Consumer medicine information

Atenolol-AFT

Atenolol

BRAND INFORMATION

Brand name

Atenolol-AFT Oral liquid

Active ingredient

Atenolol

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Atenolol-AFT.

What is in this leaflet

This leaflet answers some common questions about Atenolol-AFT. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking Atenolol-AFT against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Atenolol-AFT is used for

Atenolol belongs to a group of medicines called beta-blockers. It makes the heart beat slower and less forcefully reducing the amount of oxygen required by the heart and the volume of blood it has to pump. This results in lower blood pressure. It widens the blood vessels in the body, causing blood pressure to fall. It helps the heart to beat more regularly.

Atenolol-AFT is used to:

  • lower high blood pressure (hypertension)
  • prevent angina
  • treat irregular heart rhythm or beat (arrhythmias)
  • treat heart attacks, or reduce the risk of heart complications following a heart attack

Atenolol-AFT may be used alone or in combination with other medicines to treat your condition.

Atenolol-AFT may also be used in emergency situations or during surgery to treat a fast heart beat before, during or after surgery.

Hypertension:

Everybody has blood pressure. Blood pressure helps to move the blood around your body. Your blood pressure will change during the day, depending on how busy you are or how you are feeling.

You have hypertension (high blood pressure) when your blood pressure stays higher than is needed, even when you are calm and relaxed. Regular blood pressure checks are the only way to know if you have hypertension. There are usually no symptoms with hypertension and you may feel fine. If hypertension is not treated, serious health problems e.g. stroke, heart disease and kidney failure may occur.

Atenolol-AFT helps to lower your blood pressure.

Angina:

Angina is a discomfort or pain felt in your chest. The pain may also be felt in your arms or neck and sometimes your shoulders and back. It may be caused by not enough oxygen or blood reaching areas of your heart. Angina pain is often caused by exercise or stress.

Atenolol-AFT is used to prevent angina. It is not used to relieve a sudden attack of angina.

Irregular heart beat (arrhythmia):

Some heart diseases, an over active thyroid gland or chemical imbalances may cause your heart to have an irregular heart beat or rhythm.

Atenolol-AFT helps restore your heart's normal rhythm.

Reducing heart complications after heart attack:

After a heart attack, you may have complications e.g. an irregular heart beat or an increased chance of having another heart attack.

Atenolol-AFT helps to prevent these complications from occurring.

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

Your doctor may have prescribed Atenolol-AFT for another reason.

Atenolol-AFT is not recommended for use in children as there have been no studies on its effects in children.

There is no evidence that Atenolol-AFT is addictive.

Before you take Atenolol-AFT

When you must not take it

Do not take Atenolol-AFT if you:

  1. have or have had asthma (difficulty in breathing, wheezing and coughing), bronchitis or other lung problems.
  2. have any of the following conditions:
  • a history of allergic problems, including hayfever. Symptoms of an allergy include rash, itching, watery eyes and sneezing.
  • a very slow heart beat (less than 45-50 beats/minute)
  • a severe blood vessel disorder causing poor circulation in the arms and legs
  • certain other heart conditions
  • phaeochromocytoma (a rare tumour of the adrenal gland) which is not being treated with other medicines
  • low blood pressure (hypotension)
  • too much acid in your blood (metabolic acidosis)
  1. are receiving:
  • certain anaesthetics for medical or dental procedures
  • emergency treatment for shock or severely low blood pressure
  1. have an allergy to atenolol or any of the ingredients listed at the end of this leaflet, or to any other beta-blocker medicine.
  2. are pregnant, intend to become pregnant, are breast feeding or intend to breast feed.
    Your doctor will discuss the possible risks and benefits of using Atenolol-AFT during pregnancy and while breast feeding with you. Atenolol passes into breast milk and may therefore affect the breast-fed baby.

If you are not sure whether any of these apply to you, check with your doctor.

Do not use Atenolol-AFT if the package shows signs of tampering.

Do not use Atenolol-AFT if the expiry date (EXP) printed on the pack has passed.

It may not work as well after this date.

Before you start to take Atenolol-AFT

Tell your doctor if you:

  1. have any allergies to:
  • any other medicine, including eye drops, or other beta-blocker medicines
  • any other substances, such as foods, preservatives or dyes
  • insect stings

Atenolol-AFT may make allergies worse or harder to treat.

