Edarbi Azilsartan Medoxomil Potassium Tablets

1. Indications and Usage
Hypertension:
Indicated for the treatment of hypertension in adults to lower blood pressure.
Note: Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events (primarily strokes and myocardial infarctions).
2. Dosage and Administration
Route of Administration:
For Oral Use ONLY.
Administration Instructions:
Can be administered with or without food.
Recommended Dosage:
Starting Dose: The recommended starting dose is 40 mg once daily.
Titration: For patients whose blood pressure is not adequately controlled at the lower dose, the maximum dosage may be increased to 80 mg once daily.
Combination Therapy:
If monotherapy does not adequately control blood pressure, it can be used in combination with other antihypertensive agents, including diuretics (e.g., chlorthalidone, hydrochlorothiazide) and calcium channel blockers.
3. Mechanism of Action
Angiotensin II Receptor Blocker (ARB):
Azilsartan medoxomil is a prodrug that is rapidly converted to its active metabolite, azilsartan.
Receptor Antagonism:
It selectively blocks the binding of angiotensin II to the AT1 receptor in vascular smooth muscle and the adrenal gland. This action prevents vasoconstriction and aldosterone secretion, leading to a reduction in blood pressure.
4. Safety and Warnings
Fetal Toxicity:
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue as soon as pregnancy is detected.
Contraindications:
Hypersensitivity to any component of the product.
Pregnancy.
Do not co-administer with aliskiren in patients with diabetes mellitus or renal impairment.
Renal Impairment:
Changes in renal function, including acute kidney failure, have been reported. Monitor renal function periodically.
5. Adverse Reactions
Most Common:
Dizziness is the most frequently reported adverse reaction.
Other Common Reactions:
Diarrhea and elevated blood phosphocreatine kinase levels.
Laboratory Abnormalities:
Elevations in serum creatinine and blood uric acid levels have been observed.
Specific Combinations:
When combined with chlorthalidone: Increased frequency of elevated serum creatinine and hypotension.
When combined with amlodipine: Increased frequency of peripheral edema.
6. Drug Interactions
Aliskiren:
Avoid concomitant use with aliskiren-containing products in patients with diabetes or renal impairment due to an increased risk of renal dysfunction, hyperkalemia, and hypotension.
Diuretics & Calcium Channel Blockers:
Concomitant use may produce additive hypotensive effects.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Azilsartan medoxomil potassium.
Excipients: Mannitol, Fumaric Acid, Sodium Hydroxide, Hydroxypropyl Cellulose, Croscarmellose Sodium, Microcrystalline Cellulose, Magnesium Stearate.
Appearance:
White or practically white tablets, debossed with “ASL” on one side and “40” or “80” on the other.
Storage:
Store protected from light, in a tightly closed container at temperatures below 25°C (77°F). Short-term storage between 15°C and 30°C is permitted.