Lanoxin Infants 50mcg/2mL injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

digoxin, Quantity: 25 microgram/mL

Available from:

Aspen Pharma Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: ethanol; propylene glycol; citric acid; dibasic sodium phosphate; water for injections

Administration route:

Intravenous

Units in package:

5x2mL ampoules

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 26 JULY 2000 : Congestive heart failure - Lanoxin is useful regardless of whether the failure is predominantly of the left or right ventricle, or involves both sides of the heart. It is particularly useful in heart failure resulting from chronic overload (hypertension, valvular lesions, atherosclerotic heart disease) in which the supply of energy is not impaired. Lanoxin does not cause major benefit in situations in which the metabolic energy supply is compromised as in thyrotoxicosis, hypoxia, and severe thiamine deficiency. Atrial fibrillation - Because Lanoxin depresses conduction in the atrioventricular bundle, producing a slower ventricular beat, it is valuable in atrial fibrillation. It will frequently convert atrial flutter into fibrillation and, upon withdrawal of the drug, normal sinus rhythm may be restored. Paroxysmal atrial tachycardia - Lanoxin may relieve or prevent an attack, but its use in paroxysmal ventricular tachycardia is dangerous.

Product summary:

Visual Identification: Clear colourless liquid, free of obvious visible contamination.; Container Type: Ampoule; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-08-02

Patient Information leaflet

LANOXIN
®
Injection – Consumer Medicine Information
Page 1 of 4
LANOXIN
®
Injection
digoxin
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about LANOXIN
Injection. It does not contain all the
available information.
It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and
benefits
.
Your doctor has weighed the risks
of you being given LANOXIN
Injection against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT IS LANOXIN
INJECTION
LANOXIN Injection belongs to a
group of medicines known as
cardiac glycosides. They work by
slowing down the rate while
increasing the force of your heart
when it beats.
It is used to treat certain heart
problems, such as:
CHRONIC HEART FAILURE
Heart failure is when your heart
can’t pump strongly enough to
supply blood needed throughout
the whole body. It is not the same
as a heart attack and does not
mean that your heart stops.
CERTAIN TYPE OF IRREGULAR HEART
BEATS
Irregular heart rhythms caused by
an electrical problem in the upper
chamber of your heart. They cause
your heart to beat too fast or in an
uneven way.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY LANOXIN
INJECTION HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed it
for another reason.
There is no evidence that LANOXIN
Injection is addictive.
BEFORE YOU ARE GIVEN
IT
When you must not be given it
DO NOT USE LANOXIN INJECTION
IF YOU HAVE AN ALLERGY TO:
•
digoxin or other cardiac
glycosides
•
any of the ingredients listed at
the end of this leaflet.
Symptoms of an allergic reaction to
this medicine may include:
•
shortness of breath, wheezing
or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
skin rash, itching or hives
DO NOT USE LANOXIN INJECTION
IF YOU HAVE OR HAVE HAD ANY OF
THE FOLLOWING MEDICAL
CONDITIONS:

Summary of Product characteristics

LANOXIN – Product Information
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION
LANOXIN (DIGOXIN)
1.
NAME OF THE MEDICINE
Digoxin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
LANOXIN TABLETS contain DIGOXIN 0.250 MG.
Excipients with known effect:
Sugars (as lactose monohydrate)
LANOXIN PG TABLETS contain DIGOXIN 0.0625 MG. Excipients with known
effect: Sugars (as lactose monohydrate)
LANOXIN
PAEDIATRIC
ELIXIR:
Each
mL
contains
DIGOXIN
0.05
MG.
Excipients with known effect: Sugars (as sucrose), alcohol (as ethanol
10.6%
v/v)
LANOXIN ADULT INJECTION: Each 2 mL contains DIGOXIN 0.50 MG.
Excipients
with known effect: alcohol (as ethanol 10.6% v/v).
LANOXIN INFANTS INJECTION: Each 2 mL contains DIGOXIN 0.05 MG.
Excipients
with known effect: alcohol (as ethanol 10.6% v/v).
For the full list of excipients, see section 6.1 List of excipients
3.
PHARMACEUTICAL FORM
LANOXIN TABLETS - White, biconvex, round tablet scored and coded "X3A"
on the
upper face. Bottom face plain.
LANOXIN PG TABLETS - Blue, biconvex, round tablet, coded "U3A" on the
upper
face. Bottom face plain.
LANOXIN ELIXIR - Clear, bright yellow liquid with a characteristic
odour. Free of
obvious visible contamination.
LANOXIN
ADULT
INJECTION
-
Clear
colourless
liquid,
free
of
obvious
visible
contamination.
LANOXIN
INFANT
INJECTION
-
Clear
colourless
liquid,
free
of
obvious
visible
contamination.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
CONGESTIVE HEART FAILURE - Lanoxin is useful regardless of whether the
failure
is predominantly of the left or right ventricle, or involves both
sides of the
heart. It is particularly useful in heart failure resulting from
chronic overload
(hypertension, valvular lesions, atherosclerotic heart disease) in
which the
supply of energy is not impaired. Lanoxin does not cause major benefit
in
situations
in
which
the
metabolic
energy
supply
is
compromised
as
in
thyrotoxicosis, hypoxia, and severe thiamine deficiency.
ATRIAL
FIBRILLATION
-
Because
Lanoxin
depresses
conduction
in
the
atrioventricular bundle, producing a slower v