Consumer medicine information

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:

• intermittent or complete heart block or second degree atrioventricular block, (conditions where the heart misses beats) especially if there is a history of Stokes-Adams attacks
• ventricular tachycardia and ventricular fibrillation (a type of irregular heart rhythm)
• irregular heart rhythm caused by cardiac glycoside overdose
• certain other irregularities of heart rhythm.

If you are not sure whether you should be given LANOXIN Injection, talk to your doctor or pharmacist.

Do not use LANOXIN Injection after the expiry date (EXP) printed on the pack.

Do not use it if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

Before you start to use it

Tell your doctor if you have allergies to:

• any other medicines
• any other substances, such as foods, preservatives or dyes.

Tell your doctor if you are pregnant or intend to become pregnant. Pregnant women may require an adjustment of the dose of this medicine during pregnancy. It may have harmful effects on the developing baby if the dose is too high.

Tell your doctor if you are breast-feeding or plan to breast-feed.

Tell your doctor if you have or have had any medical conditions, especially the following:

• heart disease
• heart disease caused by lack of vitamin B, known as ‘Beri-Beri disease’
• lung problems
• liver or kidney problems – effect of LANOXIN Injection may be increased because of slower removal from the body
• thyroid disease – patients with low or high thyroid gland activity may be more or less sensitive to the effects of LANOXIN Injection
• high or low levels of calcium, potassium in your blood
• low level of magnesium in your blood
• digestion problems.

If you have not told your doctor or pharmacist about any of the above, it is important to tell them before you start being given LANOXIN Injection.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and LANOXIN I Injection may interfere with each other.

These include:

• amphetamine, appetite suppressants, medicines for colds, sinus problems, hay fever or other allergies – may increase the risk of heart rhythm problems
• medicines for heart problems, including high blood pressure (hypertension) and irregular heart beat (arrhythmia)
• diuretics (water tablets)
• potassium supplements
• medicines for cancer
• medicines for depression
• medicines for bacterial infection (antibiotics)
• medicines for fungal infections (antifungals)
• medicines for stomach problems, including for nausea, vomiting, diarrhoea or indigestion
• some laxatives
• medicines for relieving asthma attacks or other breathing problems
• corticosteroids (e.g. hydrocortisone, dexamethasone, prednisolone, prednisone)
• medicines for diabetes (e.g. insulin, glucagon)
• cholestyramine, a medicine used for high cholesterol
• phenytoin, a medicine used to control epilepsy
• indomethacin – medication used for inflammation, gout or arthritis
• St John’s Wort.

These medicines may be affected by LANOXIN Injection or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.

If you not sure if any of the above apply to you, talk to your doctor or pharmacist before using LANOXIN Injection.

How to use it

How much is given

Your doctor will tell you how much LANOXIN Injection you will receive. This depends on your condition and other factors such as your weight, age and other medicines you may be taking.

How LANOXIN Injection is given

Except under unusual circumstances, LANOXIN Injection is given as a slow injection into a vein by a doctor or nurse.

How long LANOXIN Injection is given

LANOXIN injection should be administered for as long as recommended by your doctor.

After you begin using LANOXIN Injection, your doctor may sometimes check its level in your blood. This will help your doctor find out if your dose needs to be changed.

If you are given too much (overdose)

As LANOXIN Injection is given to you under the supervision of your doctor, it is unlikely that you will receive too much. However, if you experience any side effects after being given LANOXIN Injection, tell your doctor immediately or go to Accident and Emergency at your nearest hospital. You may need urgent medical attention.

Symptoms of an overdose to LANOXIN Injection include some of the side effects listed below.

Some early warning signs of overdose are loss of appetite, nausea, vomiting, diarrhoea, or extremely slow heart beat.

In infants and small children, the earliest signs of overdose are changes in the rate and rhythm of the heart beat.

Carers should be aware that children may not show symptoms as soon as adults.

While you are using it

Things you must do

Tell your doctor immediately if you notice any side effects from LANOXIN Injection.

Tell any other doctors, dentists and pharmacists who are treating you that you are being given LANOXIN Injection.

Tell your doctor, dentist or pharmacist that you are being given LANOXIN Injection before you start taking any medicines you buy from a pharmacy, health food shop or supermarket.

If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are being given LANOXIN Injection.

If you become pregnant while using this medicine, tell your doctor immediately.

If you need to have any medical tests while you are being given it, tell your doctor. LANOXIN Injection may affect the results of some tests.

Be sure to keep all of your doctor’s appointments so that your progress can be checked. Your doctor will check your progress and may want to take some blood tests from time to time. This helps to prevent unwanted side effects.

Things to be careful of

Be careful driving or operating machinery until you know how LANOXIN Injection affects you. LANOXIN Injection may cause dizziness, blurred vision, and faintness in some patients. Make sure you know how you react to it before you drive a car, operate machinery, or do anything else that could be dangerous if this happens.

