Consumer medicine information

APO-Irbesartan

Irbesartan

BRAND INFORMATION

Brand name

APO-Irbesartan

Active ingredient

Irbesartan

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using APO-Irbesartan.

SUMMARY CMI

APO-IRBESARTAN

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 using APO-IRBESARTAN?

APO-IRBESARTAN contains the active ingredient irbesartan. APO-IRBESARTAN is used to treat high blood pressure and is also used in the treatment of kidney disease in patients with high blood pressure and type 2 diabetes.

For more information, see Section 1. Why am I using APO-IRBESARTAN? in the full CMI.

2. What should I know before I use APO-IRBESARTAN?

Do not use if you have ever had an allergic reaction to APO-IRBESARTAN 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 use APO-IRBESARTAN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with APO-IRBESARTAN 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 use APO-IRBESARTAN?

  • Your doctor will tell you how many tablets to take each day. The standard dose is one 150 mg tablet per day. This dose may be increased to a 300 mg once per day
  • Swallow the table whole with a glass of water and take APO-IRBESARTAN at about the same time each day.

More instructions can be found in Section 4. How do I use APO-IRBESARTAN? in the full CMI.

5. What should I know while using APO-IRBESARTAN?

Things you should do
  • Remind any doctor or dentist you visit that you are taking APO-IRBESARTAN.
  • If you become pregnant or plan to breastfeed while taking APO-IRBESARTAN tell your doctor immediately
  • If you are to be started on any new medicine, tell your doctor and pharmacist you are taking APO-IRBESARTAN
  • If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking APO-IRBESARTAN.
  • Make sure you drink enough water during exercise and hot weather when you are taking APO-IRBESARTAN.
  • If you have excessive vomiting and/or diarrhoea while taking APO-IRBESARTAN, tell your doctor.
  • If you feel lightheaded or dizzy when your dose is increased, tell your doctor immediately
Things you should not do
  • Do not stop taking APO-IRBESARTAN, or lower the dosage, without checking with your doctor.
Driving or using machines
  • Be careful driving or operating machinery until you know how APO-IRBESARTAN affects you. APO-IRBESARTAN may cause dizziness or light-headedness in some people. If this occurs do not drive
Drinking alcohol
  • If you drink alcohol, dizziness or light-headedness may be worse.
Looking after your medicine
  • Keep APO-IRBESARTAN tablets in a cool dry place where the temperature stays below 25°C
  • Keep your tablets in the packaging until it is time to take them

For more information, see Section 5. What should I know while using APO-IRBESARTAN? in the full CMI.

6. Are there any side effects?

Common side effects: headache, dizziness or light-headedness, unusual tiredness or weakness, fatigue, nausea/vomiting. Serious side effects: swelling of the face, lips, tongue or throat which may cause difficulty in swallowing or breathing; severe and sudden onset of pinkish, itchy swellings on the skin (hives or nettle rash). Common side effects: headache; dizziness or light-headedness (vertigo); unusual tiredness or weakness, fatigue; nausea/vomiting.

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

APO-IRBESARTAN

Active ingredient(s): Irbesartan

Consumer Medicine Information (CMI)

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

Where to find information in this leaflet:

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

1. Why am I using APO-IRBESARTAN?

APO-IRBESARTAN contains the active irbesartan.
APO-IRBESARTAN belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin II is a substance produced in the body that causes blood vessels to narrow. APO-IRBESARTAN blocks angiotensin-II and therefore widens your blood vessels, making it easier for your heart to pump blood throughout your body. This helps to lower your blood pressure. APO-IRBESARTAN also slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

APO-IRBESARTAN is used to treat high blood pressure, which doctors call hypertension. APO-IRBESARTAN is also used in the treatment of kidney disease in patients with high blood pressure and type 2 diabetes.

2. What should I know before I use APO-IRBESARTAN?

Warnings

Do not use APO-IRBESARTAN if:

  • you are allergic to irbesartan, or any of the ingredients listed at the end of this leaflet.
  • Always check the ingredients to make sure you can take this medicine.
  • you are pregnant (or think you may be pregnant) or are planning to become pregnant.
  • you are breast-feeding. It is not known if APO-IRBESARTAN passes into breast milk, therefore it is recommended that you not take it while you are breast-feeding
  • you have diabetes or have kidney problems and are being treated with medicines that lower blood pressure such as an ACE inhibitor, any medicines containing aliskiren or medicines that belong to a group of medicines known as Angiotensin-II receptor antagonists (medicines also used to treat high blood pressure.

Check with your doctor if you:

  • have any other medical conditions
  • have had recent excessive vomiting or diarrhoea
  • have kidney problems, or you have had a kidney transplant or dialysis
  • have heart problems
  • have liver problems, or have had liver problems in the past
  • have diabetes
  • have high levels of potassium in your blood
  • are strictly restricting your salt intake
  • take any medicines for any other condition
  • are pregnant or intend to become pregnant
  • if you are breast feeding or plan to breastfeed
  • plan to have surgery (even at the dentist) that needs a general anaesthetic
  • have allergies to any substances, such as foods, preservatives, or dyes
  • take any medicines for any other condition

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?

Use in children

APO-IRBESARTAN should not be given to children

Pregnancy and breastfeeding

  • Check with your doctor if you are pregnant or intend to become pregnant. Do not take APO-IRBESARTAN if you are pregnant or intend to become pregnant.
  • Talk to your doctor if you are breastfeeding or intend to breastfeed. Do not take APO-IRBESARTAN if you are breastfeeding

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.

