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Format in Drug Study
Format in Drug Study
PEDIATRIC:
injectable solution
50mg/mL
150mg/100mL
(Nexterone)
360mg/200mL
(Nexterone)
tablet
100mg
200mg
400mg
Drug Resistant
Refractory Cardiac
Arrhythmias (Off-
label)
PO
Age <1 year:
600-800
mg/1.73 m²
q24hr or divided
q12hr; continue
therapy for 4-14
days and/or until
adequate
control
achieved; if
initial treatment
effective,
decrease
dosage to 200-
400 mg/1.73 m²
q24hr or divided
q12hr
Age >1 year:
Until adequate
control, 10-15
mg/kg/day PO
qDay or divided
q12hr; if
effective, reduce
to 5 mg/kg/day
PO qDay or
divided q12hr
IV
Loading dose
(limited data): 5
mg/kg IV over
30-60 min
Maintenance
dose: 0.005
mg/kg/min IV
infusion; may
increase to 20
mcg/kg/min per
24 hr; consider
converting to
oral therapy
within 24-48 hr
Pulseless
Ventricular
Tachycardia or
Ventricular
Fibrillation (PALS
dosing) (Off-label)
5 mg/kg IV/IO rapid
bolus; not to exceed
300 mg/dose; may
repeat twice to
maximum 15 mg/kg
during acute
treatment
Supraventricular
Tachycardia (Off-
label)
Infants/children/
adolescents: 5 mg/kg
IV over 1 hr initially;
follow with 5
mg/kg/day for 47 hr
Maintenance: 10-20
mg/kg/day for 7-10
days; follow with 3-20
mg/kg/day
Dosing
Considerations
In a pediatric trial of
61 patients, aged 30
days to 15 years,
hypotension (36%),
bradycardia (20%),
and atrioventricular
block (15%) were
common dose-related
adverse events and
were severe or life-
threatening in some
cases
Injection site reactions
were seen in 5 (25%)
of the 20 patients
receiving amiodarone
HCI injection through
a peripheral vein,
irrespective of dose
regimen
Conventional IV
amiodarone contains
the preservative
benzyl alcohol; there
have been reports of
fatal “gasping
syndrome” in
neonates (children
aged less than 1
month) following the
administration of IV
solutions containing
the preservative
benzyl alcohol
Newer IV formulation
(Nexterone) does not
contain polysorbate 80
or benzyl alcohol
GENERIC Flecainide works ADULT: Documented, contraindicat Body as a Stomach ASSESMENT:
NAME: by blocking the tablet life- ed in patients Whole– problems.
FLECAINIDE
Nav1. 5 sodium 50mg threatening with pre- malaise, fever; Symptoms
channel in the 100mg ventricular existing Cardiovascular may include:
BRAND NAME: 150mg
heart, slowing the arrhythmias. second- or – tachycardia, constipation. .
TAMBOCOR
upstroke of the Arrhythmias Paroxysmal third-degree sinus pause or ..
DRUG cardiac action (Prevention) supraventricu AV block, or arrest; Vision
CLASSIFICATI potential. This lar with right Gastrointestina problems.
ON: thereby PSVT and paroxysmal tachycardias bundle l– vomiting,
atrial fibrillation
Symptoms
ANTIARRHYT slows conduction (PSVT), branch block diarrhea DIAGNOSIS:
50 mg PO BID; may include:
HMIC of the electrical paroxysmal when
may increase by blurred vision.
impulse within the atrial associated ...
50 mg every 4
heart, i.e. it days; do not fibrillation/flutt with a left PLANNING:
Low blood
"reduces exceed 300 er (PAF) in hemiblock
pressure.
excitability". mg/day patients (bifascicular
Symptoms
Sustained VT without block), unless
may
100 mg PO BID structural a pacemaker INTERVENTION:
include: dizzin
initiated in heart is present to
hospital; may ess. ...
disease. sustain the EVALUATION:
increase by 50 cardiac Uncontrollabl
mg every 4 rhythm e shaking of
days; do not parts of your
should
exceed 400 body, such as
mg/day
complete
heart block your hands,
Dosing Considerations occur. arms, head,
or legs.
Steady-state plasma
levels not achieved for Headache.
