Consumer medicine information

APX-Sotalol

Sotalol hydrochloride

BRAND INFORMATION

Brand name

APX-Sotalol

Active ingredient

Sotalol hydrochloride

Schedule

SUMMARY CMI

APX-SOTALOL

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I taking APX-SOTALOL?

APX-SOTALOL contains the active ingredient sotalol hydrochloride. APX-SOTALOL is used to treat “arrhythmias”, which is a problem when the heart beats too quickly or with the wrong rhythm.

For more information, see Section 1. Why am I taking APX-SOTALOL? in the full CMI.

2. What should I know before I take APX-SOTALOL?

Do not use if you have ever had an allergic reaction to APX-SOTALOL or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I take APX-SOTALOL? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with APX-SOTALOL and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take APX-SOTALOL?

Follow all directions given to you by your doctor or pharmacist carefully.
The usual dose is 80mg to 160mg twice a day. Your doctor may need to increase this as a very few patients may need up to three to four 160mg tablets spread over a day. The dosage may need to be different if you have a kidney problem.
You should take your tablets with water one to two hours before meals. Do not take APX-SOTALOL with milk or meals.

More instructions can be found in Section 4. How do I take APX-SOTALOL? in the full CMI.

5. What should I know while taking APX-SOTALOL?

Things you should do	Remind any doctor, dentist or pharmacist you visit that you are using APX-SOTALOL. Tell your doctor if you become pregnant while taking APX-SOTALOL.
Things you should not do	Do not give your medicine to anyone else, even if they have the same condition as you. Do not take APX-SOTALOL to treat any other complaints unless your doctor tells you to.
Driving or using machines	Be careful driving or operating machinery until you know how APX-SOTALOL affects you.
Looking after your medicine	Keep your medicine in a cool dry place where the temperature stays below 30°C. Protect from moisture. Protect from light. Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car.

For more information, see Section 5. What should I know while taking APX-SOTALOL? in the full CMI.

6. Are there any side effects?

There are a number of side effects associated with APX-SOTALOL. It is important to be aware of them so that you can identify any symptoms if they occur.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

APX-SOTALOL

Active ingredient(s): sotalol hydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about taking APX-SOTALOL. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about taking APX-SOTALOL.

Where to find information in this leaflet:

1. Why am I taking APX-SOTALOL?
2. What should I know before I take APX-SOTALOL?
3. What if I am taking other medicines?
4. How do I take APX-SOTALOL?
5. What should I know while taking APX-SOTALOL?
6. Are there any side effects?
7. Product details

1. Why am I taking APX-SOTALOL?

APX-SOTALOL contains the active ingredient sotalol hydrochloride which belongs to the family of drugs known as beta-blockers.

APX-SOTALOL is used to treat “arrhythmias”, which is a problem when the heart beats too quickly or with the wrong rhythm.

APX-SOTALOL slows down and steadies the heartbeat, reducing the effort the heart has to put into pumping blood.

Ask your doctor if you have any questions about why APX-SOTALOL has been prescribed for you.

Your doctor may have prescribed it for another reason.

There is no evidence that this medicine is addictive.

APX-SOTALOL is only available with a doctors prescription.

2. What should I know before I take APX-SOTALOL?

Warnings

Do not take APX-SOTALOL if:

you are allergic to sotalol hydrochloride,
other beta-blockers,
or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.

Some of the symptoms of an allergic reaction may include:

shortness of breath, wheezing or difficulty breathing
skin rash, itching or hives,
swelling of the face, lips, tongue or any part of the body.

Do not take APX-SOTALOL if you have asthma.

You should not take this medicine if you have allergies, or problems with your kidneys or thyroid gland, unless you have discussed it with your doctor.

Check with your doctor if you:

have any problems with your heart or circulation or amount of magnesium in your blood

You should not take APX-SOTALOL with any other medicines your doctor does not know about, particularly if they are to control high blood pressure, heart conditions, depression, hayfever, allergies, infections or diabetes.

Talk to you doctor if you are unsure whether you should start taking this medicine.

Before you start to take it

Make sure your doctor knows what other medicines you are already taking including ones you have bought yourself at the chemist or supermarket.
In particular remind your doctor if you have asthma, bronchitis or any allergies such as hay fever, food allergies or are allergic to bee or wasp stings.
Make sure your doctor is aware of any kind of heart disease, diabetes, phaeochromocytoma, kidney disease or thyroid disease that you have or have had, or if you have been told that your pulse is slow or irregular.
Tell your doctor if you have ever had trouble with the levels of salts like potassium or magnesium in your blood.
Remind your doctor if you are going to have surgery involving a general anaesthetic even if it is only minor.
Tell your doctor if you have been given APX-SOTALOL (or any other beta-blocker) before and if you had any problems.
Remind your doctor if you have hardening of the arteries (cold fingers and toes or pain in the back of your legs when you walk).
Tell your doctor if you are pregnant, if you are planning to become pregnant, or if you are breast feeding.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

You should not take this medicine if you are pregnant or are breast feeding, or if you intend to breast feed.

3. What if I am taking other medicines?

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

Some medicines can affect the way APX-SOTALOL works.

You should always tell your doctor about any other medicines you take, even those bought without a doctor's prescription.

It is especially important that you tell your doctor if you are taking the following:

medicines which lower blood pressure (including other beta-blockers)
floctafenine (medicine used for the short term treatment of mild to moderate pain)
for the treatment of certain infections (e.g. erythromycin IV, amphotericin B, pentamidine, halofantrine)
steroids
laxatives
clonidine (sometimes used to treat hot flushes or headaches)
any other medicines used to treat irregular heart rhythm or beat
digoxin, a medicine used for heart failure
medicines used to treat angina or other heart conditions
antidepressants (medicines used to treat depression)
insulin or other drugs used to control diabetes
Medicines used to control or prevent asthma (inhalers or tablets) or to control allergies or which are used for other lung problems
Antihistamine medicine including terfenadine and astemizole that may be used to treat hayfever, allergies or to relive symptoms of cold and flu
quinolone antibiotics (medicines used to treat infections)
diuretics (water tablets)
Neuromuscular blocking agents like tubocurarine
some medicine used during surgery or emergency situations, such as anaesthetics.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect APX-SOTALOL.

