Corvert 1mg/10ml Inj, 10ml

Manufacturer PFIZER U.S. Active Ingredient Ibutilide(i BYOO ti lide) Pronunciation i BYOO ti lide
WARNING: This drug is only used in certain people to treat atrial fibrillation or atrial flutter. Other abnormal heartbeats have happened with this drug. This can be deadly. Talk to the doctor if you have any questions about this drug.Your doctor will watch your heartbeat with a test called an ECG.If you have had atrial fibrillation for more than 2 to 3 days, you may need to take a blood thinner. Talk with your doctor. @ COMMON USES: It is used to treat certain types of abnormal heartbeat (atrial fibrillation, atrial flutter).
đŸˇī¸
Drug Class
Antiarrhythmic
đŸ§Ŧ
Pharmacologic Class
Class III Antiarrhythmic
🤰
Pregnancy Category
Category C
✅
FDA Approved
Aug 1995
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Ibutilide is a medication given by injection into a vein to help convert an irregular heart rhythm, specifically atrial fibrillation or atrial flutter, back to a normal heart rhythm. It works by affecting the electrical signals in your heart. Because it can cause serious side effects, you will be closely monitored with an EKG during and after the infusion.
📋

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 appropriate storage method.

If you miss a dose, contact your doctor immediately to receive guidance on the next steps to take.
💡

Lifestyle & Tips

  • You will be closely monitored in a hospital setting during and after receiving this medication.
  • Report any new or worsening symptoms, such as dizziness, lightheadedness, or feeling your heart race, immediately to your healthcare provider.
💊

Available Forms & Alternatives

Available Strengths:

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: 1 mg IV over 10 minutes; may repeat 1 mg IV once after 10 minutes if initial dose is ineffective.
Dose Range: 0.01 - 2 mg

Condition-Specific Dosing:

weightLessThan60kg: 0.01 mg/kg IV over 10 minutes; may repeat 0.01 mg/kg IV once after 10 minutes if initial dose is ineffective.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended
Moderate: No specific adjustment recommended
Severe: No specific adjustment recommended
Dialysis: Considerations: Not significantly removed by dialysis; use with caution due to potential accumulation of metabolites, though active metabolites are not known.

Hepatic Impairment:

Mild: No specific adjustment recommended
Moderate: No specific adjustment recommended
Severe: No specific adjustment recommended

Pharmacology

đŸ”Ŧ

Mechanism of Action

Ibutilide is a Class III antiarrhythmic agent that selectively prolongs the cardiac action potential by slowing repolarization. Its primary electrophysiologic effect is the blockade of the rapid component of the delayed rectifier potassium current (IKr). It also activates a slow inward sodium current, which contributes to the prolongation of the action potential duration and refractoriness in atrial and ventricular tissue.
📊

Pharmacokinetics

Absorption:

Bioavailability: 100%
Tmax: Not applicable (IV administration)
FoodEffect: Not applicable (IV administration)

Distribution:

Vd: 11 Âą 4 L/kg
ProteinBinding: 40%
CnssPenetration: Limited

Elimination:

HalfLife: 6 Âą 4 hours (range 2-12 hours)
Clearance: 25 Âą 7 L/hr/kg
ExcretionRoute: Renal (82%), Fecal (19%)
Unchanged: <1%
âąī¸

Pharmacodynamics

OnsetOfAction: Within 20-90 minutes (for conversion)
PeakEffect: Within 1 hour
DurationOfAction: Up to 4 hours, but QTc prolongation can persist longer

Safety & Warnings

âš ī¸

BLACK BOX WARNING

Ibutilide can cause potentially fatal arrhythmias, particularly Torsades de Pointes (TdP). This risk is increased in patients with structural heart disease, left ventricular dysfunction, or electrolyte abnormalities (hypokalemia, hypomagnesemia). Patients should be continuously monitored with ECG for at least 4 hours after infusion or until QTc returns to baseline. Resuscitation equipment and personnel trained in the management of TdP must be readily available.
âš ī¸

Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when 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
Chest pain or pressure
Fast or slow heartbeat
Abnormal heartbeat that is new or worsening
* Dizziness or fainting

Other Possible Side Effects

Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have any side effects that bother you or do not go away, contact your doctor for advice.

Reporting Side Effects

Not all possible side effects are listed here. If you have questions or concerns about side effects, talk 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.
🚨

Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or fainting
  • New or worsening palpitations (feeling your heart beat fast or irregularly)
  • Shortness of breath
  • Chest pain
📋

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 health conditions, including:
+ Long QT interval on an electrocardiogram (ECG)
+ Low magnesium levels
+ Low potassium levels
If you are taking any medications for an abnormal heartbeat or drugs that can cause a prolonged QT interval, a specific type of abnormal heartbeat. There are many medications that can have this effect, so ask your doctor or pharmacist if you are unsure.
If you are breastfeeding. Note that you should not breastfeed while taking this medication.