Side effects

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

If any of the following happen, tell your doctor or pharmacist immediately:

• nausea or vomiting, loss of appetite
• diarrhoea
• lower stomach pain
• slow or irregular heart beats (may be fast in children)
• unusual tiredness or extreme weakness
• general feeling of ‘unwellness’
• blurred vision or visual disturbances (e.g. coloured halos around objects i.e. yellow, green, or white)
• depression
• headache
• mental disturbances, such as confusion or feeling indifferent
• skin rash
• painful, swollen breasts, or breast enlargement in men
• bleeding or bruising more easily than normal.

These may be serious side effects. You may need urgent medical attention. Serious side effects are rare or are caused by a dose of LANOXIN Injection that may be too high for you.

Tell your doctor immediately if you have:

• palpitations
• chest pain
• shortness of breath or sweating.

These can be symptoms of a serious heart problem caused by new irregular heart beats of a different type to those caused by atrial fibrillation (which LANOXIN Injection is often used to treat).

Your doctor may do regular checks on your blood levels of digoxin and body salts, as well as your kidney function to make sure this medicine is working safely for you.

Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list. Other side effects not listed above may also occur is some people.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using it

Storage

Store LANOXIN Injection in the original packaging until it is time to use them. If you take them out of the pack, they may not keep as well.

Keep your medication in a cool place, protected from light, where the temperature stays below 30°C.

Do not store it or any other medicine in the bathroom or near a sink. Do not leave it in the car on hot days or on windowsills. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop using LANOXIN Injection or the medicine has passed its expiry date, ask your pharmacist what to do with any that is left over.

Product description

What it looks like

LANOXIN Injections are clear, colourless solutions, free from particulate matter, in clear glass ampoules. Available in boxes of 5.

Ingredients

LANOXIN INFANTS Injection

Active ingredient:

Each 2 mL ampoule contains digoxin 50 micrograms.

Other ingredients:

• propylene glycol
• ethanol
• citric acid-anhydrous
• sodium phosphate-dibasic anhydrous
• water for injections.

LANOXIN ADULT Injection

Active ingredient:

Each 2 mL ampoule contains digoxin 500 micrograms.

Other ingredients:

• propylene glycol
• ethanol
• citric acid-anhydrous
• sodium phosphate-dibasic anhydrous
• water for injections.

The Australian Product Registration Numbers for:

LANOXIN INFANTS digoxin 50 micrograms/2 mL injection ampoule: AUST R 11105

LANOXIN ADULT digoxin 500 micrograms/2 mL injection ampoule: AUST R 11106.

Sponsor

Aspen Pharma Pty Ltd
34-36 Chandos St
St Leonards NSW 2065
Australia

This leaflet was revised in September 2017.