Tell your doctor if you are taking or plan to take any of the following:

  • other medicines to treat high blood pressure
  • potassium supplements or, potassium-containing salt substitutes (you may need to have regular blood tests
  • diuretics
  • medicines containing lithium (you may need to have regular blood tests)
  • non-steroidal anti-inflammatory medicine such as diclofenac, ibuprofen) and COX-2 inhibitors (for example celecoxib) These medicines may be used to relieve pain, swelling and other symptoms of inflammation including arthritis. Taking APO-IRBESARTAN and an anti-inflammatory medicine alone or with a thiazide diuretic (fluid tablet) may damage your kidneys. It may also reduce the effect APO-IRBESARTAN has on lowering blood pressure.
  • medicines taken to treat diabetes such as repaglinide. APO-IRBESARTAN might lower your blood glucose levels

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

4. How do I use APO-IRBESARTAN?

How much to take / use

  • The usual starting dose is 150 mg tablet once a day. However, some patients may need a lower starting dose. Your doctor will tell you if this is necessary. The full blood pressure lowering effect of APO-IRBESARTAN should be reached about 4 to 6 weeks after starting treatment.
  • Depending on how your blood pressure responds, your daily dose of APO-IRBESARTAN may need to be increased. Most patients take either 150 mg or 300 mg once a day.
  • In patients with high blood pressure and type 2 diabetes,300 mg once a day is the preferred maintenance dose for slowing the progression of associated kidney disease.
  • Ask your doctor or pharmacist if you are unsure of the correct dose for you. They will tell you exactly how much to take.
  • Follow the instructions provided and take APO-IRBESARTAN until your doctor tells you to stop.

When to take / use APO-IRBESARTAN

  • APO-IRBESARTAN should be taken at about the same time each day.

How to take APO-IRBESARTAN

  • Swallow the tablet whole with a glass of water. It does not matter whether you take APO-IRBESARTAN tablets before or after food.
  • Continue taking APO-IRBESARTAN until your doctor tells you to stop.
  • To help you remember to take your tablets each day, APO-IRBESARTAN tablets are supplied in a Calendar pack with the foil backing marked with the days of the week. This is just a way to help you to remember to take your tablets. All the tablets in the pack are the same.
  • When you start a new strip of tablets, take the tablet marked "START" at the end of the blister strip. On the next day, take the tablet marked with the relevant day of the week. Continue taking your tablets each day until all the tablets are taken. Commence the next strip at "START" and continue as before.

If you forget to use APO-IRBESARTAN

APO-IRBESARTAN should be used regularly at the same time each day.

If you miss your dose at the usual time;

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to Otherwise, take it as soon as you remember, and go back to taking your tablets as you would normally.

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

If you use too much APO-IRBESARTAN

If you think that you have used too much APO-IRBESARTAN, you may need urgent medical attention. If you take too many APO-IRBESARTAN tablets you will probably feel lightheaded or dizzy.

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.

5. What should I know while using APO-IRBESARTAN?

Things you should do

  • Tell any other doctors, dentists, and pharmacists who are treating you that you are taking APO-IRBESARTAN
  • Tell your doctor immediately if you become pregnant while taking APO-IRBESARTAN
  • Have your blood pressure checked when your doctor tells you to, to make sure APO-IRBESARTAN is working
  • If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking APO-IRBESARTAN
  • If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are taking APO-IRBESARTAN. Your blood pressure may drop suddenly
  • Make sure you drink enough water during exercise and hot weather when you are taking APO-IRBESARTAN, especially if you sweat a lot. If you do not drink enough water while taking APO-IRBESARTAN, you may faint or feel light-headed or sick. This is because your body does not have enough fluid and your blood pressure is low. If you continue to feel unwell, tell your doctor.
  • Tell your doctor if you have excessive vomiting and/or diarrhoea while taking APO-IRBESARTAN. You may lose too much water and salt and your blood pressure may drop too much.
  • Tell your doctor immediately If you feel lightheaded or dizzy after taking your first dose of APO-IRBESARTAN, or when your dose is increased

Things you should not do

  • Do not give APO-IRBESARTAN tablets to anyone else, even if they have the same condition as you.
  • Do not take APO-IRBESARTAN to treat any other complaints unless your doctor or pharmacist tells you to
  • Do not stop taking APO-IRBESARTAN, or lower the dosage, without checking with your doctor.

Things to be careful of

  • you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly.
  • Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor

Driving or using machines

Be careful before you drive or use any machines or tools until you know how APO-IRBESARTAN affects you.

As with many other medicines used to treat high blood pressure, APO-IRBESARTAN may cause dizziness or light-headedness in some people. If this occurs do not drive.

Make sure you know how you react to APO-IRBESARTAN before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or light-headed.

Drinking alcohol

Tell your doctor if you drink alcohol.

If you drink alcohol, dizziness or light-headedness may be worse.

Looking after your medicine

  • Keep APO-IRBESARTAN tablets in a cool dry place where the temperature stays below 25°C
  • Keep your tablets in the blister pack until it is time to take them

Follow the instructions in the carton on how to take care of your medicine properly.

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.

Do not use this medicine after the expiry date.

Keep it where young children cannot reach it.

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 side effects

Less serious side effectsWhat to do
  • headache
  • dizziness or light-headedness (vertigo)
  • unusual tiredness or weakness, fatigue
  • nausea/vomiting
  • low blood glucose levels
  • decreased number of red blood cells (anaemia – symptoms include tiredness, headaches, being short of breath when exercising, dizziness and looking pale)
Speak to your doctor if you have any of these less serious side effects and they worry you.
They are generally mild and do not normally require treatment to be interrupted.

Serious side effects

Serious side effectsWhat to do
  • skin rash or itchiness
  • aching muscles, not caused by exercise
  • muscle pain or weakness
  • blood tests may show raised levels of an enzyme that measures the breakdown of muscle (creatine phosphokinase)
  • buzzing, ringing or other persistent noise in the ear symptoms that may indicate kidney disease, such as passing little or no urine, drowsiness, nausea, vomiting, breathlessness, loss of appetite and weakness
  • symptoms that may indicate high potassium levels in the blood, such as nausea, diarrhoea, muscle weakness, change in heart rhythm
  • yellowing of the skin and/or eyes, also called jaundice
  • symptoms that may indicate liver disease such as nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes and dark coloured urine
Allergy related symptoms:
  • swelling of the face, lips, tongue or throat which may cause difficulty in swallowing or breathing
  • severe and sudden onset of pinkish, itchy swellings on the skin, also called hives or nettle rash
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.