  1. have or have had a history of any of the following conditions:
  • heart problems
  • diabetes
  • an over active thyroid gland called hyperthyroidism.
  • kidney problems
  • circulation problems

If you have not told your doctor about any of the above, tell them before you start to take Atenolol-AFT

Taking other medicines

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

Some medicines and Atenolol-AFT may affect how each medicine works. These include:

  • other beta-blocker medicines
  • medicines used to treat high blood pressure or angina
  • medicine used to treat heart problems
  • insulin and tablets used to treat diabetes
  • medicines used to treat arthritis, pain, or inflammation

If any of these medicines and Atenolol-AFT are taken together, you may need to take different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you on which medicines to be careful with or to avoid while taking Atenolol-AFT.

How to use Atenolol-AFT

How much to take

Follow the instructions given to you by your doctor and pharmacist carefully.

They may differ from the information contained in this leaflet. If you do not understand the instructions on the label, ask your doctor or pharmacist for help.

Hypertension:
The usual dose is from 10 mL (50 mg) up to 40 mL (200 mg) of Atenolol-AFT daily. If your dose is 20 mL or less, take it once a day. If you need to take more than 20 mL, take half of your Atenolol-AFT in the morning and the other half in the evening.

Angina or Irregular Heart Beat:
The usual dose is from 10 mL up to 20 mL taken as either a single dose or half the dose in the morning and half at night.

Heart attack:
The usual dose is 10 mL of Atenolol-AFT daily. Some people e.g. the elderly or those with kidney problems, may require a lower dose.

If you have been taking tablets that containing atenolol, your doctor may wish to see you more often until they are certain that Atenolol-AFT is working in the same way as the tablets you have been taking. While there should be no problem switching from atenolol tablets to atenolol liquid (or from the liquid to the tablets) it is possible that some people may need to have their dose adjusted to achieve the same effect. If you have any concerns about how Atenolol-AFT is working for you, talk to your doctor.

When to take it

It does not matter if you take your medicine before or after food. It is best to take your medicine at the same time everyday. This will help you remember when to take it.

How long to take it

Take Atenolol-AFT as you are directed. Continue taking until your doctor advises you to stop.

It helps to treat high blood pressure, irregular heart beat, heart attacks and prevent angina but does not cure them. Do not stop taking without checking with your doctor first. Your doctor may want you to gradually reduce the amount of Atenolol-AFT you are taking. This should take place over a period of about 2 weeks before stopping completely. Do not stop suddenly, as this may worsen your condition.

If you forget to take it

If it is less than six hours since you missed your dose, take it as soon as you remember, and then go back to taking Atenolol-AFT at the same time you would normally. If it is more than six hours since your last dose, skip the dose you missed and take your next dose when you would normally.

Do not take a double dose to make up for the dose that you missed.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

While you are taking Atenolol-AFT

You must:

Make sure you attend all of your doctor's appointments so that your progress can be checked.

Tell all the doctors, dentists and pharmacists that are treating you that you are taking atenolol.

Tell your doctor immediately if you become pregnant while taking Atenolol-AFT.

Immediately tell your doctor if you have an allergic reaction to any foods, medicines or insect stings.

Atenolol can cause allergic reactions to be worse and harder to treat.

If you have diabetes, check your blood sugar level regularly and report any changes to your doctor.

Atenolol-AFT may affect your diabetes. It may hide the symptoms of low blood sugar levels, e.g. a fast heart beat. It may take longer for your blood sugar level to get back to normal even if you follow the usual treatment for diabetes. Your diabetic medicines may have to be changed or the doses adjusted.

If you continue to have angina attacks, or have more of them whilst taking Atenolol-AFT, tell your doctor.

Atenolol-AFT is used to help prevent angina, so your angina attacks should become less severe and occur less often.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. You may feel light-headed or dizzy after taking Atenolol-AFT. This is because your blood pressure is falling suddenly. If this problem gets worse or continues, talk to your doctor. To help your body get used to the change in blood pressure, you may find the following useful:

  • Stand up slowly when getting up from a chair or bed. This will allow your body get used to the change in position and blood pressure.
  • If you feel dizzy, sit or lie down until you feel better.
  • If you feel faint, sit down and put your head between your knees.