4. How do I take APX-SOTALOL?

How much to take

Your doctor will decide on the dose of APX-SOTALOL tablets for you, and may need to change the dose a few times to get the best level for you.
The usual dose is 80mg to 160mg twice a day.
Your doctor may need to increase this as a very few patients may need up to three to four 160mg tablets spread over a day. The dosage may need to be different if you have a kidney problem.

How to take APX-SOTALOL

You should take your tablets with water one to two hours before meals. Do not take APX-SOTALOL with milk or meals.

How long to take APX-SOTALOL

If you have been prescribed APX-SOTALOL you must be sure to follow your doctors instructions carefully.

Do not stop taking APX-SOTALOL tablets suddenly.

The dose needs to be reduced gradually over 7 to 14 days.

If you forget to take APX-SOTALOL

It is important not to miss a dose but if you do, take your next dose at the normal time and with the normal amount.

If you use too much APX-SOTALOL

If you think that you have used too much APX-SOTALOL, you may need urgent medical attention.

You should immediately:

phone the Poisons Information Centre
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

Too much of this medicine will cause your blood pressure and heart rate to drop to dangerous levels. Serious heart problems may develop and this could be fatal.

5. What should I know while taking APX-SOTALOL?

Things you should do

Call your doctor straight away if you:

If you become pregnant while taking APX-SOTALOL. You doctor can discuss with the risks of taking it while you are pregnant.
If you are about to be started on any new medicine, remind your doctor or pharmacist that you are taking APX-SOTALOL.

Remind any doctor, dentist or pharmacist you visit that you are using APX-SOTALOL.

Things you should not do

Do not give your medicine to anyone else, even if they have the same condition as you.
Do not take APX-SOTALOL to treat any other complaints unless your doctor tells you to.
Do not let yourself run out of tablets over weekends or on holidays.

Driving or using machines

Be careful driving or operating machinery until you know how APX-SOTALOL affects you.

As with other medicines it may cause dizziness, light-headedness or drowsiness in some people. If this occurs do not drive or operate machinery or undertake any other activity that could be dangerous if you are dizzy, light-headed or drowsy.

Looking after your medicine

Keep your tablets in the original packaging they are provided in until it is time to take them. If you take the tablets out of the blister they will not keep well.

Keep your medicine in a cool dry place where the temperature stays below 30°C. Protect from moisture. Protect from light.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

in the bathroom or near a sink, or
in the car or on window sills.

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

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious/Common side effects

Less serious side effects

What to do

dizziness, lightheadedness or fainting, especially when you get up from a sitting or lying position. Getting up slowly may help.
tiredness, lack of energy, weakness
headache, fever
cramps
irritated eyes, blurred vision, worsening of eyesight, increased sensitivity of the eyes to sunlight, eye infections
feeling sick, vomiting, stomach upset, diarrhoea, wind
change in taste sensation
anxiety, depression, mood changes
confusion, hallucinations
problems with sexual function
sleep problems, unusual dreams
worsening of psoriasis, thickening of skin, itching, alopecia (hair loss)
hearing disturbances
tingling or numbness in the hands or feet, cold limbs
muscle spasms
excessive sweating
dry mouth

Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side/rare effects

Serious side effects	What to do
chest tightness, wheezing, shortness of breath very slow heart beat fast, irregular heartbeat, palpitations chest pain any type of skin rash, itching shortness of breath (sometimes with tiredness, weakness and reduced ability to exercise), which may occur together with swelling of the feet or legs due to fluid build up fainting	Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

APX-SOTALOL helps most people with arrhythmia, but it may have unwanted side effects in some people. Rarely, serious heart problems can develop while you are taking normal doses but you must remember that you are taking this medicine because your heart already has a serious problem. It is very important that your doctor keeps a check on your progress.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What APX-SOTALOL contains

Active ingredient (main ingredient)	sotalol hydrochloride
Other ingredients (inactive ingredients)	microcrystalline cellulose magnesium stearate maize starch lactose stearic acid colloidal anhydrous silica indigo carmine (CI 73015)
Potential allergens	contains sugars as lactose

Do not take this medicine if you are allergic to any of these ingredients.

What APX-SOTALOL looks like

APX-SOTALOL are available in blister packs of 60s in two strengths.

APX-SOTALOL 80mg tablets are light blue, biconvex, capsule shaped tablets, plain on one side and engraved 'S', '80' and a break bar on the other side. (Aust R 333531).

APX-SOTALOL 160mg are light blue biconvex, capsule shaped tablets, plain on one side and engraved 'S', '160' and a break bar on the other side. (Aust R 333532).

Who distributes APX-SOTALOL

Arrotex Pharmaceuticals Pty Ltd
15 – 17 Chapel Street
Cremorne VIC 3121
www.arrotex.com.au

This leaflet was prepared in February 2025.

Published by MIMS May 2025

BRAND INFORMATION

Brand name

APX-Sotalol

Active ingredient

Sotalol hydrochloride

Schedule

1 Name of Medicine

Sotalol hydrochloride.

2 Qualitative and Quantitative Composition

APX-Sotalol tablets contain sotalol hydrochloride 80 mg or 160 mg.

Excipients with known effect.

Sugars as lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

APX-Sotalol sotalol hydrochloride 80 mg are light blue, biconvex, capsule shaped tablets, plain on one side and engraved 'S', '80' and a break bar on the other side.
APX-Sotalol sotalol hydrochloride 160 mg are light blue, biconvex, capsule shaped tablets, plain on one side and engraved 'S', '160' and a break bar on the other side.

4 Clinical Particulars

4.1 Therapeutic Indications

APX-Sotalol is indicated for use in the prevention and treatment of supraventricular and ventricular arrhythmias.

