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Diltiazem 50mg/10ml Inj, 10ml

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 (Class IV), Antihypertensive
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Pharmacologic Class
Non-dihydropyridine Calcium Channel Blocker
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Pregnancy Category
Category C
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FDA Approved
Sep 1988
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Diltiazem is a medicine given by injection into a vein. It belongs to a group of drugs called calcium channel blockers. It works by relaxing blood vessels and slowing down your heart rate. This helps to lower high blood pressure or control a fast or irregular heartbeat, such as atrial fibrillation.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all the information provided to you. It is essential to follow the dosage instructions closely. 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 proper storage procedure.

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

  • Report any dizziness, lightheadedness, or fainting immediately.
  • Inform your healthcare provider if you experience shortness of breath, swelling in your ankles or feet, or unusual fatigue, as these could be signs of heart problems.
  • Avoid grapefruit juice if you are also taking oral diltiazem, as it can increase the drug's effects (though less relevant for acute IV use, it's a general caution for CCBs).
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Initial bolus of 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. Follow with continuous IV infusion at 10 mg/hour, titrate as needed up to 15 mg/hour (some sources up to 20 mg/hour in acute settings).
Dose Range: 0.25 - 20 mg

Condition-Specific Dosing:

atrialFibrillationFlutterRateControl: Initial bolus: 0.25 mg/kg IV over 2 min (average 20 mg). If needed, second bolus: 0.35 mg/kg IV over 2 min (average 25 mg) after 15 min. Maintenance infusion: 10 mg/hour, titrate up to 15 mg/hour (max 20 mg/hour in some cases).
hypertensiveEmergency: Initial bolus: 0.25 mg/kg IV over 2 min. Maintenance infusion: 5-15 mg/hour.
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Pediatric Dosing

Neonatal: Not established; generally not recommended due to high risk of severe adverse effects (hypotension, bradycardia, asystole).
Infant: Not established; generally not recommended. Limited use for SVT in critical care settings with extreme caution (e.g., 0.05-0.1 mg/kg over 2-5 min, max 0.25 mg/kg).
Child: Not established; generally not recommended. Limited use for SVT in critical care settings with extreme caution (e.g., 0.05-0.1 mg/kg over 2-5 min, max 0.25 mg/kg).
Adolescent: Not established; generally not recommended. Limited use for SVT in critical care settings with extreme caution (e.g., 0.05-0.1 mg/kg over 2-5 min, max 0.25 mg/kg).
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required, but monitor for exaggerated effects.
Moderate: No specific dose adjustment required, but monitor for exaggerated effects.
Severe: No specific dose adjustment required, but monitor for exaggerated effects.
Dialysis: Not significantly removed by dialysis. No specific dose adjustment, but monitor closely.

Hepatic Impairment:

Mild: Consider lower initial dose and titrate cautiously.
Moderate: Reduce initial dose by 50% and titrate cautiously with close monitoring.
Severe: Contraindicated or use with extreme caution and significant dose reduction, as metabolism is severely impaired.

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 through voltage-gated L-type calcium channels. This action leads to relaxation of vascular smooth muscle (vasodilation), reduction in myocardial contractility (negative inotropy), and slowing of SA node automaticity and AV node conduction (negative chronotropy and dromotropy). These effects result in decreased peripheral vascular resistance, reduced blood pressure, and slowed ventricular rate in supraventricular tachyarrhythmias.
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Pharmacokinetics

Absorption:

Bioavailability: 100% (IV)
Tmax: Immediate (IV bolus)
FoodEffect: Not applicable for IV formulation

Distribution:

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

Elimination:

HalfLife: 3-4.5 hours (terminal half-life after IV infusion)
Clearance: 0.9-1.2 L/min
ExcretionRoute: Primarily urine (35-65%) and feces (35-65%)
Unchanged: <5% (in urine)
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Pharmacodynamics

OnsetOfAction: 2-5 minutes (IV bolus)
PeakEffect: 2-7 minutes (IV bolus)
DurationOfAction: 1-3 hours (IV bolus), dependent on infusion rate

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

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 medical help right away:

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
+ 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, which can be 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. 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 or seek medical help:

