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LANOXIN INJECTION

Active substance(s): DIGOXIN

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62000000018104

GSK-ITA-Parma-ITPAR

Aspen; United Kingdom-GBR

Lanoxin

N/A

D10071LEA

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N/A

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6200000
0018104

Lanoxin Injection

Package Leaflet: Information for the User
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. .

digoxin
Read all of this leaflet carefully before you start
using this medicine because it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions ask your doctor,
pharmacist or nurse.
- This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
- If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Lanoxin is and what it is used for
2. What you need to know before you use Lanoxin Injection
3. How to use Lanoxin Injection
4. Possible side effects
5. How to store Lanoxin Injection
6. Contents of the pack and other information

1. What Lanoxin Injection is and what
it is used for
Lanoxin contains the active substance digoxin, which
belongs to a group of medicines called cardiac glycosides. It
is used to treat arrhythmias and heart failure. An
arrhythmia is an irregularity in the heart-beat, which causes
the heart to skip a beat, beat irregularly or beat at the
wrong speed. This medicine works by correcting irregular
heartbeats to a normal rhythm and strengthens the force of
the heart-beat, which is why it is useful in heart failure.

2. What you need to know before
you use Lanoxin Injection
Do not use Lanoxin Injection if you:
- Are allergic to digoxin, other cardiac
glycosides or any of the other ingredients of
this medicine (listed in section 6).
- Have serious heart problems, such as those
with the conduction of the electrical
impulses in the heart, especially if you have
a history of Stokes-Adams attacks (abrupt,
short-lived loss of consciousness caused by
a sudden change in heart rate or rhythm).
- Have an irregular heart-beat caused by
cardiac glycoside intoxication or conditions
such as Wolff-Parkinson-White syndrome.
- Have obstructive cardiomyopathy
(enlargement of the heart muscle).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using this
medicine:
- If you are taking this medicine, your doctor may ask you
to have regular blood tests to determine the amount of
Lanoxin Injection in the blood. This may be useful in the
case of patients with kidney disorders.
- If you develop digoxin toxicity, this can lead to various
forms of heart rhythm disturbances, some of which
resemble the rhythm disturbances for which the product
was prescribed.
- If you have abnormal heart rhythm (heart block) and you
are taking this medicine, contact your doctor immediately
if you feel one or more of the following symptoms:
fainting, short-lasting loss of consciousness, dizziness or
light-headedness, fatigue (tiredness), shortness of breath,
chest pain, irregular heart-beat or confusion.
- If you have a sinoatrial disorder (a disorder in the
conduction of electrical impulses in the heart such as
Sick Sinus Syndrome), in some patients with a sinoatrial
disorder this medicine can cause a slow and/or irregular
heart-beat. Sometimes this will cause tiredness,
weakness and dizziness and when your heartbeat is very
slow you may faint.
- If you have recently suffered a heart attack.
- When heart failure occurs along with the collection of an
abnormal protein in the heart tissue (cardiac
amyloidosis), an alternative therapy may be prescribed
by the doctor.
- If you have myocarditis (inflammation of the heart
muscle) this may cause vasoconstriction (narrowing of
the blood vessels) on rare occasions. Your doctor may
prescribe you a different medicine.
- If you have Beri-beri disease (caused by a vitamin B1
deficiency).
- If you have constrictive pericarditis (inflammation of the
sac which contains the heart).
- If you are taking diuretics (drugs which promote urine
production and help reduce the amount of water in your
body) with or without an ACE inhibitor (mainly used to
treat high blood pressure), your doctor will prescribe a
lower dose of Lanoxin. Do not stop taking Lanoxin
without talking to your doctor.
- If you have a heart test called an ECG
(electrocardiogram), tell the person doing the test that
you are taking Lanoxin as it can affect the meaning of
the results.
- If you have severe respiratory (lung) disease (as you may
have an increased sensitivity to Lanoxin)
- If you have low levels of oxygen reaching certain parts
of your body, low levels of potassium, abnormally low
levels of magnesium or increased levels of calcium in
your blood
- If you have thyroid disease (such as an under-active or
over-active thyroid) as you might require changes in the
dose of this medicine
- If you have malabsorption syndrome (you cannot absorb
minerals from your food properly) or if you have ever
had gastro-intestinal reconstruction surgery
- If you will receive electric shock treatment to correct an
abnormal heart-beat.
Other medicines and Lanoxin Injection
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. Taking
several medicines can sometimes have harmful
consequences or lead to unwanted interactions.
Sensitivity to Lanxoin can be increased by medicines which
lower the level of potassium in the blood. These include:
- diuretics
- lithium salts (antidepressants),
- corticosteroid based products,
- carbenoxolone (a product which strengthens the gastric
mucosa).