4.2 Dose and Method of Administration

APX-Sotalol is administered orally for the prevention and treatment of arrhythmias.
An intravenous formulation is useful for the management of acute arrhythmias.
As with other antiarrhythmic agents, APX-Sotalol should be initiated and doses increased in a facility capable of monitoring and assessing cardiac rhythm. The dosage must be individualized for each patient on the basis of therapeutic response and tolerance. Proarrhythmic events can occur not only at initiation of therapy, but also with each upward dosage adjustment.

Oral.

APX-Sotalol should be taken preferably 1-2 hours before meals.
Oral dosage of APX-Sotalol should be adjusted gradually allowing 2-3 days between dosing increments in order to attain steady-state, and to allow monitoring of QT intervals. Graded dose adjustment will help prevent the use of doses which are higher than necessary to control the arrhythmia. The recommended initial oral dosing schedule is 160 mg/daily, given in two divided doses at approximately 12 hour intervals. This dose may be increased, if necessary, after appropriate evaluation to 240 or 320 mg/day. In most patients, a therapeutic response is obtained at a total daily dose of 160-320 mg/day, given in 2 divided doses. Some patients with life-threatening refractory ventricular arrhythmias may require doses as high as 480-640 mg/day; however, these doses should only be prescribed when the potential benefit outweighs the increased risk of adverse events particularly proarrhythmias.
Because of long elimination half-life of APX-Sotalol, dosing on more than a twice daily regimen is not usually necessary.

With impaired renal function.

As sotalol is primarily excreted by the kidneys, a dosage adjustment should be made.

4.3 Contraindications

1. Bronchospasm (e.g. bronchial asthma or chronic obstructive airway disease).
2. Allergic disorders (including allergic rhinitis) which may suggest a predisposition to bronchospasm.
3. Right ventricular failure secondary to pulmonary hypertension.
4. Significant right ventricular hypertrophy.
5. Sinus bradycardia (less than 45-50 beats/minute).
6. Second and third degree A-V block or sick sinus syndrome unless a functioning pacemaker is present.
7. Shock (including cardiogenic and hypovolaemic shock).
8. Uncontrolled congestive heart failure.
9. Severe renal impairment (CrCl < 10 mL/min).
10. Congenital or acquired long QT syndromes.
11. Hypersensitivity to sotalol hydrochloride, other beta blockers, sulfonamides or the excipients.
12. Anaesthesia that produces myocardial depression.
13. Severe sinus node dysfunction.
14. Sinoatrial block.
15. Hypomagnesaemia.
16. Hypotension.
17. Late stages of peripheral arterial occlusive disease.
18. Metabolic acidosis.
19. Torsades de pointes.
20. Raynaud's phenomenon and severe peripheral circulatory disturbance.
21. Untreated phaeochromocytoma.
22. Intravenous administration of verapamil or diltiazem calcium antagonists or other antiarrhythmic agents (such as disopyramide) is contraindicated in patients treated with sotalol hydrochloride (except in the case of intensive care medicine).
23. Hypokalaemia.

4.4 Special Warnings and Precautions for Use

No antiarrhythmic drug has been shown to reduce the incidence of sudden death in patients with supraventricular or asymptomatic ventricular arrhythmias. Since most antiarrhythmic drugs have the potential to cause proarrhythmias or increase the incidence of sudden death, physicians should carefully consider the risks and benefits of antiarrhythmic therapy in these patients.

Mortality.

Post-myocardial infarction patients with asymptomatic ventricular arrhythmias showed a significant increase in mortality and in non-fatal cardiac arrest rate in patients treated with encainide or flecainide compared with a matched placebo-treated group. The Cardiac Arrhythmia Suppression Trial (CAST) was continued using a revised protocol with the moricizine and placebo arms only. The trial was prematurely terminated because of a trend towards an increase in mortality in the moricizine treated group. The applicability of these results to other populations or other antiarrhythmic agents is uncertain, but at present it is prudent to consider these results when using any antiarrhythmic agent.

Proarrhythmia.

Post-marketing experience.

The most dangerous adverse effect of antiarrhythmic drugs is the aggravation of preexisting arrhythmias or the provocation of new arrhythmias. The drugs that prolong the QT interval may cause torsades de pointes, a polymorphic ventricular tachycardia associated with prolongation of the QT interval. Experience to date indicates that the risk of torsades de pointes is associated with the prolongation of the QT interval, reduction in heart rate, reduction in serum potassium and magnesium (e.g. as a consequence of diuretic use), high plasma drug concentrations (e.g. as a consequence of overdosage or renal insufficiency), and with the concomitant use of sotalol and other medication such as antidepressants and Class 1 antiarrhythmics which have been associated with torsades de pointes. Females appear to be at increased risk of developing torsades de pointes. EKG monitoring immediately prior to or following the episodes usually reveals a significantly prolonged QT interval and a significantly prolonged QTc interval. In clinical trials, sotalol generally has not been initiated to patients whose pretreatment QTc interval exceeded 450 msec. Sotalol should be titrated very cautiously in patients with prolonged QT intervals.
Torsades de pointes is dose dependent, usually occurs early after initiating therapy or escalation of the dose, and terminates spontaneously in the majority of patients. Although most episodes of torsades de pointes are self-limited or associated with symptoms (e.g. syncope), they can progress to ventricular fibrillation.

Clinical studies for arrhythmia.