Drink lots of water when exercising and during hot weather when taking Atenolol-AFT.

If you do not drink enough water while taking atenolol, you may feel faint, light-headed or sick.

If you are having surgery (even at the dentist), tell your doctor or dentist that you are taking atenolol.

Atenolol may affect some of the medicines used during surgery.

If you have to have any medical tests while you are taking Atenolol-AFT, tell your doctor.

Atenolol may affect the results of some tests.

Things you must not do

Do not stop taking Atenolol-AFT without checking with your doctor.

Do not take any new medicines with Atenolol-AFT, unless your doctor has told you to.

Do not give Atenolol-AFT to anyone else, even if they have the same condition as you.

Do not use Atenolol-AFT to treat any other complaint unless your doctor tells you to.

Things to be careful of

Take care driving or operating machinery until you know how Atenolol-AFT affects you.

Atenolol-AFT may cause dizziness, fatigue, light-headedness or faintness in some people.

Be careful not to over exercise when you first start taking Atenolol-AFT.

It helps prevent angina caused by physical activity and exercise. You may be tempted to exercise too much. Talk to your doctor about how much exercise you can do.

Dress warmly during cold weather, especially if you will be outside for a long time e.g. when playing or watching sport in winter.

Atenolol-AFT may make you more sensitive to cold temperatures, especially if you have circulation problems. Beta-blockers tend to decrease blood circulation in the skin, fingers and toes.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Atenolol-AFT, even if you think the problems are not connected with the medicine.

If you get any side effects, do not stop taking Atenolol-AFT without first talking to your doctor.

Atenolol-AFT can cause some side effects. If they occur, most are likely to be minor and last only a short time. However, some may be serious and need medical attention.

Tell your doctor if you notice any of the following and they worry you:

  • stomach upsets such as diarrhoea, constipation, abdominal pain or heartburn (indigestion)
  • dry mouth, change in taste sensation
  • dizziness, headache or buzzing or ringing in the ears
  • slow or irregular heart beat
  • dry eyes, problems with vision
  • runny or blocked nose
  • difficulty sleeping, nightmares
  • skin reactions (e.g. rash, itching, worsening of psoriasis)
  • cold fingers and toes
  • increased hair loss
  • tingling, 'pins and needles' or walking unsteadily
  • sexual problems

These side effects are usually mild.

Tell your doctor immediately if you notice any of the following:

  • confusion or disorientation
  • depression or mood changes or a worsening of these
  • unusual thoughts, hallucinations (seeing, feeling or hearing things that are not there)
  • light-headedness or fainting which may be due to low blood pressure
  • yellowing of the skin and/or eyes (jaundice)

These are serious side effects. You may need urgent medical attention. Serious side effects are rare.

If any of the following happen, tell your doctor immediately, or go to accident and emergency at your nearest hospital:

  • wheezing, chest tightness or difficulty breathing
  • unexplained bruising
  • swelling of the face, lips or throat

These are very serious side effects and you may need urgent medical attention or hospitalisation. These side effects are rare.

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

Some people may get different side effects while taking Atenolol-AFT.

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

Overdose

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26), or go to the Accident & Emergency Department at your nearest hospital, if you think that you or anyone else may have taken too much Atenolol-AFT. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Keep these telephone numbers handy.

If you take too much Atenolol-AFT, you may feel faint or dizzy or you may find it difficult to breathe

Storage

Store below 25 ºC.

Store in original carton to protect from light.

Use within 1 month of opening.

Do not leave Atenolol-AFT in the car or on window sills.

Heat can destroy some medicines.

Keep this medicine out of reach of children.

A locked cupboard which children cannot reach is a good place to store medicines.

Disposal

If your doctor tells you to stop using Atenolol-AFT or it has passed its expiry date, ask your pharmacist what to do with any that is left over.

Other ingredients

Atenolol-AFT also contains sorbitol, propylene glycol, sodium citrate, citric acid, methyl and propyl hydroxyl benzoates, sodium saccharin and lemon-lime flavour. It does not contain any sucrose, lactose, gluten or colouring agents.

If you want to know more

If you have any questions about Atenolol-AFT or why it was prescribed for you, talk to your doctor or pharmacist.

