally not recommended for routine use in children for arrhythmias)
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, use with caution.
Moderate: No specific adjustment recommended, use with caution.
Severe: No specific adjustment recommended, use with caution, monitor closely for adverse effects.
Dialysis: Not significantly removed by dialysis; use with caution, monitor closely.

Hepatic Impairment:

Mild: Use with caution, monitor closely.
Moderate: Use with caution, consider lower initial doses and slower titration due to extensive hepatic metabolism.
Severe: Use with caution, consider lower initial doses and slower titration due to extensive hepatic metabolism; monitor closely for prolonged effects and adverse reactions.

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, as well as the cells of the cardiac conduction system. This action leads to a reduction in myocardial contractility, a decrease in peripheral vascular resistance (vasodilation), and a slowing of conduction through the SA and AV nodes, prolonging the AV nodal refractory period. These effects result in decreased heart rate, decreased blood pressure, and termination or slowing of supraventricular tachyarrhythmias.
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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 (IV)
ProteinBinding: 70-80%
CnssPenetration: Limited

Elimination:

HalfLife: 3-4 hours (terminal half-life after IV bolus/infusion)
Clearance: Not readily available as a single rate, but hepatic clearance is significant.
ExcretionRoute: Primarily urine (metabolites, ~60%), feces (~35%)
Unchanged: <4% (urine)
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Pharmacodynamics

OnsetOfAction: 2-7 minutes (IV)
PeakEffect: 2-7 minutes (IV)
DurationOfAction: 1-3 hours (after IV bolus), dependent on infusion rate for 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
+ Symptoms may 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 not mentioned here. 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 (feeling faint or very tired)
  • Shortness of breath or difficulty breathing
  • Swelling in your ankles, feet, or hands
  • Chest pain or discomfort
  • Unusual tiredness or weakness
  • Any signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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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. Be sure to describe the allergic reaction and its symptoms.
 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, such as:
+ Fluid accumulation in the lungs
+ Low blood pressure
+ Recent heart attack
 Concurrent use of the following medications:
+ Ivabradine
+ Rifampin

Please note that this is not an exhaustive list of potential interactions. To ensure safe use, it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. They will help determine whether it is safe to take this medication with your existing regimen. 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 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 and cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or supplements.

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:

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

What to Do:

Immediate medical attention is required. Treatment is supportive and may include: IV fluids for hypotension, atropine for bradycardia, calcium chloride/gluconate (to overcome calcium channel blockade), vasopressors (e.g., norepinephrine, dopamine), glucagon, high-dose insulin/glucose, and potentially cardiac pacing. 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)
  • Severe hypotension
  • Sick sinus syndrome (without a functioning pacemaker)
  • Second- or third-degree AV block (without a functioning pacemaker)
  • Cardiogenic shock
  • Acute myocardial infarction with pulmonary congestion
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Major Interactions

  • Amiodarone (increased risk of bradycardia, AV block, hypotension)
  • Digoxin (increased digoxin levels, increased risk of bradycardia/AV block)
  • Beta-blockers (oral, increased risk of bradycardia, AV block, heart failure)
  • Statins (e.g., simvastatin, lovastatin - diltiazem inhibits CYP3A4, increasing statin levels and risk of myopathy/rhabdomyolysis)
  • Cyclosporine, Tacrolimus (increased immunosuppressant levels due to CYP3A4 inhibition)
  • Fentanyl (increased fentanyl levels, respiratory depression)
  • Midazolam, Triazolam (increased benzodiazepine levels, prolonged sedation)
  • Ivabradine (increased ivabradine exposure, additive bradycardia)
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Moderate Interactions

  • Alpha-blockers (e.g., prazosin, doxazosin - additive hypotensive effects)
  • Other antihypertensives (additive hypotensive effects)
  • Clonidine (additive bradycardia/hypotension)
  • Carbamazepine (increased carbamazepine levels)
  • Phenytoin (increased phenytoin levels)
  • Rifampin (decreased diltiazem levels)
  • Grapefruit juice (increased diltiazem levels, not relevant for IV)
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Minor Interactions

  • Cimetidine (may increase diltiazem levels slightly)
  • Ranitidine (may increase diltiazem levels slightly)

Monitoring

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Baseline Monitoring

Electrocardiogram (ECG)

Rationale: To assess baseline cardiac rhythm, PR interval, QRS duration, and rule out contraindications (e.g., high-grade AV block, sick sinus syndrome without pacemaker).

Timing: Prior to initiation of therapy.

Blood Pressure (BP)

Rationale: To establish baseline and guide dosing, as diltiazem can cause hypotension.

Timing: Prior to initiation of therapy.

Heart Rate (HR)

Rationale: To establish baseline and guide dosing, as diltiazem causes bradycardia.

Timing: Prior to initiation of therapy.

Renal Function (BUN, Creatinine)

Rationale: To assess baseline kidney function, although dose adjustment is not typically required, caution is advised in severe impairment.

