LANOXIN PG digoxin 62.5microgram tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

digoxin, Quantity: 0.0625 mg

Available from:

Aspen Pharma Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: lactose monohydrate; maize starch; magnesium stearate; povidone; indigo carmine; oxidised maize starch; rice starch

Administration route:

Oral

Units in package:

200 tablets, 60 tablets, 100 tablets (E), 500 tablets (E)

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine, Not scheduled. Not considered by committee

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: Blue, biconvex, round tablet, coded "U3A" on the upper face. Bottom face plain.; Container Type: Bottle; Container Material: Glass; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

1991-08-02

Patient Information leaflet

LANOXIN
®
Tablets and Liquid – Consumer Medicine Information
Page 1 of 5
LANOXIN
®
Tablets & Liquid
digoxin
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about LANOXIN. 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 taking LANOXIN 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
LANOXIN 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 through out
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
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
LANOXIN for another reason.
There is no evidence that LANOXIN
is addictive.
BEFORE YOU TAKE IT
When you must not take it
DO NOT TAKE LANOXIN 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
LANOXIN 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 TAKE LANOXIN IF YOU
HAVE OR HAVE HAD ANY OF THE
FOLLOWING MEDICAL CONDITIONS:
•
intermittent or complete heart
block or second degree
atrioventricular b

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