Atenolol-AFT, atenolol 50 mg/10 mL, oral solution, bottle, 300 mL, AUST R 184745

Distributor

AFT Pharmaceuticals Pty Ltd
113 Wicks Road
North Ryde
NSW 2113

14 August 2015

BRAND INFORMATION

Brand name

Atenolol-AFT Oral liquid

Active ingredient

Atenolol

Schedule

S4

 

1 Name of Medicine

Atenolol.

6.7 Physicochemical Properties

Atenolol is a racemic mixture which has the chemical name 2-[4-[(2RS)-2-hydroxy-3-[(1-methylethyl)amino] propoxy] phenyl] acetamide. It has the chemical formula C14H22N2O3 with a molecular weight of 266.3.

Chemical structure.


CAS number.

29122-68-7.

2 Qualitative and Quantitative Composition

Atenolol-AFT, oral solution, contains 50 mg atenolol per 10 mL of the solution.
Atenolol is a white or to almost white crystalline powder which is sparingly soluble in water, soluble in ethanol and slightly soluble in methylene chloride. The pKa for atenolol is 9.6.
Atenolol-AFT, oral solution also contains sorbitol solution (70 per cent) (non-crystallising), methyl hydroxybenzoate, propyl hydroxybenzoate, sodium saccharin, citric acid monohydrate, sodium citrate, propylene glycol and lemon lime flavour PHL0132956 (Proprietary Ingredient 11570).
For the full list of excipients, see Section 6.1.

3 Pharmaceutical Form

Atenolol-AFT, oral solution is a clear, colourless, slightly viscous liquid with a lemon-lime odour and flavour which contains 50 mg Atenolol per 10 mL of solution.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Atenolol is a β-adrenoreceptor blocking drug which acts preferentially on β1-receptors in the heart. Selectivity decreases with increasing dose. It has little intrinsic sympathomimetic activity and no membrane stabilising activity. Atenolol is a racemic mixture with the activity in the S(-) enantiomer. It reduces raised blood pressure by an unknown mechanism, inhibits exercise induced tachycardia and decreases plasma renin concentration. It causes slight airway obstruction but less than that seen with nonselective β-blockers. The inhibition of exercise induced tachycardia is correlated with blood levels but there is no correlation between plasma concentrations and antihypertensive effect.
Atenolol is effective and well tolerated in most ethnic populations although the response may be less in Afro-Caribbean black patients.
The possible mechanism of the antianginal activity of atenolol appears to be due to a reduction in left ventricular work and oxygen utilisation as a result of the decrease in heart rate and contractility.
The antiarrhythmic effect of atenolol is apparently due to its antisympathetic effect. There is no evidence that membrane stabilising activity or intrinsic sympathomimetic activity are necessary for antiarrhythmic efficacy. Atenolol depresses sinus node function, atrioventricular node function and prolongs atrial refractory periods. It has no direct effect on electrophysiological properties of the HIS-purkinje system.
β-adrenoreceptor blocking agents should be avoided in uncontrolled heart failure because of their negative inotropic effects.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Although absorption of atenolol is variable and incomplete (40 to 60%) the virtual lack of hepatic metabolism results in a relatively consistent systemic bioavailability compared to other β-blockers. Blood levels in humans peak 2-4 hours after a single 100 mg oral dose and are typically 0.4-0.9 microgram/mL. Blood levels are consistent and the levels after chronic oral administration are in good agreement with those predicted from single dose results.

Distribution.

Atenolol is distributed throughout the body tissues.

Metabolism.

Less than 10% of a dose is metabolised. The minor urinary metabolite has been identified as a hydroxylated derivative.

Excretion.

The main route of elimination is renal excretion.

Half-life.

The plasma half-life, measured by blood level decay or urinary build up, is approximately 7-9 hours. In patients with impaired renal function there is a progressive prolongation of the half-life.
In patients with normal kidney function, the therapeutic effect lasts for not less than 24 hours after a 50 mg oral dose.
While literature suggests that atenolol as an oral liquid behaves in the same way as atenolol tablets, no data directly comparing the bioavailability of Atenolol-AFT with atenolol tablets is available. Dose titration should be undertaken in a controlled manner and patients changing from the tablets to the oral liquid (or vice versa) should be monitored with the dosage being adjusted as appropriate.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

4 Clinical Particulars

4.1 Therapeutic Indications

All grades of hypertension, including hypertension of renal origin.
Frequent disabling angina without evidence of cardiac failure.
Cardiac arrhythmias (acute treatment of supraventricular and ventricular arrhythmias including those associated with acute myocardial infarction).
Myocardial infarction, late intervention (β-blocker class effect greater than 12 hours after onset of chest pain).

