Azilsartan Medoxomil: Patient-Friendly Medicine Information (Australia)
Basic Product Information
| International Non-Proprietary Name (INN) | Azilsartan medoxomil |
|---|---|
| Australia Brand Names | Edarbi®, generic forms may be available |
| Anatomical Therapeutic Chemical (ATC) Code | C09CA09 |
| Available Forms & Strengths | Film-coated tablets: 20 mg, 40 mg, and 80 mg |
| Manufacturers | Takeda Pharmaceuticals Australia Pty Ltd; various generics |
| Prescription Status | Prescription Only Medicine (Schedule 4 - S4) |
Mechanism of Action
For Patients: Azilsartan medoxomil is a medicine that helps lower high blood pressure (hypertension). It relaxes your blood vessels so your blood flows more easily, which lowers your blood pressure and reduces the risk of heart, kidney, and blood vessel problems.
For Specialists: Azilsartan is a selective angiotensin II receptor type 1 (AT1) blocker (ARB). By preventing angiotensin II from binding to the AT1 receptor, it inhibits vasoconstriction and aldosterone release, resulting in reduced blood pressure and lower cardiovascular risk.
Pharmacokinetics
- Absorption: Azilsartan medoxomil is rapidly absorbed from the gut after oral administration. It is a prodrug, converted to the active form (azilsartan) during absorption.
- Metabolism: It undergoes minimal metabolism in the liver, mainly via CYP2C9.
- Elimination: Most of the dose is excreted in urine and faeces. Elimination half-life: around 11 hours.
- Duration of Action: Suitable for once-daily dosing due to sustained blood pressure lowering effect for at least 24 hours.
How to Use Azilsartan in Everyday Life
- Typical Adult Dose: The usual starting dose is 40 mg once a day, taken with or without food. Your doctor may increase the dose to 80 mg once daily, depending on your response.
- Administration: Swallow the tablet whole with water. Take it at the same time each day to help you remember.
- English Context: May be prescribed in combination with other blood pressure medicines, especially when single-agent control is inadequate.
- Missed Dose: Take the missed dose as soon as you remember on the same day. If it is nearly time for your next dose, skip the missed dose—do not take a double dose.
- Stopping the Medicine: Only stop under your doctor’s guidance. Stopping suddenly may cause your blood pressure to rise again.
Dosing in the Morning vs Evening
Azilsartan can be taken either in the morning or evening. The most important aspect is consistency—take it at the same time each day. Some research suggests that blood pressure medicines work slightly better when taken at night, but the effect is modest, and sticking to a routine matters most.
- Advantages of a Morning Dose: Easier to remember with other morning routines (e.g., breakfast, brushing teeth).
- Advantages of an Evening Dose: May slightly enhance night-time blood pressure control (studies ongoing).
- Best Practice Tip: Choose a time you can stick to daily.
Taking with Food or on an Empty Stomach
Azilsartan can be taken with or without food. It does not interact significantly with typical English meals including tea, coffee, toast, cereal, or a cooked breakfast. If you prefer, you can take it before or after meals.
- No strong effect of food on absorption or action.
- Safe to take with Australian and English-style foods, including dairy products and fruit.
- If you have a sensitive stomach, you may prefer to take it with a small meal.
Interactions Warnings
Certain foods, drinks, and medicines can interact with Azilsartan, so it’s important to tell your pharmacist or doctor about anything else you are taking.
| Interaction | Possible Effect | Advice |
|---|---|---|
| Alcohol | Enhanced blood pressure lowering, possible dizziness | Limit alcohol intake or avoid excessive drinking |
| Potassium supplements, salt substitutes containing potassium | Increased risk of high potassium in blood (hyperkalaemia) | Avoid unless supervised by your doctor |
| NSAIDs (ibuprofen, naproxen) | May reduce blood pressure lowering effect; may affect kidneys | Use only as advised by your doctor; monitor kidney function if long-term use |
| Other antihypertensives | May cause excessive blood pressure lowering | Regular monitoring, dosage adjustment by your doctor |
| Diuretics (“water tablets”) | Enhanced blood pressure lowering and possible dehydration, electrolyte imbalances | Monitor for symptoms; routine blood tests |
| Lithium | Increased risk of lithium toxicity | Avoid combination if possible; close monitoring |
| ACE inhibitors, aliskiren | Potential for kidney problems, hyperkalaemia | Use with caution; monitor kidney function and potassium |
Indications for Use
| Indication | Status | Notes |
|---|---|---|
| Essential hypertension (high blood pressure) | Official (TGA approved) | Adults only; not first-line in children |
| Heart failure, chronic kidney disease | Off-label | May be considered if intolerant to other ARBs/ACE inhibitors |
| Diabetic nephropathy | Off-label | Alternative to ACE inhibitors if indicated |
Dosing According to Clinical Indications
| Population | Initial Dose | Maximum Dose | Notes |
|---|---|---|---|
| Adults | 40 mg once daily | 80 mg once daily | Increase if additional blood pressure control needed |
| Elderly (65+) | 40 mg once daily | 80 mg once daily | Monitor kidney function and blood pressure closely |
| Children (under 18) | Not routinely recommended | — | Limited safety/efficacy data; refer to specialist |
| Renal or hepatic impairment | Start at 40 mg once daily (if used) | Monitor closely | Dose adjustment may be needed; consult specialist |
Safety Profile and Side Effects
Like all prescription medications, Azilsartan can cause side effects. Most are mild and temporary. Serious side effects are rare.
