Ibutilide fumarate

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Ibutilide fumarate
Ibutilide fumarate
Ibutilide fumarate
(ih- BYOU-tih-lyd)
Pregnancy Category: C Corvert (Rx)

Classification: Antiarrhythmic agent

Action/Kinetics: Class III antiarrhythmic agent. Delays repolarization by activation of a slow, inward current (mostly sodium), rather than by blocking outward potassium currents (the way other class III antiarrhythmics act). This results in prolongation in the duration of the atrial and ventricular action potential and refractoriness. Also a dose-related prolongation of the QT interval. High systemic plasma clearance that approximates liver blood flow; protein binding is less than 40%. t 1/2, terminal: 6 hr. Over 80% is excreted in the urine (with 7% excreted unchanged) and approximately 20% is excreted through the feces.

Uses: For rapid conversion of atrial fibrillation or atrial flutter of recent onset to sinus rhythm. Determination of clients to receive ibutilide should be based on expected benefits of maintaining sinus rhythm and whether this outweighs both the risks of the drug and of maintenance therapy.

Contraindications: Use of certain class Ia antiarrhythmic drugs (e.g., disopyramide, quinidine, procainamide) and certain class III drugs (e.g., amiodarone and sotalol) concomitantly with ibutilide or within 4 hr of postinfusion.

Special Concerns: May cause potentially fatal arrhythmias, especially sustained polymorphic ventricular tachycardia, usually in association with QT prolongation (torsades de pointes). Effectiveness has not been determined in clients with arrhythmias of more than 90 days in duration. Breast feeding should be discouraged during therapy. Safety and efficacy have not been determined in children less than 18 years of age.

Side Effects: CV: Life-threatening arrhythmias, either sustained or nonsustained polymorphic ventricular tachycardia (torsades de pointes). Induction or worsening of ventricular arrhythmias. Nonsustained monomorphic ventricular extrasystoles, nonsustained monomorphic ventricular tachycardia, sinus tachycardia, SVT, hypotension, postural hypotension, bundle branch block, AV block, bradycardia, QT-segment prolongation, hypertension, palpitation, supraventricular extrasystoles, nodal arrhythmia, CHF, idioventricular rhythm, sustained monomorphic VT. Miscellaneous: Headache, nausea, syncope, renal failure.

Overdose Management: Symptoms: Increased ventricular ectopy, monomorphic ventricular tachycardia, AV block, nonsustained polymorphic VT. Treatment: Treat symptoms.

Drug Interactions: Amiodarone / Risk of prolonged refractoriness Antidepressants, tricyclic and tetracyclic / Risk of proarrhythmias Digoxin / Supraventricular arrhythmias due to ibutilide, may mask cardiotoxicity R/T high digoxin levels Disopyramide / Risk of prolonged refractoriness Histamine H 1 receptor antagonists / Risk of proarrhythmias Phenothiazines / Risk of proarrhythmias Procainamide / Risk of prolonged refractoriness Quinidine / Risk of prolonged refractoriness Sotalol / Risk of prolonged refractoriness

How Supplied: IV Solution: 0.1 mg/mL.

?IV Infusion Atrial fibrillation or atrial flutter of recent onset.
Clients weighing 60 kg or more, initial: 1 mg (one vial) infused over 10 min. Clients weighing less than 60 kg, initial: 0.01 mg/kg infused over 10 min. If the arrhythmia does not terminate within 10 min after the end of the initial infusion (regardless of the body weight), a second 10-min infusion of equal strength may be given 10 min after completion of the first infusion.

Ibutilide fumarate Ratings

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Ibutilide fumarate

Effectiveness: *****

Ease of Use: ***

Overall Satisfaction: ****


Nirmal, Nirmal - 01/11/2014

Hi Jamie, thanks for your comenmt. I think there might've been some technical glitch which delayed your comenmt from showing up. (unless you were talking about a separate comenmt made earlier?)There is certainly an expanded field of use with the EVG and COBI licenses. However, in the case where a new use of a patented product is found, then in some countries, this new use can be patented. However, not all countries grant these new use patents. This effectively extends the patent term over that product, and hence the license term as well. Therefore, as I see it, unless a country grants these 'new use patents', the expanded field of use is unnecessarily expanding into an area where the license is not required at all - ie, royalties need not be paid. I agree with your point that Cipla is unlikely to sign a license for TDF. And also that a 5% royalty rate on a small revenue generating (for generics) drug, is a relatively small amount. And certainly, the much bigger issue as you pointed out is that countries like Brazil have been left out.However, I would like to add 2, possibly abstract-ish, points about it:a) With the Gilead licenses probably serving as a template for future licenses, these effects should be brought to light, regardless of whether this particular instance makes much of a difference or not. Thus, it is not 'bad' that a 5% royalty is being charged, but it is a fact that must be acknowledged nonetheless. b) In the larger framework of what is an appropriate remuneration for companies making (life saving) drugs, the question of how much - is something that cannot be answered till pharma accounts are transparent (ie, never). So, while you could say that a 5% cost is barely anything, so it shouldn't make a difference, it can also be reversely put as - if it's too small to make a difference, why charge it? There will be at least one patient who will not be able to buy it because of that small increase. My point is Not that royalty shouldn't be charged at all, just that it seems like a mostly pointless exercise is defending a particular rate, when we don't have cost figures, but only look at 'access'. If we are looking only at access, then certainly a product which does not have a patent, new use or otherwise, should not have any royalty attached to it?