4.3 Contraindications

Bronchospasm: β-adrenergic blockade of the smooth muscle of bronchi and bronchioles may result in an increased airways resistance. These drugs also reduce the effectiveness of asthma treatment. This may be dangerous in susceptible patients. β-Blockers are therefore contraindicated in any patient with a history of airways obstruction or tendency to bronchospasm. Use of cardioselective β-blockers may also result in severe bronchospasm. If such therapy must be used, great caution should be exercised. Alternative therapy should be considered.
Congestive heart failure.
Allergic disorders (including allergic rhinitis) which may suggest a predisposition to bronchospasm.
Right ventricular failure secondary to pulmonary hypertension.
Significant right ventricular hypertrophy.
Sick sinus syndrome.
Sinus bradycardia (less than 45 to 50 beats/minute).
Second and third degree A-V block.
Shock (including cardiogenic and hypovolaemic shock).
Anaesthesia with agents that cause myocardial depression, e.g. ether, chloroform, cyclopropane.
Hypersensitivity to the drug or any other ingredient used in the medicine.
Hypotension.
Metabolic acidosis.
Severe peripheral arterial circulatory disturbances.
Untreated phaeochromocytoma.
Pregnancy and lactation, see Section 4.6 Fertility, Pregnancy and Lactation.

4.4 Special Warnings and Precautions for Use

No data directly comparing the bioavailability of Atenolol-AFT with atenolol tablets is available. While it is expected that the tablets and liquid will behave in the same manner, dose titration with the oral liquid should be undertaken in a controlled manner and patients changing from the tablets to the oral liquid (or vice versa) should be monitored with the dosage being adjusted as appropriate.

Cardiac failure.

β-blockade depresses myocardial contractility and may precipitate cardiac failure in some patients with a history of cardiac failure, chronic myocardial insufficiency or unsuspected cardiomyopathy as may occur in chronic alcoholism. In patients without a history of cardiac failure, continuing depression of the myocardium may lead to cardiac failure. If signs of cardiac failure present, the patients should be fully digitalised and/or given an ACE inhibitor or vasodilators with or without a diuretic and carefully monitored. If cardiac failure persists, the beta-blocker should be withdrawn. See Section 4.4 Special Warnings and Precautions for Use, Abrupt withdrawal of therapy.

Note.

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

Abrupt withdrawal of therapy.

Care should be taken if β-blockers have to be discontinued abruptly in patients with coronary artery disease. Severe exacerbation of angina and precipitation of myocardial infarction and ventricular arrhythmias have occurred following abrupt discontinuation of β-blockade in patients with ischaemic heart disease. It is recommended that the dosage be reduced gradually over a period of about 8-14 days during which time the patient's progress should be reassessed. The drug may be reinstituted temporarily if the angina worsens. If the drug must be withdrawn abruptly, close observation is required. In the perioperative period, β-blockers should not be withdrawn, unless indicated.

History of anaphylactic reaction.

While taking β-adrenoreceptor blocking drugs, patients with a history of anaphylactic reaction to a variety of allergens may have a more severe reaction on repeated challenge. These patients may be unresponsive to the usual doses of adrenaline used to treat the allergic reactions.

First degree heart block.

Caution must be exercised if atenolol is given to patients with first degree heart block because of its negative effect on conduction time.

Peripheral circulation.

β-blockade may impair the peripheral circulation and exacerbate the symptoms of peripheral vascular disease.

Prinzmetal angina.

If patients with Prinzmetal or variant angina are treated with a β-blocker, there is a risk of exacerbating coronary artery spasm. If this treatment is essential, it should only be undertaken in a coronary or intensive care unit.

Euthyroid hyperthyroxinaemia.

The effects of β-blockers on thyroid hormone metabolism may result in elevation 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.

Use in acute myocardial infarction.

