Vernakalant hydrochloride parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Infusion of vernakalant hydrochloride.
Drugs List
Therapeutic Indications
Uses
Atrial fibrillation
Dosage
Dose is by patient's body weight, with a maximum calculated dose based on 113kg.
Monitor patient for any signs or symptoms of a sudden decrease in blood pressure or heart rate during the administration period of 10 minutes - stop the infusion immediately if signs develop with or without symptomatic hypotension or bradycardia.
If conversion to sinus rhythm occurs during the initial or second infusion, continue the infusion to completion. If haemodynamically stable atrial flutter is observed after the initial infusion, the second infusion may be administered as patients may convert to sinus rhythm.
Adults
Initial infusion: 3mg/kg over a 10 minute period. Do not exceed the initial dose of 339mg (84.7ml of 4mg/ml solution).
If conversion to sinus rhythm has not occurred with initial infusion or within 15 minute observation period, a 2mg/kg second infusion should be administered over 10 minutes. The maximum second infusion of 226mg (56.5ml of 4mg/ml solution) should not be exceeded. Cumulative doses of greater than 5mg/kg should not be administered within 24 hours.
Administration
For intravenous infusion.
Contraindications
Children under 18 years
QT interval greater than 440 milliseconds at baseline
Sinus node dysfunction
Systolic blood pressure below 100mmHg
Congestive cardiac failure with LVEF below 36%
Constrictive pericarditis
Hypertrophic obstructive cardiomyopathy
New York Heart Association class III failure
New York Heart Association class IV failure
Non paced second/third degree AV block
Pregnancy
Restrictive cardiomyopathy
Severe aortic stenosis
Severe bradycardia
Severe hepatic impairment
Within 30 days of an acute coronary syndrome episode
Precautions and Warnings
Breastfeeding
New York Heart Association class I failure
New York Heart Association class II failure
Valvular heart disease
Advise ability to drive/operate machinery may be affected by side effects
Avoid intravenous Class I & III antiarrhythmics 4 hrs before or after dose
Correct hypovolaemia prior to administration
Treatment to be initiated and supervised by a specialist
Dilute and use as an infusion
Oral antiarrhythmics may be started or resumed 2 hours after treatment
Correct hypokalaemia before treatment
Monitor blood pressure during administration and for at least 15 mins after
Monitor vital signs and ECG for 2 hours from start of infusion
May convert atrial fibrillation to atrial flutter
Discontinue if hypotension occurs for any reason
Discontinue if patient develops ECG changes
Discontinue if severe bradycardia occurs
Pregnancy and Lactation
Pregnancy
Vernakalant hydrochloride is contraindicated during pregnancy.
The manufacturer does not recommend using vernakalant hydrochloride during pregnancy. Animal studies have shown malformations after repeated oral exposure. Human data is limited and as such a potential risk cannot be ruled out.
Lactation
Use vernakalant hydrochloride with caution during breastfeeding.
The manufacturer advises caution if vernakalant hydrochloride is used when breastfeeding. There is no information on the excretion of vernakalant and its metabolites in animal milk and the presence in human breast milk is unknown.
Side Effects
Atrial flutter
Bradycardia
Bundle branch block
Burning sensation
Cardiogenic shock
Chest discomfort
Choking sensation
Cold sweat
Complete AV block
Cough
Diarrhoea
Dizziness
Dry mouth
Dysgeusia
Dyspnoea
Eye irritation
Faecal urgency
Fatigue
Feeling hot
Feeling of suffocation
First degree AV block
Flushing
Headache
Hot flushes
Hyperhidrosis
Hypoaesthesia
Hypotension
Increased lacrimation
Local reaction at injection site
Malaise
Nasal congestion
Nasal discomfort
Nausea
Oral paraesthesia
Pain at application site
Painful extremities
Pallor
Palpitations
Paraesthesia
Parosmia
Prolongation of QT interval
Pruritus
Rhinorrhoea
Sinus arrest
Sinus bradycardia
Sneezing
Somnolence
Throat irritation
Vasovagal syncope
Ventricular extrasystoles
Ventricular tachycardia
Visual disturbances
Vomiting
Widened QRS complex
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: June 2019
Reference Sources
Summary of Product Characteristics: Brinavess 20mg/ml concentrate for solution for infusion. Correvio. Revised August 2018.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 06 September 2019
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.