LANOXIN INJECTION

העדוה העדוה

לע לע

הרמחה הרמחה

(

(

עדימ עדימ

ןולעב )תוחיטב ןולעב )תוחיטב

ל

ל

אפור אפור

ןכדועמ( ןכדועמ(

05.2013

05.2013

ךיראת

2.7.2013

םש

רישכת

תילגנאב

רפסמו

םושירה

Lanoxin Injection Reg. No. 101-75-

20033-00

םש

לעב

םושירה

:

וגירפ

לארשי

תויונכוס

מ"עב

ספוט

הז

דעוימ

טורפל

תורמחהה

דבלב

תורמחהה

תושקובמה קרפ

ןולעב טסקט

יחכונ טסקט

שדח

Special Warnings and

Special Precautions

for Use

elective

direct

current cardioversion of

a patient who is taking

digoxin, the drug should

be withheld for 24 hours

before cardioversion is

performed.

emergencies, such as

cardiac

arrest,

when

attempting cardioversion

lowest

effective

energy

should

applied.

Direct

current

cardioversion

inappropriate

treatment of arrhythmias

thought to be caused by

cardiac glycosides.

For elective direct current

cardioversion of a patient who

is taking digoxin, the drug

should be withheld for 24 hours

before

cardioversion

performed.

In emergencies,

such as cardiac arrest, when

attempting cardioversion the

lowest effective energy should

be applied.

Direct current cardioversion is

inappropriate in the treatment

of arrhythmias thought to be

caused by cardiac glycosides.

Although many patients with

chronic

congestive

cardiac

failure

benefit

from

acute

administration of digoxin, there

are some in whom it does not

lead to constant, marked or

lasting

haemodynamic

improvement. It is therefore

important

evaluate

response

each

patient

individually when Lanoxin is

continued long-term.

Herbal preparations containing

St. John’s wort (Hypericum

perfortum) should not be used

while taking Lanoxin due to the

risk

decreased

plasma

concentrations

reduced

clinical effects of Lanoxin (see

Interactions).

This

medicinal

product

contains

small

amounts

ethanol

(alcohol), less than 100mg per

dose.

Interaction with

Other Medicaments

and Other Forms of

Interaction

Milrinone does not alter

steady-state

serum

digoxin levels.

Digoxin is a substrate of

P-glycoprotein. Thus,

inhibitors of P-

glycoprotein may

increase blood

concentrations of

digoxin by enhancing its

absorption and/or by

reducing its renal

clearance (See

Pharmacokinetics).

Milrinone

does

alter

steady-state

serum

digoxin

levels.

Serum levels of digoxin can be

reduced by concomitant use of

the herbal preparations, St.

John’s wort (Hypericum

perfortum). This is due to

induction of drug metabolising

enzymes and/or P-glycoprotein

by St. John’s wort. Herbal

preparations containing St.

John’s wort should therefore

not be combined with Lanoxin.

If a patient is already taking St.

John’s wort, check digoxin

levels and stop St. John’s wort.

Digoxin levels may increase on

stopping St. John’s wort. The

dose of digoxin may need

adjusting.

Digoxin is a substrate of P-

glycoprotein. Thus, inhibitors

of P-glycoprotein may

increase blood

concentrations of digoxin by

enhancing its absorption

and/or by reducing its renal

clearance (See

Pharmacokinetics)

.