During clinical trials, 4.3% of 3257 patients with arrhythmias experienced a new or worsened ventricular arrhythmia, including sustained ventricular tachycardia (approximately 1%) and torsades de pointes (2.4%). In addition, in approximately 1% of patients, deaths were considered possibly drug-related. In patients with other, less serious, ventricular arrhythmias and supraventricular arrhythmias, the incidence of torsades de pointes was 1% and 1.4% respectively.
Serious proarrhythmias including Torsades de pointes were dose related as indicated in Table 1:

In clinical trials of patients with sustained VT/VF, the incidence of severe proarrhythmia (torsades de pointes or new sustained VT/VF) was < 2% at doses up to 320 mg. The incidence more than doubled at higher doses.
Other risk factors for Torsades de pointes were excessive prolongation of the QTc and history of cardiomegaly or congestive heart failure. Patients with sustained ventricular tachycardia and a history of congestive heart failure have the highest risk of serious proarrhythmia (~7%). Proarrhythmic events must be anticipated not only on initiating therapy, but with every upward dose adjustment; events tend to occur within 7 days of initiating therapy or with an increase in dose. Initiating therapy at 80 mg twice daily with gradual upward dose titration thereafter reduces the risk of proarrhythmia (see Section 4.2 Dose and Method of Administration). Sotalol should be used with caution if the QTc is greater than 500 msec on-therapy, and serious consideration should be given to reducing the dose or discontinuing therapy when the QT interval exceeds 550 msec. Due to the multiple risk-factors associated with Torsades de pointes, however, caution should be exercised regardless of the QTc interval.
Proarrhythmic events must be anticipated not only on initiating therapy, but with every upward dose adjustment. Proarrhythmic events most often occur within 7 days of initiating therapy or of an increase in dose; a large percentage of serious proarrhythmias (torsade de pointes and worsened VT) occurred within 7 days of initiating sotalol therapy, while the majority of such events occurred within 3 days of initiation or a dosage change. Initiating therapy at 80 mg BID with gradual upward dose titration and appropriate evaluations for efficacy (e.g. PES or Holter) and safety (e.g. QT interval, heart rate and electrolytes) prior to dose escalation, should reduce the risk of proarrhythmia. Avoiding excessive accumulation of sotalol in patients with diminished renal function, by appropriate dose reduction, should also reduce the risk of proarrhythmia (see Section 4.2 Dose and Method of Administration).

Congestive heart failure.

Sympathetic stimulation is a vital component supporting circulatory function in congestive heart failure (CHF), and beta-blockade depresses myocardial contractility and may precipitate cardiac failure in some patients with a history of cardiac failure, chronic myocardial insufficiency, or unsuspected cardiomyopathy. Moreover, patients with CHF have a higher risk of torsade de pointes (see Section 4.4 Special Warnings and Precautions for Use, Proarrhythmia). In patients without a history of cardiac failure, continuing depression of the myocardium may lead to cardiac failure. If cardiac failure persists, sotalol should be discontinued (see Section 4.4 Special Warnings and Precautions for Use, Abrupt withdrawal).
In patients with controlled CHF, sotalol should be administered cautiously. The positive inotropic action of digitalis may be reduced when the two drugs are used concomitantly. Both digitalis and sotalol slow AV conduction. If cardiac failure continues despite adequate digitalization, sotalol should be discontinued. In patients without a history of heart failure, continued depression of the myocardium over a period of time can, in some cases, lead to cardiac failure. At the first sign of impending heart failure, appropriate therapy must be established and consideration should be given to discontinuation of treatment with sotalol.
Caution is advised when initiating therapy in patients with left ventricular dysfunction controlled by therapy (i.e. ACE inhibitors, diuretics, digitalis, etc); a low initial dose and careful dose titration is appropriate.

Note.

Although congestive heart failure has been considered to be a contraindication to the use of beta-blockers, there is growing literature on the experimental use of beta-adrenergic blocking drugs in heart failure. As further trials are needed to identify which patients are most likely to respond to which drugs, beta-blockers should not normally be prescribed for heart failure outside specialist centres.

Conduction disturbances.

Excessive prolongation of the QT interval (> 550 msec) can promote serious arrhythmias and should be avoided (see Proarrhythmia). Sinus bradycardia (heart rate less than 50 bpm) occurred in some patients receiving sotalol in clinical trials and led to discontinuation in a small percentage of patients. Bradycardia itself increases the risk of torsade de pointes. Sinus pause, sinus arrest and sinus node dysfunction occur in less than 1% of patients. The incidence of 2nd- or 3rd-degree AV block is approximately 1%.

Recent myocardial infarction.

In post-infarction patients with impaired left ventricular function, the risk versus benefit of sotalol administration must be considered. Careful monitoring and dose titration are critical during initiation and follow-up of therapy. The adverse results of clinical trials involving antiarrhythmic drugs (i.e. apparent increase in mortality) suggest that sotalol should be avoided in patients with left ventricular ejection fractions ≤ 40% without serious ventricular arrhythmias.
In a large controlled trial in patients with a recent myocardial infarction without heart failure, who did not necessarily have ventricular arrhythmias, oral sotalol HCl treatment was associated with a non-statistically significant risk reduction in mortality compared to the placebo group (18%). In this post-infarction study using a fixed dose of 320 mg once daily and in a second small randomised trial in high-risk post-infarction patients with left ventricular ejection fractions ≤ 40% treated with high doses (640 mg/day), there were suggestions of an excess of early sudden deaths.

Abrupt withdrawal.

Care should be taken if beta-blockers have to be discontinued abruptly in patients with coronary artery disease. Hypersensitivity to catecholamines is observed in patients withdrawn from beta-blocker therapy. Severe exacerbation of angina pectoris and precipitation of myocardial infarction and ventricular arrhythmias have occurred following abrupt discontinuation of beta-blockade in patients with ischaemic heart disease. In addition, hypertension may develop. Therefore, it is recommended that the dosage be reduced gradually over a period of 8-14 days during which time the patient's progress should be assessed. Sotalol should be temporarily reinstituted if the angina worsens.
If the drug must be withdrawn abruptly in these patients, close observation is required, since latent coronary insufficiency may be unmasked. In the peri-operative period sotalol should not be withdrawn, unless indicated.

Non-allergic bronchospasm (e.g. chronic bronchitis and emphysema).

Patients with bronchospastic diseases should in general not receive beta-blockers. It is prudent, if sotalol is to be administered, to use the smallest effective dose, so that inhibition of bronchodilation produced by endogenous or exogenous catecholamine stimulation of beta₂ receptors may be minimized.

Sick sinus syndrome.

Sotalol should be used only with extreme caution in patients with sick sinus syndrome associated with symptomatic arrhythmias, because it may cause sinus bradycardia, sinus pauses or sinus arrest.

Concomitant therapy with calcium channel blocking drugs.

Peripheral circulation.

