Lanoxin Solution for Injection: Usage, Warnings, and Side Effects | Study notes Medicine

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Lanoxin 500 micrograms/2ml Solution for Injection

(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 Solution for Injection is and what it is used for

2. What you need to know before you use Lanoxin Solution for Injection

3. How to use Lanoxin Solution for Injection

4. Possible side effects

5. How to store Lanoxin Solution for Injection

6. Contents of the pack and other information

1. What Lanoxin Solution for 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 Solution for Injection

Do not use Lanoxin Solution for 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 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.

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Lanoxin 500 micrograms/2ml Solution for Injection (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 :

What Lanoxin Solution for Injection is and what it is used for
What you need to know before you use Lanoxin Solution for Injection
How to use Lanoxin Solution for Injection
Possible side effects
How to store Lanoxin Solution for Injection
Contents of the pack and other information 1. What Lanoxin Solution for 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 Solution for Injection Do not use Lanoxin Solution for 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 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 Solution for 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 Lanoxin 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). 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,
canagliflozin (used to treat of type 2 diabetes mellitus),
certain antibiotics: erythromycin, clarithromycin, tetracycline, gentamicin, trimethoprim,
daclatasvir (used in combination with other medications to treat hepatitis C),
flibanserin (used to treat low sexual desire in women who have not gone through menopause),
isavuconazole (used to treat fungal infections),
itraconazole (used to treat fungal infections),
ivacaftor (used to treat cystic fibrosis),

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 Solution for 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, that is to say, essentially “sodium free”.

3. How to use Lanoxin Solution for Injection This medicine is available as an injectable solution for 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 Solution for 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

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 national reporting system: HPRA Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie By reporting side effects, you can help provide more information on the safety of medicine. 5. How to store Lanoxin Solution for Injection Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label or carton. The expiry date refers to the last day of that month. Do not store above 25°C. Keep the ampoules in the outer carton to protect from light. Once opened use immediately and discard any unused contents. Do not use this medicine if you notice any visible signs of deterioration. Do not throw away any medicines via wastewater or household waste. These measures will help protect the environment. 6. Contents of the pack and other information What Lanoxin Solution for Injection contains Lanoxin Solution for Injection contains the active substance digoxin. Each ampoule contains 0.5mg (500 micrograms) digoxin. The other ingredients are ethanol, propylene glycol, citric acid monohydrate, sodium phosphate and water for injections. What Lanoxin Solution for Injection looks like and contents of the pack Lanoxin 500 micrograms/2ml Solution for Injection is a clear, colourless, sterile aqueous solution. Lanoxin Solution for Injection is available in packs containing 5 glass ampoules. Each ampoule contains 2 ml of solution. Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland Tel: +353 1 6308400 Manufacturer GlaxoSmithKline Manufacturing S.p.A, Strada Provinciale Asolana 90, 43056 San Polo di Torrile, Parma, Italy Cenexi – Fontenay Sous Bois, 52 rue Marcel et Jacques Gaucher, Fontenay-Sous Bois, 94120, France This leaflet was last revised in 03/ The following information is intended for healthcare professionals only. Handling Instructions Dilution of Lanoxin Lanoxin Solution for 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 Solution for Injection, when diluted in the ratio of 1 to 250 is known to be compatible with the following infusion solutions;  Sodium 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.

Lanoxin Solution for Injection: Usage, Warnings, and Side Effects, Study notes of Medicine

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PACKAGE LEAFLET: INFORMATION FOR THE USER