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 determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
âš ī¸

Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are pregnant or planning to become pregnant, notify your doctor promptly. You and your doctor will need to discuss the potential benefits and risks associated with using this medication during pregnancy to make an informed decision.
🆘

Overdose Information

Overdose Symptoms:

  • Prolonged QT interval
  • Torsades de Pointes
  • Ventricular tachycardia
  • Ventricular fibrillation
  • Bradycardia
  • Hypotension

What to Do:

Treatment is supportive. Discontinue infusion. Correct electrolyte imbalances (especially hypokalemia, hypomagnesemia). For Torsades de Pointes, administer IV magnesium sulfate, overdrive pacing, or electrical cardioversion/defibrillation. Call 1-800-222-1222 (Poison Control).

Drug Interactions

🔴

Major Interactions

  • Class Ia antiarrhythmics (e.g., quinidine, procainamide, disopyramide)
  • Other Class III antiarrhythmics (e.g., amiodarone, sotalol, dofetilide)
  • Phenothiazines
  • Tricyclic antidepressants
  • Macrolide antibiotics (e.g., erythromycin, clarithromycin)
  • Fluoroquinolone antibiotics (e.g., moxifloxacin, levofloxacin)
  • Certain antihistamines (e.g., terfenadine, astemizole - largely off market)
  • Drugs that prolong the QT interval
  • Drugs that cause hypokalemia (e.g., loop diuretics, thiazide diuretics, laxatives)
  • Drugs that cause hypomagnesemia
🟡

Moderate Interactions

  • Digoxin (may increase risk of proarrhythmia in presence of hypokalemia)
  • Beta-blockers (may reduce efficacy of ibutilide in converting AF/AFL)
âš ī¸

Confidence Interactions

Monitoring

đŸ”Ŧ

Baseline Monitoring

Electrocardiogram (ECG)

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

Timing: Prior to administration

Serum Potassium (K+)

Rationale: Hypokalemia increases the risk of proarrhythmia (Torsades de Pointes). Must be corrected prior to administration.

Timing: Prior to administration

Serum Magnesium (Mg++)

Rationale: Hypomagnesemia increases the risk of proarrhythmia (Torsades de Pointes). Must be corrected prior to administration.

Timing: Prior to administration

📊

Routine Monitoring

Continuous ECG monitoring

Frequency: During infusion and for at least 4 hours post-infusion (or until QTc returns to baseline)

Target: Not applicable (monitor for proarrhythmia, especially TdP)

Action Threshold: Discontinue infusion immediately if sustained or non-sustained ventricular tachycardia or Torsades de Pointes occurs. Initiate appropriate antiarrhythmic therapy (e.g., IV magnesium sulfate).

Vital Signs (BP, HR, RR)

Frequency: Frequently during and after infusion

Target: Within normal limits for patient

Action Threshold: Significant changes may indicate adverse reaction or hemodynamic instability.

Serum Electrolytes (K+, Mg++)

Frequency: Repeat if abnormal at baseline or if clinically indicated

Target: Maintain within normal limits (K+ >4.0 mEq/L, Mg++ >2.0 mEq/L)

Action Threshold: Correct abnormalities promptly.

đŸ‘ī¸

Symptom Monitoring

  • Palpitations
  • Dizziness
  • Lightheadedness
  • Syncope
  • Chest pain
  • Shortness of breath

Special Patient Groups

🤰

Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm, but human data are lacking.
Second Trimester: Potential for fetal harm, but human data are lacking.
Third Trimester: Potential for fetal harm, but human data are lacking.
🤱

Lactation

Caution advised. It is not known whether ibutilide is excreted in human milk, but it is excreted in the milk of lactating rats. Due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: Moderate risk (potential for proarrhythmia, though systemic exposure in infant is likely low).
đŸ‘ļ

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended.

👴

Geriatric Use

No specific dose adjustment is required based solely on age. However, elderly patients may have reduced renal function or multiple comorbidities, which could affect drug clearance or increase susceptibility to adverse effects. Monitor renal function and electrolytes closely.

Clinical Information

💎

Clinical Pearls

  • Ibutilide is highly effective for acute conversion of recent-onset atrial fibrillation and flutter, especially flutter.
  • Always correct hypokalemia and hypomagnesemia prior to administration to minimize the risk of Torsades de Pointes.
  • Continuous ECG monitoring is mandatory during and for at least 4 hours after infusion (or until QTc returns to baseline) due to the significant risk of proarrhythmia, particularly TdP.
  • Resuscitation equipment, including a defibrillator, and personnel trained in the management of TdP must be immediately available.
  • If TdP occurs, IV magnesium sulfate is the first-line treatment, followed by overdrive pacing or electrical cardioversion if necessary.
  • Consider electrical cardioversion as an alternative, especially in hemodynamically unstable patients or when rapid conversion is critical.
🔄

Alternative Therapies

  • Electrical cardioversion
  • Amiodarone (IV)
  • Dofetilide (IV)
  • Procainamide (IV)
  • Sotalol (IV)
  • Flecainide (IV - off-label for acute conversion)
  • Propafenone (IV - off-label for acute conversion)
💰

Cost & Coverage

Average Cost: Check current market price per 10ml vial
Generic Available: Yes
Insurance Coverage: Specialty/Tier 3 (for brand), Tier 1/2 (for generic)
📚

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 use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of 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 otherwise, do not flush medications down the toilet or drain, as this can harm the environment. Many communities offer 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, the amount, and the time it was taken to ensure prompt and effective treatment.