No

The following medicines increase the level of Lanoxin in the
blood, which can increase the risk of toxicity:
- certain products which affect the heart: amiodarone,
flecainide, prazosin, propafenone, quinidine,
- certain antibiotics: erythromycin, clarithromycin,
tetracycline, gentamicin, trimethoprim,
- itraconazole (used to treat fungal infections),
- spironolactone (a drug which increases the amount of
urine you produce),
- alprazolam (a sedative which may be used to treat
anxiety),
- indomethacin (used to treat inflammation),
- quinine (may be used to prevent malaria infection),
- propantheline (used to prevent muscle spasms),
- nefazodone (an antidepressant),
- atorvastatin (lowers blood cholesterol),
- cyclosporine (an immunosuppressant often used to
prevent transplant rejection),
- epoprostenol (used to treat pulmonary arterial
hypertension),
- tolvaptan (used to treat low blood sodium levels)
- conivaptan (used to treat low blood sodium levels),
- carvedilol (used to treat mild to severe congestive heart
failure and high blood pressure),
- ritonavir (used to treat HIV infection and AIDS),
- taleprevir (used to treat hepatitis C infection),
- dronedarone (used to treat irregular heart-beat),
- ranolazine (used to treat chest pain),
- telmisartan (used to treat high blood pressure),
- lapatinib (used to treat breast cancer),
- ticagrelor (used to prevent heart attack or stroke),
- verapamil (used to treat high blood pressure),
- felodipine (used to treat high blood pressure),
- tiapamil (used to treat chest pain),
- P-glycoprotein inhibitors.
The following medicines may increase or have no effect on
the levels of Lanoxin in the blood:
- nifedipine, diltiazem, angiotensin receptor blockers
(ARBs) and ACE inhibitors (used to treat high blood
pressure and congestive heart failure),
- non-steroidal anti-inflammatory drugs (NSAIDs) and
cyclooxygenase-2 enzyme (COX-2) inhibitors (used to
treat pain and inflammation).
If you have heart failure and are taking sennosides
(increase the amount of stools you produce to help you
have bowel movements) along with Lanoxin you may have
a moderately increased risk of digoxin toxicity.
The following medicines reduce the level of Lanoxin in the
blood:
- antacids (used to treat gastric acidity),
- some bulk-forming laxatives (increase the amount of
stools you produce to help you have bowel movements),
- kaolin-pectin (used to treat diarrhoea),
- acarbose (used to treat some types of diabetes),
- certain antibiotics: neomycin, penicillamine, rifampicin,
- some cytostatic drugs (used as chemotherapy for cancer
treatment),
- metoclopramide (a product for treating nausea and
vomiting),
- sulfasalazine (a product to counteract inflammatory
diseases of the intestine),
- adrenaline (used to treat severe allergic reactions),
- salbutamol (a product used to treat asthma),
- colestyramine (lowers blood cholesterol),
- phenytoin (used to treat epilepsy),
- St. John’s wort (Hypericum perforatum) (used to treat
depression),
- bupropion (used to treat depression),
- P-glycoprotein inducers,
- supplemental enteral nutrition (being fed by
a feeding tube).
If you are taking Lanoxin along with the
following medicines you may have an increased
risk of irregular heart rhythm:
- intravenous calcium
- beta-blockers
- sympathomimetics (used to treat heart
attack and low blood pressure),
If you are taking Lanoxin and suxamethonium (used to help
muscle relaxation and treat short-term paralysis), you may
have an increased risk of high potassium levels in the blood.
Pregnancy, breastfeeding and fertility
Pregnancy
Your doctor will prescribe this medicine with caution during
pregnancy.
You may require a higher dose of this medicine if you are
pregnant.
This medicine could be given to the mother to treat
abnormally high heart rate and congestive heart failure in
the unborn child.
Side effects of Lanoxin treatment affecting the mother may
also affect the unborn child.
Breastfeeding
This medicine is excreted in breast milk, but in very small
amounts. Therefore, this medicine can be used by women
who are breast-feeding.
Fertility
There is no information available on the effect of Lanoxin
on fertility.
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Driving and using machines
Since dizziness and blurred or yellow vision have been
reported, you should exercise caution before driving a
vehicle, using machinery or participating in dangerous
activities.
Lanoxin Injection contains ethanol and sodium
Ethanol:
• This medicine contains less than 0.2 ml of ethanol
(alcohol) in each 2 ml (0.5 mg digoxin) ampoule, i.e. up
to 176 mg of ethanol per ampoule, equivalent to
approximately 5 ml (one teaspoon) of beer, or less than
2 ml of wine. Depending on the dose the amount of
ethanol will vary. Harmful to those suffering from
alcoholism. Ask your doctor to explain this further if
your child is taking this medicine. To be taken into
account in pregnant or breast-feeding woman,
.
children and high-risk groups such as patients
. .
with liver disease, or epilepsy.

