Consumer medicine information

1. Why am I taking AVSARTAN?

AVSARTAN contains the active ingredient irbesartan. AVSARTAN 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 taking AVSARTAN? in the full CMI.

2. What should I know before I take AVSARTAN?

Do not use if you have ever had an allergic reaction to AVSARTAN or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I take AVSARTAN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with AVSARTAN and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take AVSARTAN?

• 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 AVSARTAN at about the same time each day.

5. What should I know while taking AVSARTAN?

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.

1 Name of Medicine

Irbesartan.

2 Qualitative and Quantitative Composition

Avsartan 75 mg film-coated tablets: film-coated tablets containing 75 mg of irbesartan.
Avsartan 150 mg film-coated tablets: film-coated tablets containing 150 mg of irbesartan.
Avsartan 300 mg film-coated tablets: film-coated tablets containing 300 mg of irbesartan.
Excipients with known effect. Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Avsartan 75 mg tablets. White to off-white, oval, biconvex, film-coated tablets, engraved with '75' on one face and plain on the other face.
Avsartan 150 mg tablets. White to off-white, oval, biconvex, film-coated tablets, engraved with '150' on one face and plain on the other face.
Avsartan 300 mg tablets. White to off-white, oval, biconvex, film-coated tablets, engraved with '300' on one face and plain on the other face.

4 Clinical Particulars

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 hemodialysis.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

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

6.7 Physicochemical Properties

Irbesartan. 2-butyl-3-[(2'-(1H-tetrazol-5-yl)biphenyl-4-yl)methyl]-1,3-diazaspiro [4,4] non- 1-en-4-one.
Irbesartan molecular formula of C₂₅H₂₈N₆O.
Irbesartan molecular weight of 428.5.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSIRBESA.gif CAS number. 138402-11-6.
Irbesartan is a white to almost white, crystalline powder. Practically insoluble in water, sparingly soluble in methanol, slightly soluble in methylene chloride.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription only medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/AVSARTST.gif