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 APO-IRBESARTAN contains

Active ingredient
(main ingredient)		Each tablet contains 75 mg, 150 mg or 300 mg of irbesartan
Other ingredients
(inactive ingredients)
  • croscarmellose sodium
  • lactose monohydrate
  • magnesium stearate
  • povidone
  • OPADRY II complete film coating system 30F58652 WHITE
Potential allergensSugars (as lactose monohydrate)

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

What APO-IRBESARTAN looks like

APO-IRBESARTAN is75 mg tablets: White to off-white, oval shaped, biconvex, film-coated tablet. Debossed with "L172" on one side and "75" on the other side. Pack size: 30 tablets. (AUST R 213325).

APO-IRBESARTAN 150 mg tablets: White to off-white, oval shaped, biconvex, film-coated tablet. Debossed with "L173" on one side and "150" on the other side. Pack size 30 tablets. ( AUST R 213310).

APO-IRBESARTAN 300 mg tablets: White to off-white, oval shaped, biconvex, film-coated tablet. Debossed with "L174" on one side and "300" on the other side. Pack size: 30 tablets. (AUST R 213311).

Who distributes APO-IRBESARTAN

Arrotex Pharmaceuticals Pty. Ltd.
15-17 Chapel st,
Cremorne VIC 3121
Tel 1800 195 055

This leaflet was prepared in August 2024.

Published by MIMS October 2024

BRAND INFORMATION

Brand name

APO-Irbesartan

Active ingredient

Irbesartan

Schedule

S4

 

1 Name of Medicine

Irbesartan.

2 Qualitative and Quantitative Composition

Each tablet contains 75 mg, 150 mg or 300 mg irbesartan, as the active ingredient.

Excipients with known effect.

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

3 Pharmaceutical Form

75 mg tablets.

White to off-white, oval shaped, biconvex, film-coated tablet debossed with "L172" on one side and "75" on the other side.

150 mg tablets.

White to off-white, oval shaped, biconvex, film-coated tablet debossed with "L173" on one side and "150" on the other side.

300 mg tablets.

White to off-white, oval shaped, biconvex, film-coated tablet debossed with "L174" on one side and "300" on the other side.

4 Clinical Particulars

4.1 Therapeutic Indications

Irbesartan is indicated for:
treatment of hypertension;
delaying the progression of renal disease in hypertensive type II diabetics with persistent micro-albuminuria (≥ 30 mg per 24 hours) or urinary protein in excess of 900 mg per 24 hours.

4.2 Dose and Method of Administration

APO-Irbesartan tablets are intended for oral administration.

Dosage.

Irbesartan may be used either alone or in combination with other antihypertensive agents (e.g. thiazide diuretic, beta-adrenergic blocking agent, long-acting calcium channel blocking agent).
The usual initial and maintenance dose of irbesartan is 150 mg once daily. Irbesartan may be administered with or without food. Therapy should be adjusted according to blood pressure response. Patients requiring further reduction in blood pressure should have the dose increased to 300 mg once daily.
In patients with hypertension and type II diabetic renal disease, 300 mg of irbesartan once daily is the preferred maintenance dose. Although irbesartan slowed the progression of renal disease in hypertensive patients separately to its effect on blood pressure, this does not remove the clinical requirement for a patient's blood pressure to be adequately controlled. If irbesartan alone is insufficient, then other agents should be added in order to gain blood pressure control.
Irbesartan increases the risk of significant hyperkalaemia in hypertensive patients with type II diabetes and moderate to severe renal insufficiency (see Section 4.8 Adverse Effects (Undesirable Effects); Section 4.4 Special Warnings and Precautions for Use, Effects on laboratory tests, Hyperkalaemia). Serum potassium should be monitored regularly in such patients.
If blood pressure is not adequately controlled with irbesartan alone, a diuretic (e.g. hydrochlorothiazide 12.5 mg daily) or another antihypertensive drug (e.g. beta-adrenergic blocking agent, long acting calcium channel blocking agent) may be added.

Patients with intravascular volume depletion.

Volume and/or sodium depletion should be corrected before initiating therapy with irbesartan or a lower starting dose (e.g. 75 mg) should be considered. Patients undergoing haemodialysis should receive a starting dose of 75 mg and the dose should be adjusted according to BP response. If the blood pressure is not adequately controlled, the dose can be increased.

Elderly patients.

No dosage reduction is generally necessary in the elderly unless accompanied by uncorrected volume depletion (see Section 4.2 Dose and Method of Administration, Patients with intravascular volume depletion).

Patients with renal impairment.

No dosage reduction is generally necessary in patients with impaired renal function (regardless of degree), unless accompanied by uncorrected volume depletion (see Section 4.2 Dose and Method of Administration, Patients with intravascular volume depletion).

Patients with hepatic impairment.

No dosage reduction is generally necessary in patients with impaired hepatic function (mild to moderate degree) unless accompanied by uncorrected volume depletion (see Section 4.2 Dose and Method of Administration, Patients with intravascular volume depletion).

4.3 Contraindications

Known hypersensitivity to irbesartan, or any other ingredient in these tablets (see Section 6.1 List of Excipients).
Do not co-administer irbesartan with aliskiren containing medicines in patients with diabetes or with moderate to severe renal impairment.
Do not co-administer irbesartan with ACE inhibitors in patients with diabetic nephropathy.
Pregnancy (see Section 4.6 Fertility, Pregnancy and Lactation, Use in pregnancy).

4.4 Special Warnings and Precautions for Use

Hypotension: volume-depleted patients.