3-5 days, so increases
in dosage should not
be made less than
every 4 days
Loading dose not
recommended, due to
increased incidence of
proarrhythmic events
and CHF
Patients intolerant to
BID dosing may
require 8hr dosing
Once adequate
control of arrhythmia
has been achieved,
may reduce dose,
provided there is no
loss of efficacy
After 5 doses/steady
state, obtain ECG
after initiation or
change of dose;
obtain plasma trough
flecainide levels 1
hour predose
Usual trough plasma
levels: 0.2-1 mcg/mL
When given
concomitantly with
amiodarone, reduce
flecainide dose by
50% and monitor
closely
Dose cautiously in
patients with history of
MI or CHF
When switching from
another antiarrhythmic
to flecainide, allow >2-
4 plasma half-lives to
elapse before starting
flecainide; if
discontinuation of
previous drug may
produce life-
threatening
arrhythmias, consider
hospitalizing patient
Dosage Modifications
Renal impairment
Severe (<35
mL/min): 100
mg PO qDay or
50 mg PO BID
>25 mL/min:
100 mg PO BID
Hepatic impairment
Use only if
benefits
outweigh risk;
monitor plasma
levels regularly;
reduce dose as
necessary
Narcolepsy (Orphan)
Orphan designation of
a fixed dose
combination of
modafinil and
flecainide for
narcolepsy
Sponsor
Theranexus SA;
86 Rue de
Paris; Orsay,
France
PEDIATRIC:
tablet
50mg
100mg
150mg
Arrhythmias
<6 months: 50
mg/m²/day PO divided
q8-12hr
≥6 months: 100
mg/m²/day PO divided
q8-12hr
Not to exceed 200
mg/m²/day
Dosing Considerations
Usual therapeutic
level: 200-500 ng/mL;
some may require
<800 ng/mL for
adequate control
Steady-state plasma
levels not achieved for
3-5 days, so increases
in dosage should not
be made less than
every 4 days
Loading dose not
recommended, due to
increased incidence of
proarrhythmic events
and CHF
Patients intolerant to
BID dosing may
require 8hr dosing
Once adequate
control of arrhythmia
has been achieved,
may reduce dose,
provided there is no
loss of efficacy
After 5 doses/steady
state, obtain ECG
after initiation or
change of dose;
obtain plasma trough
flecainide levels 1
hour predose
Usual trough plasma
levels: 0.2-1 mcg/mL
When given
concomitantly with
amiodarone, reduce
flecainide dose by
50% and monitor
closely
Dose cautiously in
patients with history of
MI or CHF
When switching from
another antiarrhythmic
to flecainide, allow >2-
4 plasma half-lives to
elapse before starting
flecainide; if
discontinuation of
previous drug may
produce life-
threatening
arrhythmias, consider
hospitalizing patient
Dosage Modifications
Renal impairment
Severe (<35
mL/min): 100
mg PO qDay or
50 mg PO BID
>25 mL/min:
100 mg PO BID
Hepatic impairment
Use only if
benefits
outweigh risk;
monitor plasma
levels regularly;
reduce dose as
necessary
GENERIC unique mechani ADULT: CORVERT In Contraindicat that may be affecting the ASSESMENT:
NAME: sm works by an injectable solution jection is ed in patients associated with cardiovascula
IBUTILIDE
activation of a 0.1mg/mL indicated for who have the r system (e.g.,
BRAND NAME: specific inward Atrial
the rapid previously administration arrhythmogen
CORVERT sodium current, Fibrillation/Flutter conversion of demonstrated of CORVERT ic affects,
thus producing its atrial hypersensitivi was nausea, affects on
DRUG therapeutic <60 kg: 0.01 mg/kg fibrillation or ty which occurred cardiac
CLASSIFICATI response in which (0.1 mL/kg) IV infusion atrial flutter of to ibutilide fu with a conduction,
ON: a repeat after 10 recent onset marate or any frequency palpitation,
ANTIARRHYT minutes PRN
prolonged action to sinus of the other greater than hypotension, DIAGNOSIS:
HMIC >60 kg: 1 mg (one
potential vial) IV infusion, rhythm. product 1% more hypertension),
increases repeat after 10 Patients with components. in ibutilide- nausea, and
myocytes' cardiac minutes PRN atrial If you provide treated headache PLANNING:
refractoriness in arrhythmias additional patients than reported in
case of atrial Renal Impairment of longer keywords, those treated ≤5.1% of
fibrillation and Dose adjustment not duration are you may be with placebo. patients.
flutter necessary less likely to able to INTERVENTION:
respond browse
Hepatic Impairment
to CORVERT through our EVALUATION:
Dose adjustment not . database of
necessary Scientific
Response
Documents.
GENERIC ASSESMENT:
NAME:
BRAND NAME:
DRUG
CLASSIFICATI
ON:
ANTIARRHYT
DIAGNOSIS:
HMICS
PLANNING:
INTERVENTION:
EVALUATION:
GENERIC ASSESMENT:
NAME:
DIAGNOSIS:
BRAND NAME:
DRUG PLANNING:
CLASSIFICATI
ON:
ANTIARRHYT
HMICS INTERVENTION:
EVALUATION: