DIGOXIN 250 MICROGRAMS / ML SOLUTION FOR INJECTION - patient leaflet, side effects, dosage

Patient leaflet - DIGOXIN 250 MICROGRAMS / ML SOLUTION FOR INJECTION

1. what digoxin injection is and what it is used for

Digoxin belongs to a group of medicines called cardiac glycosides. It works by increasing the strength of the heart muscle and slowing the rate of contraction of the heart, i.e. the pulse rate.

Digoxin is used to treat:

chronic heart failure. Heart failure is a condition in which the heart fails to pump the blood

round the body adequately. This may cause tiredness, breathlessness and ankle swelling

some types of irregular heart beat which may or may not accompany heart failure.

Digoxin injection is given in emergency situations when patients need a high starting dose of this medicine.

2. what you need to know before you are given digoxin injection

Do not use Digoxin Injection:

if you are allergic to active substance or any of the other ingredients of this medicine (listed in section 6)
if you 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)
if you have an irregular heart-beat caused by cardiac glycoside intoxication or conditions such as Wolff-Parkinson-White syndrome
if you have obstructive cardiomyopathy (enlargement of the heart muscle).

Warnings and precautions

Talk to your doctor 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 Digoxin 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, shortlasting 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 Digoxin. Do not stop taking Digoxin 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 Digoxin as it can affect the meaning of the results

if you have severe respiratory (lung) disease (as you may have an increased sensitivity to

Digoxin)

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
if you are elderly
if you have had a stroke.

Other medicines and Digoxin Injection

Tell your doctor if you are using, have recently used or might use any other medicines.

Taking several medicines can sometimes have harmful consequences or lead to unwanted interactions.

Sensitivity to Digoxin can be increased by medicines which lower the level of potassium in the blood. These include:

diuretics (‘water tablets’ to help you pass more water)
lithium (for depression)
corticosteroids (for allergic or inflammatory conditions such as asthma or painful joints or inflammation of joints)
carbenoxolone (a product which strengthens the gastric mucosa).

The following medicines increase the level of Digoxin 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 Digoxin 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 to have bowel movements) along with Digoxin you may have a moderately increased risk of digoxin toxicity.

The following medicines reduce the level of Digoxin 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 Digoxin 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 Digoxin 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.

If you are taking medicines used to treat heart conditions, high blood pressure or circulation disorders (e.g. Captopril) speak to your doctor before you receive Digoxin Injection.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

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 Digoxin treatment affecting the mother may also affect the unborn child.

Breast-feeding

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 Digoxin on fertility.

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.

Digoxin Injection contains sodium and ethanol

this medicinal product contains less than 1mmol sodium (23mg) per 4ml, i.e. is essentially

‘sodium-free’

This medicine contains 203 mg of alcohol ( Ethanol 96%) in each 2 ml. which is equivalent to 101.5 mg/ml. The amount in 2 ml of this medicine is equivalent to less than 26 ml of beer and 11 ml of wine.

The small amount of alcohol in this medicine will not have any noticeable effects.

This medicine contains 832 mg of propylene glycol in each 2ml which is equivalent to 416 mg/ml.

3. how you will be given digoxin injection

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. A dose of digoxin will be dissolved into a solution and slowly injected into a vein over 10 – 20 minutes. This is known as an infusion or drip. The dose should be divided so that one half is given as the first dose and the remainder is given in divided doses every 4 to 8 hours.

Adults: The dose will be calculated by your doctor according to your age and weight.

Use in children up to age 10 years and adolescents : The dose will be calculated by the doctor according to weight and age. If you are elderly, or if you have kidney problems, or if you have received a cardiac glycoside within the past two weeks, your dose will be reduced. Your doctor may want to take blood samples to ensure that your blood levels of digoxin are in the required range.

Use in the elderly:

The tendency to impaired renal function and low lean body mass in the elderly influences the action of digoxin such that high serum digoxin levels and associated toxicity can occur quite readily, unless doses of digoxin lower than those in non-elderly patients are used. Serum digoxin levels should be checked regularly and lowering of the potassium levels should be avoided.

Dose recommendations in renal disorder or with a diuretic therapy:

The dosing recommendations should be reconsidered if patients are elderly or there are other reasons for the renal clearance of digoxin being reduced. A reduction in both initial and maintenance dose should be considered. In patients receiving diuretics (water tablets) and medicines to reduce high blood pressure (ACE inhibitors) or diuretics alone, the withdrawal of digoxin has been shown to result in some clinical problems.

Monitoring:

Serum concentration of digoxin may be expressed in nanograms/ml (ng/ml). The serum concentration of digoxin can be determined by radioimmunoassay test. Blood should be taken 6 hours or more after the last dose of digoxin. Digoxin toxicity is most commonly associated with serum digoxin concentration greater than 2 nanograms/ml. However, toxicity may occur with lower digoxin serum concentrations. In deciding whether a patient symptoms are due to digoxin, the patients clinical state together with the serum potassium level and thyroid function are important factors to be considered. If you have any further questions on the use of this product ask your doctor.

If you think you have been given more Digoxin Injection than you should

As Digoxin 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 Digoxin 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 Digoxin 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 Digoxin Injection

Do not take a double dose to make up for the forgotten dose.

If you stop using Digoxin Injection

Your doctor will tell you how long you should take Digoxin Injection. Do not stop your treatment early without consulting your doctor.

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

4. possible side effects

Like all medicines, this medicine can cause side-effects, although not everybody gets them.

All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.

Tell your doctor or nurse immediately if:

you have palpitations, chest pain, shortness of breath or sweating. There can be symptoms of serious heart problem caused by new irregular heart beats. If these happen, tell your doctor immediately.

Other side effects may include:

Common (may affect up to 1 in 10 people):

slow or irregular heart rate
feeling sick, being sick, loose stools
skin rash that may be itchy
drowsiness or dizziness
visual disturbances, with blurred or yellow-green sight.

Uncommon (may affect up to 1 in 100 people):

depression.

Very rare (may affect up to 1 in 10,000 people):

bruising or bleeding more easily than normal
stomach pain caused by lack of blood supply or damage to the gut
mental disturbances, you may feel confused, indifferent or unable to judge clearly
weakness, tiredness or a general feeling of being unwell
breast enlargement in men
loss of appetite
headache
rapid heart rate.

5. how to store digoxin injection

Keep this medicine out of the sight and reach of children.

Do not store above 25°C. Keep the ampoule in the outer carton in order to protect from light.

Do not use this medicine after the expiry date which is stated on the carton and label after ‘EXP’. The expiry date refers to the last day of that month.

If only part of an ampoule is used, the remainder should be discarded.

Do not use the ampoule if the contents are discoloured in any way.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Digoxin Injection contains

The active substance is digoxin.

The other ingredients are ethanol, propylene glycol, citric acid monohydrate, disodium hydrogen phosphate and water for injections.

What Digoxin Injection looks like and contents of pack

Digoxin Injection is a clear, colourless sterile solution presented in clear glass ampoules. Each ampoule contains 2ml of solution and each 2ml of solution contains 500 micrograms (mcg) of digoxin.

The injection is available in packs of 10 ampoules.

Marketing authorisation holder

Mercury Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, UK Manufacturer

B. Braun Melsungen AG, Mistelweg 2, 12357 Berlin, Germany.

This leaflet was last revised in May 2020