Irbesartan has been rarely associated with hypotension in hypertensive patients without other co-morbid conditions. Symptomatic hypotension, as with ACE inhibitors, may be expected to occur in sodium/ volume depleted patients such as those treated vigorously with diuretics and/or salt restriction, or on haemodialysis. Volume and/or sodium depletion should be corrected before initiating therapy with irbesartan or a lower starting dose (e.g. 75 mg) should be considered. Patients undergoing haemodialysis should receive a starting dose of 75 mg and the dose should be adjusted according to BP response.

Renal function.

As a consequence of inhibiting the renin angiotensin aldosterone system, changes in renal function may be anticipated in susceptible individuals. In patients whose renal function depends on the activity of the renin angiotensin aldosterone system (e.g. hypertensive patients with renal artery stenosis in one or both kidneys, or patients with severe congestive heart failure), treatment with drugs that affect this system has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. The possibility of a similar effect occurring with the use of an angiotensin II receptor antagonist, including irbesartan cannot be excluded.
In hypertensive type II diabetic patients with proteinuria (≥ 900 mg/day), a population which has a high risk of renal artery stenosis, no patient treated with irbesartan in IDNT had an early acute rise in serum creatinine attributable to renal artery disease (see Section 5.1 Pharmacodynamic Properties, Clinical trials).
Experience is limited with irbesartan in patients with moderate to severe renal impairment; careful monitoring of renal function and potassium in such patients is advised.

Hyperkalaemia.

While hyperkalaemia in uncomplicated patients with hypertension has not been reported with irbesartan, hyperkalaemia may occur during treatment with other drugs that affect the renin-angiotensin-aldosterone system, especially in the presence of renal impairment and/or heart failure. Adequate monitoring of serum potassium in patients at risk is recommended.

Dual blockade of the renin-angiotensin-aldosterone system (RAAS).

Dual blockade of the RAAS by combining irbesartan with an ACE inhibitor or with aliskiren is not recommended since there are increased risks of hypotension, hyperkalemia and changes in renal function compared to monotherapy. The use of irbesartan in combination with aliskiren is contraindicated in patient with diabetes mellitus or renal impairment (see Section 4.3 Contraindications).
The use of irbesartan in combination with an ACE inhibitor is contraindicated in patients with diabetic nephropathy (see Section 4.3 Contraindications; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Hypoglycaemia.

Irbesartan may induce hypoglycaemia, particularly in patients treated for diabetes. Therefore, dose adjustment of antidiabetic treatment such as repaglinide or insulin may be required (see Section 4.8 Adverse Effects (Undesirable Effects)).

Psoriasis.

The use of irbesartan in patients with psoriasis or a history of psoriasis should be carefully weighed as it may exacerbate psoriasis.

Cardiac disorders.

The safety of irbesartan in the presence of heart failure has not been fully defined. Sudden death has occurred in some studies of patients with heart failure and, although such deaths may have reflected the natural history of the underlying heart failure, caution is recommended when treating such patients with irbesartan.
At this time, experience is limited with irbesartan in the treatment of patients with ventricular dysfunction or cardiac arrhythmias; caution is advised.

Use in renal impairment.

See comments under Renal function above and see Section 4.2 Dose and Method of Administration.

Paediatric use.

Safety and effectiveness in paediatric patients have not been established.

Use in the elderly.

Among patients who received irbesartan in clinical studies, no overall differences in efficacy or safety were observed between older patients (65 years or older) and younger patients.

Effects on laboratory tests.

No clinically significant changes in laboratory test parameters occurred in controlled clinical studies of hypertension. No special monitoring of laboratory parameters is necessary for patients with uncomplicated essential hypertension. Monitoring of potassium levels and renal function is recommended for patients with heart failure and those with moderate to severe renal impairment (see Section 4.4 Special Warnings and Precautions for Use, above).
In two clinical studies of patients with hypertension and type II diabetic renal disease (IDNT and IRMA 2) the following was reported.

Hyperkalaemia.

In IDNT the percent of subjects with hyperkalaemia (> 6 mmol/L) was 18.6% in the irbesartan group compared to 6.0% in the placebo group. In IRMA 2, the percent of subjects with hyperkalaemia (> 6 mmol/L) was 1.0% in the irbesartan groups and none in the placebo group. In IDNT discontinuations due to hyperkalaemia in the irbesartan group were 2.1% vs. 0.36% in the placebo group. In IRMA 2, discontinuations due to hyperkalaemia in the irbesartan groups were 0.5% vs. none in the placebo group.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Based on in vitro data, no interactions would be expected to occur with drugs whose metabolism is dependent upon cytochrome P450 isoenzymes CYP1A1, CYP1A2, CYP2A6, CYP2B6, CYP2D6, CYP2E1 or CYP3A4. Irbesartan is primarily metabolised by CYP2C9, however, during clinical interaction studies, no significant pharmacodynamic interactions were observed when irbesartan was co-administered with warfarin (a drug metabolised by CYP2C9).
Irbesartan does not affect the pharmacokinetics of digoxin. The pharmacokinetics of irbesartan is not affected by co-administration with nifedipine or hydrochlorothiazide.

Potassium-sparing diuretics, potassium supplements, potassium containing salt substitutes.

Based on experience with the use of other drugs that affect the renin angiotensin system, concomitant use of potassium sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase kalaemia with irbesartan may lead to increases in serum potassium, sometimes severe, and requires close monitoring of serum potassium.

Lithium.

Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of irbesartan. Monitor lithium levels in patients receiving irbesartan and lithium.

Combination use of ACE inhibitors or angiotensin receptor antagonists, anti-inflammatory drugs and thiazide diuretics.