Beta-blockade may impair the peripheral circulation and exacerbate the symptoms of peripheral vascular disease and circulatory disorders (such as Raynaud's syndrome and intermittent limping), especially at the start of treatment.

Antiarrhythmic drugs.

Interactions have been reported during concomitant beta-blocker therapy with the Class IA agents disopyramide, and less frequently quinidine; Class IB agents, tocainide, mexiletine and lignocaine; Class IC agents, flecainide and propafenone (not available in Australia); the Class III agent, amiodarone; and the Class IV antiarrhythmic agents. Concomitant use of sotalol with these agents, and with other beta-blocking drugs is not recommended.

Prinzmetal angina.

There is a risk of exacerbating coronary artery spasm if patients with Prinzmetal or variant angina are treated with a beta-blocker. If this treatment is essential, it should only be undertaken in a Coronary or Intensive Care Unit.

Euthyroid hyperthyroxinaemia.

The effects of beta-blockers on thyroid hormone metabolism may result in elevations of serum free thyroxine (T4) levels. In the absence of any signs or symptoms of hyperthyroidism, additional investigation is necessary before a diagnosis of thyrotoxicosis can be made.

Anaphylaxis.

Sotalol's beta-blocking properties may elevate the patient's sensitivity to allergens and exacerbate the severity of anaphylactic reactions. There may be increased difficulty in treating an allergic type reaction in patients on beta-blockers. Patients with a history of severe hypersensitivity reactions and patients who are currently undergoing desensitization therapy are at higher risk of developing severe anaphylactic reactions. Sotalol should therefore only be administered to such patients if absolutely indicated. Patients with a history of anaphylactic reaction to a variety of allergens may have a more severe reaction on repeated challenge while taking beta-blockers. Such patients may be unresponsive to the usual doses of adrenaline used to treat the allergic reaction. Epinephrine should be administered with caution since it may not have its usual effects in the treatment of anaphylaxis. On the one hand, larger doses of epinephrine may be needed to overcome the bronchospasm, while on the other hand, these doses can be associated with excessive alpha-adrenergic stimulation with consequent hypertension, reflex bradycardia, and heart block and possible potentiation of bronchospasm. Alternatives to the use of large doses of epinephrine include vigorous supportive care such as fluids and the use of beta agonists including parenteral salbutamol or isoproterenol to overcome bronchospasm and norepinephrine to overcome hypotension.

Anaesthesia and the peri-operative period.

Beta-blockade may have beneficial effects in decreasing the incidence of arrhythmias and myocardial ischaemia during anaesthesia and the post-operative period. It is currently recommended that maintenance beta-blockade be continued peri-operatively. The anaesthetist must be made aware of beta-blockade because of the potential for interactions with other drugs, resulting in severe bradyarrhythmias and hypotension, the decreased reflex ability to compensate for blood loss, hypovolaemia and regional sympathetic blockade, and the increased propensity for vagal-induced bradycardia. Incidents of protracted severe hypotension or difficulty restoring normal cardiac rhythm during anaesthesia have been reported. Sotalol should be used with caution in patients undergoing surgery.
Modern inhalational anaesthetic agents are generally well tolerated, although older agents (ether, cyclopropane, methoxyflurane, trichlorethylene) were sometimes associated with severe circulatory depression in the presence of beta-blockade.

Diabetes.

Sotalol should be used with caution in patients with diabetes (especially labile diabetes) because beta-blockers affect glucose metabolism and may mask some important premonitory signs of acute hypoglycaemia, such as tachycardia.
In patients with insulin or non-insulin dependent diabetes, especially labile diabetes, or with a history of spontaneous hypoglycaemia, beta-blockade may result in the loss of diabetic control and delayed recovery from hypoglycaemia. The dose of insulin or oral hypoglycaemic agent may need to be adjusted.
Monitoring is recommended in patients on strict fasts and diabetics whose blood sugar levels are subject to major fluctuations (masking of hypoglycaemic states).
Patients initiating treatment require close cardiac monitoring for ventricular arrhythmia in the titration phase of antiarrhythmic therapy and should only be started on the drug if emergency resuscitation equipment is available and if the possibility of monitoring is assured. Regular check ups are necessary during treatment.

Thyrotoxicosis.

Beta-blockade may mask certain clinical signs of hyperthyroidism (e.g. tachycardia). Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-blockade which might be followed by an exacerbation of symptoms of hyperthyroidism, including thyroid storm.

Other metabolic effects.

Beta adrenoreceptors are involved in the regulation of lipid as well as carbohydrate metabolism. Some drugs affect the lipid profile adversely although the long-term clinical significance of this change is unknown and the effect appears to be less for drugs with intrinsic sympathomimetic activity.

Use of catecholamine-depleting agents.

Concomitant use of drugs such as reserpine and guanethidine requires careful monitoring since the added effect of a beta-blocker may produce an excessive reduction of the resting sympathetic nervous tone.

Clonidine.

Concurrent use of beta-blockers and clonidine should be avoided because of the risk of adverse interaction and severe withdrawal symptoms. If administered concomitantly, the clonidine should not be discontinued until several days after the withdrawal of the beta-blocker.

Phaeochromocytoma.

In patients with this condition, an alpha-blocking drug (e.g. phentolamine/phenoxybenzamine) should be administered before the beta-blocker to avoid exacerbation of hypertension.

Eye and skin reactions.

Various skin rashes and conjunctival xerosis have been reported with beta-blocking agents. Cross-reactions may occur between beta-blockers, therefore substitutions within the group may not necessarily preclude occurrence of symptoms.

Allergic conditions.

Allergic reactions may be exaggerated by beta-blockade (e.g. allergic rhinitis during the pollen season and allergic reactions to bee and wasp stings). Beta-blockers should be avoided if there is a risk of bronchospasm.

Hyperthyroidism.

Because beta-blockers may mask the clinical signs of developing or continuing hyperthyroidism, resulting in symptomatic improvement without any change in thyroid status, special care should be exercised in hyperthyroid patients who are also receiving beta-blockers.
Abrupt withdrawal of beta-blockade in hyperthyroid patients may be followed by an exacerbation of symptoms of hyperthyroidism, including thyroid storm, and should be avoided in these patients.

