Ibutilide fumarate- Antiarrhythmic agents
Drug Name:
Ibutilide fumarate- Antiarrhythmic agents
List Of Brands:
Indication Type Description:
Pharmacology/ Pharmacokinetics
Drug Interaction:
Concomittant antiarrythmias- Disopyramide, quinidine and procainamide and other drugs such as amiodarone and solatol should not be given concomittantly with ibutilide or within 4 hours postinfusion because of their potential to prolong refractriness.
Other drugs that prolong QT intervals- potential for proarrhythmias may increase with administration of ibutilide to patients who are being treated with drugs that prolong QT interval, such as phenothiazines, tricyclic and tetracyclic antidepressants.
Digoxin- supraventricular arrhythmias may mask the cardiotoxicity associated with excessive digoxin levels
Indication:
LIST OF NEW DRUG APPROVED FROM 01-01-2016 To TILL DATE
BY NEW DRUG DIVISION - DRUG CONTROLLER GENERAL- INDIA
Sr.No Name of Drug Indication Date of Issue
8. Ibutilide Bulk & amp 10-06-2016
Ibutilide Fumarate Injection
0.1mg/ml
For the rapid convrsion of atrial fibrillation or atrial
flutter of recent onset to sinus rhythm.
Patient with atrial arrhythmias of longer duration are
less likely to respond to Ibutilide Injection.
The effectiveness of Ibutilide has not been determined
with arrhythmias of more than 90 days in duratiom
Approved by DCG INDIA (Ref- DCGI approved List- 01-01-2016 To Till Date)
Atrial fibrillation/flutter
Antiarrhythmic agents include-
Group I - Moricizine, Qunidine, Procainamide, Disopyramide, Lidocaine, Phenytoin, Tocainide,
Mexiletine, Flecanide, Propafenone
Group II- Propranolol, Esmolol, Acebutol
Group III- Bretylium, Amiodarone, Solatol
Group IV- Verapramil, Digoxin, Adenosine
Adverse Reaction:
Drug well tolererated- important adverse events- non-sustained monomorphic ventricular extrasystoles, tachycardia/supraventricular tachycardia, nausea, palpitation, suptraventricular extrasystoles.
Contra-Indications:
Hypersensitivity to ibutilide
Special precautions:
Heart block- ibutilide treated patients with reports of reversible heart block.
Dosages/ Overdosage Etc:
Indications:
Atrial fibrillation/flutter
Dosage:
Patients more than 60kg - one vial (1mg) -initial infusion over 10 minutes less than 60kg- 0.1ml.kg (0.01mg/kg)
Pharmacology/ Pharmacokinetics:
Pharmacology:
Ibutilide is an antiarrhythmic drug with predominantly cardiac action potential prolongation. Ibutilide prolongs action potential duration in isolated adult cardiac mycocytes and increases both atrial and ventricular refractoriness in vivo.
Pharmacokinetics:
After IV infusion, ibutilide concentrations rapidly decrease in a multiexpoential fashion. The drug is cleared rapidly and highly distributed in patients being treated for atrial flutter or atrial fibrillation. The elimination half-life averages about 6 hours.
Pregnancy and lactation:
Pregnancy:
Do not administer to pregnant woman unless clinical benefit outweighs potential risks to the fetus.
Lactation:
Discourage breast feeding during therapy
Children:
Safety and efficacy in children have not been established.