Concomitant use of a renin-angiotensin system inhibiting drug (ACE-inhibitor or angiotensin receptor antagonist) and an anti-inflammatory drug (NSAID, including COX-2 inhibitor) alone or with a thiazide diuretic may increase the risk of renal impairment, including possible acute renal failure. These effects are usually reversible. This includes use in fixed-combination products containing more than one class of drug. The combination of these agents should be administered with caution, especially in the elderly, volume depleted and in patients with pre-existing renal impairment. Renal function (serum creatinine) should be monitored after initiation of concomitant therapy, and periodically thereafter. The antihypertensive effect of angiotensin II receptor antagonists, including irbesartan, may be attenuated by NSAIDs including selective COX-2 inhibitors.
The use of irbesartan in combination with an ACE inhibitor is contraindicated in patients with diabetic nephropathy and is not recommended in other patients (see Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use).

Renin inhibitor.

The combination of irbesartan with aliskiren-containing medicinal products is contraindicated in patients with diabetes mellitus or moderate to severe renal impairment and is not recommended in other patients (see Section 4.3 Contraindications).

Angiotensin-converting enzyme inhibitors (ACE inhibitors).

The combination of irbesartan with ACE inhibitors is not recommended.

Repaglinide.

Irbesartan has the potential to inhibit OATP1B1. In a clinical study, it was reported that irbesartan increased the Cmax and AUC of repaglinide (substrate of OATP1B1) by 1.8-fold and 1.3-fold, respectively, when administered 1 hour before repaglinide. In another study, no relevant pharmacokinetic interaction was reported when the two drugs were co-administered. Therefore, dose adjustment of antidiabetic treatment such as repaglinide may be required (see Section 4.4 Special Warnings and Precautions for Use).

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Fertility and reproductive performance were not affected in studies of male and female rats at oral doses of up to 650 mg/kg/day (approximately 3 (male) and 8 (female) fold higher exposure, based on AUC, than that of humans at the maximum recommended clinical dose of 300 mg/day).
(Category D)
Several dozen cases have been reported in the world literature in patients who were taking angiotensin-converting enzyme inhibitors. When pregnancy is detected, irbesartan should be discontinued as soon as possible.
The use of drugs that act directly on the renin angiotensin system during the second and third trimesters of pregnancy have been associated with foetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased foetal renal function; oligohydramnios in this setting has been associated with foetal limb contractures, craniofacial deformation and hypoplastic lung development. Prematurity, intrauterine growth retardation and patent ductus arteriosus have also been reported, although it is not clear whether these occurrences were due to exposure to the drug.
These adverse effects do not appear to have resulted from intrauterine drug exposure that has been limited to the first trimester. Mothers whose embryos and foetuses are exposed to an angiotensin II receptor antagonist only during the first trimester should be so informed. Nonetheless, when patients become pregnant, physicians should have the patient discontinue the use of irbesartan as soon as possible.
Infants with histories of in utero exposure to an angiotensin II receptor antagonist should be closely observed for hypotension, oliguria and hyperkalaemia.
When pregnant rats were treated with irbesartan from day 0 to day 20 of gestation, at doses of 50 mg/kg/day and higher, transient effects (increased renal pelvic cavitation, hypoureter or subcutaneous oedema) were noted in full term rat foetuses but not in the young animals necropsied after 6 weeks of age. In pregnant rabbits, at doses of 30 mg/kg/day, maternal mortality, abortion and early foetal resorptions were noted. No teratogenic effects were observed in the rat or rabbit.
 Irbesartan is excreted in the milk of lactating rats. It is not known whether irbesartan or its metabolites are excreted in human milk. A decision should be made whether to discontinue breast-feeding or to discontinue the drug, taking into account the importance of irbesartan to the therapy of the mother and the potential risk to the infant.

4.7 Effects on Ability to Drive and Use Machines

The effect of irbesartan on ability to drive and use machines has not been studied. When driving vehicles or operating machines, it should be taken into account that occasionally dizziness or weariness may occur during treatment of hypertension.

4.8 Adverse Effects (Undesirable Effects)

Hypertension.

Irbesartan has been evaluated for safety in approximately 5000 subjects in clinical studies, including 1300 hypertensive patients treated for over 6 months and over 400 patients treated for one year or more. Adverse events in patients receiving irbesartan were generally mild and transient with no relationship to dose. The incidence of adverse events was not related to age, gender, or race.
In placebo-controlled clinical studies, including 1965 irbesartan-treated patients (usual duration of treatment 1 to 3 months), discontinuations due to any clinical or laboratory adverse event were 3.3% for irbesartan treated patients and 4.5% for placebo treated patients (p = 0.029).
Clinical adverse events, occurring in at least 1% of patients treated with irbesartan in placebo controlled trials are shown in Table 1. The incidence of the same adverse events in the placebo control group is also shown.
Adverse reactions that occurred in 2 or more hypertensive patients in clinical trials involving 3396 patients have been classified using standard terminology and in the following listing are categorised by body system and listed in order of decreasing frequency according to the following definitions: common adverse reactions are those occurring on one or more occasions in at least 1/100 but less than 1/10 patients; uncommon adverse reactions are those occurring in at least 1/1000 but less than 1/100 patients; rare adverse reactions are those occurring in less than 1/1000 patients.

Cardiovascular.

Uncommon: subjective rhythm disturbance, flushing, ECG abnormality, cardiac murmur, cardiac rhythm disturbance, orthostatic hypotension, atrial rhythm disturbance, bradycardia, hypotension.
Rare: syncope, conduction disorder, myocardial infarction.

Dermatological.

Uncommon: pruritus, facial erythema.
Rare: dermatitis, acne, scalp hair abnormality.

Endocrine/ metabolic/ electrolyte imbalance.

Uncommon: sexual dysfunction, libido change.
Rare: breast disorder, gout, hot flashes.

Gastrointestinal.

Uncommon: constipation, flatulence, dry mouth, abdomen distention.
Rare: abnormal stool, decreased appetite, increased appetite, oral lesion, dysphagia, oesophagitis.

General.

