Ruituoping Azilsartan Tablets

1. Indications and Usage
Hypertension: Indicated for the treatment of hypertension.
2. Dosage and Administration
Recommended Dose: The recommended dosage for adults is 20 mg once daily.
Titration: The dosage may be increased to a maximum of 40 mg once daily based on blood pressure response.
Administration: The tablets should be taken orally without regard to meals.
3. Mechanism of Action
Angiotensin II Receptor Antagonism: Azilsartan selectively blocks the binding of angiotensin II to the AT1 receptor in vascular smooth muscle and other tissues.
Vasodilation: This blockade inhibits the vasoconstrictive and aldosterone-secreting effects of angiotensin II, thereby lowering blood pressure.
4. Safety and Warnings
Fetal Toxicity: When pregnancy is detected, discontinue immediately. Drugs that act on the renin-angiotensin system can cause fetal injury and death.
Hypotension: Excessive hypotension may occur, particularly in patients who are volume-depleted (e.g., those on high-dose diuretics or strict salt restriction).
Renal Impairment: Renal blood flow and glomerular filtration rate may be reduced in patients with bilateral renal artery stenosis or unilateral stenosis of a solitary kidney.
Hyperkalemia: Serum potassium levels should be monitored, especially in patients with renal impairment or uncontrolled diabetes.
5. Adverse Reactions and Clinical Research
Adverse Reactions: Common adverse reactions include dizziness, headache, back pain, diarrhea, and hyperuricemia.
Clinical Research: Clinical trials have demonstrated that azilsartan effectively lowers blood pressure and has been shown to provide superior blood pressure reduction compared to other ARBs in head-to-head studies.
6. Drug Interactions
Dual RAAS Blockade: Concomitant use with aliskiren is contraindicated in patients with diabetes due to an increased risk of renal impairment, hyperkalemia, and hypotension.
Potassium-Sparing Diuretics: Concomitant use with potassium-sparing diuretics or potassium supplements may lead to hyperkalemia.
NSAIDs: Non-steroidal anti-inflammatory drugs may reduce the antihypertensive effect of azilsartan and may further worsen renal function.
7. Pharmaceutical Information
Composition: The active ingredient is azilsartan.
Appearance: Film-coated tablets, appearing white to off-white when the coating is removed.
Storage: Store at or below 30°C.