 Irritation at the injection site

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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 lightheadedness
  • Fainting
  • Very slow heart rate
  • Difficulty breathing or shortness of breath
  • New or worsening swelling in the legs or ankles
  • Chest pain
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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 allergic reaction you experienced.
 Certain types of abnormal heart rhythms, as this medication is not suitable for individuals with these conditions. If you are unsure, consult your doctor or pharmacist for guidance.
Specific health conditions, including:
+ Fluid accumulation in the lungs
+ Low blood pressure
+ Recent heart attack
 If you are currently taking any of the following medications:
+ Ivabradine
+ Rifampin

Please note that 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. This will help ensure your safety while taking this medication. 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.

As directed by your doctor, regularly monitor your blood pressure and heart rate. You may need to undergo an electrocardiogram (ECG) before initiating this medication and during treatment. Discuss this 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 consume grapefruit juice or eat grapefruit regularly, 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:

  • Severe hypotension (very low blood pressure)
  • Profound bradycardia (very slow heart rate)
  • AV block (heart block)
  • Asystole (cardiac arrest)
  • Heart failure
  • Cardiogenic shock

What to Do:

Immediate medical attention is required. Call 911 or emergency services. Treatment may include IV fluids, vasopressors (e.g., norepinephrine, dopamine), atropine, calcium gluconate, glucagon, and cardiac pacing. Activated charcoal may be considered for recent oral overdose.

Drug Interactions

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Contraindicated Interactions

  • Intravenous beta-blockers (especially in patients with impaired ventricular function or AV conduction abnormalities)
  • Dantrolene (risk of hyperkalemia and myocardial depression)
  • Ivabradine (additive bradycardia)
  • Patients with sick sinus syndrome, 2nd or 3rd degree AV block (unless paced), severe hypotension (<90 mmHg systolic), or cardiogenic shock.
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Major Interactions

  • Amiodarone (increased risk of bradycardia, AV block, hypotension)
  • Digoxin (increased digoxin levels, increased risk of bradycardia, AV block)
  • Fentanyl (increased risk of hypotension, bradycardia)
  • Statins (e.g., simvastatin, lovastatin - increased statin levels due to CYP3A4 inhibition, leading to increased risk of myopathy/rhabdomyolysis)
  • Other antiarrhythmics (additive effects on heart rate, conduction, contractility)
  • Other antihypertensives (additive hypotensive effects)
  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir - increased diltiazem levels)
  • CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine - decreased diltiazem levels)
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Moderate Interactions

  • Benzodiazepines (e.g., midazolam, triazolam - increased benzodiazepine levels)
  • Cyclosporine (increased cyclosporine levels)
  • Tacrolimus (increased tacrolimus levels)
  • Theophylline (increased theophylline levels)
  • Grapefruit juice (oral, but relevant for general drug interaction profile - increases diltiazem levels)
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Minor Interactions

  • Cimetidine (may increase diltiazem levels slightly)
  • Ranitidine (no significant interaction)

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and monitor for hypotension.

Timing: Prior to administration

Heart Rate (HR)

Rationale: To establish baseline and monitor for bradycardia.

Timing: Prior to administration

Electrocardiogram (ECG)

Rationale: To assess baseline rhythm, PR interval, and QTc interval; identify pre-existing conduction abnormalities.

Timing: Prior to administration

Renal Function (BUN, Creatinine)

Rationale: To assess kidney function, though dose adjustment is not typically needed, it's important for overall patient assessment.

Timing: Prior to administration

Hepatic Function (ALT, AST, Bilirubin)

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

Timing: Prior to administration

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Routine Monitoring

Blood Pressure (BP)

Frequency: Continuous during IV bolus and infusion, then frequently (e.g., every 5-15 minutes initially, then hourly once stable)

Target: Individualized, typically SBP >90 mmHg

Action Threshold: SBP <90 mmHg or significant drop from baseline; consider reducing infusion rate, discontinuing, or administering vasopressors.