Uncommon: weakness, hyperhidrosis, malaise, weight gain.
Rare: cold sensation, warmth sensation, pain.

Haematopoietic.

Rare: anaemia.

Immunology/ sensitivity disorder.

Uncommon: upper extremity oedema.
Rare: head/ neck oedema.

Musculoskeletal/ connective tissue.

Common: significant increase in blood creatine phosphokinase.
Uncommon: muscle cramp, swelling extremity.
Rare: arthritis, muscle ache, myalgia, extremity weakness, stiffness lower extremity.

Nervous system.

Uncommon: orthostatic dizziness, numbness, sleep disturbance, depression, emotion labile/ disturbance, somnolence, vertigo, paraesthesia.
Rare: stress related disorder, tremor, coordination disturbance, disturbing dreams.

Renal/ genitourinary.

Uncommon: urination abnormality.

Respiratory.

Uncommon: epistaxis, dyspnoea.

Special senses.

Uncommon: vision disturbance, hearing abnormality.
Rare: eye disturbance-other, eyelid abnormality, visual field abnormality, medication bad taste, taste disturbance.

Hypertension and type II diabetic renal disease.

In clinical studies (see Section 5.1 Pharmacodynamic Properties, Clinical trials, Hypertension and type II diabetic renal disease), the adverse experiences were similar to those in clinical trials of hypertensive patients with the exception of orthostatic symptoms (dizziness, orthostatic dizziness and orthostatic hypotension) observed in IDNT (proteinuria ≥ 900 mg/day and serum creatinine from 90-265 micromol/L). In IDNT orthostatic symptoms occurred more frequently in the irbesartan group (dizziness 10.2%, orthostatic dizziness 5.4%, orthostatic hypotension 5.4%) than in the placebo group (dizziness 6.0%, orthostatic dizziness 2.7%, orthostatic hypotension 3.2%). The rates (percents) of discontinuations due to orthostatic symptoms for irbesartan versus placebo were: dizziness 0.3 vs. 0.5; orthostatic dizziness 0.2 vs. 0.0; and orthostatic hypotension, 0.0 vs. 0.0.

Post-marketing experience.

As with other angiotensin II receptor antagonists, rare cases of hypersensitivity reactions (urticaria, angioedema, anaphylactic reactions including anaphylactic shock) have been reported since the marketing of irbesartan. The following have been reported during post-marketing surveillance: vertigo, asthenia, hyperkalaemia, thrombocytopenia (including thrombocytopenic purpura), myalgia, jaundice, elevated liver function tests, hepatitis, arthralgia, tinnitus, anaemia, psoriasis (and psoriasis exacerbation) (see Section 4.4 Special Warnings and Precautions for Use), photosensitivity and impaired renal function including cases of renal failure in patients at risk and hypoglycaemia (see Section 4.4 Special Warnings and Precautions for Use).
Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.

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 http://www.tga.gov.au/reporting-problems and contact Apotex Medical Information Enquiries/Adverse Drug Reaction Reporting on 1800 195 055.

4.9 Overdose

Experience in adults exposed to doses of up to 900 mg/day for 8 weeks revealed no toxicity. No specific information is available on the treatment of overdosage with irbesartan. The patient should be closely monitored, and the treatment should be symptomatic and supportive. If simple supine positioning is found insufficient to correct hypotension then judicious I.V. volume replacement/ augmentation may be indicated. Irbesartan is not removed from the body by haemodialysis.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Irbesartan is a specific antagonist of angiotensin II receptors (AT1 subtype). Angiotensin II is an important component of the renin angiotensin system and is involved in the pathophysiology of hypertension and in sodium homeostasis. Irbesartan does not require metabolic activation for its activity.
Irbesartan blocks the potent vasoconstrictor and aldosterone secreting effects of angiotensin II by selective antagonism of the angiotensin II (AT1 subtype) receptors localized on vascular smooth muscle cells and in the adrenal cortex. It has no agonist activity at the AT1 receptor and a much greater affinity (more than 8500-fold) for the AT1 receptor than for the AT2 receptor (a receptor that has not been shown to be associated with cardiovascular homeostasis).
Irbesartan does not inhibit enzymes involved in the renin-angiotensin system (i.e. renin, angiotensin converting enzyme [ACE]) or affect other hormone receptors or ion channels involved in the cardiovascular regulation of blood pressure and sodium homeostasis.
In healthy subjects, single oral irbesartan doses of up to 300 mg produced dose dependent inhibition of the pressor effect of angiotensin II infusions. Inhibition was complete (≥ 90%) at the time of peak irbesartan concentrations and sustained for 24 hours (60% and 40% at 300 mg and 150 mg, respectively).
In hypertensive patients, angiotensin II receptor inhibition following chronic administration of irbesartan causes a 1.5-2 fold rise in angiotensin II plasma concentration and a 2-3 fold increase in plasma renin levels. Aldosterone plasma concentrations generally decline following irbesartan administration, however serum potassium levels are not significantly affected at recommended doses.
In hypertensive patients, chronic oral doses of irbesartan (up to 300 mg) had no effect on glomerular filtration rate, renal plasma/ blood flow or filtration fraction. In multiple dose studies in hypertensive patients, there were no notable effects on fasting triglycerides, total cholesterol or HDL-cholesterol or fasting glucose concentrations. There was no effect on serum uric acid during chronic oral administration. Following repeated doses of irbesartan, there was no uricosuric effect.

Clinical trials.