Published by MIMS December 2017

1 Name of 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

4.9 Overdose

Symptoms and signs. See Section 4.8 Adverse Effects (Undesirable Effects).
The symptoms and signs of toxicity are generally similar to those described (see Section 4.8 Adverse Effects (Undesirable Effects)) but may be more frequent and can be more severe.
Signs and symptoms of digoxin toxicity become more frequent with levels above 2.0 nanogram/mL although there is considerable interindividual variation. However, in deciding whether a patient's symptoms are due to digoxin, the clinical state, together with serum electrolyte levels and thyroid function are important factors (see Section 4.2 Dose and Method of Administration).
Adults. In adults without heart disease, clinical observation suggests that an overdose of digoxin of 10 to 15 mg was the dose resulting in death of half of the patients. If more than 25 mg of digoxin was ingested by an adult without heart disease, death or progressive toxicity responsive only to digoxin immune Fab (Digibind) resulted.
Cardiac manifestations. Cardiac manifestations are the most frequent and serious sign of both acute and chronic toxicity. Peak cardiac effects generally occur 3 to 6 hours following overdosage and may persist for the ensuing 24 hours or longer. Lanoxin toxicity may result in almost any type of arrhythmia. Multiple rhythm disturbances in the same patient are common. These include paroxysmal atrial tachycardia with variable atrioventricular (AV) block, accelerated junctional rhythm, slow atrial fibrillation (with very little variation in the ventricular rate) and bidirectional ventricular tachycardia.
Premature ventricular contractions (PVCs) are often the earliest and most common arrhythmia. Bigeminy or trigeminy also occur frequently.
Sinus bradycardia and other bradyarrhythmias are very common.
First, second, third degree heart blocks and AV dissociation are also common.
Early toxicity may only be manifested by prolongation of the PR interval.
Ventricular tachycardia may also be a manifestation of toxicity.
Cardiac arrest from asystole or ventricular fibrillation due to Lanoxin toxicity is usually fatal.
Acute massive Lanoxin overdosage can result in mild to pronounced hyperkalaemia due to inhibition of the sodium potassium (Na⁺-K⁺) pump. Hypokalaemia may contribute to toxicity (see Section 4.4 Special Warnings and Precautions for Use).
Noncardiac manifestations. Gastrointestinal symptoms are very common in both acute and chronic toxicity. The symptoms precede cardiac manifestations in approximately half of the patients in most literature reports. Anorexia, nausea and vomiting have been reported with an incidence up to 80%. These symptoms usually present early in the course of an overdose.
Neurologic and visual manifestations occur in both acute and chronic toxicity. Dizziness, various CNS disturbances, including headache, disorientation, confusion, fatigue and malaise are very common, more rarely are hallucinations and psychosis. The most frequent visual disturbance is an aberration of colour vision (predominance of yellow green). These neurological and visual symptoms may persist even after other signs of toxicity have resolved.
In chronic toxicity, nonspecific extracardiac symptoms, such as malaise and weakness, may predominate.
Children. In children aged 1 to 3 years without heart disease, clinical observation suggests that an overdose of Lanoxin of 6 to 10 mg was the dose resulting in death in half of the patients. If more than 10 mg of Lanoxin was ingested by a child aged 1 to 3 years without heart disease, the outcome was uniformly fatal when Digibind Fab fragment treatment was not given.
Most manifestations of toxicity in children occur during or shortly after the loading phase with Lanoxin.
Cardiac manifestations. The same arrhythmias or combination of arrhythmias that occur in adults can occur in paediatrics. Sinus tachycardia, supraventricular tachycardia, and rapid atrial fibrillation are seen less frequently in the paediatric population.
Paediatric patients are more likely to present with an AV conduction disturbance or a sinus bradycardia.
Ventricular ectopy is less common, however, in massive overdose, ventricular ectopy, ventricular tachycardia and ventricular fibrillation have been reported.
In neonates, sinus bradycardia or sinus arrest and/or prolonged PR intervals are frequent signs of toxicity. Sinus bradycardia is common in young infants and children. In older children, AV blocks are the most common conduction disorders.
Any arrhythmia or alteration in cardiac conduction that develops in a child taking Lanoxin should be assumed to be caused by digoxin, until further evaluation probes otherwise.
Extracardiac manifestations. The frequent extracardiac manifestations similar to those seen in adults are gastrointestinal, CNS and visual. However, nausea and vomiting are not frequent in infants and small children.
In addition to the undesirable effects seen with recommended doses, weight loss in older age groups and failure to thrive in infants, abdominal pain due to mesenteric artery ischaemia, drowsiness and behavioural disturbances including psychotic manifestations have been reported in overdose.
Treatment. After recent ingestion, such as accidental or deliberate self poisoning, the load available for absorption may be reduced in conscious patients, who are not exhibiting signs of heart block or sinus bradycardia, by gastric lavage. In patients with signs of heart block or sinus bradycardia, gastric lavage can cause an increase in vagal tone and result in worsening of cardiac toxicity.
Patients with massive digitalis ingestion should receive large doses of activated charcoal to prevent absorption and bind digoxin in the gut during enteroenteric recirculation.
Supportive and symptomatic treatment should be initiated depending on the type of cardiotoxicity and continuous ECG monitoring is advisable, along with monitoring of serum electrolytes (especially potassium, calcium and perhaps magnesium).
If hypokalaemia is present, it should be corrected with potassium supplements either orally or intravenously depending on the urgency of the situation. In cases where a large amount of Lanoxin has been ingested hyperkalaemia may be present due to release of potassium from skeletal muscle. Before administering potassium in digoxin overdose, the serum potassium level must be known.
Bradyarrhythmias may respond to atropine but temporary cardiac pacing may be required. Ventricular arrhythmias may respond to lignocaine or phenytoin.
Dialysis is not particularly effective in removing digoxin from the body in potentially life threatening toxicity.
Rapid reversal of the complications that are associated with serious poisoning by digoxin, digitoxin and related glycosides has followed intravenous administration of digoxin immune Fab (Digibind) when other therapies have failed. Digibind is the only specific treatment for digoxin toxicity and is very effective. For details consult the literature supplied with Digibind.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data are available on whether or not digoxin has mutagenic, carcinogenic or teratogenic effects; however, maternally administered digoxin has been used to treat foetal tachycardia and congestive heart failure.
Carcinogenicity. See above.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSDIGOXI.gif Digoxin has the molecular formula C₄₁H₆₄O₁₄ with a molecular weight of 781.0. It is practically insoluble in water and in ether and slightly soluble in alcohol. Digoxin is obtained from the leaves of Digitalis lanata and occurs as odourless, colourless or white crystals or a white or almost white powder.
CAS number. The CAS number is 20830-75-5.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/LANOXIST.gif