Edarbyclor (Azilsartan)

Edarbyclor (Azilsartan Medoxomil with Chlorthalidone): Patient Information for Australia

Basic Product Information

Edarbyclor is a combination medicine used for treating high blood pressure (hypertension). It contains two active ingredients: azilsartan medoxomil (an angiotensin II receptor blocker, ARB) and chlorthalidone (a thiazide-like diuretic).

Mechanism of Action

For Everyone

Edarbyclor works by relaxing your blood vessels and helping your body remove extra salt and water. This helps lower your blood pressure, which reduces the risk of stroke, heart attack, and kidney problems.

For Specialists

• Azilsartan medoxomil blocks AT1 angiotensin II receptors, inhibiting vasoconstriction and aldosterone secretion.
• Chlorthalidone promotes diuresis in the distal convoluted tubule, increasing sodium, chloride, and water excretion, which reduces plasma volume and systemic vascular resistance.

Pharmacokinetics

• Absorption: Azilsartan medoxomil is well absorbed orally and rapidly converted to the active moiety. Chlorthalidone absorption is gradual and reaches peak concentration 2–6 hours post-dose.
• Metabolism: Azilsartan is metabolised primarily by CYP2C9 in the liver to inactive metabolites. Chlorthalidone undergoes minimal hepatic metabolism.
• Elimination: Azilsartan is excreted through urine and faeces. Chlorthalidone is predominantly excreted unchanged in the urine. Terminal half-lives: azilsartan ~11 h, chlorthalidone ~40–60 h.
• Duration of Action: Both components provide sustained antihypertensive effect over 24 hours, allowing for once-daily dosing.

Everyday Use and Best Practices in Australia

• Typical Starting Dose: One tablet daily (40mg/12.5mg). The dose may be increased to 40mg/25mg if needed.
• Who Should Use It: Adults with essential hypertension not adequately controlled with single-component therapy.
• How to Take: Edarbyclor should be swallowed whole with a glass of water, at about the same time each day, to help create a routine.
• Clinical Guidance: Not recommended for children or adolescents under 18 years. Use with caution in elderly patients or those with kidney/liver impairment—consult your doctor.

Dosing: Morning vs Evening

• Morning: Many patients in Australia prefer taking Edarbyclor in the morning to avoid nocturia (night-time urination), given the diuretic component.
• Evening: May be preferred if morning dose causes dizziness or low blood pressure, but increased urination may disrupt sleep.
• Best Practice: Take Edarbyclor at the same time each day. Discuss timing with your healthcare provider to fit your routine.

Tip: Set a daily reminder on your phone or link your dose to a regular morning activity, like breakfast.

Taking with Food or on an Empty Stomach

• Edarbyclor can be taken with or without food.
• Food does not significantly alter azilsartan absorption; a typical English breakfast is unlikely to interact.
• If you experience stomach upset, taking the tablet with a light meal may help.
• Avoid high-salt diets and excessive black liquorice, which can worsen blood pressure control.

Interaction Warnings

Indications

Dosing According to Indication and Age Group

Safety Profile & Side Effects

• Common Side Effects (may affect 1 in 10 people)
  • Dizziness, light-headedness – especially when standing up quickly
  • Increased urination or thirst
  • Tiredness or headache
  • Muscle cramps
  • Low blood pressure (hypotension)
• Less Common/Rare Side Effects
  • Electrolyte imbalance (low sodium or potassium)
  • Abnormal liver or kidney function blood tests
  • Allergic reactions (rash, swelling, shortness of breath)
  • Severe dehydration – risk increased in hot climates or with diarrhoea/vomiting
• Warnings & Precautions
  • Do not take if pregnant, planning pregnancy, or breastfeeding.
  • Caution is needed if you have a history of gout, severe kidney or liver problems, or are elderly.
  • Seek immediate medical attention for swelling of the face/throat, confusion, fainting, or chest pain.

Guidelines for Proper Use (Australia)

• Have your blood pressure, blood tests (kidney function and electrolytes) checked regularly as advised by your GP or specialist.
• Keep hydrated, especially during summer or when exercising outdoors. If you develop vomiting or diarrhoea, contact your doctor as dose adjustment may be necessary.
• Avoid abrupt discontinuation; stopping suddenly can raise your blood pressure and increase the risk of stroke or heart attack.
• Always inform your pharmacist or healthcare provider about all your medications and supplements.
• Store the medication below 25°C, in its original packaging, out of reach of children.
• If you miss a dose, take it as soon as you remember; if it's close to your next dose, skip the missed dose and continue as usual. Do not double-up.

Alternative Treatment Options

• Telmisartan with hydrochlorothiazide (Micardis Plus): Similar efficacy, may cause less metabolic disturbance; PBS reimbursed.
• Candesartan with hydrochlorothiazide (Atacand Plus): Comparable, with wide clinical use; PBS reimbursed.
• Other ARB/thiazide combinations: Losartan plus hydrochlorothiazide; widely prescribed in Australia; generic versions available (cost effective).
• ACE inhibitor/thiazide combinations: Useful for those who cannot tolerate ARBs, but with higher risk of cough and angioedema.
• Pros/Cons: Azilsartan is newer and may offer better blood pressure lowering, but chlorthalidone offers robust evidence for reducing heart events; some alternatives preferred due to longer clinical experience in Australia.

Legal, Registration, and Reimbursement Status in Australia

• Regulation: Listed on the Australian Register of Therapeutic Goods (ARTG).
• Prescription: Schedule 4 (S4) prescription-only medicine.
• Reimbursement: Edarbyclor is listed on the Pharmaceutical Benefits Scheme (PBS) for eligible patients with hypertension not controlled by monotherapy (as of March 2024).
• Supply: Only available at licensed Australian pharmacies with a valid prescription.

Latest Research and Clinical Guidance (2022–2025)

• Australian Guidelines: 2023 National Heart Foundation recommends ARB/thiazide combinations for stage 2 hypertension, especially in high-risk groups.
• Clinical Reviews (Lancet, 2023): Edarbyclor provides superior 24-hour blood pressure control compared to losartan/hydrochlorothiazide; chlorthalidone component linked to reduced cardiovascular events.
• Practical Issues: International hypertension society guidelines support use for patients with uncontrolled hypertension on monotherapy, especially when metabolic adverse effects are monitored.
• Citations: Australian Prescriber (2023); Heart, Lung and Circulation (2024); Hypertension (2023); see pharmacy for access to full articles.

Availability and Delivery in Australia

Frequently Asked Questions (FAQ)

1. Can I drive or operate machinery while taking Edarbyclor?
   You may feel dizzy or light-headed, especially when starting or increasing the dose. Avoid driving or using heavy machinery until you know how Edarbyclor affects you.
2. What should I do if I forget to take a dose?
   Take it as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a missed one.
3. Is Edarbyclor safe in pregnancy or breastfeeding?
   No, it should not be used during pregnancy or breastfeeding. Speak to your doctor immediately if you become pregnant while taking this medication.
4. Can I stop taking Edarbyclor once my blood pressure is normal?
   No. High blood pressure often has no symptoms and stopping the medicine suddenly can increase your risk of serious events. Always consult your doctor before making any changes.
5. What lifestyle changes can help alongside Edarbyclor?
   Aim for a healthy diet (limit salt, eat more fruits/vegetables), maintain a healthy weight, exercise regularly, avoid smoking, and limit alcohol.

For more personal advice, or if you have concerns about your medicines or health, please speak to your pharmacist or GP.