The antihypertensive effects of irbesartan were examined in seven (7) major placebo controlled 8-12 week trials in patients with baseline diastolic blood pressures of 95-110 mmHg.
The seven (7) studies of irbesartan monotherapy included a total of 1,915 patients randomised to irbesartan (1-900 mg) and 611 patients randomised to placebo. Once daily doses of 150 to 900 mg provided statistically and clinically significant decreases in systolic and diastolic blood pressure with a plateau in effect at doses above 300 mg.
Systolic/ diastolic mean decreases in blood pressure at trough (24 hours post-dosing), compared to placebo, following 6 to 12 weeks of treatment were in the range of 7.5-9.9/4.6-6.2 mmHg with a 150 mg dose, and 7.9-12.6/5.2-7.9 mmHg with a 300 mg dose.
Once-daily dosing with 150 mg gave trough and mean 24 hour responses corresponding to those observed in patients receiving twice daily dosing at the same total daily dose. Peak (3-6 hour) effects were uniformly, but moderately, larger than trough effects, with the trough to peak ratio for systolic and diastolic response generally between 60-70%.
Two of the seven placebo controlled trials identified above and two additional studies examined the antihypertensive effects of irbesartan and hydrochlorothiazide in combination.
Addition of a low dose of hydrochlorothiazide (12.5 mg) to irbesartan (75 to 300 mg) once daily resulted in further diastolic blood pressure reductions at trough (24 hours post-dosing) of 2.3-4.8 mmHg and an overall systolic/ diastolic placebo subtracted reduction of up to 13.6/11.5 mmHg at a dose of 300 mg irbesartan and 12.5 mg hydrochlorothiazide. Once daily dosing with 150 mg irbesartan and 12.5 mg hydrochlorothiazide gave systolic/ diastolic mean placebo-adjusted blood pressure reductions at trough (24 hours post-dosing) of 12.9/6.9 mmHg.
In patients not adequately controlled (SeDBP ≥ 90 mmHg) on irbesartan (up to 300 mg) alone, the addition of 12.5 mg hydrochlorothiazide gave an added reduction of up to 6.1 mmHg in trough (24 hours) diastolic blood pressure.
In patients not adequately controlled (SeDBP 93-120 mmHg) on 25 mg hydrochlorothiazide alone, the addition of irbesartan (75-150 mg) gave an added systolic/ diastolic mean reduction of 11.1/7.2 mmHg.
Analysis of age, gender and race subgroups of patients showed that men and women, and patients over and under 65 years of age, had generally similar responses.
The effect of irbesartan is apparent after the first dose, substantially present within 1-2 weeks, and reaches a maximal effect within 4-6 weeks. In long-term studies the effect of irbesartan appeared to be maintained for more than one year. After withdrawal of irbesartan, blood pressure gradually returned towards baseline; no rebound was observed. There was essentially no change in average heart rate in irbesartan treated patients in controlled trials.

Hypertension and type II diabetic renal disease.

The Irbesartan Diabetic Nephropathy Trial (IDNT) was a multicentre, randomised, controlled, double blind, morbidity and mortality trial comparing irbesartan, amlodipine and placebo. In 1,715 hypertensive patients with type II diabetes (proteinuria ≥ 900 mg/day and serum creatinine 110-265 micromol/L in men and 90-265 micromol/L in women) the long-term effects (mean 2.6 years) of irbesartan on the progression of renal disease and all cause mortality were examined. In addition, a secondary end-point, the effect of irbesartan on the risk of fatal or non-fatal cardiovascular events was assessed. Patients were randomised to receive irbesartan 75 mg, amlodipine 2.5 mg, or matching placebo once daily. Patients were then titrated to a maintenance dose of 300 mg irbesartan, 10 mg amlodipine, or placebo as tolerated. Additional antihypertensive agents (excluding ACE inhibitors, angiotensin II receptor antagonists and calcium channel blockers) were added as needed to help achieve blood pressure goal (≤ 135/85 or 10 mmHg reduction in systolic blood pressure if higher than 160 mmHg) for patients in all groups. Irbesartan demonstrated a 20% relative risk reduction in the composite primary endpoint (first occurrence of any of the following: doubling of serum creatinine, end-stage renal disease or all cause mortality) compared to placebo (95% CI (3%, 34%), p = 0.023) and a 23% relative risk reduction compared to amlodipine (95% CI (7%, 37%), p = 0.006). When the individual components of the primary endpoint were analysed, no effect in all cause mortality was observed, while a positive trend in the reduction in ESRD and a significant reduction in doubling of serum creatinine were observed. Similar blood pressure was achieved in the irbesartan and amlodipine groups. There was no significant difference in the assessment of fatal or non-fatal cardiovascular events (cardiovascular death, non-fatal myocardial infarction, hospitalisation for heart failure, permanent neurologic deficit attributed to stroke, or above the ankle amputation) among the three treatment groups.
The study of the Effects of Irbesartan on MicroAlbuminuria in Hypertensive Patients with Type II Diabetes Mellitus (IRMA 2) was a multicentre, randomised, placebo-controlled, double-blind morbidity study, conducted in 590 hypertensive patients with type II diabetes, microalbuminuria (20-200 microgram/min; 30-300 mg/day) and normal renal function (serum creatinine ≤ 130 micromol/L in males and ≤ 100 micromol/L in females). The study examined as a primary endpoint the long-term effects (2 years) of irbesartan on the progression to (overt) proteinuria (urinary albumin excretion rate [AER] > 200 microgram/min [> approximately 300 mg/day] and an increase in AER of at least 30% from baseline). In addition, after one and two years of treatment, the effect of irbesartan on the change in overnight AER and the change in 24 hour creatinine clearance was assessed. Patients were randomised to receive irbesartan 150 mg, irbesartan 300 mg, or matching placebo once daily. Additional antihypertensive agents (excluding ACE inhibitors, angiotensin II receptor antagonists and dihydropyridine calcium blockers) were added as needed to help achieve blood pressure goal (≤ 135/85 mmHg) for patients in all groups. Irbesartan 300 mg demonstrated a 70% relative risk reduction in the development of clinical (overt) proteinuria compared to placebo (95% CI (39%, 86%), p = 0.0004). Irbesartan 150 mg demonstrated a 39% relative risk reduction in the development of proteinuria compared to placebo (95% CI (-8%, 66%), p = 0.085). In the intent to treat analysis, when the primary endpoint is adjusted for urinary albumin excretion rate and mean arterial pressure, irbesartan 300 mg demonstrated a 68% relative risk reduction, (95% CI (35%, 85%), p = 0.002). The slowing of progression to clinical (overt) proteinuria was evident as early as three months and continued over the 2 year period. The decline in 24 hour creatinine clearance did not differ significantly among the 3 groups. Regression to normoalbuminuria (< 20 microgram/min; < 30 mg/day) was more frequent in the irbesartan 300 mg group (34%) than in the placebo group (21%).
The adverse experiences reported in these two studies are summarised, see Section 4.8 Adverse Effects (Undesirable Effects), Hypertension and type II diabetic renal disease; Section 4.4 Special Warnings and Precautions for Use, Effects on laboratory tests.