Timing: Prior to initiation of therapy.

Hepatic Function (ALT, AST, Bilirubin)

Rationale: To assess baseline liver function, as diltiazem is extensively metabolized by the liver and dose adjustment may be needed in severe impairment.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Continuous ECG monitoring (especially PR interval)

Frequency: Continuously during bolus and infusion, especially during titration.

Target: PR interval <0.20 seconds (or no significant prolongation beyond baseline); absence of new or worsening AV block.

Action Threshold: Significant PR prolongation (>0.24 seconds), development of 2nd/3rd degree AV block, or symptomatic bradycardia/hypotension. Reduce dose or discontinue infusion.

Blood Pressure (BP)

Frequency: Continuously or every 5-15 minutes during bolus/titration, then every 15-60 minutes during maintenance infusion.

Target: Maintain systolic BP >90-100 mmHg or as clinically appropriate.

Action Threshold: Symptomatic hypotension or significant drop in BP. Reduce dose or discontinue infusion.

Heart Rate (HR)

Frequency: Continuously or every 5-15 minutes during bolus/titration, then every 15-60 minutes during maintenance infusion.

Target: Target HR for rate control (e.g., <100-110 bpm for AF/flutter) or maintain >60 bpm.

Action Threshold: Symptomatic bradycardia (<50 bpm) or significant drop in HR. Reduce dose or discontinue infusion.

Signs/Symptoms of Heart Failure

Frequency: Regularly assess (e.g., every 1-4 hours or as clinically indicated).

Target: Absence of new or worsening dyspnea, peripheral edema, crackles.

Action Threshold: Development or worsening of heart failure symptoms. Discontinue infusion.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fatigue
  • Shortness of breath
  • Chest pain
  • Palpitations
  • Swelling in ankles/feet
  • Nausea
  • Headache

Special Patient Groups

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Pregnancy

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 at doses higher than human therapeutic doses.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity observed in animal studies at high doses; human data are limited.
Second Trimester: Limited human data; use with caution.
Third Trimester: Limited human data; use with caution, potential for effects on fetal heart rate or blood pressure.
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Lactation

Diltiazem is excreted into breast milk. The American Academy of Pediatrics considers diltiazem to be compatible with breastfeeding, but caution is advised. Monitor the infant for signs of bradycardia, hypotension, or sedation.

Infant Risk: L3 (Moderately safe). Low risk of adverse effects in breastfed infants, but monitor for bradycardia, hypotension, or lethargy.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients. Use is generally not recommended for routine management of arrhythmias in children due to limited data and potential for adverse effects. If used, extreme caution and close monitoring are required.

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Geriatric Use

Geriatric patients may be more sensitive to the hypotensive and bradycardic effects of diltiazem. Start with lower doses and titrate slowly, monitoring closely for adverse effects such as hypotension, bradycardia, and AV block. Renal and hepatic function may be impaired in older adults, necessitating careful monitoring.

Clinical Information

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Clinical Pearls

  • Diltiazem IV is a first-line agent for acute rate control in atrial fibrillation/flutter with rapid ventricular response and for termination of PSVT.
  • Always administer IV bolus slowly over 2 minutes to minimize the risk of hypotension and bradycardia.
  • Continuous ECG and blood pressure monitoring are crucial during and after administration, especially during titration of the infusion.
  • Avoid concurrent IV administration of beta-blockers due to the risk of profound bradycardia, AV block, and myocardial depression.
  • Calcium chloride can be used to reverse severe hypotension or bradycardia unresponsive to atropine, as it directly antagonizes the calcium channel blockade.
  • Patients with pre-existing left ventricular dysfunction or heart failure should be monitored closely for worsening symptoms, as diltiazem has negative inotropic effects.
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Alternative Therapies

  • For PSVT: Adenosine (first-line), Verapamil (another non-dihydropyridine CCB), Beta-blockers (e.g., Esmolol, Metoprolol)
  • For Atrial Fibrillation/Flutter with RVR: Beta-blockers (e.g., Esmolol, Metoprolol), Verapamil, Amiodarone (especially in heart failure)
  • For Hypertension (acute): Labetalol, Esmolol, Nicardipine, Clevidipine, Hydralazine, Nitroprusside
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Cost & Coverage

Average Cost: Varies widely, typically $5-$50 per 5mg/ml, 5ml vial per vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 (brand)
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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 evaluation and guidance. To ensure safe and effective treatment, never share your medication with others, and do not take medication prescribed for someone else.

Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Properly dispose of unused or expired medications by checking with your pharmacist for guidance on the best disposal method. Unless instructed to do so, avoid flushing medications down the toilet or pouring them down the drain, as this can harm the environment. Many communities have drug take-back programs, which your pharmacist can help you locate.

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, consult 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 emergency medical attention. Be prepared to provide information about the medication taken, including the dosage, time of ingestion, and any other relevant details to ensure prompt and effective treatment.