Electrocardiographic monitoring.

Regular electrocardiographic monitoring should be carried out during sotalol therapy because of prolongation of the QT interval (see Section 4.4 Special Warnings and Precautions for Use, Proarrhythmia, Post-marketing experience). Excessive prolongation of the QT interval, > 550 msec, can be a sign of toxicity and should be avoided. Sinus bradycardia (heart rate < 50 bpm) occurred at a frequency of 13% in arrhythmia patients receiving sotalol in clinical trials. Bradycardia itself increases the risk of torsade de pointes. Sinus pause, sinus arrest and sinus node dysfunction occur in less than 1% of patients. The incidence of 2nd or 3rd degree AV block is approximately 1%.

Electrolyte disturbances.

Sotalol should not be used in patients with hypokalaemia or hypomagnesaemia prior to correction of imbalance; these conditions can exaggerate the degree of QT prolongation and increase the potential for torsades de pointes. Special attention should be given to electrolyte and acid-base balance in patients experiencing severe or prolonged diarrhoea or patients receiving concomitant magnesium- and/or potassium-depleting drugs.
Prior to starting treatment with sotalol, serum electrolytes should be obtained and any electrolyte imbalance corrected. Throughout treatment it is important to monitor electrolyte balance at regular intervals and correct any imbalance. When significant diarrhoea or other intercurrent illness associated with electrolyte losses occurs during treatment with sotalol patients should be instructed to contact their doctors so that they can be closely monitored with frequent checks of plasma electrolytes and receive replacement therapy as appropriate. (See Section 4.4 Special Warnings and Precautions for Use, Proarrhythmia, Post-marketing experience.)

Excessive bradycardia.

If excessive bradycardia occurs alone or with hypotension, atropine 0.5 to 2.0 mg should be given intravenously and immediately followed, if necessary, by a beta receptor stimulating agent such as isoprenaline. (See Section 4.9 Overdose.)
Patients experiencing this effect on initial administration of sotalol should be removed temporarily from therapy. Sotalol may be later reintroduced at a lower dosage level.
A reduction in dosage by 80 or 160 mg/day may be advisable to alleviate symptoms of weakness and dizziness in cases where the blood pressure continues to fall after a month or two of sotalol administration.

Psoriasis.

Beta-blocking drugs have been reported rarely to exacerbate the symptoms of psoriasis vulgaris or lead to psoriasis forming exanthema.

Pheochromocytoma.

Sotalol hydrochloride should not be administered to patients with pheochromocytoma unless they are concomitantly receiving alpha-blocker therapy.

Use in hepatic impairment.

Since sotalol is not subject to first-pass metabolism, patients with hepatic impairment show no alteration in clearance of sotalol.

Use in renal impairment.

In patients with severe renal disease, haemodynamic changes following beta-blockade may impair renal function further. Beta-blockers which are excreted mainly by the kidney may require dose adjustment in patients with renal impairment. Sotalol excretion is reduced in patients with renal impairment. Dosage should therefore be adjusted accordingly. Sotalol is contraindicated in patients with severe renal impairment (CrCl < 10 mL/min). Physicians should bear in mind that kidney function may be impaired in elderly patients.

Use in the elderly.

No data available.

Paediatric use.

The safety and effectiveness of sotalol in children under 18 has not been established.

Effects on laboratory tests.

The presence of sotalol in the urine may result in falsely elevated levels of urinary metanephrine when measured by photometric methods. Patients suspected of having phaeochromocytoma and who are treated with sotalol should have their urine screened utilising the high performance liquid chromatographic assay with solid phase extraction.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Alcohol.

The plasma clearance of sotalol is reduced after alcohol ingestion.

Insulin and oral hypoglycaemics.

Concomitant use of sotalol hydrochloride and insulin or oral antidiabetic agents may induce hypoglycaemia. Beta-blocking drugs may prolong the hypoglycaemic action of these drugs especially in conditions where glucose mobilisation may be compromised, e.g. labile diabetes, diabetic ketoacidosis and fasting diabetic patients. Symptoms of hypoglycaemia may be masked by sotalol. Hyperglycaemia may occur, and the dosage of antidiabetic drugs may require adjustment (see Section 4.4 Special Warnings and Precautions for Use, Diabetes).

Anaesthetics.

Agents such as ether, chloroform and cyclopropane are contraindicated with sotalol (see Section 4.4 Special Warnings and Precautions for Use, Anaesthesia and the peri-operative period).

Beta-2 receptor stimulants.

Patients in need of beta-agonists should not normally receive sotalol. However, if concomitant therapy is necessary, beta-agonists may have to be administered in increased dosages.

Calcium channel blocking drugs.

Concurrent administration of beta-blocking agents and calcium channel blockers has resulted in hypotension, bradycardia, conduction defects and cardiac failure. Beta-blockers should be avoided in combination with cardiodepressant calcium-channel blockers such as verapamil and diltiazem because of the additive effects on atrioventricular conduction and ventricular function (see Section 4.4 Special Warnings and Precautions for Use, Concomitant therapy with calcium channel blocking drugs).

Catecholamine-depleting agents.

Concomitant use of catecholamine-depleting drugs, such as reserpine and guanethidine, or alpha methyldopa, with a beta-blocker may produce an excessive reduction of resting sympathetic nervous tone. Patients should be closely monitored for evidence of hypotension and/or marked bradycardia which may produce syncope.

Noradrenaline, clonidine and MAO inhibitors.

An antagonistic effect between noradrenaline or MAO inhibitors or abrupt discontinuation of concomitant clonidine and sotalol has been observed. Concurrent administration of clonidine and sotalol has caused increased blood pressure compared with clonidine or sotalol alone. The combination of beta-adrenoreceptor antagonists and clonidine should be avoided (see Section 4.4 Special Warnings and Precautions for Use, Clonidine). Beta-blocking drugs may potentiate the rebound hypertension sometimes observed after discontinuation of clonidine; therefore, the beta-blocker should be discontinued slowly several days before the gradual withdrawal of clonidine.