In addition to the contraindications listed above, patients with the following conditions are not suitable for treatment with atenolol:
Systolic blood pressure less than 120 mmHg (systolic blood pressure < 120 mmHg in combination with a heart rate > 90 beats/min has a particularly poor prognosis).
First degree A-V block. There is an increased incidence of cardiogenic shock (and need for inotropes), complete heart block and cardiovascular death in these patients, following atenolol administration.
Patients with atrial fibrillation following myocardial infarction treated with atenolol, had increased cardiovascular mortality when compared with those not treated with atenolol. It is recommended that such patients be digitalised before atenolol therapy is begun.

Bradycardia.

If a treated patient develops symptoms which may be attributable to a slow heart rate, the dose may be reduced.

Anaesthesia and the perioperative period.

β-Blockade may have beneficial effects in decreasing the incidence of arrhythmias and myocardial ischaemia during anaesthesia and the postoperative period. It is currently recommended that maintenance of β-blockade be continued perioperatively. The anaesthetist must be advised of the β-blockade due to the potential for interactions with other drugs which may result in severe bradyarrhythmias and hypotension, decreased reflex ability to compensate for blood loss, hypovolaemia and regional sympathetic blockade, and an increased propensity for vagal induced bradycardia. Incidents of protracted severe hypotension or of difficulty in restoring normal cardiac rhythm during anaesthesia have been reported. Modern inhalational anaesthetic agents are generally well tolerated, however older agents, e.g. ether, cyclopropane, methoxyflurane, trichlorethylene have been associated with severe circulatory depression in the presence of β-blockade.

Diabetes.

β-Blockers affect glucose metabolism and may mask some important premonitory signs of acute hypoglycaemia, e.g. tachycardia. In patients with insulin or noninsulin dependent diabetes (especially labile diabetes), or with a history of spontaneous hypoglycaemia, β-blockade may result in the loss of diabetic control and delay recovery from hypoglycaemia. The dose of insulin or oral hypoglycaemic agent may need to be adjusted.

Other metabolic effects.

β-adrenoreceptors are involved in the regulation of lipid and carbohydrate metabolism. While some drugs affect the lipid profile adversely, the long-term clinical significance of this change is unknown and the effect appears to be less for drugs with intrinsic sympathomimetic activity.

Phaeochromocytoma.

In patients with this condition, an α-blocking drug, e.g. phentolamine, phenoxybenzamine should be administered before the β-blocker to avoid exacerbation of hypertension.

Eye and skin reactions.

Skin rashes and conjunctival xerosis have been reported with β-blockers. Cross reactions may occur between β-blockers, therefore, substitutions within the group may not necessarily preclude occurrence of symptoms.
During long-term treatment with the β-blocker practolol, a rash bearing a superficial resemblance to psoriasis was occasionally described. In a number of patients, this rash was accompanied by adverse effects on the eye (xerophthalmia and/or keratoconjunctivitis) of varying severity. This condition is called the oculomucocutaneous syndrome or practolol syndrome. In a few patients, these eye changes occurred without a skin rash. On rare occasions, serous otitis media, sclerosing peritonitis, pericarditis and pleurisy have been reported. Although the practolol syndrome has not been observed in patients taking other β-blockers, the possibility of such side effects occurring should be kept in mind.
More recently an association between Peyronie's disease and various β-blockers has been suggested but is not proven.

Allergic conditions.

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

Hyperthyroidism.

β-Blockers may mask the clinical signs of developing or continuing hyperthyroidism, resulting in symptomatic improvement without any change in thyroid hormone status. Caution should be exercised in those patients who are hyperthyroid and also receiving β-blockers.

Use in renal impairment.

In patients with severe renal disease, haemodynamic changes following β-blockade may further impair renal function. β-Blockers which are excreted mainly by the kidney may require dose adjustment in patients with renal failure.

Use in the elderly.

See Section 4.2 Dose and Method of Administration.

Paediatric use.

See Section 4.2 Dose and Method of Administration.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Calcium antagonists.