Heart Rate (HR)

Frequency: Continuous during IV bolus and infusion, then frequently (e.g., every 5-15 minutes initially, then hourly once stable)

Target: Individualized, typically 60-100 bpm for rate control

Action Threshold: HR <50 bpm or symptomatic bradycardia; consider reducing infusion rate, discontinuing, or administering atropine/pacing.

Electrocardiogram (ECG) - Rhythm and PR interval

Frequency: Continuous during IV bolus and infusion, then frequently (e.g., every 5-15 minutes initially, then hourly once stable)

Target: Normal sinus rhythm or controlled atrial fibrillation/flutter; PR interval <0.20 seconds or no significant prolongation

Action Threshold: Development of 2nd or 3rd degree AV block, significant PR prolongation (>0.24 seconds), or new arrhythmias; discontinue infusion.

Signs/Symptoms of Heart Failure

Frequency: Daily, or more frequently if clinically indicated

Target: Absence of dyspnea, peripheral edema, crackles, or worsening of pre-existing heart failure symptoms

Action Threshold: New onset or worsening of heart failure symptoms; discontinue diltiazem.

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Symptom Monitoring

  • Dizziness
  • Lightheadedness
  • Fainting
  • Shortness of breath
  • Chest pain
  • Swelling in ankles or feet
  • Unusual fatigue
  • Palpitations

Special Patient Groups

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Pregnancy

Category C. Diltiazem should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It has been shown to be teratogenic in animal studies at doses higher than human therapeutic doses.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity observed in animal studies; human data limited.
Second Trimester: Limited human data; use with caution.
Third Trimester: Limited human data; use with caution. May affect fetal heart rate.
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Lactation

L3 (Moderate risk). Diltiazem is excreted into breast milk. Monitor breastfed infants for signs of bradycardia, hypotension, or other adverse effects. Consider alternative medications or temporary cessation of breastfeeding if necessary.

Infant Risk: Moderate risk; potential for bradycardia, hypotension, and other cardiovascular effects in the infant.
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Pediatric Use

Generally not recommended for routine use in neonates, infants, or young children due to the high risk of severe adverse effects, including profound hypotension, bradycardia, and asystole. Limited use for supraventricular tachycardia (SVT) in older children in critical care settings, but with extreme caution and lower doses, and only when other agents (e.g., adenosine, beta-blockers) are ineffective or contraindicated.

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Geriatric Use

Elderly patients may be more sensitive to the hypotensive and bradycardic effects of diltiazem. Start with lower doses and titrate slowly with close monitoring of blood pressure and heart rate. Increased risk of falls due to orthostatic hypotension.

Clinical Information

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Clinical Pearls

  • IV diltiazem is primarily used for acute rate control in atrial fibrillation/flutter and for rapid blood pressure reduction in hypertensive emergencies.
  • Always administer IV bolus slowly (over 2 minutes) to minimize the risk of sudden hypotension and severe bradycardia.
  • Continuous ECG and blood pressure monitoring are essential during IV administration and titration.
  • Do not administer to patients with sick sinus syndrome, second- or third-degree AV block (unless a functional pacemaker is in place), severe hypotension (<90 mmHg systolic), or cardiogenic shock.
  • Use with extreme caution in patients with left ventricular dysfunction or heart failure, as diltiazem has negative inotropic effects.
  • Avoid concomitant intravenous beta-blocker administration due to the synergistic risk of severe bradycardia, AV block, and myocardial depression.
  • Ensure adequate IV access and have resuscitation equipment readily available.
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Alternative Therapies

  • For Atrial Fibrillation/Flutter Rate Control: Beta-blockers (e.g., metoprolol, esmolol), Adenosine (for SVT), Amiodarone (for rhythm control or refractory rate control).
  • For Hypertensive Emergency: Labetalol, Nicardipine, Esmolol, Sodium Nitroprusside, Fenoldopam.
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Cost & Coverage

Average Cost: Varies, typically $10-$50 per 10ml vial (50mg)
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 the reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional or pharmacist, do not flush medications down the toilet or pour them down the drain. If you are unsure about the correct 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, so it is a good idea to check with your pharmacist. If you have any questions or concerns about your medication, do not hesitate to 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 it happened, as this will aid in receiving appropriate care.