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- Brand: NIPRO JMI Pharma Ltd.
- Product ID: Azilsartan Medoxomil
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Adarbi 80mg Tablet — Azilsartan Medoxomil
Generic Name: Azilsartan Medoxomil 80mg
Manufacturer: Beximco Pharmaceuticals Ltd.
Drug Class: Angiotensin II Receptor Blocker (ARB) — Antihypertensive
Dosage Form: Tablet
Prescription Status: Prescription Only (Rx)
Mechanism of Action
Azilsartan medoxomil is a prodrug converted to its active form azilsartan — a highly selective, potent antagonist of the angiotensin II type 1 (AT1) receptor. By blocking AT1 receptors, it inhibits angiotensin II-driven vasoconstriction, aldosterone release, sympathetic activation, and sodium/water retention, producing sustained blood pressure reduction. Azilsartan has the highest AT1 receptor binding affinity and slowest dissociation rate among all available ARBs, resulting in superior and more durable 24-hour blood pressure control.
80mg is the maximum approved dose — used when 40mg is insufficient to achieve blood pressure targets. Clinical trials (CATALYST, ZENITH) demonstrated 80mg azilsartan provides significantly greater 24-hour ambulatory BP reduction than maximum doses of valsartan (320mg) and olmesartan (40mg).
Why 80mg — Clinical Evidence
- CATALYST trial: Azilsartan 80mg reduced 24-hr mean SBP by ~14–15 mmHg vs. ~11 mmHg for valsartan 320mg
- ZENITH trial: Superior office and ambulatory BP lowering vs. olmesartan 40mg
- Beneficial for patients with difficult-to-control or resistant hypertension before adding a second agent
- Renoprotective at full dose — greater albuminuria reduction in diabetic nephropathy
Indications
- Hypertension not adequately controlled on Adarbi 40mg
- Hypertension with Type 2 Diabetes requiring optimal blood pressure control
- Diabetic nephropathy — maximal renoprotection via full RAAS blockade
- High-cardiovascular-risk patients requiring aggressive BP targets (<130/80 mmHg)
Dosage and Administration
| Scenario | Dose | Notes |
|---|---|---|
| Usual initiation | 40mg once daily (start low) | Titrate to 80mg after 2–4 weeks if needed |
| Maintenance at maximum dose | 80mg once daily | Maximum approved dose — no benefit above 80mg |
| Volume-depleted patients | Start at 40mg; monitor for hypotension | Correct volume depletion before 80mg dose |
| Renal/hepatic impairment | No dose adjustment required | Primarily biliary excretion |
Take once daily at the same time each day, with or without food. Full effect at 4 weeks.
Blood Pressure Targets in Diabetes
| Patient Group | Target BP | Notes |
|---|---|---|
| T2DM + Hypertension | <130/80 mmHg | ADA/ESC 2023 guideline |
| Diabetic nephropathy (proteinuria) | <130/80 mmHg | ARB preferred; monitor eGFR and K+ |
| Elderly (>65 years) | <140/90 mmHg (individualise) | Avoid over-treatment; fall/hypotension risk |
Black Box Warning — Foetal Toxicity
Contraindicated in pregnancy. Azilsartan acts on the renin-angiotensin system and can cause foetal and neonatal injury, oligohydramnios, renal failure, skull hypoplasia, or death when used in the 2nd or 3rd trimester. Discontinue immediately upon detection of pregnancy.
Contraindications
- Pregnancy (all trimesters)
- Hypersensitivity to azilsartan or any ARB
- Dual RAAS blockade: do not combine with ACE inhibitors or aliskiren (especially in diabetes or CKD eGFR <60)
Drug Interactions
| Drug / Class | Effect |
|---|---|
| ACE inhibitors / Aliskiren | Avoid — hypotension, hyperkalaemia, renal failure |
| Potassium-sparing diuretics / K+ supplements | Hyperkalaemia — monitor serum potassium |
| NSAIDs | Reduced antihypertensive effect; renal impairment |
| Lithium | Increased lithium levels — toxicity risk; monitor |
| Sulphonylureas / Insulin | May enhance glucose-lowering — monitor blood glucose |
Side Effects
| System | Side Effects |
|---|---|
| Cardiovascular | Hypotension, dizziness (especially postural) |
| Renal | Serum creatinine rise, hyperkalaemia |
| GI | Nausea, diarrhoea (uncommon) |
| Respiratory | No cough (advantage over ACE inhibitors) |
Monitoring
- Blood pressure — each clinic visit; home BP monitoring recommended
- Serum potassium and creatinine — baseline, 2 weeks post-initiation, then annually
- Urine albumin-to-creatinine ratio — annually in diabetic patients
Storage
Store below 30°C. Protect from moisture and direct sunlight. Keep out of reach of children.
Medical Disclaimer
The information provided here is for educational and informational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Adarbi 80mg (Azilsartan Medoxomil) must only be used under the supervision of a qualified physician. Strictly contraindicated in pregnancy. Monitor blood pressure, renal function, and serum potassium regularly. DiabetesStore.com.bd does not endorse self-medication.