The concomitant use of β-blockers and calcium antagonists with myocardial depressant and sinus node activity, e.g. verapamil and, to a lesser extent, diltiazem, may cause hypotension, bradycardia and asystole, particularly in patients with impaired ventricular function and/or SA or AV conduction abnormalities. Extreme caution is required if these drugs are to be used together.
The dihydropyridine calcium antagonists, e.g. nifedipine have a weaker myocardial depressant effect and can be administered cautiously with β-blockers. If excessive hypotension develops, the calcium antagonist should be stopped or the dosage reduced.

Antiarrhythmic drugs.

Class 1 antiarrhythmic drugs, e.g. disopyramide and the class III agent, amiodarone may have potentiating effect on atrial conduction time and induce negative inotropic effect. This is seen less frequently with quinidine; class IB agents, tocainide, mexiletine and lignocaine; class IC agents, flecainide and the class IV antiarrhythmic agents.

Catecholamine depleting agents.

Concomitant use of drugs such as reserpine and guanethidine requires careful monitoring because the added effect of β-blockade may produce an excessive reduction of the resting sympathetic nervous tone.

Clonidine.

Concurrent use of β-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 β-blocker.

Insulin and oral hypoglycaemics.

See Section 4.4 Special Warnings and Precautions for Use, Diabetes.

Anaesthetics.

Anaesthetics, e.g. methoxyflurane are contraindicated with Atenolol-AFT. See Section 4.4 Special Warnings and Precautions for Use, Anaesthesia and the perioperative period.

Digitalis/ digitalis glycosides.

Digitalis/ digitalis glycosides and β-blockers are commonly used together, although there have been reports of excessive bradycardia when β-blockers are used to treat digitalis intoxication.

Sympathomimetic agents.

Concomitant use of sympathomimetic agents, e.g. adrenaline may counteract the effects of β-blockers.

Prostaglandin synthetase inhibitors.

Concomitant use of prostaglandin synthetase inhibiting drugs, e.g. ibuprofen and indomethacin may decrease the hypotensive effects of β-blockers.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category C)
β-Blockers may cause bradycardia in the foetus and newborn infant. During pregnancy and parturition, these drugs should only be given after weighing the potential benefit to the mother against the potential risk to the foetus.
Atenolol crosses the placental barrier in pregnant women and appears in the cord blood. Under steady-state conditions, maternal and foetal blood levels of atenolol are approximately equal.
No studies have been performed on the use of atenolol in the first trimester and the possibility of foetal injury cannot be excluded. Atenolol has been used under close supervision for the treatment of hypertension in the third trimester. Administration of atenolol to pregnant women in the management of mild to moderate hypertension has been associated with intrauterine growth retardation.
The use of atenolol in women who are, or may become pregnant, requires that the anticipated benefit be weighed against the possible risks, particularly in the first and second trimesters as β-blockers have been associated with a decrease in placental perfusion which may result in intrauterine deaths, immature and premature deliveries.
Atenolol has been shown to produce a dose related increase in embryo/ foetal resorptions in rats at doses equal to or greater than 50 mg/kg. Although similar effects were not seen in rabbits, the compound was not evaluated in rabbits at doses above 25 mg/kg.
There is a significant accumulation of atenolol in breast milk. Caution should be exercised when atenolol is administered to nursing women and the infant should be regularly assessed for signs of β-blockade.

4.8 Adverse Effects (Undesirable Effects)

Atenolol is generally well tolerated. Adverse reactions reported in clinical studies were mainly attributable to pharmacological actions. The adverse reactions listed in Table 1 have been observed in patients in clinical trials who have received dosages of about 100 mg per day. It is not possible to give percentage incidences for each reaction, but if all mild and transient reactions are included as well as the more serious ones, up to 10% of patients may experience some form of adverse reaction.

Serious or life threatening reactions.

Myocardial insufficiency may require treatment with digitalis and diuretics. Bradycardia may respond to atropine. Bronchospasm may be reversed with a β2-stimulant. Hypotension, if severe, may require use of a vasopressor.

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 https://www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

Dose.

While literature suggests that atenolol as an oral liquid behaves in the same way as atenolol tablets, no data directly comparing the bioavailability of Atenolol-AFT with atenolol tablets is available. Dose titration should be undertaken in a controlled manner and patients changing from the tablets to the oral liquid (or vice versa) should be monitored with the dosage being adjusted as appropriate.
Given the possibility of more calibrated dose titration with an oral solution, it may be appropriate to initiate doses at less than 50 mg. However, this would require an individual risk benefit assessment to be undertaken before any such decision.