Sodium:
• This medicine contains less than 1 mmol sodium (23 mg)
per dose, i.e. essentially sodium free.

3. How to take Lanoxin Injection
This medicine is available as an injectable intravenous
administration.
Always use this medicine exactly as your doctor has told
you. Check with your doctor if you are not sure.
Your doctor will have decided how much of this medicine is
right for you:
- It depends on what heart problem you have and how
serious it is
- It also depends on your age, weight and how well your
kidneys work
- While you are taking this medicine, your doctor will take
regular blood tests. This is to determine how you are
responding to treatment.
- Your doctor will adjust your dose based on your blood
test results and on how you are responding to
treatment. This is why you must strictly adhere to the
treatment course prescribed your doctor.
- If you have taken another cardiac glycoside in the past
2 weeks, your doctor may prescribe a lower dose.
- If you feel that the effect of this medicine is too strong
or too weak, talk to your doctor or pharmacist.
Taking this medicine
You usually take this medicine in two stages:
• Stage 1 - loading dose
The loading dose gets your Lanoxin levels up to the correct
level quickly. You will either:
- take one large single dose and then begin your
maintenance dose or
- take a smaller dose each day for a week and then begin
your maintenance dose
• Stage 2 - maintenance dose
After your loading dose you will take a much smaller dose
every day, until your doctor tells you to stop.
Intravenous Administration
Each dose of Lanoxin Injection should be given as a slow
infusion into a vein over a period of 10 to 20 minutes.
Your doctor will discuss the best method of treatment
for you.
Adults and children over 10 years
• loading dose
- Usually between 0.5 mg and 1.0 mg
- This should be given in divided doses. Around half
of the total loading dose will be given to you in the
first injection and the rest of the loading dose may
be split into several injections which will be given
to you between 4 and 8 hours apart
• maintenance dose
- Your doctor will decide this, depending on your
response to Lanoxin
- Usually between 0.125 and 0.25 mg daily
Children under 10 years
• loading dose
- This is worked out using your child’s weight
- Usually between 0.020 mg and 0.035 mg per kg of
bodyweight
- This should be given in divided doses. Around half of
the total loading dose will be given to your child in
the first injection and the rest of the loading dose
may be split into several injections which will be
given to them between 4 and 8 hours apart
• maintenance dose
- The doctor will decide this, depending on your child’s
response to Lanoxin
- Usually a 1/5 (fifth) or a 1/4 (quarter) of the loading
dose daily
Elderly
Elderly people may be given a lower dose than
the usual adult dose. This is because older
people may have reduced kidney function. Your
doctor will check the levels of Lanoxin in your
blood and may change your dose if necessary.
If you use more Lanoxin Injection than you
should
As Lanoxin Injection is administered under the
supervision of a doctor, it is unlikely that you
will be given more or less than is necessary.
However, if you have any concerns about the
dose of your medicine discuss them with your
doctor.
The main symptoms of Lanoxin toxicity are heart rhythm
disturbances and gastrointestinal symptoms which may
happen before heart rhythm disturbances.
Gastrointestinal symptoms include loss of appetite,
nausea and vomiting. Other symptoms of Lanoxin toxicity
include dizziness, fatigue, a general feeling of being
unwell and various neurological disturbances including
visual disturbances (more yellow-green than usual). The
neurological and visual symptoms may persist even after
other signs of toxicity have been resolved. In chronic
toxicity, non-heart related symptoms, such as weakness
and a general feeling of being unwell, may be the main
symptoms.
If you forget to use Lanoxin Injection
Do not take a double dose to make up for the forgotten
dose.
If you stop using Lanoxin Injection
Your doctor will tell you how long you should take Lanoxin.
Do not stop your treatment early without consulting your
doctor.