| Common Side Effects | Rare/Serious Side Effects | Actions/Notes |
|---|---|---|
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Guidelines for Proper Use (Australia)
- Always take Azilsartan exactly as your doctor or pharmacist advises.
- Keep taking it unless your doctor tells you otherwise—even if you feel well, as high blood pressure often has no symptoms.
- Have regular blood pressure checks (at the clinic or pharmacy) and attend all scheduled blood and kidney function tests.
- If you are pregnant, planning a pregnancy, or breastfeeding, speak to your doctor before starting or continuing Azilsartan.
- Store at below 25°C, in the original container, away from heat and moisture.
- Bring unused or expired tablets back to your pharmacy for safe disposal (Do not throw them into household waste or water).
Alternative Treatment Options
- Other ARBs: Candesartan, losartan, olmesartan, valsartan—all act similarly, some are on the Pharmaceutical Benefits Scheme (PBS) with different subsidy and availability. Azilsartan may be considered if others cause side effects or are not effective.
- ACE inhibitors: Ramipril, perindopril—often first-line, but can cause dry cough in some patients.
- Calcium channel blockers: Amlodipine—another first-line agent; main side effect is swollen ankles.
- Thiazide-type diuretics: Hydrochlorothiazide, indapamide—effective, inexpensive, may cause electrolyte imbalances or increased urination.
- Beta-blockers: Used where other indications exist (e.g., heart disease).
Speak with your doctor for personalised advice about the best option for you.
Legal, Registration, and Reimbursement Status in Australia
- TGA (Therapeutic Goods Administration): Azilsartan medoxomil is registered as a prescription-only medicine.
- PBS (Pharmaceutical Benefits Scheme): Available for reimbursement in specific indications (check PBS website for current listing).
- Requires a valid prescription from a licensed medical practitioner or prescriber.
- Controlled and dispensed under Schedule 4 regulations.
Latest Research and Clinical Guidance (2022–2025)
- 2023 NICE hypertension guidelines (UK) and the Australian Heart Foundation continue to support ARBs, including azilsartan, as effective and well-tolerated for blood pressure control, especially when ACE inhibitors are unsuitable.
- Recent studies suggest superior 24-hour blood pressure control with azilsartan compared to some other ARBs, but individual response varies (PMID: 37221361).
- No new major safety signals reported in the last three years.
- Emerging evidence supports broader use in renal protection and heart failure—off-label use should be individualised.
Always follow the latest recommendations from your medical team for your specific condition.
Availability and Delivery
| Pack Size | Strength | Indicative Price (AUD) | Typical Delivery to Major Australian Cities |
|---|---|---|---|
| 28 tablets | 40 mg | $29–$35 (PBS prices lower with concession) | 1–2 days (Sydney, Melbourne, Brisbane); 2–4 days (Perth, Adelaide, Hobart) |
| 28 tablets | 80 mg | $35–$42 (PBS prices lower with concession) | Sizes and pricing may vary between pharmacies and locations |
Frequently Asked Questions (FAQ)
- How long does Azilsartan take to lower my blood pressure?
- Blood pressure starts to reduce within a few hours of the first dose. Maximum effect is usually seen within 2–4 weeks of regular daily use.
- Can I drink alcohol while taking Azilsartan?
- Small to moderate amounts are usually safe but may increase dizziness or light-headedness—drink with caution and avoid excessive consumption.
- What should I do if I feel dizzy or faint?
- Sit or lie down until the feeling passes. If symptoms persist or are severe, contact your doctor—do not drive or operate machinery if affected.
- Is it safe during pregnancy or breastfeeding?
- No—Azilsartan should not be used during pregnancy or breastfeeding. Talk to your doctor if you are pregnant, think you may be, or are breastfeeding, so safer alternatives can be considered.
- Can I stop taking Azilsartan if my blood pressure has improved?
- No—do not stop unless your doctor tells you. Blood pressure can rise again without symptoms, increasing health risks.
For more information: Speak to your local pharmacist or GP, or refer to the Consumer Medicine Information (CMI) leaflet provided with your medicine.