Drugs prolonging the QT interval.

Drugs known to prolong the QT interval and/or to be associated with atypical ventricular tachycardia (AVT, torsade de pointes) especially phenothiazines, quinidine, disopyramide and tricyclic antidepressants, terfenadine, astemizole and quinolone antibiotics (e.g. sparfloxacin), macrolide antibiotics (erythromycin), probucol, haloperidol, halofantrine or terodiline should be avoided (see Section 4.4 Special Warnings and Precautions for Use, Proarrhythmia, Post-marketing experience).
Other drugs that have been associated with an increased risk for torsades de pointes include erythromycin IV, halofantrine, pentamidine, and quinolone antibiotics. Patients may experience an excessive drop in blood pressure with concomitant use of sotalol hydrochloride and tricyclic antidepressants, barbiturates, phenothiazines, opioids, antihypertensives, diuretics or vasodilator.

Antiarrhythmic agents.

Potassium-depleting diuretics.

Hypokalaemia or hypomagnesemia may occur, increasing the potential for torsade de pointes (see Section 4.4 Special Warnings and Precautions for Use, Electrolyte disturbances).

Other potassium-depleting drugs.

Amphotericin B (IV route), corticosteroids (systemic administration), and some laxatives may also be associated with hypokalaemia; potassium levels should be monitored and corrected appropriately during concomitant administration with sotalol.

Digoxin.

Single and multiple doses of sotalol do not significantly affect serum digoxin levels.
Proarrhythmic events were more common in sotalol treated patients also receiving digoxin; however, this may be related to the presence of CHF, a known risk factor for proarrhythmia, in the patient receiving digoxin. Association of digitalis glycosides with beta-blockers may increase auriculo-ventricular conduction time.
The negative chronotropic and dromotropic effects of sotalol hydrochloride may be enhanced by concomitant use of reserpine, clonidine, alpha-methyldopa, guanfacine or cardiac glycosides.

Floctafenine.

Beta-adrenergic blocking agents may impede the compensatory cardiovascular reactions associated with hypotension or shock that may be induced by floctafenine.

Neuromuscular blocking agents like tubocurarine.

The neuromuscular blockade is prolonged by beta-blocking agents.

Insulin and oral hypoglycemics.

Hypoglycemia and hyperglycemia may occur and the dosage of antidiabetic drug should be adjusted accordingly (see Section 4.4 Special Warnings and Precautions for Use, Diabetes). Symptoms of hypoglycaemia (tachycardia) may be masked by beta-blocking agents.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category C)
Beta-blockers may cause bradycardia in the foetus and newborn infant. Sotalol has been shown to cross the placental barrier and cause bradycardia or hypoglycaemia in the newborn.
During the late stages of pregnancy these drugs should only be given after weighing the needs of the mother against the risk to the foetus. The neonate should be monitored very carefully for 48-72 hours after delivery if it was not possible to interrupt maternal therapy with sotalol 2-3 days before the birthdate.
Sotalol is actively excreted in breast milk (milk/plasma ratio = 5.4/1) and therefore should not be administered to nursing mothers.

4.7 Effects on Ability to Drive and Use Machines

This drug may affect the individual's ability to drive a vehicle, operate machinery or work safely under precarious conditions. This applies particularly at the beginning of treatment, on increasing the dose or when switching to another medication as well as when alcohol is consumed simultaneously.
Patients should be warned about the potential for dizziness and advised not to drive or operate machinery if these symptoms occur or until their individual susceptibility is known.

4.8 Adverse Effects (Undesirable Effects)

Sotalol is well tolerated in the majority of patients, with the most frequent adverse events arising from its beta-blockade properties. Adverse events are usually transient in nature and rarely necessitate interruption of, or withdrawal from treatment. These include dyspnoea, fatigue, dizziness, headache, fever, excessive bradycardia and/or hypotension. If they do occur, these side effects usually disappear when the dosage is reduced. The most significant adverse events, however, are those due to proarrhythmia, including torsade de pointes.
Frequency is defined using the following convention: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000) including isolated reports. The following are adverse events considered related to therapy with sotalol (see Table 2).
In clinical trials, 3256 patients with cardiac arrhythmias (1363 with sustained ventricular tachycardia) received oral sotalol hydrochloride, of whom 2451 received the drug for at least two weeks. The most significant adverse events were Torsade de pointes and other serious new ventricular arrhythmias (see Section 4.4 Special Warnings and Precautions for Use, Proarrhythmia, Post-marketing experience), which occurred at the following rates (see Table 3):
Overall, discontinuation because of unacceptable adverse events was necessary in 18% of all patients in cardiac arrhythmia trials. The most common adverse events leading to discontinuation of sotalol hydrochloride were: fatigue 4%, bradycardia (< 50 bpm) 3%, dyspnoea 3%, proarrhythmia 2%, asthenia 2% and dizziness 2%.
Cold and cyanotic extremities, Raynaud's phenomenon, increase in existing intermittent claudication and dry eyes have been seen in association with other beta-blockers.

Less common reactions < 1%.

Biochemical abnormalities.

Changes in antinuclear factor (ANF) titres have been reported but the clinical significance of this is not clear.

Cardiovascular.

Congestive heart failure, prolonged QT interval. Increased ventricular ectopic beat frequency, cardiogenic shock and AV block (I) have been observed after intravenous administration.

Dermatological.

Cutaneous thickening, pruritus.

Psychiatric.

Unusual dreams.

Others.

Retroperitoneal fibrosis, facial atrophy.

Serious or life threatening reactions.

Myocardial insufficiency may require treatment with digitalis and diuretics. Bradycardia may respond to atropine (see Section 4.4 Special Warnings and Precautions for Use, Excessive bradycardia). Bronchospasm may be reversed with a beta-2 stimulant. Hypotension, if severe, may require use of a vasopressor. Cardiac infarction following too abrupt a withdrawal of the beta-blocker from patients with ischaemic heart disease can be avoided by gradual reduction of dose. Temporary overdrive pacing is suggested as treatment of ventricular arrhythmias in association with prolonged QT interval.