Uncommon (may affect up to 1 in 100 people)
- depression

.
. .

Very rare (may affect up to 1 in 10,000 people)
- decrease in blood platelets (symptoms include bruises
and nose bleeds)
- loss of appetite (anorexia)
- psychosis, apathy, confusion
- headache
- stomach pain caused by lack of blood supply or damage
to your intestines (ischaemia and necrosis)
- enlarged breast tissue in men (gynaecomastia)
- lack of energy (fatigue), a general feeling of being
unwell and weakness
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via the
Yellow Card Scheme:
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of medicine.

5. How to store Lanoxin Injection
• K
 eep out of the reach and sight of children.
• Do not use Lanoxin after the expiry date on carton or
the ampoule label (Exp.). The expiry date refers to the
last day of that month. It would have been checked by
your doctor or nurse.
• Do not store above 25°C.
• Store in the original container.
• Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help to protect the environment.

6. Contents of the pack and other
information
What Lanoxin Injection contains
• The active ingredient is digoxin, each 2 ml contains
0.5 mg (500 micrograms).
• The other ingredients are ethanol, propylene glycol,
citric acid, sodium phosphate and Water for Injections.
What Lanoxin Injection looks like and contents of the
pack
Each carton contains 5 clear glass ampoules of a clear and
colourless solution.
Marketing Authorisation Holder and
Manufacturer
Product licence held by
Aspen Pharma Trading Limited,
3016 Lake Drive,
Citywest Business Campus, Dublin 24, Ireland
Service-Tel: +800 00404142
Manufactured by GlaxoSmithKline Manufacturing S.p.A.,
San Polo di Torrile, Parma, Italy
PL 39699/0006
Leaflet date: December 2013

The following information is intended for healthcare
professionals only.
Handling Instructions
Dilution of Lanoxin Injection
Lanoxin Injection can be administered undiluted or diluted
with a 4-fold or greater volume of 0.9% Sodium Chloride
Injection, 0.18 % Sodium Chloride/4% Glucose Injection or
5% Glucose Injection. A 4-fold volume of diluent equates to
adding one 2 ml ampoule of digoxin to 6 ml of injection
solution. The use of less than a 4-fold volume of diluent
could lead to precipitation of digoxin.
Lanoxin Injection, when diluted in the ratio of 1 to 250 is
known to be compatible with the following infusion
solutions;
• S odium Chloride I.V. Infusion, B.P., 0.9 % w/v.
• Sodium Chloride (0.18 % w/v) and Glucose (4 % w/v)
I.V. Infusion, B.P.
• Glucose I.V. Infusion, B.P., 5 % w/v.
A ratio of 1 to 250 can be obtained for example by diluting
one 2 ml ampoule with 500 ml of infusion solution.
Dilution should be carried out either under full aseptic
conditions immediately before use. Any unused solution
should be discarded
Administration of Lanoxin Injection:
Each dose should be given by I.V. infusion over 10 to
20 mins.
The total loading dose should be administered in divided
doses with approximately half of the total dose given as the
first dose and further fractions of the total dose given at
intervals of four to eight hours. An assessment of clinical
response should be performed before giving each
additional dose.
The I.M. route is painful and is associated with muscle
necrosis. This route cannot be recommended.
Rapid I.V. injection can cause vasoconstriction producing
hypertension and/or reduced coronary flow. A slow
injection rate is therefore important in hypertensive heart
failure and acute myocardial infarction.

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If you get any of the following, talk to your specialist doctor
straight away or seek urgent medical advice:
Very rare (may affect up to 1 in 10,000 people)
- palpitations, chest pain, shortness of breath or
sweating. These can be symptoms of a serious heart
problem caused by new irregular heartbeats
Other side effects may include:
Common (may affect up to 1 in 10 people)
- allergic reactions of the skin may occur (rash, urticaria)
- abnormal heart-beat
- nausea, vomiting, diarrhoea
- central nervous system disturbances such as dizziness
- visual disturbances (blurred or yellow vision)

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6200000
0018104

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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