Adults.

Hypertension.

Therapy should be initiated with 50 mg (10 mL) of Atenolol-AFT daily which may be increased each week in daily doses of 50 mg (10 mL) up to a maximum of 200 mg (40 mL).
Where patients are controlled on daily doses of 50-100 mg (10-20 mL), this may be given once daily. Doses above 100 mg (20 mL) daily should be given on a divided basis. A further reduction in blood pressure may be achieved if necessary by combining atenolol with other antihypertensive agents.
Patients can be transferred to atenolol from other antihypertensive treatments with the exception of clonidine. See Section 4.4 Special Warnings and Precautions for Use.

Angina pectoris.

Therapy should be initiated with 50 mg (10 mL) of Atenolol-AFT daily. This may be increased to 100 mg (20 mL) daily (if required), given as a single or divided dose. It is unlikely that additional benefit will be gained by increasing the dose further.

Cardiac dysrhythmias.

Having controlled the dysrhythmias with intravenous agents, Atenolol-AFT given orally at a dosage of 50-100 mg (10-20 mL) daily will help maintain control.

Acute myocardial infarction - late intervention (> 12 hours from onset of chest pain).

Atenolol has been shown to reduce infarct size, the incidence of ventricular dysrhythmias, the need for opiate analgesics and mortality in the first 7 postinfarction days with most of the benefit being in the first 48 hours.
Data from other β-blocker trials indicates that there is a significant reduction in mortality and a reduced incidence of nonfatal reinfarction if the β-blocker is continued for 1-3 years.
Therefore on going therapy with 50 mg daily of Atenolol-AFT is recommended for 1-3 years following myocardial infarction, beginning after early intervention with other agents, or immediately in those patients who present more than 12 hours after suffering an acute myocardial infarction.

Impaired renal function.

Because atenolol is excreted via the kidneys, the dosage should be adjusted in cases of severe impairment of renal function. No significant accumulation of atenolol occurs at a creatinine clearance greater than 35 mL/min/1.73 m2 (normal range is 100 to 150 mL/min/1.73 m2. For patients with a creatinine clearance of 15-35 mL/min/1.73 m2 (equivalent to serum creatinine of 300-600 micromol/L) the dose should be 50 mg daily or 100 mg on alternate days. For patients with a creatinine clearance of less than 15 mL/min/1.73 m2 (equivalent to serum creatinine > 600 micromol/L) the dose should be 50 mg on alternate days or 100 mg every fourth day.
Patients on haemodialysis should be given 50 mg (10 mL) after each dialysis; this should be done under hospital supervision as marked falls in blood pressure can occur.

Elderly.

Dosage requirements may be reduced especially in patients with impaired renal function.

Children.

There is no experience with Atenolol-AFT in children.

4.7 Effects on Ability to Drive and Use Machines

Any impairment of the ability of patients to drive or operate machinery is unlikely, however dizziness or fatigue may occur occasionally.

4.9 Overdose

While overdosage has not been reported with atenolol, in overdosage with other β-blocking agents, severe bradycardia and hypotension are commonly found. Acute heart failure and bronchospasm may also occur.

Management.

Severe bradycardia.

Atropine, 1-2 mg I.V. may be used to induce vagal blockade. If bradycardia persists, an inotrope, e.g. intravenous isoprenaline (25 microgram initially) may be given. In refractory cases, the use of a cardiac pacemaker may be considered.

Hypotension.

Severe hypotension should respond to a sympathomimetic amine, e.g. noradrenaline. In refractory cases, the use of glucagon hydrochloride should be considered.

Bronchospasm.

Therapy with a β2-stimulant, e.g. salbutamol or terbutaline or therapy with aminophylline may be considered.

Acute cardiac failure.

Conventional therapy with digitalis, diuretics and oxygen should be instituted immediately. In refractory cases, the use of intravenous isoprenaline followed by glucagon hydrochloride or intravenous aminophylline if necessary should be considered.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

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 25°C. Store in the original carton to protect from light. Use within 1 month of opening.

6.5 Nature and Contents of Container

Atenolol-AFT, oral solution is available in PET bottles which contain 300 mL.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

Summary Table of Changes