Not known (frequency cannot be estimated on the basis of available data).

Blood and lymphatic system disorders.

Thrombocytopenia - frequency unknown.

Skin and subcutaneous tissue disorders.

Alopecia and hyperhidrosis - frequency unknown.

Other potential adverse effects.

Marketing experience with sotalol hydrochloride shows an adverse experience profile similar to that described above from clinical trials. Voluntary reports since introduction include rare reports (less than one report per 10,000 patients) of: emotional lability, slightly clouded sensorium, in coordination, vertigo, paralysis, thrombocytopenia, eosinophilia, leukopenia, photosensitivity reaction, fever, pulmonary edema, hyperlipidemia, myalgia, pruritus, reversible alopecia.
Additional adverse effects have been reported with other beta-adrenergic blocking agents.

Central nervous system.

Reversible mental depression progressing to catatonia; and acute reversible syndrome characterized by disorientation for time and place, short-term memory loss and decreased performance on neuropsychometrics.

Allergic.

Fever, combined with aching and sore throat, laryngospasm; respiratory distress.

Hematologic.

Agranulocytosis; thrombocytopenic or nonthrombocytopenia purpura.

Gastrointestinal.

Mesenteric arterial thrombosis; ischemic colitis.

Other.

Peyronie's disease, Raynaud's phenomenon.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Several cases, one fatal, of sotalol intoxication have been reported. Clinical features include: asystole, severe bradycardia, congestive heart failure, hypotension, prolongation of QT interval, ventricular tachyarrhythmias, Torsades de pointes, hypoglycaemia and bronchospasm.
Close monitoring of the electrocardiogram in patients with suspected sotalol intoxication is recommended. Every effort should be made to correct promptly metabolic and electrolyte imbalances which might contribute to the initiation of ventricular arrhythmias.
Gastric lavage, and activated charcoal should be administered when an overdose of APX-Sotalol tablets is suspected. Bradycardia and hypotension should be corrected prior to gastric lavage or endotracheal intubation as these procedures may increase vagal tone.
Depending on the symptoms, the following therapeutic measures are suggested:

Severe bradycardia.

Atropine 1-2 mg intravenously may be used to induce vagal blockade. If bradycardia persists, intravenous isoprenaline may be given. An appropriate regime would be 5 microgram bolus, followed by an infusion of 0.5 to 10 microgram per minute, titrated to achieve the desired effect. In refractory cases the use of a cardiac pacemaker should be considered.

Heart block (second and third degree).

Transvenous cardiac pacing.

Hypotension.

Severe hypotension should respond to a sympathomimetic amine, such as isoprenaline or noradrenaline. In refractory cases, the use of glucagon hydrochloride should be considered.

Torsade de pointes.

DC cardioversion, transvenous cardiac pacing, adrenaline, and/or I.V. magnesium sulphate.

Dialysis.

Dialysis lowers the plasma sotalol concentration by approximately 20%.

Bronchospasm.

A beta-2-agonist and/or aminophylline.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Sotalol is a non-selective beta-adrenergic receptor blocker without sympathomimetic activity or membrane stabilising activity. It causes a decrease in heart rate and a limited reduction in the force of contraction of the heart. There is a reduction in cardiac work and in myocardial oxygen demand. Sotalol does not decrease blood pressure in normotensive subjects.
Sotalol also possesses class III antiarrhythmic activity. Sotalol has no known effect on the upstroke velocity of the action potential, therefore no known effect on the depolarisation phase. Its major effects are prolongation of the atrial, ventricular and accessory pathway effective refractory periods. The effect on the ventricular myocardium may be reflected by a lengthening of the QTc interval on electrocardiographic recordings.
Like most other beta-blockers, sotalol inhibits renin release. This suppressive effect is significant both at rest and during exercise.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Sotalol is well absorbed from the gastrointestinal tract. Peak plasma concentrations of 1.0 to 2.3 mg/L are reached at 2-3 hours after a 160 mg oral dose.

Distribution.

Total apparent volume of distribution of sotalol ranges from 1.6 to 2.4 L/kg. The volume of distribution at steady state is approximately halved in the elderly.

Protein binding.

Sotalol does not bind to plasma proteins and does not significantly cross the blood/brain barrier. However, it is excreted in breast milk and may cross the placental barrier.

Metabolism.

Sotalol is not metabolised by the liver and does not undergo biotransformation (no first-pass effect). There is a positive correlation between sotalol dose and plasma concentration.

Excretion.

Sotalol is excreted by glomerular filtration and to a small degree by tubular secretion. After oral administration, about 75% of the dose is excreted in the urine within 72 h as unchanged sotalol. Less than 10% is excreted in the faeces. The mean elimination half-life of sotalol is 12.7 + 1.6 (SE) h.

Bioavailability.

The absolute bioavailability on oral administration is close to 100%. The bioavailability is decreased when APX-Sotalol is administered with food, especially milk.

Clinical implications of pharmacokinetic data.

As sotalol is primarily excreted by the kidneys, dosage adjustment is necessary in patients with moderate renal impairment. Severe renal impairment (CrCl < 10 mL/min) is a contraindication.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

APX-Sotalol tablets contain the following inactive ingredients: lactose, microcrystalline cellulose, maize starch, indigo carmine aluminium lake, colloidal anhydrous silica, stearic acid and magnesium stearate.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf-life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C. Protect from light and moisture.

6.5 Nature and Contents of Container

APX-Sotalol sotalol hydrochloride 80 mg.

Available in blister pack (Al/PVC-PVDC) of 60 tablets.

APX-Sotalol sotalol hydrochloride 160 mg.

Available in blister pack (Al/PVC-PVDC) of 60 tablets.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

Sotalol hydrochloride is the hydrochloride salt of: 4'-(1-hydroxy-2-isopropylaminoethyl) methanesulfonanilide.
The structural formula is:

Molecular formula: C₁₂H₂₀N₂O₃S HCl.
Molecular weight: 308.83.

CAS number.

959-24-0.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

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APX-Sotalol 160 mg tablets

APX-Sotalol 80 mg Tablets