5.2 Pharmacokinetic Properties

Irbesartan is an orally active agent and does not require biotransformation for its activity.

Absorption.

Following oral administration, irbesartan is rapidly and well absorbed. In studies employing an injection and an oral solution containing radio-labelled irbesartan the average absolute oral bioavailability of irbesartan was 60-80%. Median peak plasma concentrations generally occurred 1.5-2 hours after oral administration of irbesartan capsules and tablets. Food did not affect the bioavailability.

Distribution.

Irbesartan is 90% protein bound in the plasma, and has negligible binding to cellular components of blood. The volume of distribution (Vss) is 53-93 litres.

Metabolism.

Following oral or intravenous administration of 14C-irbesartan more than 80% of the circulating plasma radioactivity was attributable to unchanged irbesartan. Irbesartan is metabolised by the liver via glucuronide conjugation and oxidation. The major circulating metabolite is irbesartan glucuronide (~ 6%). Irbesartan undergoes oxidation primarily by the cytochrome P450 isoenzyme CYP2C9; isoenzyme CYP3A4 has negligible effect. It is not metabolised by, nor does it substantially induce or inhibit most isoenzymes commonly associated with drug metabolism (i.e. CYP1A1, CYP1A2, CYP2A6, CYP2B6, CYP2D6, or CYP2E1). Irbesartan does not induce nor inhibit isoenzyme CYP3A4.

Excretion.

Irbesartan and its metabolites are excreted by both biliary and renal routes. About 20% of the administered radioactivity after an oral or intravenous dose of 14C-irbesartan was recovered in urine with the remainder in the faeces. Less than 2% of the dose was excreted in urine as unchanged irbesartan.
The terminal elimination half-life (t1/2) of irbesartan averaged 11-15 hours over a range of doses following multiple oral dosing. The total body clearance of intravenously administered irbesartan was 157 to 176 mL/min, of which 3.0-3.5 mL/min was renal clearance. Irbesartan exhibits linear pharmacokinetics over the therapeutic dose range. Steady-state plasma concentrations are attained within 3 days after initiation of a once daily dosing regimen. Limited accumulation (< 20%) is observed in plasma upon repeated once daily dosing.

Special populations.

In male and female hypertensive subjects, higher (11-44%) plasma concentrations of irbesartan were observed in females than in males, although, following multiple dosing, males and females did not show differences in either accumulation or elimination half-life. No gender specific differences in clinical effect have been observed.
In elderly (male and female) normotensive subjects (65-80 years) with clinically normal renal and hepatic function, the plasma AUC and peak plasma concentrations (Cmax) of irbesartan are approximately 20%-50% greater than those observed in younger subjects (18-40 years). Regardless of age, the elimination half-life is comparable. No significant age related differences in clinical effect have been observed.
In black and white normotensive subjects, the plasma AUC and t1/2 of irbesartan are approximately 20-25% greater in blacks than in whites; the peak plasma concentrations (Cmax) of irbesartan are essentially equivalent.
In patients with renal impairment (regardless of degree), and in haemodialysis patients, the pharmacokinetics of irbesartan are not significantly altered. Irbesartan is not removed by haemodialysis.
In patients with hepatic insufficiency due to mild to moderate cirrhosis, the pharmacokinetics of irbesartan are not significantly altered.

5.3 Preclinical Safety Data

Genotoxicity.

Irbesartan was not genotoxic in a series of assays for mutagenic and clastogenic effects.

Carcinogenicity.

The carcinogenic potential of irbesartan was assessed in two 104-week studies in mice and rats. No carcinogenic potential was observed in either species at doses of up to 500 mg/kg/day (male rats) and 1000 mg/kg/day (mice and female rats). The AUC based exposure levels were 3-6 fold higher in mice, 3-fold higher in male rats and 25-fold higher in female rats than that of humans at the maximum recommended clinical dose of 300 mg/day.

6 Pharmaceutical Particulars

6.1 List of Excipients

Lactose monohydrate, croscarmellose sodium, povidone, magnesium stearate, Opadry II complete film coating system 30F58652 White.

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.

6.5 Nature and Contents of Container

APO-Irbesartan tablets.

75 mg tablets.

Blister packs (PVC/PVdC/Al) of 30 tablets: AUST R 213325.

150 mg tablets.

Blister packs (PVC/PVdC/Al) of 30 tablets: AUST R 213310.

300 mg tablets.

Blister packs (PVC/PVdC/Al) of 30 tablets: AUST R 213311.
Not all strengths may be available.

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

Irbesartan is a white or almost white crystalline powder. Practically insoluble in water, sparingly soluble in methanol, slightly soluble in methylene chloride.
Irbesartan is a non-peptide angiotensin II receptor (AT1 subtype) antagonist.

Chemical structure.


Chemical Name: 2-butyl-3-[(2'-(1H-tetrazol-5-yl)biphenyl-4-yl)methyl]- 1,3-diazaspiro [4,4] non-1-en-4-one.
Molecular Formula: C25H28N6O.
Molecular Weight: 428.5.

CAS number.

138402-11-6.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes