Generic Edarbi ( Azilsartan medoxomil )

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Edarbi (azilsartan medoxomil) is an angiotensin II receptor blocker (ARB) used to treat high blood pressure (hypertension) in adults. It works by blocking the binding of angiotensin II to the AT1 receptor, which relaxes blood vessels and allows blood to flow more easily, thereby lowering blood pressure.
Usual adult dose: The recommended starting dose is 80 mg once daily; however, the 40 mg tablet is available for patients who are volume‑depleted or are receiving high‑dose diuretic therapy. The maximum dose is 80 mg once daily.
Dosage form: Oral tablet, 40 mg (also available as 80 mg).
Onset of action: Significant blood pressure reduction can be seen within 2 weeks; maximum effect is generally achieved after 4 weeks of daily dosing.
Duration of action: A single dose provides 24‑hour blood pressure control.
Alcohol consumption should be moderate; heavy drinking may increase the risk of dizziness or fainting, particularly when combined with blood‑pressure‑lowering medication.
Most common side effects: dizziness, diarrhea, and increased blood creatine phosphokinase.
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General Information about Edarbi

• INN (International Nonproprietary Name): Azilsartan medoxomil
• Brand names available in the USA: Edarbi® (Takeda Pharmaceuticals America, Inc.). Generic versions of azilsartan medoxomil are also available from manufacturers such as Teva Pharmaceuticals USA, Inc., Lupin Pharmaceuticals, Inc., and others.
• ATC code: C09CA09
• Dosage forms and strengths: Oral tablets: 40 mg and 80 mg.
• Manufacturers in USA: Takeda Pharmaceuticals America, Inc. (brand Edarbi®); generic manufacturers include Teva Pharmaceuticals USA, Inc., Lupin Pharmaceuticals, Inc., and other FDA‑approved companies.
• Registration status in USA: Approved by the U.S. Food and Drug Administration (FDA) on February 25, 2011 (NDA 200796).
• OTC / Rx classification: Prescription only (Rx).

Mechanism of Action and Pharmacology

Azilsartan medoxomil is a prodrug that is rapidly hydrolyzed in the gastrointestinal tract to its active metabolite, azilsartan. Azilsartan is a selective, non‑peptide antagonist of the angiotensin II type 1 (AT1) receptor. Angiotensin II is a potent vasoconstrictor hormone that also stimulates aldosterone secretion, promotes sodium and water retention, and contributes to vascular and cardiac remodeling. By blocking the binding of angiotensin II to the AT1 receptor, azilsartan inhibits these effects, leading to vasodilation, reduced aldosterone levels, decreased peripheral resistance, and a fall in blood pressure. Because it acts at the receptor level, azilsartan does not block bradykinin breakdown, which minimizes the risk of dry cough associated with ACE inhibitors. After oral administration, peak plasma concentrations of azilsartan are achieved in 1.5‑3 hours; food does not significantly affect absorption. The absolute bioavailability of azilsartan is approximately 60%. Azilsartan is metabolized mainly by CYP2C9 and is excreted via both renal (approximately 15%) and biliary routes. Its elimination half‑life is about 11 hours, and it provides consistent 24‑hour blood pressure control with once‑daily dosing.

Indications

• Treatment of hypertension, alone or in combination with other antihypertensive agents, to lower blood pressure in adults. Lowering blood pressure reduces the risk of fatal and non‑fatal cardiovascular events, primarily strokes and myocardial infarctions.

Important Warnings and Precautions

Edarbi carries a boxed warning for fetal toxicity. Drugs that act directly on the renin‑angiotensin system can cause injury and death to the developing fetus when used during pregnancy. Discontinue Edarbi as soon as pregnancy is detected. In volume‑ or salt‑depleted patients, such as those treated with high‑dose diuretics, symptomatic hypotension may occur after initiation of therapy; the 40 mg starting dose should be considered in such patients, and volume status should be corrected before starting treatment. Renal function deterioration, including acute kidney failure, can occur, particularly in patients with renal artery stenosis, severe heart failure, or volume depletion; monitor serum creatinine and potassium periodically. Hyperkalemia may develop, especially in patients with diabetes mellitus, renal impairment, or those taking potassium supplements or potassium‑sparing diuretics. Dual blockade of the renin‑angiotensin system with an ARB, an ACE inhibitor, and/or aliskiren is not recommended due to increased risk of hypotension, hyperkalemia, and changes in renal function. Use with caution in patients with hepatic impairment; no dose adjustment is required for mild or moderate impairment, but Edarbi has not been studied in severe liver disease.

At‑risk groups

• Elderly: No overall differences in safety or efficacy have been observed between elderly and younger patients, but greater sensitivity in some older individuals cannot be ruled out. Monitor for hypotension and renal function.
• Pregnancy: Contraindicated. Discontinue immediately if pregnancy is detected. Use in the second and third trimesters is associated with oligohydramnios, fetal renal dysfunction, and neonatal hypotension.
• Breastfeeding: It is not known whether azilsartan is excreted in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or the drug.
• Renal impairment: No dose adjustment is required for mild to moderate renal impairment. In patients with severe renal impairment (creatinine clearance
• Hepatic impairment: No dose adjustment is needed for mild or moderate impairment. Not studied in severe hepatic impairment; avoid use.
• Pediatric: Safety and effectiveness have not been established in patients under 18 years of age.
• Volume‑depleted patients: Initiate therapy with the 40 mg dose and correct volume depletion before starting treatment to minimize the risk of hypotension.

Driving and alcohol

Edarbi may cause dizziness or fatigue, which can impair the ability to drive or operate machinery. Patients should exercise caution until they know how the medication affects them. Alcohol consumption should be moderate; excessive drinking may increase the blood‑pressure‑lowering effect and enhance dizziness, especially when standing up.

Dosage Instructions

• Recommended initial dose: 80 mg once daily for most patients. The 40 mg once‑daily dose is recommended for patients who are volume‑depleted or receiving high‑dose diuretics; these patients should have their volume status corrected before starting therapy, if possible, or be monitored closely after the first dose.
• Maintenance dose: 80 mg once daily. If blood pressure is not controlled with 80 mg, adding a thiazide‑type diuretic may be more effective than increasing the dose.
• Administration: Take with or without food. Swallow the tablet whole with a full glass of water at the same time each day to maintain an even blood level.
• Missed dose: If a dose is missed, take it as soon as remembered. If it is almost time for the next dose, skip the missed dose and resume the regular schedule. Do not double the dose.

Side Effects and Contraindications

Most common side effects (incidence ≥2% and greater than placebo): Dizziness (2.5%), diarrhea (2.3%), and increased blood creatine phosphokinase (CPK) (1.3‑2.7%). These effects are generally mild and transient.
Other adverse reactions: Fatigue, hypotension, nausea, muscle spasm, cough (though much less common than with ACE inhibitors), and hyperkalemia.
Serious adverse reactions: Fetal toxicity (when used during pregnancy), acute renal failure (especially in susceptible patients), severe hypotension, and angioedema (rare).
Absolute contraindications: Known hypersensitivity to azilsartan or any excipient; pregnancy; concomitant use with aliskiren in patients with diabetes mellitus.

Drug Interactions

• Nonsteroidal anti‑inflammatory drugs (NSAIDs), including selective COX‑2 inhibitors: May attenuate the antihypertensive effect of azilsartan and cause deterioration of renal function, particularly in volume‑depleted or elderly patients. Monitor renal function periodically.
• Potassium‑sparing diuretics, potassium supplements, salt substitutes containing potassium: Increase the risk of hyperkalemia. Use with caution and monitor serum potassium closely.
• Lithium: Concomitant use may increase serum lithium levels and lithium toxicity. Monitor lithium levels if co‑administration is necessary.
• Aliskiren: Combined use with aliskiren in patients with diabetes is contraindicated. In patients with renal impairment (GFR
• Other antihypertensives: Additive blood‑pressure‑lowering effect; dose adjustment may be necessary.
• Alcohol: May enhance the hypotensive effect; limit intake.

Practical Advice

• Take Edarbi exactly as prescribed, once daily at the same time each day. It can be taken with or without food.
• Do not stop taking Edarbi abruptly without consulting your healthcare provider, as blood pressure may rise.
• If you miss a dose, take it as soon as you remember unless it is nearly time for the next dose. Do not double up.
• Have your blood pressure checked regularly to ensure the medication is working effectively.
• Periodic blood tests to monitor kidney function and potassium levels may be ordered by your doctor.
• Rise slowly from sitting or lying down to reduce the chance of dizziness or fainting.
• Limit alcohol consumption and avoid using potassium supplements or salt substitutes containing potassium without medical advice.
• Store at room temperature (20‑25°C / 68‑77°F) away from moisture and light. Keep out of reach of children.
• Inform your healthcare provider immediately if you become pregnant or plan to become pregnant; this drug can cause serious harm to the unborn baby.

Alternative Medications

• Other angiotensin II receptor blockers (ARBs): Losartan (Cozaar), valsartan (Diovan), irbesartan (Avapro), olmesartan (Benicar), telmisartan (Micardis). They share a similar mechanism but may differ in potency and duration.
• ACE inhibitors: Lisinopril (Zestril), enalapril (Vasotec), ramipril (Altace). Equally effective for hypertension but associated with a higher incidence of dry cough.
• Calcium channel blockers: Amlodipine (Norvasc), a common first‑line option, especially when combined with an ARB.
• Thiazide diuretics: Hydrochlorothiazide, often used in combination with azilsartan (Edarbyclor is the fixed‑dose combination of azilsartan and chlorthalidone).
• Beta‑blockers: Metoprolol, atenolol – useful in patients with specific cardiovascular comorbidities.

Clinical Efficacy

The antihypertensive efficacy of azilsartan medoxomil was demonstrated in several randomized, double‑blind, placebo‑controlled trials. In patients with mild to moderate hypertension, azilsartan 80 mg once daily produced placebo‑adjusted reductions in systolic/diastolic blood pressure of approximately 13‑15/6‑8 mmHg. Azilsartan 40 mg once daily lowered blood pressure significantly compared to placebo as well, though the 80 mg dose consistently provided numerically greater reductions. Head‑to‑head studies showed that azilsartan 80 mg lowered 24‑hour mean systolic blood pressure more than olmesartan 40 mg or valsartan 320 mg. In the long term, azilsartan effectively maintains blood pressure reduction and is well tolerated, with a safety profile consistent with other ARBs. The fixed‑dose combination of azilsartan and chlorthalidone provides additional BP lowering and is often more effective than monotherapy.

Important:

Edarbi (azilsartan medoxomil) is a prescription angiotensin receptor blocker that must be used under the supervision of a healthcare provider. It carries a boxed warning for fetal toxicity; discontinue immediately if pregnancy is detected. Do not use if you are pregnant or planning to become pregnant. This medication can cause dizziness; avoid driving until you know how it affects you. Limit alcohol intake. Hyperkalemia and acute kidney injury can occur, especially in patients with pre‑existing kidney problems, diabetes, or in those taking NSAIDs or potassium supplements. Periodic monitoring of blood pressure, renal function, and potassium is essential. Do not double dose if one is missed. Seek medical attention if you experience signs of a serious allergic reaction (swelling of the face, lips, throat) or severe dizziness. Keep out of reach of children. This information is not a substitute for professional medical advice.

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